Phase II study of TY-10721 ((Asp1-Ile5) angiotensin II) in advanced cancer patients for induced hypertension chemotherapy.

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Using TY-10721, induced-hypertension chemotherapy (IHC) was performed in 12 patients with various types of advanced cancer. The procedure of IHC, as already reported, consisted of the induction of hypertension within 150 mmHg of the mean blood pressure (MBP), and of the maintenance at the MBP level after drug administration along with the continuous infusion of angiotensin II. Totally, 100 procedures were recorded. After 2.5-4 min of start of the infusion of TY, the level of the MBP could reach 135.7 ± 10.0 mmHg and 139.3±10.0 mm Hg by using 2.5 and 5 μg/ml of TY, respectively. Administrated dose of TY was 29.8±9.7 (range: 11.7-72.1) ng/kg/min in the induction periods and 31. 8±12.1 (9.4-106.9) ng/kg/min in the maintenance periods. These coefficient variations (CV) were 32.6% and 38.1%, respectively. Conclusively, it is necessary for the control the adequate hypertensive state during IHC to adjust dose of angiotensin II according to the MBP level, not to administer a certain dose. Though there observed some slight accompanying symptoms such as dull pain and hotness at tumor region and chest oppressive sense, these did, not interrupt the treatment procedure. Randomized controlled study would have a role in the investigation of clinical merit of IHC for the selective enhancement of drug delivery to tumor tissue, based on the characterization of tumor microcirculation.
一般社団法人日本臨床薬理学会の論文