ESTRO 2024 - Abstract Book

S1827

Clinical - Lung

ESTRO 2024

Proffered Paper

efficacy and toxicity of moderately hypofractionated radiotherapy via helical tomotherapy versus conventional radiotherapy combined with concurrent chemotherapy for patients with unresectable stage III non-small cell Lung Cancer: a multicenter, randomized phase III trial

Chinese clinical trial registration: ChiCTR1800017367

Jian He, Wenhan Huang, Qi Zhang, Shaonan Fan, Xiaohong Xu

Zhongshan Hospital, Fudan University, Department of Radiation Oncology, Shanghai, China

Purpose/Objective:

The standard treatment schedule for unresectable stage III non-small-cell lung cancer (NSCLC) delivers 60 Gy in 30 fractions combined with concurrent chemotherapy, but an alternative strategy that can deliver a moderately hypofractionated radiotherapy (Hypo-RT) is found. This study aimed to compare the efficacy and toxicity of helical tomotherapy (HT) – based moderately Hypo-RT versus conventional fractionated radiotherapy (Con-RT) in unresectable stage III NSCLC.

Material/Methods:

This is a randomized, multicenter, non-blinded, phase 3 clinical trial. Eligible patients were randomized to the experimental group (Hypo-RT: 60 Gy in 20 fractions) or control group (Con-RT: 60 Gy in 30 fractions). All patients received 2 cycles of concurrent platinum-based chemotherapy plus 2 cycles of consolidation therapy. The primary endpoint was 3-year overall survival (OS) rate (intention-to-treat [ITT] population). The secondary endpoints were progression-free survival (PFS), and treatment-related adverse events (TRAE).

Results:

A total of 146 patients were finally enrolled from July 27, 2018 to November 1, 2021 . Seventy-three patients each were assigned to the experimental group and control group. The median follow-up was 46 months. The 3-year OS was 58.36% in the Hypo-RT versus 38.39% in the Con-RT (P = 0. 02). The median OS from randomization was 41 months in the Hypo-RT group and 30 months in the Con-RT group (HR, 0.61; 95% CI, 0.395 – 0.939; P = 0. 022). No significant differences in grade 2 or greater TRAEs were found between the two groups.