在NIAGARA III期试验的事后探索性分析中，IMFINZI®（durvalumab）围手术期方案提高了肌肉浸润性膀胱癌症患者的无事件生存率和总生存率，而不考虑完全的病理反应状态-动脉网

IMFINZI® (durvalumab) perioperative regimen improved event-free survival and overall survival across muscle-invasive bladder cancer patients regardless of complete pathology response status in post-hoc exploratory analysis of NIAGARA Phase III trial

businesswire 等信源发布 2025-02-14 23:10

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WILMINGTON, Del.--(

威尔明顿，德尔--(

BUSINESS WIRE

商业热线

)--Results from a post-hoc exploratory subgroup analysis from the NIAGARA Phase III trial showed AstraZeneca’s IMFINZI

)--尼亚加拉邦III期临床试验的事后探索性亚组分析结果显示，阿斯利康的Imfinzis公司的产品为阿斯利康的产品。的产品。的研究结果表明，阿斯利康的产品为阿斯利康的产品。的产品，其产品为阿斯利康的产品。的生产商，其产品为阿斯利

(durvalumab), administered perioperatively in combination with neoadjuvant chemotherapy, demonstrated improvements in event-free survival (EFS) and overall survival (OS) versus neoadjuvant chemotherapy with radical cystectomy alone in patients with or without a pathologic complete response (pCR) in muscle-invasive bladder cancer (MIBC).

（durvalumab）围手术期联合新辅助化疗，在肌肉浸润性膀胱癌（MIBC）中有或没有病理完全缓解（pCR）的患者中，与单纯根治性膀胱切除术的新辅助化疗相比，无事件生存期（EFS）和总生存期（OS）有所改善。

Patients were treated with four cycles of IMFINZI in combination with neoadjuvant chemotherapy before radical cystectomy (surgery to remove the bladder) followed by eight cycles of IMFINZI monotherapy..

在根治性膀胱切除术（手术切除膀胱）之前，患者接受了四个周期的IMFINZI联合新辅助化疗，然后进行了八个周期的IMFINZI单药治疗。。

These new data were presented today at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in San Francisco, California (abstract #659).

这些新数据今天在加利福尼亚州旧金山举行的2025年美国临床肿瘤学会泌尿生殖系统癌症研讨会（ASCO GU）上发表（摘要#659）。

In NIAGARA, treatment with the IMFINZI perioperative regimen improved EFS and OS versus the comparator arm both in patients who achieved pCR and those who did not. This regimen reduced the risk of disease progression, recurrence, not undergoing surgery, or death by 42% in patients who achieved pCR and by 23% in those who did not; and reduced the risk of death by 28% in patients who achieved pCR and by 16% in those who did not (see data table below for details)..

。该方案将达到pCR的患者的疾病进展，复发，未接受手术或死亡的风险降低了42%，而未达到pCR的患者降低了23%；并将达到pCR的患者的死亡风险降低了28%，而未达到pCR的患者的死亡风险降低了16%（详见下表）。。

The IMFINZI

IMFINZI 的

perioperative regimen also improved metastasis-free survival (MFS) and disease-specific survival (DSS), two secondary endpoints, versus the comparator arm in the intent-to-treat (ITT) population. This regimen reduced the risk of developing distant metastases or death by 33% and the risk of death specifically due to bladder cancer by 31% versus the comparator arm (see data table below for details)..

与意向治疗（ITT）人群中的对照组相比，围手术期方案还改善了无转移生存期（MFS）和疾病特异性生存期（DSS），这是两个次要终点。与对照组相比，该方案将发生远处转移或死亡的风险降低了33%，特别是由于膀胱癌导致的死亡风险降低了31%（有关详细信息，请参见下面的数据表）。。

Matthew ND. Galsky, Lillian and Howard Stratton Professor of Medicine, Director of Genitourinary Medical Oncology, The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, New York, and NIAGARA Investigator and Steering Committee member, said: “

马修ND。高尔斯基（Galsky）、莉莲（Lillian）和霍华德·斯特拉顿（Howard Stratton）医学教授、泌尿生殖系统肿瘤学主任、纽约西奈山伊坎医学院蒂希癌症研究所（Tisch Cancer Institute）以及尼亚加拉（NIAGARA）研究员和指导委员会委员说：

These NIAGARA data confirm the compelling efficacy of the durvalumab perioperative regimen in muscle-invasive bladder cancer, and importantly, show this regimen improved outcomes regardless of whether patients achieved a pathologic complete response. This insight, together with the data showing the durvalumab perioperative regimen extended the time patients live before distant metastases develop, is favorable news for patients with muscle-invasive bladder cancer who are in need of better treatment options.”.

这些尼亚加拉数据证实了durvalumab围手术期方案在肌肉浸润性膀胱癌中具有令人信服的疗效，重要的是，无论患者是否达到病理完全缓解，该方案均能改善预后。这一见解以及显示durvalumab围手术期方案延长了患者在远处转移发生之前的生存时间的数据，对于需要更好治疗选择的肌肉浸润性膀胱癌患者来说是一个好消息。”。

Cristian Massacesi, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca, said: “

阿斯利康首席医疗官兼肿瘤学首席开发官克里斯蒂安·马萨塞西（CristianMassacesi）表示：

NIAGARA was the first Phase III trial of a perioperative immunotherapy regimen in muscle-invasive bladder cancer to show statistically significant and clinically meaningful improvements in event-free and overall survival. The 33 percent reduction in the risk of distant metastases, which are associated with a poorer prognosis, further reinforces the potential of perioperative IMFINZI.

尼亚加拉是肌肉浸润性膀胱癌围手术期免疫治疗方案的第一个III期试验，显示无事件生存率和总生存率有统计学意义和临床意义的改善。与预后较差相关的远处转移风险降低33%，进一步增强了围手术期IMFINZI的潜力。

to become a new standard of care in this setting.”

在这种情况下成为新的护理标准。”

These new data build on findings

这些新数据建立在调查结果的基础上

presented

介绍

at the European Society for Medical Oncology (ESMO) Congress and published in

在欧洲肿瘤内科学会（ESMO）大会上发表

The New England Journal of Medicine

新英格兰医学杂志

which showed NIAGARA met the primary endpoint of EFS and the key secondary endpoint of OS. In the ITT population, patients treated with the IMFINZI perioperative regimen showed a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus the comparator arm, as well as a 25% reduction in the risk of death.

这表明尼亚加拉符合EFS的主要终点和OS的关键次要终点。在ITT人群中，接受IMFINZI围手术期方案治疗的患者与对照组相比，疾病进展，复发，未接受手术或死亡的风险降低了32%，死亡风险降低了25%。

There was also a 10% improvement in the pCR rate versus the comparator arm..

