晚期NSCLC治疗的新标准和新进展

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执槐雍
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1 Treatment status of Lung Cancer in China 中国肺癌治疗现状 Lu Shun 陆舜 Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai JiaoTong University 上海肺部肿瘤临床医学中心, 上海交通大学附属胸科医院

2 Lung Cancer Burden High Incidence in China 中国的肺癌包袱高发病率 Annual urban incidence population of LC in China 中国城市人口肺癌年度发病率 Key Insight 关键信息中国的肺癌发病率在过去的 20 年间快速上升老龄化女性增长最快, 其中有更多的腺癌患者 Source: Draco 2009

3 Epidemiology 流行病学 What are the principal risk factors for NSCLC in China? 中国非小细胞肺癌的主要危险因素是什么? Smoking 吸烟 Air pollution 空气污染 Aging of population 老龄化

4 Globe cigarette consumption and lung cancer deaths 全球烟草消费和肺癌死亡

5 Annual taxes and profits of China Tobacco Industry 中国烟草业年度税收和利润

6 Economic growth is fastest in Asia 亚洲地区经济增长最快

7 but potential crises lie ahead 但是隐藏了可能的危机

8 Every crisis contains an opportunity 每次危机都孕育着一次机会

9 Every crisis contains an opportunity 每次危机都孕育着一次机会 "When written in Chinese, the word 'crisis' is composed of two brush strokes: one represents danger, and the other opportunity. In a crisis, beware of the danger - but recognize the opportunity." John F. Kennedy, April 12, 1959

10 Asia versus West 东西方对比 Asia 东方 West 西方 Lung cancer incidence 肺癌发病率 Histologic subtypes 组织学类型 Rising 上升 60-70% adenocarcinoma 60-70% 腺癌 Slight decline 缓慢下降 50% adenocarcinoma 50% 腺癌 Smoker 吸烟 Response to chemotherapy 化疗敏感 40-50% 70-80% 30-40% 20-30% Median survival 中位生存 12-14months 10-12months EGFR mutation EGFR 突变 30-40% 10-15% EGFR TKI Health care system 卫生保健系统 Gefitinib 吉非替尼 Erlotinib 厄洛替尼 Heterogenous mix of free basic care from government and expensive private care 来自政府的混杂的免费基础医疗外加昂贵的个体医疗 Erlotinib 厄洛替尼 Insurance: private or national 保险 : 个体或国家

11 研究表明 : 所有基因突变互相排除 JCO Oct 20, 2010:

12 Diagnosis 诊断 In China the proportion of patients present with 在中国患者的比例 : Early disease amenable to surgery----30% 早期疾病适合手术治疗 30% Non-resectable locally advanced disease IIIA/IIIB----20% 不可手术治疗的局部晚期疾病 IIIA/IIIB 20% Advanced disease (Stage 4)----50% 晚期疾病 (4 期 )----50%

Diagnosis 诊断 What is the typical median overall survival for patients with early disease, locally advanced disease and advanced disease in China?

13 Diagnosis 诊断 What is the typical median overall survival for patients with early disease, locally advanced disease and advanced disease in China? 早期, 局部晚期和晚期患者的典型中位生存期情况 early disease amenable to surgery----5-year survival rate 60%-80%* 早期疾病适合手术治疗 5 年生存率 60%-80%* locally advanced disease IIIA/IIIB year survival rate 10%-30% 局部晚期疾病 IIIA/IIIB - 5 年生存率 10%-30% advanced disease (Stage 4) year survival rate 1%-2% 晚期疾病 (4 期 )- 5 年生存率 1%-2% * Zi-Ming Li, Yong-Feng Yu, Shun Lu, et al. Journal of Thoracic Oncology, 2009 June,Vol.4,No.6

14 Diagnosis 诊断 Who is responsible for the diagnosis and management of patients 谁负责患者诊断和治疗 Respiratory Physician 呼吸科医生 Thoracic Surgeon 胸部外科医生 Medical Oncologist 肿瘤内科医生

