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).

Autor:	Sehouli J; Department of Gynecology, European Competence Center for Ovarian Cancer, Charité University Hospital of Berlin, Berlin, Germany jalid.sehouli@charite.de., Chekerov R; Department of Gynecology, European Competence Center for Ovarian Cancer, Charité University Hospital of Berlin, Berlin, Germany., Reinthaller A; Department of Gynecology and Gynecologic Oncology, Medical University of Vienna, Vienna, Austria., Richter R; Department of Gynecology, European Competence Center for Ovarian Cancer, Charité University Hospital of Berlin, Berlin, Germany., Gonzalez-Martin A; Department of Medical Oncology, MD Anderson Cancer Center Spain, Madrid, Spain., Harter P; Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen, Germany., Woopen H; Department of Gynecology, European Competence Center for Ovarian Cancer, Charité University Hospital of Berlin, Berlin, Germany., Petru E; Department of Obstetrics and Gynecology, Division of Gynecology, Medical University of Graz, Austria., Hanker LC; Department of Obstetrics and Gynaecology, Johann Wolfgang Goethe-University Frankfurt am Main., Keil E; Department of Gynecology, Park Clinic Weißensee, Berlin., Wimberger P; Department of Gynecology and Obstetrics, Carl-Gustav Carus University, Dresden., Klare P; Gynecological Practice for Gynecologic Oncology and Women's Health, Berlin., Kurzeder C; Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen, Germany., Hilpert F; Department of Gynaecology and Obstetrics, University Hospital, Campus Kiel, Kiel., Belau AK; Department of Gynaecology and Obstetrics, University Hospital Greifswald, Greifswald, Germany., Zeimet A; Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Innsbruck Medical University, Innsbruck, Austria., Bover-Barcelo I; Servicio de Oncología del Hospital Son Llazer de Palma de Mallorca, Mallorca, Spain., Canzler U; Department of Gynecology and Obstetrics, Carl-Gustav Carus University, Dresden., Mahner S; Department of Gynecology and Gynecologic Oncology, University Medical Center Hamburg-Eppendorf, Hamburg., Meier W; Department of Gynecology and Obstetrics, Evangelisches Krankenhaus, Duesseldorf, Germany.
Jazyk:	angličtina
Zdroj:	Annals of oncology : official journal of the European Society for Medical Oncology [Ann Oncol] 2016 Dec; Vol. 27 (12), pp. 2236-2241. Date of Electronic Publication: 2016 Oct 26.
DOI:	10.1093/annonc/mdw418
Abstrakt:	Background: 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 and Methods: Patients were randomly assigned in a 1:1 ratio to the experimental TC arm (topotecan 0.75 mg/m 2 / 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. Results: 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. Conclusion: 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.)
Databáze:	MEDLINE
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