A phase II clinical study of
254-S, a new anticancer
platinum complex for
gastrointestinal cancers, was conducted by the
254-S Gastrointestinal Cancer Study Group consisting of 16 institutions.
254-S was administered at 100 mg/m2 by
intravenous drip infusion. This administration was repeated at 4-week intervals. The cases in which
254-S could be administered at least two times were regarded as complete cases evaluable for
tumor response; of 75 cases registered, 53 were complete cases (29 cases with
esophageal cancer, 12 with
stomach cancer and 12 with
colon cancer). As a result, 15 partial responses (PR) were obtained in the 29 patients with
esophageal cancer and 1 PR from the 12 patients with
stomach cancer, for a 51.7% and 8.3% response rate, respectively. 5 PR (55.6%) were obtained in 9
esophageal cancer patients with prior
chemotherapy, including 2 PR in 4 patients previously treated with
cisplatin. Major toxic effects observed were hematotoxicity including
thrombocytopenia (59.0%),
leukopenia (68.9%) and
anemia (57.4%) and gastrointestinal toxicity such as
nausea and
vomiting (63.9%) and
anorexia (41.0%); since grade 3 or 4
thrombocytopenia was observed with an incidence of 27.9%, careful monitoring seems to be required during the treatment with this product. Abnormal parameter changes on renal function included elevations of BUN (18.0%) and serum
creatinine (9.8%). Based on these results, it was concluded that
254-S is a useful
anticancer agent for the treatment of
esophageal cancer.