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Journal of Clinical Oncology, Vol 19, Issue 6 (March), 2001: 1629-1640
© 2001 American Society for Clinical Oncology

Equivalence of Three or Four Cycles of Bleomycin, Etoposide, and Cisplatin Chemotherapy and of a 3- or 5-Day Schedule in Good-Prognosis Germ Cell Cancer: A Randomized Study of the European Organization for Research and Treatment of Cancer Genitourinary Tract Cancer Cooperative Group and the Medical Research Council

By Ronald de Wit, J. Trevor Roberts, Peter M. Wilkinson, Pieter H.M. de Mulder, Graham M. Mead, Sophie D. Fosså, Pat Cook, Linda de Prijck, Sally Stenning, Laurence Collette

From the Rotterdam Cancer Institute and University Hospital, Rotterdam; University Hospital, Nijmegen, the Netherlands; Northern Centre for Cancer Treatment, Newcastle upon Tyne; Christie Hospital, Manchester; Royal South Hants Hospital, Southampton; Medical Research Council Cancer Trials Office, London, United Kingdom; The Norwegian Radium Hospital, Oslo, Norway; and The European Organization for Research and Treatment of Cancer Data Center, Brussels, Belgium.

Address reprint requests to Ronald de Wit, MD, PhD, Department of Medical Oncology, Rotterdam Cancer Institute (Dr Daniel den Hoed Kliniek) and University Hospital, PO Box 5201, 3008 AE Rotterdam, the Netherlands; email: wit{at}onch.azr.nl

PURPOSE: To test the equivalence of three versus four cycles of bleomycin, etoposide, and cisplatin (BEP) and of the 5-day schedule versus 3 days per cycle in good-prognosis germ cell cancer.

PATIENTS AND METHODS: The study was designed as a 2 x 2 factorial trial. The aim was to rule out a 5% decrease in the 2-year progression-free survival (PFS) rate. The study included the assessment of patient quality of life. A cycle of BEP consisted of etoposide 500 mg/m2, administered at either 100 mg/m2 days 1 through 5 or 165 mg/m2 days 1 through 3, cisplatin 100 mg/m2, administered at either 20 mg/m2 days 1 through 5 or 50 mg/m2 days 1 and 2. Bleomycin 30 mg was administered on days 1, 8, and 15 during cycles 1 through 3. The randomization procedure allowed some investigators to participate only in the comparison of three versus four cycles.

RESULTS: From March 1995 until April 1998, 812 patients were randomly assigned to receive three or four cycles: of these, 681 were also randomly assigned to the 5-day or the 3-day schedule. Histology, marker values, and disease extent are well balanced in the treatment arms of the two comparisons. The projected 2-year PFS is 90.4% on three cycles and 89.4% on four cycles. The difference in PFS between three and four cycles is -1.0% (80% confidence limit [CL], -3.8%, +1.8%). Equivalence for three versus four cycles is claimed because both the upper and lower bounds of the 80% CL are less than 5%. In the 5- versus 3-day comparison, the projected 2-year PFS is 88.8% and 89.7%, respectively (difference, -0.9%, (80% CL, -4.1%, +2.2%). Hence, equivalence is claimed in this comparison also. Frequencies of hematologic and nonhematologic toxicities were essentially similar. Quality of life was maintained better in patients receiving three cycles; no differences were detected between 3 and 5 days of treatment.

CONCLUSION: We conclude that three cycles of BEP, with etoposide at 500 mg/m2, is sufficient therapy in good-prognosis germ cell cancer and that the administration of the chemotherapy in 3 days has no detrimental effect on the effectiveness of the BEP regimen.

The contents of this publication are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.


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