Background

GeparX (NCT02682693) investigated efficacy and safety of adding Dmab to standard NACT and two different nP schedules for primary BC. Addition of Dmab to NACT did not improve pCR rates. nP weekly (q1w) significantly increased pCR rate compared to d1,8 q3w schedule, but was associated with higher toxicity (Blohmer et al. Cancer Res 2020). Here we present QoL.

Methods

Patients (pts) were randomized to receive or not receive Dmab 120mg s.c. q4w for 6 cycles and to either nP 125mg/m² q1w or d1,8 q3w for 4 cycles, followed by 4x epirubicin/cyclophosphamide (q2w/q3w). QoL was assessed at baseline (BL), after nP, at end of treatment and 90 days (d) post-surgery (PS) using the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane) questionnaire, FACT-Taxane Trial Outcome Index (TOI), FACT-G total score, and FACT-Taxane total score scales. Higher mean scores indicate better functioning and QoL. Mixed models including BL value as a random effect and treatment, time, and treatment by time interaction as fixed effects were used to compare the QoL scores based on the safety set. Primary endpoint was the mean score change from BL to 90d PS.

Results

Between 02/2017 and 03/2019, 780 pts were randomized and started treatment, of whom 768 were eligible for QoL analyses. BL parameters were well balanced. Questionnaire completion response remained >70% throughout the trial. Addition of Dmab did not change the QoL scores at any time point. Pts receiving nP q1w reported significantly lower mean scores of physical/functional well-being and FACT-G total score (p<0.001) compared to pts receiving nP d1,8 q3w. The decreased well-being with nP q1w partly persists 90d PS. The mean scores of additional concerns, FACT-Taxane TOI and FACT-Taxane total scores significantly differed favouring nP d1,8 q3w in all post-BL assessments (p<0.001). Social/family and emotional aspects were not affected by the regime.

Conclusions

nP q1w led to a significantly higher pCR rate but is associated with decreased QoL compared to nP d1,8 q3w, which is consistent with the higher toxicity reported for nP q1w. Benefit and risks need to be discussed with the pts.

Clinical trial identification

NCT02682693.

Legal entity responsible for the study

German Breast Group.

Funding

GeparX was financially supported by Amgen and BMS (Celgene).

