Multicenter randomized double-blind controlled phase III study of hhpg-19K as prophylactic therapy in patients with advanced non-small cell lung cancer (NSCLC) receiving myelosuppressive chemotherapy.

9614^ Background: HHPG-19K (19K) is a long-acting pegylated recombinant G-CSF that can be dosed only once-per-chemo cycle. The aim of this phase III study was to investigate the efficacy/safety of HHPG-19K as prophylactic therapy in patients with advanced NSCLC treated with myelosuppressive chemotherapy. Methods: Patients were randomized (1:1:1) blindly to three treatment arms to receive 19K 100mg/kg, 6mg fixed dose or CONTROL (saline) in cycle 1. In cycles 2 to 4 following unblinding at the end of cycle 1, patients in CONTROL received short-acting G-CSF at dose of 5μg/kg once daily subcutaneously 48h after chemotherapy while patients randomized in 2 19K arms to receive the same doses as in cycle 1. All patients received 4 cycles of docetaxel (75mg/m2) plus cisplatin (75mg/m2) or carboplatin (AUC=5) per 21 days. The primary endpoint was the incidence of grade 3/4 neutropenia evaluated in cycle 1. Results: 151 chemo-naive patients with histopathology stage III/IV NSCLC enrolled into this study. The distrib...