16. Can patients with multiple breast cancers in the same breast avoid mastectomy by having multiple lumpectomies to achieve equivalent rates of local breast cancer recurrence? A randomized controlled feasibility trial called MIAMI UK (NCT03514654)

Winters, Zoe; Roberts, Nick; McCartan, Neil; Potyka, Ingrid; Brunt, Murray; Maxwell, Anthony; Greenwood, Rosemary; Ingram, Jenny; Kandiyali, Rebecca; Schmid, Peter; Williams, Norman

Abstract

Background: Oncological safety of treating multiple ipsilateral breast cancers (MIBC) using therapeutic mammoplasty (TM) compared to mastectomy remains uncertain. A National Institute for Health Research (NIHR) - funded MIAMI feasibility phase randomized controlled trial (RCT) aims to demonstrate that sufficient numbers of eligible patients can be identified and accept randomization.
Methods: Phase 3 un-blinded prospective UK RCT. Initially aims to recruit 50 women with MIBC >40 years randomized in a 1:1 ratio to multiple lumpectomies and TM compared to mastectomy +/- reconstruction. No limitations of numbers of cancer foci with multifocal resectable by a single lumpectomy and multicentric cancers requiring separate lumpectomies. Radiation therapy (RT) will mirror IMPORT HIGH and FAST FORWARD, with individualized planning for potential dual lumpectomy RT boosts.
Results: Five centres screened 374 invasive cancers (June - Nov 2018). MIBC were diagnosed in 49 women (13.1%). Most women were ineligible for MIAMI (n=40, 81.6%) with 3 (6.1%) invited to trial participation.
Unsuitability for TM was common (n=16, 32.7%), and similarly bilateral breast cancer (n=9), previous cancer (n=7), neoadjuvant chemo (n=8), other cancers (n=3), < 2 invasive foci (n=3) and exclusive DCIS (n=2).
Three women declined randomization: two preferring a mastectomy and the other electing TM.
MIAMI TMG proposed major amendments: randomization of MIBC on mammogram and US, with breast MRI restricted to women allocated to TM only; 2:1 treatment allocation of 60 women.
Discussion: MIAMI is a world-first RCT investigating clinical and cost-effectiveness of TM being oncologically equivalent to mastectomy +/-reconstruction in MIBC. The feasibility phase will inform the main RCT.

Citation

Winters, Z., Roberts, N., McCartan, N., Potyka, I., Brunt, M., Maxwell, A., …Williams, N. (2019). 16. Can patients with multiple breast cancers in the same breast avoid mastectomy by having multiple lumpectomies to achieve equivalent rates of local breast cancer recurrence? A randomized controlled feasibility trial called MIAMI UK (NCT03514654). EJSO - European Journal of Surgical Oncology, 45(5), 881. https://doi.org/10.1016/j.ejso.2019.01.202

• Journal Article Type: Article
• Publication Date: 2019-05
• Deposit Date: Jun 21, 2023
• Journal: European Journal of Surgical Oncology
• Print ISSN: 0748-7983
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 45
• Issue: 5
• Pages: 881
• DOI: https://doi.org/10.1016/j.ejso.2019.01.202
• Keywords: Oncology; General Medicine; Surgery