1、奈达铂联合化疗方案临床研究进展,河南省肿瘤医院 河南省肺癌诊疗中心 王慧娟,概述,奈达铂( Nedaplatin)即顺-甘醇酸二氨合铂(cis-diammineglycoato- platinum)是日本盐野义制药公司开发的一个新型第二代铂类抗肿瘤药物,1995年6月在日本首次获准上市。,化学结构:,MW: 303.17 g/mol MF: C2H8N2O3Pt,上市前日本II 期临床进行了广泛的瘤谱研究:,常见肿瘤中, 奈达铂对食管癌 、头颈部癌症、 小细胞肺癌和子宫颈癌的缓解率超过 40%。,Ota K. Nedaplatin. Gan To Kagaku Ryoho 1996;23:37
2、9-87.,奈达铂联合方案临床研究进展 头颈部恶性肿瘤,一、Nedaplatin+5-FU,1998年2007年入组II-IV期的头颈部肿瘤相关研究:,1Fujii M, Tokumaru Y, Imanishi Y, Kanke M, Kanzaki J, Ohno Y. Combination chemotherapy with nedaplatin and 5-FU for head and neck cancer. Gan To Kagaku Ryoho 1998;25:53-8. 2Sasaoka M, Fuwa N, Matsumoto A, et al. Alternating
3、chemoradiotherapy for oropharyngeal cancer. Gan To Kagaku Ryoho 2000;27:2217-21. 3Maruoka Y, Ando T, Hoshino M, et al. Combination chemotherapy with nedaplatin (CDGP) and 5-FU for oral cancer. Gan To Kagaku Ryoho 2002;29:421-5. 4Yamaoka K, Fukuda M, Kuwajima S, et al. Combination chemotherapy with n
4、edaplatin and 5-fluorouracil for oral squamous cell carcinomas. Gan To Kagaku Ryoho 2003;30:951-5. 5Fuwa N, Kodaira T, Tachibana H, Nakamura T, Daimon T. Dose escalation study of nedaplatin with 5-fluorouracil in combination with alternating radiotherapy in patients with head and neck cancer. Jpn J
5、Clin Oncol 2007;37:161-7. 6管忠震, 徐瑞华. 奈达铂临床研究进展. 中国肿瘤临床 2004;31:7.,1Fujii M, Tokumaru Y, Imanishi Y, Kanke M, Kanzaki J, Ohno Y. Combination chemotherapy with nedaplatin and 5-FU for head and neck cancer. Gan To Kagaku Ryoho 1998;25:53-8. 2Sasaoka M, Fuwa N, Matsumoto A, et al. Alternating chemoradio
6、therapy for oropharyngeal cancer. Gan To Kagaku Ryoho 2000;27:2217-21. 3Maruoka Y, Ando T, Hoshino M, et al. Combination chemotherapy with nedaplatin (CDGP) and 5-FU for oral cancer. Gan To Kagaku Ryoho 2002;29:421-5. 4Yamaoka K, Fukuda M, Kuwajima S, et al. Combination chemotherapy with nedaplatin
7、and 5-fluorouracil for oral squamous cell carcinomas. Gan To Kagaku Ryoho 2003;30:951-5. 5Fuwa N, Kodaira T, Tachibana H, Nakamura T, Daimon T. Dose escalation study of nedaplatin with 5-fluorouracil in combination with alternating radiotherapy in patients with head and neck cancer. Jpn J Clin Oncol
8、 2007;37:161-7.,毒副反应:,Toxicities (WHO criteria),奈达铂联合5-FU有效率约在64%-83%,联合放疗可提高有效率。奈达铂相关毒副反应主要表现为骨髓毒性(血小板减少,白,粒细胞减少),未见中度以上肾功能毒性,相对于顺铂安全性较好。,Induction chemotherapy with nedaplatin with 5-FU followed by intensity-modulated radiotherapy concurrent with chemotherapy for locoregionally advanced nasopharyn