Disclosure

M. Reinisch: Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Other: Novartis; Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Other: Pfizer; Financial Interests, Personal, Other: Somatex; Financial Interests, Personal, Other: Daiichi Sankyo; Financial Interests, Personal, Other: Lilly; Financial Interests, Personal, Other: MSD. J. Blohmer: Financial Interests, Personal, Advisory Role, Consulting or Advisory Role, Honoraria: Amgen; Financial Interests, Personal, Advisory Role, Consulting or Advisory Role, Honoraria: AstraZeneca; Financial Interests, Personal, Advisory Role, Consulting or Advisory Role, Honoraria: Novartis; Financial Interests, Personal, Advisory Role, Consulting or Advisory Role, Travel, Accommodations, Expenses, Honoraria: Pfizer; Financial Interests, Personal, Advisory Role, Consulting or Advisory Role, Travel, Accommodations, Expenses, Honoraria: Roche; Financial Interests, Personal, Other, Honoraria: MSD Oncology; Financial Interests, Personal, Other, Honoraria: Lilly; Financial Interests, Personal, Other, Honoraria: Gilead Sciences; Financial Interests, Personal, Other, Honoraria: Eisai Germany; Financial Interests, Personal, Other, Honoraria: Seattle Genetics; Financial Interests, Personal, Other, Honoraria: Daiichi Sankyo/AstraZeneca; Financial Interests, Personal, Other, Honoraria: Exact Sciences; Financial Interests, Personal, Other, Honoraria: Molecular Health. T. Link: Financial Interests, Personal, Other, Personal Fees: Pfizer; Financial Interests, Personal, Other, Personal Fees: Roche; Financial Interests, Personal, Other, Personal Fees: Tesaro; Non-Financial Interests, Personal, Other, Personal Fees: MSD; Financial Interests, Personal, Other, Personal Fees: Amgen; Non-Financial Interests, Personal, Other, Personal Fees: Clovis; Non-Financial Interests, Institutional, Other: Celgene; Financial Interests, Personal, Other, Personal Fees: Novartis; Financial Interests, Personal, Other, Personal Fees: Lilly; Non-Financial Interests, Personal, Other, Personal Fees: GSK; Financial Interests, Personal, Other, Personal Fees: Myriad; Financial Interests, Personal, Other, Personal Fees: Eisai; Non-Financial Interests, Institutional, Other: Daiichi Sankyo; Financial Interests, Personal, Other, Personal Fees: Gilead. M. Untch: Non-Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Amgen GmbH; Non-Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: AstraZeneca; Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: BMS; Non-Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Celgene GmbH; Non-Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Daiichi Sankyo; Non-Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Eisai; Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Lilly Deutschland; Non-Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Lilly Int.; Non-Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: MSD Merck; Non-Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Myriad Genetics; Non-Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Pfizer GmbH; Non-Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Roche Pharma AG; Non-Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Sanofi Aventis Deutschland GmbH; Non-Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Novartis; Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Pierre Fabre; Non-Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Clovis Oncology; Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Seatlle Genetics; Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Seagen; Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: GSK; Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Gilead. P.A. Fasching: Financial Interests, Personal, Invited Speaker, Advisory Board, Invited Speaker: Novartis; Financial Interests, Institutional, Funding, Grant, Institutional Funding: BioNTech; Financial Interests, Personal and Institutional, Research Grant, Advisory Board, Invited Speaker, Research Grant: Pfizer; Financial Interests, Personal, Invited Speaker, Advisory Board, Invited Speaker: Daiichi Sankyo; Financial Interests, Personal, Invited Speaker, Advisory Board, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker, Advisory Board, Invited Speaker: Eisai; Financial Interests, Personal, Invited Speaker, Advisory Board, Invited Speaker: Merck Sharp & Dohme; Financial Interests, Institutional, Research