Advantage for Women Treated With Pegylated Liposomal Doxorubicin
Advantage for Women Treated With Pegylated Liposomal Doxorubicin
Gordon AN, Tonda M, Sun S, Rackoff W; Doxil Study 30-49 Investigators.
Gynecol Oncol. 2004;95:1-8.
The aim of this study was to access long-term follow-up data on survival of women treated for epithelial ovarian cancer with either pegylated liposomal doxorubicin or topotecan in a randomized multicenter phase 3 trial.
The study cohort consisted of 474 patients randomized to receive either pegylated liposomal doxorubicin, 50 mg/m every 28 days (n = 239), or topotecan, 1.5 mg/m per day for 5 days every 21 days (n = 235). Treatment was for epithelial ovarian cancer that either recurred after or failed to respond to first-line platinum-based chemotherapy. More than 70% of patients in each treatment group had received platinum or taxane therapy previously; 74% had received pegylated liposomal doxorubicin and 72% had received topotecan.
At the time of data analysis for this study, 87% of the patients (413) had died. Median survival for patients receiving pegylated liposomal doxorubicin was 62.7 weeks, compared with 59.7 weeks for patients receiving topotecan (hazard ratio [HR], 1.216; 95% confidence interval [CI], 1.000 to 1.478; P = .05). This correlated with an 18% reduction in the risk of death for patients treated with pegylated liposomal doxorubicin. The HR for the total study enrollment, including those patients who were randomized to a treatment protocol but who did not receive the treatment (N = 481), was 1.23. Median survival for patients randomized to receive pegylated liposomal doxorubicin was 63.6 weeks, compared with 57.0 weeks for patients randomized to receive topotecan (95% CI, 1.01 to 1.50; P = .038).
A 30% reduction in the risk of death was seen among patients receiving pegylated liposomal doxorubicin who had platinum-sensitive disease (median survival, 107.9 weeks compared with 70.1 weeks for patients receiving topotecan; HR, 1.432; 95% CI, 1.066 to 1.923; P = .017). In patients with platinum-refractory disease, survival rates were similar between treatment groups.
Long-term follow-up of patients receiving either pegylated liposomal doxorubicin or topotecan for the treatment of recurrent or unresponsive epithelial ovarian cancer revealed that survival is significantly prolonged with the former agent compared with the latter. This benefit is strongest among patients with platinum-sensitive disease.
Gordon AN, Tonda M, Sun S, Rackoff W; Doxil Study 30-49 Investigators.
Gynecol Oncol. 2004;95:1-8.
The aim of this study was to access long-term follow-up data on survival of women treated for epithelial ovarian cancer with either pegylated liposomal doxorubicin or topotecan in a randomized multicenter phase 3 trial.
The study cohort consisted of 474 patients randomized to receive either pegylated liposomal doxorubicin, 50 mg/m every 28 days (n = 239), or topotecan, 1.5 mg/m per day for 5 days every 21 days (n = 235). Treatment was for epithelial ovarian cancer that either recurred after or failed to respond to first-line platinum-based chemotherapy. More than 70% of patients in each treatment group had received platinum or taxane therapy previously; 74% had received pegylated liposomal doxorubicin and 72% had received topotecan.
At the time of data analysis for this study, 87% of the patients (413) had died. Median survival for patients receiving pegylated liposomal doxorubicin was 62.7 weeks, compared with 59.7 weeks for patients receiving topotecan (hazard ratio [HR], 1.216; 95% confidence interval [CI], 1.000 to 1.478; P = .05). This correlated with an 18% reduction in the risk of death for patients treated with pegylated liposomal doxorubicin. The HR for the total study enrollment, including those patients who were randomized to a treatment protocol but who did not receive the treatment (N = 481), was 1.23. Median survival for patients randomized to receive pegylated liposomal doxorubicin was 63.6 weeks, compared with 57.0 weeks for patients randomized to receive topotecan (95% CI, 1.01 to 1.50; P = .038).
A 30% reduction in the risk of death was seen among patients receiving pegylated liposomal doxorubicin who had platinum-sensitive disease (median survival, 107.9 weeks compared with 70.1 weeks for patients receiving topotecan; HR, 1.432; 95% CI, 1.066 to 1.923; P = .017). In patients with platinum-refractory disease, survival rates were similar between treatment groups.
Long-term follow-up of patients receiving either pegylated liposomal doxorubicin or topotecan for the treatment of recurrent or unresponsive epithelial ovarian cancer revealed that survival is significantly prolonged with the former agent compared with the latter. This benefit is strongest among patients with platinum-sensitive disease.
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