与对照组相比，pCR率也提高了10%。。

Summary of exploratory post-hoc analysis: NIAGARA

探索性事后分析摘要：尼亚加拉

Patients with pCR

pCR患者

Patients without pCR

无pCR的患者

ITT population

ITT人口

IMFINZI-

金融

based

基于

regimen

养生法

(n=199)

（n=199）

Neoadjuvant

新辅助药物

chemotherapy

化疗

(n=146)

（n=146）

IMFINZI-

金融

based

基于

regimen

养生法

(n=334)

（n=334）

Neoadjuvant

新辅助药物

chemotherapy

化疗

(n=384)

（n=384）

IMFINZI-

金融

based

基于

regimen

养生法

(n=533)

（n=533）

Neoadjuvant

新辅助药物

chemotherapy

化疗

(n=530)

（n=530）

pCR

聚合酶链反应

我

pCR rate

pCR率

(%)

-（笑声）

37.3

27.5

p-value

p值

二

-（笑声）

0.0005

EFS

我

EFS rate,

EFS速率，

24 months

24个月

92.1

85.8

53.3

49.5

67.8

59.8

(%)

HR (95%

人力资源（95%

0.58

0.77

0.68

CI)

CI）

(0.33-1.00)

(0.63-0.95)

(0.56-0.82)

操作系统

我

OS rate, 24

操作系统速率，24

months (%)

月份（%）

95.5

91.1

74.1

68.9

82.2

75.2

HR (95%

人力资源（95%

0.72

0.84

0.75

CI)

CI）

(0.37-1.43)

(0.66-1.07)

(0.59-0.93)

我

Data cut-off: April 29, 2024

数据截止日期：2024年4月29日

二

Nominal p-value

标称p值

Summary of additional secondary endpoint outcomes (ITT): NIAGARA

其他次要终点结果总结（ITT）：尼亚加拉

IMFINZI-based regimen

基于IMFINZI的方案

(n=533)

（n=533）

Neoadjuvant chemotherapy

新辅助化疗

(n=530)

（n=530）

MFS

我

MFS rate, 24 months (%)

MFS率，24个月（%）

75.1

65.1

Number of MFS events

MFS事件数

152

201

(%)

(28.5)

(37.9)

Median MFS (95% CI) (in

MFS中位数（95%置信区间）（单位：英寸）

编号

二

编号

二

months)

月）

(NR

（编号

二

-NR

-编号

二

)

(48.0-NR

（48.0-NR）

二

)

HR (95% CI)

人力资源（95%置信区间）

0.67

(0.54-0.83)

DSS

决策支持系统

我

DSS rate, 24 months (%)

DSS率，24个月（%）

89.2

82.2

Number of deaths due to

死亡人数

114

bladder cancer (%)

膀胱癌（%）

(15.9)

(21.5)

Median DSS (95% CI) (in

DSS中位数（95%置信区间）

编号

二

编号

二

months)

月）

(NR

（编号

二

-NR

-编号

二

)

(NR

（编号

二

-NR

-编号

二

)

HR (95% CI)

人力资源（95%置信区间）

0.69

(0.52-0.91)

我

Data cut-off: April 29, 2024

数据截止日期：2024年4月29日

二

NR, not reached

NR，未达到

IMFINZI was generally well tolerated, and no new safety signals were observed in the neoadjuvant and adjuvant settings. Further, adding IMFINZI

IMFINZI通常耐受性良好，在新辅助和辅助环境中未观察到新的安全信号。此外，添加IMFINZI

to neoadjuvant chemotherapy was consistent with the known profile for this combination and did not compromise patients’ ability to complete surgery compared to neoadjuvant chemotherapy alone. Immune-mediated adverse events (imAEs) were consistent with the known profile of IMFINZI, manageable and mostly low-grade..

与单独的新辅助化疗相比，新辅助化疗与该组合的已知特征一致，并且不损害患者完成手术的能力。免疫介导的不良事件（imAEs）与IMFINZI的已知特征一致，可控且大多为低度。。

Perioperative IMFINZI in combination with neoadjuvant chemotherapy was granted

围手术期IMFINZI联合新辅助化疗被批准

Priority Review

优先审查

in the US in December 2024 for the treatment of patients with MIBC.

2024年12月在美国用于治疗MIBC患者。

Regulatory applications are also currently under review in the European Union (EU), Japan and several other countries based on the NIAGARA trial.

。

IMPORTANT SAFETY INFORMATION

重要安全信息

There are no contraindications for IMFINZI

IMFINZI没有禁忌症

(durvalumab) or IMJUDO

（durvalumab）或IMJUDO

(tremelimumab-actl).

（tremelimumab-actl）。

Severe and Fatal Immune-Mediated Adverse Reactions

严重致命的免疫介导的不良反应

Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation.

警告和预防措施中列出的重要免疫介导的不良反应可能不包括所有可能的严重和致命的免疫介导反应。免疫介导的不良反应可能严重或致命，可能发生在任何器官系统或组织中。免疫介导的不良反应可能在开始治疗后或停药后的任何时间发生。

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection.

。在基线和每次给药前评估临床化学物质，包括肝酶，肌酐，促肾上腺皮质激素（ACTH）水平和甲状腺功能。在疑似免疫介导的不良反应的情况下，启动适当的检查以排除其他病因，包括感染。

Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI and IMJUDO depending on severity. See USPI Dosing and Administration for specific details. In general, if IMFINZI and IMJUDO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less.

及时进行医疗管理，包括适当的专业咨询。根据严重程度，停止或永久停止IMFINZI和IMJUDO。有关具体细节，请参阅USPI剂量和给药。一般来说，如果IMFINZI和IMJUDO需要中断或停药，则给予全身皮质类固醇治疗（1 mg至2 mg/kg/天泼尼松或等效药物），直到改善至1级或更低。

Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy..

在改善至1级或更低级别后，开始逐渐减少皮质类固醇，并在至少1个月内继续逐渐减少。对于免疫介导的不良反应不能用皮质类固醇治疗控制的患者，考虑服用其他全身免疫抑制剂。。

Immune-Mediated Pneumonitis

免疫介导性肺炎

IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation.

IMFINZI和IMJUDO可引起免疫介导的肺炎，这可能是致命的。先前接受过胸部放疗的患者肺炎的发生率较高。

IMFINZI as a Single Agent

IMFINZI作为单一代理人

In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2.4% (34/1414), including fatal (<0.1%), and Grade 3-4 (0.4%) adverse reactions.

在未接受近期放疗的患者中，免疫介导性肺炎的发生率为2.4%（34/1414），包括致命性（<0.1%）和3-4级（0.4%）不良反应。

In patients who received recent prior radiation, the incidence of pneumonitis (including radiation pneumonitis) in patients with unresectable Stage III NSCLC following definitive chemoradiation within 42 days prior to initiation of IMFINZI in PACIFIC was 18.3% (87/475) in patients receiving IMFINZI and 12.8% (30/234) in patients receiving placebo.

在最近接受过放射治疗的患者中，在太平洋地区IMFINZI开始之前42天内，接受IMFINZI的患者在接受确定性放化疗后无法切除的III期NSCLC患者的肺炎（包括放射性肺炎）发生率为18.3%（87/475），接受安慰剂的患者为12.8%（30/234）。

Of the patients who received IMFINZI (475), 1.1% were fatal and 2.7% were Grade 3 adverse reactions..

在接受IMFINZI治疗的患者中（475），1.1%是致命的，2.7%是3级不良反应。。

The incidence of pneumonitis (including radiation pneumonitis) in patients with LS-SCLC following chemoradiation within 42 days prior to initiation of IMFINZI in ADRIATIC was 14% (37/262) in patients receiving IMFINZI and 6% (16/265) in patients receiving placebo. Of the patients who received IMFINZI (262), 0.4% had a fatal adverse reaction and 2.7% had Grade 3 adverse reactions..

在亚得里亚海开始IMFINZI之前42天内，化放疗后LS-SCLC患者的肺炎（包括放射性肺炎）发生率在接受IMFINZI的患者中为14%（37/262），在接受安慰剂的患者中为6%（16/265）。在接受IMFINZI（262）的患者中，0.4%有致命的不良反应，2.7%有3级不良反应。。

The frequency and severity of immune-mediated pneumonitis in patients who did not receive definitive chemoradiation prior to IMFINZI were similar in patients who received IMFINZI as a single agent or with ES-SCLC or BTC when given in combination with chemotherapy.

在IMFINZI之前未接受明确放化疗的患者中，免疫介导性肺炎的频率和严重程度与接受IMFINZI作为单一药物或ES-SCLC或BTC联合化疗的患者相似。

IMFINZI with IMJUDO

IMJUDO设置

Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.

