Phase I trial of nedaplatin and S-1 in patients with advanced squamous cell lung cancer

The platinum doublet is considered to be the standard cytotoxic chemotherapy for advanced lung cancer. It has been previously reported that nedaplatin and S-1 have clinical efficacy against squamous cell lung cancer. As the combination of nedaplatin and S-1 has never been studied for advanced squamous cell lung cancer, a phase I trial of this combination in the first-line setting was conducted. Patients who had not received chemotherapy previously, aged ≤75 years and with advanced squamous cell lung cancer were recruited. Nedaplatin was administered intravenously (day 1), and S-1 was orally administered (days 1-14) at a fixed dose based on the body surface area (BSA) <1.25 m², 80 mg/day; BSA=1.25-1.5 m², 100 mg/day; and BSA ≥1.5 m², 120 mg/day. A total of 9 patients were enrolled. The maximum tolerated dose was 80 mg/m² for nedaplatin. At this dosage, dose-limiting toxicity was observed in 2 of the 6 patients. A total of one patient experienced grade 3 thrombocytopenia, and the other patient experienced grade 3 anorexia and grade 3 nausea. The recommended dose for phase II studies was determined as being 70 mg/m² for nedaplatin (clinical trial registration no. UMIN-CTR UMIN000036387).