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 Lerouge, Alain Rivière, Eric Dansin, Christos Chouaid, Cécile Dujon, Roland Schott, Armelle Lavole, Vincent Le Pennec, Elizabeth Fabre, Jacky Crequit, Francis Martin, Stéphanie Dehette, Pierre Fournel, Bénédicte Precheur-Agulhon, Eric Lartigau, Gérard Zalcman, Delphine Lerouge, Alain Rivière, Eric Dansin, Christos Chouaid, Cécile Dujon, Roland Schott, Armelle Lavole, Vincent Le Pennec, Elizabeth Fabre, Jacky Crequit, Francis Martin, Stéphanie Dehette, Pierre Fournel, Bénédicte Precheur-Agulhon, Eric Lartigau, Gérard Zalcman

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.

Figures

Figure 1
Figure 1
Patients disposition.
Figure 2
Figure 2
Treatment schedule.
Figure 3
Figure 3
Progression free survival (ITT).
Figure 4
Figure 4
Overall survival (ITT).

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