Tata Memorial Centre, Mumbai, India
Vivek Agarwala , Vijay Maruti Patil , Vanita Noronha , Amit Joshi , Anuradha Chougule , Vaishakhi Trivedi , Rajiv Kumar , Sucheta More , Supriya Goud , Amit Janu , Abhishek Mahajan , Kumar Prabhash
Background: Both Pemetrexed and Erlotinib have shown survival benefit when used as maintenance therapy in advanced non small cell lung cancer (NSCLC) after platinum doublet chemotherapy. Hence this study was planned to compare the outcomes between the 2 drugs. The current abstract is focused on quality of life (QOL) results. Methods: This was a open label, randomized, phase 3 study done in adult palliatively treated EGFR-negative, NSCLC patients who had non progressive disease post administration of first line chemotherapy Pemetrexed-Carboplatin. Patients were 1:1 randomized between tablet Erlotinib 150 mg orally administered once daily versus injection Pemetrexed 500 mg/m2 administered intravenously every 3 weeks. The therapy was continued either till disease progression or development of intolerable side effects. The primary endpoint was to compare the QOL between the 2 arms at 3 months. Other secondary endpoints were to study and compare the progression free survival (PFS), overall survival (OS) and adverse event rate. We had 200 patients in this study and the sample size had 80% power, with type 1 error of 5% to detect a difference of 0.3 in effect size. Results: Total 200 patients were recruited in the study. The median follow up was 25.37 months (95%CI 21.4-29.3 months). There was no difference in global QOL between the 2 arms at 3 months (p=0.384). There was no difference in any domain of QOL except a higher score for diarrhea was seen in the Erlotinib arm (p=0.001). The PFS (HR 0.99; 95% CI 0.73-1.34, p=0.939) and OS (HR 0.88; 95%CI 0.62-1.27, p=0.493) were similar between both the arms. Conclusion: Maintenance Pemetrexed post Pemetrexed-Platinum chemotherapy fails to improve QOL or time to event outcomes (OS & PFS) over maintenance Erlotinib in EGFR mutation negative advanced NSCLC. Clinical trial information: CTRI/2014/08/004847.
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