PHASE-II TRIAL OF WEEKLY PACLITAXEL AND CONCURRENT RADIATION-THERAPY FOR LOCALLY ADVANCED NONSMALL CELL LUNG-CANCER

We conducted a prospective Phase II study to determine the response ra te, toxicity, and 2-year survival rate of concurrent weekly paclitaxel and radiation therapy (RT) for locally advanced unresectable non-smal l cell lung cancer. The weekly paclitaxel regimen was designed to opti mize the radiosensitizing properties of paclitaxel, Thirty-three patie nts with unresectable stage IIIA and IIIB non-small cell lung cancer f rom six institutions were entered into the study between March 1994 an d February 1995, Weekly i.v. paclitaxel (60 mg/m(2); 3-h infusion) plu s concurrent chest RT (60 Gy over 6 weeks) was delivered for 6 weeks. Twenty-nine patients were evaluable for response. Three patients achie ved a complete response (10%), and 22 patients (76%) achieved a partia l response, for an overall response rate of 86% (95% confidence interv al, 68-96%), One patient progressed during the therapy, and three pati ents had stable disease. Esophagitis was the principal toxicity. Grade 3 or 4 esophagitis occurred in 11 patients (37%), One patient died of pneumonia after completion of therapy. Additional grade greater than or equal to 3 toxicities included pneumonitis (12%) and neutropenia (6 %), One patient had a grade 3 hypersensitivity reaction. The median ov erall survival duration for all 33 patients who entered the study was 20 months, and 1-, 2-, and 3-year overall survival rates were 60.6%, 3 3.3%, and 18.2%, respectively. The median progression-free survival du ration for all 33 patients was 10.7 months, and 1-, 2-, and 3-year pro gression-free survival rates were 39.4%, 12.1%, and 6.1.%, respectivel y, Weekly paclitaxel plus concurrent RT is a well-tolerated outpatient regimen. The survival outcome from this regimen is encouraging and se ems to be at least equivalent to that of other chemotherapy/radiation trials. These findings warrant further clinical evaluation of weekly p aclitaxel/RT in Phase II trials in the neoadjuvant setting and in comb ination with other cytotoxic agents.