15 Diagnosis 诊断 How widely available are diagnostic techniques 诊断技术应用的广泛程度如何? PET scanning PET 扫描 ----5%-10% Core biopsy or needle biopsy 组织活检或针刺活检 %-60% Sputum/pleural fluid cytology 痰 / 胸液细胞学 % Fiberoptic bronchoscopy 纤维支气管镜 %-20% Endobronchial ultrasound 支气管内超声 (EBUS) ----5%-10%

16 How is Lung Cancer Treated? 肺癌如何治疗 Treatment depends on the stage and type of lung cancer 基于肺癌所处阶段和类型决定治疗方案 Surgery 手术 Radiation therapy 放疗 Chemotherapy (Platinum-based doublet chemotherapy ) 化疗 ( 以铂类为基础的两药联合化疗 ) Target therapy 靶向治疗 Lung cancer is usually treated with a combination of therapies 肺癌通常和其他疾病的治疗一起进行 Guideline from the Ministry of health of China for Lung Cancer 卫生部肺癌治疗指南

17 What is the standard surgery 标准手术 Lobectomy is recommended (Pneumonectomy if physiologically feasible) 推荐肺叶切除 ( 如生理上可行则全肺切除术 ) Lung-sparing anatomic resection (sleeve lobectomy) preferred over pneumonectomy, if anatomically appropriate and margin-negative resection achieved 肺叶保存术式 ( 袖式切除术 ) 比全肺切除好, 如果解剖位置适当并且切缘阴性 N1 and N2 node resection and mapping (minimum of three N2 stations sampled or complete lymph node dissection) N1 和 N2 淋巴结切除并标明位置 ( 最少对 3 个纵隔引流区 (N2 站 ) 的淋巴结进行取样或行淋巴结清除 ) Treatment 治疗 Early Disease 早期疾病 Guideline from the Ministry of health of China for Lung Cancer 卫生部肺癌治疗指南

18 Treatment 治疗 Early Disease 早期疾病 Which patient groups receive adjuvant chemotherapy and what is the standard of care for adjuvant therapy? 哪些患者接受辅助化疗? 辅助化疗的标准治疗方案是什么?

19 Adjuvant chemotherapy significantly improves survival in completely resected stage II and IIIA NSCLC pts 辅助化疗对于 II 期和 IIIA 期完全可切的非小细胞肺癌患者可显著延长生存 Although no benefit was observed in stage IA NSCLC 但是对于 IA 期非小细胞肺癌患者未发现有获益 It is recommended that adjuvant chemotherapy for high risk IB NSCLC 对于高危的 IB 期非小细胞肺癌患者推荐进行辅助化疗 tumor 4.0 cm 肿瘤 4.0 cm Guideline from the Ministry of health of China for Lung Cancer 卫生部肺癌治疗指南

20 Treatment 治疗 Early Disease 早期疾病 Is there any role for neoadjuvant therapy? 新辅助治疗有什么样的角色? Yes 是的 2 cycles of neoadjuvant therapy was recommended 推荐两个周期的新辅助化疗 Guideline from the Ministry of health of China for Lung Cancer 卫生部肺癌治疗指南

21 Treatment 治疗 Early disease 早期疾病 Is there a role for stereotactic radiotherapy in the management of early disease? 立体定向放疗在早期疾病的治疗中是什么角色? SBRT is an option for stage I NSCLC patients ineligible for operation SBRT 对于 I 期非小细胞肺癌可手术患者是选择之一

22 Treatment 治疗 Locally advanced 局部晚期 What is the standard of care for Locally advanced unresectable Stage IIIA/IIIB patients? 局部晚期不可切的 IIIA/IIIB 期患者的标准治疗是什么? Chemoradiotherapy 放化疗 Guideline from the Ministry of health of China for Lung Cancer 卫生部肺癌治疗指南

23 Treatment 治疗 Locally advanced 局部晚期 Sequential Chemoradiotherapy is recommended 推荐序贯放化疗 Concurrent Chemoradiotherapy is recommended in some conditional hospitals 同步放化疗在某些条件的医院可以推荐 Guideline from the Ministry of health of China for Lung Cancer 卫生部肺癌治疗指南

