Radiation Oncology Raymond Terrace, Princess Alexandra Hospital, Brisbane, Australia.
School of Medicine, The University of Queensland, Brisbane, Australia.
Cochrane Database Syst Rev. 2021 Aug 30;8(8):CD007077. doi: 10.1002/14651858.CD007077.pub4.
BACKGROUND: Breast-conserving therapy for women with breast cancer consists of local excision of the tumour (achieving clear margins) followed by radiotherapy (RT). Most true recurrences occur in the same quadrant as the original tumour. Whole breast radiotherapy (WBRT) may not protect against the development of a new primary cancer developing in other quadrants of the breast. In this Cochrane Review, we investigated the delivery of radiation to a limited volume of the breast around the tumour bed (partial breast irradiation (PBI)) sometimes with a shortened treatment duration (accelerated partial breast irradiation (APBI)). OBJECTIVES: To determine whether PBI/APBI is equivalent to or better than conventional or hypofractionated WBRT after breast-conserving therapy for early-stage breast cancer. SEARCH METHODS: On 27 August 2020, we searched the Cochrane Breast Cancer Group Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and three trial databases. We searched for grey literature: OpenGrey (September 2020), reference lists of articles, conference proceedings and published abstracts, and applied no language restrictions. SELECTION CRITERIA: Randomised controlled trials (RCTs) without confounding, that evaluated conservative surgery plus PBI/APBI versus conservative surgery plus WBRT. Published and unpublished trials were eligible. DATA COLLECTION AND ANALYSIS: Two review authors (BH and ML) performed data extraction, used Cochrane's risk of bias tool and resolved any disagreements through discussion, and assessed the certainty of the evidence for main outcomes using GRADE. Main outcomes were local recurrence-free survival, cosmesis, overall survival, toxicity (subcutaneous fibrosis), cause-specific survival, distant metastasis-free survival and subsequent mastectomy. We entered data into Review Manager 5 for analysis. MAIN RESULTS: We included nine RCTs that enrolled 15,187 women who had invasive breast cancer or ductal carcinoma in-situ (6.3%) with T1-2N0-1M0 Grade I or II unifocal tumours (less than 2 cm or 3 cm or less) treated with breast-conserving therapy with negative margins. This is the second update of the review and includes two new studies and 4432 more participants. Local recurrence-free survival is probably slightly reduced (by 3/1000, 95% CI 6 fewer to 0 fewer) with the use of PBI/APBI compared to WBRT (hazard ratio (HR) 1.21, 95% confidence interval (CI) 1.03 to 1.42; 8 studies, 13,168 participants; moderate-certainty evidence). Cosmesis (physician/nurse-reported) is probably worse (by 63/1000, 95% CI 35 more to 92 more) with the use of PBI/APBI (odds ratio (OR) 1.57, 95% CI 1.31 to 1.87; 6 studies, 3652 participants; moderate-certainty evidence). Overall survival is similar (0/1000 fewer, 95% CI 6 fewer to 6 more) with PBI/APBI and WBRT (HR 0.99, 95% CI 0.88 to 1.12; 8 studies, 13,175 participants; high-certainty evidence). Late radiation toxicity (subcutaneous fibrosis) is probably increased (by 14/1000 more, 95% CI 102 more to 188 more) with PBI/APBI (OR 5.07, 95% CI 3.81 to 6.74; 2 studies, 3011 participants; moderate-certainty evidence). The use of PBI/APBI probably makes little difference (1/1000 less, 95% CI 6 fewer to 3 more) to cause-specific survival (HR 1.06, 95% CI 0.83 to 1.36; 7 studies, 9865 participants; moderate-certainty evidence). We found the use of PBI/APBI compared with WBRT probably makes little or no difference (1/1000 fewer (95% CI 4 fewer to 6 more)) to distant metastasis-free survival (HR 0.95, 95% CI 0.80 to 1.13; 7 studies, 11,033 participants; moderate-certainty evidence). We found the use of PBI/APBI in comparison with WBRT makes little or no difference (2/1000 fewer, 95% CI 20 fewer to 20 more) to mastectomy rates (OR 0.98, 95% CI 0.78 to 1.23; 3 studies, 3740 participants, high-certainty evidence). AUTHORS' CONCLUSIONS: It appeared that local recurrence-free survival is probably worse with PBI/APBI; however, the difference was small and nearly all women remain free of local recurrence. Overall survival is similar with PBI/APBI and WBRT, and we found little to no difference in other oncological outcomes. Some late effects (subcutaneous fibrosis) may be worse with PBI/APBI and its use is probably associated with worse cosmetic outcomes. The limitations of the data currently available mean that we cannot make definitive conclusions about the efficacy and safety or ways to deliver PBI/APBI. We await completion of ongoing trials.