接受IMFINZI和IMJUDO治疗的患者中有1.3%（5/388）发生免疫介导的肺炎，包括致命（0.3%）和3级（0.2%）不良反应。

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

IMFINZI联合IMJUDO和铂类化疗

Immune-mediated pneumonitis occurred in 3.5% (21/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.5%), and Grade 3 (1%) adverse reactions.

接受IMFINZI联合IMJUDO和铂类化疗的患者中有3.5%（21/596）发生免疫介导的肺炎，包括致命（0.5%）和3级（1%）不良反应。

Immune-Mediated Colitis

免疫介导的结肠炎

IMFINZI with IMJUDO and platinum-based chemotherapy can cause immune-mediated colitis, which may be fatal. IMFINZI and IMJUDO can cause immune-mediated colitis that is frequently associated with diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis.

IMFINZI联合IMJUDO和铂类化疗可引起免疫介导的结肠炎，这可能是致命的。IMFINZI和IMJUDO可引起免疫介导的结肠炎，这通常与腹泻有关。据报道，皮质类固醇难治性免疫介导性结肠炎患者的巨细胞病毒（CMV）感染/再激活。

In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies..

。。

IMFINZI as a Single Agent

IMFINZI作为单一代理人

Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (<0.1%) and Grade 3 (0.4%) adverse reactions.

接受IMFINZI治疗的患者中有2%（37/1889）发生免疫介导的结肠炎，包括4级（<0.1%）和3级（0.4%）不良反应。

IMFINZI with IMJUDO

芬兰人与犹太人

Immune‑mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions. Intestinal perforation has been observed in other studies of IMFINZI and IMJUDO.

接受IMFINZI和IMJUDO治疗的患者中有6%（23/388）发生免疫介导的结肠炎或腹泻，包括3级（3.6%）不良反应。。

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

IMFINZI联合IMJUDO和铂类化疗

Immune-mediated colitis occurred in 6.5% (39/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including fatal (0.2%) and Grade 3 (2.5%) adverse reactions. Intestinal perforation and large intestine perforation were reported in 0.1% of patients.

接受IMFINZI联合IMJUDO和铂类化疗的患者中有6.5%（39/596）发生免疫介导的结肠炎，包括致命（0.2%）和3级（2.5%）不良反应。0.1%的患者报告有肠穿孔和大肠穿孔。

Immune-Mediated Hepatitis

免疫介导的肝炎

IMFINZI and IMJUDO can cause immune-mediated hepatitis, which may be fatal.

IMFINZI和IMJUDO可引起免疫介导的肝炎，这可能是致命的。

IMFINZI as a Single Agent

IMFINZI作为单一代理人

Immune-mediated hepatitis occurred in 2.8% (52/1889) of patients receiving IMFINZI, including fatal (0.2%), Grade 4 (0.3%) and Grade 3 (1.4%) adverse reactions.

接受IMFINZI治疗的患者中有2.8%（52/1889）发生免疫介导的肝炎，包括致命（0.2%），4级（0.3%）和3级（1.4%）不良反应。

IMFINZI with IMJUDO

IMJUDO设置

Immune‑mediated hepatitis occurred in 7.5% (29/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.8%), Grade 4 (0.3%) and Grade 3 (4.1%) adverse reactions.

接受IMFINZI和IMJUDO治疗的患者中有7.5%（29/388）发生免疫介导的肝炎，包括致命（0.8%），4级（0.3%）和3级（4.1%）不良反应。

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

IMFINZI联合IMJUDO和铂类化疗

Immune-mediated hepatitis occurred in 3.9% (23/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.3%), Grade 4 (0.5%), and Grade 3 (2%) adverse reactions.

接受IMFINZI联合IMJUDO和铂类化疗的患者中有3.9%（23/596）发生免疫介导的肝炎，包括致命（0.3%），4级（0.5%）和3级（2%）不良反应。

Immune-Mediated Endocrinopathies

免疫介导的内分泌病

Adrenal Insufficiency

肾上腺皮质功能不全

IMFINZI and IMJUDO can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated.

IMFINZI和IMJUDO可引起原发性或继发性肾上腺功能不全。对于2级或更高级别的肾上腺功能不全，开始对症治疗，包括临床指示的激素替代。

IMFINZI as a Single Agent

IMFINZI作为单一代理人

Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.

接受IMFINZI治疗的患者中有0.5%（9/1889）发生免疫介导的肾上腺功能不全，包括3级（<0.1%）不良反应。

IMFINZI with IMJUDO

芬兰人与犹太人

Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.

接受IMFINZI和IMJUDO治疗的患者中有1.5%（6/388）发生免疫介导的肾上腺功能不全，包括3级（0.3%）不良反应。

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

IMFINZI联合IMJUDO和铂类化疗

Immune-mediated adrenal insufficiency occurred in 2.2% (13/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.8%) adverse reactions.

接受IMFINZI联合IMJUDO和铂类化疗的患者中有2.2%（13/596）发生免疫介导的肾上腺功能不全，包括3级（0.8%）不良反应。

Hypophysitis

垂体炎

IMFINZI and IMJUDO can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate symptomatic treatment including hormone replacement as clinically indicated..

IMFINZI和IMJUDO可引起免疫介导的垂体炎。垂体炎可出现与肿块效应相关的急性症状，如头痛，畏光或视野割伤。垂体炎可引起垂体功能减退。开始对症治疗，包括临床指示的激素替代。。

IMFINZI as a Single Agent

IMFINZI作为单一代理人

Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of patients who received IMFINZI.

接受IMFINZI治疗的患者中，3级垂体炎/垂体功能减退发生率低于0.1%（1/1889）。

IMFINZI with IMJUDO

芬兰人与犹太人

Immune-mediated hypophysitis/hypopituitarism occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO.

接受IMFINZI和IMJUDO的患者中有1%（4/388）发生了免疫介导的垂体炎/垂体功能减退症。

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

IMFINZI联合IMJUDO和铂类化疗

Immune-mediated hypophysitis occurred in 1.3% (8/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions.

接受IMFINZI联合IMJUDO和铂类化疗的患者中有1.3%（8/596）发生免疫介导的垂体炎，包括3级（0.5%）不良反应。

Thyroid Disorders (Thyroiditis, Hyperthyroidism, and Hypothyroidism)

甲状腺疾病（甲状腺炎、甲状腺功能亢进和甲状腺功能减退）

IMFINZI and IMJUDO can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated.

IMFINZI和IMJUDO可引起免疫介导的甲状腺疾病。甲状腺炎可伴有或不伴有内分泌病。甲状腺功能减退症可继发于甲状腺功能亢进症。根据临床指示，开始甲状腺功能减退症的激素替代疗法或甲状腺功能亢进症的医疗管理。

IMFINZI as a Single Agent

IMFINZI作为单一代理人

Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.

接受IMFINZI治疗的患者中有0.5%（9/1889）发生免疫介导的甲状腺炎，包括3级（<0.1%）不良反应。

Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI.

接受IMFINZI的患者中有2.1%（39/1889）发生免疫介导的甲状腺功能亢进。

Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.

接受IMFINZI治疗的患者中有8.3%（156/1889）发生免疫介导的甲状腺功能减退症，包括3级（<0.1%）不良反应。

IMFINZI with IMJUDO

IMJUDO设置

Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO.

接受IMFINZI和IMJUDO的患者中有1.5%（6/388）发生了免疫介导的甲状腺炎。

Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.

接受IMFINZI和IMJUDO治疗的患者中有4.6%（18/388）发生免疫介导的甲状腺功能亢进，包括3级（0.3%）不良反应。

Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI and IMJUDO.

接受IMFINZI和IMJUDO的患者中有11%（42/388）发生了免疫介导的甲状腺功能减退症。

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

IMFINZI联合IMJUDO和铂类化疗

Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy.

