A phase III, open label, randomized multicenter controlled trial of oral versus intravenous treosulfan in heavily pretreated recurrent ovarian cancer: a study of the North-Eastern German Society of Gynecological Oncology (NOGGO)
Autor: | Radoslav Chekerov, Desislava Dimitrova, Jalid Sehouli, Mustafa Zelal Muallem, Ingo B. Runnebaum, Michael P. Lux, Hans Werner Tessen, Oliver Tome, Oumar Camara, Beate Rautenberg, Tanja Trarbach, Gerald Gitsch |
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Jazyk: | angličtina |
Rok vydání: | 2016 |
Předmět: |
Oncology
Adult Cancer Research medicine.medical_specialty Treosulfan Drug-Related Side Effects and Adverse Reactions medicine.medical_treatment Original Article – Clinical Oncology Administration Oral 030226 pharmacology & pharmacy Disease-Free Survival Drug Administration Schedule law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Ovarian cancer Internal medicine Clinical endpoint Medicine Humans Busulfan Oral versus intravenous Aged Aged 80 and over Ovarian Neoplasms Chemotherapy Hematology Leukopenia business.industry General Medicine Middle Aged medicine.disease Surgery Treatment Outcome 030220 oncology & carcinogenesis Quality of Life Administration Intravenous Female medicine.symptom Neoplasm Recurrence Local business Recurrent medicine.drug |
Zdroj: | Journal of Cancer Research and Clinical Oncology |
ISSN: | 1432-1335 0171-5216 |
Popis: | Objective In recurrent ovarian cancer (ROC), there is a high demand on effective therapies with a mild toxicity profile. Treosulfan is an alkylating agent approved as oral (p.o.) and intravenous (i.v.) formulation for the treatment of recurrent ovarian cancer. Data on safety and efficacy for either formulation are rare. For the first time we conducted a randomized phase III study comparing both formulations in women with ROC. Methods Patients having received at least two previous lines of chemotherapy were randomly assigned to one of two treatment arms: treosulfan i.v. 7000 mg/m2 d1 q4w or treosulfan p.o. 600 mg/m2 d1-28 q8w. Primary endpoint was safety regarding hematological and gastrointestinal toxicity grade III/IV, secondary endpoints were other toxicities, clinical benefit rate (CBR), time to progression (TTP), overall survival (OS) and quality of life. Results 250 patients were treated with treosulfan i.v. (128) or treosulfan p.o. (122). In general treosulfan therapy was well tolerated in both treatment arms. Leukopenia grade III/IV occurred significantly more frequently in the p.o. arm (3.9% i.v. arm, 14.8% p.o. arm, p = 0.002). Other toxicities were similar in both arms. CBR was comparable between arms (41.4% i.v. arm, 36.9% p.o. arm). No difference in TTP (3.7 months i.v. arm, 3.5 months p.o. arm) or OS (13.6 months i.v. arm, 10.4 months p.o. arm, p = 0.087) occurred. Conclusions Given the safety and efficacy results treosulfan is an acceptable option for heavily pretreated OC patients. Regarding the toxicity profile the i.v. application was better tolerated with less grade III and IV toxicities. Electronic supplementary material The online version of this article (doi:10.1007/s00432-016-2307-0) contains supplementary material, which is available to authorized users. |
Databáze: | OpenAIRE |
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