Randomized, multicenter, phase III study of accelerated fraction radiotherapy with concomitant boost to the gross tumor volume compared with conventional fractionation in concurrent chemoradiation in patients with unresectable stage III non-small cell lung cancer: the Korean Radiation Oncology Group 09-03 trial
Mené en Corée entre 2010 et 2017 sur 303 patients atteints d'un cancer du poumon non à petites cellules de stade III non résécable, cet essai randomisé multicentrique de phase III compare l'efficacité, du point de vue de la survie globale, d'une radiothérapie hypofractionnée accélérée et d'une radiothérapie conventionnelle fractionnée
Purpose: We designed the Korean Radiation Oncology Group 09-03 Phase III clinical trial comparing accelerated hypofractionated radiotherapy (RT) using a concomitant boost to the gross tumor volume (GTV) with conventionally fractionated 60 Gy RT in patients with stage III unresectable non-small cell lung cancer (NSCLC). Methods and Materials: A conventionally fractionated RT group (Arm-1, 124 patients) received a 2 Gy daily dose to a total cumulative dose of 44 Gy to the planning target volume (PTV) in 22 fractions and 60 Gy to the GTV in 30 fractions over 6 weeks. A hypofractionated RT group (Arm-2, 142 patients) received a 1.8 Gy daily dose to the PTV with a synchronous boost of 0.6 Gy to the GTV, for total cumulative doses of 45 Gy to the PTV and 60 Gy to the GTV in 25 fractions over 5 weeks. All patients received concurrent weekly chemotherapy consisting of paclitaxel and cisplatin. Results: The objective response rate of all patients was 86.5% (Arm-1, 84.6% vs. Arm-2, 88.1%; p=0.612). The median overall survival was 26 months (Arm-1, 26 months vs. Arm-2, 27 months; p=0.508). The median progression-free survival was 11 months (Arm-1, 10 months vs. Arm-2, 13 months; p=0.295). The local tumor control rate at 2- and 5-years was 58.3% and 50.7%, respectively (Arm-1, 62.4% and 51.0% vs. Arm-2, 54.0% and 48.6%; p=0.615). There were no significant between-group differences in the cumulative incidence of grade ≥3 radiation pneumonitis (p=0.134) or radiation esophagitis (p=0.539). Conclusions: This clinical trial did not confirm the superiority of accelerated 2.4 Gy hypofractionated RT compared to conventional 2 Gy fractionation in patients with unresectable stage III NSCLC undergoing concurrent chemoradiation therapy.
International Journal of Radiation Oncology, Biology, Physics 2022