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SHR Neuro Cancer Cardio Lipid Metab Microb

Sehouli, J; Chekerov, R; Reinthaller, A; Richter, R; Gonzalez-Martin, A; Harter, P; Woopen, H; Petru, E; Hanker, LC; Keil, E; Wimberger, P; Klare, P; Kurzeder, C; Hilpert, F; Belau, AK; Zeimet, A; Bover-Barcelo, I; Canzler, U; Mahner, S; Meier, W.
Topotecan plus carboplatin versus standard therapy with paclitaxel plus carboplatin (PC) or gemcitabine plus carboplatin (GC) or pegylated liposomal doxorubicin plus carboplatin (PLDC): a randomized phase III trial of the NOGGO-AGO-Study Group-AGO Austria and GEICO-ENGOT-GCIG intergroup study (HECTOR).
Ann Oncol. 2016; 27(12):2236-2241 Doi: 10.1093/annonc/mdw418 [OPEN ACCESS]
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Co-authors Med Uni Graz: Petru Edgar
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Abstract:: Randomized, phase III trial to evaluate safety and efficacy of topotecan and carboplatin (TC) compared with standard platinum-based combinations in platinum-sensitive recurrent ovarian cancer (ROC). Patients were randomly assigned in a 1:1 ratio to the experimental TC arm (topotecan 0.75 mg/m²/ days 1-3 and carboplatin AUC 5 on day 3 every 3 weeks) or to one of the standard regimes [(PC) paclitaxel plus carboplatin; (GC) gemcitabine plus carboplatin; (PLDC) pegylated liposomal doxorubicin and carboplatin] which could be chosen by individual preference but before randomization. The primary end point was progression-free survival (PFS) after 12 months. Overall survival (OS), response rate, toxicity, quality of life and treatment preference regarding standard treatment were defined as secondary end points. A total of 550 patients were recruited. The PFS rate after 12 months was 37.0% for TC compared with 40.2% in the standard combinations (P = 0.470). The overall response rate was 73.1% for TC versus 75.1% for standard combinations (P = 0.149). After a median follow-up of 20 months, the median PFS was 10 months [95% confidence interval (CI) 9.4-10.6] and did not differ between both arms (P = 0.414). The median OS was 25 months in the TC arm versus 31 months in the standard arm (95% CI: 22.4-27.6 resp. 26.0-36.0; P = 0.163). Severe hematologic toxicities (grade 3/4) were rare in the experimental arm (P < 0.001), with 17.4% leucopenia, 27.8% neutropenia and 15.9% thrombopenia. The combination of carboplatin and topotecan was well tolerated with significant lower rates of severe hematological toxicities but did not improve PFS or OS in platinum-sensitive relapsed ovarian cancer compared with established standard regimens. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.
Find related publications in this database (using NLM MeSH Indexing): Adult -; Aged -; Aged, 80 and over -; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Austria -; Carboplatin - administration & dosage; Carboplatin - adverse effects; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Disease-Free Survival -; Doxorubicin - administration & dosage; Doxorubicin - adverse effects; Doxorubicin - analogs & derivatives; Female -; Humans -; Middle Aged -; Neoplasm Recurrence, Local - drug therapy; Neoplasm Recurrence, Local - pathology; Ovarian Neoplasms - drug therapy; Ovarian Neoplasms - pathology; Paclitaxel - administration & dosage; Paclitaxel - adverse effects; Polyethylene Glycols - administration & dosage; Polyethylene Glycols - adverse effects; Quality of Life -; Topotecan - administration & dosage; Topotecan - adverse effects
Find related publications in this database (Keywords): ovarian cancer; platinum-sensitive; topotecan