Lehman Margot, Hickey Brigid E, Francis Daniel P, See Adrienne M
Radiation Oncology Unit, Princess Alexandra Hospital, Ground Floor, Outpatients F, Ipswich Road, Woollangabba, Brisbane, Queensland, Australia, 4102.
Cochrane Database Syst Rev. 2014 Jun 18(6):CD007077. doi: 10.1002/14651858.CD007077.pub2.
Breast conserving therapy for women with breast cancer consists of local excision of the tumour (achieving clear margins) followed by radiation therapy (RT). RT is given to sterilize tumour cells that may remain after surgery to decrease the risk of local tumour recurrence. Most true recurrences occur in the same quadrant as the original tumour. Whole breast RT 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 role of delivering 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).
To determine whether PBI/APBI is equivalent to or better than conventional or hypofractionated WBRT after breast conservation therapy for early-stage breast cancer.
We searched the Cochrane Breast Cancer Group Specialised Register (07 November 2013), CENTRAL (2014, Issue 3), MEDLINE (January 1966 to 11 April 2014), EMBASE (1980 to 11 April 2014), CINAHL (11 April 2014) and Current Contents (11 April 2014). Also we searched the International Standard Randomised Controlled Trial Number Register, the World Health Organization's International Clinical Trials Registry Platform (07 November 2013) and US clinical trials registry (www.clinicaltrials.gov) (22 April 2014). We searched for grey literature: Open Grey (23 April 2014), reference lists of articles, a number of conference proceedings and published abstracts, and did not apply any language restrictions.
Randomised controlled trials (RCTs) without confounding and evaluating conservative surgery plus PBI/APBI versus conservative surgery plus whole breast RT. We included both published and unpublished trials.
Three review authors (ML, DF and BH) performed data extraction and resolved any disagreements through discussion. We entered data into Review Manager for analysis. BH and ML assessed trials, graded the methodological quality using Cochrane's Risk of Bias tool and resolved any disagreements through discussion.
We included four RCTs that had 2253 women. Two older trials examined RT techniques which do not reflect current practice and one trial had a short follow-up. We downgraded the quality of the evidence for our key outcomes due to risk of bias. Taken together with other GRADE recommendations, the quality of evidence for our outcomes was very low to low. For the comparison of partial breast irradiation/accelerated breast irradiation (PBI/APBI) with whole breast irradiation (WBRT), local recurrence-free survival appeared worse (Hazard Ratio (HR) 1.74, 95% confidence interval (CI) 1.23 to 2.45; three trials, 1140 participants, very low quality evidence). Cosmesis appeared improved with PBI/APBI in a single trial (OR 0.40, 95% CI 0.23 to 0.72; one trial, 241 participants, very low quality evidence), but late toxicity (telangiectasia OR 4.41, 95% CI 3.21 to 6.05; very low quality evidence, 708 participants) and subcutaneous fibrosis (OR 4.27, 95% CI 3.04 to 6.01; one trial, 710 participants, very low quality evidence) appeared increased in another trial. We found no clear evidence of a difference for the comparison of PBI/APBI versus WBRT for the outcomes of: overall survival (HR 0.99, 95% CI 0.83 to 1.18; three trials, 1140 participants, very low quality evidence), cause-specific survival (HR 0.95, 95% CI 0.74 to 1.22; two trials, 966 participants, low evidence quality), distant metastasis-free survival (HR 1.02, 95% CI 0.81 to 1.28; 1140 participants, low quality evidence), subsequent mastectomy rate (OR 0.20, 95% CI 0.01 to 4.21; 258 participants, low quality evidence) and relapse-free survival (HR 0.99, 95% CI 0.53 to 1.85; 258 participants, low quality evidence). We found no data for the outcomes of acute toxicity, new ipsilateral breast primaries, costs, quality of life or consumer preference.
AUTHORS' CONCLUSIONS: The limitations of the data currently available mean that we cannot make definitive conclusions about the efficacy and safety or ways to deliver of PBI/APBI. We await completion of ongoing trials.
乳腺癌女性的保乳治疗包括肿瘤局部切除(切缘阴性),随后进行放射治疗(RT)。放疗用于杀灭手术后可能残留的肿瘤细胞,以降低局部肿瘤复发风险。大多数真性复发发生在原肿瘤所在的同一象限。全乳放疗可能无法预防乳腺其他象限发生新发原发性癌症。在本Cochrane系统评价中,我们研究了对瘤床周围乳腺的有限体积进行放疗(部分乳腺照射:PBI),有时缩短治疗疗程(加速部分乳腺照射:APBI)的作用。
确定早期乳腺癌保乳治疗后,PBI/APBI是否等同于或优于传统或大分割全乳放疗。
我们检索了Cochrane乳腺癌协作组专业注册库(2013年11月7日)、Cochrane系统评价数据库(2014年第3期)、MEDLINE(1966年1月至2014年4月11日)、EMBASE(1980年至2014年4月11日)、CINAHL(2014年4月11日)和现刊目次(2014年4月11日)。我们还检索了国际标准随机对照试验编号注册库、世界卫生组织国际临床试验注册平台(2013年11月7日)和美国临床试验注册库(www.clinicaltrials.gov)(2014年4月22日)。我们检索了灰色文献:Open Grey(2014年4月23日)、文章参考文献列表、一些会议论文集和已发表的摘要,且未设任何语言限制。
无混杂因素的随机对照试验(RCT),比较保乳手术加PBI/APBI与保乳手术加全乳放疗。我们纳入了已发表和未发表的试验。
三位综述作者(ML、DF和BH)进行数据提取,并通过讨论解决任何分歧。我们将数据录入Review Manager进行分析。BH和ML评估试验,使用Cochrane偏倚风险工具对方法学质量进行分级,并通过讨论解决任何分歧。
我们纳入了4项RCT,共2253名女性。两项较早的试验研究的放疗技术不能反映当前实践,一项试验随访时间短。由于存在偏倚风险,我们对关键结局的证据质量进行了降级。结合其他GRADE建议,我们结局的证据质量非常低至极低。对于部分乳腺照射/加速乳腺照射(PBI/APBI)与全乳照射(WBRT)的比较,局部无复发生存期似乎更差(风险比(HR)1.74,95%置信区间(CI)1.23至2.45;三项试验,1140名参与者,极低质量证据)。在一项试验中,PBI/APBI的美容效果似乎有所改善(优势比(OR)0.40,95%CI 0.23至0.72;一项试验,241名参与者,极低质量证据),但在另一项试验中,晚期毒性(毛细血管扩张OR 4.41,95%CI 3.21至6.05;极低质量证据,708名参与者)和皮下纤维化(OR 4.27,95%CI 3.04至6.01;一项试验,710名参与者,极低质量证据)似乎增加。对于PBI/APBI与WBRT在以下结局的比较,我们未发现明显差异证据:总生存(HR 0.99,95%CI 0.83至1.18;三项试验,1140名参与者,极低质量证据)、特定原因生存(HR 0.95,95%CI 0.74至1.22;两项试验,966名参与者,低质量证据)、无远处转移生存(HR 1.02,95%CI 0.81至1.28;1140名参与者,低质量证据)、后续乳房切除率(OR 0.20,95%CI 0.01至4.21;258名参与者,低质量证据)和无复发生存(HR 0.99,95%CI 0.53至1.85;258名参与者,低质量证据)。我们未找到关于急性毒性、同侧乳腺新发原发性癌症、成本、生活质量或消费者偏好结局的数据。
目前可得数据的局限性意味着我们无法对PBI/APBI的疗效、安全性或给药方式得出明确结论。我们等待正在进行的试验完成。