7538 Background: Currently, the recommended treatment for inoperable stage III non-small cell lung cancer (NSCLC) is concurrent chemoradiotherapy (CCRT). The efficacy of consolidation chemotherapy after CCRT needs to be confirmed. The aim of this phase III randomized trial is to determine the efficacy of consolidation chemotherapy with docetaxel (D) and cisplatin (P) following definitive CCRT with the same agents in stage III inoperable NSCLC. Herein we report the pre-planned interim analysis. Methods: Patients with inoperable stage III NSCLC were randomized to either CCRT alone (observation arm) or CCRT followed by consolidation chemotherapy (consolidation arm). N2 or N3 disease was confirmed by PET and/or pathology. CCRT with D (20 mg/m2) and P (20 mg/m2) was administered every week for 6 weeks with a total dose of 66 Gy of thoracic RT as 33 fractions. In the consolidation arm, patients were further treated with 3 cycles of D and P (35 mg/m2 each on day 1 and 8, every 3 weeks). The primary endpoint is time to progression (TTP). Total target number of patients is 458. Results: From Oct 2005 to Mar 2008, 233 patients were enrolled and 226 were randomized (observation 112; consolidation 114). Patients’ characteristics were similar in both arms. In the consolidation arm, 83 patients (73%) received consolidation chemotherapy, of whom 52 (45%) completed 3 planned cycles. Grade 3–4 neutropenia occurred in 5.4% of 203 consolidation cycles. Common non-hematologic toxicities of all grades during consolidation were anorexia (47%), nausea (37%), vomiting (16%), fatigue (35%) and esophagitis (31%). At the time of this analysis, there were 40 and 41 deaths in the observation and consolidation arms, respectively. Treatment-related mortality rates were similar. With a median follow-up of 28.2 months, the median TTP was 9.0 months in the observation arm and 13.9 months in the consolidation arm (P=0.19). Median overall survival was 20.7 and 21.2 months, respectively (P=0.49). Conclusions: This interim analysis suggests that consolidation chemotherapy with DP after CCRT with weekly DP is feasible and relatively well tolerated. Patient enrollment is ongoing. No significant financial relationships to disclose.
MA 17.11 Prediction of Response to Trimodality Therapy Using CT-Derived Radiomic Features in Stage III Non-Small Cell Lung Cancer (NSCLC)
