THE IMPORTANCE OF BLEOMYCIN IN COMBINATION CHEMOTHERAPY FOR GOOD-PROGNOSIS GERM-CELL CARCINOMA

被引:131
作者
LEVI, JA
RAGHAVAN, D
HARVEY, V
THOMPSON, D
SANDEMAN, T
GILL, G
STUARTHARRIS, R
SNYDER, R
BYRNE, M
KERESTES, Z
MARGRIE, S
机构
[1] PETER MACCALLUM INST,MELBOURNE,AUSTRALIA
[2] ST VINCENTS HOSP,MELBOURNE,VIC,AUSTRALIA
[3] ROYAL ADELAIDE HOSP,ADELAIDE,SA 5000,AUSTRALIA
[4] SIR CHARLES GAIRDNER HOSP,NEDLANDS,WA 6009,AUSTRALIA
[5] AUCKLAND HOSP,AUCKLAND 3,NEW ZEALAND
[6] PRINCESS ALEXANDRA HOSP,WOOLLOONGABBA,QLD 4102,AUSTRALIA
[7] ROYAL PRINCE ALFRED HOSP,CAMPERDOWN,NSW 2050,AUSTRALIA
[8] WESTMEAD HOSP,SYDNEY,AUSTRALIA
[9] NHMRC,CTR CLIN TRIALS,SYDNEY,AUSTRALIA
关键词
D O I
10.1200/JCO.1993.11.7.1300
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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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页码:1300 / 1305
页数:6
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