Nedaplatin (N) and nab-paclitaxel (nab-P) are efficacious in the treatment of non-small cell lung cancer (NSCLC), especially squamous cell lung cancer. Although a combination of N and nab-P was expected in the treatment of squamous cell lung cancer, there was no sufficient data.
The eligibility criteria were no prior chemotherapy; stage IIIB or stage IV squamous cell lung cancer; a performance status (PS) of 0–1; 75 > age > 20 years; and adequate hematologic, hepatic, and renal function. Patients (pts) received escalating doses of nab-P under a fixed dose of N (100 mg/m2, day 1) every 3 weeks in the phase I part. The initial dose of nab-P was 100 mg/m2 of day 1, 8 (level 1), and that of the next dose was 100 mg/m2 of day 1, 8, 15 (level 2). In the phase II part, pts received the recommended dose (RD) of N/nab-P. The primary endpoint was tumor response, which was measured using Response Evaluation Criteria in Solid Tumors 1.1.
Five pts were enrolled in the phase I part. Three pts of level 1 have experienced no dose-limiting toxicities (DLTs). Two pts of level 2 have experienced DLTs, which were febrile neutropenia and the down of PS, respectively. Therefore, level 1 was determined to RD. 23 pts were enrolled in phase II part. Three pts in level 1 and 23 pts in phase II were evaluable, together. Partial response, stable disease, and progressive disease were noted in 21, 0, and 2 pts, respectively, yielding a response rate of 91.3% (95%confidence interval [CI]: 72.0–98.9). The median progression-free survival was 223 days (95%CI: 144–330), and the median survival time was 358 days (95%CI: 255–950). The grade 3 and 4 toxicities observed during all cycles were neutropenia (5 and 9 pts), anemia (6 and 2 pts), thrombocytopenia (5 and 3 pts). Grade 3 febrile neutropenia, pneumonia, and acute coronary syndrome were observed in 1, 2, and 1 pts, respectively. However, there was no treatment related death.
A combination of N (100 mg/m2, day 1) and nab-P (100 mg/m2, day 1, 8) every 3 weeks was the recommended dose. N/nab-P in this recommended dose appears to be efficacious and torerable in patients with untreated advanced squamous cell lung cancer.
Clinical trial identification
Legal entity responsible for the study
Kanto Respiratory Disease Study Group (KRSG)/JAPAN.
Has not received any funding.
All authors have declared no conflicts of interest.