Biweekly Carboplatin and Paclitaxel as First-Line Therapy for Elderly Advanced Non-Small Cell Lung Cancer Patients (Phase II Study)

ABSTRACT Background Incidence of elderly patients with advanced non-small cell lung cancer (NSCLC) is increasing, however the treatment for elderly patients is still waiting for the best answer. Although several studies had suggested the advantage of chemotherapy with platinum doublet for elderly patients with advanced NSCLC (e.g. Quoix E, et al., The Lancet 378, 2011), the application of platinum doublet to the elderly is still controversial. To evaluate the efficacy and tolerability of combination chemotherapy with biweekly carboplatin (CBDCA) and paclitaxel (PTX) for elderly patients with advanced NSCLC, we conducted a multicenter non-randomized open label phase II trial. Methods Eligibility criteria were as follows; histologically proven NSCLC, aged 70 years and older, ECOG Performance Status (PS) of 0 to 2, clinical stage IIIB and IV, chemotherapy naive, and adequate organ function. Patients received CBDCA (AUC = 2.5) and PTX (90 mg/m2) on day 1 and 15 every 4-week for up to 6 cycles, until disease progression or intolerable toxicity. The primary endpoint was ORR, and the secondary endpoints were PFS, OS and tolerability. Results 60 patients (median age 78 years old, range 70-85) were enrolled. 45 patients were male and 45 were stage IV. PS 0/1/2 were 26/30/4, respectively. The median number of treatment cycle was 3 (1-6). CR/PR/SD/PD were 0/28.9/37.8/33.3% as the best response, giving an ORR of 28.9 % and DCR of 66.7%. Median PFS and OS were 5.3 month (95% CI: 3.1-7.5) and 26.7 month (95% CI: 18.2-35.1), respectively. Grade 3/4 hematological toxicities were neutropenia (27%), leucopenia (15%) and anemia (8%). Grade 3 non-hematological toxicities were infusion reaction (2%), anorexia (2%), infection (10%), thrombosis (2%), fatigue (3%), diarrhea (2%) and gastrointestinal bleeding (3%). Although no grade 4 non-hematological toxicity was observed, one patient died probably due to treatment-related interstitial pneumonitis. The adverse events were relatively mild and manageable. Conclusions The combination of biweekly CBDCA (AUC = 2.5) and PTX (90 mg/m2) was effective and well tolerated for elderly patients with advanced NSCLC. (This study was registered at UMIN 000001328) Disclosure All authors have declared no conflicts of interest.