健擇gs肺癌 ppt課件

1、,所有關(guān)于鹽酸吉西他濱的國(guó)際刊物文獻(xiàn)只支持健擇®的療效和安全性,局部晚期或轉(zhuǎn)移性非小細(xì)胞肺癌 一線用藥,,一線選擇，獲益更多,一線選擇，獲益更多,化療仍是晚期非小細(xì)胞肺癌一線治療的基石,2009 年版 ASCO 指南推薦： 對(duì)于PS評(píng)分0－1的IV期非小細(xì)胞肺癌患者， 一線治療推薦使用含鉑兩藥聯(lián)合的細(xì)胞毒方案。[1],Christopher G. Azzoli

2、 et al: American Society of Clinical Oncology Clinical Practice Guideline Update on Chemotherapy for Stage IV Non-Small-Cell Lung Cancer: Published Ahead of Print on November 23, 2009as 10.1200/JCO.2009.23.5

3、622.,一線選擇，獲益更多,“對(duì)于未經(jīng)選擇的病人，沒有足夠的臨床證據(jù)支持單藥使用厄羅替尼或吉非替尼作為一線治療方案。對(duì)于EGFR突變的患者，一線使用吉非替尼可能是一種選擇。如果EGFR突變陰性或未知的病人，應(yīng)該首選細(xì)胞毒類的化學(xué)治療?！盵1],—2011 Focused Update of 2009 ASCO IV NSCLC Guideline,Christopher G. Azzoli et al: American Societ

4、y of Clinical Oncology Clinical Practice Guideline Update on Chemotherapy for Stage IV Non-Small-Cell Lung Cancer: Published Ahead of Print on November 23, 2009as 10.1200/JCO.2009.23.5622.,一線選擇，獲益更多,健擇®

5、擁有廣泛的循證醫(yī)學(xué)證據(jù),2. Lilly data on file.,一線選擇，獲益更多,健擇®在多項(xiàng)大型的臨床研究中顯示出了一致卓越的療效,所有試驗(yàn)均使用健擇®/順鉑方案21天方案,3. Alberola er al:.J Xlin Oncol 21: 3207-3213,2003.4. Bissett et al: ASCO 2002(abstr 1183).5. Cardenal et al: J Clin

6、 Oncol 17:12-18,1999.6. Giaccone et al:  J Clin Oncol 22(5):777-784, 2004.7. Scagliotti et al: J Clin Oncol 22(5): 4285-4291,2002.8. Smit et al: J Clin Oncol 21:3909-3917, 2003.9. Martoni et al:  Eur J Canc

7、er  41:81-92, 2005.10.Paz Ares et al: J Clin Oncol 24:1428-1434, 2006.,,延遲疾病進(jìn)展，更長(zhǎng)生存時(shí)間,延遲疾病進(jìn)展，更長(zhǎng)生存時(shí)間,健擇®/鉑類方案可顯著延長(zhǎng)患者疾病進(jìn)展時(shí)間(TTP)[11],符合入組標(biāo)準(zhǔn)患者疾病進(jìn)展時(shí)間 (TTP),11.Schiller JH, Harrington D, Belani C et al. Comparison

8、of four chemotherapy regimens for advanced non-small cell lung cancer. N. Engl. J. Med. 346, 92-98 (2002).,延遲疾病進(jìn)展，更長(zhǎng)生存時(shí)間,健擇®/鉑類方案可顯著延長(zhǎng)患者疾病進(jìn)展時(shí)間(TTP)[11],符合入組標(biāo)準(zhǔn)患者生存時(shí)間 (OS),ECOG1594研究顯示：較對(duì)照組紫杉醇/順鉑方案，健擇®/順鉑方案可顯著延長(zhǎng)

9、患者的疾病進(jìn)展時(shí)間 (TTP),11.Schiller JH, Harrington D, Belani C et al. Comparison of four chemotherapy regimens for advanced non-small cell lung cancer. N. Engl. J. Med. 346, 92-98 (2002).,延遲疾病進(jìn)展，更長(zhǎng)生存時(shí)間,與紫杉醇/鉑類或其他一線化療方案相比，接受健擇

10、74;/鉑類作為一線方案治療的患者有從二線化療獲得更大生存受益的趨勢(shì),Dr. Paul Bunn*基于 JMEI- 晚期非小細(xì)胞肺癌二線化療比較的Ⅲ期臨床研究所進(jìn)行的回顧性分析 [12],* Dr.Paul Bunn - 前任IASLC及ASCO主席,12.An Exploratory Analysis of a Phase III Study in Patients with advanced non-smal cell lung c

