Final analysis of a Multicenter Single-Arm Confirmatory Trial of hypofractionated whole breast irradiation after breast-conserving surgery in Japan: JCOG0906

被引：13

作者：

Nozaki, Miwako ^{[1
]}

Kagami, Yoshikazu ^{[2
]}

Machida, Ryunosuke ^{[3
,11
]}

Nakamura, Kenichi ^{[3
]}

Ito, Yoshinori ^{[2
]}

Nishimura, Yasumasa ^{[4
]}

Teshima, Teruki ^{[5
]}

Saito, Yoshihiro ^{[6
]}

Nagata, Yasushi ^{[7
]}

Matsumoto, Yasuo ^{[8
]}

Akimoto, Tetsuo ^{[9
]}

Hiraoka, Masahiro ^{[10
]}

机构：

[1] Dokkyo Med Univ, Dept Radiol, Saitama Med Ctr, Saitama, Japan

[2] Showa Univ, Dept Radiat Oncol, Sch Med, Tokyo, Japan

[3] Natl Canc Ctr, JCOG Data Ctr Operat Off, Dept Int Clin Dev, Tokyo, Japan

[4] Kindai Univ Hosp, Dept Radiat Oncol, Osaka, Japan

[5] Osaka Int Canc Inst, Dept Radiat Oncol, Osaka, Japan

[6] Saitama Canc Ctr, Div Radiat Oncol, Saitama, Japan

[7] Hiroshima Univ Hosp, Dept Radiat Oncol, Hiroshima, Japan

[8] Niigata Canc Ctr Hosp, Dept Radiat Oncol, Niigata, Japan

[9] Natl Canc Ctr Hosp East, Div Radiat Oncol & Particle Therapy, Chiba, Japan

[10] Japanese Red Cross Wakayama Med Ctr, Dept Radiat Oncol, Wakayama, Japan

[11] Natl Canc Ctr, JCOG Data Ctr Operat Off, Canc Res Adm & Support, Biostat Div,Chuo Ku, Tsukiji 5-1-1, Tokyo 1040045, Japan

来源：

JAPANESE JOURNAL OF CLINICAL ONCOLOGY | 2021年 / 51卷 / 06期

关键词：

clinical trial; early breast cancer; breast-conserving surgery; hypofractionated whole breast irradiation; RADIOTHERAPY HYPOFRACTIONATION; UK STANDARDIZATION; CARDIAC MORTALITY; RADIATION-THERAPY; CANCER; WOMEN; RISK; FRACTIONATION;

D O I：

10.1093/jjco/hyab024

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Objective: To evaluate the safety and efficacy of hypofractionated whole breast irradiation for Asian women after breast-conserving surgery. This is an updated report with 5-year follow-up. Methods and materials: Asian women who had invasive breast cancer with clinical tumor size <= 3 cm, pN0-1c and negative inked margins were enrolled. Hypofractionated whole breast irradiation of 42.56 Gy/16 fractions was delivered, and boost irradiation of 10.64 Gy/4 fractions was added when the surgical margin was <= 5 mm. The primary endpoint was the proportion of grade >= 2 late adverse reactions within 3 years. Secondary endpoints included early adverse events, overall survival, disease-free survival, ipsilateral breast relapse-free survival, late adverse reactions and cosmetic outcome. Toxicities were evaluated using CTCAE ver3.0. Cosmetic outcomes were assessed using a 4-point scale and CTCAE ver3.0 for hyper/hypopigmentation, breast nipple/areolar deformity and breast volume/deformity. Results: Between February 2010 and August 2012, 312 patients were enrolled, and 306 received hypofractionated whole breast irradiation. Median follow-up was 70.5 (range 7.6-88.9) months. The proportion of grade >= 2 late adverse reactions within 3 years was 4.3% (90% confidence interval 2.5-6.7%). Grade 2 early adverse events occurred in 38 (12.4%); none had grade 3/4. Five-year overall survival, disease-free survival and ipsilateral breast relapse-free survival were 98.7, 95.4 and 98.0%, respectively. Of the 304 evaluable patients, 29 (9.5%; 95% confidence interval 6.5-13.4%) had grade 2/3 late adverse reactions; none had grade 4/5. At 5 years, 70/289 (24.2%) showed any worsening of breast cosmetic changes. Conclusions: Hypofractionated whole breast irradiation is considered a standard treatment for Asian women with margin-negative invasive breast cancer after breast-conserving surgery.

引用

页码：865 / 872

页数：8

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