接受IMFINZI联合IMJUDO和铂类化疗的患者中，有1.2%（7/596）发生了免疫介导的甲状腺炎。

Immune-mediated hyperthyroidism occurred in 5% (30/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions.

接受IMFINZI联合IMJUDO和铂类化疗的患者中有5%（30/596）发生免疫介导的甲状腺功能亢进，包括3级（0.2%）不良反应。

Immune-mediated hypothyroidism occurred in 8.6% (51/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions.

接受IMFINZI联合IMJUDO和铂类化疗的患者中有8.6%（51/596）发生免疫介导的甲状腺功能减退症，包括3级（0.5%）不良反应。

IMFINZI with Carboplatin and Paclitaxel

IMFINZI与Carboplatin和Paclitaxel

Immune-mediated hypothyroidism occurred in 14% (34/235) of patients receiving IMFINZI in combination with carboplatin and paclitaxel.

接受IMFINZI联合卡铂和紫杉醇治疗的患者中有14%（34/235）发生免疫介导的甲状腺功能减退症。

Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis

1型糖尿病，可伴有糖尿病酮症酸中毒

: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated.

：监测患者的高血糖或其他糖尿病体征和症状。根据临床指示开始胰岛素治疗。

INFINZI as a Single Agent

英芬齐作为单一代理人

Grade 3 immune-mediated Type 1 diabetes mellitus occurred in <0.1% (1/1889) of patients receiving IMFINZI.

接受IMFINZI治疗的患者中，3级免疫介导的1型糖尿病发生率低于0.1%（1/1889）。

IMFINZI with IMJUDO

芬兰人与犹太人

Two patients (0.5%, 2/388) had events of hyperglycemia requiring insulin therapy that had not resolved at last follow-up.

两名患者（0.5%，2/388）发生高血糖事件，需要胰岛素治疗，但在最后一次随访中尚未解决。

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

IMFINZI联合IMJUDO和铂类化疗

Immune-mediated Type 1 diabetes mellitus occurred in 0.5% (3/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including Grade 3 (0.3%) adverse reactions.

接受IMFINZI联合IMJUDO和铂类化疗（包括3级（0.3%）不良反应）的患者中，有0.5%（3/596）发生免疫介导的1型糖尿病。

Immune-Mediated Nephritis with Renal Dysfunction

免疫介导性肾炎伴肾功能不全

IMFINZI and IMJUDO can cause immune-mediated nephritis.

IMFINZI和IMJUDO可引起免疫介导的肾炎。

IMFINZI as a Single Agent

IMFINZI作为单一代理人

Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.

接受IMFINZI治疗的患者中有0.5%（10/1889）发生免疫介导的肾炎，包括3级（<0.1%）不良反应。

IMFINZI with IMJUDO

芬兰人与犹太人

Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.5%) adverse reactions.

接受IMFINZI和IMJUDO治疗的患者中有1%（4/388）发生免疫介导的肾炎，包括3级（0.5%）不良反应。

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

IMFINZI联合IMJUDO和铂类化疗

Immune-mediated nephritis occurred in 0.7% (4/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions.

接受IMFINZI联合IMJUDO和铂类化疗的患者中，有0.7%（4/596）发生免疫介导的肾炎，包括3级（0.2%）不良反应。

Immune-Mediated Dermatology Reactions

免疫介导的皮肤病反应

IMFINZI and IMJUDO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), has occurred with PD-1/L-1 and CTLA-4 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes..

IMFINZI和IMJUDO可引起免疫介导的皮疹或皮炎。PD-1/L-1和CTLA-4阻断抗体发生了剥脱性皮炎，包括史蒂文斯-约翰逊综合征（SJS），嗜酸性粒细胞增多和全身症状的药疹（DRESS）和中毒性表皮坏死松解症（TEN）。局部润肤剂和/或局部皮质类固醇可能足以治疗轻度至中度非剥脱性皮疹。。

IMFINZI as a Single Agent

IMFINZI作为单一代理人

Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions.

接受IMFINZI治疗的患者中有1.8%（34/1889）发生免疫介导的皮疹或皮炎，包括3级（0.4%）不良反应。

IMFINZI with IMJUDO

IMJUDO设置

Immune-mediated rash or dermatitis occurred in 4.9% (19/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions.

接受IMFINZI和IMJUDO治疗的患者中有4.9%（19/388）发生免疫介导的皮疹或皮炎，包括4级（0.3%）和3级（1.5%）不良反应。

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

IMFINZI联合IMJUDO和铂类化疗

Immune-mediated rash or dermatitis occurred in 7.2% (43/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions.

接受IMFINZI联合IMJUDO和铂类化疗的患者中有7.2%（43/596）发生免疫介导的皮疹或皮炎，包括3级（0.3%）不良反应。

Immune-Mediated Pancreatitis

免疫介导的胰腺炎

IMFINZI in combination with IMJUDO can cause immune-mediated pancreatitis. Immune-mediated pancreatitis occurred in 2.3% (9/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions.

IMFINZI联合IMJUDO可引起免疫介导的胰腺炎。接受IMFINZI和IMJUDO治疗的患者中有2.3%（9/388）发生免疫介导的胰腺炎，包括4级（0.3%）和3级（1.5%）不良反应。

Other Immune-Mediated Adverse Reactions

其他免疫介导的不良反应

The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in patients who received IMFINZI and IMJUDO or were reported with the use of other immune-checkpoint inhibitors.

在接受IMFINZI和IMJUDO治疗或报告使用其他免疫检查点抑制剂的患者中，以下具有临床意义的免疫介导的不良反应发生率均低于1%。

Cardiac/vascular

心脏/血管

: Myocarditis, pericarditis, vasculitis.

：心肌炎，心包炎，血管炎。

Nervous system

神经系统

: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy.

：脑膜炎，脑炎，脊髓炎和脱髓鞘，肌无力综合征/重症肌无力（包括恶化），格林-巴利综合征，神经麻痹，自身免疫性神经病。

Ocular

: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss..

：可能发生葡萄膜炎，虹膜炎和其他眼部炎症毒性。有些病例可能与视网膜脱离有关。可能会出现各种程度的视力障碍，包括失明。如果葡萄膜炎与其他免疫介导的不良反应一起发生，请考虑Vogt-Koyanagi-Harada样综合征，因为这可能需要用全身类固醇治疗以降低永久性视力丧失的风险。。

Gastrointestinal

胃肠道

: Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis.

：胰腺炎包括血清淀粉酶和脂肪酶水平升高，胃炎，十二指肠炎。

Musculoskeletal and connective tissue disorders

肌肉骨骼和结缔组织疾病

: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic.

。

Endocrine

内分泌

: Hypoparathyroidism.

：甲状旁腺功能低下。

Other (hematologic/immune)

其他（血液学/免疫）

: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection..

：溶血性贫血，再生障碍性贫血，吞噬性淋巴组织细胞增多症，全身炎症反应综合征，组织细胞坏死性淋巴结炎（菊池淋巴结炎），结节病，免疫性血小板减少症，实体器官移植排斥反应，其他移植（包括角膜移植）排斥反应。。

Infusion-Related Reactions

输液相关反应

IMFINZI and IMJUDO can cause severe or life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions. Interrupt, slow the rate of, or permanently discontinue IMFINZI and IMJUDO based on the severity. See USPI Dosing and Administration for specific details.

IMFINZI和IMJUDO可引起严重或危及生命的输液相关反应。监测输液相关反应的体征和症状。根据严重程度，中断、减慢IMFINZI和IMJUDO的速度或永久停止IMFINZI和IMJUDO。有关具体细节，请参阅USPI剂量和给药。

For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses..

对于1级或2级输注相关反应，考虑使用后续剂量的预用药。。

IMFINZI as a Single Agent

IMFINZI作为单一代理人

Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving IMFINZI, including Grade 3 (0.3%) adverse reactions.

