fny5jt9 发表于 2024-6-8 00:36:03

120万一针的抗癌神药，远期效果到底怎么样?

<span style="color: black;"><img src="https://mmbiz.qpic.cn/mmbiz_gif/9cac90fPM8OScnIZ8JHZ8HAeI9y32rerYgP9Aeicwa9Lic54DIK6ianibNZKvX48t11MeibIx6icbw1qbdhg6u2sKbtg/640?wx_fmt=gif&amp;tp=webp&amp;wxfrom=5&amp;wx_lazy=1" style="width: 50%; margin-bottom: 20px;"></span><span style="color: black;">CAR</span><span style="color: black;">-</span><span style="color: black;">T细胞</span><span style="color: black;">是一种工程化细胞，<span style="color: black;">能够</span></span><span style="color: black;">靶向肿瘤细胞上的特定抗原，从而产生抗肿瘤免疫反应。</span><span style="color: black;">该<span style="color: black;">药品</span>上市后定价曾高达120万一针，<span style="color: black;">导致</span>了广泛关注。</span><img src="https://mmbiz.qpic.cn/mmbiz_png/9cac90fPM8Oo70cTutVAlPqg8YtbMlk7Kc99lh3fTIzCmCCnnOLltLWvOcYEO72Z9w8CicAx8hnbv8TSyf3lPGQ/640?wx_fmt=png&amp;tp=webp&amp;wxfrom=5&amp;wx_lazy=1&amp;wx_co=1" style="width: 50%; margin-bottom: 20px;">
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">doi: 10.3390/cancers15030663.</span></p><span style="color: black;"><span style="color: black;">初期</span>临床<span style="color: black;">实验</span><span style="color: black;">发掘</span>，靶向CD19的CAR-T细胞对复发和/或难治性(R/R) B细胞淋巴瘤<span style="color: black;">拥有</span>强大的治疗作用。靶向CD19的CAR-T细胞现已被FDA<span style="color: black;">准许</span>用于治疗R/R侵袭性B细胞淋巴瘤、套细胞淋巴瘤和惰性B细胞淋巴瘤。</span><span style="color: black;"><span style="color: black;">同期</span>，CAR-T细胞对R/R急性B淋巴细胞白血病（B-ALL）<span style="color: black;">亦</span>有较为<span style="color: black;">明显</span>的疗效，<span style="color: black;">日前</span><span style="color: black;">亦</span>被FDA<span style="color: black;">准许</span>用于R/R B-ALL<span style="color: black;">病人</span>。</span><span style="color: black;"><span style="color: black;">近期</span>，靶向B细胞成熟抗原（BCMA）的CAR-T细胞疗法在R/R多发性骨髓瘤(RRMM)<span style="color: black;">病人</span>中取得了<span style="color: black;">明显</span>成功，<span style="color: black;">实验</span><span style="color: black;">表示</span>总体缓解率为73%~98%。靶向BCMA的CAR-T细胞<span style="color: black;">日前</span>已被FDA<span style="color: black;">准许</span>用于RRMM<span style="color: black;">病人</span>。</span><img src="https://mmbiz.qpic.cn/mmbiz_png/9cac90fPM8Oo70cTutVAlPqg8YtbMlk7SSWVMtWicHrParbQe5KVlAhKia6lJeKcuXA4AibGo8suwiaiayAVK7NGhvw/640?wx_fmt=png&amp;tp=webp&amp;wxfrom=5&amp;wx_lazy=1&amp;wx_co=1" style="width: 50%; margin-bottom: 20px;"><span style="color: black;">doi: 10.1038/s41571-023-00754-1.</span><span style="color: black;">总的<span style="color: black;">来讲</span>，CAR-T细胞疗法<span style="color: black;">已然</span><span style="color: black;">作为</span>血液系统恶性肿瘤治疗的<span style="color: black;">要紧</span><span style="color: black;">构成</span>部分，并且这些疗法的适应症正继续扩大到<span style="color: black;">初期</span>治疗。