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保乳术后导管原位癌患者的大分割与常规分割全乳照射比较:一项来自全国多中心队列的倾向评分匹配分析(COBCG - 02研究)

Comparing hypofractionated and conventionally fractionated whole breast irradiation for patients with ductal carcinoma in situ after breast conservation: a propensity score-matched analysis from a national multicenter cohort (COBCG-02 study).

作者信息

De Rose Fiorenza, De Santis Maria Carmen, Meduri Bruno, Franzese Ciro, Franceschini Davide, Franco Pierfrancesco, Pasinetti Nadia, Lancellotta Valentina, Giacobazzi Patrizia, La Rocca Eliana, D'Angelo Elisa, Lozza Laura, Livi Lorenzo, Meattini Icro, Scorsetti Marta

机构信息

Radiotherapy and Radiosurgery Department, Humanitas Clinical and Research Center-IRCCS, Rozzano, Milano, Italy.

Clinical Oncology Breast Cancer Group (COBCG), Firenze, Italy.

出版信息

J Cancer Res Clin Oncol. 2021 Jul;147(7):2069-2077. doi: 10.1007/s00432-020-03483-5. Epub 2021 Jan 2.

Abstract

BACKGROUND AND PURPOSE

Randomized trials confirmed the efficacy and the safety of hypofractionated whole breast irradiation (HF-WBI) in patients with early-stage breast cancer. However, the role of HF-WBI in patients with DCIS after breast conserving surgery has not yet been clearly established in prospective randomized trials. The aim of this study was to evaluate if HF-WBI can be considered comparable to conventionally fractionated (CF)-WBI in DCIS patients.

MATERIALS AND METHODS

The analysis included DCIS patients from four Italian centers treated with CF-WBI 50 Gy/25 fractions or HFRT 40.5 Gy/15 fractions, without tumor bed boost. A propensity score matching (PSM) analysis was performed using a logistic regression that considered age, grading, presence of necrosis, resection margin status and adjuvant endocrine therapy.

RESULTS

Five hundred twenty-seven patients was included (367 in the CF-WBI-group and 160 in the HR-WBI group). After 1:1 matching, 101 patients were allocated to the CF-WBI-group and 104 to the HF-WBI group. No correlation was observed between the type of RT schedule and LRFS (HR 1.68, 95% CI 0.82-3.45; p = 0.152). After PSM, no statistical difference was observed between the two RT group (HR 1.11, 95% CI 0.40-3.04; p = 0.833), with 3- and 5-years LRFS rates of 100% and 97.9% for CF-WBI and 95.6% and 94% for HF-WBI.

CONCLUSION

A short course of radiation therapy seems to be comparable to CF-WBI in terms of clinical outcomes. These data support the use of hypofractionated schedules in DCIS patients, but considering the remaining uncertainties.

摘要

背景与目的

随机试验证实了早期乳腺癌患者接受大分割全乳照射(HF-WBI)的有效性和安全性。然而,在保乳手术后的导管原位癌(DCIS)患者中,HF-WBI的作用在前瞻性随机试验中尚未明确确立。本研究的目的是评估在DCIS患者中,HF-WBI是否可被视为与常规分割(CF)-WBI相当。

材料与方法

分析纳入了来自四个意大利中心的DCIS患者,这些患者接受了50 Gy/25次分割的CF-WBI或40.5 Gy/15次分割的大分割放疗(HFRT),未进行瘤床加量。使用逻辑回归进行倾向评分匹配(PSM)分析,该逻辑回归考虑了年龄、分级、坏死的存在、手术切缘状态和辅助内分泌治疗。

结果

共纳入527例患者(CF-WBI组367例,HF-WBI组160例)。1:1匹配后,101例患者被分配至CF-WBI组,104例被分配至HF-WBI组。未观察到放疗方案类型与局部区域无复发生存率(LRFS)之间的相关性(风险比[HR] 1.68,95%置信区间[CI] 0.82 - 3.45;p = 0.152)。PSM后,两个放疗组之间未观察到统计学差异(HR 1.11,95% CI 0.40 - 3.04;p = 0.833),CF-WBI组的3年和5年LRFS率分别为100%和97.9%,HF-WBI组分别为95.6%和94%。

结论

就临床结果而言,短疗程放疗似乎与CF-WBI相当。这些数据支持在DCIS患者中使用大分割方案,但需考虑仍存在的不确定性。

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