24 Treatment 治疗 Advanced disease 晚期疾病 What is the standard of care for 1 st line and 2 nd line treatment in adenocarcinoma and non-adenocarcinoma? 腺癌和非腺癌一线和二线的标准治疗是什么? Adenocarcinoma: Platinum-based doublet chemotherapy (Pemetrexed plus platinum and the combination of bevacizumab and platinum-based chemotherapy were preferred, but not approved in China) 腺癌 : 以铂类为基础的两药联合化疗 ( 推荐培美曲塞联合铂类, 以及贝伐单抗联合铂类为基础的化疗, 但是在中国未获审批 ) Non-adenocarcinoma: Platinum-based doublet chemotherapy 非腺癌 : 以铂类为基础的两药联合化疗 Guideline from the Ministry of health of China for Lung Cancer 卫生部肺癌治疗指南

25 If EGFR mutation testing is carried out, what is the SOC for 1 st and 2 nd line treatment in EGFR mutation positive lung cancer 如果进行了 EGFR 检测, 对于 EGFR 突变阳性的肺癌患者的一线和二线标准治疗是什么? First-line therapy : Gefitinib was approved for EGFR mutation + patients by SFDA 一线治疗 : 吉非替尼被 SFDA 批准用于 EGFR 突变阳性患者 Second-line therapy: EGFR-TKIs were approved by SFDA 二线治疗 :EGFR-TKIs 被 SFDA 批准 Treatment 治疗 Advanced disease 晚期疾病 Guideline from the Ministry of health of China for Lung Cancer 卫生部肺癌治疗指南

26 Treatment 治疗 Advanced disease 晚期疾病 Is there a role for switch maintenance or continuation maintenance treatment? 转换维持治疗或继续维持治疗有用武之地么? Yes 是的 Guideline from the Ministry of health of China for Lung Cancer 卫生部肺癌治疗指南

27 Treatment 治疗 Advanced disease 晚期疾病 Do patients with advanced disease ever have surgery? 晚期肿瘤患者可以接受手术治疗么? Solitary Brain Metastasis 孤立脑转移 Solitary suprarenal gland Metastasis 孤立肾上腺转移 T1-2N0

28 Across the stages what are the key areas of unmet medical need? Treatment 治疗不论分期, 目前主要的未被满足的医学需求是什么? EGFR mutation test EGFR 突变检测 Concurrent chemoradiotherapy 同步放化疗

29 Treatment 治疗 What is the role, if any of traditional Chinese medicine in the management of NSCLC? 非小细胞肺癌治疗中, 传统中药担当什么角色? Palliative therapy for majority patients 大多数患者的姑息治疗

30 More and More Lung Cancer Studies Developing in China 越来越多的肺癌临床研究在中国进行 number year studies involved China global studies invovled China Source:

31 Why China China plays an important role in Global Clinical Trial 中国在全球临床试验中扮演重要角色 31

32 Translational Medicine Becoming More and More Important 转化医学变得越来越重要 More and more LC clinical trial involve biomarker research in China,including: 中国越来越多的肺癌临床试验纳入生物标记物 EGFR/T790M C-Met Her-2 PTEN PI3K B-RAF

