乳房局部快速放疗又称部分乳腺短程照射、加速部分乳房照射（APBI），与全乳放疗（WBI）相比，不仅可将放疗从5周缩短至1～5天，还可有效地减少对双侧乳房、皮肤、心脏、尤其是肺部的辐射暴露。近20年来，APBI的不同技术已被引入临床实践。若干回顾研究、若干二期试验和两项三期试验采用多导管间质近距离APBI，与外照射APBI和外照射WBI（EBRT）相比，效果并不逊色。其他临床试验采用替代APBI技术（包括术中电子或50千伏光子、腔内球囊近距离放疗和三维适形或调强外照射放疗）结果尚无定论或是否定。欧洲近距离放疗协作组（GEC）和欧洲肿瘤放疗学会（ESTRO）于2004年发起APBI大样本随机对照三期临床研究，对常规外照射WBI＋瘤床补量与多导管间质近距离APBI的效果进行比较。该研究1次登上《柳叶刀》正刊、2次登上《柳叶刀》肿瘤学分册，中位随访5年结果表明，APBI与WBI相比，同侧乳腺肿瘤复发率和生存率相似，后期副作用、美观效果和生活质量指标结局显著改善。那么，中位随访10年长期结果如何？ GEC-ESTRO APBI Trial (NCT00402519): APBI Versus EBRT Therapy After Breast Conserving Surgery for Low-risk Breast Cancer (Interstitial Brachytherapy Alone Versus External Beam Radiation Therapy After Breast Conserving Surgery for Low-risk Invasive Carcinoma and Low-risk Ductal Carcinoma in Situ of the Female Breast) 相关链接
Lancet Oncol. 2023 Feb 1. IF: 54.433 Accelerated partial breast irradiation using sole interstitial multicatheter brachytherapy compared with whole-breast irradiation with boost for early breast cancer: 10-year results of a GEC-ESTRO randomised, phase 3, non-inferiority trial. Vratislav Strnad, Csaba Polgár, Oliver J Ott, Guido Hildebrandt, Daniela Kauer-Dorner, Hellen Knauerhase, Tibor Major, Jaroslaw Lyczek, Jose Luis Guinot, Cristina Gutierrez Miguelez, Pavel Slampa, Michael Allgauer, Kristina Lossl, Bülent Polat, Rainer Fietkau, Annika Schlamann, Alexandra Resch, Anna Kulik, Leo Arribas, Peter Niehoff, Ferran Guedea, Jürgen Dunst, Christine Gall, Wolfgang Uteron; Groupe Européen de Curiethérapie and European Society for Radiotherapy and Oncology. University Hospital Erlangen and Comprehensive Cancer Center Erlangen-EMN, Erlangen, Germany; University Hospital Leipzig, Leipzig, Germany; University Hospital Rostock, Rostock, Germany; University Hospital Kiel, Kiel, Germany; Sana Clinic, Offenbach, Germany; Hospital Barmherzige Brüder Regensburg, Regensburg, Germany; University Hospital Würzburg, Würzburg, Germany; University Erlangen-Nuremberg, Nuremberg, Germany; National Institute of Oncology, Budapest, Hungary; Semmelweis University, Budapest, Hungary; University Hospital AKH Wien, Vienna, Austria; Centrum Onkologii-Instytut im Marii Skl odowskej, Warsaw, Poland; Podkarpacki Hospital Cancer Center Brzozów, Brzozów, Poland; Valencian Institute of Oncology Valencia, Valencia, Spain; Catalan Institute of Oncology, Barcelona, Spain; Masaryk Memorial Cancer Institute, Brno, Czech Republic; University Hospital Bern, Inselspital, Bern, Switzerland. BACKGROUND: Several randomised, phase 3 trials have investigated the value of different techniques of accelerated partial breast irradiation (APBI) for patients with early breast cancer after breast-conserving surgery compared with whole-breast irradiation. In a phase 3 randomised trial, we evaluated whether APBI using multicatheter brachytherapy is non-inferior compared with whole-breast irradiation. Here, we present the 10-year follow-up results. METHODS: We did a randomised, phase 3, non-inferiority trial at 16 hospitals and medical centres in Austria, Czech Republic, Germany, Hungary, Poland, Spain, and Switzerland. Patients aged 40 years or older with early invasive breast cancer or ductal carcinoma in situ treated with breast-conserving surgery were centrally randomly assigned (1:1) to receive either whole-breast irradiation or APBI using multicatheter brachytherapy. Whole-breast irradiation was delivered in 25 daily fractions of 50 Gy over 5 weeks, with a supplemental boost of 10 Gy to the tumour bed, and APBI was delivered as 30.1 Gy (seven fractions) and 32.0 Gy (eight fractions) of high-dose-rate brachytherapy in 5 days or as 50 Gy of pulsed-dose-rate brachytherapy over 5 treatment days. Neither patients nor investigators were masked to treatment allocation. The primary endpoint was ipsilateral local recurrence, analysed in the as-treated population; the non-inferiority margin for the recurrence rate difference (defined for 5-year results) was 3 percentage points. The trial is registered with ClinicalTrials.gov, NCT00402519; the trial is complete. FINDINGS: Between April 20, 2004, and July 30, 2009, 1328 female patients were randomly assigned to whole breast irradiation (n=673) or APBI (n=655), of whom 551 in the whole-breast irradiation group and 633 in the APBI group were eligible for analysis. At a median follow-up of 10.36 years (IQR 9.12-11.28), the 10-year local recurrence rates were 1.58% (95% CI 0.37 to 2.8) in the whole-breast irradiation group and 3.51% (1.99 to 5.03) in the APBI group. The difference in 10-year rates between the groups was 1.93% (95% CI -0.018 to 3.87; p=0.074). Adverse events were mostly grade 1 and 2, in 234 (60%) of 393 participants in the whole-breast irradiation group and 314 (67%) of 470 participants in the APBI group, at 7.5-year or 10-year follow-up, or both. Patients in the APBI group had a significantly lower incidence of treatment-related grade 3 late side-effects than those in the whole-breast irradiation group (17 [4%] of 393 for whole-breast irradiation vs seven [1%] of 470 for APBI; p=0.021; at 7.5-year or 10-year follow-up, or both). At 10 years, the most common type of grade 3 adverse event in both treatment groups was fibrosis (six [2%] of 313 patients for whole-breast irradiation and three [1%] of 375 patients for APBI, p=0.56). No grade 4 adverse events or treatment-related deaths have been observed. INTERPRETATION: Postoperative APBI using multicatheter brachytherapy after breast-conserving surgery in patients with early breast cancer is a valuable alternative to whole-breast irradiation in terms of treatment efficacy and is associated with fewer late side-effects. FUNDING: German Cancer Aid, Germany. DOI: 10.1016/S1470-2045(23)00018-9