11、ancer(NSCLC):The impact of first-line gemcitabine and platinum therapy on the outcome of second therapy with Pemetrexed or Docetaxel. Abstract PD-068, 2005 WCLC.,延遲疾病進(jìn)展，更長(zhǎng)生存時(shí)間,健擇®/鉑類一線治療非小細(xì)胞肺癌療效優(yōu)于其它含鉑方案，顯著延長(zhǎng)疾

12、病無進(jìn)展生存期 [13],13.T. Le Chevalier et al., Efficacy of gemcitabine plus platinum chemotherapy compared with other platinum containing regimens in advanced non-small-cell lung cancer: ameta-analysis of survival outcomes. Lun

13、g Cancer .2005; 47: 69-80.,延遲疾病進(jìn)展，更長(zhǎng)生存時(shí)間,健擇®/鉑類一線治療非小細(xì)胞肺癌療效優(yōu)于其它含鉑方案，顯著延長(zhǎng)總生存期[13],13.T. Le Chevalier et al., Efficacy of gemcitabine plus platinum chemotherapy compared with other platinum containing regimens

14、in advanced non-small-cell lung cancer: ameta-analysis of survival outcomes. Lung Cancer .2005; 47: 69-80.,延遲疾病進(jìn)展，更長(zhǎng)生存時(shí)間,一項(xiàng)比較了三代化療藥物的meta分析，匯聚了45個(gè)隨機(jī)臨床試驗(yàn)，11867例患者；其中，按疾病進(jìn)展風(fēng)險(xiǎn)進(jìn)行了4項(xiàng)獨(dú)立的薈萃分析[14],14.Francesco Grossi et a

15、l: Impact of third-generation drugs on the activity of first-line chemotherapy in advanced non-small cell lung cancer: a meta-analytical approach: The Oncologist 2009; 14:497-510.,延遲疾病進(jìn)展，更長(zhǎng)生存時(shí)間,在晚期非小細(xì)胞肺癌一線治療中，與其它三代化療方案相比

16、健擇®/鉑類方案顯著降低疾病進(jìn)展風(fēng)險(xiǎn)達(dá)14%,疾病進(jìn)展風(fēng)險(xiǎn)降低提示： 患者能獲得更長(zhǎng)生存時(shí)間的機(jī)會(huì)更多,延遲疾病進(jìn)展，更長(zhǎng)生存時(shí)間,健擇®對(duì)于晚期 NSCLC鱗癌和非鱗癌患者的療效同樣顯著,比較健擇®/順鉑方案與新藥/順鉑方案治療晚期一線 NSCLC 的Ⅲ期臨床試驗(yàn)證明 [15]：,健擇®對(duì)于不同組織學(xué)類型的晚期 NSCLC 都具有一致卓越的療效,15.Giorgio Vittori

17、o Scagliotti et al: Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy -naive patients with advanced-stage non-small-cell lung cancer: J Clin Oncol 26:3543-3551.,延遲疾病進(jìn)展，更

18、長(zhǎng)生存時(shí)間,ECOG1594回顧性分析再次證實(shí)健擇®對(duì)于晚期 NSCLC腺癌和鱗癌患者的療效同樣卓越,回顧性分析 ECOG1594 研究顯示 [16]：,16.Hoang, Tien et al: abstract of 13 th WCLC, PD6.4.1.,延遲疾病進(jìn)展，更長(zhǎng)生存時(shí)間,IFCT-GFPC0502：一線健擇®聯(lián)合順鉑 4－6 個(gè)周期后，繼以健擇®單藥維持治療，可顯著延長(zhǎng)疾病無進(jìn)展生存期

19、[17],17.Perol M, Chouaid C, Milleron BJ, et al. Maintenance with either gemcitabine or erlotinib versus observation with predefined second-line treatment after cisplatin-gemcitabline induction chemotherapy in advanced

20、 NSCLC:IFCT-GFPC 0502 phase III study [abstract]. J Clin Oncol 2010;28 (Suppl 15): Abstract 7507.,延遲疾病進(jìn)展，更長(zhǎng)生存時(shí)間,IFCT-GFPC0502：一線健擇®聯(lián)合順鉑 4－6 個(gè)周期后，繼以健擇®單藥維持治療，可顯著延長(zhǎng)疾病無進(jìn)展生存期[17],基于 IFCT-GFPC 0502 研究結(jié)果，2012 年 V