Grant, Institutional Funding: Cepheid; Financial Interests, Personal, Advisory Board, Advisory Board, Invited Speaker: Lilly; Financial Interests, Personal, Advisory Board, Advisory Board: Pierre Fabre; Financial Interests, Personal, Advisory Board, Advisory Board, Invited Speaker: Seagen; Financial Interests, Personal, Advisory Board, Advisory Board, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board, Advisory Board: Hexal; Financial Interests, Personal, Advisory Board, Advisory Board: Agendia; Financial Interests, Personal, Advisory Board, Advisory Board: Sanofi Aventis; Financial Interests, Personal, Advisory Board, Advisory Board, Invited Speaker: Gilead. A. Schneeweiss: Financial Interests, Personal, Research Grant, Research Grant, Travel expenses, Honoraria: BMS; Financial Interests, Personal, Research Grant, Research Grant, Expert testimony, Travel expenses, Honoraria: Roche; Financial Interests, Institutional, Research Grant, Research Grant: AbbVie; Financial Interests, Institutional, Research Grant, Research Grant: Molecular Partner; Financial Interests, Personal, Expert Testimony, Expert testimony, Honoraria: AstraZeneca; Financial Interests, Personal, Other, Honoraria, Travel expenses: Pfizer; Financial Interests, Personal, Other, Honoraria: Novartis; Financial Interests, Personal, Other, Honoraria: MSD; Financial Interests, Personal, Other, Honoraria: Tesaro; Financial Interests, Personal, Other, Honoraria: Lilly; Financial Interests, Personal, Other, Honoraria: Gilead; Financial Interests, Personal, Other, Honoraria: Seagen. P. Wimberger: Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: MSD; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: Lilly; Financial Interests, Institutional, Research Grant: Roche Pharma GmbH; Financial Interests, Institutional, Research Grant: GSK. S. Seiler: Financial Interests, Institutional, Research Grant, Grant: Amgen; Financial Interests, Institutional, Research Grant, Grant: BMS; Financial Interests, Personal, Other, Presentations: AbbVie. J. Huober: Financial Interests, Personal, Other: Gilead; Financial Interests, Personal, Other: Seagen; Financial Interests, Personal and Institutional, Research Grant, Grant: Lilly; Financial Interests, Personal and Institutional, Research Grant, Grant, Travel, Other: Novartis; Financial Interests, Personal, Other, Travel, Other: Pfizer; Financial Interests, Personal, Other, Travel, Other: Daiichi; Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Other: MSD; Financial Interests, Personal, Other: AbbVie; Financial Interests, Personal, Other: Eisai; Financial Interests, Institutional, Research Grant, Grant: Hexal; Financial Interests, Institutional, Research Grant, Grant, Travel, Other: BMS. M. Thill: Non-Financial Interests, Personal, Other, Personal Fees: Amgen; Financial Interests, Personal, Other, Personal Fees: AstraZeneca; Non-Financial Interests, Personal, Other, Personal Fees: BMS; Financial Interests, Personal, Other, Personal Fees: Daiichi Sankyo; Financial Interests, Personal, Other, Personal Fees: Eisai; Non-Financial Interests, Personal and Institutional, Research Grant, Trial funding, Grant, Personal Fees: Exact Sciences; Financial Interests, Personal, Other, Personal Fees: Lilly; Financial Interests, Personal, Other, Personal Fees: MSD; Financial Interests, Personal, Other, Personal Fees: Hexal; Financial Interests, Personal, Other, Personal Fees: Novartis; Financial Interests, Personal, Other, Personal Fees: Pfizer; Non-Financial Interests, Personal, Other, Manuscript support, Other: PFM Medical; Non-Financial Interests, Personal, Other, Personal Fees: Roche; Financial Interests, Personal, Other, Personal Fees: Tesaro; Financial Interests, Personal, Other, Manuscript support, Other: Clovis; Financial Interests, Personal, Other, Personal Fees: Seagen; Financial Interests, Institutional, Research Grant, Grant, Trial funding: Endomagnetics; Financial Interests, Personal, Other, Personal Fees: Norgine; Non-Financial Interests, Institutional, Other: RTI Surgical; Non-Financial Interests, Institutional, Other, Manuscript support, Other: Clearcut; Financial Interests, Personal, Other, Personal Fees: Becton and Dickinson; Financial Interests, Personal, Other, Manuscript support, Other: Servier; Financial Interests, Personal, Other, Personal Fees: Gilead Sciences; Financial