1、,所有关于盐酸吉西他滨的国际刊物文献只支持健择的疗效和安全性,局部晚期或转移性非小细胞肺癌 一线用药,一线选择，获益更多,一线选择，获益更多,化疗仍是晚期非小细胞肺癌一线治疗的基石,2009 年版 ASCO 指南推荐： 对于PS评分01的IV期非小细胞肺癌患者， 一线治疗推荐使用含铂两药联合的细胞毒方案。1,Christopher G. Azzoli et al: American Society of Clinical Oncology Clinical Practice Guideline Update on Chemotherapy for Stage IV Non-Small-Cell
2、 Lung Cancer: Published Ahead of Print on November 23, 2009as 10.1200/JCO.2009.23.5622.,一线选择，获益更多,“对于未经选择的病人，没有足够的临床证据支持单药使用厄罗替尼或吉非替尼作为一线治疗方案。对于EGFR突变的患者，一线使用吉非替尼可能是一种选择。如果EGFR突变阴性或未知的病人，应该首选细胞毒类的化学治疗。”1,2011 Focused Update of 2009 ASCO IV NSCLC Guideline,Christopher G. Azzoli et al: American Societ
3、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.,一线选择，获益更多,健择拥有广泛的循证医学证据,2. Lilly data on file.,一线选择，获益更多,健择在多项大型的临床研究中显示出了一致卓越的疗效,所有试验均使用健择/顺铂方案21天方案,3. Albero
4、la er al:.J Xlin Oncol 21: 3207-3213,2003.4. Bissett et al: ASCO 2002(abstr 1183).5. Cardenal et al: J Clin 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:
5、 Eur J Cancer 41:81-92, 2005.10.Paz Ares et al: J Clin Oncol 24:1428-1434, 2006.,延迟疾病进展，更长生存时间,延迟疾病进展，更长生存时间,健择/铂类方案可显著延长患者疾病进展时间(TTP)11,符合入组标准患者疾病进展时间 (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. Me
6、d. 346, 92-98 (2002).,延迟疾病进展，更长生存时间,健择/铂类方案可显著延长患者疾病进展时间(TTP)11,符合入组标准患者生存时间 (OS),ECOG1594研究显示：较对照组紫杉醇/顺铂方案，健择/顺铂方案可显著延长患者的疾病进展时间 (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).,
7、延迟疾病进展，更长生存时间,与紫杉醇/铂类或其他一线化疗方案相比，接受健择/铂类作为一线方案治疗的患者有从二线化疗获得更大生存受益的趋势,Dr. Paul Bunn*基于 JMEI- 晚期非小细胞肺癌二线化疗比较的期临床研究所进行的回顾性分析 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 cancer(NSCLC):The impact of first-line gemcitabine
8、 and platinum therapy on the outcome of second therapy with Pemetrexed or Docetaxel. Abstract PD-068, 2005 WCLC.,延迟疾病进展，更长生存时间,健择/铂类一线治疗非小细胞肺癌疗效优于其它含铂方案，显著延长疾病无进展生存期 13,13.T. Le Chevalier et al., Efficacy of gemcitabine plus platinum chemotherapy compared with other platinum containing regimens in a
9、dvanced non-small-cell lung cancer: ameta-analysis of survival outcomes. Lung Cancer .2005; 47: 69-80.,延迟疾病进展，更长生存时间,健择/铂类一线治疗非小细胞肺癌疗效优于其它含铂方案，显著延长总生存期13,13.T. Le Chevalier et al., Efficacy of gemcitabine plus platinum chemotherapy compared with other platinum containing regimens in advanced non-sma
10、ll-cell lung cancer: ameta-analysis of survival outcomes. Lung Cancer .2005; 47: 69-80.,延迟疾病进展，更长生存时间,一项比较了三代化疗药物的meta分析，汇聚了45个随机临床试验，11867例患者；其中，按疾病进展风险进行了4项独立的荟萃分析14,14.Francesco Grossi et al: Impact of third-generation drugs on the activity of first-line chemotherapy in advanced non-small cell lu
11、ng cancer: a meta-analytical approach: The Oncologist 2009; 14:497-510.,延迟疾病进展，更长生存时间,在晚期非小细胞肺癌一线治疗中，与其它三代化疗方案相比健择/铂类方案显著降低疾病进展风险达14%,疾病进展风险降低提示： 患者能获得更长生存时间的机会更多,延迟疾病进展，更长生存时间,健择对于晚期 NSCLC鳞癌和非鳞癌患者的疗效同样显著,比较健择/顺铂方案与新药/顺铂方案治疗晚期一线 NSCLC 的期临床试验证明 15：,健择对于不同组织学类型的晚期 NSCLC 都具有一致卓越的疗效,15.Giorgio Vittorio
12、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.,延迟疾病进展，更长生存时间,ECOG1594回顾性分析再次证实健择对于晚期 NSCLC腺癌和鳞癌患者的疗效同样卓越,回顾性分析 ECOG1594 研究显示 16：,16.Hoang,
