[A phase II study of ranomustine (MCNU) tablets in patients with gastrointestinal cancer--by cooperative study group]

A phase II study of MCNU tablets in gastrointestinal cancer was carried out by the Hanshin MCNU cooperative study group involving 21 institutions. The selection of patients and evaluation of tumor response were based on the Criteria for the Evaluation of tumor Response by Chemotherapy in Solid Tumor Patients by Koyama and Saito. Of 67 patients who were entered into the study, 46 patients were evaluable, and comprised of 27 cases of gastric cancer, 13 of colorectal cancer, 2 hepatoma, and 4 patients suffering from other typas of gastrointestinal cancer. MCNU was administered orally at a dose of 50 mg/body/day for 4-6 days consecutive every 6-8 weeks. Only one partial response was obtained among the rectal cancer patients, with a response rate of 2.3% (1/43) in evaluable patients. Minor responses were obtained in 3 patients including 2 of gastric cancer with liver metastasis and 1 colon cancer with liver metastasis. Major side effects were marrow suppression and gastrointestinal symptoms. The former consisted of mainly leukopenia (15 patients, 30.0%), thrombocytopenia (20 patients, 40.0%), and oligochromaemia (10 patients, 20.0%). The latter consisted of mainly nausea and vomiting (5 patients, 10.0%).