Abstract
7108 Objective: Concurrent chemoradiotherapy using docetaxel has been shown to improve the survival of patients with locally advanced non-small cell lung cancer (NSCLC). We conducted a phase I/II study to identify the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of this regimen and to evaluate the efficacy and safety when administered with concomitant chest radiation (RT) in patients with locally advanced NSCLC. Methods: In a phase I study, standard chest radiotherapy (30 daily 2-Gy fractions for a total of 60 Gy) and concurrent chemotherapy with cisplatin (CDDP) starting at 60 mg/m2 on day 1 every 4 weeks and docetaxel (DOC) starting at 20 mg/m2 on days 1 and 8 (total 2 courses), were followed by consolidation chemotherapy with full-dose CDDP(80 mg/m2 on day 1, 29)/DOC(60 mg/m2 on days 1, 29). Results: The recommended dose for phase II was CDDP 70mg/m2 on day 1 and DOC 25 mg/m2 on days 1 and 8 every 4 weeks with concomitant chest RT. DLTs were esophagitis and febrile neutropenia. In the phase II study, previously untreated advanced stage III NSCLC pts (10F, 33M). Patients: median age, 66 (range 46–74); PS 0/1(56%/44%); stage IIIa,12pts (28%). Grade3,/4 toxicity: neutropenia, 28pts; anemia, 10pts; thrombocytopenia, 4pts; esophagitis 4pts; pneumonitis 2pts. Tumor response was confirmed in 33 of the 43 pts (response rate, 76.7%; 95% confidence interval, 64% to 89%). The median survival time was 22 months and two-year survival rate was 44%. Conclusion: This concurrent chemoradiotherapy with near-full dose CDDP/DOC followed by full dose CDDP/DOC consolidation chemotherapy is a well-tolerated regimen with promising survival results. The update date will be presented at the meeting. No significant financial relationships to disclose.
Published Version
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