Cardiac events in phase II trials with mitoxantrone

B. J. Foster, L. Lev, C. Bergemann, S. Marsoni

Research output: Chapter in Book/Report/Conference proceedingChapter


Mitoxantrone is used widely in clinical trials sponsored by the National Cancer Institute (NCI). Since June 1981, the Investigational Drug Branch of NCI has received scattered reports of cardiac events in patients treated with this drug. As of June 30, 1983, 2228 adult and 231 pediatric patients have been treated in phase II trials. A total of 1595 of the adults were treated under Southwest Oncology Group and Southeastern Cooperative Group protocols. Of the remaining 633 adults, seven have developed cardiac events, including one acute myocardial infarction, four instances of congestive heart failure, and two cases of decreased ejection fraction. In two patients, the cardiac event was considered a contributing cause of death. In the pediatric population, six cases of congestive heart failure and one case of decreased ejection fraction have occurred. In six cases, the cardiac event appeared to contribute to death. Of the 14 patients who developed a cardiac event, 13 had defined risk factors (prior anthracyclines, chest irradiation, or other diseases associated with an increased risk of heart disease) before starting mitoxantrone therapy. The cardiotoxic potential of mitoxantrone and the characterization of its cardiotoxicity are therefore difficult to analyze from this patient population. Ongoing randomized studies of mitoxantrone versus doxorubicin in breast cancer patients are prospectively monitoring the use of both drugs and will compare their effects on cardiac functioning.

Original languageEnglish
Title of host publicationCancer Treatment Symposia
Number of pages4
VolumeVOL. 3
Publication statusPublished - 1984

ASJC Scopus subject areas

  • Cancer Research
  • Oncology


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