A phase II study of cisplatin with intravenous and oral vinorelbine as induction chemotherapy followed by concomitant chemoradiotherapy with oral vinorelbine and cisplatin for locally advanced non-small cell lung cancer
1 Department of Oncology radiotherapy, CRLCC F. Baclesse, Caen, France
2 Department of Pneumology, Centre O. Lambret, Lille, France
3 Department of Pneumology, Centre hospitalier Intercommunal de Créteil, Créteil, France
4 Department of Oncology, Hôpital A. Mignot, Le Chesnay, France
5 Department of Pneumology, Centre P. Strauss, Strasbourg, France
6 Department of Pneumology, Hôpital Tenon, Paris, France
7 Department of Radiology, Centre Hospitalier Universitaire de Caen, Caen, France
8 Department of Medical Oncology, Hôpital européen G Pompidou, Paris, France
9 Department of Pneumology, Centre Hospitalier de Creil, Creil, France
10 Department of Pneumology, Centre hospitalier, Compiègne, France
11 Department of Pneumology, Institut de Cancérologie Lucien Neuwirth, Saint-Etienne, France
12 Institut de Recherche Pierre Fabre, Boulogne-Billancourt, France
13 Deparment of Pneumology and Thoracic Oncology, Centre Hospitalier Universitaire de Caen, France
BMC Cancer 2014, 14:231 doi:10.1186/1471-2407-14-231Published: 30 March 2014
Concomitant platinum-based chemotherapy and radiotherapy (CT-RT) is the recommended treatment for unresectable locally advanced stage III non-small cell lung cancer (NSCLC). We conducted a phase II study to evaluate the efficacy and safety of fractionated oral vinorelbine with cisplatin as induction CT followed by CT-RT.
Patients with stage III NSCLC received 2 induction cycles of intravenous vinorelbine 25 mg/m2 and cisplatin 80 mg/m2 on day 1 and oral vinorelbine 60 mg/m2 on day 8. Responding patients received 2 more cycles of cisplatin 80 mg/m2 on day 1 and oral vinorelbine 20 mg on days 1, 3 and 5 concomitantly with radiotherapy 2 Gy daily, 5 days/week for a total of 66 Gy.
Seventy patients, median age 61 years, were enrolled. Overall response rate (ORR) was 50.0%; Disease Control Rate was 81.42%. Median PFS was 14.58 months [95% CI, 10.97-18.75]. Median OS was 17.08 months [95% CI, 13.57-29.57]. One-year and 2-year survival rates were 68.6% [95% CI, 57.7-79.4] and 37%. One patient had a grade 3 pulmonary radiation injury and 26.5% had graded 1/2 esophagitis.
In non-operable IIIA-IIIB NSCLC, the combination oral vinorelbine (fractionated fixed dose) plus cisplatin, during concomitant CT-RT, could offer a well-tolerated option, with comparable activity to I.V. vinorelbine-based chemoradiotherapy regimens.