Testicular 1.2011_12-10-10

Testicular 1.2011_12-10-10_fi.

NCCN Guidelines Index Testicular Cancer TOC NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™)
Version 1.2011, 12/10/10 National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.
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NCCN Guidelines™ Version 1.2011 Panel Members
* Robert J. Motzer, MD/Chair † Þ
Gary R. Hudes, MD † ‡
Thomas W. Ratliff, MD †
Memorial Sloan-Kettering Cancer Center
Fox Chase Cancer Center
St. Jude Children's Research Hospital/University
of Tennessee Cancer Institute
Neeraj Agarwal, MD ‡
Eric Jonasch, MD †
Huntsman Cancer Institute at the
The University of Texas M. D. Anderson Cancer
Bruce G. Redman, DO †
University of Utah
University of Michigan Comprehensive Cancer
Center
Clair Beard, MD §
David Josephson, MD w
Dana-Farber/Brigham and Women's
City of Hope Comprehensive Cancer Center
Cary N. Robertson, MD w
Duke Comprehensive Cancer Center
Ellis G. Levine, MD †
Sam Bhayani, MD w
Roswell Park Cancer Institute
Charles J. Ryan, MD † w
Siteman Cancer Center at Barnes-Jewish
UCSF Helen Diller Family Comprehensive Cancer
Hospital and Washington University
Daniel W. Lin, MD w
School of Medicine
University of Washington Medical
Center/Seattle Cancer Care Alliance
Joel Sheinfeld, MD w
Graeme B. Bolger, MD †
Memorial Sloan-Kettering Cancer Center
University of Alabama at Birmingham
Kim A. Margolin, MD † ‡
Comprehensive Cancer Center
Fred Hutchinson Cancer Research
Philippe E. Spiess, MD w
Center/Seattle Cancer Care Alliance
H. Lee Moffitt Cancer Center & Research Institute
Michael A. Carducci, MD † Þ
The Sidney Kimmel Comprehensive
M. Dror Michaelson, MD, PhD †
Jue Wang, MD †
Cancer Center at Johns Hopkins
Massachusetts General Hospital Cancer Center
UNMC Eppley Cancer Center at
The Nebraska Medical Center
Thomas Olencki, DO †
Sam S. Chang, MD w
The Ohio State University Comprehensive
Vanderbilt-Ingram Cancer Center
Richard B. Wilder, MD §
Cancer Center - James Cancer Hospital and
H. Lee Moffitt Cancer Center & Research Institute
Toni K. Choueiri, MD † Þ
Solove Research Institute
Dana-Farber/Brigham and Women's
Roberto Pili, MD †
Roswell Park Cancer Institute
† Medical oncology‡ Hematology/hematology oncology Steven L. Hancock, MD § Þ
§ Radiotherapy/Radiation oncology Stanford Comprehensive Cancer Center
ф Diagnostic Radiology£ Supportive Care including Palliative, Pain Management, Pastoral care and Oncology social work Þ Internal medicinew Urology* Writing committee member Version 1.2011, 12/10/10 National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.
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NCCN Guidelines™ Version 1.2011 Table of Contents
Clinical Trials: The NCCN
believes that the best managementfor any cancer patient is in a clinical trial. Participation in clinical trials isespecially encouraged.
To find clinical trials online at NCCN NCCN Categories of Evidence and
Consensus: All recommendations
are Category 2A unless otherwise
The NCCN Guidelines™ are a statement of evidence and consensus of the authors regarding their views of currently accepted approaches totreatment. Any clinician seeking to apply or consult the NCCN Guidelines is expected to use independent medical judgment in the context of individualclinical circumstances to determine any patient's care or treatment. The National Comprehensive Cancer Network® (NCCN®) makes norepresentations or warranties of any kind regarding their content, use or application and disclaims any responsibility for their application or use in anyway. The NCCN Guidelines are copyrighted by National Comprehensive Cancer Network®. All rights reserved. The NCCN Guidelines and theillustrations herein may not be reproduced in any form without the express written permission of NCCN. 2010.
Version 1.2011, 12/10/10 National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.
Printed by Tomasz Sarosiek on 1/3/2011 3:21:15 PM. For personal use only. Not approved for distribution. Copyright 2011 National Comprehensive Cancer Network, Inc., All Rights Reserved.
NCCN Guidelines™ Version 1.2011 Updates
Updates in Version 1.2011 of the NCCN Testicular Cancer Guidelines from Version 2.2010 include:
Testicular cancer
· Workup, "optional" was removed from testicular ultrasound.
· Pathologic diagnosis,
> "Pure" was added to seminoma germ cell tumor.
> "Includes mixed seminoma tumors and seminoma histology with elevated AFP" was added to nonseminoma.
· Footnote b, "Though rare, when a patient presents with rapidly increasing beta-hCG, symptoms related to disseminated disease and a testicular mass,
chemotherapy can be initiated immediately without a biopsy diagnosis" was added to the page.
Seminoma
· Postdiagnostic workup, "if elevated preoperatively" was removed from "repeat beta-hCG, LDH, AFP".
· Footnote ‘c' was modified, "Mediastinal primary site seminoma should be treated by risk status used for gonadal seminomas with.".
· Footnote ‘e' was modified, "Elevated values should be followed after orchiectomy with repeated determination to allow precise staging." (Also for TEST-5)
· Stage IA, IB
7 "for pT1 or pT2 tumors" and "preferred" were added.
7 "horseshoe or pelvic kidney, inflammatory bowel disease, and prior RT" were removed.
7 dose range was changed from 20-30 Gy to 20-25 Gy.
7 "preferred for pT3 tumors or tumors > 4 cm" was added.
7 "± ipsilateral iliac nodes" was removed.
> Footnote h, "In special circumstances, RT to ipsilateral iliac nodes may be administered (category 3)" is new to the page.
> Follow-up after surveillance or single dose carboplatin with abdominal/pelvic CT was changed from "at each visit" to "every 3-4 mo for years 1-3, every
6 mo for years 4-7, then annually at each visit up to 10 years" and chest x-ray was changed from "at alternate visits" to "as clinically indicated".
· Stage IS
> RT dose range was changed from 25-30 Gy to 25 Gy.
> Follow-up after RT, chest x-ray was changed to "as clinically indicated". Also for Stages IA, IB.
· Stage IIA, IIB
> RT dose range was changed from 35-40 Gy to 30-35 Gy.
> Chemotherapy, "BEP for 3 cycles" was added.
· Residual mass and normal markers
> "> 3 cm" was added as a qualifier to residual mass.
> PET scan not feasible was removed.
> PET scan, "approximately 6 wks post chemotherapy" was added.
> PET scan negative, "Consider RPLND, if technically feasible" replaced "surgery with biopsy".
· "or residual mass £ 3cm" was added to "no residual mass and normal markers".
· Follow-up, "abdominal/pelvic CT 4 mo post surgery then as clinically indicated" was changed to Abdominal/pelvic CT
, post RPLND: 3-6 mo, then as
clinically indicated" and "after all other primary management as clinically indicated".
Version 1.2011, 12/10/10 National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.
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NCCN Guidelines™ Version 1.2011 Updates
Updates in Version 1.2011 of the NCCN Testicular Cancer Guidelines from Version 2.2010 include:
Nonseminoma
· Post diagnostic workup, "Chest CT if abnormal abdominal CT or abnormal chest x-ray" was removed and "± chest imaging" was added to "abdominal/
pelvic CT".
· Footnote j, "PET scan is not clinically indicated for nonseminoma" was added to the page.
· Stage IB, primary chemotherapy, "BEP for 1 cycle" was added with a category 2B designation.
· Stage IS with persistent elevated markers has been redirected to TEST-10.
· Statement in the box was modified, "The EP and BEP chemotherapy regimens given at doses and schedules on TEST-B may be considered as category 1
compared with other chemotherapy regimens". Also for TEST-7 and TEST-10.
· Stage IIA and IIB with persistent marker elevation have been redirected to TEST-10.
