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First-line fadrozole HCI (CGS 16949A) versus tamoxifen in postmenopausal women with advanced breast cancer: Prospective randomised trial of the Swiss Group for Clinical Cancer Research SAKK 20/88 |
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| Authors: | Thurlimann B; Beretta K; Bacchi M; Castiglione-Gertsch M; Goldhirsch A; Jungi W F; Cavalli F; Senn H-J; Fey M; Lohnert T; Swiss Group for Clinical Cancer Research |
| Institution: | 1Department of Intenal Medicine C, Division Oncology-Hematology Kantonsspital, St. Gallen 2Servizio Oncologico Cantonale Ospedale Sun Giovanni, Bellinzona 3SAKK Coordination Center Inselspital, Bern, Switzerland 4Department of Medical Oncology Inselspital, Bern, Switzerland |
| Abstract: | BACKGROUND:: In a phase III randomized trial, we compared the effectivenessand tolerability of fadrozole (CGS 16949A), a non-steroidalaromatase inhibitor, to tamoxifen as first-line endocrine therapyin postmenopausal women with advanced breast cancer. PATIENTS AND METHODS:: Two hundred twelve eligible patients were randomized to receivetamoxifen 20 mg daily, or fadrozole 1 mg twice daily orallyuntil disease progression or the advent of undue toxicity. Thetreatments were to be discontinued upon disease progression. RESULTS:: Prognostic factors were well balanced between the treatmentgroups, except for sites of metastatic disease. Fadrozole-treatedpatients had significantly more visceral, especially liver,involvement and less bone-dominant disease. Response rates forfadrozole and tamoxifen were similar, 20% and 27% (95% ConfidenceLimits (CL): 13%–29% and 21%–35%), respectively.Time to treatment failure was longer in patients randomizedto tamoxifen (8.5 months for tamoxifen vs. 6.1 months for fadrozole),but did not reach statistical significance after adjustmentfor prognostic factors (P=0.09). Fadrozole, for which a significantlylower percentage of clinically relevant toxic effects (WHO toxicitygrade |
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