[Randomized controlled trial of induced hypertension chemotherapy (IHC) using angiotensin II human (TY-10721) in advanced gastric carcinoma (TY-10721 IHC Study Group Report)].

A randomized controlled trial was carried out to elucidate the enhancement of chemotherapeutic effect of induced hypertension chemotherapy (IHC) using newly synthesized angiotensin II human (TY-10721) in advanced gastric carcinoma under multi-institutional cooperation. In IHC, the drugs were administered under the hypertensive state induced and maintained by the continuous infusion of TY-10721. The regimen for the trial was as follows: adriamycin (33 mg/m2, day 3), 5-fluorouracil (330 mg/m2/day through day 1 to 3, 8 to 10) and mitomycin C (5 mg/m2, day 8). It was repeated every 4 weeks. Of 67 registered cases, 62 eligible patients were randomized to either IHC arm or control arm (non-IHC) in which the drugs were administered by an ordinary i.v. injection. According to the Criteria of Japanese Society for Cancer Treatment, the response rate of IHC group was 31.3% and that of non-IHC was 6.7% with statistically significant difference (p less than 0.05; chi 2c). There were 4 CR and 6 PR in 32 eligible cases of IHC and 2 PR in 30 of non-IHC. Clinical characteristics of patients and toxicities were not different in both groups. Clinical advantage of IHC was confirmed by increase of the response rate in this trial.