内容紹介
Initial Evaluation of the Efficacy and Safety of Tablets Containing Trifluridine and Tipiracil Hydrochloride―Safety Measures Devised by a Multidisciplinary Team Including a Pharmaceutical Outpatient Clinic
Summary
In May 2014, tablets containing both trifluridine and tipiracil hydrochloride(Lonsurf® tablets)were launched in Japan ahead of other countries, for the treatment of advanced/relapsed unresectable colorectal cancer. The benefits of these tablets in terms of a new therapeutic option have been demonstrated. However, the manufacturer has requested healthcare professionals to help develop safety measures for the appropriate and safe use of the tablets. In this study, we evaluated the efficacy and safety of the tablets in 16 patients who received the tablets at our hospital. Among the 4 evaluable patients, none achieved a complete or partial response. One patient(25.0%)had stable disease according to the Response Evaluation Criteria in Solid Tumors(RECIST)Guidelines outlined in the General Rules of the Study of Colorectal Cancer(The 8th Edition). Lonsurf® is considered to be a third-line(or later)treatment. Among the 16 cases studied, Lonsurf® was used as a third-, fourth-, and fifth-line treatment in 9, 6, and 1 cases, respectively. Therefore, Grade 3 or worse toxicities were a potential concern. Despite a high incidence of Grade 3 or worse neutropenia(7 of the 16 patients[43.8%]), none of the patients were hospitalized due to neutropenia or other treatment-related adverse events. Pharmacists have made 126 proposals to physicians regarding the use of Lonsurf®, 121(96.0%)of which have been adopted. All of the adverse reactions experienced by our patients were resolved after supportive therapy.
要旨
2014年5月にトリフルリジン・チピラシル塩酸塩配合錠(ロンサーフ®配合錠)は,治癒切除不能な進行・再発の結腸・直腸癌に対して世界に先駆け日本で販売された。新たな治療選択肢として有用性が示されている一方で,適正使用および安全性確保を図るために製薬会社より医療関係者に安全対策への協力が求められている。今回,当院において本剤を導入した患者16例を対象として有効性および安全性の評価を行った。大腸癌取扱い規約(第8版)の効果判定基準Response Evaluation Criteria in Solid Tumors(RECIST)ガイドラインで評価可能な4例の解析ではCR 0例,PR 0例,SD 1例で病勢コントロール率25.0%であった。三次治療以降で使用する保険適応のため,16例のうち三次治療9例,四次治療6例,五次治療が1例であった。そのためGradeの高い副作用を懸念していた。Grade 3以上の好中球減少が7/16例(43.8%)と高頻度に認められたが,その他の有害事象含め,この薬剤に関連した治療中の副作用での入院例はなく全例外来治療可能であった。薬剤師の医師への提案は121/126件(96.0%)が採択され,副作用に対する支持療法施行後はすべて改善を認めた。
目次
Summary
In May 2014, tablets containing both trifluridine and tipiracil hydrochloride(Lonsurf® tablets)were launched in Japan ahead of other countries, for the treatment of advanced/relapsed unresectable colorectal cancer. The benefits of these tablets in terms of a new therapeutic option have been demonstrated. However, the manufacturer has requested healthcare professionals to help develop safety measures for the appropriate and safe use of the tablets. In this study, we evaluated the efficacy and safety of the tablets in 16 patients who received the tablets at our hospital. Among the 4 evaluable patients, none achieved a complete or partial response. One patient(25.0%)had stable disease according to the Response Evaluation Criteria in Solid Tumors(RECIST)Guidelines outlined in the General Rules of the Study of Colorectal Cancer(The 8th Edition). Lonsurf® is considered to be a third-line(or later)treatment. Among the 16 cases studied, Lonsurf® was used as a third-, fourth-, and fifth-line treatment in 9, 6, and 1 cases, respectively. Therefore, Grade 3 or worse toxicities were a potential concern. Despite a high incidence of Grade 3 or worse neutropenia(7 of the 16 patients[43.8%]), none of the patients were hospitalized due to neutropenia or other treatment-related adverse events. Pharmacists have made 126 proposals to physicians regarding the use of Lonsurf®, 121(96.0%)of which have been adopted. All of the adverse reactions experienced by our patients were resolved after supportive therapy.
要旨
2014年5月にトリフルリジン・チピラシル塩酸塩配合錠(ロンサーフ®配合錠)は,治癒切除不能な進行・再発の結腸・直腸癌に対して世界に先駆け日本で販売された。新たな治療選択肢として有用性が示されている一方で,適正使用および安全性確保を図るために製薬会社より医療関係者に安全対策への協力が求められている。今回,当院において本剤を導入した患者16例を対象として有効性および安全性の評価を行った。大腸癌取扱い規約(第8版)の効果判定基準Response Evaluation Criteria in Solid Tumors(RECIST)ガイドラインで評価可能な4例の解析ではCR 0例,PR 0例,SD 1例で病勢コントロール率25.0%であった。三次治療以降で使用する保険適応のため,16例のうち三次治療9例,四次治療6例,五次治療が1例であった。そのためGradeの高い副作用を懸念していた。Grade 3以上の好中球減少が7/16例(43.8%)と高頻度に認められたが,その他の有害事象含め,この薬剤に関連した治療中の副作用での入院例はなく全例外来治療可能であった。薬剤師の医師への提案は121/126件(96.0%)が採択され,副作用に対する支持療法施行後はすべて改善を認めた。