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本帖最后由 橙色雨丝 于 2015-3-28 11:02 编辑
Q & A With Dr. Andrew Evens: Frontline Bortezomib in MCL
美国专家谈硼替佐米在套细胞淋巴瘤治疗上的作用
Late last year, the FDA approved bortezomib (Velcade) in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP) to be used as a frontline treatment in patients with mantle cell lymphoma (MCL).
去年年底，FDA批准了硼替佐米（万珂）与美罗华，环磷酰胺，阿霉素及泼尼松（VR-CAP）联合化疗作为套细胞淋巴瘤（MCL）的一线治疗方案。
The decision was based on findings from the phase III LYM-3002 study that compared VR-CAP with standard R-CHOP in previously untreated patients with MCL. In the study, VR-CAP improved progression-free survival (PFS) by 37% compared with standard R-CHOP. Data from the study were recently published in The New England Journal of Medicine.
这个决定是基于来自LYM-3002三期临床试验的结果，这项研究对VR-CAP与标准R-CHOP在初治MCL中的效果进行了比较。研究中，与标准的R-CHOP相比，VR-CAP将无进展生存率提高了37%。研究的结果最近发表在新英格兰医学杂志上。
To gain new insight on this pivotal study and bortezomib’s use in the frontline MCL setting, Targeted Oncology interviewed Andrew Evens, DO, MSc, director of the Tufts Cancer Center and chief of the Division of Hematology/Oncology at Tufts University School of Medicine.
为了深入了解这项重要的研究以及硼替佐米在MCL初治中的作用，我们采访了Tufts癌症中心和Tufts大学医学院血液/肿瘤科主任Andrew Evens博士。
What was the rationale behind this study?
这项研究的出发点是什么？
MCL is a subtype of non-Hodgkin lymphoma that is very treatable but is often aggressive and not curable. Despite being able to give patients treatment and obtain remission, these remissions are often short-lived. There is a need to find tolerable treatments that can extend the time that patients are in remission or even find a cure.
MCL是非霍奇金淋巴瘤的一个亚型，可以有多种手段治疗但是通常呈侵袭性发展并不可治愈。尽管可以通过治疗获得缓解，但是这些缓解经常是短暂的。我们需要找到可耐受的治疗方法以延长缓解时间甚至治愈疾病。
This study represents another step in that process. There have been a few studies over the years that have tried to improve upon the natural history of MCL, but we have not had many breakthroughs for patients with newly diagnosed disease. There are several new targeted agents that have been approved by the FDA for patients with relapsed or refractory MCL, but there had really been none approved for patients with newly-diagnosed or untreated disease.
这项研究代表了在这个方向上前进的另一步。近些年来有几项研究试图改善MCL的自然病史，但是对于新发的病人我们并没有太多的突破性进展。FDA批准了几个针对复发难治病人的新的靶向药物，但是没有一个是针对新发或者是初治病人的。
Bortezomib is one agent that’s been approved for patients with relapsed or refractory disease. The hope is not to wait for a relapse, but rather, to bring it to the frontline or untreated patient population. In this study, the research team replaced vincristine with bortezomib in frontline therapy with R-CHOP.
硼替佐米是被批准用于复发难治病人的药物。我们的希望是不要等到复发，而是将其用于一线或是初治的病人。在这项研究中，研究小组用硼替佐米替代了一线方案R-CHOP中的长春新碱。
What did the study find?
研究发现了什么？
The study really hit all of its endpoints in terms of response and PFS. Median PFS was 14.4 months among patients receiving the standard R-CHOP, and it was 24.7 months among patients in the bortezomib arm.
这项研究在应答率和无进展生存率上都达到了预期终点。接受标准R-CHOP方案的病人中位无进展生存率是14.4个月，而硼替佐米治疗组的病人则达到了24.7个月。
On the bortezomib arm, there was an increased risk of hematologic toxicity. It’s known that vincristine is associated with neurologic toxicity. How do these toxicities compare?
在硼替佐米组，血液毒性的风险增加了。众所周知长春新碱有神经度毒性。两个组的毒性反应比较如何？
We don’t want to increase any toxicity, but in treating these lymphomas, we are very used to managing hematologic toxicities. These toxicities are not life-threatening— they’re manageable. Patients usually don’t feel hematologic toxicities. They’re just blood numbers. However, a neurologic toxicity can really affect a patient’s quality of life.
