Abstract |
A multi-institutional late-phase II clinical trial of CGS 16949A was conducted at the dose of 1 mg twice daily in postmenopausal patients with advanced or recurrent breast cancer. Seventy patients entered into the study; 65 were eligible and 53 were complete cases. There were 3 CR, 11 PR, 10 long-NC, 14 NC and 25 PD with an overall response rate of 22.2% in 63 evaluable cases. The median period of overall duration of responses was 327.5 days. There were 22 cases that drug was found useful or better, and global usefulness rate was 33.8%. Forty six (76.7%) of patients experienced no side effects in this therapy. Grade 2 toxicities included anorexia (1 pt.), feeling of distension of abdomen (1 pt.), vomiting (1 pt.), fatigue (1 pt.), and only one patient experienced Grade 3 toxicity ( anorexia). Grade 2 laboratory abnormalities were confirmed in two patients; one with elevated gamma- GTP and another with elevated LDH, and both were in the absence of liver metastasis. From these results, it is concluded that CGS16949A seemed to be a useful hormonal agent in the treatment of postmenopausal breast cancer.
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Authors | H Aoyama, K Asaishi, R Abe, T Kajiwara, K Enomoto, M Yoshida, Y Ohasi, T Tominaga, O Abe |
Journal | Gan to kagaku ryoho. Cancer & chemotherapy
(Gan To Kagaku Ryoho)
Vol. 21
Issue 4
Pg. 477-84
(Mar 1994)
ISSN: 0385-0684 [Print] Japan |
PMID | 8129388
(Publication Type: Clinical Trial, Clinical Trial, Phase II, English Abstract, Journal Article, Multicenter Study)
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Chemical References |
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Topics |
- Administration, Oral
- Adult
- Aged
- Anorexia
(chemically induced)
- Breast Neoplasms
(drug therapy, pathology)
- Drug Administration Schedule
- Fadrozole
(administration & dosage, adverse effects)
- Female
- Humans
- Middle Aged
- Nausea
(chemically induced)
- Neoplasm Recurrence, Local
(drug therapy)
- Postmenopause
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