Cardiovascular safety profile of taxanes and vinca alkaloids: 30 years FDA registry experience
Objective Antimicrotubular agents are among the most commonly used classes of chemotherapeutic agents, but the risk of cardiovascular adverse events (CVAEs) remains unclear. Our objective was to study the CVAEs associated with antimicrotubular agents.Methods The Food and Drug Administration’s Advers...
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BMJ Publishing Group
2021-12-01
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| Series: | Open Heart |
| Online Access: | https://openheart.bmj.com/content/8/2/e001849.full |
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| author | Avirup Guha Sarju Ganatra Brijesh Patel Daniel Addison Anita Deswal Sherry-Ann Brown Michael Fradley Akshee Batra Lauren A Baldassarre Nihar Desai Neal Weintraub Zeeshan Hussain Vivek Agarwala Purvish M Parikh Arjun Ghosh |
| author_facet | Avirup Guha Sarju Ganatra Brijesh Patel Daniel Addison Anita Deswal Sherry-Ann Brown Michael Fradley Akshee Batra Lauren A Baldassarre Nihar Desai Neal Weintraub Zeeshan Hussain Vivek Agarwala Purvish M Parikh Arjun Ghosh |
| author_sort | Avirup Guha |
| collection | DOAJ |
| description | Objective Antimicrotubular agents are among the most commonly used classes of chemotherapeutic agents, but the risk of cardiovascular adverse events (CVAEs) remains unclear. Our objective was to study the CVAEs associated with antimicrotubular agents.Methods The Food and Drug Administration’s Adverse Event Reporting System was used to study CVAEs in adults from 1990 to 2020. Reported single-agent (only taxane or vinca alkaloid) CVAEs were compared with combination therapy (with at least one of the four major cardiotoxic drugs: anthracycline, HER2Neu inhibitors, tyrosine kinase inhibitors and checkpoint inhibitors) using adjusted polytomous logistic regression.Results Over 30 years, 134 398 adverse events were reported, of which 18 426 (13.4%) were CVAEs, with 74.1% due to taxanes and 25.9% due to vinca alkaloids. In 30 years, there has been a reduction in the proportion of reported CVAEs for taxanes from 15% to 11.8% (Cochran-Armitage P-trends <0.001) with no significant change in the proportion of reported CVAEs for vinca alkaloids (9.2%–11.7%; P-trends=0.06). The proportion of reported CVAEs was lower in both taxane and vinca alkaloid monotherapy versus combination therapy (reporting OR=0.50 and 0.55, respectively). Anthracyclines and HER2Neu inhibitor combinations with taxanes or vinca alkaloids primarily drove the higher burden of combination CVAEs. Hypertension requiring hospitalisation and heart failure was significantly lower in monotherapy versus combination antimicrotubular agent therapy.Conclusions Antimicrotubular agents are associated with CVAEs, especially in combination chemotherapy regimens. Based on this study, we suggest routine cardiovascular assessment of patients with cancer before initiating antimicrotubular agents in combination therapy. |
| format | Article |
| id | doaj-art-d9c0db28375a417db7a0c3b3065f5a43 |
| institution | Kabale University |
| issn | 2053-3624 |
| language | English |
| publishDate | 2021-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | Open Heart |
| spelling | doaj-art-d9c0db28375a417db7a0c3b3065f5a432024-11-11T19:50:27ZengBMJ Publishing GroupOpen Heart2053-36242021-12-018210.1136/openhrt-2021-001849Cardiovascular safety profile of taxanes and vinca alkaloids: 30 years FDA registry experienceAvirup Guha0Sarju Ganatra1Brijesh Patel2Daniel Addison3Anita Deswal4Sherry-Ann Brown5Michael Fradley6Akshee Batra7Lauren A Baldassarre8Nihar Desai9Neal Weintraub10Zeeshan Hussain11Vivek Agarwala12Purvish M Parikh13Arjun Ghosh14Cardiology, University Hospitals Harrington Heart & Vascular Institute, Cleveland, Ohio, USADepartment of Cardiovascular Medicine, Lahey Clinic Medical Center, Burlington, Massachusetts, USAHeart and Vascular Institute, West Virginia University, Morgantown, West