Open-label, multicenter, randomized phase III trial of pemetrexed/carboplatin doublet vs pemetrexed singlet in chemotherapy-naïve elderly patients aged 70 or more with advanced non-squamous non-small cell lung cancer and good performance status.

9081 Background: We aimed to compare pemetrexed/carboplatin doublet (PC) versus pemetrexed singlet (P) in chemotherapy-naïve elderly patients aged 70 or more with advanced non-squamous non–small-cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. Methods: In an open-label multicenter phase III randomized trial, elderly patients aged 70 or more with advanced non-squamous NSCLC, ECOG PS of 0-1, no prior chemotherapy, adequate organ function and measurable disease were assigned to PC doublet (P, 500 mg/m2; C, area under the curve of 5) or P singlet (500 mg/m2) after stratified randomization according to center, gender and Charson Comorbidity Index (CCI). The treatment was given every 3 weeks till disease progression, unacceptable toxicity or withdrawal of consent. However, carboplatin was given only for the first four cycles. The primary end point was progression-free survival (PFS). Secondary endpoints included overall survival, response rate, and safety. Results: A total of 267 eligible patients were enrolled from six centers between March 2012 and October 2015; median age was 74 years (70~86); 95% had PS of 1; 65% were men; and 63% had CCI of 1 or more. The median PFS was 5.5 months for PC doublet and 4.3 months for P singlet, respectively (hazard ratio [HR], 0.85; 95% CI, 0.64 to 1.12; P = 0.246). The median survival time was 12.5 months for PC and 9.3 months for P, respectively (HR, 1.03; 95% CI, 0.70 to 1.52; P = 0.865). There were 13 deaths (4.9%) during the treatment. Conclusions: The addition of carboplatin to pemetrexed did not show the improvement of survival time in elderly patients aged 70 or more with advanced non-squamous NSCLC and ECOG PS of 0-1. Updated data will be presented. Clinical trial information: NCT01593293.