Gan to kagaku ryoho. Cancer & chemotherapy
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Gan To Kagaku Ryoho · Aug 1992
Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial[Examination of anti-emetic effect, safety and usefulness of single oral dose of ondansetron tablet in nausea and emesis induced by anti-cancer drugs--dose-finding study of ondansetron tablet in patients receiving non-platinum anti-cancer drugs].
Inhibitory effects on acute nausea and emesis, safety and usefulness of a single oral dose of Ondansetron tablet were evaluated in 3 different dose levels for comparison by telephone registration system, in patients receiving non-platinum anti-cancer drugs. A single dose of ondansetron at 4 mg, 8 mg or 12 mg was given orally at 2 hrs before the initial administration of anti-cancer drugs. The patients were observed for 24 hours after administration of anti-cancer drugs, for occurrence of nausea and emesis. ⋯ Side effects were observed in 3 cases (headache, cold feeling and trembling in limbs, sleepiness) in 12 mg dose group, but these symptoms were not severe and disappeared after several hours or several days. No abnormality in clinical laboratory findings attributable to Ondansetron was observed. From the above, it was considered that Ondansetron was a clinically useful anti-emetic for nausea and emesis induced by non-platinum anti-cancer drugs and that 4 mg once daily was the optimal dose.
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Gan To Kagaku Ryoho · Mar 1990
Randomized Controlled Trial Clinical Trial[Prognostic factors affecting survival and response in patients with advanced non-small cell lung cancer treated with combination chemotherapy].
One-hundred and ninety-nine patients who had an inoperable stage III or IV non-small cell lung cancer (NSCLC) and collected were analyzed on the basis of factors affecting survival duration and response to chemotherapy. These patients were registered into a prospective randomized trial conducted from May of 1986 to April of 1988, and received either cisplatin and vindesine, cisplatin, vindesine and mitomycin C, or cisplatin and etoposide alternating with vindesine and mitomycin C. In the univariate analysis, sex, ECOG's performance status (PS), weight loss within previous 6 months, clinical stage, serum albumin value, serum lactate dehydrogenase level and hemoglobin (Hb) level were considered to be significant factors for survival (p less than 0.05). ⋯ When the response to chemotherapy was included in a conditional multivariable analysis, it was strongly associated with survival duration. A multivariable analysis of response using the logistic regression method demonstrated that female sex, cisplatin, vindesine and mitomycin combination regimen, squamous cell type, and no weight loss were significantly predictive of response outcome. These results are useful when comparing the response data and survival of completed studies and designing future trials in advanced NSCLC.