</span><span style="color: black;"><strong style="color: blue;"><span style="color: black;"><span style="color: black;">1、</span>CAR-T细胞疗法对血液系统肿瘤的远期疗效</span></strong></span><strong style="color: blue;"><span style="color: black;">● CAR-T细胞疗法对B细胞淋巴瘤和慢性淋巴细胞白血病（CLL）</span></strong><span style="color: black;"><span style="color: black;">近期</span>一项<span style="color: black;">触及</span>43例R/R B细胞淋巴瘤或CLL<span style="color: black;">病人</span>的临床<span style="color: black;">科研</span><span style="color: black;">显示</span>，CAR-T细胞治疗后58%的<span style="color: black;">病人</span>达到了完全缓解（CR）, 76%的CR<span style="color: black;">病人</span>保持<span style="color: black;">长时间</span>缓解，<span style="color: black;">连续</span>时间为43~113个月。</span><span style="color: black;">另一项对B细胞淋巴瘤的<span style="color: black;">科研</span><span style="color: black;">发掘</span>，<span style="color: black;">病人</span>接受CAR-T细胞治疗后CR率为55%，其中60%的<span style="color: black;">病人</span>在5年后仍<span style="color: black;">处在</span>缓解状态。这些结果<span style="color: black;">显示</span>，相当一部分接受靶向CD19的CAR-T细胞治疗的B细胞淋巴瘤<span style="color: black;">病人</span>可能不<span style="color: black;">必须</span>进一步<span style="color: black;">干涉</span>就能达到治愈。</span><img src="https://mmbiz.qpic.cn/mmbiz_png/9cac90fPM8Oo70cTutVAlPqg8YtbMlk7RmoAL1rPUTUic2dz72ibZrkxic33CjUmE8IzBwdiaURBZdXE2WI6o3KyfA/640?wx_fmt=png&amp;tp=webp&amp;wxfrom=5&amp;wx_lazy=1&amp;wx_co=1" style="width: 50%; margin-bottom: 20px;"><span style="color: black;">www.veer.com</span><span style="color: black;"><strong style="color: blue;"><span style="color: black;">●&nbsp;</span></strong><strong style="color: blue;">CAR-T细胞疗法对B-ALL</strong></span><span style="color: black;">CAR-T细胞疗法对B-ALL成年<span style="color: black;">病人</span>的CR率为69%，中位<span style="color: black;">没</span>复发<span style="color: black;">存活</span>期为7个月。而在B-ALL儿童<span style="color: black;">病人</span>中，CR率为82%，中位<span style="color: black;">没</span>复发<span style="color: black;">存活</span>期为24个月。这些数据<span style="color: black;">显示</span>，与成年人相比，接受CD19靶向CAR-T细胞治疗的儿童<span style="color: black;">病人</span>的<span style="color: black;">存活</span><span style="color: black;">显著</span>更优。</span><span style="color: black;"><span style="color: black;">针对</span>CAR-T细胞治疗后B-ALL<span style="color: black;">病人</span><span style="color: black;">可否</span><span style="color: black;">必须</span>进行巩固性造血干细胞移植，<span style="color: black;">日前</span>还存在争议。儿童和成人<span style="color: black;">病人</span>的<span style="color: black;">长时间</span>预后<span style="color: black;">显著</span>不同，<span style="color: black;">因此呢</span><span style="color: black;">必须</span>单独讨论巩固性造血干细胞移植在这些人群中的价值。</span><span style="color: black;">在儿童中，有相当比例的<span style="color: black;">病人</span>在单独<span style="color: black;">运用</span>CAR-T细胞治疗后<span style="color: black;">得到</span><span style="color: black;">长时间</span>缓解。<span style="color: black;">因此呢</span>，巩固性造血干细胞移植则被常规<span style="color: black;">举荐</span>给<span style="color: black;">身患</span>B-ALL的成人<span style="color: black;">病人</span>。总体而言，CD19靶向CAR-T细胞的CR率非常高，在许多<span style="color: black;">科研</span>中都超过80%。与B细胞淋巴瘤<span style="color: black;">病人</span>相比，B-ALL<span style="color: black;">病人</span>更有可能达到CR。