Atypical Lobular Hyperplasia (ALH) and Lobular carcinoma in situ (LCIS)

Public Comment

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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. Association Between ALH and LCIS and Lifetime Risk of Breast Cancer

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1a. Patients diagnosed with ALH and C-LCIS with no personal history of breast cancer should be counseled about their increased lifetime risk of breast cancer and should be offered risk reducing strategies including chemoprevention. Consultation with a physician or APP experienced in risk evaluation and management should be made available to patients when possible to determine their level or risk. (Strong Consensus)

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1b. Patients diagnosed with pleomorphic LCIS (P-LCIS) and florid LCIS (F-LCIS) with no personal history of breast cancer should be counseled about their increased lifetime risk of breast cancer. If estrogen receptor data is available, chemoprevention should only be offered to those patients with estrogen receptor positive P-LCIS or F-LCIS otherwise chemoprevention should be considered for all patients. Consultation with a physician or APP experienced in risk evaluation and management should be made available to patients when possible to determine their level or risk. (Strong Consensus)

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1c. The Gail breast cancer risk-assessment model, the Tyrer-Cuzick Risk Calculator v.7 and v.8 model and the Breast Cancer Screening Consortium risk model should not be used to estimate breast cancer risk in patients with ALH or any type of LCIS (classic, florid and pleomorphic). (Consensus)*

*Literature on the natural history of lobular neoplasia is more informative on lifetime risk[YK1] [LR2] of LCIS and ALH

2. Imaging

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2a. No additional diagnostic imaging workup is necessary after a diagnosis of ALH or LCIS (classic, florid and pleomorphic types) on core biopsy. (Consensus)

3. Percutaneous Interventions

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3a. There are no recommended percutaneous interventions following a core biopsy demonstrating ALH or LCIS (classic, florid and pleomorphic types).(Consensus)

4. Indications for Surgical Excision

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4a. ALH and C-LCIS identified on core biopsy of breast imaging abnormalities* deemed concordant do not require diagnostic excision. (Consensus)

*The strength of this recommendation is based on series predominantly including MMG detected ALH and C-LCIS. The data on observation for MRI detected ALH and C-LCIS is limited.

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4b. P-LCIS and F-LCIS should undergo diagnostic excision regardless of the imaging modality of diagnosis.(Consensus)

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4c. A negative margin (no lesion at ink) resection is recommended for P-LCIS and F-LCIS cases. (Consensus)

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4d. In patients undergoing surgery for in situ or invasive breast cancer, re-excision is not required for ALH or C-LCIS identified at the margin of resection. (Strong Consensus)

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4e. In patients undergoing surgery for in situ or invasive breast cancer, re-excision should be considered for P-LCIS of F-LCIS identified at the margin of resection. (Consensus)

5. Performance of the Surgical Procedure

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5a. For patients diagnosed with ALH or LCIS (classic, florid and pleomorphic types), one type of localization device is not recommended over another. (Strong Consensus)

6. Other non-Surgical Management

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6a. In select cases of P-LCIS and F-LCIS, a referral to radiation oncology can be considered. These cases should undergo multidisciplinary discussion, preferably at a multidisciplinary breast conference. (No Consensus)

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6b. The use of adjuvant radiation therapy for ALH or C-LCIS is not warranted. (Strong Consensus)

7. Follow Up Care

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7a. Following a discussion of the risks and benefits, yearly supplemental screening with MRI may be considered in conjunction with other breast cancer risk factors for patients with a personal history of ALH or LCIS (classic, florid or pleomorphic types). (Strong Consensus)

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7b. For those patients not undergoing excision of their ALH or C-LCIS, no specific follow up imaging is required, and patients may return to age-appropriate screening. (Consensus)

Appendix 2. References

1. Fisher B, Costantino JP, Wickerham DL, Redmond CK, Kavanah M, Cronin WM, Vogel V, Robidoux A, Dimitrov N, Atkins J, Daly M, Wieand S, Tan-Chiu E, Ford L, Wolmark N. Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst. 1998 Sep 16;90(18):1371-88. doi: 10.1093/jnci/90.18.1371. PMID: 9747868.

