P2.02-029 Concomitant ChemoRadiotherapy for Locally Advanced Non-Small Cell Lung Cancer: A Phase II Study from the Galician Lung Cancer Group: Topic: Multimodality Treatment

Concomitant platinum-based ChemoRadiotherapy (CT-RT) is the recommended treatment for unresectable locally advanced Non-Small Cell Lung Cancer (NSCLC). We conducted a phase II study to evaluate the efficacy and safety of concomitant CT-RT with cisplatin (C) and intravenous and oral vinorelbine (V) and thoracic radiotherapy. 31 chemo-naive patients with histologically confirmed inoperable locally advanced NSCLC, stage IIIA (T4 or N2)/IIIB, PS 0-1 and adequate lung function (FEV1 > 1.1, V20 < 30%) were included in concomitant CT-RT with: C 80 mg/m2 day 1 and intravenous V 25 mg/m2 day 1 and oral V 25 mg/m2 day 8 for three cycles, during conformal thoracic radiotherapy (66 Gys, 180 cGy/day). The primary objective was overall survival (OS); secondary objectives were progression free survival (PFS), response rate (RR) and toxicity. Median follow-up: 18,1 months. The patients characteristics were: mean age 59,6 years (44-75); male/female: 26/5; ECOG PS 0/1: 5/26; adeno/squamous/large cell carcinoma: 15/12/4; stage IIIA 16 patients and stage IIIB 15 patients. 28 patients were evaluable for response (3 patients in treatment) and 31 for toxicity. RR: 3 CR, 18 PR (RR 75%; 95% CI: 59-91), 5 SD (17.8%) and 2 PD (7.2%). The median PFS was 12 months (95% CI:6-18) and median OS was 28 months (95% CI:21-34). The PFS at 1/3 years were 47%/20% and the OS at 1/3 years were 77%/45%. Main toxicities (NCI-CTC 4.0) per patient in CT-RT (89 cycles of chemotherapy, 2.9 per patient; mean doses RT: 65,4 Gys) grade 1-2/3-4 (%) were: neutropenia 32/22.5; anemia 39/10; thrombocytopenia 13/0; nausea/vomiting 31/3; fatigue 29/0; esophagitis 39/6 and pneumonitis 16/0; hospitalizations was necessary in 9 patients: febrile neutropenia in 3 patients and grade 3 esophagitis in 2 patients. Concomitant CT-RT with Cisplatin and intravenous and oral Vinorelbine during thoracic radiotherapy is a feasible treatment option for inoperable locally advanced stage III NSCLC, showing good clinical efficacy and tolerability with acceptable long-term survival.