7559 Background: Consolidation chemotherapy following concurrent CRT may improve systemic control and possibly prolong survival of pt with stage III NSCLC. Phase II study using docetaxel showed promising result but subsequent phase III study was negative. We explored the role of single agent gemcitabine (G) and combination with carboplatin (C) as consolidation chemotherapy. Methods: Study was conducted by Asian mutli-center group. Eligible criteria: stage IIIA/B, histologic/cytologic confirmed NSCLC, completed concurrent CRT according to preset cisplatin and RT doses, attained CR/PR/SD from CRT, randomized within 6 weeks from last day of CRT, ECOG 0–1, adequate organ function, no brain met. Exclusion: unresolved radiation pneumonitis/esophagitis. Randomized to G at 1250mg/m2 day 1,8 q21d x3 or G at same dose plus C at 5 x AUC at day 1 x3. Primary and 2nd end points are 2-yr survival rate, median survival and toxicity, respectively. Sample size was estimated to detect a 15% difference in 2 yrs survival rate. Results: Between 3/04 and 6/06 we screened 111 pts and enrolled 61. 10 pts were excluded because of unresolved pneumonitis/esophagitis. Pt characteristics are similar between 2 arms.(Table) Median age: 56. Dose of RT/cisplatin during CRT were similar. 3 pts in G arm skipped day 8 G while 10 in GC arm (p=0.16). 3 pt and 2 pt attained higher response status during G and GC respectively, while 3 and 4 pt progressed. Survival outcomes are similar. More hematologic toxicity in GC arm (G3/4 Anemia 3 v 44%; Neutro 25 v 51%; Plat 15.6 v 31%) 5 out of 61 pt had grade 3/4 post gemcitabine radiation pneumonitis and all 5 are from G arm. Conclusion: It is feasible to give G-based consolidation chemotherapy in selected patients after concurrent CRT. Combination therapy with platinum did not improve survival but it added to myelotoxicity. “Re-call” radiation pneumonitis by gemcitabine is relatively uncommon. Patient Characteristics and Primary Efficacy G (n=32) GC (n-29) p M/F 29/3 26/3 IIIA/IIIB 5/27 7/22 0.4 Adenocarcinoma/Non-adenocinoma 15/17 13/16 0.87 Median # of cycles 2 2 0.84 2 yr survival rate 46.3% 42.2% 0.89 1 yr progression free rate 34.4% 38.7% 0.53 Median survival 1.78 yr 1.75 yr 0.98 Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Abraxis, AstraZeneca, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer, Roche AstraZeneca, Eli Lilly, Merck, Novartis, Pfizer, Roche Bayer, Novartis
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