In an editorial accompanying the study, Dr. Karen L. Reckamp wrote that although older patients dominate the lung cancer population, they nevertheless continue to be underrepresented in clinical trials. Accounting for 47% of the U.S. adults with cancer, patients aged 70 years or older constitute just 13% of patients who are enrolled in clinical trials, according to the Southern Italy Cooperative Oncology Group (SICOG).
Nevertheless, there are some studies that provide guidance, she wrote.
A study by the SICOG compared vinorelbine alone with vinorelbine plus gemcitabine in patients aged 70 years and older (J. Clin. Oncol. 2000;18:2529-36). "Combination chemotherapy resulted in a significantly lower risk of death," she wrote. "Adverse events were greater in the combination group, but patients had a delay" in quality of life deterioration.
A second investigation, MILES (Multicenter Italian Lung Cancer in the Elderly Study), compared vinorelbine or gemcitabine alone or in combination. "Combination therapy did not improve overall survival and was more toxic than was either single-agent regimen," wrote Dr. Reckamp.
A third study from Japan was stopped because of futility when the interim analysis showed inferior survival with increased toxic effects in patients who were treated with weekly cisplatin and docetaxel vs. docetaxel every 3 weeks (J. Clin. Oncol. 2011;29:abstract 7509).
"The appropriate assessment to predict efficacy and toxic effects of therapy has not yet been identified," said Dr. Reckamp. As previous trials assessed multiple regimens with fractionated doses and non–platinum-based doublets, "the optimum chemotherapy regimen remains unknown, she added, concluding that "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 ratio in treatment decisions, so that a personalized approach can be taken."
Dr. Reckamp is at the City of Hope Comprehensive Cancer Center in Duarte, Calif. She disclosed consulting for Amgen, Genentech, and Tragara Pharmaceuticals, as well as serving on speakers bureaus for Lilly Oncology and Genentech. These remarks were adapted from an editorial that accompanied the study (Lancet 2011 Aug. 9 [doi:10.1016/S0140-6736(11)61259-2]).
