Abstract |
The efficacy and safety of TAT-59 (miproxifene phospate) were compared with tamoxifen citrate (TAM) in ER-positive or ER-unknown patients with advanced or recurrent breast cancer, using the double-blind method. TAT-59 and TAM were both given 20 mg/body orally for over 12 weeks in daily doses. Eligible cases were 93 in the TAT-59 group and 102 patients in the TAM group. The response rate was shown to be 30.1% (28/93) in the TAT-59 group and 26.5% (27/102) in the TAM group. Statistical equivalence between both treatments was proven at 90% confidence interval (-8.5% < or =, < or = 12.8%). Adverse reactions observed in the patients receiving TAT-59 were hot flush, nausea and vomiting, sweating, anorexia, abnormal values in liver function tests, and anemia, showing no differences from the TAM group. Leukopenia (4.9%) and thrombopenia (2.9%) reactions were found only in the TAM group. Two patients in the TAT-59 group and three in the TAM group discontinued treatment due to adverse reactions. However, these adverse reactions were reversible in both groups. In conclusion, TAT-59 was showed comparable efficacy and safety with TAM in ER-positive or ER-unknown patients with advanced or recurrent breast cancer.
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Authors | Y Nomura, M Nakajima, T Tominaga, O Abe |
Journal | Gan to kagaku ryoho. Cancer & chemotherapy
(Gan To Kagaku Ryoho)
Vol. 25
Issue 7
Pg. 1045-63
(Jun 1998)
ISSN: 0385-0684 [Print] Japan |
PMID | 9644320
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Comparative Study, Controlled Clinical Trial, English Abstract, Journal Article, Multicenter Study)
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Chemical References |
- Antineoplastic Agents
- Antineoplastic Agents, Hormonal
- Estrogen Antagonists
- Receptors, Estrogen
- Tamoxifen
- TAT 59
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Topics |
- Administration, Oral
- Antineoplastic Agents
(therapeutic use)
- Antineoplastic Agents, Hormonal
(therapeutic use)
- Breast Neoplasms
(drug therapy)
- Double-Blind Method
- Estrogen Antagonists
(therapeutic use)
- Female
- Humans
- Neoplasm Recurrence, Local
(drug therapy)
- Receptors, Estrogen
(analysis)
- Tamoxifen
(analogs & derivatives, therapeutic use)
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