Etoposide and Cisplatin vs Paclitaxel and Carboplatin With Concurrent Thoracic Radiotherapy in Unresectable Stage III Non–Small Cell Lung Cancer : A Multicenter Randomized Phase III Trial
Mené en Chine sur 191 patients atteints d'un cancer du poumon non à petites cellules de stade III non résécable (durée médiane de suivi : 73 mois), cet essai multicentrique de phase III évalue, du point de vue de la survie globale à 3 ans, la supériorité d'un traitement par étoposide-cisplatine par rapport à un traitement par carboplatine-paclitaxel dans le cadre d'une chimiothérapie en combinaison avec une radiothérapie thoracique concomitante
Background : The optimal chemotherapy regimen administered currently with radiation in patients with stage III non-small cell lung cancer (NSCLC) remains unclear. A multi-center phase III trial was conducted to compare the efficacy of concurrent thoracic radiation therapy (TRT) with either etoposide/cisplatin (EP) or carboplatin/paclitaxel (PC) in patients with stage III non-small cell lung cancer (NSCLC). Patients and methods : Patients were randomly received 60 to 66 Gy of TRT concurrent with either etoposide 50 mg/m2 on days 1 to 5 and cisplatin 50 mg/m2 on days 1 and 8 every 4 weeks for two cycles (EP arm), or paclitaxel 45 mg/m2 and carboplatin (AUC 2) on day 1 weekly (PC arm). The primary end point was overall survival (OS). The study was designed with 80% power to detect a 17% superiority in 3-year OS with a type I error rate of 0.05. Results : A total of 200 patients were randomized and 191 patients were treated (95 in the EP arm and 96 in the PC arm). With a median follow-up time of 73 months, the 3-year OS was significantly higher in the EP arm than that of the PC arm. The estimated difference was 15.0% (95% CI 2.0%-28.0%) and P value of 0.024. Median survival times were 23.3 months in the EP arm and 20.7 months in the PC arm (log-rank test P=0.095, HR 0.76, 95%CI 0.55-1.05). The incidence of Grade ≥2 radiation pneumonitis was higher in the PC arm (33.3% versus 18.9%, P=0.036), while the incidence of Grade ≥ 3 esophagitis was higher in the EP arm (20.0% versus 6.3%, P=0.009). Conclusion : EP might be superior to weekly PC in terms of OS in the setting of concurrent chemoradiation for unresectable stage III NSCLC. Trial registration ID : NCT01494558.