Eligible patients with unresectable Stage III NSCLC, age ?0 years, performance status 0?, percent of volume of normal lung receiving 20 GY or more (V20) ?0 % received three to four cycles of cisplatin (80 mg/m2 Day 1) and vinorelbine (20 mg/m2 Days 1 and 8) repeated every 4 weeks. The doses of 3D-CRT were 66 Gy, 72 Gy, and 78 Gy at dose levels 1 to 3, respectively.
Of the 17, 16, and 24 patients assessed for eligibility, 13 (76 % ), 12 (75 % ), and 6 (25 % ) were enrolled at dose levels 1 to 3, respectively. The main reasons for exclusion were V20 >30 % (n?= 10) and overdose to the esophagus (n?= 8) and brachial plexus (n?= 2). There were 26 men and 5 women, with a median age of 60 years (range, 41?5). The full planned dose of radiotherapy could be administered to all the patients. Grade 3? neutropenia and febrile neutropenia were noted in 24 (77 % ) and 5 (16 % ) of the 31 patients, respectively. Grade 4 infection, Grade 3 esophagitis, and Grade 3 pulmonary toxicity were noted in 1 patient, 2 patients, and 1 patient, respectively. The dose-limiting toxicity was noted in 17 % of the patients at each dose level. The median survival and 3-year and 4-year survival rates were 41.9 months, 72.3 % , and 49.2 % , respectively.
72 Gy was the maximum dose that could be achieved in most patients, given the predetermined normal tissue constraints.