Efficacy and toxicity profile of maintenance pemetrexed in patients with stage IV adenocarcinoma lung in Indian population

Abstract

Context:Lung cancer has been the most common cancer in the world for several decades. Pemetrexed is recommended as an option for the maintenance treatment in metastatic adenocarcinoma lung, if disease has not progressed immediately following platinum-based chemotherapy.Aims:To study efficacy and toxicity profile of pemetrexed as a maintenance chemotherapeutic agent in patients with stage IV adenocarcinoma lung, not progressing after first line chemotherapy. Settings and Design: This was an observational, prospective. We enrolled patients with stage IV adenocarcinoma lung who has not progressed on first line chemotherapy, from September 2013 to August 2014 at a tertiary care cancer institute in North India.Materials and Methods:In all, 108 patients with stage IV adenocarcinoma lung were started on induction pemetrexed/platinum chemotherapy. 60 patients with no disease progression & ECOG PS 0-2 were started on Pemetrexed maintenance. Progression free survival (PFS) and toxicity profile were recorded.Results:The mean number of maintenance cycles was 8.3 (range 2-28). 13 (21.6%) patients took >10 maintenance cycles. Pemetrexed maintenance therapy resulted in progression free survival (PFS) of 5.4 months. PFS on pemetrexed was consistent for all patient subgroups, including induction response: complete/partial responders (n-31) and stable disease (n-29). 14 patients had grade III/IV adverse events with anemia being the most common in 3/60 patients (5%). 3 patients (5%) developed renal dysfunction out of which 1 was grade III.Conclusions:Pemetrexed continuation maintenance chemotherapy is active and well tolerated. Pemetrexed maintenance should be considered in patients with advanced adenocarcinoma lung patients who have not progressed on completion of induction chemotherapy.

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“…Pemetrexed maintenance therapy resulted in PFS of 5.4 months. [30] One of the two other smaller retrospective studies with 36 patients incorporating maintenance chemotherapy showed survival benefit over 6 months compared to no maintenance therapy. [20,31] The benefit may have been overestimated due to case selection bias of maintenance therapy in better PS and fewer number of patients in the above retrospective case audits [ Table 2].…”

“…Phase III randomized trial 3% 4.1 13.9 0.6% 2.8 (P=0.001) 11 (P=0.01) Pandey A et al [28] Maintenace Pemetrexed (188) Retrospective -8 20 Pankaj G et al [30] Maintenance Pemetrexed (60) Retrospective -5.4 NR Murali et al [31] Maintenance Pemetrexed (26) Retrospective -9.6 24.6 Profile-1014 [35] Pemetrexed/platinum combination 343 74% vs 45% 10.9 vs 7 motnhs Alectinib Alex [50] Crizotinib 303 25.7 months vs. 10.4 months Ceritinib Ascend-4 [51] Pemetrexed/platinum combination 376 72.5% vs 26.7% 16.6 vs 8.1 months Murthy et al conducted a retrospective observational study on 341 Indian patients with lung adenocarcinoma to determine the clinical features and outcomes of ALK-positive patients. [55] Thirty-seven patients were ALK-positive by fluorescence in situ hybridization, of which 27 received crizotinib therapy.…”