O2-016 - Phase I Trial of Combination Chemotherapy of Pemetrexed (PEM) Plus Cisplatin (CDDP) and Concurrent Thoracic Radiotherapy (TRT) Followed by PEM Consolidation Therapy in Patients with Locally Advanced Non-Squamous (NON-SQ) Non-Small-Cell Lung Cancer (NSCLC): Post-Hoc Analysis for Progression-Free Survival (PFS) and Recurrent Sites

Abstract

ABSTRACT Background Combination chemotherapy of PEM plus CDDP is established as a standard treatment of advanced non-Sq 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 TRT at a total dose of 66 Gy 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 PFS and recurrent sites in those patients who were enrolled in the phase I trial. Methods Patients received PEM 500 mg/m2 plus CDDP 75 mg/m2 on day 1 of a 21-day interval for three cycles and concurrent TRT of 60 Gy (n = 6) or 66 Gy (n = 12) followed by consolidation PEM 500 mg/m2 of a 21-day interval for three 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. Twelve 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% CI 8.7 to 12.3), and the 2-year PFS rate was 32%. The median follow-up time for censored cases was 21.8 months (range: 17.2–35.6 months). Conclusions Median PFS in our study was comparable with that in historical controls of chemoradiotherapy.