13、 Tien et al: abstract of 13 th WCLC, PD6.4.1.,延迟疾病进展，更长生存时间,IFCT-GFPC0502：一线健择联合顺铂 46 个周期后，继以健择单药维持治疗，可显著延长疾病无进展生存期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 indu
14、ction chemotherapy in advanced NSCLC:IFCT-GFPC 0502 phase III study abstract. J Clin Oncol 2010;28 (Suppl 15): Abstract 7507.,延迟疾病进展，更长生存时间,IFCT-GFPC0502：一线健择联合顺铂 46 个周期后，继以健择单药维持治疗，可显著延长疾病无进展生存期17,基于 IFCT-GFPC 0502 研究结果，2012 年 V1 版NCCN 指南推荐健择用于一线治疗后同药维持治疗18,17.Perol M, Chouaid C, Milleron BJ, et al
15、. Maintenance with either gemcitabine or erlotinib versus observation with predefined second-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 Guideli
16、nes in Oncology Version1. 2012,延迟疾病进展，更长生存时间,在晚期非小细胞肺癌治疗中健择单药维持治疗显著延长TTP达 1.6个月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 phase III trial. Lung Cancer. 2006; 52:
17、 155-163.,延迟疾病进展，更长生存时间,健择单药维持治疗对身体状况良好的患者 显著提高总生存期达 13.1个月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 phase III trial. Lung Cancer. 2006; 52: 155-163.,礼来原创，放心选择,
18、礼来原创，放心选择,健择/顺铂方案耐受性较好20,3度或4度的毒性显著低于伊立替康/顺铂组（p0.05） 3度或4度的毒性显著高于伊立替康/顺铂组（p0.05）,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 lung cancer: Four-Arm C
19、ooperative Study in Japan: Annals of oncology 18:317-323, 2007.,健择引起的血小板降低通常可逆，且一般无临床出血性并发症21,血小板下降常出现于化疗周期的第 15 天,血小板再生功能良好，下一化疗周期开始前，血小板计数基本恢复正常,21.Martin J. Edelman, Commentary on “Gemcitabine: Single-Agent and Combination Therapy in Non-Small Cell Lung Cancer”, The Oncologist 1999; 4: 241-251.,2
20、2.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；92:146-152.,礼来原创，放心选择,所有国际刊物上的大型临床研究证实的疗效 和安全性数据只支持健择,截止 2011 年底：,健择在晚期非小细胞肺癌一线治疗中：共有87个期临床研究，38,050例病人入组【2】,健择在局部晚期和转移性胰腺癌治疗中：共有61个
21、期临床研究，16,616例病人入组【2】,健择在复发或转移性乳腺癌治疗中：共有19个期临床研究，7,311例病人入组【2】,2. Lilly data on file.,礼来原创，放心选择,所有国际刊物上的大型临床研究证实的疗效 和安全性数据只支持健择,迄今为止：健择已经在全球超过90个国家上市【2】已有超过230万患者接受了健择的治疗【2】,2. Lilly data on file.,礼来原创，放心选择,全球 90 多个国家所使用的健择都是同样的高品质,健择是目前唯一被全球（美国FDA、欧盟EMA及中国SFDA）一致批准的吉西他滨,健择按照欧盟 GMP 标准生产，具有优良的生产工艺,全球统
22、一的原材料标准并销往全球,具有三年保质期，稳定性好,2. Lilly data on file.,礼来原创，放心选择,健择是目前唯一获得中国 SFDA 批准用于以下三个适应症的吉西他滨,局部晚期或转移性非小细胞肺癌,局部晚期或转移性胰腺癌（仅限于健择）,复发或转移性乳腺癌（仅限于健择）,一线选择，获益更多,延迟疾病进展，更长生存时间,礼来原创，放心选择,局部晚期或转移性非小细胞肺癌 一线用药,礼来原创，放心选择,参考文献1. Christopher G. Azzoli et al: American Society of Clinical Oncology Clinical Practice
23、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 file.3. Alberola er al: Cisplatin Plus Gemcitabine Versus a Cisplatin-Based Triplet Versus Nonplatinum Sequential Doublets in Advanced
24、Non-Small-Cell Lung Cancer: A Spanish Lung Cancer Group Phase Randomized Trial.J Xlin Oncol 21: 3207-3213,2003.4. Bissett et al: Phase study of the matrix metalloprotease (MMP) inhibitor prinomastat (P) in combination with gemcitabine (G) and cisplatin ( C ) in non-small cell lung cancer (NSCLC). AS
25、CO 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 17:12-18,1999.6. Giaccone et al: Gefitinib in Combination With Gemcitabine and Cisplatin i
