Treosulfan in the Treatment of Advanced Ovarian Cancer - Results of a German Multicenter Non-interventional Study.

Abstract

BACKGROUND:

Data on routine systemic treatment of patients with ovarian cancer are currently available only to a limited degree. The alkylating agent treosulfan is approved in oral (p.o.) and intravenous (i.v.) form for the treatment of ovarian carcinoma. The present non-interventional study analyzed the clinical use of treosulfan in Germany, evaluating the mode of application, toxicity, and response and survival rate.

PATIENTS AND METHODS:

Two hundred and forty-eight ovarian cancer patients in 57 Centers, who received treosulfan mainly either i.v. (5,000-8,000 mg/m(2) d1, q21d or q28d) or p.o. (400-600 mg/m(2) d1-14 or 21, q28d) for at least one therapy cycle were evaluable and were included in the study.

RESULTS:

With a median age of 70 years (range=36-92 years), predominantly elderly patients received treosulfan treatment. Most participants presented serous histology (131, 52.8%) and advanced-stage FIGO III (122, 49%) or IV (55, 22%) disease. Median ECOG status was 1 (range=0-2), whereas cardiac co-morbidity was common (31%). Treosulfan was usually administered as second- (26%), third- (21%) or fourth-line (17%) therapy. Two hundred and one patients received i.v. and 47 p.o.

TREATMENT:

The most common reason for dose modifications was due to hematological toxicity (46%). The main reason for a therapy discontinuation was progressive disease (38.5%). Response was observed in 25.8% of participants, disease stabilization in 28.6 % and progress in 45.6%. The median progression-free and overall survival was 196 and 405 days, respectively.

CONCLUSION:

In predominantly elderly and heavily pre-treated patients with recurrent ovarian cancer, treosulfan featured a clinical relevant efficacy and well-manageable, mostly hematological, toxicity, which resulted in a positive therapeutic index.

• Authors: Radoslav Chekerov, Gabriele Kaltenecker, Dietmar Reichert, Thomas Göhler, Peter Klare, Gülten Oskay-Özcelik, Uwe Sauer, Arthur Wischnik, Ursula Vehling-Kaiser, Martin Becker, Ulrich Hutzschenreuter, Andreas Ammon, Elke Heidrich-Lorsbach, Jalid Sehouli
• Journal: Anticancer research (Anticancer Res) Vol. 35 Issue 12 Pg. 6869-75 (Dec 2015) ISSN: 1791-7530 [Electronic] Greece
• PMID: 26637909 (Publication Type: Journal Article, Multicenter Study, Observational Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright© 2015 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

Chemical References

• Antineoplastic Agents, Alkylating
• treosulfan
• Busulfan

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Agents, Alkylating (therapeutic use)
• Busulfan (adverse effects, analogs & derivatives, therapeutic use)
• Disease-Free Survival
• Female
• Humans
• Middle Aged
• Ovarian Neoplasms (drug therapy, mortality)