Gan to kagaku ryoho. Cancer & chemotherapy
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The Brain is one of the common relapse sites in small cell lung cancer because of isolation from chemotherapeutic agents by the blood-brain barrier. Prophylactic cranial irradiation (PCI) is expected to reduce brain relapse and increase the survival rate. PCI prolonged the survival in only 10-20% of patients with small cell lung cancer after complete response. ⋯ No standard PCI dose and schedule are established, however, over 30Gy for total dose, over 3Gy per fraction. Concurrent use with chemotherapy is considered to induce central nerve toxicity. PCI should be proposed for patients with complete response as an optional treatment.
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Gan To Kagaku Ryoho · Oct 1997
[Implementation of new Japanese GCP and the quality of clinical trials--from the standpoint of the pharmaceutical industry].
As a part of the amendment of the pharmaceutical law and regulations in Japan, the GCP has been revised and enacted into the law and regulations. The new GCP is based on ICH-GCP and aims at upholding the quality of the Japanese clinical trials to an internationally acceptable level. The roles of the people involved in clinical trials have been renewed. ⋯ In this article are described major responsibilities newly assigned to the sponsor, medical institutions and investigators as well as the matters to be tackled. Discussion was also made extending the theme to matters other than GCP for upholding the quality of clinical trials in Japan to the internationally acceptable level. It is evident that we will confront many difficulties to solve these matters, but the implementation of the new GCP should give us a good chance to improve the quality of clinical studies performed in Japan.
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Gan To Kagaku Ryoho · Sep 1997
Clinical Trial Controlled Clinical Trial[Clinical evaluation of intra-arterial infusion chemotherapy for advanced or recurrent cervical cancer with or without radiotherapy].
We analyzed 52 cases of advanced or recurrent cancer of the cervix treated by intra-arterial infusion chemotherapy (IAIC) with or without radiotherapy. IAIC regimen was separated into two groups: Group I consisted of 5-FU + MMC +/- ADR (30 cases) and group II of CDDP + MMC +/- 5-FU (22 cases). The tip of the catheter was placed in the bifurcation of abdominal aorta or the bilateral internal iliac arteries (7 cases). ⋯ In 7 cases in which the tip of the catheter was placed in internal iliac arteries, there were severe skin ulcers in 2 cases and severe pain of leg or gluteal region requiring narcotics in 2 cases. These data suggest that IAIC mainly with cisplatin with or without radiotherapy is one of the effective treatments for advanced or recurrent cervix cancer. But we should check the blood flow distribution periodically, and control the concentration of drugs.
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The main therapy for primary breast cancer is not surgery, but a systemic therapy involving administration of cytotoxic chemotherapy or the use of ablative or additive endocrine therapy to control disseminated micrometastasis. The results of randomized trials and meta-analysis show that CMF, the standard adjuvant chemotherapy, is effective regardless of axillar lymph node involvement or menopausal status. Effectiveness of adjuvant chemotherapy with an anthracyclin-based regimen remains controversial. The trial by CUBC and NSAS-BC comparing UFT, widely used in the management of patients with breast cancer in Japan, with CMF is on-going.
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Gan To Kagaku Ryoho · Jul 1997
Clinical Trial[Clinical evaluation of 2-mg granisetron tablet for nausea and vomiting induced by anticancer drugs including cisplatin].
The antiemetic effects on nausea and vomiting induced by anticancer drugs and safety of a 2-mg granisetron tablet were studied in cancer patients, particularly in the field of gynecology, who had been treated with anticancer drugs including cisplatin (CDDP) at 50 mg/m2 or more. The 1-mg granisetron tablet is already commercially available and used widely in clinical practice by oral administration of two tablets per dosage. In this investigation, the clinical efficacy, safety and usefulness of a 2-mg tablet, which can be taken more easily, were studied. ⋯ For safety, neither adverse experiences nor abnormal laboratory values were judged to be of clinical significance. The 2-mg granisetron tablet was considered "extremely useful" or "useful" in 22 (66.7%) of 33 patients. The above results confirmed the excellent antiemetic effect on nausea and vomiting induced by anticancer drugs including CDDP and the high degree of safety of a 2-mg granisetron tablet.