Gan to kagaku ryoho. Cancer & chemotherapy
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Gan To Kagaku Ryoho · Jul 2001
Randomized Controlled Trial Multicenter Study Clinical Trial[Examination on efficacy and safety of concurrent use of ondansetron hydrochloride and steroid in lung cancer patients on cisplatin].
The anti-emetic effect and safety in patients receiving ondansetron hydrochloride (OND group) and concurrent use of ondansetron and dexamethasone (DEX group) in cases of acute and delayed onset emesis induced by a single high dose of cisplatin, given as a chemotherapy to lung cancer patients, were comparatively studied. The study subjects were 78 lung cancer patients. The OND group received 4 mg of ondansetron via slow intravenous injection on Day 1, 30 minutes prior to cisplatin, and for Days 2 to 5, the subjects orally received 4 mg ondansetron tablet each day. ⋯ The group also achieved better efficacy in delayed onset of emesis. Two cases of adverse reactions (hiccups and elevation of ALT and BUN) were observed in the DEX group; however, since the symptoms were all mild, we did not consider there was any problem in safety. We conclude from the above findings that concurrent administration of ondansetron hydrochloride and dexamethasone is a clinically useful treatment for acute and delayed onset emesis induced by a single high dose of cisplatin given to lung cancer patients.
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Gan To Kagaku Ryoho · Jul 2000
Multicenter Study Clinical Trial[Clinical evaluation of granisetron hydrochloride for nausea and vomiting induced by oral anticancer drugs].
We investigated the antiemetic effect, safety and usefulness of granisetron hydrochloride tablets on nausea and vomiting induced by oral anticancer drugs used in chemotherapy for gastric cancer and colorectal cancer. In the present trial, oral administration of granisetron hydrochloride was performed during 5 days after nausea or vomiting. 1) Clinically, the effective rate of granisetron hydrochloride (the percentage of cases in which the drug was assessed as "Remarkably effective" or "Effective") was more than 75% on each day of administration. There were no adverse events or abnormal laboratory tests. 2) In terms of usefulness, granisetron hydrochloride was rated "Extremely useful" or "Useful" in 17 out of 23 cases (78.2%). The above results have shown that granisetron hydrochloride tablets, administrated orally once daily at a dose of 2 mg, have an excellent antiemetic effect, and that this is a safe and useful drug.
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Gan To Kagaku Ryoho · May 2000
Randomized Controlled Trial Multicenter Study Clinical TrialPreliminary results of multicenter phase II trial of docetaxel (Taxotere) in combination with doxorubicin as first line chemotherapy in Indonesian patients with advanced or metastatic breast cancer.
Docetaxel and doxorubicin have produced a high degree of activity in previously untreated/treated patients with metastatic breast cancer (MBC). The efficacy of Taxotere (T) single agent as 2nd line chemotherapy is well established in large randomized phase III studies. ⋯ Taxotere--doxorubicin combination is very active in the first-line treatment of MBC, seems to be especially effective in patients with liver metastases, and is associated with a manageable toxicity profile.
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Gan To Kagaku Ryoho · Aug 1999
Multicenter Study Clinical Trial[Clinical experiences of implantable vascular access device, "Vital Port" for arterial infusion chemotherapy].
We had the opportunity to use "Vital Port", a subcutaneous implantable vascular access port which was developed in the U. S. and has been used clinically in a multicenter study for clinical evaluation. To prevent the result from varying by facility, standardized criteria were made. ⋯ No complications were observed in any of the cases. Intra-arterial infusion chemotherapy was carried out without any problem. This port is lightweight and has good biocompatibility, and the clinical results were evaluated highly.
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Gan To Kagaku Ryoho · Aug 1999
Multicenter Study Clinical Trial[Clinical evaluation of granisetron (BRL43694) in nausea and vomiting induced by anticancer drugs--pediatrics].
Granisetron has been used widely for the prevention and treatment of nausea and vomiting associated with anticancer drugs in adult patients with cancer. This multi-center open study was conducted to study the efficacy, safety and usefulness of granisetron in children with cancer. ⋯ No serious adverse effects were observed. As granisetron 40 micrograms/kg had an excellent antiemetic effect and a high degree of safety against nausea and vomiting associated with anticancer drugs, it was shown to be useful for children with cancer.