9、geal carcinoma(国内研究),60例IIBIVB(AJCC分期) NPC患者,ECOG:01,新辅助2周期 N100mg/m2,day 1;5-FU 700mg/m2,day1-4,放化疗同步 IMRT N100mg/m2,day1,22,43,ORR 3Y-OS 3Y-PFS,试验设计:,结果:,Objective response rate of 86.7% (95% CI, 78.195.3%),The 3-year PFS 75.0% (95% CI, 63.087.0%),The 3-year OS 85.5% (95% CI, 75.995.1%),Zheng J, W
10、ang G, Yang GY, et al. Induction chemotherapy with nedaplatin with 5-FU followed by intensity-modulated radiotherapy concurrent with chemotherapy for locoregionally advanced nasopharyngeal carcinoma. Jpn J Clin Oncol 2010;40:425-31.,Induction chemotherapy with nedaplatin with 5-FU followed by intens
11、ity-modulated radiotherapy concurrent with chemotherapy for locoregionally advanced nasopharyngeal carcinoma,毒副反应:,Zheng J, Wang G, Yang GY, et al. Induction chemotherapy with nedaplatin with 5-FU followed by intensity-modulated radiotherapy concurrent with chemotherapy for locoregionally advanced n
12、asopharyngeal carcinoma. Jpn J Clin Oncol 2010;40:425-31.,3-4度血液血毒性(粒细胞减少,血小板下降)见少数患者,未见2度以上肾功能损伤。,Nedaplatin or cisplatin combined with 5-fluorouracil for treatment of stage III-IVa nasopharyngeal carcinoma: a randomized controlled study (11年国内研究),试验设计:,试验结果:,NF 组和PF组患者达CR各3例,NF组的有效率为86.0%,PF组为84.0
13、%,两组差异无统计学意义(x2=0.078,P=0.779).,曹卡加, 张爱兰, 马文娟, 黄培钰, 罗东华, 夏伟雄. 奈达铂或顺铂联合5-氟尿嘧啶治疗鼻咽癌的随机对照研究. 中华肿瘤杂志 2011;33.,Nedaplatin or cisplatin combined with 5-fluorouracil for treatment of stage III-IVa nasopharyngeal carcinoma: a randomized controlled study,不良反应对比:,PF 组患者恶心、呕吐的发生率(88.0%)明显高于NF 组(56.0%,x2=23.268
14、,P=0.000);两组患者外周血白细胞数、血小板数、谷丙转氨酶、尿素氮和肌酐异常的发生率比较,差异无统计学意(P0.05)。,结论:奈达铂联合5-Fu是治疗局部中晚期鼻咽癌的有效方案,有效率与CF方案相似.在减少恶心、呕吐方面,奈达铂联合5-Fu有明显的优势,但研究缺乏长期生存的对照。,曹卡加, 张爱兰, 马文娟, 黄培钰, 罗东华, 夏伟雄. 奈达铂或顺铂联合5-氟尿嘧啶治疗鼻咽癌的随机对照研究. 中华肿瘤杂志 2011;33.,二、Nedaplatin+ docetaxel,II期临床:,1Kurita H, Yamamoto E, Nozaki S, et al. Multicente
15、r phase 2 study of induction chemotherapy with docetaxel and nedaplatin for oral squamous cell carcinoma. Cancer Chemother Pharmacol 2010;65:503-8. 2Miyazaki A, Kobayashi J, Yamamoto T, et al. A single-institute phase I/II trial combining nedaplatin dose escalation with a fixed dose of docetaxel for
16、 induction chemotherapy of oral squamous cell carcinoma. Oral Oncol 2008;44:471-6. 3Kobayashi W, Teh BG, Sakaki H, et al. Superselective intra-arterial chemoradiotherapy with docetaxel-nedaplatin for advanced oral cancer. Oral Oncology 2010;46:860-3. 4Uchiyama K, Iwabuchi H, Nakayama S. Phase I/II c
17、linical trial of induction chemotherapy with nedaplatin (CDGP), docetaxel (DOC) and 5-fluorouracil (5-FU) for squamous cell carcinoma of head and neck. Gan To Kagaku Ryoho 2007;34:43-8.,奈达铂联合多西他赛治疗头颈肿瘤(研究中口腔鳞癌居多)有效率约在65%-76%,联合放疗可提高有效率。,毒副反应:,1Kurita H, Yamamoto E, Nozaki S, et al. Multicenter phase