</span><img src="https://mmbiz.qpic.cn/mmbiz_png/9cac90fPM8Oo70cTutVAlPqg8YtbMlk7iaLIGGkd2o8CibjNzuFCh0mFtvGVwogbvqmtpNlyibUWLc82sE0waAGXw/640?wx_fmt=png&amp;tp=webp&amp;wxfrom=5&amp;wx_lazy=1&amp;wx_co=1" style="width: 50%; margin-bottom: 20px;"><span style="color: black;">www.veer.com</span><span style="color: black;"><strong style="color: blue;"><span style="color: black;">●</span></strong><strong style="color: blue;">BCMA靶向CAR-T细胞疗法对RRMM</strong></span><span style="color: black;">与CD19靶向CAR-T细胞相比，BCMA靶向CAR-T细胞治疗的RRMM<span style="color: black;">病人</span>的<span style="color: black;">长时间</span>预后数据较少。<span style="color: black;">关联</span>的临床数据<span style="color: black;">表示</span>，治疗的总体缓解率为73%~100%，CR率为33%~83%。</span><span style="color: black;">国外<span style="color: black;">长时间</span>随访数据<span style="color: black;">表示</span>，<span style="color: black;">病人</span>的中位<span style="color: black;">没</span><span style="color: black;">发展</span><span style="color: black;">存活</span>期为8.8个月，接受最高剂量治疗的<span style="color: black;">病人</span>中位<span style="color: black;">没</span><span style="color: black;">发展</span><span style="color: black;">存活</span>期可<span style="color: black;">增多</span>到12.1个月。<span style="color: black;">得到</span>CR的<span style="color: black;">病人</span>的中位缓解<span style="color: black;">连续</span>时间为19个月。</span><img src="https://mmbiz.qpic.cn/mmbiz_png/9cac90fPM8Oo70cTutVAlPqg8YtbMlk7yneY3LiaiaPYBmsibHSic1IRxFuVSpvu6M8dUmp8BhcqSFUCmq4P3heuGA/640?wx_fmt=png&amp;tp=webp&amp;wxfrom=5&amp;wx_lazy=1&amp;wx_co=1" style="width: 50%; margin-bottom: 20px;"><span style="color: black;">www.veer.com</span><span style="color: black;">来自中国的针对74例RRMM<span style="color: black;">病人</span>的<span style="color: black;">长时间</span>随访<span style="color: black;">科研</span><span style="color: black;">表示</span>，<span style="color: black;">病人</span>中位<span style="color: black;">没</span><span style="color: black;">发展</span><span style="color: black;">存活</span>期为18个月。综合来看，这些数据<span style="color: black;">显示</span>，在接受BCMA靶向CAR-T细胞治疗后，RRMM<span style="color: black;">病人</span><span style="color: black;">能够</span><span style="color: black;">得到</span>较长的缓解期，但随着时间的推移，<span style="color: black;">疾患</span><span style="color: black;">发展</span>的<span style="color: black;">危害</span>会<span style="color: black;">增多</span>。</span><span style="color: black;"><strong style="color: blue;"><span style="color: black;"><span style="color: black;">2、</span>CAR-T细胞疗法在实体肿瘤中的应用<span style="color: black;">发展</span></span></strong></span><span style="color: black;">总的<span style="color: black;">来讲</span>，CAR-T细胞疗法在实体肿瘤中的应用还很局限，其疗效较血液系统肿瘤差。</span><span style="color: black;"><strong style="color: blue;"><span style="color: black;">●</span></strong><strong style="color: blue;">CAR-T细胞疗法对结直肠癌</strong></span><span style="color: black;">CEA是在大<span style="color: black;">都数</span>结直肠癌中表达的肿瘤标志物。<span style="color: black;">日前</span>，有几项正在进行的I期<span style="color: black;">科研</span>用于<span style="color: black;">评定</span>CEA靶向CAR-T细胞治疗晚期结直肠癌的安全性和有效性，这些<span style="color: black;">科研</span>的结果仍未正式<span style="color: black;">颁布</span>。