Volume 9 , Issue 3 , September 2021 , Pages: 171 - 175
A Phase 1 Dose Escalation Study of Eribulin in Combination with Weekly Carboplatin for the Treatment of Metastatic Breast Cancer
Aixa Elena Soyano, Department of Breast Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, USA
Michael Shafique, Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, USA
Roohi Ismail-Khan, Satellite and Community Oncology Program, H. Lee Moffitt Cancer Center and Research Institute, Tampa, USA
Dawn Goodridge, Department of Late Phase Research, Florida Cancer Specialists & Research Institute, Tampa, USA
David Boulware, Department of Biostatistics, H. Lee Moffitt Cancer Center and Research Institute, Tampa, USA
Hatem Soliman, Department of Breast Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, USA
Hyo Sook Han, Department of Breast Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, USA
Received: Aug. 2, 2021;       Accepted: Aug. 24, 2021;       Published: Aug. 31, 2021
DOI: 10.11648/j.crj.20210903.17        View        Downloads  
Abstract
Background: Metastatic breast cancer is a common and devastating diagnosis. New strategies for treatment are needed to help improve outcomes. Eribulin is an anti-microtubule agent approved in 2010 for advanced breast cancer. Combination with other chemotherapeutic agents provides an alternative treatment option for these patients. Purpose: This study evaluates the safety, tolerability and activity of eribulin and weekly carboplatin in a dose-escalation schema in patients with metastatic breast cancer. Methods: Patients were treated with eribulin and carboplatin AUC 2 administered on the first and eighth days of a 21-day cycle. Three doses of eribulin (0.9, 1.1 and 1.4 mg/m2) were examined. An additional 10 patients were enrolled into an expansion cohort at the recommended Phase 2 dose. Results: A total of 19 patients were treated, including 10 patients in the dose expansion cohort. There was no dose limiting toxicity related to the study therapy in the dose escalation cohorts. Grade 3 toxicities included neutropenia (21%), anemia (10%), fatigue (10%), peripheral sensory neuropathy (10%), infusion related reactions (5%), pericardial effusion (5%), diarrhea (5%) and pleural effusion (5%). Twenty-six percent of patients had grade 4 neutropenia, but there were no events of sepsis or febrile neutropenia. The maximum tolerated dose (MTD) of eribulin in combination with carboplatin AUC 2 was determined to be 1.4 mg/m2. Four patients experienced clinical benefit, 2 patients with stable disease greater than 6 months and 2 patients with partial response, demonstrating a clinical benefit rate of 21%. Conclusion: Eribulin and weekly carboplatin appeared to be safe and well tolerated with demonstrated clinical benefit. The recommended Phase 2 dose level was 1.4 mg/m2 of eribulin. Further studies can be pursued for this combination regimen to establish its efficacy.
Keywords
Eribulin, Breast Neoplasms, Drug Therapy, Breast Cancer
To cite this article
Aixa Elena Soyano, Michael Shafique, Roohi Ismail-Khan, Dawn Goodridge, David Boulware, Hatem Soliman, Hyo Sook Han, A Phase 1 Dose Escalation Study of Eribulin in Combination with Weekly Carboplatin for the Treatment of Metastatic Breast Cancer, Cancer Research Journal. Vol. 9, No. 3, 2021, pp. 171-175. doi: 10.11648/j.crj.20210903.17
Copyright
Copyright © 2021 Authors retain the copyright of this article.
This article is an open access article distributed under the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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