Gan to kagaku ryoho. Cancer & chemotherapy
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Gan To Kagaku Ryoho · Nov 2004
Review[In regard to gastric cancer treatment guidelines--a revised edition].
The Japanese Gastric Cancer Association issued a revised edition of gastric cancer treatment guidelines in April 2004. Distinctive features of this revision are adopting newly published literatures after the first edition of the guidelines, laparoscopy-assisted gastrectomy and perioperative management, and illustrating evidence levels in the clinical study of chemotherapy. The treatment protocol of the phase III study is an actual example of this. ⋯ Furthermore, a revised edition of chemotherapy was the only one that could be able to show a high evidence level. According to a questionnaire investigation of the revised guidelines, more than 90% of the respondents (the members of Japanese Gastric Cancer Association) have used the guidelines. Hence, the role of the guidelines is important.
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Gan To Kagaku Ryoho · Feb 2004
Review[Controversies in breast conservation treatment for breast cancer].
Breast conservation treatment has become the standard treatment for early breast cancer patients, after the equivalence of mastectomy and breast conservation treatment was demonstrated in prospective, randomized trials and large retrospective studies. New questions, such as the feasibility of neoadjuvant chemotherapy in improving breast conserving rate, the appropriateness of breast conservation treatment in ductal carcinoma in situ, the effectiveness of radiation therapy in patients treated by breast conservation, and patient selection for breast conservation without radiation, are now being raised. Future work that needs to be done to answer these questions is discussed in this review.
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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.