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1、大肠癌辅助化疗的新进展ASCO 03,辅助化疗在大肠癌治疗中的作用,1988: NSABP C-O1 BSC vs MOF ( MeCCNU, Oncovin, 5FU) 三年生存率改善 1988: Meta-analysis by M. Buyse 17 随机对照研究证实 5FU 辅助化疗能改善1年生存率,减少复发危险40% 减少死亡危险33%,5FU IV + Levamisole,P 0.0001 (control versus 5FU + Levamisole) P 4) LV5FU2 CPT11NSABP C07 B2/C FUFOL OXA,OXALIPLATIN/5-FU/LV
2、IN ADJUVANT COLON CANCER: RESULTS OF THE INTERNATIONAL RANDOMIZED Phase III “MOSAIC” TRIAL,A. de Gramont, M. Banzi, M. Navarro, J. Tabernero, T. Hickish, J. Bridgewater, F. Rivera, A. Figer, G. Fountzilas, T. Andr,MOSAIC: Treatment arms,Primary: Disease Free Survival (DFS) Secondary: Safety (includi
3、ng long-term) Overall Survival (OS),Endpoints,de Gramont A et al. J Clin Oncol 2000 Goldberg R et al. ASCO 2002, 2003,FOLFOX4 in metastatic colon cancer,Compared to LV5FU2:improved efficacymanageable toxicity: neutropenia, sensory neuropathy,Compared to IFL:improved efficacydecreased toxicity,LV,OXA
4、,MOSAIC: Treatment arms,*Baxter LV5 infusors,LV5FU2,FOLFOX4: LV5FU2 + Oxaliplatin 85mg/m,Every 2 weeks, 6 months of treatment (12 cycles),MOSAIC: Main inclusion criteria,Stage II (Dukes B2: T3, T4, N0, M0) and Stage III (Dukes C: any T; N1, N2, M0) Complete resection of the primary tumor Treatment w
5、ithin 7 weeks following surgery No prior chemo-, immuno-, or radiotherapy Age 1875 years old ECOG PS 2,MOSAIC: Statistical hypotheses,Stage II / III ratio = 40 / 60% 2.5 year enrollment Expected 3-year DFS: 79% for test arm and 73% for control arm or 25% reduction in risk of recurrence,N = 2200 for
6、a statistical power of 90% (a=0.05),MOSAIC: Randomization,Treatment assignment was stratified for: Center Extent of invasion of the primary tumor (T2, T3, or T4) Number of lymph nodes involved (N0, N1, N2) Bowel obstruction or tumor perforation,MOSAIC: Follow-up and recurrence,Every 6 months: Clinic
7、al examination, imaging, CEADiagnosis of recurrence:- imaging- cytology or biopsy,an elevated CEA, as a solitary finding, was not considered as acceptable evidence of recurrence,MOSAIC: Accrual curve,2246 pts,Number of patients,Months,Oct 98,Feb 99,Jun 99,Oct 99,Feb 00,Jun 00,Oct 00,Jan 01,2246 pati
8、ents,病例分布,2246 patients,477 patients 364 patients 294 patients 249 patients 135 patients 133 patients 107 patients,103 patients 69 patients 58 patients 51 patients 37 patients 36 patients,27 patients 26 patients 22 patients 21 patients 17 patients 17 patients 3 patients,Cy,Au,UK,B,MOSAIC: Patient ch
9、aracteristics,MOSAIC: Treatment administration,FOLFOX4 LV5FU2 Patients randomized 1123 1123 Patients treated 1108 1111 Total no. of cycles 11829 12506 Mean 10.7 11.3 12 cycles 74.7% 86.5% Median Relative Dose Intensity % Oxaliplatin 81 NA 5-FU 85 98,Status of the study by treatment arm (ITT population),
