胃癌治疗现状及2008ASCO进展.ppt
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1、胃癌治疗现状及 2008ASCO进展,Rui-hua Xu (徐瑞华) Sun Yat-sen University Cancer Center Tel: 020-8734 3468,胃癌治疗有效的化疗药物,Old Drugs Fluoropyrimidines 5-FU Platinum Cisplatin Anthracyclines Doxorubicin Epirubicin Etoposide Methotrexate,New Drugs Fluoropyrimidines Capecitabine S-1 Platinum Oxaliplatin Taxanes Paclitax
2、el Docetaxel Irinotecan,FP vs FAM vs UFTM: JCOG 9912 trial,Ohtsu et al 2003,FP 5-FU UFTM p value,No. Patients 105 105 70,Response (%) 34.8 11.4 8.6 0.0001,PFS (weeks) 3.9 1.9 2.4 0.001,MS (weeks) 7.1 7.3 6.0 NS,UFTM, tegafur uracil / mitomycin,Waters et al 1999,ECF vs FAMTX: UK Trial,Chemotherapy fo
3、r gastric cancer in the past,FP regimen has been the standard or reference regimen in Asia ECF is recommended mostly in Europe,Where we have been in AGC 我们所知道的胃癌化疗,Eloxatin: REAL-2, phase III Xeloda: ML17032, phase III Taxotere: TAX 325, phase III CPT-11 V306, phase III Eloxatin: FLO vs FLP, phase I
4、II S1: JCOG 9912, phase III S1: SPIRITS, phase III 2008 ASCO DC vs FLP phase III Phase II clinical trials,E Epirubicin 50 mg/m2 iv C Cisplatin 60 mg/m2 iv F PVI 5-FU 200 mg/m2/day q3w,REAL-2: 研究设计,2 x 2 randomisation Planned treatment duration 24 weeks,E Epirubicin 50 mg/m2 iv C Cisplatin 60 mg/m2 i
5、v X Capecitabine 625 mg/m2/bid q3w,E Epirubicin 50 mg/m2 iv O Oxaliplatin 130 mg/m2 iv F PVI 5-FU 200 mg/m2/day q3w,E Epirubicin 50 mg/m2 iv O Oxaliplatin 130 mg/m2 iv X Capecitabine 625 mg/m2/bid q3w,PVI, portal vein infusion,Cunningham D, et al. ASCO 2006 (Abstract LBA4017).,Hazard ratio (95% CI):
6、 0.86 (0.800.99),Time (years),Probability (%),0,1,2,3,4,5,6,0,20,40,60,80,100,8,206,178,37,52,12,No. at risk,484,480,28,3,1,5-FU,Capecitabine,5-FU,Capecita-bine,Cunningham D, et al. ASCO 2006 (Abstract LBA4017).,REAL-2: overall survival for fluoropyrimidine comparison (per protocol),REAL-2: overall
7、survival for platinum comparison (per protocol),Hazard ratio (95% CI): 0.92 (0.801.10),Probability (%),0,1,2,3,4,5,6,0,20,40,60,80,100,10,198,187,41,48,10,490,474,1,4,1,Cisplatin,Oxaliplatin,Cisplatin,Oxaliplatin,Time (years),No. at risk,Cunningham D, et al. ASCO 2006 (Abstract LBA4017).,ECF EOX,Pro
8、bability (%),Time (years),Cunningham D, et al. ASCO 2006 (Abstract LBA4017).,REAL-2: overall survival for ECF and EOX (ITT),*p0.05 vs ECF; *p0.01 vs ECF,Cunningham D, et al. ASCO 2006 (Abstract LBA4017).,REAL-2: grade 34 血液学毒性,Phase III Trial in AGC with 5Fu/LV Plus Either oxaliplatin or Cisplatin (
9、FLO vs FLP),Al-Batran. J Clin Oncol 2008; 26(9),Best Overall Response (ITT),Time to Treatment Failure (ITT),FLO vs FLP: subgroup of patients over 65 years,Grade Hematological and Neurosensory toxicities,R A N D O M I S A T I O N,ML17032 : Phase III study: XP vs FP Xeloda + cisplatin vs 5-FU + cispla
10、tin,FP 5-FU c.i. 800mg/m2 d15 q3w Cisplatin 80mg/m2 3-hour i.v. infusion,XP Xeloda 1 000mg/m2 bid d114 q3w Cisplatin 80mg/m2 3-hour i.v. infusion,Advanced and/or metastatic gastric cancer n=316,n=156,n=160,Primary end-point: non-inferiority in PFS,Kang Y et al. Proc Am Soc Clin Oncol 2006 (Abst LBA4
11、018),XP vs FP: non-inferior PFS,Estimated probability,Per-protocol analysis,XP (n=139) FP (n=137),Median PFS months (95% CI) 5.6 (4.97.3) 5.0 (4.26.3),0,Months,2,4,6,8,10,12,14,16,18,20,22,24,26,1.0,0.8,0.6,0.4,0.2,0.0,HR=0.81 (95% CI: 0.631.04) Compared to HR upper limit 1.25, p=0.0008,Kang Y et al
