内容紹介
Summary
We report the case of a 72-year-old female who underwent laparoscopic total gastrectomy for gastric cancer. The pathological diagnosis was pT3, N1, M0, pStageⅡB. She received adjuvant chemotherapy with the TS-1Ⓡ combination OD tablet, beginning 48 days after gastrectomy. The first course was stopped at day 7 because of neutropenia. The dose was decreased, a second course was started, and the patient completed her second course without neutropenia. After completion of the second course, we discovered that she had taken generic drugs(NKS-1Ⓡ combination OD tablet)during the second course. She was enrolled in a clinical trial in which the administration of generic drugs was not permitted, as per the protocol. Beginning with the third course, we once again treated her with TS-1, and we observed a return of neutropenia in every subsequent course. We decreased the dose of TS-1 and changed the administration schedule each time. She exhibited no neutropenia only when using the generic S-1 formulation. It is possible that the anti-tumor effect of the generic S-1 formulation, and its associated adverse events, are not identical to the innovator formulation.
要旨
症例は72歳,女性。胃体上部癌に対して腹腔鏡下胃全摘を施行した。pT3,N1,M0,pStageⅡBであり,術後48日目より補助化学療法としてティーエスワンⓇ(TS-1)配合OD錠の投与を開始した。1コース目は好中球減少により7日目以降スキップした。減量して2コース目を行い,好中球減少を認めず完遂できた。臨床試験参加症例であり,後発医薬品の使用は認められていなかったが,患者への聞き取りで2コース目はエヌケーエスワンⓇ配合OD錠が投与されていたことが判明した。3コース目以降はTS-1に戻して継続したが,毎コース好中球減少を認め,減量と投与スケジュールの変更を行った。後発医薬品内服時のみ好中球減少が軽快しており,先発医薬品と薬理作用の違いがある可能性が考えられた。
目次
We report the case of a 72-year-old female who underwent laparoscopic total gastrectomy for gastric cancer. The pathological diagnosis was pT3, N1, M0, pStageⅡB. She received adjuvant chemotherapy with the TS-1Ⓡ combination OD tablet, beginning 48 days after gastrectomy. The first course was stopped at day 7 because of neutropenia. The dose was decreased, a second course was started, and the patient completed her second course without neutropenia. After completion of the second course, we discovered that she had taken generic drugs(NKS-1Ⓡ combination OD tablet)during the second course. She was enrolled in a clinical trial in which the administration of generic drugs was not permitted, as per the protocol. Beginning with the third course, we once again treated her with TS-1, and we observed a return of neutropenia in every subsequent course. We decreased the dose of TS-1 and changed the administration schedule each time. She exhibited no neutropenia only when using the generic S-1 formulation. It is possible that the anti-tumor effect of the generic S-1 formulation, and its associated adverse events, are not identical to the innovator formulation.
要旨
症例は72歳,女性。胃体上部癌に対して腹腔鏡下胃全摘を施行した。pT3,N1,M0,pStageⅡBであり,術後48日目より補助化学療法としてティーエスワンⓇ(TS-1)配合OD錠の投与を開始した。1コース目は好中球減少により7日目以降スキップした。減量して2コース目を行い,好中球減少を認めず完遂できた。臨床試験参加症例であり,後発医薬品の使用は認められていなかったが,患者への聞き取りで2コース目はエヌケーエスワンⓇ配合OD錠が投与されていたことが判明した。3コース目以降はTS-1に戻して継続したが,毎コース好中球減少を認め,減量と投与スケジュールの変更を行った。後発医薬品内服時のみ好中球減少が軽快しており,先発医薬品と薬理作用の違いがある可能性が考えられた。