title: Dose-response and dose-survival advantage for high versus low-dose cisplatin combined with vinblastine and bleomycin in disseminated testicular cancer. A Southwest Oncology Group study.
abstract: One-hundred fourteen patients with advanced testicular cancer were randomized to treatment consisting of either high-dose (120 mg/m2, monthly) or low-dose (15 mg/m2, daily X 5 monthly) cisplatin, both combined with vinblastine and bleomycin. There were 60 (53%) complete remissions and 42 partial remissions for an overall response rate of 90%. An additional 11 patients, 4 with carcinoma and 7 with mature teratoma, following surgical cytoreduction, were rendered free of disease. There was a significantly higher complete response rate for high dose induction chemotherapy, 63%, when compared with low dose, 43% (P = 0.03). A survival advantage was also observed for patients receiving high-dose therapy (P = 0.009). For the subgroup of patients with maximal disease and embryonal +/- teratoma +/- seminoma histology there was a clear advantage in favor of high-dose over low-dose therapy both in complete response rate and survival (P = 0.03). There have been only four relapses, all occurring within 1 year of study entry. While there has been a higher frequency of leukopenia, renal, neuromuscular, and mucosal toxicity with high-dose therapy, thus far no irreversible toxicity leading to functional impairment has been seen. The authors have demonstrated a clear-cut relationship for dose of therapy, not only with response and survival, but with the increased potential for cure as well.
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001761:Bleomycin / Q000008:administration & dosage; D002945:Cisplatin / Q000008:administration & dosage; D002986:Clinical Trials as Topic; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009373:Neoplasms, Germ Cell and Embryonal / Q000188:drug therapy*; D011897:Random Allocation; D013736:Testicular Neoplasms / Q000188:drug therapy*; D014747:Vinblastine / Q000008:administration & dosage
chemical_list: D001761:Bleomycin; D014747:Vinblastine; D002945:Cisplatin