Abstract

Results: Of 154 screened, 95 were eligible (53 RT and 42 control). Demographics: median age 67 yrs, 54% female, 96% white, and 91% current / former smokers. Operations consisted of 56% lobectomy, 26% pneumonectomy, and 18% segmentectomy/wedge. Adjuvant doublet consisted of 48% taxane, 32% gemcitabine, or 20% other. Mean RT dose 54.8 Gy, median follow-up 3.5 yrs. Histology: 64% adeno, 25% squamous, 10% large-cell. Mean tumor volume 58 cm, 77% pN2, 58% had angiolymphatic invasion and 51% were poorly-differentiated. Mean preoperative PET SUVmax was 9.5. No imbalance in clinical factors was observed between RSI-good vs RSI-poor. On univariate analysis, for RT group, median DFS for RSI-good vs RSI-poor was 5.8 yrs vs 1.4 yrs (HR Z 4.2, 95% CI Z 1.9 9.5, p Z 0.02). Five-year DFS was 63% vs 22%, p Z 0.01. No significant difference was observed for the chemo-only control group, with median DFS for RSI-good vs RSI-poor: 2.3 vs 2.7 yrs (HR Z 0.7, 95% CI Z 0.3 1.6, p Z 0.98). A test for interaction confirmed that the effect was restricted to the RT group and not the control, with p Z 0.04. On multivariate analysis, for the RT group, the RSI remained an independent predictive variable with HR Z 3.8 (95% CI Z 1.6 9.2, p Z 0.003). For E1, 486 screened, 74 eligible. median DFS for RSI-good vs RSI-poor in RT group was 2.0 yrs vs 0.8 yrs, HR Z 2.2 (95% CI Z 1.0 4.8, p Z 0.05). For E2, 139 screened, 26 eligible, median DFS for RT group 12.1 vs 0.7 yrs, HR Z 3.6 (95% CI Z 0.6 10.1, p Z 0.18). No association trend was identified in either control group. By random effects model, the predictive effect of RSI was consistent across all three RT groups, with summary HR Z 1.6 (95% CI Z 1.3 2.1), Q Z 1.33. Conclusions: RSI appears to be predictive for benefit from adjuvant radiation. Additional independent prospective validation is required. Author Disclosure: B. Creelan: A. Employee; H. Lee Moffitt Cancer Center, Clinical Instructor. E. Research Grant; University of South Florida Graduate Medical Education Grant Initiative 0018449. S.A. Eschrich: A. Employee; H. Lee Moffitt Cancer Center, Faculty. C. Partner; Co-founder, CvergenX, Inc. K. Advisory Board; Co-founder, CvergenX, Inc. Q. Patent/ License Fee/Copyright; US 20130344169, US 20120041908, US 20120053911, US 7,879,545, US 20100240540, US 20090076734, US 20080234946, and US 20060195269. R. Ownership Other; Co-founder, CvergenX, Inc. W.J. Fulp: A. Employee; H. Lee Moffitt Cancer Center. J.F. Torres-Roca: A. Employee; H. Lee Moffitt Cancer Center Faculty. C. Partner; Co-Founder and Chief Scientific Officer, CvergenX, Inc. K. Advisory Board; Co-Founder and Chief Scientific Officer, CvergenX, Inc. Q. Patent/License Fee/Copyright; Awarded patent 12/053,796. R. Ownership Other; Co-Founder and Chief Scientific Officer, CvergenX, Inc.

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