21、1 版NCCN 指南推薦健擇®用于一線治療后同藥維持治療[18],17.Perol M, Chouaid C, Milleron BJ, et al. Maintenance with either gemcitabine or erlotinib versus observation with predefined second-line treatment after cisplatin-gemcitabline ind

22、uction chemotherapy in advanced NSCLC:IFCT-GFPC 0502 phase III study [abstract]. J Clin Oncol 2010;28 (Suppl 15): Abstract 7507.,18.NCCN Clinical Practice Guidelines in Oncology Version1. 2012,延遲疾病進(jìn)展，更長(zhǎng)生存時(shí)間,在晚期非小細(xì)胞

23、肺癌治療中健擇®單藥維持治療顯著延長(zhǎng)TTP達(dá) 1.6個(gè)月[19],19.Thomas Brodowicz et al., Cisplatin and gemcitabine first-line chemotherapy followed by maintenace gemcitabine or best supportive care in advanced non-small cell lung cancer: A ph

24、ase III trial. Lung Cancer. 2006; 52: 155-163.,延遲疾病進(jìn)展，更長(zhǎng)生存時(shí)間,健擇®單藥維持治療對(duì)身體狀況良好的患者 顯著提高總生存期達(dá) 13.1個(gè)月[19],19.Thomas Brodowicz et al., Cisplatin and gemcitabine first-line chemotherapy followed by

25、maintenace gemcitabine or best supportive care in advanced non-small cell lung cancer: A phase III trial. Lung Cancer. 2006; 52: 155-163.,,禮來原創(chuàng)，放心選擇,禮來原創(chuàng)，放心選擇,健擇®/順鉑方案耐受性較好[20],3度或4度的毒性顯著低于伊立替康/順鉑組（p＜0.05） 3度或4度的毒

26、性顯著高于伊立替康/順鉑組（p＜0.05）,20.Y.Ohe et al., Randomized phase III study of cisplatin plus irinotecan versus carboplatin plus paclitaxel, cisplatin plus gemcitabine, and cisplatin plus vinorelbine for advanced non-small-cell lu

27、ng cancer: Four-Arm Cooperative Study in Japan: Annals of oncology 18:317-323, 2007.,健擇®引起的血小板降低通?？赡?，且一般無臨床出血性并發(fā)癥[21],血小板下降常出現(xiàn)于化療周期的第 15 天,血小板再生功能良好，下一化療周期開始前，血小板計(jì)數(shù)基本恢復(fù)正常,,,21.Martin J. Edelman, Commentary o

28、n “Gemcitabine: Single-Agent and Combination Therapy in Non-Small Cell Lung Cancer”, The Oncologist 1999; 4: 241-251.,22.Martin J. Edelman, David R. Gandara, Derrick H. M. Lau, et al. Sequential Combination Chemotherapy

29、in Patients with Advanced Nonsmall Cell Lung Carcinoma,Cancer 2001；92:146-152.,禮來原創(chuàng)，放心選擇,所有國(guó)際刊物上的大型臨床研究證實(shí)的療效 和安全性數(shù)據(jù)只支持健擇®,截止 2011 年底：,健擇®在晚期非小細(xì)胞肺癌一線治療中：共有87個(gè)Ⅲ期臨床研究，38,050例病人入組【2】,健擇®在局

30、部晚期和轉(zhuǎn)移性胰腺癌治療中：共有61個(gè)Ⅲ期臨床研究，16,616例病人入組【2】,健擇®在復(fù)發(fā)或轉(zhuǎn)移性乳腺癌治療中：共有19個(gè)Ⅲ期臨床研究，7,311例病人入組【2】,2. Lilly data on file.,禮來原創(chuàng)，放心選擇,所有國(guó)際刊物上的大型臨床研究證實(shí)的療效 和安全性數(shù)據(jù)只支持健擇®,迄今為止：健擇®已經(jīng)在全球超過90個(gè)國(guó)家上市【2】已有超過23

31、0萬患者接受了健擇®的治療【2】,2. Lilly data on file.,禮來原創(chuàng)，放心選擇,全球 90 多個(gè)國(guó)家所使用的健擇®都是同樣的高品質(zhì),健擇®是目前唯一被全球（美國(guó)FDA、歐盟EMA及中國(guó)SFDA）一致批準(zhǔn)的吉西他濱,健擇®按照歐盟 GMP 標(biāo)準(zhǔn)生產(chǎn)，具有優(yōu)良的生產(chǎn)工藝,全球統(tǒng)一的原材料標(biāo)準(zhǔn)并銷往全球,具有三年保質(zhì)期，穩(wěn)定性好,2. Lilly data on file.,禮來原

