Gan to kagaku ryoho. Cancer & chemotherapy
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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 · Aug 1995
Multicenter Study Comparative Study Clinical Trial Controlled Clinical Trial[Clinical phase III study of tropisetron capsule in the treatment of nausea and vomiting induced by anti-cancer drug; a placebo-controlled, multicenter, double-blind comparative study].
A placebo-controlled, double-blind comparative study of tropisetron capsule was conducted to assess its clinical usefulness for nausea and vomiting induced by the anticancer drug, cisplatin, at a single dose of 50 mg/m2 or higher. Either 5mg tropisetron capsule or its placebo was given orally to patients 2 hours prior to cisplatin administration; the clinical efficacy was determined the severity of nausea and the number of emesis that occurred during 24 hours after cisplatin. Tropisetron significantly exceeded the placebo in the assessment of clinical efficacy. ⋯ Adverse events observed were one case of headache in the tropisetron group and one diarrhea in the placebo group, while neither case was serious nor clinically problematic in particular. The above results reveal that tropisetron 5 mg capsule is significantly effective in the treatment of anticancer drug-induced nausea and vomiting. It has also been confirmed that tropisetron is a useful agent without any safety problems.
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Recent progress in chemotherapy for advanced nonsmall cell lung cancer (NSCLC) and small cell lung cancer (SCLC) maybe summarized as follows. 1) In seven randomized trials of combination chemotherapy compared with best supportive care in stage IV NSCLC, meta-analysis of indicated that combination chemotherapy modestly improves survival of patients with advanced NSCLC. 2) Cisplatin-based combination chemotherapy followed by chest irradiation improves outcomes of patients with stage III unresectable NSCLC as compared with radiation therapy alone. 3) Meta-analysis has shown that survival is prolonged when radiotherapy is used in combination with chemotherapy in the treatment of limited-stage SCLC. 4) Randomized trials evaluating alternating chemotherapy could not demonstrate the survival benefit in the treatment of extensive-stage (ES) SCLC. 5) The approach to increasing dose intensity has been attempted in the treatment of ES-SCLC. The most common approach is weekly chemotherapy. ⋯ In conclusion, despite these advances of treatment, the cure rate remains quite low in lung cancer. Further investigations are needed to improve the treatment results for patients with this disease.
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Gan To Kagaku Ryoho · Feb 1995
Review[Phase III studies of combined chemotherapy and radiation in locally advanced non-small-cell lung cancer and limited small-cell lung cancer].
Large phase III studies for lung cancer are reviewed. In an effort to improve survival results in locally advanced inoperable non-small-cell lung cancer (NSCLC), several studies have documented survival advantage for cisplatin + vinka alkaloid followed by radiotherapy (RT) when compared with RT alone. In SCLC, meta-analyses show that thoracic radiotherapy moderately improves survival in patients who are treated with combination chemotherapy. The optimum combination of chemotherapy and radiotherapy needs to be established.
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Gan To Kagaku Ryoho · Feb 1995
Multicenter Study Clinical Trial[The clinical phase I study of TNP-351. The TNP-351 Research Committee].
The clinical phase I study of TNP-351, an antifolate drug having a novel structure, was performed through a multicenter cooperative program in 40 patients with solid tumors. The test drug was used on dosage schedules of single and daily doses for 5 or 3 days (by intravenous drip over 30 minutes, respectively). From the daily administration for 5 days, severe adverse reactions such as myelosuppression, became manifest at 5 mg/m2 (1n). ⋯ On the 3-day daily administration schedule, the test drug was not accumulated in vivo. In the present study, two patients with malignant fibrous histiocytoma responded to the test drug with tumor regression. The results suggested that the recommended dosage regimen for the clinical early phase II study of the test drug should comprise a course of 9 mg/m2/day (by intravenous drip infusion over 30 minutes) every day for 3 days, which should be repeated every 3 weeks.