abstract
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.
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