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Stöger, H; Bauernhofer, T; Schmid, M; Ploner, F; Moser, R; Derstvenscheg, E; Steindorfer, P; Wilders-Truschnig, M; Kuss, I; Samonigg, H.
A phase I/II study of 4'-O-tetrahydropyranyl-doxorubicin, 5-fluorouracil, and high-dose leucovorin as first-line therapy in advanced breast cancer patients.
Cancer Chemother Pharmacol. 1994; 35(2):174-178 Doi: 10.1007/BF00686643
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Leading authors Med Uni Graz
Stöger Herbert
Co-authors Med Uni Graz
Bauernhofer Thomas
Ploner Ferdinand
Samonigg Hellmut
Schaberl-Moser Renate
Truschnig-Wilders Martini
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Abstract:
A total of 50 patients were treated weekly with 5-fluorouracil (FU), leucovorin (LV), and 4'-O-tetrahydropyranyl-doxorubicin (THP) as first-line chemotherapy for advanced breast cancer (ABC). In phase I the doses of LV (500 mg/m2, day 1) and FU (350 mg/m2, day 1) were held constant, while the dose of THP (day 1) was escalated, from the initial dose of 10 mg/m2 up to the maximum tolerated dose (MTD). Twenty-eight patients entered phase I, and MTD for THP was defined as 35 mg/m2 in this combination. Dose-limiting toxicities were myelosuppression and hepatotoxicity. In phase II, another 22 patients were treated with THP at a dose level of 30 mg/m2. Including 4 patients already treated at this dose in the first part, 25 patients were evaluable for response: 1 patient obtained a complete response (CR) and 13 showed a partial response (PR), giving an objective response rate of 56%. The median duration of response was 9.1+ months and median survival, 15.5+ months. Side effects were generally mild, with ECOG grade I and II leukopenia in 51% of all cycles and grade III in 3% of the courses. Other toxicity included nausea and vomiting (54% and 8%, respectively) and alopecia (24%), all restricted to ECOG grade I and II. Our results suggest that weekly THP/LV-FU represents an active regimen for first-line treatment of ABC with relative low toxicity.
Find related publications in this database (using NLM MeSH Indexing)
Adult -
Aged -
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Breast Neoplasms - drug therapy
Diarrhea - chemically induced
Doxorubicin - adverse effects
Doxorubicin - analogs & derivatives
Doxorubicin - therapeutic use
Drug Administration Schedule -
Female -
Fluorouracil - adverse effects
Fluorouracil - therapeutic use
Humans -
Leucovorin - adverse effects
Leucovorin - therapeutic use
Leukopenia - chemically induced
Middle Aged -
Nausea - chemically induced

Find related publications in this database (Keywords)
BREAST CANCER
4'-O-TETRAHYDROPYRANYL-DOXORUBICIN
FLUOROURACIL/LEUCOVORIN
WEEKLY SCHEDULE
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