背景:乳腺癌患者的保乳治疗包括肿瘤(达到明确的边缘)的局部切除,随后进行放疗(RT)。大多数真正的复发发生在原始肿瘤的同一象限。全乳房放疗(WBRT)可能无法预防在乳房其他象限发展出新的原发性癌症。在本次 Cochrane 综述中,我们研究了在肿瘤床周围的乳房有限体积(部分乳房照射(PBI))中给予放射治疗,有时缩短治疗时间(加速部分乳房照射(APBI))。 目的:确定 PBI/APBI 是否与常规或低分割 WBRT 等效或优于早期乳腺癌保乳治疗后的 WBRT。 检索方法:于 2020 年 8 月 27 日,我们检索了 Cochrane 乳腺癌组专业注册库、CENTRAL、MEDLINE、Embase、CINAHL 和三个试验数据库。我们检索了灰色文献:OpenGrey(2020 年 9 月)、文章参考文献、会议论文集和已发表的摘要,并应用了无语言限制。 入选标准:无混杂的随机对照试验(RCT),评估了保守手术加 PBI/APBI 与保守手术加 WBRT。已发表和未发表的试验均符合入选条件。 数据收集和分析:两名综述作者(BH 和 ML)进行了数据提取,使用 Cochrane 的偏倚风险工具,并通过讨论解决了任何分歧,并使用 GRADE 评估了主要结局的证据确定性。主要结局是局部无复发生存率、美容效果、总生存率、毒性(皮下纤维化)、病因特异性生存率、远处无转移生存率和随后的乳房切除术。我们将数据输入 Review Manager 5 进行分析。 主要结果:我们纳入了 9 项 RCT,共纳入 15187 名患有浸润性乳腺癌或导管原位癌(6.3%)、T1-2N0-1M0 分级 I 或 II 单发肿瘤(小于 2 厘米或 3 厘米或更小)的女性,接受保乳治疗并获得阴性切缘。这是该综述的第二次更新,包括两项新研究和 4432 名更多的参与者。与 WBRT 相比,使用 PBI/APBI 可能会略微降低(减少 3/1000,95%CI 6 个更少到 0 个更少)局部无复发生存率(风险比(HR)1.21,95%CI 1.03 至 1.42;8 项研究,13168 名参与者;中等确定性证据)。美容效果(医生/护士报告)可能更差(增加 63/1000,95%CI 35 个更多到 92 个更多)使用 PBI/APBI(优势比(OR)1.57,95%CI 1.31 至 1.87;6 项研究,3652 名参与者;中等确定性证据)。与 WBRT 相比,总生存率相似(减少 0/1000,95%CI 6 个更少到 6 个更多)使用 PBI/APBI(HR 0.99,95%CI 0.88 至 1.12;8 项研究,13175 名参与者;高确定性证据)。晚期放射毒性(皮下纤维化)可能增加(增加 14/1000,95%CI 102 个更多到 188 个更多)使用 PBI/APBI(OR 5.07,95%CI 3.81 至 6.74;2 项研究,3011 名参与者;中等确定性证据)。使用 PBI/APBI 可能对病因特异性生存率(HR 1.06,95%CI 0.83 至 1.36;7 项研究,9865 名参与者;中等确定性证据)没有显著影响。我们发现与 WBRT 相比,使用 PBI/APBI 可能对远处无转移生存率(HR 0.95,95%CI 0.80 至 1.13;7 项研究,11033 名参与者;中等确定性证据)没有显著影响(减少 1/1000,95%CI 4 个更少到 6 个更多)。我们发现与 WBRT 相比,使用 PBI/APBI 对乳房切除术率(OR 0.98,95%CI 0.78 至 1.23;3 项研究,3740 名参与者,高确定性证据)没有显著影响(减少 2/1000,95%CI 20 个更少到 20 个更多)。 作者结论:似乎 PBI/APBI 与局部无复发生存率较差相关;然而,差异较小,几乎所有女性都仍无局部复发。与 WBRT 相比,总生存率相似,我们发现其他肿瘤学结局几乎没有差异。一些晚期效应(皮下纤维化)可能更差,PBI/APBI 的使用可能与美容效果较差有关。目前可用数据的局限性意味着我们无法对 PBI/APBI 的疗效和安全性或其应用方式做出明确的结论。我们正在等待正在进行的试验完成。
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