Gan to kagaku ryoho. Cancer & chemotherapy
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Gan To Kagaku Ryoho · Nov 2003
Case Reports[Marked reduction of BCR-ABL fusion chromosome positive cells with interferon therapy combined with short-term imatinib in chronic myelogenous leukemia].
A 71-year-old man with chronic myelogenous leukemia received interferon therapy for 21 months, but did not have complete cytogenetic response. Imatinib was then added to the former therapy. Imatinib was prescribed for only 12 days and discontinued because of severe erythema. Since then, however, marked reduction of bcr-abl fusion chromosome positive cells was observed, and this state has been maintained to the present day even though treatment has consisted only of interferon. we discuss efficacy of the combined therapy, composed of interferon and imatinib, for chronic myelogenous leukemia and other bcr-abl fusion chromosome positive diseases.
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Gan To Kagaku Ryoho · Oct 2003
Review[Doctor-initiated clinical trials and the revised pharmaceutical affairs law].
In Japan, clinical trials aiming at application for approval of new drugs take a long time and a lot of money, and their quality thought to be poor. Japanese pharmaceutical companies tend to conduct more clinical studies in the United States and/or Europe than in Japan. The Ministry of Health, Labour and Welfare (MHLW) announced a three-year plan to facilitate clinical trials in Japan; the establishment of a large-scale clinical trial network, the improvement of the clinical research infrastructure, and the utilization of doctor-initiated clinical trials. ⋯ Drugs needed by some patients but unapproved because they are unprofitable for companies are expected to be approved under this system. MHLW stipulated the ethical and scientific quality standard of doctor-initiated clinical trials, which is consistent with the principles of the Declaration of Helsinki, and Good Clinical Practice (GCP). To establish a system that allows expedited approval of safer and more effective products, the integration of the functions of the current review bodies, such as the Organization for Pharmaceutical Safety and Research (OPSR) and the Pharmaceuticals and Medical Devices Evaluation Center (PMDEC), into an independent administrative agency is scheduled.
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Imatinib mesylate is an inhibitor of Bcr/Abl tyrosine kinase, which essentially participates the pathogenesis of chronic myelogenous leukemia (CML). Imatinib is highly effective in the treatment of CML. Because imatinib also inhibits c-kit and platelet-derived growth-factor (PDGF) receptor, it may be efficacious against some tumors which possess c-kit or PDGF receptors.
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CHOP has been the standard chemotherapy for aggressive non-Hodgkin's lymphoma (NHL). However, indolent NHL remains largely an incurable diseases, with nearly static overall survival, and only 40% of patients with aggressive NHL are cured by CHOP. Monoclonal antibodies are an exciting advance in the treatment of lymphoma. ⋯ These included combination with chemotherapy, prolonged or increased dosing regimens, and maintenance therapy, in which rituximab is administered to patients in remission to eliminate minimal residual disease and reduce the risk of relapse. Rituximab in vivo purging and maintenance is also being evaluated in autologous transplantation setting. Newer agents, including radiolabelled antibodies, Immunotoxin-linked antibodies and antibodies against novel target antigens are being tested in on-going clinical trial.
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Gan To Kagaku Ryoho · Jul 2003
Case Reports[Metastatic gastrointestinal stromal tumors responded to the treatment with STI571 after polysurgery for recurrent lesions--report of two cases].
Two cases of metastatic gastrointestinal stromal tumors (GIST) that had responded to the treatment with STI571 were presented. Case 1 was a 49-year-old woman who had undergone proximal gastrectomy because of a giant submucosal tumor of the stomach. For 21 months after surgery, the patient received repeated tumor removal four times due to hepatic metastasis and/or peritoneal recurrence. ⋯ At present, the patient has no abdominal complaints and has a good quality of life. GIST was confirmed in both cases, by histopathological analyses of the resected specimens: positive expression of c-kit and CD34. These clinical observations suggest that ST1571 therapy for metastatic lesions from GIST may be preferred over aggressive, repeated tumor removal.