32、創(chuàng)，放心選擇,健擇®是目前唯一獲得中國(guó) SFDA 批準(zhǔn)用于以下三個(gè)適應(yīng)癥的吉西他濱,局部晚期或轉(zhuǎn)移性非小細(xì)胞肺癌,局部晚期或轉(zhuǎn)移性胰腺癌（僅限于健擇®）,復(fù)發(fā)或轉(zhuǎn)移性乳腺癌（僅限于健擇®）,一線選擇，獲益更多,延遲疾病進(jìn)展，更長(zhǎng)生存時(shí)間,禮來原創(chuàng)，放心選擇,局部晚期或轉(zhuǎn)移性非小細(xì)胞肺癌 一線用藥,禮來原創(chuàng)，放心選擇,參考文獻(xiàn)1. Christopher G. Azzoli et al: America

33、n Society of Clinical Oncology Clinical Practice Guideline Update on Chemotherapy for Stage IV Non-Small-Cell Lung Cancer: Published Ahead of Print on November 23, 2009 as 10.1200/JCO.2009.23.5622.2. Lilly data on

34、file.3. Alberola er al: Cisplatin Plus Gemcitabine Versus a Cisplatin-Based Triplet Versus Nonplatinum Sequential Doublets in Advanced Non-Small-Cell Lung Cancer: A Spanish Lung Cancer Group Phase Ⅲ Randomized Tria

35、l.J Xlin Oncol 21: 3207-3213,2003.4. Bissett et al: Phase Ⅲstudy of the matrix metalloprotease (MMP) inhibitor prinomastat (P) in combination with gemcitabine (G) and cisplatin ( C ) in non-small cell lung cancer (NSCLC

36、). ASCO 2002(abstr 1183).5. Cardenal et al: Randomized Phase III Study of Gemcitabine-Cisplatin Versus Etoposide-Cisplatin in the Treatment of Locally Advanced or Metastatic Non-Small-Cell Lung Cancer. J Clin Oncol 1

37、7:12-18,1999.6. Giaccone et al: Gefitinib in Combination With Gemcitabine and Cisplatin in Advanced Non-Small-Cell Lung Cancer: A Phase Ⅲ Trial-INTACT 1. J Clin Oncol 22(5):777-784, 2004.7. Scagliotti et al: Phase Ⅲ Ra

38、ndomized Trial Comparing Three Platinum-Based Doublets in Advanced Non-Small-Dell Lung Cancer. J Clin Oncol 22(5): 4285-4291,2002.8. Smit et al: Three-Arm Randomized Study of Two Cisplatin-Based Regimens and Paclitaxel

39、Plus Gemcitabine in Advanced Non-Small-Cell Lung Cancer: A Phase Ⅲ Trial of the European Organization for Research and Treatment of Cancer Lung Cancer Group-EORTC 08975. J Clin Oncol 21:3909-3917, 2003.9. Martoni e

40、t al: Multicentre randomised phase Ⅲ study comparing the same dose and schedule of cisplatin plus the same schedule of vinorelbine or gemcitabine in advanced non-small cell lung cancer. Eur J Cancer 41:81-92, 2005.

41、10.Paz Ares et al: Phase Ⅲ Study of Gemcitabine and Cisplatin With or Without Aprinocarsen, a Protein Kinase C-Alpha Antisense Oligonucleotide, in Patients With Advanced-Stage Non-Small-Cell Lung Cancer. J Clin Onc

42、ol 24:1428-1434, 2006.11.Schiller JH, Harrington D, Belani C et al. Comparison of four chemotherapy regimens for advanced non-small cell lung cancer. N. Engl. J. Med. 346, 92-98 (2002).12.An Exploratory Analysis of a P

43、hase III Study in Patients with advanced non-smal cell lung cancer(NSCLC):The impact of first-line gemcitabine and platinum therapy on the outcome of second therapy with Pemetrexed or Docetaxel. Abstract PD-068, 20

44、05 WCLC.13.T. Le Chevalier et al., Efficacy of gemcitabine plus platinum chemotherapy compared with other platinum containing regimens in advanced non-small-cell lung cancer: ameta-analysis of survival outcomes. Lung

45、 Cancer .2005; 47: 69-80.14.Francesco Grossi et al: Impact of third-generation drugs on the activity of first-line chemotherapy in advanced non-small cell lung cancer: a meta-analytical approach: The Oncologist 2009;