26、n Advanced Non-Small-Cell Lung Cancer: A Phase Trial-INTACT 1. J Clin Oncol 22(5):777-784, 2004.7. Scagliotti et al: Phase Randomized 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
27、Two Cisplatin-Based Regimens and Paclitaxel Plus Gemcitabine in Advanced Non-Small-Cell Lung Cancer: A Phase 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 et al: Multicentre randomised phase study com
28、paring 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, 2005.10.Paz Ares et al: Phase Study of Gemcitabine and Cisplatin With or Without Aprinocarsen, a Protein Kinase C-Alpha Antisense Oligonu
29、cleotide, in Patients With Advanced-Stage Non-Small-Cell Lung Cancer. J Clin Oncol 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 Pha
30、se 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, 2005 WCLC.13.T. Le Chevalier et al., Efficacy of gemcitabine plus platinum chemotherapy co
31、mpared with other platinum containing regimens in advanced non-small-cell lung cancer: ameta-analysis of survival outcomes. Lung 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 me
32、ta-analytical approach: The Oncologist 2009; 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 Clin Oncol 26:3543-3551. 16.Hoang, Tien
33、 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-line treatment after cisplatin-gemcitabline induction chemotherapy in advanced NSCLC:IFCT-GFPC 0502 phase III study abstract.
34、J Clin Oncol 2010;28 (Suppl 15): Abstract 7507.18.NCCN Clinical Practice Guidelines 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 t
35、rial. 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 advanced non-small-cell lung cancer: Four-Arm Cooperative Study in Japan: Annals of oncolog
36、y 18:317-323, 2007.21.Martin J. Edelman, Commentary on “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 in Patients with Advanced No
37、nsmall Cell Lung Carcinoma,Cancer 2001；92:146-152.,所有关于盐酸吉西他滨的国际刊物文献只支持健择的疗效和安全性,局部晚期或转移性非小细胞肺癌 一线用药,化疗是基石 健择是优选,化疗是基石，健择是优选,ORCH研究1：该项III期临床研究旨在比较未经过选择的晚期NSCLC患者，一线使用健择/顺铂方案和一线使用TKI案的疗效优劣,1. C.Gridelli et al; ASCO 2010 Abstract No.7508.,化疗是基石，健择是优选,晚期NSCLC患者，一线使用健择/顺铂较厄洛替尼PFS延长近3倍，OS显著延长3.5个月,1. C.
38、Gridelli et al; ASCO 2010 Abstract No.7508.,化疗是基石，健择是优选,IPASS研究回顾性分析显示：即使在腺癌、非吸烟优势人群，超过40%无EGFR突变【2】,2. Tony S. Mok et al: ESMO 2008 abstract LBA2.,化疗是基石，健择是优选,IPASS研究回顾性分析显示：对于 EGFR 突变阴性患者，一线使用 TKI 的缓解率只有1.1%【3】,3. Tony S. Mok et al: Gefitinib or Carboplatin-Paclitaxel in Pulmonary Adenocarcinoma,
39、N. Engl. J.Med. 361；10: 947-957，2009。,化疗是基石，健择是优选,对于 EGFR 突变人群，无论一线选用化疗或 TKI ，总生存无统计学差异【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 treatment: a meta-analysis, Annals of oncolog
40、y 22:2277-2285,2011.,化疗是基石，健择是优选,权威指南一致推荐：对于 EGFR 突变阴性或未知的晚期 NSCLC 患者，一线应该选择化疗,5. Azzoli CG, et al: 2011 Focused Update of 2009 American Society of Clinical Oncology Clinical 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. DAddario et al: Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and followup, Annals of Oncology 21 (Supplement 5): v116v119, 2010.,
