MammoSite Balloon Brachytherapy for Accelerated Partial Breast Irradiation Following Breast-conserving Surgery for Patients with Early Stage Breast Cancer: A Single Arm Meta-analysis_Chinese Journal of Evidence-Based Medicine

Authors：

 HUANGZi-han ^1,2 , WANGXiao-hu ³ , TIANJin-hui ^2,3 , HEJuan ^2,4 , MACong ^1,4 , MAZhan-jun ^2,4 , YANGYan ³ ,  ZHANGQiu-ning ³

1. The First Clinical Medical College of Lanzhou University, Lanzhou 730000, China;
2. The Evidence-Based Medicine Center of Lanzhou University, Lanzhou 730000, China;
3. Gansu Provincial Academic Institute for Medical Research, Gansu Provincial Cancer Hospital, Lanzhou 730050, China;
4. The Second Clinical Medical College of Lanzhou University, Lanzhou 730000, China;

Corresponding?author：

ZHANGQiu-ning, Email: zqn168@sina.com

Keywords：

Breast carcinoma; Breast-conserving therapy; MammoSite; Accelerated partial breast irradiation (APBI); Single arm; Case series; Systematic review

DOI：

10.7507/1672-2531.20160197

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Objective To assess the cosmetic outcomes and adverse events of MammoSite balloon brachytherapy for Accelerated Partial Breast Irradiation following breast-conserving surgery for patients with early stage breast cancer. Methods We searched PubMed, EMbase, Chinese Biomedical Database, Chinese Studies Online, China Journal Full-text Database up to March 2016, to collect clinical trials about MammoSite balloon brachytherapy following breast-conserving surgery for early stage breast cancer. And meta-analyses were performed by OpenMeta and Stata softwares. Results Twenty trials involving 3 796 patients were enrolled. The single arm meta-analysis results showed that:the cosmetic results were rated as excellent to good in 93% (95%CI 0.91 to 0.96), and the 5-year incidence of ipsilateral breast tumor recurrence (IBTR) was 3% (95%CI 0.020 to 0.040). Conclusion To carry out the conclusion above, we still need controlled trials, especially randomized controlled trials (RCTs) to prompt further verification.

Citation： HUANGZi-han, WANGXiao-hu, TIANJin-hui, HEJuan, MACong, MAZhan-jun, YANGYan, ZHANGQiu-ning. MammoSite Balloon Brachytherapy for Accelerated Partial Breast Irradiation Following Breast-conserving Surgery for Patients with Early Stage Breast Cancer: A Single Arm Meta-analysis. Chinese Journal of Evidence-Based Medicine, 2016, 16(11): 1298-1305. doi: 10.7507/1672-2531.20160197 Copy