Interests, Personal, Other, Personal Fees: Sysmex; Non-Financial Interests, Personal, Other, Personal Fees: Neodynamics; Financial Interests, Personal, Other, Personal Fees: GSK; Financial Interests, Personal, Other, Personal Fees: Vifor; Financial Interests, Personal, Other, Personal Fees: Organon; Financial Interests, Personal, Other, Personal Fees: Viatris; Financial Interests, Personal, Other, Manuscript support, Other: Vifor. C. Jackisch: Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Other: Amgen; Financial Interests, Personal, Other: Celgene; Financial Interests, Personal, Other: Pfizer; Financial Interests, Personal, Other: Lilly; Financial Interests, Personal, Other: Novartis; Financial Interests, Personal, Other: Exact Sciences; Financial Interests, Institutional, Other: Seagen. K. Rhiem: Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Other: Amgen. C. Hanusch: Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Other: Novartis; Financial Interests, Personal, Other: Lilly; Financial Interests, Personal, Other: AstraZeneca. C. Denkert: Financial Interests, Personal, Ownership Interest, Stock and Other Ownership Interests: Sividon Diagnostics; Financial Interests, Personal, Advisory Role, Consulting or Advisory Role: MSD Oncology; Financial Interests, Personal, Advisory Role, Consulting or Advisory Role: Daiichi Sankyo; Financial Interests, Personal, Advisory Role, Consulting or Advisory Role: Molecular Health; Financial Interests, Personal, Advisory Role, Consulting or Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role, Consulting or Advisory Role: Merck; Financial Interests, Personal and Institutional, Advisory Role, Consulting or Advisory Role, Research Funding: Roche; Financial Interests, Personal, Advisory Role, Consulting or Advisory Role: Lilly; Financial Interests, Institutional, Funding, Research Funding: Myriad Genetics; Other, Personal, Royalties, Patents, Royalties, Other Intellectual Property: VMScope digital pathology software; Other, Personal, Royalties, Patents, Royalties, Other Intellectual Property: WO2015114146A1; Other, Personal, Royalties, Patents, Royalties, Other Intellectual Property: WO2010076322A1; Other, Personal, Royalties, Patents, Royalties, Other Intellectual Property: WO2020109570A1. S. Loibl: Financial Interests, Institutional, Advisory Board, Grant, Other: AbbVie; Financial Interests, Institutional, Advisory Board, Other: Amgen; Financial Interests, Institutional, Advisory Board, Grant, Other: AstraZeneca; Financial Interests, Institutional, Advisory Board, Other: Bayer; Financial Interests, Institutional, Advisory Board, Other: BMS; Financial Interests, Institutional, Advisory Board, Grant, Other: Celgene; Non-Financial Interests, Institutional, Research Grant, Grant, Medical Writing, Other: Daiichi Sankyo; Financial Interests, Institutional, Advisory Board, Other: Eirgenix; Financial Interests, Institutional, Advisory Board, Other: GSK; Non-Financial Interests, Institutional, Research Grant, Grant, Medical Writing, Other: Immunomedics/Gilead; Financial Interests, Institutional, Advisory Board, Other: Lilly; Financial Interests, Institutional, Advisory Board, Other: Merck; Non-Financial Interests, Institutional, Research Grant, Grant, Medical Writing, Other: Novartis; Non-Financial Interests, Institutional, Research Grant, Grant, Medical Writing, Other: Pfizer; Financial Interests, Institutional, Advisory Board, Other: Pierre Fabre; Financial Interests, Institutional, Advisory Board, Other: prIME/Medscape; Non-Financial Interests, Institutional, Advisory Board, Medical Writing, Other: Puma; Financial Interests, Institutional, Other, honorarium for Lecture: Samsung; Non-Financial Interests, Institutional, Advisory Board, honorarium for Ad Boards, Medical Writing: Seagen; Non-Financial Interests, Institutional, Research Grant, Grant, Medical Writing, Other: Roche; Other, Institutional, Other, Patent Pending, Immunsignature in TNBC: EP14153692.0; Other, Institutional, Other, Patent Pending, Signature for CDK 4/6 Inhibitor: EP21152186.9; Other, Institutional, Other, Patent Issued, Predicting response to an Anti-HER2 containing therapy: EP15702464.7; Other, Institutional, Other, Patent Pending, GeparNuevo: EP19808852.8; Other, Institutional, Royalties, Patent Issued, Royalties, VM Scope GmbH: Digital Ki67 Evaluator. All other authors have declared no conflicts of interest.

