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  • Title: Phase I study of concurrent high-dose three-dimensional conformal radiotherapy with chemotherapy using cisplatin and vinorelbine for unresectable stage III non-small-cell lung cancer.
    Author: Sekine I, Sumi M, Ito Y, Horinouchi H, Nokihara H, Yamamoto N, Kunitoh H, Ohe Y, Kubota K, Tamura T.
    Journal: Int J Radiat Oncol Biol Phys; 2012 Feb 01; 82(2):953-9. PubMed ID: 21377282.
    Abstract:
    PURPOSE: To determine the maximum tolerated dose in concurrent three-dimensional conformal radiotherapy (3D-CRT) with chemotherapy for unresectable Stage III non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Eligible patients with unresectable Stage III NSCLC, age ≥ 20 years, performance status 0-1, percent of volume of normal lung receiving 20 GY or more (V(20)) ≤ 30% received three to four cycles of cisplatin (80 mg/m(2) Day 1) and vinorelbine (20 mg/m(2) 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. RESULTS: 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 V(20) >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, 41-75). The full planned dose of radiotherapy could be administered to all the patients. Grade 3-4 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. CONCLUSIONS: 72 Gy was the maximum dose that could be achieved in most patients, given the predetermined normal tissue constraints.
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