· For negative markers, "³ 1 cm" was added to residual mass.
· Negative markers, normal CT scan, no mass, "or residual mass < 1 cm" was added.
· "Bilateral" was added to "nerve-sparing RPLND."
· Stage IS and Stage IIA,S1 and Stage IIB, S1 were added to the good risk category.
· Complete response, negative markers, "nerve-sparing RPLND" was changed to "bilateral RPLND ± nerve-sparing".
· Surveillance after Stage IA, IB testicular cancer:
> "Months between abdominal/pelvic CT" was change to "Months between abdominal CT".
> The intervals for each year were modified as follows:
7 Year 1 from 2-3 mo to 3-4 mo
7 Year 2 from 3-4 mo to 4-6 mo
7 Year 3 from 4 mo to 6-12 mo
7 Year 4 from 6 mo to 6-12 mo
7 Year 6+ from 12 mo to 12-24 mo
· Surveillance after complete response to chemotherapy and/or RPLND
> The intervals for each year were modified as follows:
7 Year 3 from 4 mo to 3-6 mo
7 Year 4 from 4 mo to 6 mo
7 Year 5 from 6 mo to 6-12 mo
· Footnote p, "It is preferred that patients with recurrent nonseminoma be treated at centers with expertise in the management of this disease" was added to
the page.
· "For advanced disease" was added to the title "risk classification".
· "Post-orchiectomy" was added under the title.
· Principles of Surgery is new to the guidelines.
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NCCN Guidelines™ Version 1.2011
Pure seminoma germ cell
tumor (pure seminoma
histology and AFP
negative; may have
· Discuss sperm banking
· Radical inguinal orchiectomy
· Alpha-fetoprotein (AFP)
· Consider inguinal biopsy of
· beta-hCG
contralateral testis if:
> Suspicious ultrasound for
· Chemistry profile
· Chest x-ray
> Cryptorchid testis
· Testicular ultrasound
> Marked atrophy
cell tumor (includes
mixed seminoma tumors
and seminoma histology
with elevated AFP)
a Quantitative analysis of beta subunit.
b Though rare, when a patient presents with rapidly increasing beta-hCG, symptoms related to disseminated disease and a testicular mass, chemotherapy can be initiated immediately without waiting for a biopsy diagnosis.
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
Version 1.2011, 12/10/10 National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.
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NCCN Guidelines™ Version 1.2011
Testicular Cancer- Pure Seminoma
· Abdominal/pelvic CT
· Chest CT if:
Pure seminoma g
erm cell tumor
> Positive abdominal CT or
(pure seminoma histology and
abnormal chest x-ray
AFP negative;d may have elevated
· Repeat beta-hCG, LDH, AFPe
· Brain MRI, if clinically indicated
· Bone scan, if clinically indicated
· Discuss sperm banking
c Mediastinal primary site seminoma should be treated by risk status used for gonadal seminomas with etoposide/cisplatin for 4 cycles or bleomycin/etoposide/cisplatin for 3 cycles.
d If AFP positive, treat as nonseminoma.
e Elevated values should be followed after orchiectomy with repeated determination to allow precise staging.
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
Version 1.2011, 12/10/10 National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.
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NCCN Guidelines™ Version 1.2011
Testicular Cancer - Pure Seminoma
· H&P, AFP, beta-hCG, LDH:
Surveillance for pT1 or pT2 tumors
every 3-4 mo for years 1-3,
(category 1) (preferred)
every 6 mo for years 4-7, then annually
Abdominal/pelvic CT every 3-4 mo for
according to extent of
years 1-3, every 6 mo for years 4-7,
Single agent carboplatin (category 1)
disease at relapse
then annually at each visit up to 10
(AUC=7 x 1 cycle or AUC=7 x 2 cycles)
years; chest x-ray as clinically
RT: Infradiaphragmatic (20-25 Gy) to include
H&P + AFP, beta-hCG, LDH: every 3-4
(category 1) (preferred
mo for year 1,
for pT3 tumors or tumors > 4 cm)
every 6 mo for year 2, then annually
according to extent of
Pelvic CT annually for 3 years (for
disease at relapse
RT: Infradiaphragmatic (25 Gy) to include
patients status post only para-aortic RT)
para-aortic ± ipsilateral iliac nodes
chest x-ray as clinically indicated
· H&P + chest x-ray, AFP, beta-hCG, LDH:
RT: Infradiaphragmatic (30-35 Gy) to include
every 3-4 mo for years 1-3,
para-aortic and ipsilateral iliac nodes
according to extent of
every 6 mo for year 4, then annually
disease at relapse
· Abdominal CT at month 4 of year 1
Consider primary chemotherapy for selected
stage IIB patients:g
EP for 4 cycles or BEP for 3 cycles
Primary chemotherapy:g
EP for 4 cycles (category 1)
Good riskf
BEP for 3 cycles (category 1)
EP = Etoposide/cisplatin
BEP for 4 cycles (category 1)
BEP = Bleomycin/etoposide/cisplatin
h In special circumstances, RT to ipsilateral iliac nodes may be administered (category 3).
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
Version 1.2011, 12/10/10 National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.
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NCCN Guidelines™ Version 1.2011
Testicular Cancer - Pure Seminoma
STAGE IIB, IIC, III AFTER PRIMARY
TREATMENT WITH CHEMOTHERAPY
No residual mass
or residual mass
£ 3cm and normal
· H&P + chest x-ray, AFP,
beta-hCG, LDH:
every 2 mo for year 1
every 3 mo for year 2,
every 6 mo for year 3
and 4, then annually
Post RPLND:
3-6 mo, then as
· Chest, abdominal,
pelvic CT scan
(> 3 cm)
Consider RPLND, if
> After all other
· Serum tumor
6 wks post
as clinically indicated
Second line
· PET scan as clinically
or
RT (category 2B)
mass or rising
RPLND = retroperitoneal lymph node dissection
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
Version 1.2011, 12/10/10 National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.
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NCCN Guidelines™ Version 1.2011
Testicular Cancer - Nonseminoma
Stage IA, IB, IS:

· Abdominal/pelvic CT ± chest imaging
Nonseminomatous germ cell
· Repeat beta-hCG, LDH, AFPe
Stage IIA, IIB:
tumor (includes mixed seminoma
· Brain MRI, if clinically indicated
tumors and seminoma histology
· Bone scan, if clinically indicated
with elevated AFP)
· Discuss sperm banking
Stage IIC, IIIA, IIIB, IIIC,
and brain metastasis:

e Elevated values should be followed after orchiectomy with repeated determination to allow precise staging.
j PET scan is not clinically indicated for nonseminoma.
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
Version 1.2011, 12/10/10 National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.
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NCCN Guidelines™ Version 1.2011
Testicular Cancer - Nonseminoma
(in compliant patients)
BEP for 2 cycles or
BEP for 1 cycle (category 2B)
Surveillance (only if T2,
compliant patients [category 2B])
The EP and BEP chemotherapy regimens given
may be
considered as category 1 compared with other
EP = Etoposide/cisplatin
BEP = Bleomycin/etoposide/cisplatin
k Retroperitoneal lymph node dissection (RPLND) is recommended within 4 weeks of CT scan and 7-10 days of markers (category 2B).
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
Version 1.2011, 12/10/10 National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.
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NCCN Guidelines™ Version 1.2011
Testicular Cancer - Nonseminoma
Primary chemotherapyg (category 2B):
Stage IIA
EP for 4 cycles or BEP for 3 cycles
Lymph node metastases,
within lymphatic drainage
sites (landing zone positive)
Primary chemotherapy:g
EP for 4 cycles or BEP for 3 cycles
Multifocal, symptomatic, or
lymph node metastases with
Stage IIB
EP for 4 cycles or BEP for 3 cycles
aberrant lymphatic drainage
The EP and BEP chemotherapy regimens given
EP = Etoposide/cisplatin
at doses and schedules on may be
BEP = Bleomycin/etoposide/cisplatin
considered as category 1 compared with other
chemotherapy regimens.
k Retroperitoneal lymph node dissection (RPLND) is recommended within 4 weeks of CT scan and 7-10 days of markers (category 2B).
