High-dose chemotherapy (HDCT) and autologous bone marrow transplantation (ABMT) do not improve the evolution of poor prognosis (PP) germ-cell tumors (GCT) (Meeting abstract).

Important note: Information in this article was accurate in 1993. The state of the art may have changed since the publication date.

High-dose chemotherapy (HDCT) and autologous bone marrow transplantation (ABMT) do not improve the evolution of poor prognosis (PP) germ-cell tumors (GCT) (Meeting abstract).

Ann Oncol; 3(Suppl 5):164 1992. Unique Identifier : AIDSLINE ICDB/93689791
Biron P; Droz JP; Pico JL; Kramar A; Bouzy J; GU group of the French Federation of Cancer Centers

Abstract: The role of early HDCT + ABMT in the treatment of PP nonseminomatous GCT as defined in our group (Droz, Cancer 62:54, 1988) was studied by a multicentric Phase III trial. Patients (pts) were randomized to receive either arm A: the NCI cisplatin (P), vinblastine (Ve), bleomycin (B), VP16 (V) regimen (PVeBV; Ozols, JCO 6:1031, 1988) or arm B: 2 cycles of a modified PVeBV and high-dose cyclophosphamide + V + P (PEC) + ABMT (Droz, EJC 27:831, 1991). 115 pts were included, 1 pt was ineligible. Primaries were testis 81, mediastinum 18, retroperitoneum 15. Arm A results: 57 pts of whom 7 pts did not complete the treatment: PD 4, pt refusal 2, toxic death 1. There were 15 failures, 9 PR with normal tumor markers (NMq), 6 cCR + 24 pCR + 3 sCR (58% CR). Seven pts relapsed. The 2-yr survival is 82%. Arm B results: 57 pts of whom 16 pts did not complete the treatment: early deaths 6, pt refusal 3, toxic death 2, pulmonary, liver, septic toxicities: one of each, poor PS 1, HIV infection 1 pt. There were 26 failures, 7 PR with NMq, 10 cCR + 12 pCR + 2 sCR (42% CR). Nine pts relapsed. The 2-yr survival is 60%. Neither the CR rate nor the 2-yr survival are statistically different: the p values are 0.11 and 0.08, respectively. Conclusion: Early HDCT + ABMT failed to improve the prognosis of poor-risk GCT in this randomized trial.

Keywords: Antineoplastic Agents, Combined/ADVERSE EFFECTS/*THERAPEUTIC USE Bleomycin/ADMINISTRATION & DOSAGE *Bone Marrow Transplantation Cisplatin/ADMINISTRATION & DOSAGE Combined Modality Therapy Cyclophosphamide/ADMINISTRATION & DOSAGE Dose-Response Relationship, Drug Human Mediastinal Neoplasms/DRUG THERAPY/MORTALITY/SURGERY/THERAPY Peritoneal Neoplasms/DRUG THERAPY/MORTALITY/SURGERY/THERAPY Prognosis Survival Analysis Teratoma/DRUG THERAPY/MORTALITY/SURGERY/*THERAPY Testicular Neoplasms/DRUG THERAPY/MORTALITY/SURGERY/THERAPY Transplantation, Autologous Vinblastine/ADMINISTRATION & DOSAGE ABSTRACT CLINICAL TRIAL, PHASE III MULTICENTER STUDY
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