1.	申良方, 趙雅潔, 井笛.早期乳腺癌保乳術后部分乳腺放療的研究進展.中國現代醫學雜志, 2014, 24(11):67-70.
2.	Koukourakis G. Radiation therapy for early breast cancer. Clin Transl Oncol, 2009, 11(9):596-603.
3.	Clarke M, Collins R, Darby S, et al. Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival:an overview of the randomised trials. Lancet, 2005, 366(9503):2087-2106.
4.	潘建基, 吳君心.近距離放射治療的臨床應用進展.中國癌癥雜志, 2006, 16(6):459-463.
5.	Streeter OE Jr, Vicini FA, Keisch M, et al. MammoSites radiation therapy system. Breast, 2003, 12(6):4912496.
6.	Benitez PR, Streeter O, Vicini F, et al. Preliminary results and evaluation of MammoSite balloon brachytherapy for partial breast irradiation for pure ductal carcinoma in situ:a phase Ⅱ clinical study. Am J Surg, 2006, 192(4):427-433.
7.	Dowlatshahi K, Snider HC, Gittleman MA, et al. Early experience with balloon brachytherapy for breast cancer. Arch Surg, 2004, 139(6):603-607.
8.	Benitez PR, Keisch ME, Vicini F, et al. Five-year results:the initial clinical trial of MammoSite balloon brachytherapy for partial breast irradiation in early-stage breast cancer. Am J Surg, 2007, 194(4):456-462.
9.	Keisch M, Vicini F, Kuske RR, et al. Initial clinical experience with the MammoSite breast brachytherapy applicator in womenwith early-stage breast cancer treated with breast-conserving therapy. Int J Radiat Oncol Biol Phys, 2003, 55(2):289-293.
10.	Belkacémi Y, Chauvet MP, Giard S, et al. Partial breast irradiation as sole therapy for low risk breast carcinoma:early toxicity, cosmesis and quality of life results of a MammoSite brachytherapy phase II study. Radiother Oncol, 2009, 90(1):23-29.
11.	Harper JL, Jenrette JM, Vanek KN, et al. Acute complications of MammoSite brachytherapy:a single institution's initial clinicalexperience. Int J Radiat Oncol Biol Phys, 2005, 61(1):169-174.
12.	Vicini FA, Beitsch PD, Quiet CA, et al. First analysis of patient demographics, technical reproducibility, cosmesis, and earlytoxicity:results of the American Society of Breast Surgeons MammoSite breast brachytherapy trial. Cancer, 2005, 104(6):1138-1148.
13.	Goyal S, Vicini F, Beitsch PD, et al. Ductal carcinoma in situ treated with breast-conserving surgery and accelerated partialbreast irradiation:comparison of the Mammosite registry trial with intergroup study E5194. Cancer, 2011, 117(6):1149-1155.
14.	Richards GM, Berson AM, Rescigno J, et al. Acute toxicity of high-dose-rate intracavitary brachytherapy with the MammoSite applicatorin patients with early-stage breast cancer. Ann Surg Oncol, 2004, 11(8):739-746.
15.	Beitsch PD, Wilkinson JB, Vicini FA, et al. Tumor bed control with balloon-based accelerated partial breast irradiation:incidence of truerecurrences versus elsewhere failures in the American Society of Breast SurgeryMammoSite (^?) Registry Trial. Ann Surg Oncol, 2012, (10):3165-3170.
16.	Haynes AB, Bloom ES, Bedrosian I, et al. Timing of infectious complications following breast-conserving therapy with catheter-basedaccelerated partial breast irradiation. Ann Surg Oncol, 2014, 21(8):2512-2516.
17.	DiFronzo LA, Tsai PI, Hwang JM, et al. Breast conserving surgery and accelerated partial breast irradiation using the MammoSitesystem:initial clinical experience. Arch Surg, 2005, 140(8):787-794.
18.	Wallace MF, Martinez AA, Chen PY, et al. Phase Ⅰ/Ⅱ study evaluating early tolerance in breast cancer patients undergoing accelerated partial breast irradiation treated with MammoSite balloon breast brachytherapy catheter using a two-day dose schedule. Cancer Res January, 2009, 69(15):5131.
19.	Tsai PI, Ryan M, Meek K, et al. Accelerated partial breast irradiation using the MammoSite device:early technical experience and short-term clinical follow-up. Am Surg, 2006, 72(10):929-934.
20.	Ravi A, Lee S, Karsif KS, et al. Accelerated partial breast irradiation for early stage breast cancer using MammoSite (registered trademark) a in postmenopausal patients:6-Year results from a single institution. Abstracts/Brachytherapy, 2010, 9:S23e-S102.
21.	Abbott AM, Portschy PR, Lee C, et al. Prospective multicenter trial evaluating balloon-catheter partial-breast irradiation for ductal carcinoma in situ. Int J Radiat Oncol Biol Phys, 2013, 87(3):494-498.
22.	Small W Jr, Refaat T, Strauss JB, et al. Clinical outcomes with the MammoSite radiation therapy system: results of a prospectivetrial. Radiat Oncol, 2015, 4(4):395-400.
23.	Mann JM, Osian AD, Brandmaier A, et al. Excellent Long-term Breast Preservation Rate After Accelerated Partial Breast Irradiation Using a Balloon Device. Clin Breast Cancer, 2016, 16(3):217-222.
24.	Shah S, Holzwanger E, Khwaja R, et al. A Single-Site Retrospective, Nonrandomized Study of Accelerated Partial Breast Irradiation Brachytherapy for Early-Stage Breast Cancer Treatment to Evaluate Local Tumor Control, Cosmetic Outcome, and Toxicities. Technol Cancer Res Treat, 2016, 15(5):645-650.
25.	Dickler A, Kirk MC, Choo J, et al. Cosmetic outcome and incidence of infection with the MammoSite breast brachytherapy applicator. Breast J, 2005, 11(5):306-310.
26.	姜慶豐, 譚榜憲.乳腺癌保乳術后加速部分乳腺放射治療的臨床應用現狀.華西醫學, 2012, 27(2):304-308.
27.	張秋寧, 王強, 冶秀鵬, 等.早期乳腺癌保乳術后加速部分乳腺放療的Meta分析.腫瘤學雜志, 2011, 17(7):524-529.
28.	Vicini F, Beitsch PD, Quiet CA, et al. Three year analysis of treatment efficacy, cosmesis, and toxicity by the Am erican Society of Breast Surgeons MammoSite Breast Brachytherapy Registry Trial in patients treated with accelerated partial breast irradiation (APBI). Cancer, 2008, 112(4):758-766.
29.	Monticciolo DL, Biggs K, Gist AK, et al. Breast conserving therapy with accelerated partial breast versus external beam whole breastirradiation:comparison of imaging sequela and complications in a matched population. Breast J, 2011, 17(2):187-190.
30.	曾憲濤, 劉慧, 陳曦.等. Meta分析系列之四:觀察性研究的質量評價工具.中國循證心血管醫學雜志, 2012, 4(4):297-299.

