Randomized trial of etoposide and cisplatin versus etoposide and carboplatin in patients with good-risk germ cell tumors: A multiinstitutional study Journal Article

Authors: Bajorin, D. F.; Sarosdy, M. F.; Pfister, D. G.; Mazumdar, M.; Motzer, R. J.; Scher, H. I.; Geller, N. L.; Fair, W. R.; Herr, H.; Sogani, P.; Sheinfeld, J.; Russo, P.; Vlamis, V.; Carey, R.; Vogelzang, N. J.; Crawford, E. D.; Bosl, G. J.
Article Title: Randomized trial of etoposide and cisplatin versus etoposide and carboplatin in patients with good-risk germ cell tumors: A multiinstitutional study
Abstract: Purpose: This multicenter, randomized phase III clinical trial evaluated the efficacy of etoposide plus carboplatin (EC) versus etoposide plus cisplatin (EP) in good-risk germ cell tumor (GCT) patients. Patients and Methods: Between October 1986 and December 1990, 270 patients with good-risk GCTs were randomized to receive four cycles of either EP or EC. The etoposide dose in all patients was 100 mg/m2 on days 1 through 5. EP patients received cisplatin at 20 mg/m2 on days 1 through 5 and therapy was recycled at 21- day intervals. For EC patients, the carboplatin dose was 500 mg/m2 on day 1 of each cycle and the EC recycling interval was 28 days. Results: Two hundred sixty-five patients were assessable: 131 patients treated with EC and 134 treated with EP. One hundred fifteen of 131 assessable patients (88%) treated with EC achieved a complete response (CR) versus 121 of 134 patients (90%) treated with EP (P = .32). Sixteen patients (12%) treated with EC relapsed from CR versus four patients (3%) treated with EP. Therefore, 32 patients (24%) who received carboplatin experienced an event (incomplete response [IR] or relapse) compared with 17 of 134 patients (13%) who received cisplatin (P = .02). At a median follow-up of 22.4 months, event-free and relapse-free survival were inferior for patients treated with EC (P = .02 and P = .005, respectively). No difference in overall survival was evident (P = .52). Conclusion: Two-drug therapy with EC using this dose and schedule was inferior to therapy with EP. Cisplatin remains as the standard platinum analog in the treatment of patients with good-risk GCTs. Carboplatin should be restricted to investigational trials in GCT.
Keywords: adolescent; adult; cancer survival; aged; major clinical study; neutropenia; cancer recurrence; cisplatin; cancer combination chemotherapy; cancer risk; drug efficacy; carboplatin; anemia; etoposide; thrombocytopenia; peripheral neuropathy; phase 3 clinical trial; germ cell tumor; human; priority journal; article
Journal Title: Journal of Clinical Oncology
Volume: 11
Issue: 4
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 1993-04-01
Start Page: 598
End Page: 606
Language: English
DOI: 10.1200/jco.1993.11.4.598
PUBMED: 8386751
PROVIDER: scopus
Notes: Article -- Export Date: 1 March 2019 -- Source: Scopus
Citation Impact
MSK Authors
  1. Paul Russo
    542 Russo
  2. Dean Bajorin
    601 Bajorin
  3. Robert Motzer
    1075 Motzer
  4. Madhu Mazumdar
    127 Mazumdar
  5. David G Pfister
    339 Pfister
  6. Joel Sheinfeld
    241 Sheinfeld
  7. Pramod C Sogani
    68 Sogani
  8. Harry W Herr
    555 Herr
  9. Howard Scher
    1068 Scher
  10. George Bosl
    417 Bosl
  11. William R Fair
    337 Fair
  12. Vaia   Vlamis
    38 Vlamis
  13. Nancy L. Geller
    58 Geller