Gan to kagaku ryoho. Cancer & chemotherapy
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Gan To Kagaku Ryoho · Feb 1998
[Development of an anticancer drug in Japan based on a new clinical trial system].
According to the revision of Pharmaceutical Affairs Law in 1996, the GCP has been enacted into the law. Next year the new GCP was established based on the ICH-GCP and it has been active since April, 1997. Though the new GCP makes it possible for the regulatory authorities (Japan, the United States and European Union) to accept clinical trial data mutually, the circumstances of clinical trial in Japan have been required big changes. ⋯ At the first time, in this article are described the process of both the revision of Japanese pharmaceutical law and the establishment of the new Japanese GCP. The second, the characteristics of the new Japanese GCP especially about the roles and responsibilities of investigators are discussed. Furthermore approaches of the US FDA for new anticancer drugs development are also described.
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Gan To Kagaku Ryoho · Jan 1998
Clinical Trial Controlled Clinical Trial[Clinical evaluation based on cost-effectiveness].
We carried out two Phase III clinical trials using high dose rate (HDR) remote afterloading brachytherapy unit. We evaluated the clinical results based not only on the medical but also the economical standpoint. The first trial is the Phase III trial for cervical cancer treated with HDR or medium dose rate (MDR) intracavitary radiotherapy. ⋯ However, HDR can be treated without admission for patients who live near the hospital. HDR can be applied for these patients with less expense. We must be aware of not only the medical results but also the cost-effectiveness.
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Gan To Kagaku Ryoho · Dec 1997
[Multi-drug antiemetic treatment and effect of treatment duration of concurrent steroids--for complete control of chemotherapy-induced nausea/vomiting in gynecological cancer].
Antiemetic effect and safety of concurrent administration of ondansetron and other antiemetics (dexamethasone, domperidone and ethyl loflazepate), given for complete suppression of nausea/vomiting, were examined in 46 patients (109 courses) with gynecological cancer receiving single high-dose of cisplatin or carboplatin. As for the delayed emesis, antiemetic effect depending on the steroid treatment duration, given concurrently to ondansetron, was compared. The results were as follows; 1. ⋯ No adverse event or laboratory abnormality due to the multi-antiemetic treatment was observed. Based on the above, the efficacy of the antiemetic treatment in this study was confirmed. In delayed emesis, concurrent steroids given for 3 days after chemotherapy were considered effective and were also regarded to improve food intake.
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This is a review of the recent progress in chemoradiotherapy of locally advanced lung cancer. In the limited disease stage of small cell lung cancer, a meta-analysis showed patients treated with a combination of chemotherapy and radiotherapy have a statistically significantly longer survival than those with chemotherapy alone. However, the timing of the combination of radiation and chemotherapy has not been clarified. ⋯ Our randomized study indicated the addition of radiotherapy after chemotherapy is superior in long-term survival to chemotherapy alone. The West Japan Lung Cancer Group conduct a phase III randomized study comparing concurrent and sequential chemoradiotherapy, and the determination of survival is now in the follow-up stage. The role of induction chemoradiotherapy before surgical resection, comparison of chemoradiotherapy with induction chemoradiotherapy followed by surgery, and the effects and safety of the combination of new drugs and radiotherapy are now under investigation.