2. King TA, Pilewskie M, Muhsen S, Patil S, Mautner SK, Park A, Oskar S, Guerini-Rocco E, Boafo C, Gooch JC, De Brot M, Reis-Filho JS, Morrogh M, Andrade VP, Sakr RA, Morrow M. Lobular Carcinoma in Situ: A 29-Year Longitudinal Experience Evaluating Clinicopathologic Features and Breast Cancer Risk. J Clin Oncol. 2015 Nov 20;33(33):3945-52. doi: 10.1200/JCO.2015.61.4743. Epub 2015 Sep 14. PMID: 26371145; PMCID: PMC4934644.

3. Valero MG, Zabor EC, Park A, Gilbert E, Newman A, King TA, Pilewskie ML. The Tyrer-Cuzick Model Inaccurately Predicts Invasive Breast Cancer Risk in Women With LCIS. Ann Surg Oncol. 2020 Mar;27(3):736-740. doi: 10.1245/s10434-019-07814-w. Epub 2019 Sep 26. PMID: 31559544; PMCID: PMC7500748.

4. Nakhlis F, Gilmore L, Gelman R, Bedrosian I, Ludwig K, Hwang ES, Willey S, Hudis C, Iglehart JD, Lawler E, Ryabin NY, Golshan M, Schnitt SJ, King TA. Incidence of Adjacent Synchronous Invasive Carcinoma and/or Ductal Carcinoma In-situ in Patients with Lobular Neoplasia on Core Biopsy: Results from a Prospective Multi-Institutional Registry (TBCRC 020). Ann Surg Oncol. 2016 Mar;23(3):722-8. doi: 10.1245/s10434-015-4922-4. Epub 2015 Nov 5. PMID: 26542585; PMCID: PMC4984674.

5. Nakhlis F, Harrison BT, Giess CS, Lester SC, Hughes KS, Coopey SB, King TA. Evaluating the Rate of Upgrade to Invasive Breast Cancer and/or Ductal Carcinoma In Situ Following a Core Biopsy Diagnosis of Non-classic Lobular Carcinoma In Situ. Ann Surg Oncol. 2019 Jan;26(1):55-61. doi: 10.1245/s10434-018-6937-0. Epub 2018 Oct 25. PMID: 30362065.

6. Laws A, Katlin F, Nakhlis F, Chikarmane SA, Schnitt SJ, King TA. Atypical Lobular Hyperplasia and Classic Lobular Carcinoma In Situ Can Be Safely Managed Without Surgical Excision. Ann Surg Oncol. 2022 Mar;29(3):1660-1667. doi: 10.1245/s10434-021-10827-z. Epub 2021 Sep 23. PMID: 34554341.

7. Miller ME, Muhsen S, Zabor EC, Flynn J, Olcese C, Giri D, Van Zee KJ, Pilewskie M. Risk of Contralateral Breast Cancer in Women with Ductal Carcinoma In Situ Associated with Synchronous Ipsilateral Lobular Carcinoma In Situ. Ann Surg Oncol. 2019 Dec;26(13):4317-4325. doi: 10.1245/s10434-019-07796-9. Epub 2019 Sep 24. PMID: 31552614; PMCID: PMC6868341.

8. Nakhlis F, Katlin FD, Grossmith SC, DiPasquale A, Harrison BT, Schnitt SJ, King TA. Presence of Non-classic LCIS Is Not a Contraindication to Breast Conservation in Patients with Concomitant Invasive Breast Cancer or DCIS. Ann Surg Oncol. 2022 Nov;29(12):7696-7702. doi: 10.1245/s10434-022-12066-2. Epub 2022 Jun 30. PMI

Atypical Lobular Hyperplasia (ALH) and Lobular carcinoma in situ (LCIS)

Public Comment

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* Name (Required.)

