Efficacy and Toxicity of Moderately Hypofractionated Radiation Therapy with Helical TomoTherapy Versus Conventional Radiation Therapy in Patients with Unresectable Stage III Non-Small Cell Lung Cancer Receiving Concurrent Chemotherapy: A Multicenter, Randomized Phase 3 Trial.

Autor: Zhang Q; Department of Radiation Oncology, Zhongshan Hospital, Fudan University, Shanghai, China., Fan S; Department of Radiation Oncology, Zhongshan Hospital, Fudan University, Shanghai, China., Xu X; Department of Radiation Oncology, Zhongshan Hospital, Fudan University, Shanghai, China., Du S; Department of Radiation Oncology, Zhongshan Hospital, Fudan University, Shanghai, China., Zhu G; Department of Radiation Oncology, Peking University China-Japan Friendship School of Clinical Medicine, Beijing, China., Jiang C; Department of Oncology, The General Hospital of Western Theater Command, Chengdu, Sichuan, China., Xia SA; Department of Oncology, Xinhua Hospital Affiliated to School of Medicine, Shanghai Jiaotong University, Shanghai, China., Li Q; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China., Wang Q; Department of Radiation Oncology, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, Sichuan, China., Qian D; Department of Radiation Oncology, The First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei, Anhui, China., Zhang M; Department of Radiation Oncology, Yunnan Cancer Hospital & the Third Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China., Xiao H; Department of Radiation Oncology, Zhongshan Hospital, Fudan University, Shanghai, China., Chen G; Department of Radiation Oncology, Zhongshan Hospital, Fudan University, Shanghai, China., Zeng Z; Department of Radiation Oncology, Zhongshan Hospital, Fudan University, Shanghai, China. Electronic address: zeng.zhaochong@zs-hospital.sh.cn., He J; Department of Radiation Oncology, Zhongshan Hospital, Fudan University, Shanghai, China. Electronic address: hejian62@163.com.
Jazyk: angličtina
Zdroj: International journal of radiation oncology, biology, physics [Int J Radiat Oncol Biol Phys] 2024 Oct 01; Vol. 120 (2), pp. 422-431. Date of Electronic Publication: 2024 Apr 15.
DOI: 10.1016/j.ijrobp.2024.03.030
Abstrakt: Purpose: The standard treatment schedule for unresectable stage III non-small cell lung cancer (NSCLC) is chemotherapy with concurrent radiation therapy (60 Gy delivered in 30 fractions), although moderately hypofractionated radiation therapy (Hypo-RT) has also been considered as an alternative strategy. This study aimed to compare the efficacy and toxicity of moderately Hypo-RT with helical TomoTherapy versus conventionally fractionated radiation therapy (Con-RT) in patients with unresectable stage III NSCLC receiving concurrent chemotherapy.
Methods and Materials: In this randomized, multicenter, nonblinded phase 3 clinical trial, eligible patients were randomised at a 1:1 ratio to either the Hypo-RT group (60 Gy in 20 fractions) or Con-RT group (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) in the intention-to-treat population. The secondary endpoints were progression-free survival and treatment-related adverse events.
Results: A total of 146 patients were enrolled from July 27, 2018, to November 1, 2021. The median follow-up was 46 months. The 3-year OS rates in the Hypo-RT and Con-RT groups were 58.4% and 38.4%, respectively (P = .02). The median OS from randomisation was 41 months in the Hypo-RT group and 30 months in the Con-RT group (hazard ratio, 0.61; 95% confidence interval, 0.40-0.94; P = .02). There was no significant difference in the rates of grade ≥2 treatment-related adverse events between the 2 groups.
Conclusions: Moderately Hypo-RT using helical TomoTherapy may improve OS in patients with unresectable stage III NSCLC, while maintaining toxicity rates.
(Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE