Patient-Reported Outcomes Between Whole-Breast Plus Regional Irradiation and Whole-Breast Irradiation Only in pN1 Breast Cancer After Breast-Conserving Surgery and Taxane-Based Chemotherapy: A Randomized Phase 3 Clinical Trial (KROG 17-01)
Nalee Kim MD, PhD , Won Park MD, PhD , Haeyoung Kim MD, PhD , Won Kyung Cho MD , Sung Ja Ahn MD , Mi Young Kim MD , Shin-Hyung Park MD , Ik Jae Lee MD , Inbong Ha MD , Jin Hee Kim MD , Tae Hyun Kim MD , Kyu Chan Lee MD , Hyung-Sik Lee MD , Tae Gyu Kim MD , Kyung Hwan Shin MD , Jong Hoon Lee MD , Jinhong Jung MD , Oyeon Cho MD , Yong Bae Kim MD , Eun Seog Kim MD , Sunrock Moon MD
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引用次数: 0
Abstract
Purpose
The role of regional node irradiation (RNI) with whole-breast irradiation (WBI) in patients with pN1 breast cancer receiving taxane-based adjuvant chemotherapy is not well defined. The KROG 1701 trial, a phase 3, multicenter, noninferiority study, aimed to compare the disease-free survival between WBI+RNI and WBI alone in this patient cohort. Comprehensive patient-reported outcomes (PROs) collected at multiple timepoints are reported.
Methods and Materials
The trial (NCT03269981) enrolled patients with pN1 breast cancer after breast-conserving surgery and taxane-based adjuvant chemotherapy, allocating them to receive either WBI+RNI or WBI only. PROs were assessed using European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaires Core 30and breast cancer-specific module 23 modules at baseline, during radiation therapy, and at subsequent follow-up intervals of 3 to 6 months, and annually up to 4 years.
Results
From April 2017 to December 2021, 840 patients were enrolled; 777 received intervention as assigned, and 750 completed baseline PRO questionnaires (387 in WBI+RNI, 363 in WBI only). All PRO domains showed improvements over time (P < .001). During radiation therapy, the WBI+RNI group reported greater fatigue and nausea. Higher arm symptom scores were observed in the WBI+RNI group 3 months post-treatment (P = .030). No other significant PRO domain differences, including arm/breast symptoms, were observed between the 2 groups.
Conclusions
In patients with pN1 breast cancer treated with taxane-based chemotherapy, adding RNI to WBI resulted in minor, temporary declines in specific PRO domains, but these differences were not clinically significant. This indicates that overall patient experience between WBI+RNI and WBI is comparable, supporting the safety and patient tolerability of both treatments.
期刊介绍：
International Journal of Radiation Oncology • Biology • Physics (IJROBP), known in the field as the Red Journal, publishes original laboratory and clinical investigations related to radiation oncology, radiation biology, medical physics, and both education and health policy as it relates to the field.
This journal has a particular interest in original contributions of the following types: prospective clinical trials, outcomes research, and large database interrogation. In addition, it seeks reports of high-impact innovations in single or combined modality treatment, tumor sensitization, normal tissue protection (including both precision avoidance and pharmacologic means), brachytherapy, particle irradiation, and cancer imaging. Technical advances related to dosimetry and conformal radiation treatment planning are of interest, as are basic science studies investigating tumor physiology and the molecular biology underlying cancer and normal tissue radiation response.
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