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A double‐blind trial of tamoxifen plus prednisolone versus tamoxifen plus placebo in postmenopausal women with metastatic breast cancer. A collaborative trial of the north central cancer treatment group and mayo clinic
Author(s) -
Ingle James N.,
Long Harry J.,
Loprinzi Charles L.,
Mailliard James A.,
Schaid Daniel J.,
Krook James E.,
Dalton Robert J.,
Gesme Dean H.,
Windschitl Harry E.,
Pfeifle Delano M.,
Etzell Paul S.,
Gerstner James G.,
Foley John F.
Publication year - 1991
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(19910701)68:1<34::aid-cncr2820680107>3.0.co;2-q
Subject(s) - medicine , tamoxifen , breast cancer , metastatic breast cancer , placebo , cancer , oncology , gynecology , alternative medicine , pathology
This trial was conducted to determine if the reported superiority of tamoxifen (TAM) plus prednisolone (PRDLN) over TAM alone in postmenopausal women with metastatic breast cancer could be corroborated. A total of 326 patients were randomized on a double‐blind trial to TAM (10 mg twice daily) plus placebo or TAM plus PRDLN (5 mg twice daily). Six patients (2%) were disqualified. Considering 256 patients with measurable or evaluable disease, objective responses were seen in 48 (38%) of 126 TAM patients and 61 (47%) of 130 TAM plus PRDLN patients (chi‐square, P = 0.15). Considering all 320 evaluated patients, median time to disease progression was 11 months for TAM and 10 months for TAM plus PRDLN (log rank, P = 0.81), and median survival time was 35 and 32 months, respectively ( P = 0.40). Covariate analyses showed no significant association between treatment and outcome. Weight gain and edema were significantly greater with TAM plus PRDLN. The addition of PRDLN to TAM is not advocated for the management of postmenopausal women with metastatic breast cancer.