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乳腺导管原位癌和淋巴结阴性乳腺癌保乳术后部分乳腺加速照射不亚于全乳照射
作者:小柯机器人 发布时间:2019/12/6 17:26:47

加拿大朱拉文斯基癌症中心Timothy J Whelan团队近日取得一项新成果。他们的最新研究比较了乳腺导管原位癌和淋巴结阴性乳腺癌保乳术后,部分乳腺加速照射与全乳腺照射的治疗效果。相关论文2019年12月5日发表于国际顶尖学术期刊《柳叶刀》上。

保乳术后3-5周内每天进行一次全乳照射,可减少局部复发,整容效果好。为了提供更方便的治疗,研究组在肿瘤床上安装了部分乳腺加速照射(APBI)装置。

研究组在加拿大、澳大利亚和新西兰的33个癌症中心进行了一项多中心、随机、非劣效性的试验。2006年2月7日至2011年7月15日,研究组共招募了2135名患乳腺导管原位癌或淋巴结阴性乳腺癌的女性,均行保乳手术,年龄在40岁以上,将其按1:1随机分为两组,其中1070例接受APBI,1065例接受全乳照射。

中位随访8.6年后,APBI组中8年累积的同侧乳腺肿瘤复发(IBTR)率为3.0%,而全乳照射组为2.8%,风险比为1.28。放疗开始3个月内,APBI组中有28%的患者发生2级以上急性放射毒性,显著低于全乳照射组(45%)。放疗3个月后,APBI组中有32%的患者发生2级以上晚期放射毒性,显著高于全乳照射组(13%)。APBI组在治疗后第3年、第5年和第7年与全乳照射组相比,更容易发生整容不良反应。

总之,APBI在预防IBTR方面不亚于全乳照射。虽然APBI的急性毒性较小,但中度晚期毒性和整容不良反应较大,这可能与每日两次放疗有关。下一步研究应尝试每日一次放疗的安全性。

附:英文原文

Title: External beam accelerated partial breast irradiation versus whole breast irradiation after breast conserving surgery in women with ductal carcinoma in situ and node-negative breast cancer (RAPID): a randomised controlled trial

Author: Timothy J Whelan, Jim A Julian, Tanya S Berrang, Do-Hoon Kim, Isabelle Germain, Alan M Nichol, Mohamed Akra, Sophie Lavertu, Francois Germain, Anthony Fyles, Theresa Trotter, Francisco E Perera, Susan Balkwill, Susan Chafe, Thomas McGowan, Thierry Muanza, Wayne A Beckham, Boon H Chua, Chu Shu Gu, Mark N Levine, Ivo A Olivotto, Carson Leong, Beverly Helen Lester, Winkle Bingchung Kwan, Medhat Zikry Abd-El-Malek, Arthur Cheung, Maha Almahmudi, Joel Broomfield, Michael Sia, Melanie Jean Reed, Jane Wilson, Islam Gharib Mohamed, Caroline Holloway, Kenneth Mills, David W. Petrik, Juanita Mary Crook, Frances Lai-Wah Wong, Hannah Mills Carolan, David Voduc, Paris-Ann Ingledew, Sonia Nguyen, Mira Keyes, Lorna M. Weir, Scott Tyldesley, Peter Lim, Christina Aquino Parsons, Robert Olson, Paul Blood, Elaine Sze-Sze Wai, Pauline Truong, Hosam (Sam) Kader, Abraham Alexander, Aminudin Rahman Mohd Mydin, Sally Smith, Maria Vlachaki, Valerie Panet-Raymond, Krystine Lupe, Jennifer Goulart, David Nguyen, Karen Chu, Joycelin Canavan, Julianna Caon, Susan Tyler, Negin Shahid, Jacqueline Lam, John Amanie, Diane Marie Severin, Bassam Abdul Karim, Keith Tankel, Nadeem Pervez, Kurian Joseph, Zsolt Gabos, Barbara Krause, Fleur Huang, Tien Phan, Peter Craighead, Elizabeth Yan, J.A. (Jack) MacKinnon, Robert Nordal, Siraj Husain, Jon-Paul Voroney, Richie Sinha, James Pinilla, Andrew Cooke, Kalyani Vijayraghavan, Steven Latosinsky, Elizabeth Saettler, Yiu-Keung (James) Lau, Marianne Krahn, Ethel MacIntosh, Maged Nashed, Bashir Bashir, Vamsee Torri, Benjamin Goldenberg, Christina Kim, Vasanth Basrur, Ramana Rachakonda, Darin Gopaul, Sundeep Shahi, Sofya Kobeleva, Ian Dayes, David Hodson, Barbara Strang, Sachi Voruganti, William McMillan, Harold Reiter, Jim Wright, Jonathan Sussman, Som Mukherjee, Susan Gudelis, David DSouza, Michael Lock, Nancy Read, Olga Vujovic, Brian Yaremko, Edward Yu, Theodore Vandenberg, Jawaid Younus, Kylea Potvin, Tracy Sexton, Brian Dingle, Brian Findlay, Janice Giesbrecht, Philip Hughes, Martin Samosh, Michael Levesque, Radhika Yelamanchili

