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FRIDAY, Jan. 19 (HealthDay News) -- A trial testing whether the chemotherapy drug mitoxantrone would benefit men with prostate cancer has been stopped because three of the 488 patients who received the drug developed leukemia.
According to the Southwest Oncology Group, which was running this phase III trial, 983 patients were randomly assigned to receive hormone deprivation therapy alone or hormone deprivation therapy plus six doses of mitoxantrone.
"We were surprised by the incidence of leukemia," said principal investigator Dr. L. Michael Glode, a professor of medical oncology at the University of Colorado in Denver. "This general category of drugs has been associated with leukemia."
One expert thinks the decision to end the trial was correct.
"They are doing the right thing," said Dr. Anthony D'Amico, chief of radiation oncology at Brigham and Women's Hospital, in Boston. "The initial studies of mitoxantrone were done in men with end-stage prostate cancer -- but their life expectancy was about a year and a half. The life expectancy of the men in this study is 10 to 15 years or more. Only in a study like this can you see the long-term side effects of chemotherapeutic agents like mitoxantrone."
However, another expert doesn't see anything unusual about the incidence of leukemia among men receiving mitoxantrone.
"This is the first trial that tested adjuvant chemotherapy in men with high-risk prostate cancer," said Dr. Mario Eisenberger, a professor of oncology at Johns Hopkins University. "I wouldn't be so alarmed with the very low number of leukemias in this setting, especially if you put that against the possible gain that you can get from this approach."
Mitoxantrone has been approved for use in prostate cancer as well as in breast cancer, and it is commonly used to treat multiple sclerosis. In this trial, mitoxantrone was being used to treat "poor risk" prostate cancer patients. These are men whose cancer has spread to the tissues next to the prostate, or whose cancer has a high probability of returning after surgery or radiation therapy.