18、 2 study of induction chemotherapy with docetaxel and nedaplatin for oral squamous cell carcinoma. Cancer Chemother Pharmacol 2010;65:503-8. 2Miyazaki A, Kobayashi J, Yamamoto T, et al. A single-institute phase I/II trial combining nedaplatin dose escalation with a fixed dose of docetaxel for induct
19、ion chemotherapy of oral squamous cell carcinoma. Oral Oncol 2008;44:471-6. 3Kobayashi W, Teh BG, Sakaki H, et al. Superselective intra-arterial chemoradiotherapy with docetaxel-nedaplatin for advanced oral cancer. Oral Oncology 2010;46:860-3. 4Uchiyama K, Iwabuchi H, Nakayama S. Phase I/II clinical
20、 trial of induction chemotherapy with nedaplatin (CDGP), docetaxel (DOC) and 5-fluorouracil (5-FU) for squamous cell carcinoma of head and neck. Gan To Kagaku Ryoho 2007;34:43-8.,二、Nedaplatin+ docetaxel,毒副反应方面:主要表现为骨髓抑制(白细胞下降),未见明显肾毒性。,Phase II multicenter clinical trial of nedaplatin in the treatme
21、nt of malignant tumors(国内研究),目的:观察比较NDP与顺铂(DDP)联合化疗治疗头颈部鳞癌、非小细胞肺癌、食管癌、卵巢上皮癌的疗效和安全性,疗效对比:,1、NDP联合方案治疗头颈鳞癌、非小细胞肺癌、卵巢癌和食管癌的疗效与DDP相近。NDP胃肠反应较DDP轻,两组中均未见中度以上肾毒性。2、联合方案在头颈癌和食管癌的有效率低于既往II期研究报告,可能与研究组病例数较少,病例选择、疗效判断标准与之不尽相同等因素有关,Zhang P, Feng F-y, Wu L-y, et al. Phase II multicenter clinical trial of nedapl
22、atin in the treatment of malignant tumors. Zhonghua zhong liu za zhi Chinese journal of oncology 2006;28:230-4.,奈达铂联合方案临床研究进展 食管癌,Nedaplatin + 5FU(二期临床研究),1Jingu K, Nemoto K, Matsushita H, et al. Results of radiation therapy combined with nedaplatin (cis-diammine-glycoplatinum) and 5-fluorouracil fo
23、r postoperative locoregional recurrent esophageal cancer. BMC Cancer 2006;6:50. 2Kodaira T, Fuwa N, Kamata M, Furutani K, Tachibana H, Yamazaki T. Single-institute phase I/II trial of alternating chemoradiotherapy with 5-FU and nedaplatin for esophageal carcinoma. Anticancer Res 2006;26:471-8. 3徐瑞华,
24、 史艳侠, 管忠震, et al. 国产奈达铂治疗食管癌的期临床试验报告. 癌症 2006;25:4.,既往研究包括含DDP方案的有效率对比:,奈达铂联合5-FU双药物方案+放疗治疗局部晚期或局部复发食管癌的有效率约76%,与既往含顺铂的方案疗效相近。,1Jingu K, Nemoto K, Matsushita H, et al. Results of radiation therapy combined with nedaplatin (cis-diammine-glycoplatinum) and 5-fluorouracil for postoperative locoregional
25、 recurrent esophageal cancer. BMC Cancer 2006;6:50. 2Kodaira T, Fuwa N, Kamata M, Furutani K, Tachibana H, Yamazaki T. Single-institute phase I/II trial of alternating chemoradiotherapy with 5-FU and nedaplatin for esophageal carcinoma. Anticancer Res 2006;26:471-8. 3徐瑞华, 史艳侠, 管忠震, et al. 国产奈达铂治疗食管癌
