Anti PD1藥品的安全性 @ 探索癌症

Anti PD1藥品對多數人而言附作用比化療輕許多

Anti PD1藥品雖然毒性低但是卻有可能會造成嚴重問題威脅生命甚至導致死亡

我的朋友肺腺癌4期就是打OPDIVO (Nivolumab)造成肝腎衰竭去世的

所以Anti PD1藥品的安全性

PD-1抑制劑能夠作用於所有活化的T細胞

活化的T細胞一旦被PD-1抑制劑沾粘後免疫系統將無法調節這些T細胞 (即讓這些T細胞自然死亡)

如果病人肺部或腸道對某些細菌或病毒有活化的T細胞免疫系統將無法調節這些T細胞有可能會造成肺炎潰瘍性腸炎肝炎腎臟發炎

其中以肺炎最為常見(不良事件3/4級 10-14%) 有可能需要長期使用類固醇來調節這些不受控制的T細胞

最糟糕的狀況是病人體內有一些會攻擊自體器官的T細胞

被PD-1抑制劑沾粘後免疫系統無法調節這些T細胞

失控T細胞有可能攻擊重要器官包括肝肺腸腦造成肝衰竭腎衰竭腦炎

PD-1抑制劑有可能引起嚴重的自體免疫疾病威脅病人生命

藥商OPDIVO安全性的說明是

OPDIVO可以造成你的免疫系統攻擊你身體正常器官和組織影響它們的功能

可能會造成嚴重問題威脅生命甚至導致死亡

這些問題可能在治療中甚至於治療結束後任何時間出現

OPDIVO can cause your immune system to attack normal organs and tissues in many areas of your body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended.

KEYTRUDA^® (pembrolizumab) can cause your immune system to attack normal organs and tissues in many areas of your body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death.

nivolumab臨床實驗有4位病人因nivolumab引發的肺炎死亡 14%的病人有3級以上的不良事件

pembrolizumab臨床實驗有1位病人因pembrolizumab引發的肺炎死亡 13-16%的病人3級以上不良事件

藥商官網

OPDIVO

http://www.opdivo.bmscustomerconnect.com/advanced-nsclc/side-effects

KEYTRUDA

https://www.keytruda.com/non-small-cell-lung-cancer/

藥商官網要病人注意的事項當你出現其中一些現象要告知你的醫師

肺部問題: 新或惡化的咳嗽胸痛氣喘

腸道問題: 經常性腹瀉血便或深色黏稠性大便腹痛

肝臟問題: 皮膚或眼白變黃嚴重嘔吐胃的右側疼痛極度疲倦茶色尿液皮膚淤血或淤青失去胃口

賀爾蒙腺體問題: 持續性頭痛極度疲倦體重增加或減少情緒改變頭暈掉髮感覺冷便秘聲音變沉口渴尿多

腎臟問題: 尿量減少血尿腳關節水腫失去胃口

皮膚問題: 紅疹癢起泡口腔黏膜潰瘍

腦炎: 頭痛發燒疲倦嗜睡糊塗混淆精神錯亂抽筋

其他問題: 視力改變嚴重肌肉關節痛嚴重肌肉無力

嚴重注射反應:發冷發抖紅疹癢呼吸困難頭暈發燒感覺要休克

PD1抑制劑毒性管理

二級不良症狀應停止注射直到症狀低於一級如果在一週內沒好轉應開始類固醇0.5 mg/kg/day

三級四級不良症狀應永久停止注射PD1抑制劑病人應給予高劑量類固醇1 to 2 mg/kg/day 當症狀好轉至一級可以開始逐漸減少類固醇劑量

In general, treatment of moderate or severe irAEs requires interruption of the checkpoint inhibitor and the use of corticosteroid immunosuppression. Treatment is based upon the severity of the observed toxicity:

For patients with grade 2 (moderate) immune-mediated toxicities, treatment with the checkpoint inhibitor should be withheld and should not be resumed until symptoms or toxicity is grade 1 or less. Corticosteroids (prednisone 0.5 mg/kg/day or equivalent) should be started if symptoms do not resolve within a week.

For patients experiencing grade 3 or 4 (severe or life-threatening) immune-mediated toxicities, treatment with the checkpoint inhibitor should be permanently discontinued. High doses of corticosteroids (prednisone 1 to 2 mg/kg/day or equivalent) should be given. When symptoms subside to grade 1 or less, steroids can be gradually tapered over at least one month.

http://www.uptodate.com/contents/toxicities-associated-with-checkpoint-inhibitor-immunotherapy