Randomized phase III PITCAP trial and meta-analysis of induction chemotherapy followed by thoracic irradiation with or without concurrent taxane-based chemotherapy in locally advanced NSCLC
Menée à partir des données d'un essai de phase III incluant 151 patients atteints d'un cancer du poumon non à petites cellules de stade III (durée médiane de suivi : 6,1 ans) et à partir d'une méta-analyse des données de 5 essais incluant au total 866 patients, cette étude évalue, du point de vue du taux de survie à 3 ans et de la survie globale à 1 an, l'intérêt d'ajouter de manière concomitante le paclitaxel à une radiothérapie thoracique en combinaison avec une chimiothérapie d'induction par sels de platine et paclitaxel
Background : Chemo-radiotherapy is standard of care in the treatment of unresectable stage III NSCLC. We aimed at assessing whether the addition of concurrent taxane-chemotherapy to thoracic irradiation following chemotherapy was able to improve treatment outcome. Material and methods : In PITCAP trial, patients with unresectable stage III NSCLC were randomized to receive 2 cycles of platinum-paclitaxel followed by 60-61.2 Gy thoracic irradiation (control arm) or by same radiotherapy with concomitant weekly paclitaxel (experimental arm). A literature-based meta-analysis including all studies with same design was also performed. Results : At the time of the second interim analysis, when 151 patients were randomized, accrual was terminated. With a median follow-up of 6.1 years, median survival was 13.2 vs 15.1 months, with a 3-year survival rate of 19.5 vs 21.2% in the control and experimental arm, respectively (HR: 0.97; 95%CI 0.69-1.36; p = 0.845). Treatment toxicity was manageable in both arms. The meta-analysis of 5 trials (n = 866) confirmed the lack of a meaningful effect on 1-year overall survival of a taxane added concurrently to radiotherapy. Conclusions : These results do not support a meaningful survival benefit with the addition of single agent taxane given concurrently to radiotherapy after platinum-based induction in locally advanced NSCLC.