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
Version 1.2011, 12/10/10 National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.
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NCCN Guidelines™ Version 1.2011
Testicular Cancer - Nonseminoma
Nerve-sparing bilateral RPLNDk,l
residual mass (³ 1 cm)
Stage IB, IIA, IIB
treated with primary
Nerve-sparing bilateral RPLNDk,l
normal CT scan, no
mass or residual
mass (< 1 cm)
k Retroperitoneal lymph node dissection (RPLND) is recommended within 4 weeks of CT scan and 7-10 days of markers (category 2B).
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
Version 1.2011, 12/10/10 National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.
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NCCN Guidelines™ Version 1.2011
Testicular Cancer - Nonseminoma
Chemotherapy:g
EP for 2 cycles
or BEP for 2 cycles
EP for 2 cycles
Stage IA, IB, IIA, IIB
or BEP for 2 cycles
treated with nerve-
EP for 2 cycles or BEP for 2 cycles
EP for 2 cycles
or BEP for 2 cycles
EP for 4 cycles
or BEP for 3 cycles
EP = Etoposide/cisplatin
BEP = Bleomycin/etoposide/cisplatin
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
Version 1.2011, 12/10/10 National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.
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NCCN Guidelines™ Version 1.2011
Testicular Cancer - Nonseminoma
Good riskf
Surveillance (category 2B)
Stage IIA, S1
EP for 4 cycles
Stage IIB, S1
category 2B)
± nerve-sparing (
Stage IIC
BEP for 3 cycles
Stage IIIA
Teratoma or
resection of
with normal AFP
all residual
Stage IIIB
BEP for 4 cycles
and beta-hCG levels
yolk sac,
for 2 cycles
(EPg or TIPi or
Poor riskf
Stage IIIC
BEP for 4 cycles
The EP and BEP chemotherapy regimens given
at doses and schedules on may be
VIP for 4 cycles in
considered as category 1 compared with other
EP = Etoposide/cisplatin
Primary chemotherapyg + RT
BEP = Bleomycin/etoposide/cisplatin
± surgery, if clinically indicated
TIP = Paclitaxel/ifosfamide/cisplatin
VeIP = Vinblastine/ifosfamide/cisplatin
VIP = Etoposide/ifosfamide/cisplatin
Patients should receive adequate treatment for brain metastases, in addition to n Patients who may not tolerate bleomycin.
Retroperitoneal lymph node dissection (RPLND) is recommended within 4 There is limited predictive value for PET scan for residual masses.
weeks of CT scan and 7-10 days of markers (category 2B).
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
Version 1.2011, 12/10/10 National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.
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NCCN Guidelines™ Version 1.2011
Testicular Cancer - Nonseminoma
FOLLOW-UP FOR NONSEMINOMA
Surveillance for Stage IA, IB Testicular Cancer
Surveillance After Complete Response to
Chemotherapy and/or RPLND
Months between visits,
Months between visits,
markers, chest x-ray
markers, chest x-ray
abdominal CT
(category 2B for
chest x-ray frequency)
abdominal/pelvic CT *
As clinically indicated
* CT scans apply only to patients
treated with chemotherapy alone.
For patients who are post RPLND,
a postoperative baseline CT scan
is recommended and additional
CT scans as clinically indicated.
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
Version 1.2011, 12/10/10 National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.
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NCCN Guidelines™ Version 1.2011
Testicular Cancer - Nonseminoma
SECOND LINE THERAPY
> High-dose chemotherapy
(preferred if not previously given)
> Clinical trial
or relapse
· Surgical salvage should be
considered if solitary site
Low markers
dose therapy
· Best supportive care
Low volume
(VeIP or TIP)
· Complete response
on first-line therapy
· Incomplete response
> Clinical trial (preferred) or
· High markers
> Conventional dose therapy (VeIP or TIP) or
· High volume
> High-dose chemotherapy (category 2B)
· Surgical salvage should be considered if
· Late relapse
· Best supportive care
TIP = Paclitaxel/ifosfamide/cisplatin
p It is preferred that patients with recurrent nonseminoma be treated at centers with expertise in the management of this disease.
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
Version 1.2011, 12/10/10 National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.
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NCCN Guidelines™ Version 1.2011
Testicular Cancer - Nonseminoma
RISK CLASSIFICATION FOR ADVANCED DISEASE
Risk Status
Good Risk
Testicular or retroperitoneal primary tumor
Any primary site
No nonpulmonary visceral metastases
No nonpulmonary visceral metastases
Post-orchiectomy markers- all of:
Normal AFP
AFP < 1,000 ng/mL
hCG < 5,000 iu/L
LDH < 1.5 x upper limit of normal
Testicular or retroperitoneal primary tumor
Any primary site
No nonpulmonary visceral metastases
Nonpulmonary visceral metastases
Post-orchiectomy markers- any of:
Normal AFP
AFP 1,000-10,000 ng/mL
hCG 5,000-50,000 iu/L
LDH 1.5-10 x upper limit of normal
Poor Risk
Mediastinal primary tumor
No patients classified as poor
Nonpulmonary visceral metastases
or
Post-orchiectomy markers- any of:
AFP > 10,000 ng/mL
hCG > 50,000 iu/L
LDH > 10 x upper limit of normal
Source: Figure 4 from the International Germ Cell Cancer Collaborative Group: International Germ Cell Consensus Classification: A Prognostic Factor-Based Staging System for Metastatic Germ Cell Cancers. J Clin Oncol 1997;15(2):594-603. Reprinted withpermission of the American Society of Clinical Oncology.
1 Markers used for risk classification are post-orchiectomy.
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
Version 1.2011, 12/10/10 National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.
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NCCN Guidelines™ Version 1.2011
Testicular Cancer - Nonseminoma
PRIMARY CHEMOTHERAPY REGIMENS
FOR GERM CELL TUMORS
EP
Etoposide 100 mg/m2 IV on Days 1 - 5
Cisplatin 20 mg/m2 IV on Days 1 - 5
Repeat every 21 days1
BEP
Etoposide 100 mg/m2 IV on Days 1 - 5
Cisplatin 20 mg/m2 IV on Days 1 - 5
Bleomycin 30 units IV weekly on Days 1, 8, and 15*
Repeat every 21 days2
VIP
Etoposide 75 mg/m2 IV on Days 1-5
Mesna 120 mg/m2 slow IV push before ifosfamide on Day 1, then
Mesna 1200 mg/m2 IV continuous infusion on Days 1-5
Ifosfamide 1200 mg/m2 on Days 1-5
Cisplatin 20 mg/m2 IV on Days 1-5
Repeat every 21 days3
*Some NCCN Institutions administer bleomycin on a 2, 9, 16 schedule.
1 Xiao H, Mazumdar M, Bajorin DF, et al. Long-term follow-up of patients with good-risk germ cell tumors treated with etoposide and cisplatin. J Clin Oncol 2 Saxman SB, Finch D, Gonin R & Einhorn LH. Long-term follow-up of a phase III study of three versus four cycles of bleomycin, etoposide, and cisplatin in favorable-prognosis germ-cell tumors: The Indiana University Experience. J Clin Oncol 1998;16:702-706.
3 Nichols CR, Catalano PJ, Crawford ED, et al. Randomized comparison of cisplatin and etoposide and either bleomycin or ifosfamide in treatment of advanced disseminated germ cell tumors: An Eastern Cooperative Oncology Group, Southwest Oncology Group, and Cancer and Leukemia Group BStudy. J Clin Oncol 1998;16:1287-1293.
