LOS ANGELES--Using paclitaxel (Taxol) rather than cyclophosphamide
in combination with 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.