A phase II study of induction chemotherapy followed by thoracic radiotherapy and erlotinib in poor risk stage III non-small cell lung cancer: Results of CALGB 30605 (Alliance)/RTOG 0972 (NRG)
Mené sur 78 patients atteints d'un cancer du poumon non à petites cellules de stade III, non résécable et de pronostic défavorable (âge médian : 68 ans), cet essai de phase II évalue, du point de vue du taux de réponse globale, du taux de contrôle de la maladie et du taux de survie globale à 1 an, l'efficacité d'un traitement comportant une chimiothérapie d'induction par carboplatine-nab-paclitaxel puis une radiothérapie thoracique en combinaison avec l'erlotinib
Introduction : Patients with stage III non-small cell lung cancer (NSCLC) and poor performance status (PS) and/or weight loss (WL) do not seem to benefit from standard therapy. Based on the pre-clinical interaction between epidermal growth factor receptor (EGFR) inhibitors and radiation, we designed a trial of induction chemotherapy followed by thoracic radiotherapy (TRT) and concurrent erlotinib. Methods : Patients with poor risk unresectable stage III NSCLC received 2 cycles of carboplatin at an AUC of 5 and nab-paclitaxel at 100 mg/m2 on days 1 and 8 every 21 days, followed by erlotinib administered concurrently with TRT. Maintenance was not permitted. Molecular analysis was performed in available specimens. Seventy-two eligible patients were required to test whether the 1-year survival rate was <50% or >=65% with approximately 90% power at a significance level of 0.10. Results : From March 2008 to October 2011, 78 patients were enrolled, 3 of which were ineligible. The median age was 68 (range, 39 to 88) and 32% were >=75 years of age. Patients were evenly distributed between stage IIIA and IIIB and the majority had PS 2. The overall response rate was 67% and the disease control rate was 93%. Treatment was well tolerated. The median PFS and OS were 11 and 17 months, respectively. The overall 12-month OS was 57%, which narrowly missed the pre-specified target for significance. Conclusions : Patients with poor risk stage III NSCLC had better than expected outcomes with a regimen of induction carboplatin/nab-paclitaxel followed by TRT and erlotinib. However, as per the statistical design, the 12-month OS was not sufficiently high to warrant further studies.