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
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NCCN Guidelines™ Version 1.2011
Testicular Cancer - Nonseminoma
SECOND LINE OR SUBSEQUENT CHEMOTHERAPY REGIMENS FOR
METASTATIC GERM CELL TUMORS
Conventional dose chemotherapy regimens
High-dose chemotherapy regimens
Carboplatin 700 mg/m2 (Body Surface Area) IV
Vinblastine 0.11 mg/kg IV Push on Days 1 - 2
Etoposide 750 mg/m2 IV
Mesna 400 mg/m2 IV every 8 hours on Days 1 - 5
Administer 5, 4, and 3 days before peripheral blood stem cell
Ifosfamide 1200 mg/m2 IV on Days 1 - 5
infusion for 2 cycles6
Cisplatin 20 mg/m2 IV on Days 1 - 5
Repeat every 21 days1
Paclitaxel 200 mg/m2 IV over 24 hours
Ifosfamide 2000 mg/m2 over 4 hours with mesna protection
Paclitaxel 250 mg/m2 IV on Day 1
Repeat every 14 days for 2 cycles followed by
Ifosfamide 1500 mg/m2 IV on Days 2 - 5
Carboplatin AUC 7 - 8 IV over 60 minutes Days 1 - 3
Mesna 500 mg/m2 IV before ifosfamide, and then 4 and 8 hours
Etoposide 400 mg/m2 IV Days 1 - 3
after each ifosfamide dose on Days 2 - 5
Administer with peripheral blood stem cell support at 14 - 21 day
Cisplatin 25 mg/m2 IV on Days 2 - 5
intervals for 3 cycles7
Repeat every 21 days2
Palliative chemotherapy regimen
GEMOX
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 followed by
Oxaliplatin 130 mg/m2 IV on Day 1
Repeat every 21 days3,4
Gemcitabine 1250 mg/m2 IV on Days 1 and 8 followed by
Oxaliplatin 130 mg/m2 IV on Day 1
Repeat every 21 days5
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
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NCCN Guidelines™ Version 1.2011
Testicular Cancer - Nonseminoma
SECOND LINE OR SUBSEQUENT CHEMOTHERAPY REGIMENS FOR
METASTATIC GERM CELL TUMORS
1 Loehrer PJ Sr, Lauer R, Roth BJ, et al. Salvage therapy in recurrent germ cell cancer: ifosfamide and cisplatin plus either vinblastine or etoposide. Ann Intern 2 Kondagunta GV, Bacik J, Donadio A, et al. Combination of paclitaxel, ifosfamide, and cisplatin is an effective second-line therapy for patients with relapsed testicular germ cell tumors. J Clin Oncol 2005;23:6549-6555.
3 Pectasides D, Pectasides M, Farmakis D, et al. Gemcitabine and oxaliplatin (GEMOX) in patients with cisplatin-refractory germ cell tumors: a phase II study.
Ann Oncol 2004;15:493-497.
4 Kollmannsberger C, Beyer J, Liersch R, et al. Combination chemotherapy with gemcitabine plus oxaliplatin in patients with intensively pretreated or refractory germ cell cancer: A study of the German Testicular Cancer Study Group. J Clin Oncol 2004; 22(1):108-114.
5 De Giorgi U, Rosti G, Aieta M, et al. Phase II study of oxaliplatin and gemcitabine salvage chemotherapy in patients with cisplatin-refractory nonseminomatous germ cell tumor. Eur Urol 2006;50:893-894.
6 Einhorn LH, Williams SD, Chamness A, et al. High-dose chemotherapy and stem-cell rescue for metastatic germ-cell tumors. N Engl J Med 2007;357:340-348.
7 Kondagunta GV, Bacik J, Sheinfeld J, et al. Paclitaxel plus Ifosfamide followed by high-dose carboplatin plus etoposide in previously treated germ cell tumors.
J Clin Oncol 2007;25:85-90.
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
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NCCN Guidelines™ Version 1.2011
Testicular Cancer - Nonseminoma
PRINCIPLES OF SURGERY
· RPLND is the standard approach to the surgical management of nonseminoma germ cell tumor (NSGCT) in both primary and
· A template dissection or a nerve-sparing approach to minimize the risk of ejaculatory disorders should be considered in patients
undergoing primary RPLND for stage I nonseminoma.
· The "split and roll" technique in which lumbar vessels are identified and sequentially ligated allows resection of all lymphatic tissue
around and behind the great vessels (aorta, IVC) and minimizes the risk of an in-field recurrence.
Post-chemotherapy setting
· Referral to high volume centers should be considered for surgical resection of masses post-chemotherapy.
· Completeness of resection is an independent and consistent predictive variable of clinical outcome. In post-chemotherapy RPLND,
surgical margins should not be compromised in an attempt to preserve ejaculation. Additional procedures and resection of adjacent
structures may be required.
· Post-chemotherapy RPLND is indicated in metastatic NSGCT patients with a residual retroperitoneal mass following systemic
chemotherapy and normalized post-chemotherapy serum tumor markers.
· A full bilateral template RPLND should be performed in all patients undergoing RPLND in the post-chemotherapy setting, with the
boundaries of dissection being the renal hilar vessels (superiorly), ureters (laterally), and the common iliac arteries (inferiorly).
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
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NCCN Guidelines™ Version 1.2011 Staging
American Joint Committee on Cancer (AJCC)
TNM Staging System for Testis Cancer (7th ed., 2010)
Primary Tumor (T)*
Regional Lymph Nodes (N)
The extent of primary tumor is usually classified after radical orchiectomy, and for this reason, a pathologic stage is assigned.
Regional lymph nodes cannot be assessed No regional lymph node metastasis Primary tumor cannot be assessed Metastasis with a lymph node mass 2 cm or less in No evidence of primary tumor (e.g. histologic scar in greatest dimension; or multiple lymph nodes, none more than 2 cm in greatest dimension Intratubular germ cell neoplasia (carcinoma in situ) Metastasis with a lymph node mass, more than 2 cm but not more than 5 cm in greatest dimension; or multiple Tumor limited to the testis and epididymis without lymph nodes, any one mass greater than 2 cm but not vascular/lymphatic invasion; tumor may invade into the more than 5 cm in greatest dimension tunica albuginea but not the tunica vaginalis Metastasis with a lymph node mass more than 5 cm in Tumor limited to the testis and epididymis with greatest dimension vascular/lymphatic invasion, or tumor extending throughthe tunica albuginea with involvement of the tunica Pathologic (pN) Regional lymph nodes cannot be assessed Tumor invades the spermatic cord with or without No regional lymph node metastasis Metastasis with a lymph node mass 2 cm or less in Tumor invades the scrotum with or without greatest dimension and less than or equal to five nodes positive, none more than 2 cm in greatest dimension Metastasis with a lymph node mass more than 2 cm but *Note: Except for pTis and pT4, extent of primary tumor is classified not more than 5 cm in greatest dimension; or more than by radical orchiectomy. TX may be used for other categories in the five nodes positive, none more than 5 cm; or evidence of absence of radical orchiectomy.
extranodal extension of tumor Metastasis with a lymph node mass more than 5 cm in greatest dimension Used with the permission of the American Joint Committee on Cancer(AJCC), Chicago, Illinois. The original and primary source for this informationis the AJCC Cancer Staging Manual, Seventh Edition (2010) published by Distant Metastasis (M)
Springer Science and Business Media LLC (SBM). (For complete information No distant metastasis and data supporting the staging tables, visit www.springer.com.) Any citationor quotation of this material must be credited to the AJCC as its primary Distant metastasis source. The inclusion of this information herein does not authorize any reuse Nonregional nodal or pulmonary metastasis or further distribution without the expressed, written permission of SpringerSBM, on behalf of the AJCC.
Distant metastasis other than to nonregional lymph Version 1.2011, 12/10/10 National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.
