Publication | Closed Access
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
60
Citations
0
References
2007
Year
Radiation MedicineOncologyRadiation TherapyEligible PtsConsolidation DocetaxelPhase Iii TrialClinical TrialsConcurrent Chest RadiationConcurrent ChemoradiationCancer TreatmentLung CancerClinical Radiation OncologyMedicineRadiation OncologyNuclear MedicineChest XrtRadiologyHealth Sciences
7512 Background: Concurrent chemoradiation is standard treatment for pts with inoperable stage III NSCLC. A previously reported single-arm, phase II study by SWOG (Gandara et al JCO 2003) suggested D following EP/XRT further improved survival. We report results from a randomized, prospective phase III trial comparing EP/XRT with or without consolidation D. Methods: 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 2 iv d 1,8,29,36 and E 50 mg/m 2 iv d1–5, 29–33 concurrently with chest XRT to 5940 cGy. Non-progressing pts were randomized to D 75 mg/m 2 iv every 21 d for 3 cycles vs observation (O). The primary endpoint was to compare OS (Kaplan-Meier analysis). Accrual of 259 pts to randomize180 was planned to demonstrate a difference in MST of 25 vs 15 mos (5% 2-sided alpha, 80% power). Based upon evidence of futility (predefined as p>0.7271), a DSMB recommended early termination after an analysis of the initial 203 pts. Results: Median f/u 25.6 mos. Pt characteristics (n=203): 34%/66% F:M; median age 63; 39.4%/60.6% IIIA/B. G3/4 toxicities during EP/XRT included 9.8% febrile neutropenia (FN), 17.2% esophagitis. 147 of 203 pts (72.4%) were randomized to D (n=73) or O (n=74). G3/4 toxicities during D included: 10.9% FN, 8.2% pneumonitis. 28.8% of pts were hospitalized during D (vs 8.1% in O arm) and 5.5% died due to D. PFS for D was 12.3 vs 12.9 mos for O (p=0.9412). The MST for all pts was 21.15 mos; MST for D was 21.6 mos (95% C.I. 17.7–35) vs 24.2 mos for O (95% C.I. 18.1–34.4) (p=0.9402). Conclusions: The MST with EP/XRT was higher than historical controls; however, consolidation D does not further improve survival, is associated with significant toxicity including an increased rate of hospitalization and premature death, and should no longer be used for pts with unresectable stage III NSCLC. [Table: see text]