Open Access Highly Accessed Research article

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

Delphine Lerouge1, Alain Rivière1, Eric Dansin2, Christos Chouaid3, Cécile Dujon4, Roland Schott5, Armelle Lavole6, Vincent Le Pennec7, Elizabeth Fabre8, Jacky Crequit9, Francis Martin10, Stéphanie Dehette10, Pierre Fournel11, Bénédicte Precheur-Agulhon12, Eric Lartigau2 and Gérard Zalcman13*

Author Affiliations

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

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BMC Cancer 2014, 14:231  doi:10.1186/1471-2407-14-231

Published: 30 March 2014

Abstract

Background

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.

Methods

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.

Results

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.

Conclusion

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.

Trial registration

ClinicalTrials.gov, NCT01839032

Keywords:
Locally advanced non-small cell lung cancer; Oral vinorelbine; Chemoradiotherapy