NEW ORLEANS--Intraperitoneal (IP) administration of cisplatin(Drug information on cisplatin) (Platinol) plus IV cyclophosphamide(Drug information on cyclophosphamide) produced an improved outcome over IV cisplatin plus IV cyclophosphamide in a pivotal phase III ovarian cancer trial, intergroup study 0051 (SWOG-GOG-ECOG), researchers reported at the Society of Gynecologic Oncologists meeting.
Patients receiving cisplatin by the IP route vs IV administration had better survival and less clinical hearing loss, neuropathy, and neutropenia, said
David S. Alberts, MD, deputy director, Arizona Cancer Center, Tucson. "I believe this is a major advance in gynecologic oncology in terms of treating optimal disease ovarian cancer," he said.
Eligible patients included 544 women with residual tumor of 2 cm or less after primary surgery and no more than 4 weeks before therapy. They were randomized into the IP or IV arm (100 mg/m² cisplatin plus IV cyclophosphamide 600 mg/m²) to be given in six courses at 3-week intervals. Patient characteristics were very similar between the groups. Second-look laparotomies were done at the conclusion of treatment.
Median survival (with more than 55 months of follow-up) was 49 months in the IP arm and 41 months in the IV arm (P = .02). The IP arm showed more pathological complete responses and less gross residual disease, Dr. Alberts said.
The IV-to-IP death hazard ratio was 0.76, which suggested a 24% reduction in mortality for patients receiving regional drug administration.
"This is not a clinically insignificant finding," Dr. Alberts commented. "It is comparable to the effect of adjuvant CMF or tamoxifen(Drug information on tamoxifen) in women with early-stage breast cancer. If I were showing a 24% reduction in mortality from breast cancer simply by changing the dosing route of a standard drug treatment, people would be standing up and applauding."