Virginia, USADivision of Cancer Prevention and Control, Department of Internal Medicine, College of Medicine, Ohio State University, Columbus, Ohio, USAThe University of Texas MD Anderson Cancer Center, Houston, TX, USAMedical College of Wisconsin, Milwaukee, Wisconsin, USADepartment of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USADepartment of Medicine, University of Vermont Medical Center, Burlington, Vermont, USADepartment of Cardiology, Yale School of Medicine, New Haven, Connecticut, USADepartment of Cardiology, Yale School of Medicine, New Haven, Connecticut, USACardio-Oncology Program, Division of Cardiology, Department of Internal Medicine, Augusta University Medical College of Georgia, Augusta, Georgia, USAHarrington Heart and Vascular Institute, University Hospitals, Cleveland, Ohio, USADepartment of Medical Oncology, Narayana Superspeciality Hospital-Howrah, Howrah, West Bengal, IndiaMumbai Oncocare Centers, Mumbai, Maharashtra, India2North Bristol NHS TrustObjective Antimicrotubular agents are among the most commonly used classes of chemotherapeutic agents, but the risk of cardiovascular adverse events (CVAEs) remains unclear. Our objective was to study the CVAEs associated with antimicrotubular agents.Methods The Food and Drug Administration’s Adverse Event Reporting System was used to study CVAEs in adults from 1990 to 2020. Reported single-agent (only taxane or vinca alkaloid) CVAEs were compared with combination therapy (with at least one of the four major cardiotoxic drugs: anthracycline, HER2Neu inhibitors, tyrosine kinase inhibitors and checkpoint inhibitors) using adjusted polytomous logistic regression.Results Over 30 years, 134 398 adverse events were reported, of which 18 426 (13.4%) were CVAEs, with 74.1% due to taxanes and 25.9% due to vinca alkaloids. In 30 years, there has been a reduction in the proportion of reported CVAEs for taxanes from 15% to 11.8% (Cochran-Armitage P-trends <0.001) with no significant change in the proportion of reported CVAEs for vinca alkaloids (9.2%–11.7%; P-trends=0.06). The proportion of reported CVAEs was lower in both taxane and vinca alkaloid monotherapy versus combination therapy (reporting OR=0.50 and 0.55, respectively). Anthracyclines and HER2Neu inhibitor combinations with taxanes or vinca alkaloids primarily drove the higher burden of combination CVAEs. Hypertension requiring hospitalisation and heart failure was significantly lower in monotherapy versus combination antimicrotubular agent therapy.Conclusions Antimicrotubular agents are associated with CVAEs, especially in combination chemotherapy regimens. Based on this study, we suggest routine cardiovascular assessment of patients with cancer before initiating antimicrotubular agents in combination therapy.https://openheart.bmj.com/content/8/2/e001849.full |
| spellingShingle | Avirup Guha Sarju Ganatra Brijesh Patel Daniel Addison Anita Deswal Sherry-Ann Brown Michael Fradley Akshee Batra Lauren A Baldassarre Nihar Desai Neal Weintraub Zeeshan Hussain Vivek Agarwala Purvish M Parikh Arjun Ghosh Cardiovascular safety profile of taxanes and vinca alkaloids: 30 years FDA registry experience Open Heart |
| title | Cardiovascular safety profile of taxanes and vinca alkaloids: 30 years FDA registry experience |
| title_full | Cardiovascular safety profile of taxanes and vinca alkaloids: 30 years FDA registry experience |
| title_fullStr | Cardiovascular safety profile of taxanes and vinca alkaloids: 30 years FDA registry experience |
| title_full_unstemmed | Cardiovascular safety profile of taxanes and vinca alkaloids: 30 years FDA registry experience |
| title_short | Cardiovascular safety profile of taxanes and vinca alkaloids: 30 years FDA registry experience |
| title_sort | cardiovascular safety profile of taxanes and vinca alkaloids 30 years fda registry experience |
| url | https://openheart.bmj.com/content/8/2/e001849.full |
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