Early intensified chemotherapy with autologous bone marrow transplantation in first line treatment of poor risk non-seminomatous germ cell tumours. Preliminary results of a French randomized trial.
For 30 months we have treated 115 non-pretreated non-seminomatous germ cell tumour (NSGCT) patients with poor risk characteristics. Patients were allocated randomly to either arm A: NCI regimen with vinblastine, etoposide (E), bleomycin and double dose cisplatin (P2) (PVeBV) 3 or 4 cycles Q3W, or arm B: modified PVeBV protocol (bleomycin in continuous infusion) Q4W than a cycle of high-dose E + cyclophosphamide + P2 (PEC) and autologous bone marrow transplantation (ABMT). 114 patients are evaluable: 81 testicular, 18 mediastinal and 15 retroperitoneal primaries.


RESULTS
Arm A 57 patients: 7 patients did not complete the treatment. There were 15 failures, 9 PR, 33 CR. Seven patients relapsed. The 2-year survival is 82%. Arm B 57 patients: 16 patients did not complete the treatment. There were 26 failures, 7 PR and 24 CR. Nine patients relapsed. The 2-year survival is 60%. Both CR rates and survival are not statistically different. This trial fails to show any benefit of early intensified chemotherapy + ABMT to increase the CR and survival rates in poor risk NSGCT.
Chevreau
C
C
Centre Claudius Regaud, Toulouse, France.
Droz
J P
JP
Pico
J L
JL
Biron
P
P
Kerbrat
P
P
Cure
H
H
Héron
J F
JF
Chevallier
B
B
Fargeot
P
P
Kramar
A
A
D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000097:blood; D016026:Bone Marrow Transplantation; D003131:Combined Modality Therapy; D006801:Humans; D008297:Male; D008479:Mediastinal Neoplasms / Q000628:therapy; D009373:Neoplasms, Germ Cell and Embryonal / Q000097:blood / Q000556:secondary / Q000628:therapy*; D012074:Remission Induction; D012186:Retroperitoneal Neoplasms / Q000628:therapy; D012306:Risk; D013736:Testicular Neoplasms / Q000628:therapy
D014408:Biomarkers, Tumor