A prospective multicenter study of treosulfan in elderly patients with recurrent ovarian cancer: results of a planned safety analysis.

Abstract

BACKGROUND:

Treosulfan, an alkylating agent, has demonstrated activity in recurrent ovarian carcinoma. It is equieffective as oral (p.o.) and intravenous (i.v.) formulation. To explore the preference and compliance of elderly patients regarding p.o. or i.v. treosulfan for the treatment of relapsed ovarian carcinoma, women aged 65 years or older were included in this prospective multicenter study. Since elderly patients usually have several concomitant diseases and experience more treatment toxicity, an interim safety analysis was planned and performed after 25 patients finished therapy to assess the tolerability of the treatment regimens.

METHODS:

Patients had a free choice of treosulfan i.v. (7,000 mg/m(2) day 1 of a 28-day cycle) or p.o. (600 mg/m(2) day 1-28 of a 56-day cycle) for a maximum of 12 cycles (i.v.) or 12 months (p.o.). Indecisive patients were randomized. Toxicity was evaluated according to the NCI-CTC version 2.0.

RESULTS:

Twenty-five of 51 recruited patients completed therapy at the time of the planned interim analysis (median age, 75 years; range, 70-82). Median ECOG was 1, and median number of prior chemotherapy regimens was 2. A median number of 4 cycles (range, 1-12) were administered per patient. Anemia was the most common hematological toxicity (88 % of patients). Most frequent non-hematological toxicities were nausea (76 %), constipation (68 %), and fatigue (64 %).

CONCLUSION:

Treatment was generally well tolerated despite the fact that most patients suffered from multiple comorbidities and were heavily pretreated. There were no unexpected hematological or non-hematological toxicities. Based on this safety analysis, the next step of study recruitment was continued.

• Authors: Sven Mahner, Gülten Oskay-Özcelik, Elke Heidrich-Lorsbach, Stefan Fuxius, Harald Sommer, Peter Klare, Antje Belau, Birgit Ruhmland, Thomas Heuser, Heinz Kölbl, Susanne Markmann, Jalid Sehouli
• Journal: Journal of cancer research and clinical oncology (J Cancer Res Clin Oncol) Vol. 138 Issue 8 Pg. 1413-9 (Aug 2012) ISSN: 1432-1335 [Electronic] Germany
• PMID: 22526159 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents, Alkylating
• treosulfan
• Busulfan

Topics

• Aged
• Aged, 80 and over
• Alopecia (chemically induced)
• Anemia (chemically induced)
• Antineoplastic Agents, Alkylating (adverse effects, therapeutic use)
• Busulfan (adverse effects, analogs & derivatives, therapeutic use)
• Constipation (chemically induced)
• Drug Administration Schedule
• Fatigue (chemically induced)
• Female
• Humans
• Leukopenia (chemically induced)
• Neoplasm Recurrence, Local
• Neoplasm Staging
• Ovarian Neoplasms (drug therapy, pathology)
• Prospective Studies
• Quality of Life
• Recurrence
• Surveys and Questionnaires
• Treatment Outcome