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 cancerReport as inadecuate




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 - Download this document for free, or read online. Document in PDF available to download.

BMC Cancer

, 14:231

Clinical oncology

Abstract

BackgroundConcomitant 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.

MethodsPatients with stage III NSCLC received 2 induction cycles of intravenous vinorelbine 25 mg-m and cisplatin 80 mg-m on day 1 and oral vinorelbine 60 mg-m on day 8. Responding patients received 2 more cycles of cisplatin 80 mg-m 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.

ResultsSeventy 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.

ConclusionIn 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.

Trial registrationClinicalTrials.gov, NCT01839032

KeywordsLocally advanced non-small cell lung cancer Oral vinorelbine Chemoradiotherapy Electronic supplementary materialThe online version of this article doi:10.1186-1471-2407-14-231 contains supplementary material, which is available to authorized users.

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Author: Delphine Lerouge - Alain Rivière - Eric Dansin - Christos Chouaid - Cécile Dujon - Roland Schott - Armelle Lavole - Vince

Source: https://link.springer.com/







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