33 C-TONG Study List Study number NCT number Investigational drug Study title status C-TONG 0801 NCT Bisphospohnates Screening Non Small Cell Lung Cancer With Bone Metastasis and Efficacy and Safety Research of Receiving Bisphosphonates (BLEST) Ongoing, but not recruiting C-TONG 0802 NCT Erlotinib Erlotinib Versus Gemcitabine/Carboplatin in Chemo-naive Stage IIIB/IV Non-Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Exon 19 or 21 Mutation(Optimal) Ongoing, but not recruiting C-TONG 0803 NCT Erlotinib Efficacy of Erlotinib for Brain Metastasis of Non-Small Cell Lung Cancer Ongoing, but not recruiting C-TONG 0804 NCT Gefitinib Assess the Efficacy, Safety and Tolerability of Gefitinib (Iressa 250mg) as Maintenance Therapy in Locally Advanced or Metastatic (Stage IIIB/IV) Non Small Cell Lung Cancer (NSCLC) (INFORM) Completed C-TONG 0805 NCT Sorafenib Sorafenib Treatment in Non-Small Cell Lung Cancer After Failure of Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor Recruiting C-TONG 0806 NCT Pemetrexed Gefitinib Study of Pemetrexed Versus Gefitinib in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer Who Have Previously Received Platinum-Based Chemotherapy Without Epidermal Growth Factor Receptor (EGFR) Mutations Recruiting C-TONG 0807 NCT Erlotinib/ Carpecitabine A Study of TX Regimen as First-Line Treatment in Elderly Patients With Stage IIIB/IV Adenocarcinoma Non-Small Cell Lung Cancer Ongoing, but not recruiting C-TONG 0901 NCT Erlotinib/ Gefitinib Erlotinib Versus Gefitinib in Advanced Non Small Cell Lung Cance With exon21 Mutation:A Randomized Trial Recruiting

34 C-TONG Study List(Continued) Study number NCT number Investigational drug Study title status C-TONG 0902 NCT Erlotinib A Study of Tarceva (Erlotinib) or Placebo in Combination With Platinum-Based Therapy as First Line Treatment in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer Ongoing, but not recruiting C-TONG 0904 NCT Docetaxel Tax First-line Chemotherapy With Different Doses and Then Maintenance Therapy (TFINE) Recruiting C-TONG 1001 C-TONG 1002 C-TONG 1003 C-TONG 1101 C-TONG 1102 NCT rhtpo NCT Nab-Paclitaxel/ Gemcitabine NCT Rad001 (Afinitor) NCT Erlotinib Clinical Trial on the Prevention of Thrombocytopenia After Firstline Chemotherapy Nab-Paclitaxel Treatment in Advanced Squamous Cell Carcinoma of Lung Safety and Tolerability Profile of RAD001 Daily in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor A single arm, one center, phase II study of sequential administration of erlotinib in combination with Gemcitabine/Cisplatin as neoadjuvant treatment in patients with stage IIIA NSCLC Recruiting Not yet opening Ongoing, but not recruiting Recruiting Gefitinib Iressa vs chemo as intermittent treatment in advanced NSCLC Not yet opening C-TONG 1103 Ertlotinib Erlotinib vs chemo as neoadjuvant in IIIA-N2 NSCLC with EGFR Mutation in exon 19 or 21 Not yet opening

35 Our Center - Rich experience in global clinical trails 我们中心丰富的全球临床试验经验 A phase II randomized double-blind trial of sequential erlotinib and chemotherapy as first-line treatment in patients (pts) with stage IIIB/IV non-small cell lung cancer (NSCLC). Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial Phase III, randomised, open-label,first-line study of gefitinib vs carboplatin / paclitaxel in clinically selected patients with advanced non-small-cell lung cancer (IPASS) A Phase II Multicenter Uncontrolled Trial of BAY in Patients With Relapsed or Refractory Advanced Non-small Cell Lung Carcinoma A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients With Stage IIIb With Effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC) A multicentre, randomised, open-label Phase III trial of afatinib (compound code BIBW 2992) versus chemotherapy (cisplatin/gemcitabine) as first-line treatment in patients (pts) with stage IIIB/IV non-small cell lung cancer (NSCLC). An Investigational Drug, PF , Is Being Studied In Patients With Advanced Non- Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene 35

36 Thank you very much for your attention Welcome to China

一、口朊給藥護理技術操作標準

一、口朊給藥護理技術操作標準食道癌壹疾病導因一定義食道任何一處的組織細胞有了惡性的轉變發展出來的惡性腫瘤都叫做食道癌, 依細胞的來源又再區別為鱗狀上皮癌平滑肉癌等, 其中以由最內層黏膜上皮長出的癌最多再者, 食道上三分之二為由鱗狀上皮組成,