Phase II study of coumarin and cimetidine in patients with metastatic renal cell carcinoma
| Autor: | Karen Fitz, Christopher J. Logothetis, Robert J. Amato, Avishay Sella, James M. Reuben, Francisco H. Dexeus, Nicki Dozier |
|---|---|
| Rok vydání: | 1990 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty medicine.medical_treatment Phases of clinical research Lymphocyte Activation Gastroenterology T-Lymphocytes Regulatory chemistry.chemical_compound Renal cell carcinoma Coumarins Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans In patient Hypersensitivity Delayed Cimetidine Carcinoma Renal Cell Aged Immunity Cellular business.industry Remission Induction Middle Aged medicine.disease Coumarin Confidence interval Nephrectomy Kidney Neoplasms Endocrinology Oncology chemistry Toxicity Drug Evaluation Female business medicine.drug |
| Zdroj: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 8(2) |
| ISSN: | 0732-183X |
| Popis: | Fifty patients with locally advanced or metastatic renal cell carcinoma were treated with coumarin (1,2-benzopyrone) at 100 mg orally daily starting on day 1 and cimetidine 300 mg orally four times a day starting on day 15. When disease progressed, coumarin was escalated to 100 mg orally four times a day. Three patients (6%; 95% confidence interval [Cl], 2% to 17%) achieved a partial response, one of those after dose escalation. In addition, one patient had a minor response, then progressing disease, and again had a minor response after dose escalation. All four responders had nonassessable primary tumors (three had had prior nephrectomy and one a renal angioinfarction). The only major toxicity was renal (37 patients had minor to moderate elevations in serum creatinine level). Immunologic studies (hypersensitivity skin testing, lymphocyte blastogenesis response, number of lymphocytes, T lymphocytes, T helper and T suppressor subsets, and T helper: suppressor ratio), performed before and after therapy, showed a relative lymphopenia and decreased hypersensitivity skin-testing results at baseline, and a general decline over time in the number of T cells and T helper and T suppressor subsets. There was no enhancement in any of the immunologic parameters tested. The response rate was 6%, lower than previously reported; a general immunodeficiency was noted at baseline, and the lymphopenia worsened with progressing disease, unaffected by therapy. |
| Databáze: | OpenAIRE |
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