NEW ORLEANS--Intraperitoneal (IP) administration of cisplatin
(Platinol) plus IV 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
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,"
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 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."