Gridelli C, et al. - Within a combined analysis of two parallel phase III trials, MILES-3 and MILES-4, researchers tested the effectiveness in elderly patients of adding cisplatin to first-line treatment for advanced non–small-cell lung cancer (NSCLC). In elderly patients with advanced NSCLC, the addition of cisplatin to single-agent chemotherapy did not significantly prolong overall survival, nor did it improve global health status score of quality of life.

Methods

• For this investigation, subjects with advanced NSCLC who were older than age 70 years with Eastern Cooperative Oncology Group performance status 0 to 1 were randomly assigned to gemcitabine or pemetrexed, without or with cisplatin.
• Three hundred eighty-two events were required to detect a hazard ratio (HR) of death of 0.75, with 80% power and two-tailed α of .05 in each trial.
• Trials were closed prematurely because of slow accrual.
• The joint database allowed researchers to study the effectiveness of cisplatin on the basis of intention-to-treat and adjusted by trial, histotype, non-platinum companion drug, stage, performance status, sex, age, and size of the study center.

Results

• Five hundred thirty-one subjects (MILES-3, 299; MILES-4, 232) were assigned to gemcitabine or pemetrexed without (n=268) or with cisplatin (n=263) from March 2011 to August 2016.
• It was observed that median age was 75 years, 79% were male, and 70% had nonsquamous histology.
• Three hundred eighty-four deaths and 448 progression-free survival events were recorded at a median 2-year follow-up.
• Overall survival was not significantly prolonged with cisplatin (HR, 0.86; 95% CI, 0.70 to 1.05; P=.14) and global health status score of quality of life was not improved.
• On the other hand, progression-free survival (HR, 0.76; 95% CI, 0.63 to 0.92; P=.005) and objective response rate (15.5% v 8.5%; P=.02) were significantly better.
• The present data indicated that significantly more severe hematologic toxicity, fatigue, and anorexia were found with cisplatin.