Results of a multi-institutional, randomized, non-inferiority, phase 3 trial of accelerated fractionation versus standard fractionation in radiation therapy for T1-2N0M0 glottic cancer: Japan Clinical Oncology Group study (JCOG0701)
Mené au Japon auprès de 370 patients atteints d'un cancer glottique de stade T1-2N0M0, cet essai multicentrique de phase III évalue la non infériorité, du point de vue du taux de survie sans progression à 3 ans, et la toxicité d'une radiothérapie fractionnée accélérée par rapport à une radiothérapie fractionnée standard
Background : We assessed the non-inferiority of accelerated fractionation (AF) (2.4 Gy/fraction) compared with standard fractionation (SF) (2 Gy/fraction) regarding progression-free survival (PFS) in patients with T1-2N0M0 glottic cancer (GC). Patients and Methods : In this multi-institutional, randomized, phase 3 trial, patients were enrolled from 32 Japanese institutions. Key inclusion criteria were GC T1 − 2N0M0, age 20 − 80, Eastern Cooperative Oncology Group (ECOG) performance status of 0 − 1, and adequate organ function. Patients were randomly assigned to receive either SF of 66 − 70 Gy (33 − 35 fractions), or AF of 60 − 64.8 Gy (25 − 27 fractions). The primary endpoint was the proportion of 3-year PFS. The planned sample size was 360 with a non-inferiority margin of 5%. Results : Between 2007 and 2013, 370 patients were randomized (184/186 to SF/AF). Three-year PFS was 79.9% (95% confidence interval [CI] 73.4 − 85.4) for SF and 81.7% (95% CI 75.4 − 87.0) for AF (difference 1.8%, 91% CI 5.1%−8.8%; one-sided P = 0.047 > 0.045). The cumulative incidences of local failure at 3 years for SF/AF were 15.9%/10.3%. No significant difference was observed in 3-year OS between SF and AF. Grade 3 or 4 acute and late toxicities developed in 22 (12.4%)/21 (11.5%) and 2 (1.1%)/1(0.5%)) in the SF/AF arms. Conclusion : Although the non-inferiority of AF was not confirmed statistically, the similar efficacy and toxicity of AF compared to SF, as well as the practical convenience of its fewer treatment sessions, suggest the potential of AF as a treatment option for early GC. UMIN000000819
Annals of Oncology 2018