Background

The surgical staging procedure of the axilla in patients who convert from clinically positive (cN+) to clinically negative node status (ycN0) through neoadjuvant chemotherapy is still controversial. Different techniques such as Axillary Lymph Node Dissection (ALND), Targeted Axillary Dissection (TAD), Target Lymph Node Biopsy (TLNB) and Sentinel Lymph Node Biopsy (SLNB) are recommended by the national and international guidelines. In case of TAD and TLNB, the target lymph node can be marked using such markers as clip/coil, carbon ink, magnetic or radioactive seed, or a radar or radiofrequency marker. The AXSANA study is aiming to compare outcomes and morbidity rates between different techniques and will hopefully contribute to defining the optimal axillary staging procedure resulting in high oncological safety and improved quality of life.

Methods

AXSANA is an international prospective, non-interventional cohort study including patients clinically node-positive and scheduled to receive neoadjuvant chemotherapy. The surgical staging procedure is performed according to the standard at their treating institution.

Results

So far, 1,524 patients from 19 countries were recruited and 68% converted to ycN0 status after NACT. In 53% of patients, the planned surgical staging procedure was TAD, followed by ALND (30%), SLNB (15%) and TLNB (2%). In 55% of enrolled patients, at least one node was marked before NACT, mostly using clips/coils (81%), carbon ink (10%), magnetic seeds (8%) and radar markers (1%).

