Efficacy and safety of intraoperative radiotherapy in breast conservative surgery for breast cancer patients: a meta-analysis

doi:10.3877/cma.j.issn.1674-0807.2019.03.004

Abstract

Abstract:

Objective

To evaluate the clinical efficacy and safety of intraoperative radiotherapy in breast conservative surgery for breast cancer patients.

Methods

The databases including CNKI, VIP, Wanfang, PubMed, Cochrane, Web of Science, Embase were retrieved to identify clinical trials which investigated the efficacy and safety of intraoperative radiotherapy in breast conservative surgery from the date of establishment to December 20, 2018. Two researchers independently performed literature screening, data extraction, and methodological quality evaluation according to the inclusion and exclusion criteria. An meta-analysis of the included studies was performed using RevMan 5.3 software.

Results

Totally 12 clinical trials (6 277 subjects) including 8 randomized controlled trials (RCT) and 4 non-RCT were enrolled. Meta-analysis showed that the local recurrence rate in patients with intraoperative radiotherapy was significantly higher than that in patients with postoperative radiotherapy (RR=2.78, 95%CI: 1.25-6.19, P=0.01), and the wound healing time was significantly longer [mean difference (MD)=5.92, 95%CI: 5.46-6.37, P<0.01]. There was no significant difference in distant metastasis rate and overall survival between intraoperative radiotherapy group and postoperative radiotherapy group (RR=0.92, 95%CI: 0.62-1.37, P=0.68; RR=1.01, 95%CI: 1.00-1.01, P=0.26). The patients undergoing intraoperative radiotherapy had significantly better cosmetic effect compared with the patients with postoperative radiotherapy (RR=1.17, 95%CI: 1.05-1.31, P<0.01). The fat liquefaction rate and exudation rate presented no significant difference between intraoperative radiotherapy group and postoperative radiotherapy group(RR=2.18, 95%CI: 0.71-6.72, P=0.18; RR=1.55, 95%CI: 0.36-6.68, P=0.56).

Conclusion

Intraoperative radiotherapy is not inferior to postoperative radiotherapy in distant metastasis rate, overall survival and adverse reaction, but with better cosmetic effect and a higher local recurrence rate, so the patients with low risk of recurrence are recommended.

Key words: Breast neoplasms, Meta-analysis, Radiotherapy, Breast conservative surgery

Yu Xue, Xiaofan Xu, Jun Gu. Efficacy and safety of intraoperative radiotherapy in breast conservative surgery for breast cancer patients: a meta-analysis[J]. Chinese Journal of Breast Disease(Electronic Edition), 2019, 13(03): 150-158.

