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Paclitaxel Improves Survival Among Women With Platinum-Sensitive Ovarian Cancer: Presented at CFS

By Charlene Laino

NEW YORK, NY -- November 19, 2003 -- Adding paclitaxel to conventional platinum-based chemotherapy improves overall survival and progression free-survival in patients with relapsed, platinum-sensitive ovarian cancer, according to results of two large European studies.

Results from the International Collaborative Ovarian Neoplasm-4 and German Arbeitsgemeinschaft Gynaekologische Onkologie Study Group Ovarian Cancer-2.2 trials were presented here on November 13^th at Chemotherapy Foundation Symposium XXI.

"All women relapsing more than 6 months after completion of previous platinum-based chemotherapy should be considered for combination therapy with paclitaxel plus platinum, even if they received paclitaxel as part of their previous therapy," said Jonathan A. Ledermann, Department of Oncology, University College, London, United Kingdom.

Despite improvements in the treatment of ovarian cancer, most patients develop recurrent disease within 3 years of diagnosis, he said. Since there is no agreed second-line treatment at relapse, the researchers assessed the role of paclitaxel plus platinum in two parallel, randomised trials.

From 1996 to 2002, they enrolled 802 women with platinum-sensitive ovarian cancer that relapsed after a treatment-free interval of more than 6 months. Ninety percent were randomised after their first relapse, and 93% had a baseline World Health Organisation performance status of 0 to 1.

Women were given a maximum of 6 cycles, at 3-week intervals, of platinum-based chemotherapy or paclitaxel plus platinum. The paclitaxel dose was 175 mg/m² or 185 mg/m² given at 3-week intervals. In general, carboplatin was given as the platinum agent at a minimum area under the curve of 5, but in some women, both in the control and treatment arms, cisplatin was used as the platinum agent, at 75 mg/m² when used alone, or 50 mg/m² when used in combination.

A total of 530 women died by a median follow-up of 42 months. Women who received the combination therapy were 12% less likely to die than those who received platinum-based chemotherapy alone (P = .02), the study showed.

At 2 years of follow-up, the absolute difference in survival was 7%, with a survival rate of 57% in the paclitaxel group, compared to 50% in the platinum group, Dr. Ledermann reported. Median survival was 29 month versus 24 months, he added.

Patients in the paclitaxel group were 24% less likely to have a relapse or died by 42 months (P < .001), with a 10% difference in absolute progression-free survival rates observed at 1 year, he said.

Nausea and vomiting were slightly more common among patients receiving conventional platinum-based chemotherapy; however, this difference seemed to be transient, lasting 15 weeks, Dr. Ledermann reported.

"There was no good evidence that the effect of paclitaxel plus platinum was larger or smaller in any subgroup of patients, including those who had been treated with a taxane as first-line therapy," he said.


[Study title: ICON4 and AGO-OVAR-2.2: Two Parallel Randomized Trials of Paclitaxel in Combination with Platinum-Based Chemotherapy Versus Platinum-Based Chemotherapy in the Treatment of Relapsed "Platinum-Sensitive" Ovarian Cancer. Abstract 29]

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