内容紹介
Summary
Cabazitaxel, which is a novel semi-synthetic anti-cancerous agent, is newly approved for the treatment of metastatic castration resistant prostate cancer(CRPC). The main dose-limiting toxicity is considered to be febrile neutropenia(FN). In this study, we retrospectively investigated the safety profiles of Japanese patients during cabazitaxel therapy. From September 2014 to August 2016, 17 patients initiated receiving cabazitaxel therapy in our institution. Prophylactically, pegfilgrastim was administered to all patients. Among 17 patients, 5 patients(29.4%)developed FN. Four of these patients(80%)developed FN in the first cycle and could continue the cabazitaxel therapy with dose modification, whereas 1 patient(20%)developed FN leading to septic shock in the 8th cycle. Although he recovered after appropriate medical treatment, he discontinued the cabazitaxel therapy. Regarding non-hematological adverse events, no unknown adverse events were observed. The most frequently observed adverse event was back pain(n=4, 23.5%). There was no influence on the continuation of treatment. Treatment discontinuation due to adverse events was observed in 1 patient(5.9%). Due to the prophylactic pegfilgrastim in combination, the occurrence rate of FN seemed to decrease. However, we must remember that FN is still frequently expressed even under the prophylactic pegfilgrastim.
要旨
cabazitaxel治療においてpegfilgrastimを予防的投与した際の安全性を検討する目的で,治療実施状況,発熱性好中球減少症(fibrile neutropenia: FN)の発現率と発現時期,有害事象発現状況について2014年9月～2016年8月まで当院でcabazitaxelを投与された去勢抵抗性前立腺癌(castration resistant prostate cancer: CRPC)の患者17例を対象にレトロスペクティブに調査を行った。その結果,FNの発現率は29.4%(5/17例)で,そのうち80%(4/5例)が1サイクル目に発現した。有害事象に関してはこれまでに報告のないものは認めなかったが,背部痛の発現が23.5%(4/17例)にみられた。いずれもGrade 2以下で治療継続には影響はなかった。副作用による治療中止は5.9%(1/17例)にみられ,FNによるものであった。cabazitaxelは国内第Ⅰ相臨床試験において54.5%のFN発現率が報告されたが,pegfilgrastimを併用することで有効で安全に投与できた。FNはpegfilgrastim併用した場合においても高頻度に発現することがわかり,FN発現の有無を十分に観察し治療継続する必要がある。
目次
Cabazitaxel, which is a novel semi-synthetic anti-cancerous agent, is newly approved for the treatment of metastatic castration resistant prostate cancer(CRPC). The main dose-limiting toxicity is considered to be febrile neutropenia(FN). In this study, we retrospectively investigated the safety profiles of Japanese patients during cabazitaxel therapy. From September 2014 to August 2016, 17 patients initiated receiving cabazitaxel therapy in our institution. Prophylactically, pegfilgrastim was administered to all patients. Among 17 patients, 5 patients(29.4%)developed FN. Four of these patients(80%)developed FN in the first cycle and could continue the cabazitaxel therapy with dose modification, whereas 1 patient(20%)developed FN leading to septic shock in the 8th cycle. Although he recovered after appropriate medical treatment, he discontinued the cabazitaxel therapy. Regarding non-hematological adverse events, no unknown adverse events were observed. The most frequently observed adverse event was back pain(n=4, 23.5%). There was no influence on the continuation of treatment. Treatment discontinuation due to adverse events was observed in 1 patient(5.9%). Due to the prophylactic pegfilgrastim in combination, the occurrence rate of FN seemed to decrease. However, we must remember that FN is still frequently expressed even under the prophylactic pegfilgrastim.
要旨
cabazitaxel治療においてpegfilgrastimを予防的投与した際の安全性を検討する目的で,治療実施状況,発熱性好中球減少症(fibrile neutropenia: FN)の発現率と発現時期,有害事象発現状況について2014年9月～2016年8月まで当院でcabazitaxelを投与された去勢抵抗性前立腺癌(castration resistant prostate cancer: CRPC)の患者17例を対象にレトロスペクティブに調査を行った。その結果,FNの発現率は29.4%(5/17例)で,そのうち80%(4/5例)が1サイクル目に発現した。有害事象に関してはこれまでに報告のないものは認めなかったが,背部痛の発現が23.5%(4/17例)にみられた。いずれもGrade 2以下で治療継続には影響はなかった。副作用による治療中止は5.9%(1/17例)にみられ,FNによるものであった。cabazitaxelは国内第Ⅰ相臨床試験において54.5%のFN発現率が報告されたが,pegfilgrastimを併用することで有効で安全に投与できた。FNはpegfilgrastim併用した場合においても高頻度に発現することがわかり,FN発現の有無を十分に観察し治療継続する必要がある。