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NCCN Guidelines™ Version 1.2011 Staging
Table 1 (continued)
American Joint Committee on Cancer (AJCC)
TNM Staging System for Testis Cancer (7th ed., 2010)
ANATOMIC STAGE/PROGNOSTIC GROUPS
Serum Tumor Markers (S)
S (Serum Tumor
Marker studies not available or not performed Marker study levels within normal limits LDH < 1.5 x N* and hCG (mIu/mL) < 5,000 and AFP (ng/ml) < 1,000 LDH 1.5-10 x N or hCG (mIu/mL) 5,000-50,000 or AFP (ng/ml) 1,000-10,000 LDH > 10 x N or hCG (mIu/mL) > 50,000 or AFP (ng/ml) > 10,000 *N indicates the upper limit of normal for the LDH assay.
Used with the permission of the American Joint Committee on Cancer (AJCC), Chicago, Illinois. The original and primary source for this informationis the AJCC Cancer Staging Manual, Seventh Edition (2010) published by Springer Science and Business Media LLC (SBM). (For complete information and data supporting the staging tables, visit www.springer.com.) Any citationor quotation of this material must be credited to the AJCC as its primarysource. The inclusion of this information herein does not authorize any reuseor further distribution without the expressed, written permission of SpringerSBM, on behalf of the AJCC.
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NCCN Guidelines™ Version 1.2011
Testicular Cancer
Seminoma Stages IIA and IIB
absence of a residual mass and the status of serum tumor markers. Stage IIA is defined as disease measuring less than 2 cm in diameter Patients with no residual mass and normal markers need no further on CT scan, and stage IIB as disease measuring 2 to 5 cm in maximum treatment and undergo surveillance. In patients with a residual mass diameter. For patients with stage IIA or IIB disease, 35 to 40 Gy is with normal markers, a positron emission tomography (PET) scan is administered to the infradiaphragmatic area, including para-aortic and recommended to assess for residual viable tumor.16 To reduce the ipsilateral iliac lymph nodes. As in the management of stage I disease, incidence of false-positive results, the PET scan is typically performed prophylactic mediastinal radiation therapy is not indicated.9 Surveillance no less then 6 weeks after completion of chemotherapy. Notably, is not an option for patients with stage IIA or IIB disease with relative granulomatous disease, such as sarcoid, is a frequent source of contraindications for radiation. In stage IIB chemotherapy with 4 false-positive results. If the PET scan is negative, no further treatment courses of etoposide and cisplatin (EP) is an alternative is needed however, the patient should be observed closely for recurrence. If it is positive, then biopsy should be considered followed by surgical excision (category 2B) or second line chemotherapy. Follow-up for patients with stage IIA or IIB disease includes a history Alternatively, the patient can be treated with radiation therapy (category and physical, with measurement of serum tumor markers, should be 2B). Cisplatin-based combination chemotherapy is used for second line performed every 3 to 4 months for the first 3 years, and 6 months for treatment. The recommended regimens are four cycles of TIP the fourth year and annually thereafter. Abdominal CT is recommended (paclitaxel, ifosfamide, cisplatin) 17 or four cycles of VeIP (vinblastine, after 4 months during the first year. ifosfamide, cisplatin).18,19 Seminoma Stages IIC and III
For patients who cannot undergo a PET scan, post-chemotherapy Patients with stage IIC or III disease are those considered at good or management is based on CT scan findings. Controversy exists intermediate risk. All stage IIC and stage III disease is considered good regarding optimal management when the residual mass is greater than risk except for stage III disease with non-pulmonary visceral 3 cm, because approximately 25% of these patients have a viable metastases, which is considered intermediate risk. Standard seminoma or previously unrecognized nonseminoma.20 Options include chemotherapy is used for both groups of patients, but for patients with surgery (category 2B), radiation therapy (category 2B), and good risk, either 4 cycles of EP 10,11 are recommended or 3 cycles of observation. If surgery is selected, the procedure consists of resection bleomycin, etoposide, and cisplatin (BEP).12-14 In contrast, 4 cycles of of the residual mass or multiple biopsies. A full bilateral or modified BEP are recommended for those with intermediate risk disease.15 All retroperitoneal lymph node dissection (RPLND) is not performed these options are category 1 recommendations. because of its technical difficulty in patients with seminoma and because of extensive fibrosis, which may be associated with severe After initial chemotherapy, patients with stage IIC and III are evaluated morbidity.21 If the residual mass is 3 cm or less, patients should with serum tumor markers and a CT scan of the chest abdomen and undergo observation, which is detailed in TEST-4. pelvis. Patients are then classified according to the presence or Version 1.2011, 12/10/10 National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.
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NCCN Guidelines™ Version 1.2011
Testicular Cancer
Recurrent disease is initially treated according to the stage at number of positive nodes identified, inadequate sampling may lead to recurrence. Second line chemotherapy therapy is recommended for partial treatment.24 patients with rising serum tumor markers or a growing mass detected on CT scan. Second line therapy for seminoma and nonseminoma is Nonseminoma Stage IA
similar and is discussed further in the section on nonseminoma. Two management options exist for patients with stage IA disease after Approximately 90% of patients with advanced seminoma are cured with orchiectomy: (1) surveillance (in compliant patients) 25-27 or (2) open cisplatin-containing chemotherapy.22 nerve-sparing RPLND. Patients with seminoma arising from an extragonadal site, such as the The cure rate with either approach exceeds 95%. However, the high mediastinum, are treated with standard chemotherapy regimens cure rate associated with surveillance depends on adherence to according to risk status. periodic follow-up examinations and subsequent chemotherapy for the 20% to 30% of patients who experience relapse. Nonseminoma
Noncompliant patients are treated with open RPLND. The open nerve The risk classification for nonseminoma into good-, intermediate- and sparing RPLND is typically performed within 4 weeks of a CT scan and poor-risk groups by the IGCCCG 4 is defined in TEST-A. within 7 to 10 days of repeat serum marker testing to ensure accurate Stage-dependent treatment options after inguinal orchiectomy include presurgical staging. If the dissected lymph nodes are not involved with surveillance, chemotherapy, and RPLND. Although the timing of the a tumor (pN0), no adjuvant chemotherapy is given after open nerve RPLND may vary, most patients with nonseminoma will undergo an sparing RPLND. However, if the resected lymph nodes involve tumor, RPLND for either diagnostic or therapeutic purposes at some point the decision whether to use adjuvant chemotherapy is based on the during treatment. The major morbidity associated with bilateral degree of nodal involvement and the ability of the patient to comply with dissection is retrograde ejaculation, resulting in infertility. surveillance. Chemotherapy is preferred over surveillance in patients Nerve-dissection techniques preserve antegrade ejaculation in 90% of with pN2 or pN3 disease. Recommended regimens include either EP or cases.23 Template dissections, which avoid the contralateral BEP; 2 cycles of either regimen are recommended for patients with pN1 sympathetic chain, postganglionic sympathetic fibers, and hypogastric or pN2 disease. 28-34 For patients with pN3 disease, longer courses of plexus, preserve ejaculation in approximately 80% of patients. In chemotherapy with 4 cycles of EP or 3 cycles of BEP (preferred) is general, an open nerve-sparing RPLND rather than a laparoscopic RPLND is recommended for therapeutic purposes. For example, a concern exists that a laparoscopic RPLND may result in false-negative The follow-up examinations in those electing surveillance in the current results caused by inadequate sampling, and no published reports focus NCCN guidelines include an abdominopelvic CT scan every 2 to 3 on the therapeutic efficacy of a laparoscopic dissection. Because the months for the first year and every 3 to 4 months during the second recommended number of cycles of chemotherapy is based on the year. Serum marker determination and the chest radiograph should be Version 1.2011, 12/10/10 National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.