Conclusions

The preliminary data show a strong heterogeneity regarding axillary staging among participating countries. After only 20 months of recruitment, over half of the target accrual (3,000 patients) has been reached. TAD is a widely used technique, but ALND and SLNB are also common. The results of the AXSANA study will clarify whether de-escalation of axillary surgery is a safe option for patients converting from cN+ to ycN0 through neoadjuvant chemotherapy.

Clinical trial identification

NCT04373655.

Editorial acknowledgement

Dr. Rosa Dr Micco; San Raffaele Hospital Milan, Milan, Italy Ellen Schlichting, MD, PhD; Department for Breast and Endocrine Surgery, Oslo University Hospital, Oslo, Norway Dr. Lia Pamela Rebaza, Unit of Basic and Transnational Reseach, Oncosalud-AUNA Clinic, Lima, Perus Dr. Petr V. Krivorotko, Department of Breast Surgical Oncology, N.N. Petrov National Medical Research Center of Oncology, St. Petersburg, Russia David Pinto, MD; Breast Unit, Champalimaud Clinical Center, Campalimaud Foundation, Lisbon, Portugal Prof. Florentia Peintinger, Medical University of Graz, Graz. Austria Dr. Maria Luisa Gasparri, Department of Gynecology and Obstetrics, Ente Ospedaliero Cantonale, Ospedale Regionale di Lugano, Lugano, Switzerland and University of the Italian Switzerland (USI), Faculty of Biomedicine, Lugano, Switzerland Dr. Hagigat Valiyeva; Oncology Clinc of Azerbaijan Medical University, Baku, Azerbaijan Lukas Dostalek, MD Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University, General University Hospital, Prague, Czech Republic Dr. Helidon Nina; University Medical Center \"Mother Teresa\", Tirana, Albania Dr. Semra Gunay; Ministry of Health Istanbul Provincal Health Directorate Prof. Dr. Cemil Tascioglu City Hospital, Turkey Dr. Meryem Gunay Gurleyik, Ministry of Health Istanbul Provincial Helath Directorate Istanbul Haydarpasa Numune Research and Training Hospita, Turkey Dr. Elisabeth Thiemann, Brustzentrum Osnabrück, Niels-Stensen-Kliniken, Osnabrück, Germany Dr. Gabriele Kaltenecker, Department of Obstetrics and Gynecology, Städtisches Klinikum Karlsruhe, Karlsruhe, Germany.

Legal entity responsible for the study

EUBREAST.

Funding

AGO-B, AWOgyn e.V., Claudia von Schilling Foundation for Breast Cancer Research, Ehmann-Stiftung, Endomag, Merit Medical and Mammotome.

