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Cco Gi 2008 Cr Slideset
1. January 25-27, 2008 Orlando, Florida CCO Independent Conference Coverage of the 2008 Gastrointestinal Cancers Symposium* *CCO is an independent medical education company that provides state-of-the-art medical information to healthcare professionals through conference coverage and other educational programs. This program is supported by educational grants from
16. CONcePT Trial Design Hochster HS, et al. GI Cancers Symposium 2008. Abstract 280. Patients with metastatic colorectal cancer (N = 140) *Treat to failure. † 8 cycles with oxaliplatin, 8 cycles without oxaliplatin, 8 cycles with oxaliplatin. Continuous Oxaliplatin* mFOLFOX7 + bevacizumab + placebo (n = 34) Continuous Oxaliplatin* mFOLFOX7 + bevacizumab + Ca 2+ /Mg 2+ (n = 35) Intermittent Oxaliplatin † mFOLFOX7 + bevacizumab + placebo (n = 36) Intermittent Oxaliplatin † mFOLFOX7 + bevacizumab + Ca 2+ /Mg 2+ (n = 35)
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19. X-ACT Trial Design Twelves C, et al. GI Cancers Symposium 2008. Abstract 274. Bolus 5-FU/Leucovorin 5-FU 425 mg/m 2 + LV 20 mg/m 2 on Days 1-5, every 28 days (n = 983) Capecitabine 1250 mg/m 2 twice daily on Days 1-14, every 21 days (n = 1004) Chemotherapy-naive patients with operable stage III colorectal cancer and resection ≤ 8 weeks (N = 1987) Median follow-up: 6.8 years
20. X-ACT Trial: 5-Year DFS Twelves C, et al. GI Cancers Symposium 2008. Abstract 274. 0 6 12 18 24 30 36 42 48 54 60 66 72 78 84 90 96 Months 0 0.2 0.4 0.6 0.8 1.0 Test of noninferiority: P < .0001 Test of superiority: P = .0682 Estimated Probability HR: 0.88 (95% CI: 0.77-1.01) NI margin: 1.20 Capecitabine (n = 1004) 5-FU/LV (n = 983) 5-Year DFS 60.8% 56.7% ITT population
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24. KRAS Status and Response to Panitumumab: Phase III Trial Analysis Amado RG, et al. GI Cancers Symposium 2008. Abstract 278. Panitumumab 6 mg/kg every 2 weeks + Best Supportive Care (n = 231) Best Supportive Care* (n = 232) Colorectal cancer patients stratified by ECOG 0-1 vs 2 and region (N = 463) *Optional crossover to panitumumab upon disease progression.
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26. OS by KRAS Status and Treatment Amado RG, et al. GI Cancers Symposium 2008. Abstract 278. Median OS (Months) 8.1 7.6 4.9 4.4 0 2 4 6 8 10 WT KRAS WT KRAS Mutant KRAS Mutant KRAS Pmab BSC Pmab BSC
35. OE02 Update: Design Allum WH, et al. GI Cancers Symposium 2008. Abstract 9. Preoperative Chemotherapy Then Surgery Cisplatin 80 mg/m 2 on Day 1 + 5-FU 1 g/m 2 /day for 4 days, two 4-day courses 3 weeks apart (n = 400 ) Patients with resectable esophageal cancer (N = 802) Median follow-up: 5.9 years Surgery Alone (n = 402) Median follow-up: 6.1 years
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38. JCOG 9907: Study Design Ando N, et al. GI Cancers Symposium 2008. Abstract 10. Treatment-naive patients aged younger than 75 years with squamous cell carcinoma of thoracic esophagus, T1-3/N0-1/M0, and ECOG PS 0-2 (N = 330) 5-FU/Cisplatin 5-FU 800 mg/m 2 on Days 1-5 Cisplatin 80 mg/m 2 on Day 1 (n = 164) Surgery Transthoracic esophagectomy with lymphadenectomy ≥ D2 (n = 166) Postoperative chemotherapy Preoperative chemotherapy Surgery Transthoracic esophagectomy with lymphadenectomy ≥ D2 5-FU/Cisplatin 5-FU 800 mg/m 2 on Days 1-5 Cisplatin 80 mg/m 2 on Day 1
39. JCOG 9907: PFS, OS Ando N, et al. GI Cancers Symposium 2008. Abstract 10. Second Interim Analysis Unadjusted 2-sided log-rank P = .013 HR by Cox model: 0.64 (95% CI: 0.45-0.91; P = .014) Unadjusted 1-sided stratified Log- rank P = .0444 > .0254 (alpha) HR: 0.76 (94.91% CI: 0.56-1.04) OS Postop 5-yr OS: 38.4% Preop 5-yr OS: 60.1% Years After Randomization 0 1 2 3 4 5 6 7 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 PFS Postop median PFS: 2 yrs Preop median PFS: 3 yrs Years After Randomization 0 1 2 3 4 5 6 7 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0
