1215 - Phase I Trial of Combination Chemotherapy of Pemetrexed Plus Cisplatin and Concurrent Thoracic Radiotherapy in Patients with Locally Advanced Non-Squamous Non-Small-Cell Lung Cancer: Post-Hoc Analysis for Survival and Recurrent Sites

Abstract

ABSTRACT Background Combination chemotherapy of pemetrexed (PEM) plus cisplatin (CDDP) is established as a standard treatment for advanced non-squamous (Non-Sq) non-small-cell lung cancer (NSCLC). PEM has radiosensitizing potential when evaluated in vitro in combination with platinum-containing compounds and radiation. Our previous phase I trial demonstrated that combination chemotherapy of PEM plus CDDP with concurrent thoracic radiotherapy (TRT) at a total dose of 66Gy was well tolerated in patients with locally advanced Non-Sq NSCLC, and the response rate was 83% (The European Multidisciplinary Cancer Congress 2011, #9060). We conducted a post-hoc analysis of progression-free survival (PFS) and recurrent sites in those patients who were enrolled in the phase I trial. Methods Patients received PEM 500mg/m2 plus CDDP 75mg/m2 on day 1 of a 21-day interval for 3 cycles and concurrent TRT of 60Gy (n = 6) or 66Gy (n = 12) followed by consolidation PEM 500mg/m2 of a 21-day interval for 3 cycles. We reviewed the medial records to collect data on progression, recurrent sites, late toxicity and survival. Results Between November 2008 and December 2010, 20 patients were enrolled in this study, and 18 patients received the protocol treatment. No late radiation morbidity was observed. 12 patients had progressed, and recurrence included distant metastases (n = 7), local (n = 7) (in the radiation field (n = 6), out of the radiation field (n = 2), and both (n = 1)), and local plus distant sites (n = 2). Median PFS was 10.5 months (95% confidence interval: 8.7-12.3), and 2-year PFS rate was 32%. Median follow-up time for censored cases was 21.8 months (range: 17.2-35.6 months). Overall survival data will be presented. Conclusions Median PFS in our study was comparable with that in historical controls of chemoradiotherapy. Disclosure All authors have declared no conflicts of interest.