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

BMC Cancer

Delphine Lerouge¹⁰  Alain Rivière¹⁰  Eric Dansin⁴  Christos Chouaid⁸  Cécile Dujon⁵  Roland Schott¹  Armelle Lavole¹³  Vincent Le Pennec⁷  Elizabeth Fabre¹²  Jacky Crequit¹¹  Francis Martin⁶  Stéphanie Dehette⁶  Pierre Fournel³  Bénédicte Precheur-Agulhon²  Eric Lartigau⁴  Gérard Zalcman⁹ 

[1] Department of Pneumology, Centre P. Strauss, Strasbourg, France

[2] Institut de Recherche Pierre Fabre, Boulogne-Billancourt, France

[3] Department of Pneumology, Institut de Cancérologie Lucien Neuwirth, Saint-Etienne, France

[4] Department of Pneumology, Centre O. Lambret, Lille, France

[5] Department of Oncology, Hôpital A. Mignot, Le Chesnay, France

[6] Department of Pneumology, Centre hospitalier, Compiègne, France

[7] Department of Radiology, Centre Hospitalier Universitaire de Caen, Caen, France

[8] Department of Pneumology, Centre hospitalier Intercommunal de Créteil, Créteil, France

[9] Deparment of Pneumology and Thoracic Oncology, Centre Hospitalier Universitaire de Caen, France

[10] Department of Oncology radiotherapy, CRLCC F. Baclesse, Caen, France

[11] Department of Pneumology, Centre Hospitalier de Creil, Creil, France

[12] Department of Medical Oncology, Hôpital européen G Pompidou, Paris, France

[13] Department of Pneumology, Hôpital Tenon, Paris, France

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

Others  :  858927
DOI  :  10.1186/1471-2407-14-231

 received in 2013-05-04, accepted in 2014-03-25,  发布年份 2014

【 摘 要 】

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

【 授权许可】

   
2014 Lerouge et al.; licensee BioMed Central Ltd.

【 图 表 】

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