WEDNESDAY, June 6 (HealthDay News) -- A new drug can buy months of life for people with one of the rarest kinds of cancer without too-severe side effects, a European study finds.
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The cancer is adrenocortical carcinoma, with not many more than 200 cases a year occurring in the United States. It is a malignancy of the adrenal glands, which sit atop the kidneys. The cortex of an adrenal gland produces a variety of hormones, most notably steroids.
"It is very rare," added Dr. Naomi Haas, a medical oncologist at the Fox Chase Cancer Center in Philadelphia. "We probably see about five cases of this type of malignancy a year here at Fox Chase."
Surgery is the standard treatment, but many patients experience relapses, and "it is very common to relapse again and again and again," Haas said. Mitotane, the drug used in the European trial, has been tried against those relapses, usually in very large doses, she said.
Mitotane is given by mouth, which is convenient, but the drug's major side effect is fatigue, and the dosage used by some physicians is so large that "the patient is totally exhausted." Haas said. "They have no quality of life at all."
Haas was not involved in the study, which was led by Dr. Massimo Terzolo of the University of Turin, and is published in the June 7 New England Journal of Medicine.
The European trial generally used smaller doses, one to 3 grams a day. It enrolled 177 patients who underwent surgery at centers in Germany and 47 who were treated in Italy. Patients who received mitotane treatment were compared with those who did not.
The results were striking. Average recurrence-free survival was 42 months for those who got mitotane, compared to 10 months in one control group and 25 months in another. Side effects of mitotane generally were under control, although the dosage had to be lowered in 13 percent of cases.
It was a major achievement simply to conduct such a trial, since "it was a lot of work to put together so many patients," Haas explained. "This is very valuable, because you're not going to get any prospective trial, and also very valuable because it looks at a number of patients who were receiving quite tolerable therapy."
The trial results probably cause Haas to turn to mitotane more often as she treats adrenal cancer patients after surgery, the doctor said. Fatigue will still be a potential problem, but the study results "suggest that you can titrate the dosage up or down" to manage side effects, she said.
SOURCES: Naomi Haas, M.D., medical oncologist, Fox Chase Cancer Center, Philadelphia; June 7, 2007, New England Journal of Medicine
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