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.
| Published in | Cancer Research Journal (Volume 9, Issue 3) |
| DOI | 10.11648/j.crj.20210903.17 |
| Page(s) | 171-175 |
| Creative Commons |
This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited. |
| Copyright |
Copyright © The Author(s), 2021. Published by Science Publishing Group |
Eribulin, Breast Neoplasms, Drug Therapy, Breast Cancer
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APA Style
Aixa Elena Soyano, Michael Shafique, Roohi Ismail-Khan, Dawn Goodridge, David Boulware, et al. (2021). A Phase 1 Dose Escalation Study of Eribulin in Combination with Weekly Carboplatin for the Treatment of Metastatic Breast Cancer. Cancer Research Journal, 9(3), 171-175. https://doi.org/10.11648/j.crj.20210903.17
ACS Style
Aixa Elena Soyano; Michael Shafique; Roohi Ismail-Khan; Dawn Goodridge; David Boulware, et al. A Phase 1 Dose Escalation Study of Eribulin in Combination with Weekly Carboplatin for the Treatment of Metastatic Breast Cancer. Cancer Res. J. 2021, 9(3), 171-175. doi: 10.11648/j.crj.20210903.17
AMA Style
Aixa Elena Soyano, Michael Shafique, Roohi Ismail-Khan, Dawn Goodridge, David Boulware, et al. A Phase 1 Dose Escalation Study of Eribulin in Combination with Weekly Carboplatin for the Treatment of Metastatic Breast Cancer. Cancer Res J. 2021;9(3):171-175. doi: 10.11648/j.crj.20210903.17
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Download@article{10.11648/j.crj.20210903.17,
author = {Aixa Elena Soyano and Michael Shafique and Roohi Ismail-Khan and Dawn Goodridge and David Boulware and Hatem Soliman and Hyo Sook Han},
title = {A Phase 1 Dose Escalation Study of Eribulin in Combination with Weekly Carboplatin for the Treatment of Metastatic Breast Cancer},
journal = {Cancer Research Journal},
volume = {9},
number = {3},
pages = {171-175},
doi = {10.11648/j.crj.20210903.17},
url = {https://doi.org/10.11648/j.crj.20210903.17},
eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.crj.20210903.17},
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.},
year = {2021}
}
TY - JOUR T1 - A Phase 1 Dose Escalation Study of Eribulin in Combination with Weekly Carboplatin for the Treatment of Metastatic Breast Cancer AU - Aixa Elena Soyano AU - Michael Shafique AU - Roohi Ismail-Khan AU - Dawn Goodridge AU - David Boulware AU - Hatem Soliman AU - Hyo Sook Han Y1 - 2021/08/31 PY - 2021 N1 - https://doi.org/10.11648/j.crj.20210903.17 DO - 10.11648/j.crj.20210903.17 T2 - Cancer Research Journal JF - Cancer Research Journal JO - Cancer Research Journal SP - 171 EP - 175 PB - Science Publishing Group SN - 2330-8214 UR - https://doi.org/10.11648/j.crj.20210903.17 AB - 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. VL - 9 IS - 3 ER -
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