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
Mené sur 70 patients atteints d'un cancer du poumon non à petites cellules de stade III (âge médian : 61 ans), cet essai de phase II évalue l'efficacité, du point de vue du taux de réponse globale, du taux de contrôle de la maladie et du taux de survie à 1 et 2 ans, et la toxicité d'un traitement comportant une chimiothérapie d'induction à base de cisplatine et de vinorelbine, administrée par intraveineuse puis par voie orale, suivie d'une chimiothérapie par vinorelbine orale et cisplatine en combinaison avec une radiothérapie concomitante
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.