LOS ANGELES--Using paclitaxel(Drug information on paclitaxel) (Taxol) rather than cyclophosphamide(Drug information on cyclophosphamide) in combination with cisplatin(Drug information on cisplatin) (Platinol) significantly increases both progression-free and overall survival in patients with advanced ovarian cancer, William P. McGuire, MD, said in his presentation at the plenary session of ASCO.
Two years ago, Dr. McGuire presented preliminary data from this randomized Gynecologic Oncology Group study showing that paclitaxel/cisplatin produced better response rates than cyclophosphamide/cisplatin in 386 patients with optimally debulked stage III and IV disease. Now the mature data, with a median follow-up of 38 months, show a 13-month survival advantage for the paclitaxel-treated patients.
"The combination of Taxol and cis-platin should now become the standard to which other therapies should be compared in advanced ovarian carcinoma, particularly those patients with suboptimal stage III and IV disease," said Dr. McGuire, professor of medicine, Winship Cancer Center of Emory University.
Median progression-free survival in the paclitaxel patients was 5 months longer than with standard therapy, with a relative risk of .66, meaning a reduction of approximately one third in the risk of progression. The 13-month paclitaxel advantage in median overall survival gave a relative risk of .61 and was highly statistically significant (P less than.0001).
The overall clinical response was significantly higher in the paclitaxel arm (73% vs 60% for standard therapy).
Although grade 4 neutropenia and leukopenia were significantly more common in the paclitaxel arm, the overall incidence of febrile neutropenia was relatively small. "This is due, in large part, to the relatively brief period of neutropenia that is induced by the Taxol/cisplatin combination," Dr. McGuire said.
Alopecia, allergic reactions, and cardiac events were also more common in the experimental arm, but did not appear to be clinically significant. However, the bottom line in regard to toxicities, Dr. McGuire said, is that in the later courses of cyclophosphamide/cisplatin, there were treatment delays due to chronic and cumulative hematologic toxicity. "We were able to give therapy more efficiently with Taxol/cisplatin," he said.