Public Comment

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The deadline to submit comments is October 31, 2024.

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* Name

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* Institution/Organization

Methodology
Strong Consensus If >90% of panelist rate a recommendation as either “strongly agree” or “agree” and the median score is 1
Consensus If > 75% and <90% of panelists rate a recommendation as either “strongly agree” or “agree” and the median is either 2 or 1
No Consensus any other rating scores



1. General Overall Comments

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* 1a. Clinicians should manage all biopsy proven concordant fibroadenomas containing an atypical lesion as the atypical lesion would be managed. (Strong Consensus)

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* 1b. Clinicians should manage complex, juvenile and cellular fibroadenomas as standard fibroadenomas as recommendations do not differ. (Strong Consensus)

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* 1c. In patients who are diagnosed with fibroadenomas during pregnancy or who plan to become pregnant, clinicians should manage them as a typical fibroadenoma. (Strong Consensus)

2. Imaging

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* 2a. For patients with biopsy proven concordant fibroadenomas, no further imaging beyond what was done to diagnose the fibroadenoma is needed.(Strong Consensus)

3. Percutaneous Interventions

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* 3a. Cryotherapy for symptomatic biopsy proven fibroadenomas can be considered for lesions smaller than 2.0cm provided the proceduralist has sufficient ultrasound skills and cryotherapy experience. (Consensus)

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* 3b. Vacuum-assisted excision of a biopsy-proven, concordant fibroadenoma can be considered for lesions smaller than 2cm provided the proceduralist has sufficient ultrasound skills and experience with vacuum-assisted excisions. Imaging should be utilized to ensure complete removal of the lesion after the procedure. (Consensus)

4. Indications for Surgical Excision

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* 4a. Routine excision is not recommended for patients with biopsy proven, concordant fibroadenomas. (Strong Consensus)

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* 4b. Clinicians may consider excision of a biopsy-proven fibroadenoma based on patient preference or symptoms.(Consensus)

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* 4c. Clinicians should excise a biopsy-proven fibroadenoma that has demonstrated more than 20% growth. (Consensus)

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* 4d. Clinicians should excise a biopsy-proven fibroadenoma that is larger than 5cm. (Strong Consensus)

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* 4e. Clinicians should excise a biopsy-proven fibroadenoma that is considered discordant by the radiologist. (Strong Consensus)

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* 4f. Multiple bilateral circumscribed masses seen on mammography and sonography are deemed benign and usually do not require excision. (Strong Consensus)

5. Performance of the Surgical ProcedureOther non-Surgical Management

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* 5a. For patients undergoing surgical excision of a biopsy proven fibroadenoma, complete enucleation without transection or morcellation of the mass is recommended. (Strong Consensus)

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* 5b. For patients undergoing excision of a fibroadenoma, one method of localization is not recommended over another, when necessary. (Strong Consensus)

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* 5c. For patients undergoing excision of a fibroadenoma, surgeons should consider aesthetics, implications on future breast feeding, and nipple/skin sensation, when selecting incision placement. (Strong Consensus)

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* 5d. For patients undergoing excision of a fibroadenoma, continuous intra-operative palpation until dissection is carried down to a definitive capsule of the fibroadenoma is recommended to avoid excessive breast tissue excision and unnecessary deformity. (Strong Consensus)

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* 5e. For pediatric patients undergoing excision of a fibroadenoma, surgeons should preserve the breast bud and consider avoiding the nipple-areolar complex. (Strong Consensus)

6. Other Non-Surgical Management

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* 6a. No medications are currently recommended for treatment of fibroadenomas. (Strong Consensus)

7. Follow-Up Care

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* 7a. Patients with biopsy-proven, concordant fibroadenomas do not require imaging follow-up and can return to age-appropriate screening. (Strong Consensus)

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* 7b. Patients with biopsy-proven, concordant fibroadenomas should return to see the surgeon for excision of the fibroadenoma if there is significant growth or the fibroadenoma reaches a size of 5cm or greater. (Strong Consensus)

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* 7c. Patients with multiple bilateral circumscribed masses with benign imaging features on mammography and ultrasound do not require imaging follow-up and can return to age-appropriate screening. (Strong Consensus)

Appendix 2. Literature Search Results

A review of the literature was conducted in support of development of these pathway recommendations. Search parameters and resulting references are below.

