PD-L1低表達的膀胱癌患者使用PD-1/PD-L1抗體治療和順鉑化療相比死的更快

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原因是幾乎同一時間，美國FDA在去年夏天修改了PD-1/PD-L1抗體用於膀胱癌的標準，僅限於PD-L1高表達並且不能使用順鉑的病人。因為去年NIH就發布公報，根據正在進行的大型臨床試驗數據，對於PD-L1低表達的膀胱癌病人，使用PD-1抗體或者PD-L1抗體治療相比順鉑化療死的更快。

所以我的預判就是，國內目前正在使用BGB-A317治療的膀胱癌病人，如果是PD-L1低表達，應該會比對照的化療組死的更快。

「（百濟神州）這項臨床試驗（CTR20170071）早已經獲得了國家葯監部門的批准，目的是研究BGB-A317在已經治療的、PD-L1陽性、局部晚期或轉移性尿路上皮癌患者中的安全性和有效性，目前正在上海、北京、廣州、南京、天津、杭州、南昌、廣州、成都、武漢、福州、溫州、瀋陽等地多家三甲醫院的泌尿外科或腫瘤科開展。」

國內對PD-L1陽性的標準目前是1%, 實際上這還是屬於低表達， 我個人認為超過20%以上的高表達才適合。

所以美國FDA 趕緊叫停了PD-L1低表達膀胱癌患者使用PD1或者PD-L1抗體，但是我相信中國的監管機構CFDA並沒有叫停百濟神州正在中國多地進行的膀胱癌臨床試驗，這意味著幾十到上百名PD-L1低表達的膀胱癌患者將會成為百濟神州這項臨床試驗（CTR20170071）的受害者。

關於PD-1抗體和PD-L1抗體對PD-L1低表達膀胱癌危害的信息可以參考美國NIH的官網：

https://www.cancer.gov/news-events/cancer-currents-blog/2018/bladder-cancer-checkpoint-inhibitor-change?

www.cancer.gov

Last year』s approvals were based on results from two small, early-phase clinical trials. On June 20, however, the agency announced that data from two larger, ongoing clinical trials showed that patients with metastatic bladder cancer treated with either pembrolizumab or atezolizumab died sooner than those treated with a standard chemotherapy regimen.

The worse survival was seen specifically in people whose tumor cells had very low levels of the protein PD-L1.

As a result of the new findings, FDA announced that it was changing the prescribing label for both drugs. Under the change, pembrolizumab and atezolizumab should be used as an initial, or first-line, treatment in only those people with metastatic bladder cancer who can』t receive cisplatin-based chemotherapy and whose tumors have high levels of PD-L1. The assessment of PD-L1 levels must be made using an FDA-cleared test.

Under the labeling change, Dr. Apolo noted, patients who can』t be treated with any platinum-containing therapy can still receive either immunotherapy drug, regardless of their PD-L1 levels.

最後一點說的是，如果病人無法使用化療，不管他們的PD-L1水平高低，還是可以使用免疫治療(因為沒有更好的選擇)。

所以我給國內膀胱癌患者的建議就是，不要盲目嘗試PD1抗體，除非你無法耐受順鉑或者腫瘤組織的PD-L1水平很高。