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43. Phase III IRIS Study: Design Imamura H, et al. GI Cancers Symposium 2008. Abstract 5. S-1 Oral Fluoropyrimidine 80 mg/m 2 /day on Days 1-28, every 6 weeks (n = 160) Patients aged 20-75 years with nonresectable and advanced gastric cancer and ECOG PS 0-2 (N = 315) Irinotecan + S-1 (IRIS) Irinotecan 80 mg/m 2 /day IV on Days 1 and 15 + S-1 80 mg/m 2 /day given on Days 1-21, every 5 weeks (n = 155 ) Median follow-up 10.4 months Median follow-up 12.6 months
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46. AMC 0201 Adjuvant Mitomycin C: Design Kang Y, et al. GI Cancers Symposium 2008. Abstract 6. Mf Mitomycin C 20 mg/m 2 + short-term Doxifluridine 600 mg/m 2 /day x 3 cycles (n = 424) Chemotherapy-naive patients aged 18-70 years with advanced gastric cancer and D2 dissection, M0 (N = 855) MFP Mitomycin C + long-term Doxifluridine x 14 cycles + Cisplatin 60 mg/m 2 on Day 1, every 4 weeks x 6 months (n = 431) Median follow-up 3.2 years Randomization 3-6 weeks postsurgery
57. Chemoradiation in Resected Pancreatic Cancer Patients: OS Picozzi VJ, et al. GI Cancers Symposium 2008. Abstract 125. 18-month OS 67% 90 100 80 70 60 50 40 30 20 10 0 Survival (%) 0 1 2 3 Time (Yrs) 18-month OS 67%
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59. Adjuvant Chemoradiation in Pancreatic Adenocarcinoma: Survival Hsu CC, et al. GI Cancers Symposium 2008. Abstract 124. 0 0.8 1.0 0.6 0.4 0.2 Survival, proportion 0 1 2 3 4 5 Follow-up (Yrs) mOS 2-yr OS 5-yr OS CRT 21.1 mo 44.7% 22.3% Obs 15.5 mo 34.6% 16.1% ( P < .001) Observation only (n= 509) Adjuvant chemoradiation (n = 583) RR: 0.74 (95% CI 0.62-0.87)
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61. CFTR Mutation and Risk of Pancreatic Cancer: Incidence and Age of Onset McWilliams RR, et al. GI Cancers Symposium 2008. Abstract 187. CFTR carrier Noncarrier 0 12 24 36 48 60 72 Overall Ever Smokers Never Smokers Age of Pancreatic Cancer Onset (Yrs) 0 2 4 6 8 < 60 < 55 < 50 Incidence of CFTR Mutation (%) Age (Yrs)
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64. Combined SNP Genotypes and Survival Javle MM, et al. GI Cancers Symposium 2008. Abstract 126. Combined Genotype: hCNT1 (16AA/AG); hCNT2 (17CC); hENT1 (913CC) Number of alleles: P = .008 Combined Genotype: CDA (111C); CDA (76AA); RRM1 (42GG); DCTD (47AG) Number of alleles: P = .052 Cumulative Survival, % 100 80 60 40 20 0 0 20 40 60 80 100 Time (Mos) Cumulative Survival, % 3 1-2 0 100 80 60 40 20 0 0 20 40 60 80 100 Time (Mos) 3 1-2 0
65. SNPs and Gemcitabine: OS by Genotype Javle MM, et al. GI Cancers Symposium 2008. Abstract 126. 0 10 20 30 40 CC CT TT AA AG GG CDA C111T RRM1 G42A Median OS (Mos) n = 48 n = 17 n = 3 n = 15 n = 56 n = 97
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72. Sorafenib Plus Doxorubicin in HCC Phase II Study: Design Abou-Alfa GK, et al. GI Cancers Symposium 2008. Abstract 128. Treatment-naive patients with advanced HCC, Child-Pugh A, and ECOG PS 0-2 (N = 96) Placebo/Doxorubicin* Doxorubicin 60 mg/m 2 IV every 21 days (n = 49) Sorafenib/Doxorubicin* Sorafenib 400 mg twice daily Doxorubicin 60 mg/m 2 IV every 21 days (n = 47) *After 18 weeks, patients allowed to continue on single-agent sorafenib or placebo until disease progression.
73. Sorafenib Plus Doxorubicin in HCC Phase II Study: Results Abou-Alfa GK, et al. GI Cancers Symposium 2008. Abstract 128. 4.8 6.5 2.8 8.6 13.8 6.9 0 3 6 9 12 15 TTP OS PFS Placebo Sorafenib Median (Mos) ( P = .0129) ( P = .076)