1. 申良方, 趙雅潔, 井笛.早期乳腺癌保乳術后部分乳腺放療的研究進展.中國現代醫學雜志, 2014, 24(11):67-70.
2. Koukourakis G. Radiation therapy for early breast cancer. Clin Transl Oncol, 2009, 11(9):596-603.
3. Clarke M, Collins R, Darby S, et al. Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival:an overview of the randomised trials. Lancet, 2005, 366(9503):2087-2106.
4. 潘建基, 吳君心.近距離放射治療的臨床應用進展.中國癌癥雜志, 2006, 16(6):459-463.
5. Streeter OE Jr, Vicini FA, Keisch M, et al. MammoSites radiation therapy system. Breast, 2003, 12(6):4912496.
6. Benitez PR, Streeter O, Vicini F, et al. Preliminary results and evaluation of MammoSite balloon brachytherapy for partial breast irradiation for pure ductal carcinoma in situ:a phase Ⅱ clinical study. Am J Surg, 2006, 192(4):427-433.
7. Dowlatshahi K, Snider HC, Gittleman MA, et al. Early experience with balloon brachytherapy for breast cancer. Arch Surg, 2004, 139(6):603-607.
8. Benitez PR, Keisch ME, Vicini F, et al. Five-year results:the initial clinical trial of MammoSite balloon brachytherapy for partial breast irradiation in early-stage breast cancer. Am J Surg, 2007, 194(4):456-462.
9. Keisch M, Vicini F, Kuske RR, et al. Initial clinical experience with the MammoSite breast brachytherapy applicator in womenwith early-stage breast cancer treated with breast-conserving therapy. Int J Radiat Oncol Biol Phys, 2003, 55(2):289-293.
10. Belkacémi Y, Chauvet MP, Giard S, et al. Partial breast irradiation as sole therapy for low risk breast carcinoma:early toxicity, cosmesis and quality of life results of a MammoSite brachytherapy phase II study. Radiother Oncol, 2009, 90(1):23-29.
11. Harper JL, Jenrette JM, Vanek KN, et al. Acute complications of MammoSite brachytherapy:a single institution's initial clinicalexperience. Int J Radiat Oncol Biol Phys, 2005, 61(1):169-174.
12. Vicini FA, Beitsch PD, Quiet CA, et al. First analysis of patient demographics, technical reproducibility, cosmesis, and earlytoxicity:results of the American Society of Breast Surgeons MammoSite breast brachytherapy trial. Cancer, 2005, 104(6):1138-1148.
13. Goyal S, Vicini F, Beitsch PD, et al. Ductal carcinoma in situ treated with breast-conserving surgery and accelerated partialbreast irradiation:comparison of the Mammosite registry trial with intergroup study E5194. Cancer, 2011, 117(6):1149-1155.
14. Richards GM, Berson AM, Rescigno J, et al. Acute toxicity of high-dose-rate intracavitary brachytherapy with the MammoSite applicatorin patients with early-stage breast cancer. Ann Surg Oncol, 2004, 11(8):739-746.
15. Beitsch PD, Wilkinson JB, Vicini FA, et al. Tumor bed control with balloon-based accelerated partial breast irradiation:incidence of truerecurrences versus elsewhere failures in the American Society of Breast SurgeryMammoSite (^?) Registry Trial. Ann Surg Oncol, 2012, (10):3165-3170.
16. Haynes AB, Bloom ES, Bedrosian I, et al. Timing of infectious complications following breast-conserving therapy with catheter-basedaccelerated partial breast irradiation. Ann Surg Oncol, 2014, 21(8):2512-2516.
