Does the kinetic of tumor marker decline predict outcome in patients with relapsed disseminated germ-cell tumors treated by high-dose or conventional chemotherapy? An analysis of the IT94 randomized trial

Abstract

5085 Background: Conventional dose chemotherapy is the standard salvage therapy for patients with progressive or relapsed germ-cell tumors (GCT). The IT94 phase III randomized trial compared conventional chemotherapy (4 cycles of cisplatin, ifosfamide, and vinblastine [VeIP]) with high-dose chemotherapy (3 cycles of VeIP followed by 1 cycle of high-dose carboplatin, etoposide, and cyclophosphamide [PEC]). Early serum tumor marker decline during chemotherapy was previously shown to predict survival in patients with poor prognosis disseminated non-seminomatous GCT in first line. The aim of this study was to assess whether serum tumor marker decline also correlates with outcome in the salvage setting. Methods: Serum tumor markers were obtained before chemotherapy and after two cycles of treatment from 235 patients accrued in the IT94 trial (114 and 121 in the 4VeIP and the 3 VeIP+PEC arms, respectively). The decline of serum alfa-fetoprotein (AFP) and human chorionic gonadotropin (hCG) was assessed and class...