LOS ANGELES--Administration of cisplatin (Platinol) by the intraperitoneal
rather than intravenous route to patients with optimally debulked
stage III ovarian cancer reduced toxicity and improved survival
by about 25%, David S. Alberts, MD, said at the ASCO meeting.
In this Intergroup study of 544 patients, the largest prospective
phase III trial ever performed in ovarian cancer, median survival
after more than 50 months of follow-up was 51 months on the IP
arm vs 41 months on the IV therapy arm, a significant difference.
The IP to IV death hazard ratio was .75. "Thus, at any time
during this study and its follow-up, there was a 25% greater likelihood
of being alive if the patient was treated with IP therapy,"
said Dr. Alberts, deputy director, Arizona Cancer Center, Tucson.
There were 171 deaths on the IV arm vs 143 on the IP arm.
Patients in the study had less than 2 cm residual tumor after
primary surgery (more than 70% had less than 0.5 cm) and were
stratified according to degree of residual disease and performance
status before randomization.
They then received cisplatin, 100 mg/m², either IV or IP
(in 2 liters of saline), plus IV cyclophosphamide, 600 mg/m²,
every 3 weeks for six cycles.
Patients on IP therapy had significantly less grade 3 or 4 neutropenia,
which was not unexpected, since the peak plasma level of the drug
is dramatically reduced with IP delivery. More IP patients had
abdominal pain, but this was well controlled with narcotics.
The IP patients also had a significantly lower incidence of tinnitus
and clinical hearing loss (5% clinical hearing loss of grade 2
or greater vs 14% on the IV arm).