Evaluation of optimal duration of chemotherapy in favorable-prognosis disseminated germ cell tumors: a Southeastern Cancer Study Group protocol.

Abstract

Four courses of PVP16B (cisplatin plus etoposide [VP-16] plus bleomycin) has been standard chemotherapy for disseminated germ cell tumors at Indiana University and the Southeastern Cancer Study Group (SECSG) since 1984. We began a random prospective phase III study in patients with favorable-prognosis (minimal and moderate extent) disseminated germ cell tumors comparing four courses of PVP16B over 12 weeks to the identical dose PVP16B administered in three courses over 9 weeks. The categories of minimal and moderate disease constitute approximately two thirds of all disseminated germ cell tumors that require chemotherapy. One hundred eighty-four patients entered this trial, and all patients have a minimal follow-up of 1 year. Overall, 106 of 107 (99%) minimal extent and 73 of 77 moderate patients (95%) achieved an initial disease-free status (NED), confirming the favorable prognostic categories. Eighty-six of 88 patients (98%) randomized to three courses and 93 of 96 randomized to four courses (97%) of PVP16B achieved disease-free status. There have been ten relapses (5%), with five on each arm. Currently, 81 of 88 (92%) and 88 of 96 (92%) patients randomized to three v four courses of PVP16B are continuously disease-free. This study confirms the high cure rate with PVP16B in favorable-prognosis germ cell tumors. The deletion of the fourth course of PVP16B significantly reduces the toxicity, cost, and inconvenience of this curative regimen. We conclude that three courses of PVP16B is the preferred regimen for favorable-prognosis germ cell tumors.

Bleomycin, Etoposide and Cisplatinum (BEP) Chemotherapy for Metastatic Germ Cell Tumours: Treatment Outcomes at UKM Medical Centre, Malaysia

“…The EORTC/ MRC trial with 812 patients comparing 3 to 4 cycles of BEP chemotherapy found equivalent efficacy and toxicity between the two arms (de Wit et al, 2001). An earlier US trial compared 3 and 4 cycles of BEP in 184 patients and found similar survival but less toxicity with the shorter treatment arm (Einhorn et al, 1989).…”

Clinicopathological Features and Survival of Young Turkish Patients with Testicular Germ Cell Tumors

“…Only a minority of the patients (13.5%) relapsed. Previous studies reported a relapse rate ranging between 6% and 14% (Einhorn et al, 1989 et al. 1998;de Wit et al, 2001;Bokemeyer et al, 2004;Kondagunta et al, 2005;Culine et al, 2007;Grimison et al, 2010).…”

Experience with dose and schedule variations in germ cell tumors

“…In the previously-m entioned study of 184 patients w ho received either three or four BEP cycles, one patient died from chem o th erap y -related sep sis. 19 As it apco n sid ered the gold stan d ard c h e m o th e ra p y in pears from this latter study that the efficacy of three…”