内容紹介
Retrospective Analysis of the Afatinib Clinical Pathway during the 28-Day Introductory Period―The Japanese Style of Collaborative Drug Therapy Management(J-CDTM)
Summary
Afatinib is a newly approved second-generation epidermal growth factor receptor-tyrosine kinase inhibitor(EGFR-TKI). Afatinib has been shown to prolong the overall survival of patients with non-small cell lung cancer(NSCLC)with EGFR mutations compared with the standard chemotherapy. However, Grade 3 or 4 toxicities, including diarrhea, rash, paronychia, and stomatitis, have been observed more frequently in patients treated with afatinib than in those treated with first-generation EGFR-TKIs. Accordingly, our institution developed an afatinib clinical pathway(the afatinib pathway), which was designed by certified nurses, medical physicians, and certified pharmacists, with the goal of reducing the severity of diarrhea and rash that occur most frequently during the 28-day introductory period of afatinib treatment. Between May and October 2014, afatinib was administered according to the afatinib pathway to 14 patients with NSCLC and EGFR mutations. Of these patients, only one(7.1%)experienced Grade 3 diarrhea. No other patient experienced Grade 3 or 4 toxicity. The afatinib pathway was effective in reducing the severities of the diarrhea and rash during the 28-day introductory period of the afatinib treatment. Our implementation of the afatinib pathway could be considered the Japanese style of collaborative drug therapy management(J-CDTM).
要旨
アファチニブは新規に承認された第二世代epidermal growth factor receptor-tyrosine kinase inhibitor(EGFR-TKI)である。アファチニブは,EGFR-TKIとしては初めて化学療法に対し有意に全生存期間を延長するという優れた抗腫瘍効果を示した一方で,Grade 3～4下痢,皮疹,爪周囲炎などの発現頻度が高いことが報告された。これを受けて当センターの認定看護師・医師・がん専門薬剤師の多職種協働の下,アファチニブの導入期28日間で治療中止の原因となり得る下痢や皮疹の重症度を軽減することを主眼においたアファチニブ・パス(本パス)を作成した。2014年5月～10月にアファチニブで加療したEGFR変異を有する非小細胞肺癌14症例に本パスを適用した。その結果,14例中1例(7.1%)だけがGrade 3の下痢を発症し,他のGrade 3～4の副作用は認めなかった。本パスはアファチニブ導入期28日間に起こる下痢や皮疹の重症度を低下させるのに有効であった。看護師,医師,薬剤師が協働で作成した本パスを運用する試みは,日本版collaborative drug therapy management(J-CDTM)の実践といえる。
目次
Summary
Afatinib is a newly approved second-generation epidermal growth factor receptor-tyrosine kinase inhibitor(EGFR-TKI). Afatinib has been shown to prolong the overall survival of patients with non-small cell lung cancer(NSCLC)with EGFR mutations compared with the standard chemotherapy. However, Grade 3 or 4 toxicities, including diarrhea, rash, paronychia, and stomatitis, have been observed more frequently in patients treated with afatinib than in those treated with first-generation EGFR-TKIs. Accordingly, our institution developed an afatinib clinical pathway(the afatinib pathway), which was designed by certified nurses, medical physicians, and certified pharmacists, with the goal of reducing the severity of diarrhea and rash that occur most frequently during the 28-day introductory period of afatinib treatment. Between May and October 2014, afatinib was administered according to the afatinib pathway to 14 patients with NSCLC and EGFR mutations. Of these patients, only one(7.1%)experienced Grade 3 diarrhea. No other patient experienced Grade 3 or 4 toxicity. The afatinib pathway was effective in reducing the severities of the diarrhea and rash during the 28-day introductory period of the afatinib treatment. Our implementation of the afatinib pathway could be considered the Japanese style of collaborative drug therapy management(J-CDTM).
要旨
アファチニブは新規に承認された第二世代epidermal growth factor receptor-tyrosine kinase inhibitor(EGFR-TKI)である。アファチニブは,EGFR-TKIとしては初めて化学療法に対し有意に全生存期間を延長するという優れた抗腫瘍効果を示した一方で,Grade 3～4下痢,皮疹,爪周囲炎などの発現頻度が高いことが報告された。これを受けて当センターの認定看護師・医師・がん専門薬剤師の多職種協働の下,アファチニブの導入期28日間で治療中止の原因となり得る下痢や皮疹の重症度を軽減することを主眼においたアファチニブ・パス(本パス)を作成した。2014年5月～10月にアファチニブで加療したEGFR変異を有する非小細胞肺癌14症例に本パスを適用した。その結果,14例中1例(7.1%)だけがGrade 3の下痢を発症し,他のGrade 3～4の副作用は認めなかった。本パスはアファチニブ導入期28日間に起こる下痢や皮疹の重症度を低下させるのに有効であった。看護師,医師,薬剤師が協働で作成した本パスを運用する試みは,日本版collaborative drug therapy management(J-CDTM)の実践といえる。