(ChemotherapyAdvisor) – Patients with relapsed or refractory germ cell tumors achieve durable long-term survival after single or sequential high-dose chemotherapy; however, overall survival at five years with sequential therapy is superior due to fewer toxic deaths, a study published in the Journal of Clinical Oncology online January 30 has found.
Jörg Beyer, MD, of the Klinik für Hämatologie and Onkologie, Berlin, Germany, and colleagues reported on the long-term survival of 211 patients randomly assigned between November 1999 and November 2004 to either one cycle of cisplatin 100mg/m2, etoposide 375mg/m2, and ifosfamide 6g/m2 (VIP) plus three cycles of high-dose carboplatin 1,500mg/m2 and etoposide 1,500mg/m2 (arm A, n=108); or three cycles of VIP plus one cycle of high-dose carboplatin 2,200 mg/m2, etoposide 1,800mg/m2, and cyclophosphamide 6,400mg/m2 (arm B, n=103) followed by autologous stem-cell reinfusion.
Excess treatment-related mortality in arm B stopped the study prematurely. At six years after random assignment of the last patient, long-term progression-free survival (PFS) and overall survival (OS) were compared. As of December 2010, 94 of 211 patients (45%) were alive, 88 (94%) of whom were progression free; 9 (5%) were lost to follow-up. Five-year PFS was 47% in arm A and 45% in arm B (HR 1.16); and 5-year OS was 49% in arm A and 39% in arm B (HR 1.42; P=0.057).
“This analysis confirms that relapses or progressions after two years are rare events and supports the concept that PFS at two years can be used as a surrogate marker for long-term remission or cure in patients with relapsed or refractory germ cell tumors,” the investigators concluded.