接受IMFINZI的患者中有2.2%（42/1889）发生输注相关反应，包括3级（0.3%）不良反应。

IMFINZI with IMJUDO

芬兰人与犹太人

Infusion-related reactions occurred in 2.6% (10/388) of patients receiving IMFINZI and IMJUDO.

接受IMFINZI和IMJUDO的患者中有2.6%（10/388）发生了输注相关反应。

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

IMFINZI联合IMJUDO和铂类化疗

Infusion-related reactions occurred in 2.9% (17/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions.

接受IMFINZI联合IMJUDO和铂类化疗的患者中有2.9%（17/596）发生输注相关反应，包括3级（0.3%）不良反应。

Complications of Allogeneic HSCT after IMFINZI

IMFINZI术后异基因造血干细胞移植的并发症

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/L-1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause).

在接受PD-1/L-1阻断抗体治疗之前或之后接受异基因造血干细胞移植（HSCT）的患者可能会发生致命和其他严重并发症。与移植相关的并发症包括超急性移植物抗宿主病（GVHD），急性GVHD，慢性GVHD，低强度调理后的肝静脉闭塞性疾病（VOD）和需要类固醇的发热综合征（没有确定的感染原因）。

These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT..

尽管在PD-1/L-1阻断和同种异体HSCT之间进行了干预治疗，但仍可能发生这些并发症。密切关注患者的移植相关并发症证据，并及时干预。考虑在同种异体HSCT之前或之后用PD-1/L-1阻断抗体治疗的益处与风险。。

Embryo-Fetal Toxicity

胚胎-胎儿毒性

Based on their mechanism of action and data from animal studies, IMFINZI and IMJUDO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. In females of reproductive potential, verify pregnancy status prior to initiating IMFINZI and IMJUDO and advise them to use effective contraception during treatment with IMFINZI and IMJUDO and for 3 months after the last dose of IMFINZI and IMJUDO..

根据它们的作用机制和动物研究数据，IMFINZI和IMJUDO在给孕妇服用时会造成胎儿伤害。告知孕妇对胎儿的潜在风险。对于具有生殖潜力的女性，在开始使用IMFINZI和IMJUDO之前，请验证其妊娠状况，并建议他们在使用IMFINZI和IMJUDO治疗期间以及最后一剂IMFINZI和IMJUDO后3个月内使用有效的避孕措施。。

Lactation

哺乳期

There is no information regarding the presence of IMFINZI and IMJUDO in human milk; however, because of the potential for serious adverse reactions in breastfed infants from IMFINZI and IMJUDO, advise women not to breastfeed during treatment and for 3 months after the last dose.

没有关于母乳中存在IMFINZI和IMJUDO的信息；然而，由于IMFINZI和IMJUDO母乳喂养的婴儿可能会产生严重的不良反应，因此建议女性在治疗期间和最后一次给药后3个月内不要母乳喂养。

Adverse Reactions

不良反应

Unresectable Stage III NSCLC

不可切除的III期非小细胞肺癌

In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), the most common adverse reactions (≥20%) were cough (40%), fatigue (34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract infections (26%), dyspnea (25%), and rash (23%). The most common Grade 3 or 4 adverse reactions (≥3%) were pneumonia (7%) and pneumonitis/radiation pneumonitis (3.4%)..

在接受IMFINZI（n=475）的太平洋研究中，III期NSCLC患者最常见的不良反应（≥20%）是咳嗽（40%），疲劳（34%），肺炎或放射性肺炎（34%），上呼吸道感染（26%），呼吸困难（25%）和皮疹（23%）。。。

In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), discontinuation due to adverse reactions occurred in 15% of patients in the IMFINZI arm. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. The most frequent serious adverse reactions (≥2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%).

在接受IMFINZI（n=475）的太平洋研究中，III期NSCLC患者中，IMFINZI组15%的患者因不良反应而停药。29%接受IMFINZI治疗的患者发生严重不良反应。最常见的严重不良反应（≥2%）是肺炎或放射性肺炎（7%）和肺炎（6%）。

Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of patients and were similar across arms..

致命性肺炎或放射性肺炎和致命性肺炎发生率低于2%，两组相似。。

Resectable NSCLC

可切除的非小细胞肺癌

In patients with resectable NSCLC in the AEGEAN study, the most common adverse reactions (occurring in ≥20% of patients) were anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash.

爱琴海研究中可切除NSCLC患者最常见的不良反应（发生率≥20%）是贫血，恶心，便秘，疲劳，肌肉骨骼疼痛和皮疹。

In patients with resectable NSCLC in the neoadjuvant phase of the AEGEAN study receiving IMFINZI in combination with platinum-containing chemotherapy (n=401), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 6.7% of patients. Serious adverse reactions occurred in 21% of patients.

在爱琴海研究新辅助阶段接受IMFINZI联合含铂化疗（n=401）的可切除NSCLC患者中，6.7%的患者因不良反应而永久停用IMFINZI。21%的患者发生严重不良反应。

The most frequent (≥1%) serious adverse reactions were pneumonia (2.7%), anemia (1.5%), myelosuppression (1.5%), vomiting (1.2%), neutropenia (1%), and acute kidney injury (1%). Fatal adverse reactions occurred in 2% of patients, including death due to COVID-19 pneumonia (0.5%), sepsis (0.5%), myocarditis (0.2%), decreased appetite (0.2%), hemoptysis (0.2%), and death not otherwise specified (0.2%).

最常见（≥1%）的严重不良反应是肺炎（2.7%），贫血（1.5%），骨髓抑制（1.5%），呕吐（1.2%），中性粒细胞减少（1%）和急性肾损伤（1%）。2%的患者发生致命的不良反应，包括因新型冠状病毒肺炎（0.5%），败血症（0.5%），心肌炎（0.2%），食欲下降（0.2%），咯血（0.2%）和未另行说明的死亡（0.2%）。

Of the 401 IMFINZI treated patients who received neoadjuvant treatment and 398 placebo-treated patients who received neoadjuvant treatment, 1.7% (n=7) and 1% (n=4), respectively, did not receive surgery due to adverse reactions..

在接受新辅助治疗的401名接受IMFINZI治疗的患者和接受新辅助治疗的398名接受安慰剂治疗的患者中，分别有1.7%（n=7）和1%（n=4）由于不良反应而未接受手术。。

In patients with resectable NSCLC in the adjuvant phase of the AEGEAN study receiving IMFINZI as a single agent (n=265), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 8% of patients. Serious adverse reactions occurred in 13% of patients. The most frequent serious adverse reactions reported in >1% of patients were pneumonia (1.9%), pneumonitis (1.1%), and COVID-19 (1.1%).

在爱琴海研究辅助阶段接受IMFINZI作为单一药物（n=265）的可切除NSCLC患者中，8%的患者因不良反应而永久停用IMFINZI。13%的患者发生严重不良反应。>1%的患者报告的最常见的严重不良反应是肺炎（1.9%），肺炎（1.1%）和新型冠状病毒肺炎（1.1%）。

Four fatal adverse reactions occurred during the adjuvant phase of the study, including COVID-19 pneumonia, pneumonia aspiration, interstitial lung disease and aortic aneurysm..

在研究的辅助阶段发生了四种致命的不良反应，包括新型冠状病毒肺炎，肺炎吸入，间质性肺病和主动脉瘤。。

Metastatic NSCLC

转移性非小细胞肺癌

In patients with mNSCLC in the POSEIDON study receiving IMFINZI and IMJUDO plus platinum-based chemotherapy (n=330), the most common adverse reactions (occurring in ≥20% of patients) were nausea (42%), fatigue (36%), musculoskeletal pain (29%), decreased appetite (28%), rash (27%), and diarrhea (22%)..