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* Institution/Organization (Required.)

Question Title

* Email (Required.)

Question Title

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* 2a. No additional diagnostic imaging workup is necessary after a diagnosis of ALH or LCIS (classic, florid and pleomorphic types) on core biopsy. (Consensus)

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* 3a. There are no recommended percutaneous interventions following a core biopsy demonstrating ALH or LCIS (classic, florid and pleomorphic types).(Consensus)

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* 4b. P-LCIS and F-LCIS should undergo diagnostic excision regardless of the imaging modality of diagnosis.(Consensus)

Question Title

* 4c. A negative margin (no lesion at ink) resection is recommended for P-LCIS and F-LCIS cases. (Consensus)

Question Title

* 4d. In patients undergoing surgery for in situ or invasive breast cancer, re-excision is not required for ALH or C-LCIS identified at the margin of resection. (Strong Consensus)

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* 4e. In patients undergoing surgery for in situ or invasive breast cancer, re-excision should be considered for P-LCIS of F-LCIS identified at the margin of resection. (Consensus)

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* 5a. For patients diagnosed with ALH or LCIS (classic, florid and pleomorphic types), one type of localization device is not recommended over another. (Strong Consensus)

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* 6a. In select cases of P-LCIS and F-LCIS, a referral to radiation oncology can be considered. These cases should undergo multidisciplinary discussion, preferably at a multidisciplinary breast conference. (No Consensus)

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* 6b. The use of adjuvant radiation therapy for ALH or C-LCIS is not warranted. (Strong Consensus)

Question Title

* 7a. Following a discussion of the risks and benefits, yearly supplemental screening with MRI may be considered in conjunction with other breast cancer risk factors for patients with a personal history of ALH or LCIS (classic, florid or pleomorphic types). (Strong Consensus)

Question Title

* 7b. For those patients not undergoing excision of their ALH or C-LCIS, no specific follow up imaging is required, and patients may return to age-appropriate screening. (Consensus)

Question Title

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

Name (Required.)

Institution/Organization (Required.)

Email (Required.)

2a. No additional diagnostic imaging workup is necessary after a diagnosis of ALH or LCIS (classic, florid and pleomorphic types) on core biopsy. (Consensus)

3a. There are no recommended percutaneous interventions following a core biopsy demonstrating ALH or LCIS (classic, florid and pleomorphic types).(Consensus)

4b. P-LCIS and F-LCIS should undergo diagnostic excision regardless of the imaging modality of diagnosis.(Consensus)

4c. A negative margin (no lesion at ink) resection is recommended for P-LCIS and F-LCIS cases. (Consensus)

4d. In patients undergoing surgery for in situ or invasive breast cancer, re-excision is not required for ALH or C-LCIS identified at the margin of resection. (Strong Consensus)

4e. In patients undergoing surgery for in situ or invasive breast cancer, re-excision should be considered for P-LCIS of F-LCIS identified at the margin of resection. (Consensus)

5a. For patients diagnosed with ALH or LCIS (classic, florid and pleomorphic types), one type of localization device is not recommended over another. (Strong Consensus)

6a. In select cases of P-LCIS and F-LCIS, a referral to radiation oncology can be considered. These cases should undergo multidisciplinary discussion, preferably at a multidisciplinary breast conference. (No Consensus)

6b. The use of adjuvant radiation therapy for ALH or C-LCIS is not warranted. (Strong Consensus)

7a. Following a discussion of the risks and benefits, yearly supplemental screening with MRI may be considered in conjunction with other breast cancer risk factors for patients with a personal history of ALH or LCIS (classic, florid or pleomorphic types). (Strong Consensus)

7b. For those patients not undergoing excision of their ALH or C-LCIS, no specific follow up imaging is required, and patients may return to age-appropriate screening. (Consensus)

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