Phase II Trial of Single-Agent Pemetrexed in Chemonaive Elderly Patients with Advanced Non-Small-Cell Lung Cancer (NSCLC) and its Accrual Rate in a Community-Based Clinical Trial Group: LCEN1001

ABSTRACT Background Optimal treatment for elderly patients with advanced NSCLC has been under investigation. This study evaluated the safety and efficacy of single-agent pemetrexed for elderly patients with advanced NSCLC. Moreover, the reasons that prevented accrual and the preferential regimen for such patients in a community-based group were investigated. Patients and methods Chemonaive elderly (≥ 70 years) patients with stage IIIB/IV non-squamous NSCLC received 500 mg/m2 of pemetrexed (day 1, every 3 weeks) for 4-6 cycles. As a QOL assessment, FACT-L lung cancer symptom subscale and Comprehensive Geriatric Assessment were also evaluated. Moreover, clinical trial enrollment decisions were noted. Results From May 2010 to October 2011, 193 consecutive patients were diagnosed as chemonaive elderly (≥ 70 years) patients with stage IIIB/IV non-squamous NSCLC. Among them, 25 patients were enrolled in phase II trial. Characteristics were m/f, 19/6; median age, 78 years (range 70-89); PS 0/1/2, 6/18/1; stage IIIB/IV, 6/19. After a median of 4 cycles of pemetrexed, the ORR and DCR were 16.0% and 68.0%, respectively. Furthermore, the median PFS was 126.0 days and the median OS was not reached. Grade 3/4 hematologic toxicity consisted of leukopenia (20%), neutropenia (24%), thrombocytopenia (4%), and anemia (12%), whereas grade 3/4 nonhematologic toxicity consisted of nausea (4%), anorexia (12%), fatigue (8%), pneumonitits (G3, 8%), febrile neutropenia (0%), and treatment-related death (0%). Among 168 patients who were not enrolled in the trial, 83 and 85 patients were eligible and ineligible, respectively. Therefore, the accrual rate was 25 (23.1%) of 108 eligible patients and 25 (13.0%) of total 193 patients, whereas ineligible rate was 85 (44.0%) of total 193 patients. The most common reason for not participating in the trial despite appropriate eligibility was the preference of platinum doublet chemotherapy (57.8%), whereas the most common treatment choice for ineligible patients was best supportive care (67.1%). Conclusions Single-agent pemetrexed has shown moderate activity and is well tolerated as first-line treatment for advanced NSCLC in elderly patients. However, in our community-based clinical trial group, platinum doublet chemotherapy was the preferential regimen for such patients. Disclosure All authors have declared no conflicts of interest.