17. DiFronzo LA, Tsai PI, Hwang JM, et al. Breast conserving surgery and accelerated partial breast irradiation using the MammoSitesystem:initial clinical experience. Arch Surg, 2005, 140(8):787-794.
18. Wallace MF, Martinez AA, Chen PY, et al. Phase Ⅰ/Ⅱ study evaluating early tolerance in breast cancer patients undergoing accelerated partial breast irradiation treated with MammoSite balloon breast brachytherapy catheter using a two-day dose schedule. Cancer Res January, 2009, 69(15):5131.
19. Tsai PI, Ryan M, Meek K, et al. Accelerated partial breast irradiation using the MammoSite device:early technical experience and short-term clinical follow-up. Am Surg, 2006, 72(10):929-934.
20. Ravi A, Lee S, Karsif KS, et al. Accelerated partial breast irradiation for early stage breast cancer using MammoSite (registered trademark) a in postmenopausal patients:6-Year results from a single institution. Abstracts/Brachytherapy, 2010, 9:S23e-S102.
21. Abbott AM, Portschy PR, Lee C, et al. Prospective multicenter trial evaluating balloon-catheter partial-breast irradiation for ductal carcinoma in situ. Int J Radiat Oncol Biol Phys, 2013, 87(3):494-498.
22. Small W Jr, Refaat T, Strauss JB, et al. Clinical outcomes with the MammoSite radiation therapy system: results of a prospectivetrial. Radiat Oncol, 2015, 4(4):395-400.
23. Mann JM, Osian AD, Brandmaier A, et al. Excellent Long-term Breast Preservation Rate After Accelerated Partial Breast Irradiation Using a Balloon Device. Clin Breast Cancer, 2016, 16(3):217-222.
24. Shah S, Holzwanger E, Khwaja R, et al. A Single-Site Retrospective, Nonrandomized Study of Accelerated Partial Breast Irradiation Brachytherapy for Early-Stage Breast Cancer Treatment to Evaluate Local Tumor Control, Cosmetic Outcome, and Toxicities. Technol Cancer Res Treat, 2016, 15(5):645-650.
25. Dickler A, Kirk MC, Choo J, et al. Cosmetic outcome and incidence of infection with the MammoSite breast brachytherapy applicator. Breast J, 2005, 11(5):306-310.
26. 姜慶豐, 譚榜憲.乳腺癌保乳術后加速部分乳腺放射治療的臨床應用現狀.華西醫學, 2012, 27(2):304-308.
27. 張秋寧, 王強, 冶秀鵬, 等.早期乳腺癌保乳術后加速部分乳腺放療的Meta分析.腫瘤學雜志, 2011, 17(7):524-529.
28. Vicini F, Beitsch PD, Quiet CA, et al. Three year analysis of treatment efficacy, cosmesis, and toxicity by the Am erican Society of Breast Surgeons MammoSite Breast Brachytherapy Registry Trial in patients treated with accelerated partial breast irradiation (APBI). Cancer, 2008, 112(4):758-766.
29. Monticciolo DL, Biggs K, Gist AK, et al. Breast conserving therapy with accelerated partial breast versus external beam whole breastirradiation:comparison of imaging sequela and complications in a matched population. Breast J, 2011, 17(2):187-190.
30. 曾憲濤, 劉慧, 陳曦.等. Meta分析系列之四:觀察性研究的質量評價工具.中國循證心血管醫學雜志, 2012, 4(4):297-299.

Chinese Journal of Evidence-Based Medicine

MammoSite Balloon Brachytherapy for Accelerated Partial Breast Irradiation Following Breast-conserving Surgery for Patients with Early Stage Breast Cancer: A Single Arm Meta-analysis

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