Search Parameters:

Search 1. ‘Breast fibroadenoma’; Filters applied: Clinical Trial, Controlled Clinical Trial, Meta-Analysis, Randomized Controlled Trial, Systematic Review, in the last 10 years, English.
Search 2. ‘Breast fibroadenoma’ AND ("Follow-Up Studies"[MeSH] OR "Retrospective Studies"[MeSH]; Filters applied: in the last 10 years, English
Limited to studies with 100+ Cases

1. Alipour S(1)(2), Abedi M(3), Saberi A(2), Maleki-Hajiagha A(4), Faiz F(5), Shahsavari S(6)(7), Eslami B(8). Metformin as a new option in the medical management of breast fibroadenoma; a randomized clinical trial. BMC Endocr Disord. 2021 Aug 20;21(1):169. doi: 10.1186/s12902-021-00824-4.

2. Liang M(1), Zhang Z(1), Zhang C(2)(3)(4), Chen R(1), Xiao Y(2), Li Z(2), Li T(5), Liu Y(1), Ling L(1), Xie H(1), Chen L(1), Liu X(1), Wang S(1), Xia T(1)(2). Feasibility and efficacy of ultrasound-guided high-intensity focused ultrasound of breast fibroadenoma. Int J Hyperthermia. 2023;40(1):2240548. doi: 10.1080/02656736.2023.2240548.

3. Sosin M(1), Pulcrano M(1), Feldman ED(1), Patel KM(1), Nahabedian MY(1), Weissler JM(1), Rodriguez ED(1).Giant juvenile fibroadenoma: a systematic review with diagnostic and treatment recommendations. Gland Surg. 2015 Aug;4(4):312-21. doi: 10.3978/j.issn.2227-684X.2015.06.04.

4. Brownstone ND(1), Celie KB(2), Spigland NA(1), Otterburn DM(1). Pediatric Breast Fibroadenomas: A Systematic Review and Algorithm for Treatment. Ann Plast Surg. 2019 Nov;83(5):601-605. doi: 10.1097/SAP.0000000000001717.

5. Imankulov S(1), Tuganbekov T(2), Razbadauskas A(3), Seidagaliyeva Z(4). HIFU treatment for fibroadenoma - a clinical study at National Scientific Research Centre, Astana, Kazakhstan. J Pak Med Assoc. 2018 Sep;68(9):1378-1380.

6. Pasta V(1), Dinicola S, Giuliani A, Harrath AH, Alwasel SH, Tartaglia F, Cucina A, Bizzarri M. A randomized trial of Boswellia in association with betaine and myo-inositol in the management of breast fibroadenomas. Eur Rev Med Pharmacol Sci. 2016 May;20(9):1860-5.

7. Kim I(1), Choi HJ(2), Ryu JM(2), Lee SK(2), Yu JH(2), Lee JE(2), Nam SJ(2), Shin HJ(3), Kim SW(4). The efficacy and safety of indocyanine green-hyaluronic acid mixture (LuminoMark™) for localization in patients with non-palpable breast lesions: a multi-center open-label parallel phase-2 clinical trial. BMC Surg. 2021 Mar 16;21(1):134. doi: 10.1186/s12893-021-01129-y.

8. Peek MC(1)(2), Ahmed M(1), Scudder J(2), Baker R(3), Pinder SE(1)(2), Douek M(1)(2); HIFU-F Trialists’ Group. High intensity focused ultrasound in the treatment of breast fibroadenomata: results of the HIFU-F trial. Int J Hyperthermia. 2016 Dec;32(8):881-888. doi: 10.1080/02656736.2016.1212278. Epub 2016 Sep 7.
9. Elnahas W(1), Metwally IH(1), Bonna K(1), Youssef M(1), AbdAllah S(1), Bonna M(2), Ali Faried M(2), Atef Tira M(2), Hamdy O(1). Fibroadenoma of the breast; incidence of malignancy and indicators for surgical intervention: An analysis of 1392 patients. Breast Dis. 2022;41(1):421-426. doi: 10.3233/BD-210074.

