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| |  ECCO: Platinum Sensitivity Predicts Response to Liposomal Doxorubicin in Women with Recurrent Ovarian Cancer By Cameron Johnston COPENHAGEN, DENMARK -- September 22, 2003 -- Patients with recurrent epithelial ovarian cancer who are treated with pegylated liposomal doxorubicin (Doxil/Caelyx) seem to have longer overall survival rates compared with patients who are treated with topotecan, suggests a recently released phase II study. The overall survival is particularly pronounced among patients who are sensitive to platinum-based therapies, according to the study presented here September 22nd at ECCO 12: The European Cancer Conference. According to Dr. Alan Gordon, principal investigator and director of research, US Oncology, Dallas, Texas, United States, between 50% and 75% of women who are treated with surgery and chemotherapy for ovarian cancer eventually relapse and require second-line treatment. In this study, 239 women were treated with pegylated liposomal doxorubicin 50 mg/m2 as a 1-hour infusion every 28 days over a course of 6 cycles. In the other arm, 235 women were treated with topotecan 1.5 mg/m2 as a 30-minute infusion for the first 5 days of a 21-day cycle. The regimen was repeated 8 times. Overall survival was only slightly longer among women treated with liposomal doxorubicin compared with those treated with topotecan -- 63 weeks compared with 60 weeks. Overall 1- and 2-year survival rates also favoured those receiving doxorubicin -- 56% and 35% among those in the doxorubicin group compared with 54% and 24% among those treated with topotecan. Although these differences were not highly statistically significant, there were significant differences in outcomes when the women were stratified as to whether they were platinum-sensitive or platinum-refractory. Among women who were determined to be platinum-sensitive (46%), the median overall survival was 112 weeks with doxorubicin and 77 weeks with topotecan. One- and 2-year survival rates were 79% and 55% respectively for those treated with doxorubicin, compared with 68% and 33%, respectively, for those treated with topotecan. This represents a 37% reduction in the risk of death among patients receiving doxorubicin. Among those who were platinum-refractory, however, there were no significant differences in overall median survival: 36 weeks compared with 41 weeks. Also, the 1- and 2-year survival rates were 37% and 18% among those treated with doxorubicin compared with 41% and 15% among those treated with topotecan. Overall, there were no significant differences in progression-free survival between either of the groups, although again, those who were sensitive to platinum had a 24% reduction in the possibility of recurrence. Dr. Gordon concluded that although the overall results suggest little or no difference in outcomes between the 2 drugs, the differences are significant when the woman's sensitivity, or lack of sensitivity, to platinum-based therapies is considered. In cases where the woman is sensitive to platinum, there are significant increases in 1-and 2-year survival rates, as well as overall survival and progression-free survival. These findings suggest that clinicians may want to consider whether their patients with recurrent ovarian cancer are responsive to platinum-based therapies before deciding which agents to use as second-line therapies, he reported.
[Study title: Overall Survival Advantage for Pegylated Liposomal Doxorubicin Compared to Topotecan in Recurrent Epithelial Ovarian Cancer. Abstract 157]
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