Oral Vinorelbine and Cisplatin with Concurrent Radiotherapy After Induction Chemotherapy with Cisplatin and Docetaxel for Patients with Locally Advanced Non-small Cell Lung Cancer: The GFPC 05-03 Study

• Published in: Journal of thoracic oncology Vol. 6; no. 2; pp. 351 - 357
• Main Authors: Descourt, Renaud, Vergnenegre, Alain, Barlesi, Fabrice, Lena, Herve, Fournel, Pierre, Falchero, Lionel, Berard, Henri, Hureaux, Jose, Le Caer, Herve, Chavaillon, Jean Michel, Geriniere, Laurence, Monnet, Isabelle, Chouabe, Stéphane, Robinet, Gilles
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.02.2011; International Association for the Study of Lung Cancer
• Subjects: Adenocarcinoma - pathology; Adenocarcinoma - therapy; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Carcinoma, Large Cell - pathology; Carcinoma, Large Cell - therapy; Carcinoma, Non-Small-Cell Lung - pathology; Carcinoma, Non-Small-Cell Lung - therapy; Carcinoma, Squamous Cell - pathology; Carcinoma, Squamous Cell - therapy; Chemoradiotherapy; Cisplatin - administration & dosage; Combined Modality Therapy; Female; Follow-Up Studies; Humans; Lung neoplasms; Lung Neoplasms - pathology; Lung Neoplasms - therapy; Male; Maximum Tolerated Dose; MeSH; Middle Aged; Neoplasm Staging; Oral vinorelbine; Radiotherapy Dosage; Remission Induction; Survival Rate; Taxoids - administration & dosage; Treatment Outcome; Vinblastine - administration & dosage; Vinblastine - analogs & derivatives; Oral vinorelbine; MeSH; Chemoradiotherapy; Lung neoplasms
• ISSN: 1556-0864; 1556-1380
• DOI: 10.1097/JTO.0b013e318200f47e

The aim of this multicenter phase II trial was to evaluate the combination of oral vinorelbine and cisplatin with radiotherapy (RT) after cisplatin-docetaxel induction chemotherapy (CT) in patients with locally advanced non-small cell lung cancer (NSCLC). Patients with previously untreated, inoperable, histologically or cytologically confirmed stage IIIA or IIIB NSCLC, with performance status ≤1 and weight loss ≤10% received two cycles of induction CT with cisplatin (75 mg/m2) and docetaxel (75 mg/m2) every 3 weeks. Patients with a tumor response or stabilization continued to receive cisplatin (80 mg/m2) and oral vinorelbine (40 mg/m2) on days 1 and 8 for two cycles, with concomitant thoracic RT (2 Gy/d, 5 d/wk, and total dose 66 Gy). Fifty-six patients were enrolled. All patients (n = 38) who received CT-RT were assessable for the tumor response. There were no complete responses. In the intent-to-treat analysis, the response rates were 32.1% after induction CT and 41.1% after CT-RT. The median progression-free and overall survival times were 9.2 months (95% confidence interval: 7–14) and 20.8 months (95% confidence interval: 13.7–24.1), respectively. Adverse effects of RT-CT were grades 3 to 4 neutropenia (four patients) and grade 3 esophageal toxicity (one patient). No treatment-related deaths occurred. The oral vinorelbine-cisplatin combination with concurrent RT is feasible and has a favorable risk-benefit ratio in stage IIIA/IIIB NSCLC.