10. Nassar A(1), Visscher DW, Degnim AC, Frank RD, Vierkant RA, Frost M, Radisky DC, Vachon CM, Kraft RA, Hartmann LC, Ghosh K. Complex fibroadenoma and breast cancer risk: a Mayo Clinic Benign Breast Disease Cohort Study. Breast Cancer Res Treat. 2015 Sep;153(2):397-405. doi: 10.1007/s10549-015-3535-8. Epub 2015 Aug 12.

11. Lee SR(1). Surgery for fibroadenoma arising from axillary accessory breast. BMC Womens Health. 2021 Apr 7;21(1):139. doi: 10.1186/s12905-021-01278-5.

12. Shaylor SD(1), Heller SL, Melsaether AN, Gupta D, Gupta A, Babb J, Moy L. Short interval follow-up after a benign concordant MR-guided vacuum assisted breast biopsy--is it worthwhile? Eur Radiol. 2014 Jun;24(6):1176-85. doi: 10.1007/s00330-014-3125-x. Epub 2014 Mar 14. 13. Dialani V(1), Chansakul T(2), Lai KC(3), Gilmore H(4), Sayegh NY(5), Slanetz PJ(6). Enlarging biopsy-proven fibroadenoma: Is surgical excision necessary? Clin Imaging. 2019 Sep-Oct;57:35-39. doi: 10.1016/j.clinimag.2019.03.014. Epub 2019 Apr 4.

13. Dialani V(1), Chansakul T(2), Lai KC(3), Gilmore H(4), Sayegh NY(5), Slanetz PJ(6). Enlarging biopsy-proven fibroadenoma: Is surgical excision necessary? Clin Imaging. 2019 Sep-Oct;57:35-39. doi: 10.1016/j.clinimag.2019.03.014. Epub 2019 Apr 4.

14. Johansson A(1), Christakou AE(1), Iftimi A(2), Eriksson M(3), Tapia J(3), Skoog L(1), Benz CC(4)(5), Rodriguez-Wallberg KA(1)(6), Hall P(3)(7), Czene K(3), Lindström LS(1). Characterization of Benign Breast Diseases and Association With Age, Hormonal Factors, and Family History of Breast Cancer Among Women in Sweden. JAMA Netw Open. 2021 Jun 1;4(6):e2114716. doi: 10.1001/jamanetworkopen.2021.14716.

15. Lee A(1), James J(2), Whisker L(2), Rakha EA(1), Ellis IO(1). Which lesions with a radiological or core biopsy diagnosis of fibroadenoma should be excised? Ann R Coll Surg Engl. 2022 May;104(5):361-366. doi: 10.1308/rcsann.2021.0208. Epub 2021 Dec 23.

16. Park HL(1), Kim KY(2), Park JS(3), Shin JE(2), Kim HR(2), Yang B(2), Kim JY(4), Shim JY(4), Shin EA(4), Noh SM(4). Clinicopathological Analysis of Ultrasound-guided Vacuum-assisted Breast Biopsy for the Diagnosis and Treatment of Breast Disease. Anticancer Res. 2018 Apr;38(4):2455-2462. doi: 10.21873/anticanres.12499.

17. Sanders LM(1), Sharma P(2), El Madany M(2), King AB(3), Goodman KS(4), Sanders AE(5). Clinical breast concerns in low-risk pediatric patients: practice review with proposed recommendations. Pediatr Radiol. 2018 Feb;48(2):186-195. doi: 10.1007/s00247-017-4007-6. Epub 2017 Oct 27.

18. McLaughlin CM(1), Gonzalez-Hernandez J(1), Bennett M(2), Piper HG(3). Pediatric breast masses: an argument for observation.J Surg Res. 2018 Aug;228:247-252. doi: 10.1016/j.jss.2018.03.056. Epub 2018 Apr 12.

19. Golatta M(1), Harcos A, Pavlista D, Danes J, Klein R, Simovich P, Gruber I, Hahn M. Ultrasound-guided cryoablation of breast fibroadenoma: a pilot trial. Arch Gynecol Obstet. 2015 Jun;291(6):1355-60. doi: 10.1007/s00404-014-3553-5. Epub 2014 Nov 19.