Disclosure

M. Thill: Financial Interests, Institutional, Advisory Board: Amgen; Financial Interests, Institutional, Advisory Board: AstraZeneca; Financial Interests, Institutional, Advisory Board: Aurikamed; Financial Interests, Institutional, Advisory Board: Becton/Dickinson; Financial Interests, Institutional, Advisory Board: Biom'Up; Financial Interests, Institutional, Advisory Board: Celgene; Financial Interests, Institutional, Advisory Board: ClearCut; Financial Interests, Institutional, Advisory Board: Clovis; Financial Interests, Institutional, Advisory Board: Daiichi Sankyo; Financial Interests, Institutional, Advisory Board: Eisai; Financial Interests, Institutional, Advisory Board: Exact Sciences; Financial Interests, Institutional, Advisory Board: Gilead Science; Financial Interests, Institutional, Advisory Board: Lilly; Financial Interests, Institutional, Advisory Board: MSD; Financial Interests, Institutional, Advisory Board: Norgine; Financial Interests, Institutional, Advisory Board: Neodynamics; Financial Interests, Institutional, Advisory Board: Novartis; Financial Interests, Institutional, Advisory Board: Onkowissen; Financial Interests, Institutional, Advisory Board: Pfizer; Financial Interests, Institutional, Advisory Board: pff Medical; Financial Interests, Institutional, Advisory Board: Pierre Fabre; Financial Interests, Institutional, Advisory Board: Roche; Financial Interests, Institutional, Advisory Board: RTI Surgical; Financial Interests, Institutional, Advisory Board: Seagen; Financial Interests, Institutional, Advisory Board: Sysmex; Financial Interests, Institutional, Writing Engagements: Servier; Financial Interests, Personal and Institutional, Invited Speaker: Art Tempi; Financial Interests, Personal and Institutional, Invited Speaker: Connect Medica; Financial Interests, Personal and Institutional, Invited Speaker: Hexal; Financial Interests, Personal and Institutional, Invited Speaker: I-Med-Institute; Financial Interests, Personal and Institutional, Invited Speaker: Medtronic; Financial Interests, Personal and Institutional, Invited Speaker: Omniamed; Financial Interests, Institutional, Funding: Endomag; Financial Interests, Institutional, Funding: Exact Science. M.P. Lux: Financial Interests, Institutional, Advisory Board: SamanTree; Financial Interests, Institutional, Advisory Board: PFM; Financial Interests, Institutional, Advisory Board: Sysmex/Endomag. M. Banys- Paluchowski: Financial Interests, Institutional, Advisory Board: Novartis; Financial Interests, Institutional, Advisory Board: Roche; Financial Interests, Institutional, Advisory Board: AstraZeneca; Financial Interests, Institutional, Advisory Board: Pfizer; Financial Interests, Institutional, Advisory Board: pfm; Financial Interests, Institutional, Advisory Board: Gilead; Financial Interests, Institutional, Advisory Board: Lilly; Financial Interests, Institutional, Advisory Board: Daiichi Sankyo; Financial Interests, Institutional, Advisory Board: MSD; Financial Interests, Institutional, Advisory Board: Amgen; Financial Interests, Institutional, Advisory Board: Seagen. All other authors have declared no conflicts of interest.

Background

Up to 30% of metastatic breast cancer (BC) patients (pts) develop brain metastases (BM). Prognosis of pts with BM is poor and long-term survival is rare. Identification of factors associated with long-term survival is important for improving treatment modalities.

Methods

A total of 2889 out of 3234 pts of the BMBC registry were available for this analysis. Long-term survival was defined as overall survival (OS) in the upper third of the survival curve resulting in a cut-off of 15 months. 887 patients were categorized as long-term survivors.

Results

Long-term survivors compared to other pts were younger at BC and BM diagnosis (median 48 vs 54 years and 53 vs 59 years), had more often HER2+ tumors (59.1% vs 36.3%), less frequently luminal-like (29.1% vs 35.7%) or TNBC (11.9% vs 28.1%), showed better ECOG at time of BM diagnosis (ECOG 0-1 76.9% vs 51.0%), higher pCR rate (21.6% vs 13.7%) and lower number of BM (n=1 BM 40.9% vs 25.4%; n=2-3 BM 26.5% vs 26.7%; n≥4 BM 32.6% vs 47.9%) (p<0.001). Long-term survivors had less leptomeningeal metastases (10.4% vs 17.5%) and extracranial metastases (ECM, 73.6% vs 82.5%), and more often asymptomatic BM at time of BM diagnosis (26.5% vs 20.1, p<0.001). Median OS in long-term survivors was 30.9 months (95% CI 28.8-32.6) overall, 33.9 (95% CI 31.5-37.9) in HER2+, 26.9 (95% CI 25.0-30.9) in luminal-like and 26.5 (95% CI 22.7-31.2) in TNBC pts. Factors significantly associated with a categorization of long-term survivors are presented in the table below. Table: 170P

Multivariate logistic regression in long-term vs short-term survivors

Conclusions

Our analysis identified factors associated with long-term survival of BC pts with BM and characterized clinical features of this patient cohort. Pts with better ECOG status, younger age, lower number of BM, less extended visceral metastases are more likely to show a long-term survival and therefore are more eligible for extended local and systemic treatment.

Legal entity responsible for the study

GBG Forschung.

Funding

Partial Funding Daiichi Sankyo Europe.

