Phase I/II study of nedaplatin and nab-paclitaxel for patients with previously untreated advanced squamous cell lung cancer: Kanto Respiratory Disease Study Group (KRSG) 1302

Background Nedaplatin and nab-paclitaxel are each efficacious in the treatment of squamous cell lung cancer. Patients and methods Eligibility criteria were: no prior chemotherapy, advanced squamous cell lung cancer; performance status 0-1, age > 20 years but < 75 years, and adequate hematologic, hepatic and renal function. Patients received escalating doses of nab-paclitaxel under a fixed dose of nedaplatin (100 mg/m(2), day 1) every 3 weeks in phase I. The initial nab-paclitaxel dose was 100 mg/m(2) on days 1 and 8 (level 1), and the next dose was 100 mg/m(2) on days 1, 8, and 15 (level 2). In phase II, patients received the recommended doses. The primary endpoint was tumor response rate. Results In phase I, three patients at level 1 experienced no dose-limiting toxicities (DLTs) and two patients at level 2 experienced DLTs. Level 1 was thus determined as the recommended dose. Twenty-three patients were enrolled in phase II. The 3 patients in level 1 and 23 patients in phase II were included together for analyses. Three of these 26 patients were excluded from response analysis due to pneumonia and patient refusal. Response rate was 91.3% (95% confidence interval, 72.0-98.9%). Toxicities observed during all cycles were tolerable. Conclusions The recommended dose for this combination was nedaplatin at 100 mg/m(2) on day 1 and nab-paclitaxel at 100 mg/m(2) on days 1 and 8 every 3 weeks. The combination of nedaplatin and nab-paclitaxel appears safe and efficacious in patients with untreated advanced squamous cell lung cancer.