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Phase II study of 5-azacytidine in solid tumors
Cancer Treatment Reports
|January 1, 1977
Summary
This study evaluated 5-azacytidine in 177 patients. While showing some antitumor effects in breast cancer and lymphomas, its efficacy as a single agent in solid tumors is limited due to rapid resistance.
Area of Science:
- Oncology
- Pharmacology
Background:
- 5-azacytidine is an antineoplastic agent.
- Evaluating different administration methods for 5-azacytidine is crucial for optimizing patient outcomes.
Purpose of the Study:
- To assess the efficacy and toxicity of 5-azacytidine in patients with various cancers.
- To compare the outcomes of rapid intravenous infusion versus prolonged infusion of 5-azacytidine.
Main Methods:
- 177 patients received 5-azacytidine (1.6 mg/kg/day for 10 days) followed by maintenance.
- Patients were divided into rapid IV infusion (148) and prolonged infusion (29) groups.
- Evaluated hematologic toxicity, nausea, and antitumor response.
Main Results:
- Significant but transient hematologic toxicity observed in both groups.
- Severe nausea with rapid infusion; minimal nausea with prolonged infusion.
- Antitumor response rates: 17% in breast carcinoma, 21% in malignant lymphomas; occasional responses in other solid tumors.
Conclusions:
- 5-azacytidine demonstrated transient antitumor effects, with rapid development of clinical resistance.
- No significant difference in response rates or duration between administration methods.
- 5-azacytidine has minimal value as a single agent in solid tumors with the described administration methods.