Issue&Volume: December 05, 2019

Abstract:

Background

Whole breast irradiation delivered once per day over 3–5 weeks after breast conserving surgery reduces local recurrence with good cosmetic results. Accelerated partial breast irradiation (APBI) delivered over 1 week to the tumour bed was developed to provide a more convenient treatment. In this trial, we investigated if external beam APBI was non-inferior to whole breast irradiation.

Methods

We did this multicentre, randomised, non-inferiority trial in 33 cancer centres in Canada, Australia and New Zealand. Women aged 40 years or older with ductal carcinoma in situ or node-negative breast cancer treated by breast conserving surgery were randomly assigned (1:1) to receive either external beam APBI (38·5 Gy in ten fractions delivered twice per day over 5–8 days) or whole breast irradiation (42·5 Gy in 16 fractions once per day over 21 days, or 50 Gy in 25 fractions once per day over 35 days). Patients and clinicans were not masked to treatment assignment. The primary outcome was ipsilateral breast tumour recurrence (IBTR), analysed by intention to treat. The trial was designed on the basis of an expected 5 year IBTR rate of 1·5% in the whole breast irradiation group with 85% power to exclude a 1·5% increase in the APBI group; non-inferiority was shown if the upper limit of the two-sided 90% CI for the IBTR hazard ratio (HR) was less than 2·02. This trial is registered with ClinicalTrials.gov, NCT00282035.

Findings

Between Feb 7, 2006, and July 15, 2011, we enrolled 2135 women. 1070 were randomly assigned to receive APBI and 1065 were assigned to receive whole breast irradiation. Six patients in the APBI group withdrew before treatment, four more did not receive radiotherapy, and 16 patients received whole breast irradiation. In the whole breast irradiation group, 16 patients withdrew, and two more did not receive radiotherapy. In the APBI group, a further 14 patients were lost to follow-up and nine patients withdrew during the follow-up period. In the whole breast irradiation group, 20 patients were lost to follow-up and 35 withdrew during follow-up. Median follow-up was 8·6 years (IQR 7·3–9·9). The 8-year cumulative rates of IBTR were 3·0% (95% CI 1·9–4·0) in the APBI group and 2·8% (1·8–3·9) in the whole breast irradiation group. The HR for APBI versus whole breast radiation was 1·27 (90% CI 0·84–1·91). Acute radiation toxicity (grade ≥2, within 3 months of radiotherapy start) occurred less frequently in patients treated with APBI (300 [28%] of 1070 patients) than whole breast irradiation (484 [45%] of 1065 patients, p<0·0001). Late radiation toxicity (grade ≥2, later than 3 months) was more common in patients treated with APBI (346 [32%] of 1070 patients) than whole breast irradiation (142 [13%] of 1065 patients; p<0·0001). Adverse cosmesis (defined as fair or poor) was more common in patients treated with APBI than in those treated by whole breast irradiation at 3 years (absolute difference, 11·3%, 95% CI 7·5–15·0), 5 years (16·5%, 12·5–20·4), and 7 years (17·7%, 12·9–22·3).

Interpretation

External beam APBI was non-inferior to whole breast irradiation in preventing IBTR. Although less acute toxicity was observed, the regimen used was associated with an increase in moderate late toxicity and adverse cosmesis, which might be related to the twice per day treatment. Other approaches, such as treatment once per day, might not adversely affect cosmesis and should be studied.

DOI: 10.1016/S0140-6736(19)32515-2

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32515-2/fulltext

期刊信息

LANCET:《柳叶刀》,创刊于1823年。隶属于爱思唯尔出版社,最新IF:59.102
官方网址:http://www.thelancet.com/
投稿链接:http://ees.elsevier.com/thelancet