46、 14:497-510. 15.Giorgio Vittorio Scagliotti et al: Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy -naive patients with advanced-stage non-small-cell lung cancer: J C

47、lin Oncol 26:3543-3551. 16.Hoang, Tien et al: abstract of 13 th WCLC, PD6.4.1.17.Perol M, Chouaid C, Milleron BJ, et al. Maintenance with either gemcitabine or erlotinib versus observation with predefined second

48、-line treatment after cisplatin-gemcitabline induction chemotherapy in advanced NSCLC:IFCT-GFPC 0502 phase III study [abstract]. J Clin Oncol 2010;28 (Suppl 15): Abstract 7507.18.NCCN Clinical Practice Guidelines

49、in Oncology Version1. 201219.Thomas Brodowicz et al., Cisplatin and gemcitabine first-line chemotherapy followed by maintenace gemcitabine or best supportive care in advanced non-small cell lung cancer: A phase III tria

50、l. Lung Cancer. 2006; 52: 155-163.20.Y.Ohe et al., Randomized phase III study of cisplatin plus irinotecan versus carboplatin plus paclitaxel, cisplatin plus gemcitabine, and cisplatin plus vinorelbine for advance

51、d non-small-cell lung cancer: Four-Arm Cooperative Study in Japan: Annals of oncology 18:317-323, 2007.21.Martin J. Edelman, Commentary on “Gemcitabine: Single-Agent and Combination Therapy in Non-Small Cell Lung

52、Cancer”, The Oncologist 1999; 4: 241-251.22.Martin J. Edelman, David R. Gandara, Derrick H. M. Lau, et al. Sequential Combination Chemotherapy in Patients with Advanced Nonsmall Cell Lung Carcinoma,Cancer 2001；92:146-15

53、2.,,所有關(guān)于鹽酸吉西他濱的國(guó)際刊物文獻(xiàn)只支持健擇®的療效和安全性,局部晚期或轉(zhuǎn)移性非小細(xì)胞肺癌 一線用藥,化療是基石 健擇®是優(yōu)選,化療是基石，健擇®是優(yōu)選,ORCH研究[1]：該項(xiàng)III期臨床研究旨在比較未經(jīng)過選擇的晚期NSCLC患者，一線使用健擇®/順鉑方案和一線使用TKI案的療效優(yōu)劣,1. C.Gridelli et al; ASCO 2010 Abstract No

54、.7508.,化療是基石，健擇®是優(yōu)選,晚期NSCLC患者，一線使用健擇®/順鉑較厄洛替尼PFS延長(zhǎng)近3倍，OS顯著延長(zhǎng)3.5個(gè)月,1. C.Gridelli et al; ASCO 2010 Abstract No.7508.,化療是基石，健擇®是優(yōu)選,IPASS研究回顧性分析顯示：即使在腺癌、非吸煙優(yōu)勢(shì)人群，超過40%無EGFR突變【2】,2. Tony S. Mok et al: ESMO 2008

55、 abstract ＃LBA2.,化療是基石，健擇®是優(yōu)選,IPASS研究回顧性分析顯示：對(duì)于 EGFR 突變陰性患者，一線使用 TKI 的緩解率只有1.1%【3】,3. Tony S. Mok et al: Gefitinib or Carboplatin-Paclitaxel in Pulmonary Adenocarcinoma, N. Engl. J.Med. 361；10: 947-957，2009。,化療是基石，

56、健擇®是優(yōu)選,對(duì)于 EGFR 突變?nèi)巳海瑹o論一線選用化療或 TKI ，總生存無統(tǒng)計(jì)學(xué)差異【4】,4.E.Bria et al: Outcome of advanced NSCLC patients harboring sensitizing EGFR mutations randomized to EGFR tyrosine kinase inhibitors or chemotherapy as first-line tr

57、eatment: a meta-analysis, Annals of oncology 22:2277-2285,2011.,化療是基石，健擇®是優(yōu)選,權(quán)威指南一致推薦：對(duì)于 EGFR 突變陰性或未知的晚期 NSCLC 患者，一線應(yīng)該選擇化療,5. Azzoli CG, et al: 2011 Focused Update of 2009 American Society of Clinical Oncology Clini

58、cal Practice Guideline Update on Chemotherapy for Stage IV Non-Small-Cell Lung Cancer J Clin Oncol ; 29(28): 3825-31, 2011.6.NCCN Clinical Practice Guidelines in Oncology Version1. 20127. G. D’Addario et al: Metastatic