在波塞冬研究中接受IMFINZI和IMJUDO加铂类化疗（n=330）的mNSCLC患者中，最常见的不良反应（发生率≥20%）是恶心（42%），疲劳（36%），肌肉骨骼疼痛（29%），食欲下降（28%），皮疹（27%）和腹泻（22%）。。

In patients with mNSCLC in the POSEIDON study receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy (n=330), permanent discontinuation of IMFINZI or IMJUDO due to an adverse reaction occurred in 17% of patients. Serious adverse reactions occurred in 44% of patients, with the most frequent serious adverse reactions reported in at least 2% of patients being pneumonia (11%), anemia (5%), diarrhea (2.4%), thrombocytopenia (2.4%), pyrexia (2.4%), and febrile neutropenia (2.1%).

在波塞冬研究中接受IMFINZI联合IMJUDO和铂类化疗（n=330）的mNSCLC患者中，17%的患者因不良反应而永久停用IMFINZI或IMJUDO。44%的患者发生严重不良反应，其中至少2%的患者报告最常见的严重不良反应是肺炎（11%），贫血（5%），腹泻（2.4%），血小板减少症（2.4%），发热（2.4%）和发热性中性粒细胞减少症（2.1%）。

Fatal adverse reactions occurred in a total of 4.2% of patients..

共有4.2%的患者发生致命的不良反应。。

Limited-stage Small Cell Lung Cancer

局限期小细胞肺癌

In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI (n=262), the most common adverse reactions occurring in ≥20% of patients receiving IMFINZI were pneumonitis or radiation pneumonitis (38%), and fatigue (21%). The most common Grade 3 or 4 adverse reactions (≥3%) were pneumonitis or radiation pneumonitis and pneumonia..

在接受IMFINZI（n=262）的亚得里亚海研究中，有限期SCLC患者中，≥20%接受IMFINZI的患者最常见的不良反应是肺炎或放射性肺炎（38%）和疲劳（21%）。最常见的3或4级不良反应（≥3%）是肺炎或放射性肺炎和肺炎。。

In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI (n=262), IMFINZI was permanently discontinued due to adverse reactions in 16% of the patients receiving IMFINZI. Serious adverse reactions occurred in 30% of patients receiving IMFINZI. The most frequent serious adverse reactions reported in ≥1% of patients receiving IMFINZI were pneumonitis or radiation pneumonitis (12%), and pneumonia (5%).

在亚得里亚海研究中接受IMFINZI（n=262）的有限期SCLC患者中，16%接受IMFINZI的患者由于不良反应而永久停用IMFINZI。接受IMFINZI治疗的患者中有30%发生严重不良反应。接受IMFINZI治疗的患者中，≥1%报告的最常见严重不良反应是肺炎或放射性肺炎（12%）和肺炎（5%）。

Fatal adverse reactions occurred in 2.7% of patients who received IMFINZI including pneumonia (1.5%), cardiac failure, encephalopathy and pneumonitis (0.4% each)..

接受IMFINZI治疗的患者中有2.7%发生致命不良反应，包括肺炎（1.5%），心力衰竭，脑病和肺炎（各0.4%）。。

Extensive-stage Small Cell Lung Cancer

广泛期小细胞肺癌

In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), the most common adverse reactions (≥20%) were nausea (34%), fatigue/asthenia (32%), and alopecia (31%). The most common Grade 3 or 4 adverse reaction (≥3%) was fatigue/asthenia (3.4%).

在里海研究中接受IMFINZI加化疗（n=265）的广泛期SCLC患者中，最常见的不良反应（≥20%）是恶心（34%），疲劳/虚弱（32%）和脱发（31%）。最常见的3或4级不良反应（≥3%）是疲劳/虚弱（3.4%）。

In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), IMFINZI was discontinued due to adverse reactions in 7% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 31% of patients receiving IMFINZI plus chemotherapy.

在里海研究中接受IMFINZI加化疗（n=265）的广泛期SCLC患者中，7%接受IMFINZI加化疗的患者因不良反应而停用IMFINZI。。

The most frequent serious adverse reactions reported in at least 1% of patients were febrile neutropenia (4.5%), pneumonia (2.3%), anemia (1.9%), pancytopenia (1.5%), pneumonitis (1.1%), and COPD (1.1%). Fatal adverse reactions occurred in 4.9% of patients receiving IMFINZI plus chemotherapy..

至少1%的患者报告的最常见的严重不良反应是发热性中性粒细胞减少症（4.5%），肺炎（2.3%），贫血（1.9%），全血细胞减少症（1.5%），肺炎（1.1%）和COPD（1.1%）。接受IMFINZI加化疗的患者中有4.9%发生致命的不良反应。。

Locally Advanced or Metastatic Biliary Tract Cancers

局部晚期或转移性胆道癌

In patients with locally advanced or metastatic BTC in the TOPAZ-1 study receiving IMFINZI (n=338), the most common adverse reactions (occurring in ≥20% of patients) were fatigue (42%), nausea (40%), constipation (32%), decreased appetite (26%), abdominal pain (24%), rash (23%), and pyrexia (20%).

在接受IMFINZI治疗的TOPAZ-1研究中，局部晚期或转移性BTC患者（n=338），最常见的不良反应（发生率≥20%）是疲劳（42%），恶心（40%），便秘（32%），食欲下降（26%），腹痛（24%），皮疹（23%）和发热（20%）。

In patients with locally advanced or metastatic BTC in the TOPAZ-1 study receiving IMFINZI (n=338), discontinuation due to adverse reactions occurred in 6% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 47% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 2% of patients were cholangitis (7%), pyrexia (3.8%), anemia (3.6%), sepsis (3.3%) and acute kidney injury (2.4%).

在接受IMFINZI（n=338）的TOPAZ-1研究中，局部晚期或转移性BTC患者中，6%接受IMFINZI加化疗的患者因不良反应而停药。47%接受IMFINZI联合化疗的患者发生严重不良反应。至少2%的患者报告的最常见的严重不良反应是胆管炎（7%），发热（3.8%），贫血（3.6%），败血症（3.3%）和急性肾损伤（2.4%）。

Fatal adverse reactions occurred in 3.6% of patients receiving IMFINZI plus chemotherapy. These include ischemic or hemorrhagic stroke (4 patients), sepsis (2 patients), and upper gastrointestinal hemorrhage (2 patients)..

接受IMFINZI加化疗的患者中有3.6%发生致命的不良反应。这些包括缺血性或出血性中风（4例），败血症（2例）和上消化道出血（2例）。。

Unresectable Hepatocellular Carcinoma

不可切除的肝细胞癌

In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), the most common adverse reactions (occurring in ≥20% of patients) were rash (32%), diarrhea (27%), fatigue (26%), pruritus (23%), musculoskeletal pain (22%), and abdominal pain (20%).

在接受IMFINZI和IMJUDO（n=388）的喜马拉雅研究中，无法切除的HCC患者中，最常见的不良反应（发生率≥20%）是皮疹（32%），腹泻（27%），疲劳（26%），瘙痒（23%），肌肉骨骼疼痛（22%）和腹痛（20%）。

In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), serious adverse reactions occurred in 41% of patients. Serious adverse reactions in >1% of patients included hemorrhage (6%), diarrhea (4%), sepsis (2.1%), pneumonia (2.1%), rash (1.5%), vomiting (1.3%), acute kidney injury (1.3%), and anemia (1.3%).

在接受IMFINZI和IMJUDO（n=388）的喜马拉雅研究中，无法切除的HCC患者中，41%的患者发生严重不良反应。>1%的患者出现严重不良反应，包括出血（6%），腹泻（4%），败血症（2.1%），肺炎（2.1%），皮疹（1.5%），呕吐（1.3%），急性肾损伤（1.3%）和贫血（1.3%）。

Fatal adverse reactions occurred in 8% of patients who received IMFINZI and IMJUDO, including death (1%), hemorrhage intracranial (0.5%), cardiac arrest (0.5%), pneumonitis (0.5%), hepatic failure (0.5%), and immune-mediated hepatitis (0.5%). Permanent discontinuation of treatment regimen due to an adverse reaction occurred in 14% of patients..

