Abstract P2-19-01: Impact of bone-only metastatic breast cancer on outcome in a real-life setting: A comprehensive analysis of 5,041 women from the ESME database
Authors: Bertho Marion , Fraisse Julien , Patsouris Anne , Cottu Paul , Delaloge Suzette , Pérol David , Jaffré Anne , Goncalves Anthony , Lebitasy Marie-Paule , D'Hondt Véronique , Dalenc Florence , Ferrero Jean-Marc , Levy Christelle , Arveux Patrick , Rouzier Roman , Penault-Llorca Frédérique , Uwer Lionel , Eymard Jean-Christophe , Breton Mathias , Chevrot Michaël , Leheurteur Marianne , Velten Michel , Simon Gaëtane , Frenel Jean-Sébastien 
Published: March 2020

Abstract
Background: Bone-only (BO) metastatic breast cancer (MBC), defined as bone as unique site of metastasis at MBC diagnosis, is thought to carry a better prognosis among MBC. However, only small retrospective series and data from selected randomized controlled trials have been reported so far. Based on a national database, we aimed at providing a large comprehensive analysis of BO MBC, and at evaluating its impact on clinical outcome.
Methods: The ESME MBC platform (NCT03275311) is a French multicenter retrospective real-life database using a clinical trial-like methodology to collect data from 18 French Comprehensive Cancer Centers. It includes data from each newly diagnosed MBC patient having initiated at least one treatment between 2008 and 2016. BO cases occurring in women were retrieved and compared to the overall non-BO population, regarding treatment effects and survival.
Results: Of the 22,463 women selected in the database, 5,041 (22.4%) patients with BO disease were identified. Most (N=4,102, 81.4%) had HR+/HER2- disease while 644 (12.8%) and 295 (5.9%) patients had HER2+ or HR-/HER2- disease, respectively. Compared to non-BO MBC, BO MBC patients were older in the global cohort and in HR-/HER2- patients (mean age 61.0y versus 59.5y, and 59.3y vs 56.4y, all p&lt;0.0001, respectively), and tumor histology was more frequently a lobular carcinoma in the global cohort, in HR+/HER2- and in HR-/HER2- patients (18.6% vs 10.8%, 20.6% vs 15.2%, 13.8% vs 3.2%, all p&lt;0.0001, respectively). In addition, metastatic disease occurred de novo more frequently in BO MBC patients (37.9% versus 29.2%) (p&lt;0.0001), and a statistically significant difference was also observed within each tumor subtype group. The management of bone disease included bisphosphonates or denosumab, radiotherapy, and invasive bone metastasis procedures in 3,913 (77.6%), 2,929 (58.1%), and 1,154 (22.9%) patients, respectively. Median follow up was 52.4 months (95% CI [50.8-54.2]) in BO population and 50.9 months (95% CI [49.7-51.8]) in non-BO population. BO MBC patients had improved median progression-free survival (PFS) 1, regarding first-line treatment, and overall survival (OS) compared to non-BO MBC, globally and within each tumor subtype group (Table). Indeed, 5-year OS rates reached up to 43%, 54% and 16% in HR+/HER2-, HER2+ and HR-/HER2- BO MBC groups, respectively. This suggests that a substantial number of these patients could be considered as long survivors. In the BO MBC cohort, de novo BO MBC patients had a higher 5-year OS rate than relapsed BO MBC patients. BO disease was an independent prognostic factor of OS (hazard ratio 0.68 (95% CI [0.65-0.72]), p&lt;0.0001) together with age, tumor subtype, grade, adjuvant treatment and metastatic-free interval.
Conclusion: This large comprehensive study is the largest cohort of BO MBC to date. BO MBC has a distinct presentation from non-BO MBC and carry a better prognosis compared to non-BO MBC. A significant proportion of BO MBC patients have a very long survival and may benefit from aggressive local therapy, as stereotactic radiotherapy. Dedicated studies are warranted to tailor the management of these patients.
Funding: This work was supported by UNICANCER. The ESME MBC database is supported by an industrial consortium (Roche, Pfizer, AstraZeneca, MSD, Eisai and Daiichi Sankyo). Data collection, analyses and publications are totally managed by R&D UNICANCER independently of the industrial consortium.
TableBOBOBOBOnon-BOnon-BOnon-BOnon-BON (%)median OS monthsmedian PFS1 months5-year OS rate %N (%)median OS monthsmedian PFS1 months5-year OS rate %(95% CI)(95% CI)(95% CI)(95% CI)(95% CI)(95% CI)Overall population5,041 (100%)52.1 (50.3-54.1) 13.1 (12.6-13.8) 43.41 (41.66-45.15)15,054 (100%)34.7 (34.0-35.6) 8.5 (8.3-8.7) 30.55 (29.62-31.48)HR+/HER-4,102 (81.4%)52.6 (50.5-54.8)13.6 (13.0-14.3)43.52 (41.56-45.46)9,127 (60.6%) 39.0 (37.8-40.1)9.6 (9.3-9.9)32.69 (31.47-33.93)HER2+644 (12.8%)66.4 (59.8-71.9) 14.9 (12.9-17.3) 54.49 (49.54-59.16)3,265 (21.7%) 46.5 (44.2-48.9)10.6 (10.1-11.3)39.88 (37.77-41.98)HR-/HER2-295 (5.9%)20.8 (18.3-27.4) 5.6 (4.9-7.5)16.21 (11.21-22.02)2,662 (17.7%) 14.3 (13.6-15.1)4.8 (4.6-5.0)10.89 (9.4-12.5)De novo MBC patients1,909 (37.9%)58.6 (55.4-62.1)17.9 (17.0-18.9)48.24 (45.28-51.14)4,399 (29.2%) ---Relapsed MBC patients3,132 (62.1%)48.3 (46.5-50.5)10.7 (10.2-11.2)40.51 (38.34-42.67)10,655 (70.8%)---
Citation Format: Marion Bertho, Julien Fraisse, Anne Patsouris, Paul Cottu, Suzette Delaloge, David Pérol, Anne Jaffré, Anthony Goncalves, Marie-Paule Lebitasy, Véronique D'Hondt, Florence Dalenc, Jean-Marc Ferrero, Christelle Levy, Patrick Arveux, Roman Rouzier, Frédérique Penault-Llorca, Lionel Uwer, Jean-Christophe Eymard, Mathias Breton, Michaël Chevrot, Marianne Leheurteur, Michel Velten, Gaëtane Simon, Jean-Sébastien Frenel. Impact of bone-only metastatic breast cancer on outcome in a real-life setting: A comprehensive analysis of 5,041 women from the ESME database [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-19-01.