Comparison of two standard chemotherapy regimens for good-prognosis germ-cell tumours: a randomised trial

Toner, G. C., Stockler, M. R., Boyer, M. J., Jones, M., Thomson, D. B., Harvey, V. J., Olver, I. N., Dhillon, H., McMullen, A., Gebski, V. J., Levi, J. A. and Simes, R. J. (2001) Comparison of two standard chemotherapy regimens for good-prognosis germ-cell tumours: a randomised trial. Lancet, 357 9258: 739-745. doi:10.1016/S0140-6736(00)04165-9


Author Toner, G. C.
Stockler, M. R.
Boyer, M. J.
Jones, M.
Thomson, D. B.
Harvey, V. J.
Olver, I. N.
Dhillon, H.
McMullen, A.
Gebski, V. J.
Levi, J. A.
Simes, R. J.
Title Comparison of two standard chemotherapy regimens for good-prognosis germ-cell tumours: a randomised trial
Journal name Lancet   Check publisher's open access policy
ISSN 0140-6736
Publication date 2001-03-10
Sub-type Article (original research)
DOI 10.1016/S0140-6736(00)04165-9
Volume 357
Issue 9258
Start page 739
End page 745
Total pages 7
Place of publication London
Publisher Lancet Publishing Group
Language eng
Subject 1112 Oncology and Carcinogenesis
Formatted abstract
Background: Most patients with metastatic germ-cell tumours are cured with chemotherapy. However, the optimum chemotherapy regimen is uncertain, and there is variation in international practice. We did a multicentre randomised trial to compare two standard chemotherapy regimens for men with good-prognosis germ-cell tumours.

Methods
: Good prognosis was defined by modified Memorial Sloan-Kettering criteria. The first regimen (regimen A) was based on treatment recommendations from Indiana University and comprised three cycles of 20 mg/m(2) cisplatin on days 1-5, 100 mg/m(2) etoposide on days 1-5, and 30 kU bleomycin on days 1, 8, and 15, repeated every 21 days. The second regimen (regimen B) was based on the control regimen of a published randomised clinical trial and comprised four cycles of 100 mg/m(2) cisplatin on day 1, 120 mg/m(2) etoposide on days 1-3, and 30 kU bleomycin on day 1, repeated every 21 days. The primary outcome measure was overall survival. Analysis was by intention to treat.

Findings: 166 patients were randomised, 83 to each regimen. The trial was stopped when the second planned interim analysis met predefined stopping rules. The median follow-up was 33 months, Overall survival was substantially better with regimen A (three vs 13 deaths, hazard ratio 0.22 [95% CI 0.06-0.77], p=0.008). This difference was due to deaths from cancer tone vs nine), and not deaths from treatment (two vs two) and remained significant after adjustment for other prognostic factors (0.25 [0.07-0.88], p=0.03).

Interpretation
: In men with good-prognosis germ-cell tumours, the regimen developed at Indiana University is superior to the alternative regimen studied in this trial. The lower total dose and dose-intensity of bleomycin and the lower dose-intensity of etoposide in regimen B could be responsible for the worse outcome.
Keyword testicular cancer
combination chemotherapy
clinical-trials
poor risk
bleomycin
tumors
etoposide
cisplatin
therapy
carcinoma
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Unknown

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
 
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Created: Tue, 08 Jan 2008, 13:05:06 EST by Laura McTaggart on behalf of School of Medicine