Gan to kagaku ryoho. Cancer & chemotherapy
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Gan To Kagaku Ryoho · Apr 1997
Randomized Controlled Trial Comparative Study Clinical Trial[A randomized cross-over comparative study of granisetron alone and combination of granisetron, methylprednisolone and droperidol as antiemetic prophilaxis in CDDP-based chemotherapy for gynecologic cancer].
A cross-over clinical trial was carried out to compare the efficacy and safety of granisetron alone (40 micrograms/kg) as a "single" group, with that of granisetron, methylprednisolone (250 mg/ body) and droperidol (0.5 ml/body) as a "cocktail" group for control of emesis and vomiting induced by CDDP-based chemotherapy in 68 courses of 34 patients with gynecologic malignancies. At the first course, "single" or "cocktail" drugs were administered at day 1, 2, and 3 of chemotherapy, and at the second course, "cocktail" or "single" drugs in as cross-over fashion. We examined the degree of nausea and frequency of vomiting during the first 7 days of chemotherapy. ⋯ Clinical response (extremely good, good) in the current series of 68 courses of chemotherapy was also evaluated to be 45% and 35% in the "single" group, respectively, against 75% and 20% in the "cocktail" group, respectively. There was no clinical toxicity or side effects in either treatment group. We conclude that the cocktail treatment is very useful for not only acute, but also late emesis in CDDP-based chemotherapy in gynecologic malignancies.
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Gan To Kagaku Ryoho · Sep 1995
Randomized Controlled Trial Comparative Study Clinical Trial[Comparison of granisetron alone and granisetron plus dexamethasone or hydroxyzine hydrochloride for the prevention of nausea and vomiting during chemotherapy including cisplatin].
The comparative study among granisetron alone and granisetron combined with hydroxyzine hydrochloride or dexamethasone was undertaken for the prevention of nausea and vomiting during chemotherapy including cisplatin in patients with advanced head and neck carcinomas. The results indicated that the combination antiemetic therapies were more effective than granisetron alone for acute nausea and vomiting, whereas a significant difference was not observed among these three groups in the acute adverse effects. Otherwhile, there were statistically significant improvements in the prevention of delayed nausea and vomiting for patients receiving granisetron combined with the other antiemetic drugs, especially the combination antiemetic therapy with dexamethasone. These results confirm the antiemetic activity of granisetron in acute nausea and vomiting induced by cisplatin and show that it has an additive effect in combination with dexamethasone.
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Gan To Kagaku Ryoho · Aug 1995
Randomized Controlled Trial Multicenter Study Clinical TrialInduction chemotherapy and irradiation in advanced carcinoma of the cervix.
The survival rate of patients with locally advanced cervical cancer has not changed during the past several years. The purpose of the study is to evaluate the efficacy of concomitant Mitomycin and 5-FU with irradiation. Six hundred seventy-three patients were randomized into four arms. ⋯ The disease-free survival data from life table analysis suggested a better disease-free survival in arms 3 and 4 (concomitant arms) and arm 2 (maintenance oral 5-FU arm) than in control (RT alone arm). The pattern of failure showed a greater difference in loco-regional recurrence in stage IIB than IIIB patients. This interim analysis shows a trend favoring the arm with concomitant chemotherapy.
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Gan To Kagaku Ryoho · Feb 1995
Randomized Controlled Trial Clinical Trial[5-FU concentrations in the blood and tumor tissue after 5'-DFUR or UFT administration in the patients with uterine cervical cancer].
In order to verify the antitumor activity of fluorinated pyrimidine drugs, we conducted an investigation of the clinical pharmacology with two drugs, 5'-DFUR and UFT. Total 21 cases of cervical cancer were alloted randomly into 5'-DFUR group (daily dose 800 mg for 3 days) consisting of 11 patients and UFT group (daily dose 600 mg for 3 days) consisting of 10 patients, the unchanged substances (5'-DFUR in the 5'-DFUR group and tegafur concentrations in the UFT group) and 5-FU concentrations in serum and tissues were measured 6 hours after administration of the drugs. The 5'-DFUR concentration in the 5'-DFUR group was not detected in serum and less than a detectable limit for all of cancerous tissues, normal cervical tissues, and lymph nodes. ⋯ The 5-FU concentrations in the 5'-DFUR treated group were 0.018 +/- 0.046 micrograms/g for cancerous tissues, but less than a detectable limit for serum and normal cervical tissues. On the other hand, in the UFT group, 0.271 +/- 0.247 micrograms/g for a cancerous tissue, 0.035 +/- 0.018 micrograms/ml for serum, 0.125 +/- 0.073 micrograms/g for normal cervical tissues, showing significantly high values (p < 0.01, p < 0.001, and p < 0.01, respectively) compared to those in the 5'-DFUR treated group. These results suggest that UFT is a promising drug for the treatment of cancer of the uterine cervix.
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Gan To Kagaku Ryoho · Aug 1992
Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial[Clinical evaluation of ondansetron (injection of a single intravenous dose) against nausea and emesis associated with anti-cancer drugs--dose-finding study in patients receiving cisplatin].
We examined anti-emetic effects, safety and the optimal dose of Ondansetron Injection given in a single intravenous dose in patients receiving a single high dose of cisplatin in randomized controlled comparative study using telephone registration. Ondansetron was injected intravenously in a single dose of 4 mg, 8 mg or 12 mg, at 15 minutes before administration of cisplatin. Nausea and emesis were observed for 24 hours after administration of cisplatin. ⋯ No abnormal findings attributable to Ondansetron were observed in clinical laboratory test. From the above, it was considered that Ondansetron given by a single intravenous injection was highly effective to inhibit nausea and emesis induced by cisplatin, and was highly safe. As to the dose, 4 mg once daily was considered to be adequate for prophylaxis of cisplatin-induced nausea and emesis.