Gan to kagaku ryoho. Cancer & chemotherapy
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Gan To Kagaku Ryoho · Nov 1996
Multicenter Study Clinical Trial[An early phase II study of gemcitabine hydrochloride (LY 188011). Gemcitabine Cooperative Study Group for Early Phase II].
An early phase II cooperative study of Gemcitabine Hydrochloride (abbreviated to "gemcitabine" herewith) was conducted in patients with a variety of solid tumors (i.e., lung cancer, gastric cancer, pancreatic cancer, colon/rectum cancer, cervical cancer, ovarian cancer and breast cancer) at 56 institutions. The aim of the first step (Step I) was to investigate the feasibility of gemcitabine in a variety of different solid tumors, including lung cancer regarding efficacy and safety. The aim of the second step (Step II) was as a result of step I (Responses were observed) to continue to investigate the efficacy and safety of gemcitabine in chemonaive patients with non-small cell lung cancer. ⋯ Incidence as well as severity of main adverse reactions in these patients were comparable to those seen in patients with lung cancer. A Step II study, in which gemcitabine was administered once weekly at a dose of 1,000 mg/m2 to chemonaive patients with non-small cell lung cancer, was conducted, referring to the results of Step I and clinical studies conducted overseas. The results of the Step II study demonstrated PR in 5 (14.3%, 95% confidence interval: 4.8 - 30.3%) out of 35 eligible patients with non-small cell lung cancer and that the main adverse reactions were comparable to those seen in the Step I study, posing no tolerability problems in particular.
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Gan To Kagaku Ryoho · Nov 1996
Clinical Trial[Evaluation of hepatic arterial infusion chemotherapy for gastric cancer].
Hepatic arterial infusion chemotherapy (HAIC) using implantable reservoir was performed for liver metastases of gastric cancer and the therapeutic effects were evaluated. A catheter was placed in the hepatic artery via left subclavian artery or by direct insertion at laparotomy. Cisplatin, adriamycin and 5-FU were administered. ⋯ The 50% survival period was 395 days for HAIC, and it was significantly prolonged compared with 198 days for systemic chemotherapy (p < 0.01). But 4 among 10 cases responding to HAIC showed subsequent extrahepatic spread of the disease. Treatment of these extra-hepatic lesions is difficult.