26、的期临床试验报告. 癌症 2006;25:4.,毒副反应:,Nedaplatin + 5FU(二期临床研究),Jingu K1,Kodaira T2,NDB+5-FU主要中重度毒副反应在于骨髓抑制(白细胞下降,血小板下降),但未见明显肾毒性。奈达铂联合5-FU双药物方案+放疗治疗局部晚期或复发食管癌疗效肯定。,死亡原因考虑放射性肺炎,Nedaplatin + paclitaxel or docetaxel (二期临床研究),1Cao W, Xu C, Lou G, et al. A phase II study of paclitaxel and nedaplatin as first-lin
27、e chemotherapy in patients with advanced esophageal cancer. Jpn J Clin Oncol 2009;39:582-7. 2Gong Y, Ren L, Zhou L, et al. Phase II evaluation of nedaplatin and paclitaxel in patients with metastatic esophageal carcinoma. Cancer Chemother Pharmacol 2009;64:327-33. 3Guo JF, Zhang B, Wu F, et al. A ph
28、ase II trial of docetaxel plus nedaplatin and 5-fluorouracil in treating advanced esophageal carcinoma. Chin J Cancer 2010;29:321-4.,奈达铂联合紫杉醇双药物方案治疗晚期食管癌的有效率约42%,NDF(奈达铂+多西他赛+5-FU)可能会提高有效率,但在PFS和OS两方案似乎无明显差异。,Nedaplatin + paclitaxel or docetaxel方案与既往研究PFS及OS的结果相似,与既往含顺铂的方案疗效相近。,Nedaplatin + paclitax
29、el or docetaxel (二期临床研究),1Cao W, Xu C, Lou G, et al. A phase II study of paclitaxel and nedaplatin as first-line chemotherapy in patients with advanced esophageal cancer. Jpn J Clin Oncol 2009;39:582-7. 2Gong Y, Ren L, Zhou L, et al. Phase II evaluation of nedaplatin and paclitaxel in patients with
30、metastatic esophageal carcinoma. Cancer Chemother Pharmacol 2009;64:327-33. 3Guo JF, Zhang B, Wu F, et al. A phase II trial of docetaxel plus nedaplatin and 5-fluorouracil in treating advanced esophageal carcinoma. Chin J Cancer 2010;29:321-4.,毒副反应:,三组研究毒副反应类别和严重程度相近。,奈达铂联合方案临床研究进展 宫颈癌及卵巢癌,既往国外奈达铂治疗
31、妇科癌症的临床研究汇总:,Hirabayashi Y, Okada E. .Cancer, 1992, 71:2769一2775 Adachi S, Ogasawara T, Yamasaki N, et al. Oncol Rep, 1998, 5(4):881一884 Ito K, Adachi S, tani Y, et al. Jpn J Olin Oncol, 1999, 29(6):299一302 Adachi S, Ogasawara T, Wakimoto E, et al. Cancer, 2001, 91(1):74一79 Kodama J, Hashimoto I, Se
32、ki N, et al.Gan To Kagaku Ryoho, 2001, 28(3):351一355 Adachi S, Ogasawara T, Tsubamoto H, et al.Int_J Clin Pharmacol Res, 2001, 21(3-4):105一110,奈达铂对妇科癌症的治疗 临床报道提示 :(1)奈达铂既可单独用药 也可和其它化疗药物及放疗合用 并可作为手术的辅助治疗 ;(2)静脉输注奈达铂和动脉内灌注顺铂联合经导管栓塞术治疗晚期局部子宫颈癌疗效较好;(3)子宫颈和卵巢癌大多数患者对于含铂类制剂的化疗会产生疗效的比例很高。,PROSPECTIVE STUDYO
33、FALTERNATING CHEMORADIOTHERAPY CONSISTING OF EXTENDED-FIELD DYNAMIC CONFORMATIONAL RADIOTHERAPYAND SYSTEMIC CHEMOTHERAPY USING 5-FU AND NEDAPLATIN FOR PATIENTS IN HIGH-RISK GROUP WITH CERVICAL CARCINOMA(2009),二、Nedaplatin+5-FU,研究为I/II期临床试验,评价了扩大野适形放疗与化疗(Nedaplatin+5-FU)交替治疗高危子宫颈癌的疗效。,试验设计:入组40例初治 II
