TY - JOUR
T1 - A phase 2 study of oxaliplatin combined with continuous infusion topotecan for patients with previously treated ovarian cancer
AU - Stein, Stacey M.
AU - Tiersten, Amy
AU - Hochster, Howard S.
AU - Blank, Stephanie V.
AU - Pothuri, Bhavana
AU - Curtin, John
AU - Shapira, Ilan
AU - Levinson, Benjamin
AU - Ivy, Percy
AU - Joseph, Benson
AU - Guddati, Achuta Kumar
AU - Muggia, Franco
PY - 2013
Y1 - 2013
N2 - Background: Phase 2 trials suggest that prolonged intravenous (IV) infusion of the topoisomerase 1 inhibitor topotecan may be less toxic than when given by standard IV bolus 5-day administration. Oxaliplatin exhibits efficacy in platinum-pretreated disease and shows preclinical synergy with topoisomerase 1 inhibitors.We sought to determine the efficacy and safety of oxaliplatin plus infusion topotecan in recurrent platinum-pretreated ovarian cancer. Methods: Patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancers previously treated with 1 to 2 prior regimens including platinum and taxane received oxaliplatin (85 mg/m2 day 1 and day 15) and topotecan (0.4 mg/m2 per day) by continuous IV infusion over 14 days every 4 weeks. The primary objective of the trialwas to estimate the objective response rate in platinum-resistant disease (stratum 1) and in platinum-sensitive disease (stratum 2). Toxicities were assessed in all patients. Results: Thirty-eight patients received 144 cycles of therapy (median, 4; range, 1-6). The most common grade 3 and grade 4 toxicities included thrombocytopenia (grade 3, 37%; and grade 4, 19%), neutropenia (grade 3, 37%; grade 4, 11%), and anemia (grade 3, 15%). Response occurred in 4 of 19 patients in stratum I (21%; 95% confidence intervals, 6%-46%) and 9 of 19 patients in stratum 2 (47%; 95% CI, 24%-71%). Three in each stratum had lengthy complete responses. Conclusions: Biweekly oxaliplatin plus a 14-day continuous IV infusion of topotecan, given monthly, is an active regimen in platinum-pretreated ovarian cancer and merits additional evaluation.
AB - Background: Phase 2 trials suggest that prolonged intravenous (IV) infusion of the topoisomerase 1 inhibitor topotecan may be less toxic than when given by standard IV bolus 5-day administration. Oxaliplatin exhibits efficacy in platinum-pretreated disease and shows preclinical synergy with topoisomerase 1 inhibitors.We sought to determine the efficacy and safety of oxaliplatin plus infusion topotecan in recurrent platinum-pretreated ovarian cancer. Methods: Patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancers previously treated with 1 to 2 prior regimens including platinum and taxane received oxaliplatin (85 mg/m2 day 1 and day 15) and topotecan (0.4 mg/m2 per day) by continuous IV infusion over 14 days every 4 weeks. The primary objective of the trialwas to estimate the objective response rate in platinum-resistant disease (stratum 1) and in platinum-sensitive disease (stratum 2). Toxicities were assessed in all patients. Results: Thirty-eight patients received 144 cycles of therapy (median, 4; range, 1-6). The most common grade 3 and grade 4 toxicities included thrombocytopenia (grade 3, 37%; and grade 4, 19%), neutropenia (grade 3, 37%; grade 4, 11%), and anemia (grade 3, 15%). Response occurred in 4 of 19 patients in stratum I (21%; 95% confidence intervals, 6%-46%) and 9 of 19 patients in stratum 2 (47%; 95% CI, 24%-71%). Three in each stratum had lengthy complete responses. Conclusions: Biweekly oxaliplatin plus a 14-day continuous IV infusion of topotecan, given monthly, is an active regimen in platinum-pretreated ovarian cancer and merits additional evaluation.
KW - Continuous infusion
KW - Ovarian cancer
KW - Oxalipatin
KW - Phase 2
KW - Topotecan
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UR - http://www.scopus.com/inward/citedby.url?scp=84888309055&partnerID=8YFLogxK
U2 - 10.1097/IGC.0b013e3182a809e0
DO - 10.1097/IGC.0b013e3182a809e0
M3 - Article
C2 - 24172094
AN - SCOPUS:84888309055
SN - 1048-891X
VL - 23
SP - 1577
EP - 1582
JO - International Journal of Gynecological Cancer
JF - International Journal of Gynecological Cancer
IS - 9
ER -