NO EVIDENCE OF A BENEFIT OF EARLY INTENSIFIED CHEMOTHERAPY (HDCT) WITH AUTOLOGOUS BONE MARROW TRANSPLANTATION (ABMT) IN FIRST-LINE TREATMENT OF POOR-RISK NONSEMINOMATOUS GERM CELL TUMORS (NSGCT): PRELIMINARY RESULTS OF A RANDOMIZED TRIAL (MEETING ABSTRACT) NLM AIDSLINE Important note: Information in this article was accurate in 1992. The state of the art may have changed since the publication date.

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NO EVIDENCE OF A BENEFIT OF EARLY INTENSIFIED CHEMOTHERAPY (HDCT) WITH AUTOLOGOUS BONE MARROW TRANSPLANTATION (ABMT) IN FIRST-LINE TREATMENT OF POOR-RISK NONSEMINOMATOUS GERM CELL TUMORS (NSGCT): PRELIMINARY RESULTS OF A RANDOMIZED TRIAL (MEETING ABSTRACT)

Proc Annu Meet Am Soc Clin Oncol; 11:A602 1992. Unique Identifier : AIDSLINE ICDB/92681333
Droz JP; Pico JL; Biron P; Kerbrat P; Cure H; Heron JF; Chevreau C; Chevallier B; Fargeot P; Bouzy J; et al; Institut Gustave-Roussy (IGR), 94800 Villejuif, France

Abstract: Recent data have emphasized a hypothetic role of HDCT + ABMT in relapsing or refractory patients (pts; Nichols, JCO 7:932, 1989; Droz, EJ 27:831, 1991). Between January 1988 and June 1991 we conducted a randomized trial in 115 nonpretreated NSGCT pts with poor-risk characteristics according to the IGR 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, JCO 6:1031, 1988) 3 or 4 cycles q 3 wk. Arm B was 2 cycles of a modified PVeBV regimen (bleomycin in continuous infusion, q 4 wk) then a cycle of high-dose E + cyclophosphamide + P2 (PEC) and ABMT (Droz, ASCO 8:130, 1989) whatever was the response to the 2 cycles of PVeBV. Pts with residual disease (RD) and normal tumor markers (NTMq) were submitted to resection of RD. 102 pts are evaluable (13 are too early): 65 testis and 34 extragonadal NSGCT. The characteristics of the 2 groups were well balanced. Results: In arm A (49 pts), 4 pts did not complete the treatment (1 toxic death, 1 refusal, 2 PD); there were 7 failures, 8 PR with NTMq and 30 CR (61%; 7 cCR + 21 pCR + 2 sCR). One pt relapsed. The 1- and 2-yr survival rates are 82 and 82%. In arm B (53 pts), 13 pts did not complete the treatment (2 toxic deaths, 6 early deaths due to pulmonary failure, 2 refusals, 1 HIV(+) pt, 1 hepatitis, 1 PD). There were 12 failures, 6 PR with NTMq, 22 CR (41%; 4 cCR + 17 pCR + 1 sCR). Two pts relapsed. The 1- and 2-yr survival rates are 76% and 61%, respectively. The CR rate in arm A is significantly higher than in arm B (p = 0.01). However, the survival rates in arms A and B are not statistically different (p = 0.1). After 2 cycles of PVeBV, 9 and 17 pts had NTMq in arms A and B, respectively. After 1 or 2 additional cycles of PVeBV, 29 additional pts had NTMq in arm A as did 11 pts after HDCT + ABMT in arm B. Conclusion: This randomized multicenter study does not show any benefit of early HDCT + ABMT to increase CR rate and survival in poor-risk NSGCT.
Keywords: Antineoplastic Agents, Combined/*THERAPEUTIC USE Bleomycin/ADMINISTRATION & DOSAGE *Bone Marrow Transplantation Cisplatin/ADMINISTRATION & DOSAGE Etoposide/ADMINISTRATION & DOSAGE Human Teratoma/DRUG THERAPY/SURGERY/*THERAPY Testicular Neoplasms/DRUG THERAPY/SURGERY Transplantation, Autologous Vinblastine/ADMINISTRATION & DOSAGE ABSTRACT MULTICENTER STUDY RANDOMIZED CONTROLLED TRIAL CLINICAL TRIAL

KWDantineoplasticagents,combined/KWDtherapeuticusebleomycin/administration&dosageKWDbonemarrowtransplantationcisplatin/administration&dosageetoposide/administration&dosagehumanteratoma/drugtherapy/surgery/KWDtherapytesticularneoplasms/drugtherapy/surgerytransplantation,autologousvinblastine/administration&dosageabstractmulticenterstudyrandomizedcontrolledtrialclinicaltrial
921130
M92B0888

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