ASCO LOS ANGELES--A review of survival data from a phase I study
of intraperitoneal interleukin-2 (IL-2) performed from 1987 to
1990 has shown durable responses in women with refractory ovarian
Speaking at a media briefing held in conjunction with the American
Society of Clinical Oncology meeting, Robert P. Edwards, MD, said
that the study was "ahead of its time." Recombinant
IL-2 (aldesleukin, Proleukin) had become available in 1985, and
giving it to ovarian cancer patients in the IP cavity as locoregional
treatment "was really an insightful thing to do," he
A phase II study of the treatment is planned at the University
of Pittsburgh/Magee-Womens Hospital, where Dr.Edwards is director,
Division of Gynecologic Oncology, and if the promising phase I
results are confirmed, intraperitoneal IL-2 could offer an effective
second-line therapy for patients with recurrent ovarian cancer.
The original University of Pittsburgh investigators, Drs. Herberman
and Kirkwood, used escalating doses of two different delivery
schedules: 7-day continuous infusion every other week or a weekly
The investigator's initial bias, based on animal data, was that
the 7-day infusion would be superior. "However," Dr.
Edwards said, "it became clear around 1990 that toxicity
with the 7-day infusion was excessive, and the weekly infusion
produced more responses, although this did not reach significance."
Dr. Edwards and his colleagues determined long-term survivors
from the study by reviewing the patients' charts and contacting
survivors. They found that the patients who responded at the lower
dose tiers were still alive and free of disease 57 to 84 months
"These are patients who had persistent ovarian cancer after
receiving very intensive chemotherapy," Dr. Edwards stressed.
The majority had received three- drug regimens that included platinum
and doxorubicin. All underwent surgical evaluation to document
the extent of disease prior to treatment with IL-2.