内容紹介
Results of a Drug Use Investigation of Nanoparticle Albumin-Bound Paclitaxel for Breast Cancer
Summary
A drug use investigation of nanoparticle albumin-bound paclitaxel was conducted based on conditions for approval. A total of 963 patients were enrolled in this study from September 24, 2010 to February 14, 2011. Twenty-nine patients were excluded, and a total of 934 patients were evaluated for determining the safety of nanoparticle albumin-bound paclitaxel. Adverse drug reactions were observed in 92.8% of the patients, and major adverse drug reactions included myelosuppression and peripheral sensory neuropathy, both of which are characteristic adverse reactions of paclitaxel treatment. Both adverse drug reactions were observed at a high frequency after the second course of treatment, resulting in these reactions being primary causes for discontinuation. Increase in the rates of continuous drug administration may be accomplished by carrying out laboratory tests and noting the medical history in order to prevent myelosuppression from becoming serious and to perform earlier countermeasures for peripheral sensory neuropathy, leading to improved therapeutic effects.
要旨 承認条件に基づき,パクリタキセル注射剤(アルブミン懸濁型)の使用成績調査を実施した。2010年9月24日～2011年2月14日に963例が登録された。29例が除外例となり,安全性評価症例数は934例であった。副作用発現率は92.8%,主な副作用はパクリタキセル製剤に特徴的な骨髄抑制と末梢性感覚神経障害であった。いずれも2コース目までに高頻度で発現し,投与中止例の主たる有害事象であった。骨髄抑制の重篤化を防止するため臨床検査や問診を実施すること,および末梢性感覚神経障害に対し早期に対処することが,投与継続率を高め,治療効果を向上させると期待できた。
目次
Summary
A drug use investigation of nanoparticle albumin-bound paclitaxel was conducted based on conditions for approval. A total of 963 patients were enrolled in this study from September 24, 2010 to February 14, 2011. Twenty-nine patients were excluded, and a total of 934 patients were evaluated for determining the safety of nanoparticle albumin-bound paclitaxel. Adverse drug reactions were observed in 92.8% of the patients, and major adverse drug reactions included myelosuppression and peripheral sensory neuropathy, both of which are characteristic adverse reactions of paclitaxel treatment. Both adverse drug reactions were observed at a high frequency after the second course of treatment, resulting in these reactions being primary causes for discontinuation. Increase in the rates of continuous drug administration may be accomplished by carrying out laboratory tests and noting the medical history in order to prevent myelosuppression from becoming serious and to perform earlier countermeasures for peripheral sensory neuropathy, leading to improved therapeutic effects.
要旨 承認条件に基づき,パクリタキセル注射剤(アルブミン懸濁型)の使用成績調査を実施した。2010年9月24日～2011年2月14日に963例が登録された。29例が除外例となり,安全性評価症例数は934例であった。副作用発現率は92.8%,主な副作用はパクリタキセル製剤に特徴的な骨髄抑制と末梢性感覚神経障害であった。いずれも2コース目までに高頻度で発現し,投与中止例の主たる有害事象であった。骨髄抑制の重篤化を防止するため臨床検査や問診を実施すること,および末梢性感覚神経障害に対し早期に対処することが,投与継続率を高め,治療効果を向上させると期待できた。