Journal of Clinical Oncology, Vol 11, 1300-1305, Copyright © 1993 by American Society of Clinical Oncology
The importance of bleomycin in combination chemotherapy for good- prognosis germ cell carcinoma. Australasian Germ Cell Trial Group
JA Levi, D Raghavan, V Harvey, D Thompson, T Sandeman, G Gill, R Stuart-Harris, R Snyder, M Byrne and Z Kerestes
Department of Clinical Oncology, Royal North Shore Hospital of Sydney, St Leonards, NSW, Australia.
PURPOSE: In an effort to maintain the excellent long-term results achieved
with combination chemotherapy for good-prognosis germ cell carcinoma, but
to reduce the toxicities encountered, a randomized trial was conducted
comparing cisplatin and vinblastine with or without bleomycin. PATIENTS AND
METHODS: Two hundred eighteen assessable patients with a good prognosis
were randomized to receive induction chemotherapy with cisplatin 100 mg/m2
intravenously (IV) day 1 and vinblastine 6 mg/m2 IV days 1 and 2 every 3
weeks (PV) with or without bleomycin 30 mg intramuscularly (IM) weekly
(PVB) for a maximum of 12 weeks. Once maximum response was achieved,
patients with a complete remission (CR) received two courses of
consolidation chemotherapy, while those with residual abnormalities and
normal tumor markers underwent surgical resection whenever possible.
RESULTS: Toxicities encountered in this study were clearly greater for
those patients who received bleomycin, with significantly more leukopenia,
thrombocytopenia, anemia, alopecia, and renal and pulmonary toxicities. The
proportion of patients who achieved CR and had no evidence of disease
(resection of all viable malignancy) was 89% for PV and 94% for PVB (P =
.29). After a minimum of 4 years of follow-up, relapses have occurred in 7%
of patients who received PV and 5% who received PVB. A total of five
patients on each therapy arm were successfully treated with further salvage
chemotherapy and surgery. Thus, deaths from progressive malignancy have
occurred in 15% of patients on PV and 5% on PVB (P = .02), a rate that was
partly offset by the higher proportion of toxic deaths with PVB (P = .06).
CONCLUSION: Despite the toxicities encountered with bleomycin in
cisplatin-based combination chemotherapy for these patients, complete
deletion of this drug compromises therapeutic efficacy.
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