No advantage for the use of an early high dose chemotherapy (HDCT) with autologous bone marrow transplant (ABMT) in first line treatment of poor risk nonseminomatous germ cell tumors (NSGCT) (Meeting abstract).

Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.

Fourth International Congress on Anti-cancer Chemotherapy. February 2-5, 1993, Paris, France, p. 131, 1993.. Unique Identifier : AIDSLINE ICDB/94697878
Cure H; Droz JP; Pico JL; Biron P; Kerbrat P; Heron JH; Chevreau C; Chevallier B; Fargeot P; Bouzy J; et al; French Federation of Cancer Centers, Clermont Ferrand, France

Abstract: In order to evaluate the place of HDCT + ABMT in first line treatment of NSGCT we have conducted between 1/1988 and 6/1991 a randomized trial in 115 non-pretreated patients with poor risk characteristics according to the Institut Gustave Roussy prognostic mathematical model (Droz, Cancer 62:54, 1988). Arm A was the NCI regimen with vinblastine + etoposide (E) + bleomycin + double dose cisplatin (P2, PVeBV; Ozols, J Clin Oncol 6:1031, 1988) for 3 or 4 cycles, q3w. Arm B was 2 cycles of a modified PVeBV regimen (bleomycin in continuous infusion, q4w) then a cycle of high-dose E + cyclophosphamide + P2 and ABMT whatever was the response to the 2 cycles of PVeBV. Surgical resection of residual disease was performed in patients with normal tumor markers (NTMq). Except 1 patient with good risk criteria, all the patients were evaluable: 81 testis and 33 extragonadal NSGCT (18 mediastinal and 15 retroperitoneal primary sites). The characteristics of the 2 groups were well balanced. Results: Arm A (57 patients): 7 patients did not complete the treatment (PD = 4, patient refusal = 2, toxic death = 1). There were 15 failures, 9 PR with NTMq and 33 CR (58%; 6 cCR + 24 pCR + 4 sCR). Seven patients relapsed. The 2 year survival rate is 82%. Arm B (57 patients): 16 patients did not complete the treatment (6 early deaths, 3 refusals, 2 toxic deaths, 3 pulmonary or liver or septic toxicities, 1 poor PS, 1 HIV). There were 26 failures, 7 PR with NTMq and 24 CR (42%; 10 cCR + 12 pCR + 2 sCR). Nine patients relapsed. The 2 year survival rate is 60%. Both CR and survival rates are not statistically different (p = 0.11 and 0.08, respectively). After 2 cycles of PVeBV, 6 patients in arm A and 22 patients in arm B had NTMq. After 1 or 2 additional cycles of PVeBV, 33 additional patients had NTMq in arm A as did 8 patients after HDCT + ABMT in arm B. Conclusion: This randomized multicenter study fails to show any benefit of early HDCT + ABMT to increase the CR rate and survival in poor risk NSGCT.

Keywords: Antineoplastic Agents, Combined/ADVERSE EFFECTS/*THERAPEUTIC USE Bleomycin/ADMINISTRATION & DOSAGE *Bone Marrow Transplantation Cisplatin/ADMINISTRATION & DOSAGE Combined Modality Therapy Cyclophosphamide/ADMINISTRATION & DOSAGE Etoposide/ADMINISTRATION & DOSAGE Human Male Mediastinal Neoplasms/DRUG THERAPY/SURGERY/*THERAPY Neoplasm Recurrence, Local Neoplasms, Germ Cell and Embryonal/DRUG THERAPY/SURGERY/*THERAPY Retroperitoneal Neoplasms/DRUG THERAPY/SURGERY/*THERAPY Vinblastine/ADMINISTRATION & DOSAGE ABSTRACT
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M9470926

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