Efficacy and safety of pemetrexed (P) in elderly cancer patients (pts)
8544 Background: P, a novel multitargeted antifolate, has demonstrated antitumor activity in a broad range of tumor types. Approximately 60% of all new cases of cancer and 70% of all cancer-related deaths occur in the elderly population. However, few studies have specifically analyzed the utility of chemotherapy in this population. The objective of this posthoc analysis was to understand the efficacy and tolerability of pemetrexed (alone or in combination) when used in the elderly cancer population. Methods: Data from three pemetrexed registration trials conducted between April 1999 and February 2003 were pooled together. Pts in these studies were diagnosed with malignant pleural mesothelioma, NSCLC, or advanced pancreatic cancer. Pts receiving P as monotherapy or in combination with another drug (gemcitabine or cisplatin) who received at least one cycle of therapy were included in this analysis (n=764). In all studies, P 500 mg/m2 was administered every 21 days. Demographics, efficacy, and safety data from pts receiving P were stratified by age ± 65 years. Kaplan-Meier method was used to estimate survival and time to PD. Cox regression model was also used to test the survival effect of pemetrexed on age after adjusting for disease stage, performance status, gender, and type of tumors, the prognostic factors considered to influence survival. Results: * P<.05 from fisher’s exact test. The adjusted hazard ratio of elderly patients over younger patients was 1.074 with p-value 0.42. Conclusions: P produced similar treatment effects in older and younger patients and appeared to be well tolerated in the elderly population. CTC grade 3/4 Lab and Non-Lab toxicity between two age groups were similar except, as expected, the elderly group had modestly higher myelosuppression. Non-hematologic toxicities were similar between the two age groups. [Table: see text] [Table: see text]