A prospective multicenter (phase IIIb) trialstudy of Treosulfan in elderly patients with recurrent ovarian cancer: results of a planned safety analysis

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

This open-label multicenter phase-IIIb trial was conducted at 47 German institutions; the first 25 patients analyzed in this safety analysis were recruited in 10 centers.

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.


Table 1 - 6 

• Patient characteristics
• Concomitant diseases
• Treatment delivery
• Reasons for early therapy discontinuation [less than 12 cycles (i.v.) or 12 months of therapy 
• Non-hematological toxicities: highest grade per patient (in alphabetic order)
• Hematological toxicities: highest grade per patient

"Altogether 16 serious adverse events (SAE) were documented for nine patients. The predominant reason for SAE-reporting was hospitalization (14 reports). Death was the matter for the remaining 2 SAEs. An additional patient was hospitalized due to progressive disease and died in hospital. In all 3 cases, death was concerned as not related to study medication and progress of the underlying malignant tumor was stated as cause of death."

"In summary, the observed toxicities were in the same range as reported in previous studies with significantly younger patients and less comorbidity or with old women having received fewer previous lines of chemotherapy.

There were no unexpected hematological or non-hematological toxicities. Based on this safety analysis, treosulfan proved to be a safe and tolerable therapeutic option in elderly, heavily pretreated patients and the next step of study recruitment was initiated. Of note, the majority of patients in the interim safety population chose i.v. treosulfan over the oral application. Detailed analysis after completion of the trial will hopefully yield new insight into therapy preference and compliance of elderly patients with recurrent ovarian cancer."

Conflict of interest  The trial was supported by Medac GmbH.