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NCCN Guidelines™ Version 1.2011
Testicular Cancer
performed every 1 to 2 months during the first year and every 2 months the patient and the physician must be compliant with follow-up during the second year. recommendations. Nonseminoma Stage IB
Nonseminoma Stage IS
After orchidectomy, either open nerve sparing RPLND or chemotherapy Patients with stage IS disease exhibit a persistent elevation of serum with 2 cycles of BEP (category 2B) are adjuvant treatment options to tumor markers post orchiectomy but no radiographic evidence of reduce the risk of relapse in patients with stage IB disease.31,35. disease. These patients are treated with standard chemotherapy with either 4 cycles of EP or 3 cycles of BEP. Either regimen is preferable to A trial by Albers et al randomized stage I patients after orchiectomy, to initial open nerve sparing RPLND because these patients nearly always undergo RPLND (n = 191) or one adjuvant course of BEP.(n = 191) 36 have disseminated disease.37,38 Primary chemotherapy may be After a median follow-up of 4.7 years two relapses were reported in the followed by open nerve sparing RPLND or surveillance. group of patients treated with one course of adjuvant BEP and 13 patients with relapse in the arm treated with RPLND (P = 0.0011). This Nonseminoma Stages IIA and IIB
study indicates that one course of BEP is active in patients and could Treatment for patients with stage IIA nonseminoma depends on post be an option in patients unable to tolerate the toxicity of treatment. The orchiectomy serum tumor marker levels. When the levels of tumor results of this study are promising and merits further investigation. The markers are persistently elevated, patients are treated with current standard of care practiced by most NCCN institutions is two chemotherapy with 4 cycles of EP or 3 cycles of BEP, followed by open nerve sparing RPLND or surveillance. The subsequent management following primary open nerve sparing For patients with stage IIA disease, when the tumor marker levels are RPLND for patients with IB is similar to that described for stage IA in normal, 2 treatment options are available. Patients can undergo primary the section above. Subsequent management following primary chemotherapy with 4 cycles of EP or 3 cycles of BEP (category 2B), chemotherapy may be open nerve sparing RPLND or surveillance (if followed by open nerve sparing RPLND 39 or surveillance. This the patient is compliant). treatment is considered particularly appropriate if the patient has multifocal disease. Alternatively, the patient can undergo primary nerve- Surveillance alone may be offered to compliant patients with T2 sparing RPLND with adjuvant chemotherapy (two cycles of EP or BEP). disease (category 2B). Vascular invasion is a significant predictor of relapse when orchiectomy is followed by surveillance alone.2 Treatment for patients with stage IIB disease depends on both post Surveillance is generally not recommended for T2 disease with orchiectomy tumor marker levels and radiographic findings. When vascular invasion because of the 50% chance of relapse. Exceptions tumor markers are negative, the CT findings determine the proper are made according to individual circumstances in compliant patients. course of treatment. If abnormal radiographic findings are limited to When surveillance is opted in selected patients with T2 disease, both sites within the lymphatic drainage in the retroperitoneum (i.e., the Version 1.2011, 12/10/10 National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.
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NCCN Guidelines™ Version 1.2011
Testicular Cancer
landing zone), two management options are available. One option is to 100% relapse-free survival rate.45 For pN3, the guidelines recommend perform open nerve sparing RPLND and to consider adjuvant 4 cycles of EP or 3 cycles of BEP. chemotherapy as described for patients with stage IIA disease. The second option is to treat with primary chemotherapy with either 4 cycles Nonseminoma Stages IIC and III
of EP or 3 cycles of BEP, followed by open nerve sparing RPLND or Patients with stage IIC and stage III disease are treated with primary chemotherapy regimens based on risk status. Also, patients with an extragonadal primary site, whether retroperitoneal or mediastinal, are Both options, of primary chemotherapy or primary RPLND are treated with initial chemotherapy. Classifications of risk status emerged comparable options in terms of outcome but side-effects and toxicity from chemotherapy research designed to decrease the toxicity of the are different.40 The reported relapse free survival with either approach regimens while maintaining maximal efficacy. is close to 98%.41-47 Initial chemotherapy combinations studied in the 1970s contained If metastatic disease (based on radiographic findings) is not confined to cisplatin, vinblastine, and bleomycin and achieved a complete response the lymphatic drainage (i.e., multifocal lymph node metastases outside in 70% to 80% of patients with metastatic GCTs. These regimens were the lymphatic drainage sites), or if there is persistent marker elevation, associated with serious adverse effects, including neuromuscular toxic similar primary chemotherapy (4 cycles of EP or 3 cycles of BEP) is effects, death from myelosuppression or bleomycin-induced pulmonary recommended. Initial open RPLND is not recommended in this fibrosis, and Raynaud's phenomenon. The high cure rate and toxicity associated with cisplatin, vinblastine, Subsequent management of Stage IIA and IIB and bleomycin regimens resulted in efforts to stratify patients and tailor Following primary chemotherapy, either surveillance or an open nerve therapy according to risk. Extent of disease and levels of post sparing RPLND is recommended depending on the presence of a orchiectomy serum tumor markers were identified as important prognostic features, and models were developed to stratify patients. The International Germ Cell Cancer Consensus Classification was Following primary open nerve sparing RPLND, surveillance may be developed and incorporated the risk groups into the American Joint opted for depending on the number of positive lymph nodes identified Committee on Cancer staging for GCTs. This classification categorized and patient compliance. For example, surveillance is opted in pN0 patients as good-, intermediate-, or poor-risk.4 patients and is preferred in compliant patients with pN1 disease, whereas chemotherapy is preferred for pN2 disease and surveillance is Good-Risk (Stages IIC and IIIA) Nonseminoma
not recommended for pN3 disease. Recommended chemotherapy for Treatment programs for good-risk GCTs were designed to decrease pN1 and pN2 consists of 2 cycles of BEP or EP, resulting in a nearly toxicity while maintaining maximal efficacy. Randomized clinical trials showed that this was achieved by substituting etoposide for Version 1.2011, 12/10/10 National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.
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NCCN Guidelines™ Version 1.2011
Testicular Cancer
vinblastine,48,49 and either eliminating or reducing the dose of metastasis, depending on the systemic state of the disease, the bleomycin.48,50 Presently, 2 regimens are considered standard histology of the primary tumor and the location of the metastasis. treatment programs in the United States for good-risk GCTs: 4 cycles of EP or 3 cycles of BEP. Either regimen is well tolerated and cures Postchemotherapy Management for Stages IIC and IIIA–IIIC
Nonseminoma
approximately 90% of patients with good risk.51 At the conclusion of induction chemotherapy, CT scans of the abdomen Intermediate- (Stage IIIB) and Poor-Risk (Stage IIIC)
and pelvis are indicated, along with serum tumor marker assays. PET Nonseminoma
scans for residual disease have limited predictive value. If a complete Between 20% and 30% of all patients with metastatic GCTs are not response is found and the tumor markers are negative, 2 management cured with conventional cisplatin therapy. Poor prognostic features at options exist: surveillance (category 2B) or an open nerve sparing diagnosis that can be used to identify these patients include RPLND (category 2B). nonpulmonary visceral metastases and high serum tumor marker concentrations or mediastinal primary site in patients with If residual disease is found and the serum tumor markers (AFP and nonseminoma.52 In patients with these prognostic factors, clinical trials beta-HCG) have normalized, then all sites of residual disease are are directed at improving efficacy. resected. If only necrotic debris or mature teratoma is encountered, no further therapy is necessary and patients must be put under For patients with intermediate risk, the cure rate is approximately 70% surveillance. In the 15% of patients who have viable residual cancer, 2 with standard therapy using 4 cycles of BEP.53,54 cycles of conventionally dosed chemotherapy (EP, VelP [paclitaxel/ifosfamide/cisplatin], or TIP [vinblastine/ifosfamide/cisplatin]) In patients with poor-risk GCTs (stage IIIC), less than one half are administered. experience a durable complete response to 4 cycles of BEP, and therefore treatment in a clinical trial is preferred.51 The panel After patients are rendered disease-free, standard observation is recommends 4 cycles of etoposide, ifosfamide, and cisplatin (VIP initiated. Patients who experience an incomplete response to first-line regimen) for patients who may not tolerate bleomycin.55 Due to the less therapy or unresectable disease at surgery are treated with second-line than favorable prognosis of patients in the poor-risk group, treating them in the context of a clinical trial is the preferred recommendation by the NCCN Testicular Cancer panel. Second Line Therapy for Metastatic Germ Cell Tumors
Patients who do not experience a durable complete response to Primary chemotherapy using cisplatin-based regimen plus radiotherapy first-line therapy can be divided into those with a favorable or is indicated for patients in whom brain metastases are detected. If unfavorable prognosis based on prognostic factors. clinically indicated, surgery should also be performed. Surgery can be performed if clinically indicated such as in the case of a solitary Version 1.2011, 12/10/10 National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.
