OBJECTIVE: Provide long-term follow-up data for women treated in a randomized multicenter study of pegylated liposomal doxorubicin compared with topotecan. METHODS:Patients with epithelial ovarian cancer that recurred after or failed to respond to first-line platinum-based chemotherapy were randomized to receive pegylated liposomal doxorubicin 50 mg/m(2) every 28 days (n = 239) or topotecan 1.5 mg/m(2) per day for 5 days every 21 days (n = 235). Patients were stratified prospectively based on response to initial platinum-based chemotherapy as well as the presence or absence of bulky disease. Most patients had been previously treated with platinum and taxanes (74% in the pegylated liposomal doxorubicin group and 72% in the topotecan group). Survival data are mature: 87% of patients have died (n = 413). RESULTS: There was an 18% reduction in the risk of death for patients treated with pegylated liposomal doxorubicin (median survival 62.7 weeks for pegylated liposomal doxorubicin and 59.7 weeks for topotecan-treated patients; HR = 1.216; 95% confidence interval (CI) 1.000-1.478; P = 0.050). The hazard ratio for all randomized subjects (includes those randomized, but never treated; n = 481) was 1.23 (median survival 63.6 weeks for pegylated liposomal doxorubicin and 57.0 weeks for topotecan-treated patients; 95% CI 1.01-1.50; P = 0.038). For patients with platinum-sensitive disease, there was a 30% reduction in the risk of death for the pegylated liposomal doxorubicin-treated group (median survival 107.9 weeks for pegylated liposomal doxorubicin and 70.1 weeks for topotecan-treated patients; HR = 1.432; 95% CI 1.066-1.923; P = 0.017). In patients with platinum-refractory disease, survival was similar between treatment groups. CONCLUSION: Long-term follow-up demonstrates that treatment with pegylated liposomal doxorubicin significantly prolongs survival compared with topotecan in patients with recurrent and refractory epithelial ovarian cancer. The survival benefit is pronounced in patients with platinum-sensitive disease.
RCT Entities:
OBJECTIVE: Provide long-term follow-up data for women treated in a randomized multicenter study of pegylated liposomal doxorubicin compared with topotecan. METHODS:Patients with epithelial ovarian cancer that recurred after or failed to respond to first-line platinum-based chemotherapy were randomized to receive pegylated liposomal doxorubicin 50 mg/m(2) every 28 days (n = 239) or topotecan 1.5 mg/m(2) per day for 5 days every 21 days (n = 235). Patients were stratified prospectively based on response to initial platinum-based chemotherapy as well as the presence or absence of bulky disease. Most patients had been previously treated with platinum and taxanes (74% in the pegylated liposomal doxorubicin group and 72% in the topotecan group). Survival data are mature: 87% of patients have died (n = 413). RESULTS: There was an 18% reduction in the risk of death for patients treated with pegylated liposomal doxorubicin (median survival 62.7 weeks for pegylated liposomal doxorubicin and 59.7 weeks for topotecan-treated patients; HR = 1.216; 95% confidence interval (CI) 1.000-1.478; P = 0.050). The hazard ratio for all randomized subjects (includes those randomized, but never treated; n = 481) was 1.23 (median survival 63.6 weeks for pegylated liposomal doxorubicin and 57.0 weeks for topotecan-treated patients; 95% CI 1.01-1.50; P = 0.038). For patients with platinum-sensitive disease, there was a 30% reduction in the risk of death for the pegylated liposomal doxorubicin-treated group (median survival 107.9 weeks for pegylated liposomal doxorubicin and 70.1 weeks for topotecan-treated patients; HR = 1.432; 95% CI 1.066-1.923; P = 0.017). In patients with platinum-refractory disease, survival was similar between treatment groups. CONCLUSION: Long-term follow-up demonstrates that treatment with pegylated liposomal doxorubicin significantly prolongs survival compared with topotecan in patients with recurrent and refractory epithelial ovarian cancer. The survival benefit is pronounced in patients with platinum-sensitive disease.
Authors: Evanthia Galanis; Pamela J Atherton; Matthew J Maurer; Keith L Knutson; Sean C Dowdy; William A Cliby; Paul Haluska; Harry J Long; Ann Oberg; Ileana Aderca; Matthew S Block; Jamie Bakkum-Gamez; Mark J Federspiel; Stephen J Russell; Kimberly R Kalli; Gary Keeney; Kah Whye Peng; Lynn C Hartmann Journal: Cancer Res Date: 2014-11-14 Impact factor: 12.701
Authors: Jennifer S Park; Joseph M Kinsella; Danielle D Jandial; Stephen B Howell; Michael J Sailor Journal: Small Date: 2011-06-01 Impact factor: 13.281
Authors: S John Weroha; Ann L Oberg; Katie L Allen Ziegler; Shaker R Dakhilm; Kendrith M Rowland; Lynn C Hartmann; Dennis F Moore; Gary L Keeney; Prema P Peethambaram; Paul Haluska Journal: Gynecol Oncol Date: 2011-04-22 Impact factor: 5.482
Authors: Lubomir Bodnar; Gabriel Wcislo; Anna Nasilowska; Katarzyna Szarlej-Wcislo; Agnieszka Gasowska-Bodnar; Marta Smoter; Cezary Szczylik Journal: J Cancer Res Clin Oncol Date: 2008-11-26 Impact factor: 4.553