接受IMFINZI和IMJUDO治疗的患者中有8%发生致命不良反应，包括死亡（1%），颅内出血（0.5%），心脏骤停（0.5%），肺炎（0.5%），肝衰竭（0.5%）和免疫介导的肝炎（0.5%）。14%的患者因不良反应而永久停止治疗方案。。

Primary advanced or Recurrent dMMR Endometrial Cancer

原发性晚期或复发性dMMR子宫内膜癌

In patients with advanced or recurrent dMMR endometrial cancer in the DUO-E study receiving IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single-agent (n=44), the most common adverse reactions, including laboratory abnormalities (occurring in >20% of patients) were peripheral neuropathy (61%), musculoskeletal pain (59%), nausea (59%), alopecia (52%), fatigue (41%), abdominal pain (39%), constipation (39%), rash (39%), decreased magnesium (36%), increased ALT (32%), increased AST (30%), diarrhea (27%), vomiting (27%), cough (27%), decreased potassium (25%), dyspnea (25%), headache (23%), increased alkaline phosphatase (20%), and decreased appetite (18%).

在DUO-E研究中，接受IMFINZI联合卡铂和紫杉醇治疗的晚期或复发性dMMR子宫内膜癌患者（n=44），最常见的不良反应包括实验室异常（发生率>20%）是周围神经病变（61%），肌肉骨骼疼痛（59%），恶心（59%），脱发（52%），疲劳（41%），腹痛（39%），便秘（39%），皮疹（39%），镁降低（36%），ALT升高（32%），AST升高（30%），腹泻（27%），呕吐（27%），咳嗽（27%），钾降低（25%），呼吸困难（25%），头痛（23%），碱性增加磷酸酶（20%）和食欲下降（18%）。

The most common Grade 3 or 4 adverse reactions (≥3%) were constipation (4.5%) and fatigue (4.5%)..

最常见的3或4级不良反应（≥3%）是便秘（4.5%）和疲劳（4.5%）。。

In patients with advanced or recurrent dMMR endometrial cancer in the DUO-E study receiving IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single-agent (n=44), permanent discontinuation of IMFINZI due to adverse reactions occurred in 11% of patients. Serious adverse reactions occurred in 30% of patients who received IMFINZI with carboplatin and paclitaxel; the most common serious adverse reactions (≥4%) were constipation (4.5%) and rash (4.5%)..

在DUO-E研究中，接受IMFINZI联合卡铂和紫杉醇，然后接受IMFINZI作为单一药物（n=44）的晚期或复发性dMMR子宫内膜癌患者中，11%的患者因不良反应而永久停用IMFINZI。接受IMFINZI联合卡铂和紫杉醇治疗的患者中有30%发生严重不良反应；最常见的严重不良反应（≥4%）是便秘（4.5%）和皮疹（4.5%）。。

The safety and effectiveness of IMFINZI and IMJUDO have not been established in pediatric patients.

IMFINZI和IMJUDO的安全性和有效性尚未在儿科患者中确立。

Indications:

适应症：

IMFINZI, as a single agent, is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).

IMFINZI作为一种单一药物，适用于治疗不可切除的III期非小细胞肺癌（NSCLC）成年患者，这些患者在同时进行铂类化疗和放疗（cCRT）后疾病尚未进展。

IMFINZI in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, is indicated for the treatment of adult patients with resectable (tumors ≥4 cm and/or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements..

IMFINZI联合含铂化疗作为新辅助治疗，随后IMFINZI继续作为单一药物作为手术后的辅助治疗，适用于治疗可切除（肿瘤≥4 cm和/或淋巴结阳性）NSCLC且无已知表皮生长因子受体（EGFR）突变或间变性淋巴瘤激酶（ALK）重排的成年患者。。

IMFINZI, in combination with IMJUDO and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations.

IMFINZI与IMJUDO和铂类化疗相结合，适用于治疗没有致敏EGFR突变或ALK基因组肿瘤畸变的成年转移性NSCLC患者。

IMFINZI, as a single agent, is indicated for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).

IMFINZI作为单一药物，适用于治疗局限期小细胞肺癌（LS-SCLC）的成年患者，这些患者在同时进行铂类化疗和放疗（cCRT）后疾病尚未进展。

IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

IMFINZI联合依托泊苷和卡铂或顺铂，适用于成人广泛期小细胞肺癌（ES-SCLC）患者的一线治疗。

IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).

IMFINZI与吉西他滨和顺铂联合用于治疗局部晚期或转移性胆道癌（BTC）的成年患者。

IMFINZI in combination with IMJUDO is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).

IMFINZI联合IMJUDO适用于治疗成人不可切除肝细胞癌（uHCC）。

IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).

IMFINZI联合卡铂和紫杉醇，然后IMFINZI作为单一药物，用于治疗错配修复缺陷（dMMR）的原发性晚期或复发性子宫内膜癌的成年患者。

Please see additional Important Safety Information throughout and Full Prescribing Information including Medication Guide for

请参阅整个过程中的其他重要安全信息和完整的处方信息，包括药物指南

IMFINZI

NS2RW 金融

and

和

IMJUDO

IMJUDE

You may

你可以

report side effects related to AstraZeneca products

报告与阿斯利康产品相关的副作用

Notes

注释

Muscle-invasive bladder cancer

肌肉浸润性膀胱癌

Bladder cancer is the 9th most common cancer in the world, with more than 614,000 patients diagnosed each year.

膀胱癌是世界上第九大最常见的癌症，每年诊断出614000多名患者。

The most common type of bladder cancer is urothelial carcinoma, which begins in the urothelial cells of the urinary tract.

最常见的膀胱癌类型是尿路上皮癌，它始于泌尿道的尿路上皮细胞。

Approximately one in four patients with bladder cancer has evidence of the tumor invading the muscle wall of the bladder (without distant metastases), known as MIBC.

大约四分之一的膀胱癌患者有证据表明肿瘤侵犯膀胱肌壁（无远处转移），称为MIBC。

3-4

In MIBC, a curative-intent setting, approximately 117,000 patients are treated with the current standard of care, which includes neoadjuvant chemotherapy and radical cystectomy.

在治疗意图设置的MIBC中，大约117000名患者接受了当前的护理标准，包括新辅助化疗和根治性膀胱切除术。

5-6

However, even after cystectomy, approximately 50% of patients experience disease recurrence and have a poor prognosis.

然而，即使在膀胱切除术后，大约50%的患者也会出现疾病复发，预后不良。

Treatment options that prevent disease recurrence after surgery are critically needed in this curative-intent setting.

在这种治疗意图设置中，迫切需要预防手术后疾病复发的治疗选择。

NIAGARA

尼亚加拉

NIAGARA is a randomized, open-label, multi-center, global Phase III trial evaluating perioperative IMFINZI as treatment for patients with MIBC before and after radical cystectomy. In the trial, 1,063 patients were randomized to receive IMFINZI plus neoadjuvant chemotherapy prior to cystectomy followed by IMFINZI.

NIAGARA是一项随机，开放标签，多中心，全球III期试验，评估围手术期IMFINZI治疗根治性膀胱切除术前后MIBC患者的疗效。在该试验中，1063名患者被随机分配接受IMFINZI加新辅助化疗，然后进行膀胱切除术。

or neoadjuvant chemotherapy alone prior to cystectomy with no further treatment after surgery. NIAGARA is the largest global Phase III trial in this setting.