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References 27

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纳入研究	年份	研究设计	例数(T/C)	年龄(岁)	肿瘤直径(cm)	随访时间(月)	干预措施	结局指标	质量评分
Vaidya^[3]	2016	RCT	1 721/1 730	≥45	≤3.5	29	T:术中20 Gy 50 kV X线；C:体外放射治疗	①②③⑦	5^b
Veronesi^[4]	2013	RCT	651/654	48～75	≤2.5	70	T:术中21 Gy；C:全乳放射治疗	①②③⑦	5^b
孙春雷^[8]	2010	非RCT	36/41	35～69	≤2.5	30	T:术中21 Gy 9 MeV电子线3～5 min；C:全乳放射治疗50～60 Gy，5～6周(全乳50 Gy，瘤床加量至60 Gy)	①②④⑤	18^a
Zhou^[9]	2012	非RCT	72/71	≥40	≤2.5	32	T:术中21 Gy 9/12 MeV电子线3～5 min；C:术后传统放射治疗	①②③④⑥	20^a
Cracco^[10]	2015	非RCT	81/105	38～81	≤3.0	17	T:术中21 Gy；C:体外放射治疗	④⑥⑦	21^a
Sorrentino^[11]	2018	非RCT	223/220	≥50	≤3.0	≥12	T:术中21 Gy 2～4 min；C:体外放射治疗	①②③⑥	22^a
Sperk^[12]	2012	RCT	54/55	T:中位64.4;C:中位69.0	≤3.5	40	T:术中20 Gy；C:全乳放射治疗46～50 Gy	①②③	4^b
肖海燕^[13]	2013	RCT	70/70	33～68	未提及	8～24	T:术中21 Gy 9/12 MeV电子线3～5 min；C:全乳放射治疗	①②③④⑤	2^b
彭宗玉^[14]	2013	RCT	60/60	29～68	≤2.5	8～24	T:术中21 Gy 9/12 MeV电子线3～5 min；C:全乳放射治疗	①②③④⑤⑥	3^b
董世亮^[15]	2016	RCT	44/44	30～68	≤2.5	12	T:术中21 Gy 9/12 MeV电子线3～5 min；C:全乳放射治疗	④⑥⑦	2^b
刘军^[16]	2017	RCT	54/55	30～68	≤3.0	12	T:术中21 Gy 9 MeV电子线5 min；C: 21 Gy全乳放射治疗	②④⑥⑦	2^b
宋艾红^[17]	2018	RCT	53/53	45～71	≤3.0	60	T：术中9 Gy 9/12 MeV电子线3～5 min；C:全乳放射治疗	②③④⑤⑥	5^b

纳入研究	年份	研究设计	例数(T/C)	年龄(岁)	肿瘤直径(cm)	随访时间(月)	干预措施	结局指标	质量评分
Vaidya^[3]	2016	RCT	1 721/1 730	≥45	≤3.5	29	T:术中20 Gy 50 kV X线；C:体外放射治疗	①②③⑦	5^b
Veronesi^[4]	2013	RCT	651/654	48～75	≤2.5	70	T:术中21 Gy；C:全乳放射治疗	①②③⑦	5^b
孙春雷^[8]	2010	非RCT	36/41	35～69	≤2.5	30	T:术中21 Gy 9 MeV电子线3～5 min；C:全乳放射治疗50～60 Gy，5～6周(全乳50 Gy，瘤床加量至60 Gy)	①②④⑤	18^a
Zhou^[9]	2012	非RCT	72/71	≥40	≤2.5	32	T:术中21 Gy 9/12 MeV电子线3～5 min；C:术后传统放射治疗	①②③④⑥	20^a
Cracco^[10]	2015	非RCT	81/105	38～81	≤3.0	17	T:术中21 Gy；C:体外放射治疗	④⑥⑦	21^a
Sorrentino^[11]	2018	非RCT	223/220	≥50	≤3.0	≥12	T:术中21 Gy 2～4 min；C:体外放射治疗	①②③⑥	22^a
Sperk^[12]	2012	RCT	54/55	T:中位64.4;C:中位69.0	≤3.5	40	T:术中20 Gy；C:全乳放射治疗46～50 Gy	①②③	4^b
肖海燕^[13]	2013	RCT	70/70	33～68	未提及	8～24	T:术中21 Gy 9/12 MeV电子线3～5 min；C:全乳放射治疗	①②③④⑤	2^b
彭宗玉^[14]	2013	RCT	60/60	29～68	≤2.5	8～24	T:术中21 Gy 9/12 MeV电子线3～5 min；C:全乳放射治疗	①②③④⑤⑥	3^b
董世亮^[15]	2016	RCT	44/44	30～68	≤2.5	12	T:术中21 Gy 9/12 MeV电子线3～5 min；C:全乳放射治疗	④⑥⑦	2^b
刘军^[16]	2017	RCT	54/55	30～68	≤3.0	12	T:术中21 Gy 9 MeV电子线5 min；C: 21 Gy全乳放射治疗	②④⑥⑦	2^b
宋艾红^[17]	2018	RCT	53/53	45～71	≤3.0	60	T：术中9 Gy 9/12 MeV电子线3～5 min；C:全乳放射治疗	②③④⑤⑥	5^b

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