Platinum-based combination therapy improved survival in elderly patients with NSCLC

Quoix E. Lancet. 2011;doi:10.1016/S0140-6736(11)60780-0.

Issue: September 10, 2011

Elderly patients with non–small cell lung cancer may experience improved survival with platinum-based doublet chemotherapy compared with vinorelbine or gemcitabine monotherapy, despite increased toxic effects.

Researchers reported improvements in OS, PFS and response rates.

ASCO guidelines from 2004 recommend monotherapy for elderly patients with NSCLC based on phase 3 trial data demonstrating superior results with vinorelbine or gemcitabine as monotherapy. Non-platinum-based doublet chemotherapy with gemcitabine plus vinorelbine was associated with higher risk for toxicity compared with monotherapy. However, subgroup analyses of young and elderly patients have demonstrated that platinum-based doublet chemotherapy increases survival in older people. Therefore, researchers conducted a multicenter, open-label, phase 3, randomized trial to compare carboplatin and paclitaxel doublet therapy with monotherapy in this age group.

The study included 451 patients aged 70 to 89 years with locally advanced or metastatic NSCLC and WHO performance status scores between 0 and 2. Patients received either four cycles of carboplatin plus paclitaxel (n=225) or five cycles of vinorelbine or gemcitabine monotherapy (n=226). The median follow-up was 30.3 months and the primary endpoint was OS.

There was a significant difference in median OS for the doublet chemotherapy (10.3 months) and monotherapy arms (6.2 months; HR=0.64; 95% CI, 0.52-0.78). One-year OS was 44.5% (95% CI, 37.9-50.9) for the doublet chemotherapy arm and 25.4% (95% CI, 19.9-31.3) for the monotherapy arm. One-year PFS was also superior in the doublet arm (13.4%; 95% CI, 9.3-18.3) vs. the monotherapy arm (1.8%; 95% CI, 0.6-4.2). Median PFS was 6.0 in the doublet arm (95% CI, 5.5-6.8) vs. 2.8 in the monotherapy arm (95% CI, 2.6-3.7).

In an accompanying editorial, Karen L. Reckamp, MD, assistant professor of medicine in hematology and medical oncology at the City of Hope’s Beckman Research Institute, said in the context of data from two previous phase 3 trials of combination vs. single-agent therapy in this population, the current study offers useful insights.

“Older patients dominate the lung cancer population, but continue to be under-represented in clinical trials,” Reckamp said. “Additional studies are needed that enroll adequate numbers of older adults, and include a comprehensive geriatric assessment to provide the knowledge required to properly assess the risk-benefit ration in treatment decisions, so that a personalized approach can be taken.”

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