Background: We wanted to assess the efficacy and toxicity of paclitaxel (Taxol) in previously untreated patients with advanced ovarian cancer. No such study had been performed at the time of initiation of this study.
Patients and methods: The study population in this analysis consisted of 35 previously untreated stage III ovarian cancer patients, suboptimally resected at primary surgery. The initial paclitaxel dose was 175 mg/m2 given as a three-hour i.v. infusion every three weeks.
Results: A total of 225 paclitaxel courses were given to 35 patients of whom 34 were evaluable for clinical response. Nine (26%) patients obtained a complete response to paclitaxel, ten (29%) a partial response, seven (21%) stable disease and eight (24%) had progressive disease. Thus, the total response rate to paclitaxel treatment was 55% (19 of 34). The median duration of response for the 19 responding patients was eight months (range 1-44.5+). The median duration for nine patients with clinical complete response was 16 months (range 2-44.5+). A second-look laparotomy was performed in 15 patients after six courses of paclitaxel. Of these, five obtained a histopathologically complete remission, five a partial remission and five stable disease. The five patients with pathologically complete remissions are alive with a median progressive-free survival of 24.5 months (range 15(+)-44.5+). The median progression-free survival for all patients was 6.1 months (range 1-44.5+). Toxicity consisted mainly of neutropenia, easily controlled. Other toxicities were myalgia/arthralgia and peripheral neuropathy. Three patients experienced a severe anaphylactic reaction during the first course.
Conclusion: This study showed that paclitaxel is an effective and safe drug for first-line treatment of ovarian cancer.