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NCCN Guidelines™ Version 1.2011
Testicular Cancer
Standard second line therapy includes conventional dose undergoes surgical resection.61 Other options are participation in a chemotherapy or high dose chemotherapy. Prognostic factors can be clinical trial or best supportive care. used in deciding whether a patient is a candidate for conventional dose therapy or high-dose therapy with stem cell support as a second line Subsequent Therapy for Patients with Persistent or Recurrent
Metastatic Germ Cell Tumors
option. Favorable prognostic factors to conventional dose second-line chemotherapy include a testicular primary site, prior complete response The more advanced the disease, the higher the likelihood of to first-line therapy, low levels of post orchiectomy serum tumor recurrence. All patients with either persistent or recurrent disease markers, and low-volume disease.56 The conventional dose regimen should be considered for palliative chemotherapy or radiation therapy. include cisplatin and ifosfamide combined with either vinblastine or A recommended palliative chemotherapy for patients with intensively paclitaxel.57 If the patient experiences an incomplete response or pretreated, cisplatin-resistant, or refractory germ cell tumor is relapses after second-line conventional dose chemotherapy, the combination of gemcitabine with oxaliplatin (category 2A preferred third-line option would be high-dose chemotherapy with recommendation). This recommendation is based on data from phase II autologous stem cell support. studies.62-64 These studies investigated the efficacy and the toxicity of gemcitabine and oxaliplatin (GEMOX) in patients with relapsed or Unfavorable prognostic features include incomplete response to first- cisplatin-refractory GCTs. The results showed that line treatment, high levels of serum markers, high volume disease and oxaliplatin-gemcitabine combination is a safe for patients with presence of extratesticular primary tumor. Patients with a testicular cisplatin-refractory testicular GCTs and may offer a chance of long-term primary site and rising post orchiectomy serum tumor markers during survival.62-64 Toxicity of GEMOX was found to be primarily first-line therapy are usually considered for high-dose programs. hematological and generally manageable. Chemotherapy options for patients with poor prognostic features include chemotherapy in the context of a clinical trial (preferred); conventional-dose second line therapy; high-dose chemotherapy plus autologous stem cell support (category 2B). Alternatively, the patients may be put on best supportive care or salvage surgery if feasible. The high dose regimens include high-dose carboplatin plus etoposide followed by autologous stem cell transplant 58,59 or paclitaxel, ifosfamide followed by high dose carboplatin plus etoposide with stem cell support.60 For patients who do not experience complete response to second line high-dose therapy, the disease is nearly always incurable; the only exception is the rare patient with elevated serum tumor markers and a solitary site of metastasis (usually retroperitoneal) that Version 1.2011, 12/10/10 National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.
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NCCN Guidelines™ Version 1.2011
Testicular Cancer
References
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NCCN Guidelines™ Version 1.2011
Testicular Cancer
18. Miller KD, Loehrer PJ, Gonin R, Einhorn LH. Salvage chemotherapy 27. Kakiashvili D, Anson-Cartwright, L, Sturgeon, JF, Warde, PR, with vinblastine, ifosfamide, and cisplatin in recurrent seminoma. J Clin Chung, P, Moore, M, Wang, L, Azuero, J, Jewett, MA. Non risk-adapted Oncol. 1997;15:1427-1431. surveillance management for clinical stage I nonseminomatous testis 19. Loehrer PJ, Sr., Lauer R, Roth BJ, Williams SD, Kalasinski LA, tumors. J Urol 2007;177:278 (abstract 835). Einhorn LH. Salvage therapy in recurrent germ cell cancer: ifosfamide and cisplatin plus either vinblastine or etoposide. Ann Intern Med. 28. Bohlen D, Borner M, Sonntag RW, Fey MF, Studer UE. Long-term 1988;109:540-546. results following adjuvant chemotherapy in patients with clinical stage I testicular nonseminomatous malignant germ cell tumors with high risk 20. Warde P, Gospodarowicz MK, Panzarella T, et al. Stage I testicular factors. J Urol. 1999;161:1148-1152. seminoma: results of adjuvant irradiation and surveillance. J Clin Oncol. 1995;13:2255-2262. 29. Bohlen D, Burkhard FC, Mills R, Sonntag RW, Studer UE. Fertility and sexual function following orchiectomy and 2 cycles of 21. Puc HS, Heelan R, Mazumdar M, et al. Management of residual chemotherapy for stage I high risk nonseminomatous germ cell cancer. mass in advanced seminoma: results and recommendations from the J Urol. 2001;165:441-444. Memorial Sloan-Kettering Cancer Center. J Clin Oncol. 1996;14:454-460. 30. Chevreau C, Mazerolles C, Soulie M, et al. Long-term efficacy of two cycles of BEP regimen in high-risk stage I nonseminomatous 22. Mencel PJ, Motzer RJ, Mazumdar M, Vlamis V, Bajorin DF, Bosl testicular germ cell tumors with embryonal carcinoma and/or vascular GJ. Advanced seminoma: treatment results, survival, and prognostic invasion. Eur Urol. 2004;46:209-214. factors in 142 patients. J Clin Oncol. 1994;12:120-126. 31. Cullen MH, Stenning SP, Parkinson MC, et al. Short-course 23. Sheinfeld J, Herr HW. Role of surgery in management of germ cell adjuvant chemotherapy in high-risk stage I nonseminomatous germ cell tumor. Semin Oncol. 1998;25:203-209. tumors of the testis: a Medical Research Council report. J Clin Oncol. 1996;14:1106-1113. 24. Carver BS, Sheinfeld J. The current status of laparoscopic retroperitoneal lymph node dissection for non-seminomatous germ-cell 32. Oliver RT, Raja MA, Ong J, Gallagher CJ. Pilot study to evaluate tumors. Nat Clin Pract Urol. 2005;2:330-335. impact of a policy of adjuvant chemotherapy for high risk stage 1 malignant teratoma on overall relapse rate of stage 1 cancer patients. J 25. Colls BM, Harvey VJ, Skelton L, et al. Late results of surveillance of Urol. 1992;148:1453-1455. clinical stage I nonseminoma germ cell testicular tumours: 17 years' experience in a national study in New Zealand. BJU Int. 1999;83:76-82. 33. Pont J, Albrecht W, Postner G, Sellner F, Angel K, Holtl W. Adjuvant chemotherapy for high-risk clinical stage I nonseminomatous 26. Read G, Stenning SP, Cullen MH, et al. Medical Research Council testicular germ cell cancer: long-term results of a prospective trial. J prospective study of surveillance for stage I testicular teratoma. Medical Clin Oncol. 1996;14:441-448. Research Council Testicular Tumors Working Party. J Clin Oncol. 1992;10:1762-1768. 34. Studer UE, Fey MF, Calderoni A, Kraft R, Mazzucchelli L, Sonntag RW. Adjuvant chemotherapy after orchiectomy in high-risk patients with Version 1.2011, 12/10/10 National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.
