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- Kim, Nalee;
- Park, Won;
- Kim, Haeyoung;
- Cho, Won Kyung;
- Ahn, Sung Ja;
- ... Ha, Inbong;
- 외 23명
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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. © 2024 Elsevier Inc.
키워드
- 제목
- 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)
- 저자
- Kim, Nalee; Park, Won; Kim, Haeyoung; Cho, Won Kyung; Ahn, Sung Ja; Kim, Mi Young; Park, Shin-Hyung; Lee, Ik Jae; Ha, Inbong; Kim, Jin Hee; Kim, Tae Hyun; Lee, Kyu Chan; Lee, Hyung-Sik; Kim, Tae Gyu; Shin, Kyung Hwan; Lee, Jong Hoon; Jung, Jinhong; Cho, Oyeon; Kim, Yong Bae; Kim, Eun Seog; Jo, In Young; Koo, Taeryool; Kim, Kyubo; Park, Hae Jin; Shin, Young-Joo; Ha, Boram; Kwon, Jeanny; Lee, Ju Hye; Moon, Sunrock
- 발행일
- 2025-02
- 유형
- Article
- 권
- 121
- 호
- 2
- 페이지
- 341 ~ 351