</span><img src="https://mmbiz.qpic.cn/mmbiz_png/9cac90fPM8Oo70cTutVAlPqg8YtbMlk7BaNzICh4R9MUQlgTibD5Jf6CCtkd7gt2MLVDZcUaib5VFkicxOicN8U0mg/640?wx_fmt=png&amp;tp=webp&amp;wxfrom=5&amp;wx_lazy=1&amp;wx_co=1" style="width: 50%; margin-bottom: 20px;"><span style="color: black;">www.veer.com</span><span style="color: black;">一项I期<span style="color: black;">科研</span>的初步结果<span style="color: black;">表示</span>，在15名不可切除的转移性结直肠癌<span style="color: black;">病人</span>中，接受CAR-T治疗的<span style="color: black;">病人</span>里有2名<span style="color: black;">显现</span>部分缓解，9名病情稳定。</span><span style="color: black;"><strong style="color: blue;"><span style="color: black;">●</span></strong><strong style="color: blue;">CAR-T细胞疗法对肝细胞癌</strong></span><span style="color: black;">在肝细胞癌中，CAR-T针对的抗原靶点是GPC3。在一项<span style="color: black;">评定</span>CAR-T细胞治疗对GPC3阳性肝细胞癌疗效的I期<span style="color: black;">科研</span>中，<span style="color: black;">病人</span>接受环磷酰胺和氟达拉滨淋巴细胞清除输注。<span style="color: black;">科研</span>共纳入13例<span style="color: black;">病人</span>，总<span style="color: black;">存活</span>率在6个月时为50.3%，1年为42%，3年为10.5%。</span><span style="color: black;">在另一项I期<span style="color: black;">科研</span>中，晚期转移性肝细胞癌<span style="color: black;">病人</span>接受CD133靶向CAR-T治疗，13%的<span style="color: black;">病人</span>达到部分缓解，61%的<span style="color: black;">病人</span>病情稳定。中位<span style="color: black;">没</span><span style="color: black;">发展</span><span style="color: black;">存活</span>期为5个月，3个月<span style="color: black;">疾患</span><span style="color: black;">掌控</span>率为65%。</span><span style="color: black;"><strong style="color: blue;"><span style="color: black;">●</span></strong><strong style="color: blue;">CAR-T细胞疗法对胸部肿瘤</strong></span><span style="color: black;"><span style="color: black;">针对</span>胸部肿瘤的治疗，EGFR和MSLN特异性CAR-T细胞较有<span style="color: black;">期盼</span>临床应用，<span style="color: black;">由于</span>抗原<span style="color: black;">拥有</span>更高的特异性和更低的毒性。在一项<span style="color: black;">科研</span>中，27例恶性胸膜<span style="color: black;">疾患</span><span style="color: black;">病人</span>接受了CAR-T细胞治疗，治疗后中位总<span style="color: black;">存活</span>期为17.7个月，1年<span style="color: black;">存活</span>率为74%。</span><span style="color: black;"><span style="color: black;">
            <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">参考文献：</span></p>
            <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">1、Chen YJ, et al. CAR-T: What Is Next? Cancers (Basel). 2023, 15(3):663. doi: 10.3390/cancers15030663.</span></p>
            <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">2、Cappell KM, et al. Long-term outcomes following CAR T cell therapy: what we know so far. Nat Rev Clin Oncol. 2023, 20(6):359-371. doi: 10.1038/s41571-023-00754-1.</span></p>
            <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">3、Patel U, et al. CAR T cell therapy in solid tumors: A review of current clinical trials. EJHaem. 2022, 3:24–31. doi: 10.1002/jha2.356.</span></p>
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星☆雨 发表于 2024-9-7 12:51:33

楼主节操掉了，还不快捡起来！
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