140DAI54300模块备件

140DAI54300

审查TA524；Brentuximab-vedotin治疗CD30-
阳性霍奇金淋巴瘤
TA524于2018年6月发布，计划在
2021.
决定
1.TA524仍然相关，不需要更新。
根本原因
2.自TA524发表以来，已经发表了18篇与
TA524的结论。大部分新证据报告了新的生存数据和
分析。大多数适用于英国。无重大安全问题
已经提出。因为这些新文章的发现支持
委员会从TA524得出的结论，并且没有新的证据可以解决
复发或进展风险增加人群中的关键不确定性
自体干细胞移植（群体2；不推荐）后
无需对指南进行全面审查。我们不知道有什么新的
证据将在未来几年内公布，这将推迟
审查决定是适当的。没有正在进行的临床指南更新
本指南应交叉引用。建议：
指南仍然相关，无需更新。
新证据概述和审查的影响
自
指南发布了吗？
不，价格不变。
©NICE 2021。保留所有权利。以权利通知为准。第2页，共9页
市场营销是否存在任何现有或拟议变更
会影响现有指南的授权？
4.营销授权已扩大，包括“ADCETRIS是
适用于先前未经治疗的CD30+IV期霍奇金淋巴瘤的成年患者
淋巴瘤（HL）联合阿霉素、长春花碱和达卡巴嗪
（AVD）（见第4.2节和第5.1节）这不会影响现有指南，但
对这一新人口进行评估将是适当的。
原始指南中是否确定了任何不确定性？有吗
可能解决这个问题的新证据？
5.存活率、健康相关生活质量和干细胞相对比率的估计
化疗或布伦妥昔单抗、维多汀后的移植是关键
原始指南中的不确定性。
6.英国和德国的一项现实世界数据研究（2018年）发现
ASCT后布伦妥昔单抗和维多汀的存活率高于接受ASCT的患者
化疗另一项英国研究（2020年）针对复发或难治患者
自体干细胞移植后的经典霍奇金淋巴瘤（cHL）
移植（ASCT），发现服用
布伦妥昔单抗和维多汀（92.2%）高于接受挽救性化疗的患者
(30.5%). 有利于布伦妥昔单抗的类似统计显著益处也有：
这是在考虑无进展生存时发现的。试验后5年随访
（AETHRA）在ASCT后复发风险增加的人群中
出版。研究发现，ASCT后与布伦妥昔单抗韦多汀合并
与安慰剂相比，无进展生存率提高。另一项研究发现
在2次治疗失败后使用布伦妥昔单抗、维多汀或第二次SCT（人群3）
这可以提高生存率。虽然这一新的证据可能解决了一些问题
在先前与生存相关的高度不确定性中，发现如下
支持委员会关于以下方面的原始考虑和结论：
原始证据库。因此，这一证据不太可能改变
这是初的建议。
7.没有发布任何新的证据来解决与
CD30+霍奇金病患者的长期健康相关生活质量
©NICE 2021。保留所有权利。以权利通知为准。第3页，共9页
自体移植后复发或进展风险增加的淋巴瘤

140DAI54300

140DAI54300

Review of TA524; Brentuximab vedotin for treating CD30-
positive Hodgkin lymphoma
TA524 was published in June 2018 and scheduled to be considered for review in
2021.
Decision
1. TA524 remains relevant and an update is not needed.
Rationale
2. Since the publication of TA524 18 articles have been published relating to the
conclusions of TA524. Much of this new evidence reports new survival data and
analyses. The majority is generalisable to the UK. No major safety concerns
have been raised. Because the findings of these new articles support the
committee’s conclusions from TA524, and there is no new evidence to address
the key uncertainties in population at increased risk of relapse or progression
after autologous stem cell transplant (population 2; not recommended), there is
no need to undertake a full review of the guidance. We are unaware of any new
evidence being published in the next few years which would make the deferral of
the review decision appropriate. There are no ongoing clinical guidance updates
to which this guidance should be cross-referred. It is recommended that this
guidance remains relevant and an update is not needed.
Summary of new evidence and implications for review
Has there been any change to the price of the technology(ies) since the
guidance was published?
3. No, price unchanged. 
© NICE 2021. All rights reserved. Subject to Notice of rights. 2 of 9
Are there any existing or proposed changes to the marketing
authorisation that would affect the existing guidance?
4. The marketing authorisation has been expanded to include “ADCETRIS is
indicated for adult patients with previously untreated CD30+ Stage IV Hodgkin
lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine
(AVD) (see sections 4.2 and 5.1).” This does not affect the existing guidance, but
an appraisal for this new population would be appropriate.
Were any uncertainties identified in the original guidance? Is there any
new evidence that might address this?
5. Estimates of survival, health-related quality of life, and relative rates of stem cell
transplants after chemotherapy or brentuximab vedotin were the key
uncertainties in the original guidance.
6. A UK and German real-world data study (2018) found people who received
brentuximab vedotin after ASCT had better survival than people received
chemotherapy. Another UK study (2020) in people with relapsed or refractory
(R/R) classical Hodgkin lymphoma (cHL) after autologous stem cell
transplantation (ASCT), found 5-year survival was higher for people taking
brentuximab vedotin (92.2%) than those people receiving salvage chemotherapy
(30.5%). Similar statistically significant benefits favouring brentuximab were also
found when considering progression free survival. 5-year follow-up from the trial
(AETHERA) in people at increased risk of relapse after ASCT has been
published. It found that consolidation with brentuximab vedotin after ASCT
improved progression free survival compared to placebo. Another study found
using brentuximab vedotin or a 2nd SCT after 2 failed therapies (population 3)
could improve survival. While this newly available evidence may address some
of the previously highly uncertainties relating to survival, the findings are
supportive of the committee’s original considerations and conclusions relating to
the original evidence base. So, it is unlikely this evidence would change the
original recommendation.
7. No new evidence has been published which would address uncertainties relating
to long-term health related quality of life in people with CD30+ Hodgkin’s 
© NICE 2021. All rights reserved. Subject to Notice of rights. 3 of 9
Lymphoma at increased risk of relapse or progression after autol