Phase III trial of cisplatin (P) plus etoposide (E) plus concurrent chest radiation (XRT) with or without consolidation docetaxel (D) in patients (pts) with inoperable stage III non-small cell lung cancer (NSCLC): HOG LUN 01-24/USO-023-Updated results.

7519 Background: Concurrent chemoradiation is standard treatment for pts with inoperable stage III NSCLC. We present updated results from a previously reported randomized phase III trial comparing EP/XRT with or without consolidation D (Hanna et al. ASCO 2007).,Eligible pts had inoperable, stage IIIA/B NSCLC, PS 0-1, FEV-1 ≥ 1 L, and < 5% wt loss. Pts (n=243) received P 50 mg/m iv d 1,8,29,36 and E 50 mg/m iv d1-5, 29-33 concurrently with chest XRT to 5940 cGy. Non- progressing pts were randomized to D 75 mg/m iv every 21d for 3 cycles vs observation (O). The primary endpoint was to compare overall survival (OS) by Kaplan-Meier analysis. Accrual of 259 pts to randomize180 was planned to show a difference in median survival time (MST) of 25 vs 15 mos (5% 2-sided alpha, 80% power). Accrual reached 243 pts; however the DSMB recommended early termination, after analysis of 203 pts, based upon evidence of futility (p>0.7271).,Characteristics for all pts entered (n=243) were similar to pts evaluated by the DSMB (n=203): F: M 34%/66%; median age 63; PS 0/1 59.7%/40.3%; IIIA/B 41.2%/58.8%; FEV-1 >2 47.7%. Characteristics of all randomized pts (n=166; O arm: n=84; D arm: n=82) were similar to pts evaluated by the DSMB (n=147; O arm: n=74; D arm: n=73). Toxicities during EP/XRT and consolidation D were previously reported for the 203 pts evaluated by the DSMB. Similar rates of toxicities were observed for the entire cohort receiving EP/XRT and pts randomized to D. Updated survival rates for the previously reported pts evaluated by the DSMB as well as survival data for all pts entered and randomized are reported in Table 1 .,Our updated results confirm our prior conclusion that consolidation D does not improve survival following EP/XRT, is associated with significant toxicities and can no longer be considered as standard treatment for pts with inoperable stage III NSCLC. [Table: see text] [Table: see text].