Phase II Study of Modified Carboplatin Plus Weekly Nab‐Paclitaxel in Elderly Patients with Non‐Small Cell Lung Cancer: North Japan Lung Cancer Study Group Trial 1301

LESSONS LEARNED. Weekly nanoparticle albumin‐bound‐paclitaxel (75 mg/m(2)) in combination with carboplatin (area under the curve 6 mg/mL/min) in elderly patients with previously untreated, advanced non‐small cell lung cancer showed favorable efficacy, was well tolerated, and showed less neuropathic toxicity. This modified regimen offers potential for the treatment of elderly patients. BACKGROUND. The CA031 trial suggested weekly nanoparticle albumin‐bound‐paclitaxel (nab‐PTX) was superior in efficacy to paclitaxel (PTX) once every 3 weeks when combined with carboplatin (CBDCA) for advanced non‐small cell lung cancer (NSCLC) patients; a subgroup analysis of elderly patients looked promising. In a multicenter phase II trial, we prospectively evaluated the efficacy and tolerability of modified CBDCA plus weekly nab‐PTX for elderly patients with untreated advanced NSCLC. METHODS. Eligible patients received CBDCA (area under the curve [AUC] 6 mg/mL/min) on day 1 and nab‐PTX (75 mg/m(2)) on days 1, 8, and 15 every 4 weeks. The primary endpoint was an overall response rate (ORR), and secondary endpoints were progression‐free survival (PFS), overall survival (OS), and toxicity. RESULTS. Of 32 patients (median age of 78 years), 84% were male, 56% had stage IV NSCLC, and 56% had squamous cell carcinoma. ORR and disease control rates were 50% (95% confidence interval (CI): 33–67) and 94% (95% CI: 85–100), respectively. Median PFS and OS were 6.4 months (95% CI: 4.8–8.0) and 17.5 months (95% CI: 11.9–23.1), respectively. Grade ≥3 toxicities were neutropenia (47%), leukopenia (38%), anemia (34%), thrombocytopenia (25%), and anorexia (9%). Febrile neutropenia and treatment‐related deaths were not observed. CONCLUSION. Modified CBDCA plus weekly nab‐PTX demonstrated significant efficacy and acceptable toxicities in elderly patients with advanced NSCLC.