title: 4'-O-tetrahydropyranyl-doxorubicin in advanced breast cancer: a phase II study.
abstract: In a phase II study, 35 patients with advanced breast cancer were treated with 4'-O-tetrahydropyranyl-doxorubicin (THP-DXR) (70 mg/m2 i.v. on day 1); treatment was repeated every 3 weeks. Eight patients had failed prior chemotherapy for advanced disease. A total of 34 patients were evaluable for response. After a median of 10 treatment courses (range, 3-15), objective tumor response was seen in 59% (20 of 34 patients) (95% confidence limits, 42%-75%). In all, 17 partial remissions and 3 complete remissions were observed; stable disease occurred in 13 patients. The median duration of response was 42+ weeks (range, 21 - 77+ weeks). The dose-limiting side effects were leukopenia (26 patients, WHO grade III-IV) and thrombocytopenia (9 patients, WHO grade II-IV). Nausea/vomiting was experienced by 34 patients; in 18, it reached WHO grade II-III. Other treatment-related side effects included alopecia (WHO grade II-III) in 26 patients and stomatitis and diarrhea (WHO grade I-III) in 9 patients. At cumulative doses of THP-DXR of at least 700 mg/m2 (range, 700-1,050 mg/m2), no signs of congestive heart failure were observed. We conclude that THP-DXR is effective for first- and second-line chemotherapy in advanced breast cancer and that side effects are manageable.
authors.affiliation: Department of Internal Medicine, Karl Franzens-University, Graz, Austria.
authors.forename: H
authors.initials: H
authors.lastname: Samonigg
authors.forename: A K
authors.initials: AK
authors.lastname: Kasparek
authors.forename: H
authors.initials: H
authors.lastname: Stöger
authors.forename: M
authors.initials: M
authors.lastname: Schmid
authors.forename: B
authors.initials: B
authors.lastname: Eber
authors.forename: G
authors.initials: G
authors.lastname: Stark
authors.forename: V
authors.initials: V
authors.lastname: Weinrauch
authors.forename: K
authors.initials: K
authors.lastname: Pfeiffer
authors.forename: M
authors.initials: M
authors.lastname: Smola
authors.forename: P
authors.initials: P
authors.lastname: Steindorfer
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004317:Doxorubicin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007958:Leukocyte Count; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D010976:Platelet Count; D016019:Survival Analysis
chemical_list: D004317:Doxorubicin; C027260:pirarubicin