Background. The preoperative intratumoral injection with OK‐432 (Picibanil, Chugai Pharmaceutical Co., Tokyo, Japan), an immunomodulatory agent prepared from an attenuated strain of streptococcus pyogenes, activates the regional immune system and causes degeneration of cancer tissue in carcinoma of the stomach.
Methods. A multi‐institutional randomized trial of OK‐432 to determine its clinical usefulness was conducted. Three hundred and ninety‐five patients with gastric cancer were assigned randomly either to receive or not to receive a preoperative intratumoral injection of OK‐432. Among them, 277 patients with advanced cancer were treated by common postoperative chemoimmunotherapy consisting of mitomycin C, tegafur, and OK‐432. All patients were followed for at least 5 years.
Results. The adverse effects of OK‐432 injected intratumorally predominantly were mild fever, anorexia, and abdominal pain, however, no treatment was required for these symptoms. Overall, there were no differences in outcome between the OK‐432 and control groups. However, analysis based on stage showed that a preoperative intratumoral injection of OK‐432 significantly improved the 5‐year survival rate of patients with Stage III cancer (P = 0.0229), at 47.7% for the OK‐432 group and 27.5% for the control group. In subset analysis, when the 5‐year survival of patients with and without tumor infiltrating lymphocytes (TIL) was compared, OK‐432 injected intratumorally had a significant positive effect on the group showing a moderate to marked number of TIL (P = 0.0438).
Conclusion. These results showed that the intratumoral injection of OK‐432 may improve survival of patients with Stage III gastric cancer.
Recent studies indicate the existence in natural waters of 'hidden' arsenic which had previously been undetected by the hydride generation technique. A speciation method for arsenic species has been developed in which hidden arsenic was classified into two fractions by their lability to the photochemical degradation procedure: the ultraviolet-labile fraction and the ultravioletresistant fraction. The ultraviolet-labile fraction was the major fraction of hidden arsenic and comprised 15-45% and 4-26% of the total arsenic in Uranouchi Inlet and Lake Biwa (Japan), respectively. The highest concentration of the ultraviolet-resistant fraction was observed in Uranouchi Inlet during the summer, in which dimethylarsinic acid increased in the water column. We discuss the hidden arsenic fraction as the key to explaining arsenic speciation in natural waters.
A 53‐year‐old woman was treated with 5 courses of CAP treatment following operation for FIGO Stage Ia cancer of the ovary in September 1986. And in April 1987, she started an oral adjuvant chemotherapy with 400 mg/day of carmofur. In early June, she developed vertigo and dysarthia and was hospitalized. A CT scan showed low‐density areas adjacent to both lateral ventricles, and an EEG revealed abnormally slow waves. She improved gradually after carmofur was discontinued and left the hospital in October 1987.
There have been 24 reported cases of leukoencephalopathy because of carmofur in Japan, but the pathophysiological mechanism involved is not known. Since it is more common in women than in men, its incidence will probably increase in gynecological patients. Therefore, we must be on the lookout for central nervous system signs and symptoms in patients receiving adjuvant chemotherapy with carmofur.
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