34、I/IVA 期或 IB/II 有高危风险的(肿瘤直径50 mm 或淋巴结阳性)宫颈癌患者。终点指标:5Y-PFS5Y-OAS(放化疗改 善总生存)毒副反应,Kodaira T, Fuwa N, Nakanishi T, et al. PROSPECTIVE STUDY OF ALTERNATING CHEMORADIOTHERAPY CONSISTING OF EXTENDED-FIELD DYNAMIC CONFORMATIONAL RADIOTHERAPY AND SYSTEMIC CHEMOTHERAPY USING 5-FU AND NEDAPLATIN FOR PATIENTS IN
35、 HIGH-RISK GROUP WITH CERVICAL CARCINOMA. Int J Radiat Oncol Biol Phys 2009;73:251-8.,结果:,不良反应:,5年OAS 为 78.8% (95%CI,65.692.1%) 较历史单纯放疗对照组5Y-OAS48.8% (95%CI, 33.963.8%; p = 0.02, Fig. 2)明显提高.5年PFS为 66.5%(95%CI, 51.481.6%), 也较历史对照37.2% (95%CI, 22.851.7%; p = 0.006,Fig. 3)明显提高研究中3度以上毒副反应主要表现为血液学毒性和胃肠道
36、反应(27.545%),但可以较好控制。,Nedaplatin+5-FU方案与放疗交替治疗高危子宫颈癌可以较好的控制疾病延迟生存期。,Kodaira T, Fuwa N, Nakanishi T, et al. PROSPECTIVE STUDY OF ALTERNATING CHEMORADIOTHERAPY CONSISTING OF EXTENDED-FIELD DYNAMIC CONFORMATIONAL RADIOTHERAPY AND SYSTEMIC CHEMOTHERAPY USING 5-FU AND NEDAPLATIN FOR PATIENTS IN HIGH-RISK
37、GROUP WITH CERVICAL CARCINOMA. Int J Radiat Oncol Biol Phys 2009;73:251-8.,CONCURRENT CHEMORADIOTHERAPY WITH PACLITAXEL AND NEDAPLATIN FOLLOWED BY CONSOLIDATION CHEMOTHERAPY IN LOCALLYADVANCED SQUAMOUS CELL CARCINOMA OF THE UTERINE CERVIX: PRELIMINARY RESULTS OF A PHASE II STUDY(2010 CHINA),目的:评价联合放
38、化疗及巩固化疗在局部晚期子宫颈鳞癌中的疗效和毒性。,试验设计:共入组34例初治局部晚期宫颈鳞癌患者LASCC (FIGO Stage IIBIIIB) ; ECOG(0-2分)。终点指标:RR,2Y-PFS毒副反应,Zhang MQ, Liu SP, Wang XE. CONCURRENT CHEMORADIOTHERAPY WITH PACLITAXEL AND NEDAPLATIN FOLLOWED BY CONSOLIDATION CHEMOTHERAPY IN LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE UTERINE CERVIX:
39、 PRELIMINARY RESULTS OF A PHASE II STUDY. Int J Radiat Oncol Biol Phys 2010;78:821-7.,二、Nedaplatin+ paclitaxel,CONCURRENT CHEMORADIOTHERAPY WITH PACLITAXEL AND NEDAPLATIN FOLLOWED BY CONSOLIDATION CHEMOTHERAPY IN LOCALLYADVANCED SQUAMOUS CELL CARCINOMA OF THE UTERINE CERVIX: PRELIMINARY RESULTS OF A
40、 PHASE II STUDY(2010 CHINA),Zhang MQ, Liu SP, Wang XE. CONCURRENT CHEMORADIOTHERAPY WITH PACLITAXEL AND NEDAPLATIN FOLLOWED BY CONSOLIDATION CHEMOTHERAPY IN LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE UTERINE CERVIX: PRELIMINARY RESULTS OF A PHASE II STUDY. Int J Radiat Oncol Biol Phys 2010;78:8
41、21-7.,2Y-PFS: 82%(95% CI,6895%),2Y-OS: 93%(95% CI, 83100%),39例可评估患者CCRT完成1月后CR:27 (79%) ,PR :7 (21%) , 巩固化疗后CR率升高至 30 (88%; 95% CI, 7396%) 。,3-4级化疗相关毒副反应主要见于白/粒细胞减少,胃肠道反应。,CONCURRENT CHEMORADIOTHERAPY WITH PACLITAXEL AND NEDAPLATIN FOLLOWED BY CONSOLIDATION CHEMOTHERAPY IN LOCALLYADVANCED SQUAMOUS C
