Anticancer Res. 2014 Apr;34(4):1959-66.

Full-dose Cisplatin and Oral Vinorelbine Concomitant with Radiotherapy in Unresectable Stage III Non-small Cell Lung Cancer: A Multi-center Phase II Study.

Juan O1, Sánchez-Hernández A, Vázquez S, Casal J, Firvida JL, Aparisi F, Muñoz J, García-Sánchez J, Gironés R, Lázaro M, Giner V.

Author information

• 1Department of Medical Oncology, La Fe University Hospital, Bulevar Sur s/n. 46026, Valencia, Spain. juan_osc@gva.es.

Abstract

Aim: To evaluate the efficacy and toxicities of combination of cisplatin and oral vinorelbine given at full doses concomitantly with radiotherapy for non-small cell lung cancer (NSCLC).

PATIENTS AND METHODS:

Untreated patients with locally advanced inoperable stage IIIA/IIIB NSCLC were eligible for study inclusion. Treatment consisted of four cycles of oral vinorelbine at 60 mg/m(2) on days 1 and 8, and cisplatin at 80 mg/m(2) on day 1 every three weeks plus radiotherapy 66 Gy starting on day 1 of cycle 2 in fractions of 2 Gy/day over 6.5 weeks.

RESULTS:

Forty-eight patients were enrolled. Their characteristics included: median age 61 years; female gender 10%; stage IIIA 46% and IIIB 54%;squamous carcinoma 63%, performance status PS0 42%; PS1 58%. Selected grade 3/4 toxicities were as follows: neutropenia 33%, concomitant febrile neutropenia 14.6%, anemia 12.5%, thrombocytopenia 16.6%, and esophagitis 12.5%. Two treatment-related deaths were reported, both during cycle 1. Radiotherapy was administered to 87.5% of patients; 7.1% of them received less than 60 Gy and 23.8% had delays due to adverse events. The objective response rate was 77.3%, with two complete responses and 32 partial responses. With a median follow-up of 19 months, the median progression-free survival was 12 months, and the 1-year overall survival rate was 72.3%. Median overall survival was 27.8 months, although the 95% confidence interval has not yet been achieved.

CONCLUSION:

Full doses of cisplatin and oral vinorelbine can be administered with concomitant radiotherapy, with good efficacy and an acceptable safety profile for patients with stage IIIA/IIIB NSCLC.