Disclosure

M. Schmidt: Financial Interests, Personal, Other: Pierre Fabre; Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Other: Pfizer; Financial Interests, Personal, Other: Novartis; Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Other: Eisai; Financial Interests, Personal, Other: Pantarhei; Financial Interests, Personal, Other: BioNTech; Financial Interests, Personal, Other: Genentech; Financial Interests, Personal, Other: Daiichi Sankyo; Financial Interests, Personal, Other: Lilly; Financial Interests, Personal, Other: MSD. J. Puppe: Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Synlab; Financial Interests, Personal, Invited Speaker: Pierre Fabre; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Board: Pierre Fabre; Financial Interests, Personal, Advisory Board: Gilead; Financial Interests, Personal, Invited Speaker: Novartis. K. Lübbe: Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Eisei; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Advisory Board: Exact Sciences; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Roche. M. Thill: Financial Interests, Personal, Advisory Board: Sysmex; Financial Interests, Personal, Advisory Board: Seagen; Financial Interests, Personal, Advisory Board: RTI Surgical; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Pierre Fabre; Financial Interests, Personal, Advisory Board: pfm Medical; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Onkowissen; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Neodynamics; Financial Interests, Personal, Advisory Board: Norgine; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Advisory Board: Gilead Science; Financial Interests, Personal, Advisory Board: Exact Sciences; Financial Interests, Personal, Advisory Board: Eisai; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Clovis; Financial Interests, Personal, Advisory Board: ClearCut; Financial Interests, Personal, Advisory Board: Celgene; Financial Interests, Personal, Advisory Board: Biom‘Up; Financial Interests, Personal, Advisory Board: Becton/Dickinson; Financial Interests, Personal, Advisory Board: Aurikamed; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Funding: Endomag; Financial Interests, Personal, Funding: Exact Sciences; Financial Interests, Personal, Invited Speaker: Viatris; Financial Interests, Personal, Invited Speaker: Vifor; Financial Interests, Personal, Invited Speaker: Sysmex; Financial Interests, Personal, Invited Speaker: Seagen; Financial Interests, Personal, Invited Speaker: RTI Surgical; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: pfm Medical; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Omniamed; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Medtronic; Financial Interests, Personal, Invited Speaker: MCI; Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Invited Speaker: Jörg Eickeler; Financial Interests, Personal, Invited Speaker: I-Med-Institute; Financial Interests, Personal, Invited Speaker: Hexal; Financial Interests, Personal, Invited Speaker: Gilead Science; Financial Interests, Personal, Invited Speaker: Exact Sciences; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Invited Speaker: Connect Medica; Financial Interests, Personal, Invited Speaker: Clovis; Financial Interests, Personal, Invited Speaker: Celgene; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Art Tempi; Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Personal, Other: Clear Cut. C. Denkert: Financial Interests, Personal, Advisory Board: MSD Oncology; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Molecular Health; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Merck; Financial Interests, Personal, Ownership Interest, Cofounder and shareholder of Sividon Diagnostics until 2016: Sividon Diagnostic; Financial Interests, Personal, Invited Speaker: VmScope digital pathology software; Financial Interests, Institutional, Funding: Roche; Financial Interests, Institutional, Research Grant: Myriad. S. Loibl: Financial Interests, Institutional, Advisory Board, Member: AbbVie; Financial Interests, Institutional, Advisory Board, Member: Amgen; Financial Interests, Institutional, Advisory Board, Member: AstraZeneca; Financial Interests, Institutional, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Advisory Board, Member: Bayer; Financial Interests, Institutional, Advisory Board, Member: BMS; Financial Interests, Institutional, Advisory Board, Member: Celgene; Financial Interests, Personal, Invited Speaker: Chugai; Financial Interests, Institutional, Advisory Board: DSI; Financial Interests, Institutional, Invited Speaker: DSI; Financial Interests, Institutional, Advisory Board, Member: EirGenix; Financial Interests, Institutional, Advisory Board, Member: GSK; Financial Interests, Institutional, Invited Speaker: Ipsen; Financial Interests, Institutional, Advisory Board, Member: Lilly; Financial Interests, Institutional, Advisory Board: Merck KG; Financial Interests, Institutional, Invited Speaker: Novartis; Financial Interests, Institutional, Advisory Board, Member: Novartis; Financial Interests, Institutional, Invited Speaker: Pfizer; Financial Interests, Institutional, Advisory Board: Pfizer; Financial Interests, Institutional, Advisory Board, Member: Pierre Fabre; Financial Interests, Institutional, Invited Speaker: Pierre Fabre; Financial Interests, Institutional, Invited Speaker: prIME/Medscape; Financial Interests, Institutional, Advisory Board, Member: prIME/Medscape; Financial Interests, Institutional, Advisory Board, Member: Puma; Financial Interests, Institutional, Advisory Board, Member: Roche; Financial Interests, Institutional, Invited Speaker: Roche; Financial Interests, Institutional, Invited Speaker: Samsung; Financial Interests, Institutional, Advisory Board, Member: Seagen; Financial Interests, Personal, Full or part-time Employment, CEO: GBG Forschungs GmbH; Financial Interests, Institutional, Invited Speaker, Ki67: VM Scope GmbH; Financial Interests, Institutional, Research Grant: Amgen; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Funding: AbbVie; Financial Interests, Institutional, Research Grant: Celgene; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Immunomedics; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Personal, Other, PIPenelope/Padma: Pfizer; Financial Interests, Personal, Other, SC PALOMA3: Pfizer; Financial Interests, Personal, Other, SC SOLAR1: Novartis; Financial Interests, Personal, Other, SC ASCENT: Immunomedics; Financial Interests, Personal, Other, SC HERCLIMB: Seagen; Financial Interests, Personal, Other, SC Katherine: Roche; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Funding: Cepheid; Financial Interests, Institutional, Research Grant: Daiichi Sankyo; Non-Financial Interests, Principal Investigator, After publication of primary endpoint: PI Aphinity; Non-Financial Interests, Invited Speaker, Executive Board: BIG; Non-Financial Interests, Other, Medical Writing: Amgen; Non-Financial Interests, Other, Medical Writing: AstraZeneca; Non-Financial Interests, Other, Medical Writing: BMS; Non-Financial Interests, Other, Medical Writing: Celgene; Non-Financial Interests, Other, Medical Writing: Daiichi Sankyo; Non-Financial Interests, Other, Medical Writing: Novartis; Non-Financial Interests, Other, Medical Writing: Pfizer; Non-Financial Interests, Other, Medical Writing: Roche; Non-Financial Interests, Member, German Gynaecological Oncology society: AGO; Non-Financial Interests, Member, German Cancer Society: DKG; Non-Financial Interests, Member: ASCO; Non-Financial Interests, Member, Chair ESMO Breast; SC: ESMO; Other, EP18209672.7No financial interest, Institutional: Patent; Other, EP21152186.9No financial interest, institutional: Patent; Other, EP15702464.7No financial interest, institutional: Patent. V. Müller: Financial Interests, Personal, Invited Speaker: Gilead; Financial Interests, Personal, Invited Speaker: GSK; Financial Interests, Personal, Invited Speaker: Seagen; Financial Interests, Personal, Invited Speaker: Teva; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Invited Speaker: Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Personal, Other: Gilead; Financial Interests, Personal, Other: GSK; Financial Interests, Personal, Other: Lilly; Financial Interests, Personal, Other: Eisai; Financial Interests, Personal, Other: Daiichi Sankyo; Financial Interests, Personal, Other: MSD; Financial Interests, Personal, Other: Novartis; Financial Interests, Personal, Other: ClinSol; Financial Interests, Personal, Other: Amgen; Financial Interests, Personal, Other: Pierre Fabre; Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Other: Hexal; Financial Interests, Personal, Other: Genomic Health; Financial Interests, Institutional, Research Grant: Seagen; Financial Interests, Institutional, Research Grant: Genentech; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Research Grant: Novartis. I. Witzel: Financial Interests, Personal, Invited Speaker: Seagen; Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: AstraZeneca. All other authors have declared no conflicts of interest.