42、ELL CARCINOMA OF THE UTERINE CERVIX: PRELIMINARY RESULTS OF A PHASE II STUDY(2010 CHINA),Zhang MQ, Liu SP, Wang XE. CONCURRENT CHEMORADIOTHERAPY WITH PACLITAXEL AND NEDAPLATIN FOLLOWED BY CONSOLIDATION CHEMOTHERAPY IN LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE UTERINE CERVIX: PRELIMINARY RESULT
43、S OF A PHASE II STUDY. Int J Radiat Oncol Biol Phys 2010;78:821-7.,既往同步放化疗联合巩固化疗治疗(EPI;DDP为基础)局部晚期宫颈鳞癌研究汇总:,Nedaplatin+ paclitaxel联合方案进行同步放化疗及巩固治疗局部晚期宫颈鳞癌疗效、 生存改善情况与既往DDP为基础的研究相近。,Ota K. Nedaplatin Kangku Roho. 1996 Feb; 23(3):379-387,有效率,铂类单药疗效数据,奈达铂联合方案临床研究进展 肺癌临床研究回顾,日本肺癌临床研究回顾 有化疗史的患者仍然有效,有效率,Ot
44、a K. Nedaplatin Kangku Roho. 1996 Feb; 23(3):379-387,奈达铂与顺铂随机对照研究,一线NSCLC治疗 随机分组:TN: Taxol 175mg/m2 d1 NDP 30mg/m2 d1-3TP: Taxol 175mg/m2 d1 DDP 30mg/m2 d1-3 每4周重复,陈丽昆,徐光川,管忠震,等,中华肿瘤杂志,2007.6:437-440,近期疗效,陈丽昆,徐光川,管忠震,等,中华肿瘤杂志,2007.6:437-440,生存曲线,陈丽昆,徐光川,管忠震,等,中华肿瘤杂志,2007.6:437-440,毒副反应,陈丽昆,徐光川,管忠震等,
45、中华肿瘤杂志,2007.6:437-440,二线治疗晚期非小细胞肺癌的临床研究,联合组: N=20 Doc 60mg/m2 d1 + NDP 80mg/m2 d1单药组: N=38Doc 60mg/m2 d128天为一周期,顾淋萍,沈盛萍,陈智伟 .中华肿瘤杂志,2010,32(12):939-942,二线治疗晚期非小细胞肺癌的临床研究,顾淋萍,沈盛萍,陈智伟 .中华肿瘤杂志,2010,32(12):939-942,二线治疗晚期非小细胞肺癌的临床研究,顾淋萍,沈盛萍,陈智伟 .中华肿瘤杂志,2010,32(12):939-942,血液学毒性比价,二线治疗晚期非小细胞肺癌的临床研究,顾淋萍,沈盛
46、萍,陈智伟 .中华肿瘤杂志,2010,32(12):939-942,结 论,奈达铂一线治疗NSCLC与顺铂疗效相当,不良反应优于顺铂。 二线NSCLC患者奈达铂联合多西他塞,中位PFS与单药组有差异(p0.05),未增加明显毒副反应。,奈达铂在腺鳞癌分型中的研究,2004年 2006年 初治NSCLC患者 N = 46 PS : 0 1 男/女 = 39/7 中位年龄 : 65 分期:B /IV = 20/26,S. Fujino, Journal of Clinical Oncology, 2007 ASCO,治疗方案:NDP: 80mg/m2 d1 TXT: 60 mg/m2 d1 疗效:
47、RR: 52.2%( 鳞癌 66.7%, 腺癌44.0% )MST: 12个月,1-yr OS: 50% 不良反应: 3-4级的白细胞减少,中性粒细胞减少,恶心/呕吐和食欲不振发生率分别为29.2、34.7、3.5、4.2。 没出现有3-4级贫血,血小板减少症和神经病变。,S. Fujino, Journal of Clinical Oncology, 2007 ASCO,奈达铂在腺鳞癌分型中的研究,奈达铂、CPT-11治疗NSCLC 鳞及非鳞癌 Meta分析,F Oshita, J Thorac Oncol, January 1, 2011; 6(1): 128-131.,Patient C
48、haracteristics,奈达铂、CPT-11治疗NSCLC 鳞及非鳞癌 Meta分析,结论:奈达铂联合CPT-11治疗NSCLC鳞癌更有效,疗效比较,F Oshita, J Thorac Oncol, January 1, 2011; 6(1): 128-131.,结 论,奈达铂在食管癌、鼻咽癌、宫颈癌等以鳞癌为主的实体瘤中,已经显示出较好的疗效。 近期临床报道显示:奈达铂对肺鳞癌效果似乎也好于腺癌。,黑龙江省肿瘤医院应用奈达铂联合新药治疗 NSCLC的回顾性研究,回顾黑龙江省肿瘤医院2009年6月30日至2011年9月30日 应用新药联合奈达铂(或顺铂)治疗NSCLC 完整病历共计45
49、3例(初治378例,复治75例),研究目的,分别观察奈达铂、顺铂一线治疗NSCLC,在疗效及毒副反应上的差异? 在组织学分型上,奈达铂的应用是否也存在疗效上的差异?,治疗方案,NDP 30 mg/m2 或 顺铂 30 mg/m2 d1-3 每3周重复 紫杉醇(TP) 135 mg/m2 多西他赛(DP) 75mg/m2 吉西他滨(GP) 1000mg/m2 长春瑞滨(NP) 25mg/m2 培美曲塞(CP) 500mg/m2,观察指标,近期疗效不良反应,患者一般资料,患者一般资料,病理分型,患者一般资料,总体疗效显示奈达铂组疗效优于顺铂组,近期疗效,近期疗效,分层分析 初复治分析,数据显示初治患者使用奈达铂获益更多,近期疗效,分层分析 腺鳞癌分析,奈达铂治疗鳞癌,有效率和获益率均优于顺铂,近期疗效,分层分析 临床分期分析,对于期患者奈达铂显示较好的疗效,尤其是A期,但对IV患者而言,两者没有差异,近期疗效,