20. Hubbard JL(1), Cagle K(2), Davis JW(2), Kaups KL(2), Kodama M(2). Criteria for excision of suspected fibroadenomas of the breast.Am J Surg. 2015 Feb;209(2):297-301. doi: 10.1016/j.amjsurg.2013.12.037. Epub 2014 Apr 3.
21. Limberg J(1), Barker K(1), Hoda S(2), Simmons R(1), Michaels A(3), Marti JL(4). Fibroepithelial Lesions (FELs) of the Breast: Is Routine Excision Always Necessary? World J Surg. 2020 May;44(5):1552-1558. doi: 10.1007/s00268-020-05385-6.

22. Xiao Y(1), Liang M(2), Chen M(3), Li Z(1), Xia T(2), Yue X(1), Yin H(3), Yang H(3), Huang H(1)(4), Wang Z(1), Zhang C(1)(4). Evaluating the learning curve of high intensity focus ultrasound for breast fibroadenoma by CUSUM analysis: a multi-center study. Int J Hyperthermia. 2022;39(1):1238-1244. doi: 10.1080/02656736.2022.2123566.

23. Omar L(1), Gleason MK(1), Pfeifer CM(1), Sharma P(2), Kwon JK(1). Management of Palpable Pediatric Breast Masses With Ultrasound Characteristics of Fibroadenoma: A More Conservative Approach. AJR Am J Roentgenol. 2019 Feb;212(2):450-455. doi: 10.2214/AJR.17.19482. Epub 2018 Nov 26.

24. Mousa-Doust D(1), Dingee CK(2)(1), Chen L(1), Bazzarelli A(2)(1), Kuusk U(2)(1), Pao JS(2)(1), Warburton R(2)(1), McKevitt EC(3)(4). Excision of breast fibroepithelial lesions: when is it still necessary?-A 10-year review of a regional centre. Breast Cancer Res Treat. 2022 Jul;194(2):307-314. doi: 10.1007/s10549-022-06631-2. Epub 2022 May 31.

25. Westfal ML(1), Perez NP(2), Hung YC(2), Chang DC(2), Kelleher CM(2)(3).Pathologic discordance to clinical management decisions suggests overtreatment in pediatric benign breast disease. Breast Cancer Res Treat. 2019 Jul;176(1):101-108. doi: 10.1007/s10549-019-05224-w. Epub 2019 Apr 13.

26. Lee KH(1), Kim SJ(1), Park YM(2), Kim W(3), Yoon JH(1), Song JW(1), Kim SH(1), Lim YJ(1), Baek HJ(1), Kim SJ(4), Lee Y(1). Gray-scale and color Doppler sonographic features of complex fibroadenomas of the breast. J Clin Ultrasound. 2015 Nov-Dec;43(9):556-62. doi: 10.1002/jcu.22278. Epub 2015 Jul 21.

27. Lee S(1), Mercado CL(2), Cangiarella JF(3), Chhor CM(4). Frequency and outcomes of biopsy-proven fibroadenomas recommended for surgical excision. Clin Imaging. 2018 Jul-Aug;50:31-36. doi: 10.1016/j.clinimag.2017.12.008. Epub 2017 Dec 16.

28. Barakzai N(1), Mansoor E(1), Buccimazza I(2). Is conservative management of fibroadenomas feasible? 5-year results from the Durban Breast Unit. S Afr J Surg. 2021 Jun;59(2):41-46.

29. Lai HW(1)(2)(3)(4), Lin HY(5), Chen SL(6)(7), Chen ST(6)(8)(7), Chen DR(6)(8)(7), Kuo SJ(6)(8)(7). Endoscopy-assisted surgery for the management of benign breast tumors: technique, learning curve, and patient-reported outcome from preliminary 323 procedures. World J Surg Oncol. 2017 Jan 11;15(1):19. doi: 10.1186/s12957-016-1080-5.

30. Van Osdol AD(1), Landercasper J(2), Andersen JJ(3), Ellis RL(4), Gensch EM(4), Johnson JM(2), De Maiffe B(5), Marcou KA(4), Al-Hamadani M(5), Vang CA(5). Determining whether excision of all fibroepithelial lesions of the breast is needed to exclude phyllodes tumor: upgrade rate of fibroepithelial lesions of the breast to phyllodes tumor. JAMA Surg. 2014 Oct;149(10):1081-5. doi: 10.1001/jamasurg.2014.73.

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* Please indicate in the box any general comments or global suggestions on the entire document.

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