12、. Proc Am Soc Clin Oncol 2006 (Abst LBA4018),XP vs FP: trend to superior PFS,Estimated probability,Intent-to-treat analysis,XP (n=160) FP (n=156),Median PFS months (95% CI) 5.6 (4.86.9) 5.0 (3.95.7),0,2,4,6,8,10,12,14,16,18,20,22,24,26,1.0,0.8,0.6,0.4,0.2,0.0,HR=0.80 (95% CI: 0.631.03) Test for supe
13、riority p=0.0801,Kang Y et al. Proc Am Soc Clin Oncol 2006 (Abst LBA4018),Months,Superior response rate with XP vs FP,Kang Y et al. Proc Am Soc Clin Oncol 2006 (Abst LBA4018),22,DCF Docetaxel 75 mg/m2 over 1 h, Day 1 Cisplatin 75 mg/m2 over 13 h, Day 1 5-FU 750 mg/m2/day over 5 days, q3w (n=227),CF
14、Cisplatin 100 mg/m2 over 13 h, Day 1 5-FU 1000 mg/m2/day over 5 days, q4w (n=230),Measurable/evaluable metastatic or measurable locally recurrent gastric adenocarcinoma Age 18 years KPS 70 Adequate hematologic/ biochemical parameters No prior palliative chemotherapy,RANDOM I S A T I ON,Treatment unt
15、il PD, consent withdrawn or unacceptable toxicity; tumor assessments q8w,Docetaxel-based chemotherapy in advanced gastric cancer: Phase III trial (TAX 325),Van Cutsem E, et al. J Clin Oncol (accepted for publication).,Log-rank p=0.0004 Hazard ratio: 1.47 (95% CI: 1.191.83) Risk reduction: 32.1%,0,0,
16、10,20,30,40,50,60,70,80,90,100,DCF,CF,3,6,9,12,15,18,21,24,Probability (%),TAX 325: time to progression (primary endpoint),Time (months),Van Cutsem E, et al. J Clin Oncol (accepted for publication).,Log-rank p=0.0201 Hazard ratio: 1.29 (95% CI: 1.041.61) Risk reduction: 22.7%,0,10,20,30,40,50,60,70,
17、80,90,100,DCF,CF,TAX 325: overall survival,Time (months),Van Cutsem E, et al. J Clin Oncol (accepted for publication).,Probability (%),DCF,CF,(n=221),(n=224),CR (%),2,1,PD (%),17,26,ORRa (%),37,25,95% CI,30.343.4,19.931.7,p-value,0.01,95% CI,Responders with response duration 9 months (%),26,14,TAX 3
18、25: best overall response,Response parameter,SD (%),30,31,Median response duration (months),6.1 5.08.3,5.6 4.26.4,0.32,0.02,aConfirmed and independently reviewed,Van Cutsem E, et al. J Clin Oncol (accepted for publication).,TAX 325 Clinical Benefit: time to definitive worsening of KPSa,0 3 6 9 12 15
19、 18 21 24 27,100,90,80,70,60,50,40,30,20,10,0,Time (months),Probability (%),DCF,CF,p=0.0088 HR: 1.38 (95% CI: 1.081.76) Risk reduction: 27.5%,aWorsening defined as a definitive decrease in PS by 1 KPS category vs baseline,Moiseyenko V, et al. WCGIC 2005 (Abstract O-013).,Patients (%),DCF (n=221),CF
20、(n=224),Lethargy,19,14,Stomatitis,21,27,Diarrhea,19*,8,Infection,13,7,Nausea,14,17,Vomiting,14,17,Anorexia,10,9,Neurosensory,8*,3,1 event,69,59,Adverse eventsa,aPossibly or probably related to study treatment; treatment-emergent non-hematologic toxicities occurring at grade 3 to 4 in 5% of patients
21、in either group *p0.05 vs CF,TAX 325: main grade 34 non-hematologic adverse events,Van Cutsem E, et al. J Clin Oncol (accepted for publication).,% of evaluable patients,DCF,CF,Neutropenia Anemia Thrombocytopenia,82.3 18.2 7.7,56.8 25.6 13.5,(n=221),(n=224),Adverse events regardless of secondary prop
22、hylactic treatment,28.3,12.2,13.1,15.0,% of patients with febrile neutropenia/ neutropenic infection,(n=219),(n=41),(n=222),(n=20), / + secondary prophylactic G-CSF,+,+,Van Cutsem E, et al. WCGIC 2005 (Abstract O-012).,TAX 325: grade 34 hematologic adverse events,TAX325: Conclusions and interpretati
23、ons,T + CF CF The TCF regimen is the proof of the concept that docetaxel provides the benefit our patients need Docetaxel should be incorporated in safer regimen using oxaliplatin, S-1 or capecitabine Develop a regimen to allow addition of a biologic,V306: FUFIRI vs FP as 1st Line Chemotherapy for A
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