Real-world clinical and survival outcomes of patients with early relapsed triple-negative breast cancer from the ESME national cohort.

Background: Early metastatic relapse of triple-negative breast cancer (mTNBC) after anthracyclins and/or taxanes based (A/T) primary treatment represents a highly aggressive cancer situation requiring urgent characterisation and handling. Epidemio-Strategy-Medico-Economical-Metastatic Breast Cancer (ESME-MBC) database, a multicenter, national, observational cohort (NCT03275311) provides recent data on this entity.
Methods: All ESME patients diagnosed between 2008 and 2020 with mTNBC occurring as a relapse after a systemic neoadjuvant/adjuvant taxane and/or anthracycline-based chemotherapy were included. Early relapses were defined by a metastatic diagnosis up to 12 months of the end of neo/adjuvant A/T chemotherapy. We assessed overall survival (OS) and progression-free-survival under first-line treatment (PFS1) by early versus late relapse (≥12 months).
Results: Patients with early relapse (N = 881, 46%) were younger and had a larger tumour burden at primary diagnosis than those with late relapses (N = 1045). Early relapse rates appeared stable over time. Median OS was 10.1 months (95% CI 9.3-10.9) in patients with early relapse versus 17.1 months (95% CI 15.7-18.2) in those with late relapse (adjusted hazard-ratio (aHR): 1.92 (95% CI 1.73-2.13); p < 0.001). The median PFS1 was respectively 3.1 months (95% CI 2.9-3.4) and 5.3 months (95% CI 5.1-5.8); (aHR: 1.66; [95% CI 1.50-1.83]; p < 0.001). Among early relapsed patients, a higher number of metastatic sites, visceral disease but not treatment types, were independently associated with a poorer OS.
Conclusion: These real-world data provide strong evidence on the dismal prognosis, higher treatment resistance and major unmet medical need associated with early relapsed mTNBC. Database registration: clinicaltrials.gov Identifier NCT032753.
Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Delaloge discloses: Financial interests, all to my institution (advisory boards, speaker activities): AstraZeneca, MSD, Rappta, Besins, Gilead, Elsan. Research and clinical research funding, all to my institution: Sanofi, Pfizer, Novartis, AstraZeneca, Roche Genentech, Lilly, Puma, Orion, Amgen, Servier, MSD, BMS, Pierre Fabre, Seagen, Exact Sciences, Rappta, Taiho, European Commission, French government, Fondation ARC. Recipient, Horizon 2020 grant MyPeBS. Non-financial interests, personal: Pfizer, Novartis, AstraZeneca, Seagen. Dr. Frenel reports consulting fees from Pfizer, Lilly, Novartis, Astra Zeneca, Clovis Oncology, GSK, Gilead, Daiichi Sankyo, Seagen; honoraria from Lilly, Novartis, Astra Zeneca, Gilead, Daiichi Sankyo, Seagen; support for attending meetings and/or travel from Pfizer, Lilly, Novartis, Astra Zeneca, Clovis Oncology, GSK, Gilead, Daiichi Sankyo, Seagen. Dr. Jacot reports Grants or contracts from Astra Zeneca and Daiichi Sankyo; Payment or honoraria for lectures from Astra Zeneca, Eisai, BMS, Lilly France, Daiichi Sankyo, MSD, Novartis, Pfizer, Roche, Seagen; Participation on a Data Safety Monitoring Board or Advisory Board from Astra ZenecaEisai, BMS, Lilly France, Daiichi Sankyo, MSD, Novartis, Pfizer, Roche, Seagen. Dr. Pérol reports grants or contracts from Roche and ESME, payment or honoraria for lectures from Astrazeneca, Bayer, Boehringher-Ingelheim, Bristol Myers Squibb, Daiichi-Sankyo, Eli-Lilly, Ipsen, Roche, Novartis, Merck Sharp And Dohme, Takeda, Janssen, Pfizer. Dr. Arnedos reports grants or contracts from Roche and Astrazeneca; Consulting fees from Astra Zeneca, Eli-Lilly, Pfizer; Payment or honoraria for lectures from Gilead and Novartis; Support for attending meetings and/or travel from Astra Zeneca, Daiichi-Sankyo, Eli-Lilly; Participation on a Data Safety Monitoring Board or Advisory Board from Novartis, Astra Zeneca. A Antoine reports a grant from the National French Research and Technology Association (ANRT) and Roche (France) via CIFRE doctoral fellowship no. 2020/1054, outside the submitted work. All remaining authors have nothing to disclose.
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