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Challenging Endocrine Sensitivity of Hormone Receptor-Positive/HER2-Negative Advanced Breast Cancer with the Combination of Eribulin and Endocrine Therapy: The REVERT Study

Authors :
Ana López González
Sonia Del Barco Berrón
Isabel Grau
Maria Galan
Beatriz Castelo Fernández
Alfonso Cortés
Pedro Sánchez Rovira
Alejandro Martinez-Bueno
Xavier Gonzalez
Almudena García
Petra Gener
Leonardo Mina
Daniel Alcalá-López
Miguel Sampayo
Javier Cortés
José Manuel Pérez-Garcia
Antonio Llombart-Cussac
Elena López-Miranda
Source :
Cancers; Volume 14; Issue 23; Pages: 5880
Publication Year :
2022
Publisher :
MDPI AG, 2022.

Abstract

Background: Luminal advanced breast cancer (ABC) patients eventually progress on endocrine therapy. REVERT aimed to explore whether eribulin could restore endocrine sensitivity in a randomized, non-comparative phase II trial. Methods: Aromatase inhibitor (AI)-resistant patients with luminal ABC were randomized 1:1 to receive eribulin +/− AI. Patients were stratified by prior cyclin-dependent kinases 4/6 inhibitor (CDK4/6i) treatment. The primary endpoint was an investigator-assessed overall response rate (ORR) according to RECIST version 1.1 in the eribulin + AI arm. An interim analysis was planned with 11 evaluable patients according to a two-stage Simon design. Results: Twenty-two patients were enrolled (15 eribulin + AI arm; 7 eribulin arm). The trial was terminated early in March 2021, with eight (36.4%) patients still on treatment. ORR was 26.7% in the eribulin + AI arm (95% CI, 7.8–55.1%; p = 0.0541). In the eribulin arm, two (28.6%) patients had an objective response (95% CI, 3.7–71.0%). The difference between the study arms was not significant (p = 0.918). The addition of AI to eribulin also failed to show improvement in other efficacy endpoints. A significant interaction between the treatment arm and previous CDK4/6i treatment was observed for ORR (p = 0.018) and progression-free survival (p = 0.084). Overall, the toxicity profile was consistent with the known safety profile of eribulin. No treatment-related deaths were reported. Conclusion: Eribulin + AI does not seem to improve outcomes compared with eribulin monotherapy in patients with AI-resistant luminal ABC. This chemo–endocrine approach deserves further investigation after progression to CDK4/6i-based therapy.

Details

ISSN :
20726694
Volume :
14
Database :
OpenAIRE
Journal :
Cancers
Accession number :
edsair.doi.dedup.....30b6d2a9b417942df6831d7efd77614a
Full Text :
https://doi.org/10.3390/cancers14235880