我们不希望增加任何毒性，但是在淋巴瘤治疗中，我们对血液毒性的控制很有经验。这些毒性不是致命的，它们是可控的。病人们通常不会感觉到血液毒性。它们只是一些血液指标而已。但是，神经毒性的确会影响病人的生活质量。
How are these hematologic toxicities managed?
怎样来控制这些血液毒性呢？
In the control arm, there was an increased incidence of thrombocytopenia. This is usually managed with observation. If it dips too low, the patient would need a platelet transfusion. In this case, though, only a small percentage needed this procedure.
在对照组中，发生血小板缺乏症的几率增加了。这通常是进行观察就可以了。如果血小板降的太低，就需要输血小板。但是，试验中只有极少数需要这样做。
What does the approval of frontline bortezomib mean for practicing oncologists/hematologists?
批准硼替佐米的一线使用对临床肿瘤医师/血液科医师意味着什么？
This is an important breakthrough in the treatment of newly diagnosed MCL. We now have a novel therapeutic agent that, when integrated into standard frontline therapy, can benefit meaningful endpoints.
这是在新发MCL治疗上的一个重要突破。我们现在有了一个新药，与标准一线方案联合使用可以使病人在各项生存指标上获益。
Is this practice changing now?
那么目前是否已经改变了临床常规？
I think this is potentially practice changing. When these studies are designed, they are designed with an understanding of the science at that time.
我认为存在改变临床常规的潜能。在设计这些临床试验的时候，方案的设计包含了最新的科学成果。
When the trial started, R-CHOP was a fairly standard regimen. Now, we still use R-CHOP, but we’ll then give 2 years of rituximab maintenance. The unanswered question here is, “Would these patients who benefitted from bortezomib benefit in the same way when given rituximab as maintenance?” There are studies ongoing right now that are addressing this.
在试验开始的时候，R-CHOP仍是非常标准的方案。现在，我们依然使用R-CHOP，但是我们接下去还做两年的美罗华维持。还不能回答的问题是，“这些从硼替佐米获益的病人，是否也可以从美罗华维持中获益？”目前有临床试验正在试图回答这个问题。
E1411 should really define and potentially be practice changing, given the current standard of rituximab maintenance.
基于目前标准的美罗华维持，E1411应该可以规范并且潜在的改变临床常规。
[E1411 is a phase II four-arm study of patients with untreated MCL. The study is comparing rituximab plus bendamustine followed by rituximab consolidation; rituximab plus bendamustine and bortezomib followed by rituximab consolidation; rituximab plus bendamustine followed by lenalidomide plus rituximab consolidation; and rituximab plus bendamustine and bortezomib followed by lenalidomide plus rituximab consolidation.]E1411是一项针对新发MCL病人的二期四臂临床试验。该试验对以下四种治疗方式进行比较：美罗华联合本达莫斯汀加美罗华巩固；美罗华联合本达莫斯汀和硼替佐米加美罗华巩固；美罗华联合本达莫斯汀加来那度胺和美罗华巩固；美罗华联合本达莫斯汀及硼替佐米加来那度胺和美罗华巩固。
What questions remain in newly diagnosed MCL?
对于新发的MCL还有什么问题？
I think the whole platform is integrating targeted therapeutic agents with agents we already have. We’re still figuring out out the impact of adding bortezomib and lenalidomide, but what about ibrutinib? How do we integrate ibrutinib into practice? We might use ibrutinib with chemotherapy or we could use it with other targeted agents.
我认为整个治疗平台是将靶向药物与现有药物进行整合。我们正在试图弄清楚加入硼替佐米和来那度胺的影响，但是伊布替尼呢？我们如何把伊布替尼也加入进去？我们也许会将伊布替尼与化疗联合或者与其它靶向药物联合使用。
Immune checkpoint inhibitors have not had as big of an impact yet in MCL, but they’re not a priority yet.
免疫检查点抑制剂到目前为止还没有对MCL的治疗产生很大影响，但是它们目前尚不是重点。
We could get to a point in the next decade when we use all targeted agents in this space. That’s where oncology is moving in general, not just in MCL.
我们也许可以在今后十年内在这上面使用所有的靶向药物。这是肿瘤学的一个大方向，不仅仅是针对MCL。
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