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NCCN Guidelines™ Version 1.2011
Testicular Cancer
clinical stage I non-seminomatous testicular cancer. Eur Urol. 42. Hartlapp JH, Weissbach L, Bussar-Maatz R. Adjuvant 1993;23:444-449. chemotherapy in nonseminomatous testicular tumour stage II. Int J Androl. 1987;10:277-284. 35. Sharir S, Foster RS, Donohue JP, Jewett MA. What is the appropriate follow-up after treatment? Semin Urol Oncol. 1996;14:45- 43. Horwich A, Norman A, Fisher C, Hendry WF, Nicholls J, Dearnaley DP. Primary chemotherapy for stage II nonseminomatous germ cell tumors of the testis. J Urol. 1994;151:72-77. 36. Albers P, Siener R, Krege S, et al. Randomized Phase III Trial Comparing Retroperitoneal Lymph Node Dissection With One Course 44. Logothetis CJ, Swanson DA, Dexeus F, et al. Primary of Bleomycin and Etoposide Plus Cisplatin Chemotherapy in the chemotherapy for clinical stage II nonseminomatous germ cell tumors Adjuvant Treatment of Clinical Stage I Nonseminomatous Testicular of the testis: a follow-up of 50 patients. J Clin Oncol. 1987;5:906-911. Germ Cell Tumors: AUO Trial AH 01/94 by the German Testicular Cancer Study Group. J Clin Oncol. 2008;26:2966-2972. 45. Motzer RJ, Sheinfeld J, Mazumdar M, et al. Etoposide and cisplatin adjuvant therapy for patients with pathologic stage II germ cell tumors. 37. Culine S, Theodore C, Terrier-Lacombe MJ, Droz JP. Primary J Clin Oncol. 1995;13:2700-2704. chemotherapy in patients with nonseminomatous germ cell tumors of the testis and biological disease only after orchiectomy. J Urol. 46. Sternberg CN. Role of primary chemotherapy in stage I and low- 1996;155:1296-1298. volume stage II nonseminomatous germ-cell testis tumors. Urol Clin North Am. 1993;20:93-9109. 38. Davis BE, Herr HW, Fair WR, Bosl GJ. The management of patients with nonseminomatous germ cell tumors of the testis with 47. Williams SD, Stablein DM, Einhorn LH, et al. Immediate adjuvant serologic disease only after orchiectomy. J Urol. 1994;152:111-113; chemotherapy versus observation with treatment at relapse in pathological stage II testicular cancer. N Engl J Med. 1987;317:1433-1438. 39. Foster R, Bihrle R. Current status of retroperitoneal lymph node dissection and testicular cancer: when to operate. Cancer Control. 48. Bosl GJ, Geller NL, Bajorin D, et al. A randomized trial of etoposide + cisplatin versus vinblastine + bleomycin + cisplatin + cyclophosphamide + dactinomycin in patients with good-prognosis 40. Weissbach L, Bussar-Maatz R, Flechtner H, Pichlmeier U, germ cell tumors. J Clin Oncol. 1988;6:1231-1238. Hartmann M, Keller L. RPLND or primary chemotherapy in clinical stage IIA/B nonseminomatous germ cell tumors? Results of a 49. Williams SD, Birch R, Einhorn LH, Irwin L, Greco FA, Loehrer PJ. prospective multicenter trial including quality of life assessment. Eur Treatment of disseminated germ-cell tumors with cisplatin, bleomycin, Urol. 2000;37:582-594. and either vinblastine or etoposide. N Engl J Med. 1987;316:1435-1440. 41. Donohue JP, Thornhill JA, Foster RS, Bihrle R, Rowland RG, Einhorn LH. The role of retroperitoneal lymphadenectomy in clinical 50. Einhorn LH, Williams SD, Loehrer PJ, et al. Evaluation of optimal stage B testis cancer: the Indiana University experience (1965 to 1989). duration of chemotherapy in favorable-prognosis disseminated germ J Urol. 1995;153:85-89. Version 1.2011, 12/10/10 National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.
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NCCN Guidelines™ Version 1.2011
Testicular Cancer
cell tumors: a Southeastern Cancer Study Group protocol. J Clin Oncol. 59. Einhorn LH, Williams SD, Chamness A, Brames MJ, Perkins SM, Abonour R. High-dose chemotherapy and stem-cell rescue for metastatic germ-cell tumors. N Engl J Med. 2007;357:340-348. 51. Jones RH, Vasey PA. Part II: testicular cancer--management of advanced disease. Lancet Oncol. 2003;4:738-747. 60. Feldman DR, Sheinfeld J, Bajorin DF, et al. TI-CE high-dose chemotherapy for patients with previously treated germ cell tumors: 52. Toner GC, Motzer RJ. Poor prognosis germ cell tumors: current results and prognostic factor analysis. J Clin Oncol. 2010;28:1706- status and future directions. Semin Oncol. 1998;25:194-202. 53. de Wit R, Stoter G, Sleijfer DT, et al. Four cycles of BEP vs four 61. Wood DP, Jr., Herr HW, Motzer RJ, et al. Surgical resection of cycles of VIP in patients with intermediate-prognosis metastatic solitary metastases after chemotherapy in patients with testicular non-seminoma: a randomized study of the EORTC nonseminomatous germ cell tumors and elevated serum tumor Genitourinary Tract Cancer Cooperative Group. European Organization markers. Cancer. 1992;70:2354-2357. for Research and Treatment of Cancer. Br J Cancer. 1998;78:828-832. 62. De Giorgi U, Rosti G, Aieta M, et al. Phase II study of oxaliplatin 54. Frohlich MW, Small EJ. Stage II nonseminomatous testis cancer: and gemcitabine salvage chemotherapy in patients with cisplatin- the roles of primary and adjuvant chemotherapy. Urol Clin North Am. refractory nonseminomatous germ cell tumor. Eur Urol. 2006;50:1032- 1998;25:451-459. 1038; discussion 1038-1039. 55. Nichols CR, Catalano PJ, Crawford ED, Vogelzang NJ, Einhorn LH, 63. Kollmannsberger C, Beyer J, Liersch R, et al. Combination Loehrer PJ. Randomized comparison of cisplatin and etoposide and chemotherapy with gemcitabine plus oxaliplatin in patients with either bleomycin or ifosfamide in treatment of advanced disseminated intensively pretreated or refractory germ cell cancer: a study of the germ cell tumors: an Eastern Cooperative Oncology Group, Southwest German Testicular Cancer Study Group. J Clin Oncol. 2004;22:108- Oncology Group, and Cancer and Leukemia Group B Study. J Clin Oncol. 1998;16:1287-1293. 64. Pectasides D, Pectasides M, Farmakis D, et al. Gemcitabine and 56. Motzer RJ, Geller NL, Tan CC, et al. Salvage chemotherapy for oxaliplatin (GEMOX) in patients with cisplatin-refractory germ cell patients with germ cell tumors. The Memorial Sloan-Kettering Cancer tumors: a phase II study. Ann Oncol. 2004;15:493-497. Center experience (1979-1989). Cancer. 1991;67:1305-1310. 57. Loehrer PJ, Sr., Gonin R, Nichols CR, Weathers T, Einhorn LH. Vinblastine plus ifosfamide plus cisplatin as initial salvage therapy in recurrent germ cell tumor. J Clin Oncol. 1998;16:2500-2504. 58. Motzer RJ, Bosl GJ. High-dose chemotherapy for resistant germ cell tumors: recent advances and future directions. J Natl Cancer Inst. 1992;84:1703-1709. Version 1.2011, 12/10/10 National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.

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Testicular 1.2011_12-10-10_fi.

NCCN Guidelines Index Testicular Cancer TOC NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) Version 1.2011, 12/10/10 © National Comprehensive Cancer Network, Inc. 2010, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®. Printed by Tomasz Sarosiek on 1/3/2011 3:21:15 PM. For personal use only. Not approved for distribution. Copyright © 2011 National Comprehensive Cancer Network, Inc., All Rights Reserved.

Dt-el-usb-tcv4.cdr:coreldraw

Thermocouple Data Logger with USB Interface This data logger measures and stores over 32,000 temperature readings from either a K, J or T type thermocouple . Athermocouple is attached via the thermocouple socket at the base of the unit. The user can easily set up the thermocouple type, logging rate, start-time, logging mode, and download the stored data by plugging the modulestraight into a PC'sUSB port and running the purpose designed software underWindows 2000, XP or Vista. Data can