或在膀胱切除术前单独使用新辅助化疗，术后无需进一步治疗。尼亚加拉是在这种情况下最大的全球III期试验。

The trial is being conducted at 192 centers across 22 countries including in North America, South America, Europe, Australia and Asia. Its dual primary endpoints are EFS and pCR, the latter defined as the proportion of patients with no detectable cancer cells (T0N0M0) at the time of cystectomy. Key secondary endpoints are OS and safety..

该试验正在包括北美、南美、欧洲、澳大利亚和亚洲在内的22个国家的192个中心进行。。关键的次要终点是操作系统和安全性。。

IMFINZI

NS2RW 金融

IMFINZI

NS2RW 金融

(durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumor's immune-evading tactics and releasing the inhibition of immune responses.

（durvalumab）是一种与PD-L1蛋白结合并阻断PD-L1与PD-1和CD80蛋白相互作用的人单克隆抗体，可抵抗肿瘤的免疫逃避策略并释放对免疫反应的抑制作用。

IMFINZI is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, IMFINZI is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of IMJUDO.

IMFINZI是基于OS的全球护理标准，用于放化疗（CRT）后疾病未进展的患者的不可切除的III期非小细胞肺癌（NSCLC）的治疗意图。此外，IMFINZI被批准作为围手术期治疗，与可切除的非小细胞肺癌的新辅助化疗相结合，并与短期IMJUDO相结合。

(tremelimumab-actl) and chemotherapy for the treatment of metastatic NSCLC. IMFINZI

（tremelimumab actl）和化疗治疗转移性NSCLC。伊姆芬齐

is also approved for limited-stage small cell lung cancer (SCLC) in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy (etoposide and either carboplatin or cisplatin) for the treatment of extensive-stage SCLC.

对于同时进行铂类CRT后疾病未进展的患者，也被批准用于有限期小细胞肺癌（SCLC）；并联合化疗（依托泊苷和卡铂或顺铂）治疗广泛期SCLC。

In addition to its indications in lung cancers, IMFINZI is approved in combination with chemotherapy (gemcitabine plus cisplatin) in locally advanced or metastatic biliary tract cancer and in combination with IMJUDO

除了肺癌的适应症外，IMFINZI还被批准与局部晚期或转移性胆道癌的化疗（吉西他滨加顺铂）联合使用，并与IMJUDO联合使用

in unresectable hepatocellular carcinoma (HCC). IMFINZI is also approved as a monotherapy in unresectable HCC in Japan and the EU.

在不可切除的肝细胞癌（HCC）中。IMFINZI在日本和欧盟也被批准作为不可切除的HCC的单一疗法。

IMFINZI

NS2RW 金融

is also approved in combination with chemotherapy (carboplatin and paclitaxel) followed by IMFINZI

也被批准与化疗（卡铂和紫杉醇）联合使用，然后是IMFINZI

monotherapy in primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) in the US. In the EU, IMFINZI

美国错配修复缺陷（dMMR）的原发性晚期或复发性子宫内膜癌的单一疗法。在欧盟，IMFINZI

plus chemotherapy followed by olaparib and IMFINZI

加上化疗，然后是奥拉帕尼和伊姆芬齐

is approved for patients with mismatch repair proficient (pMMR) advanced or recurrent endometrial cancer, and IMFINZI plus chemotherapy followed by IMFINZI

被批准用于错配修复熟练（pMMR）晚期或复发性子宫内膜癌患者，IMFINZI加化疗后再加IMFINZI

alone is approved for patients with dMMR disease. In Japan, IMFINZI plus chemotherapy followed by IMFINZI

单独批准用于dMMR疾病患者。在日本，IMFINZI加化疗，然后是IMFINZI

monotherapy has also been approved as 1st-line treatment in primary advanced or recurrent endometrial cancer, and IMFINZI plus chemotherapy followed by IMFINZI and olaparib has been approved for patients with pMMR disease.

单药治疗也被批准为原发性晚期或复发性子宫内膜癌的一线治疗，IMFINZI加化疗，然后是IMFINZI和olaparib已被批准用于pMMR疾病患者。

Since the first approval in May 2017, more than 374,000 patients have been treated with IMFINZI. As part of a broad development program, IMFINZI is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, breast cancer, several gastrointestinal and gynaecologic cancers, and other solid tumors..

自2017年5月首次批准以来，已有374000多名患者接受了IMFINZI治疗。。。

AstraZeneca in immuno-oncology (IO)

阿斯利康免疫肿瘤学（IO）

AstraZeneca is a pioneer in introducing the concept of immunotherapy into dedicated clinical areas of high unmet medical need. The Company has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumor immune response and stimulate the body’s immune system to attack tumors..

阿斯利康是将免疫疗法的概念引入高度未满足医疗需求的专用临床领域的先驱。该公司拥有一个全面而多样化的IO组合和管道，以免疫疗法为基础，旨在克服抗肿瘤免疫反应的逃避，并刺激人体免疫系统攻击肿瘤。。

AstraZeneca strives to redefine cancer care and help transform outcomes for patients with IMFINZI as a monotherapy and in combination with IMJUDO as well as other novel immunotherapies and modalities. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, including cell therapy and T-cell engagers..

阿斯利康致力于重新定义癌症护理，并帮助将IMFINZI患者的结果转化为单一疗法，并与IMJUDO以及其他新型免疫疗法和方式相结合。该公司还正在研究下一代免疫疗法，如双特异性抗体和利用免疫的不同方面来靶向癌症的疗法，包括细胞疗法和T细胞参与者。。

AstraZeneca is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. The Company is focused on exploring novel combination approaches to help prevent treatment resistance and drive longer immune responses.

阿斯利康正在寻求一种创新的临床策略，将基于IO的疗法引入各种癌症类型的新环境中，以提供长期生存。该公司专注于探索新的组合方法，以帮助预防治疗耐药性并驱动更长的免疫反应。

With an extensive clinical program, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure..

凭借广泛的临床计划，该公司还倡导在疾病早期阶段使用IO治疗，因为在疾病早期阶段有最大的治愈潜力。。

AstraZeneca in oncology

阿斯利康肿瘤学

AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

阿斯利康（AstraZeneca）正在领导一场肿瘤学革命，致力于为各种形式的癌症提供治疗，遵循科学理解癌症及其复杂性，发现、开发并向患者提供改变生命的药物。

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience.

该公司专注于一些最具挑战性的癌症。正是通过不断的创新，阿斯利康建立了行业内最多样化的投资组合和渠道之一，有可能催化医学实践的变化并改变患者的体验。

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

阿斯利康的愿景是重新定义癌症护理，并有一天消除癌症作为死亡原因。

AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 125 countries, and its innovative medicines are used by millions of patients worldwide.

阿斯利康是一家以科学为主导的全球生物制药公司，专注于肿瘤学、罕见病和生物制药（包括心血管、肾脏和代谢以及呼吸和免疫学）处方药的发现、开发和商业化。。

For more information, please visit .

有关更多信息，请访问。

www.astrazeneca-us.com

and follow us on socia media

@AstraZeneca

@阿斯利康

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世界卫生组织。国际癌症研究机构。。网址：

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https://www.cancer.org/cancer/bladder-cancer/about/what-is-bladder-cancer.html

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Burger M等人。尿路上皮性膀胱癌的流行病学和危险因素。

Eur Urol

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国家癌症合作中心。膀胱癌：诊断和管理。伦敦：国家健康与护理卓越研究所（NICE）。网址：

https://www.ncbi.nlm.nih.gov/books/NBK356289

. Accessed February 2025.

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Cerner CancerMPact数据库。2024年2月访问。反映了G8国家（美国，欧盟，日本，中国）的流行病学估计。

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Witjes JA等。EAU关于肌肉浸润性和转移性膀胱癌的指南。

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US-98018 Last Updated 2/25