Disclosures. Colorectal Cancer Update GAFP November Risk Assessment. Colon and Rectal Cancer The Challenge. Issues in Colon and Rectal Cancer

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1 Disclosures Colorectal Cancer Update GAFP November 2006 Robert C. Hermann, MD Georgia Center for Oncology Research and Education Northwest Georgia Oncology Centers, PC WellStar Health System Marietta, GA Employment Northwest Georgia Oncology Centers, PC WellStar Health System Consultant Amgen Clinical Research Genentech: Avastin, Herceptin, Rituxan, Tarceva Bristol-Myers Squibb: Erbitux Sanofi Aventis: Oxaliplatin, Taxotere Amgen: Vectibix Colon and Rectal Cancer The Challenge Third Most Common Cancer US 2006: 106,680 New Cases (49,220 male, 57,460 female) 55,170 Deaths (27,870 male, female) Georgia 2005: 3510 New Cases (1779 male, 1731 female) 1256 Deaths (613 male, 642 female) Death Rates have been decreasing since 1980» Cancer Facts and Figures, 2006, American Cancer Society» Georgia Cancer Data Report, 2005, Georgia Department of Human Resources Issues in Colon and Rectal Cancer Risk Assessment Screening Diagnosis Treatment Surgery Radiation Therapy Adjuvant Chemotherapy Chemotherapy for Advanced Disease Risk Assessment Age >90% Age >50 Diet Caloric intake Fiber Polyps, Inflammatory Bowel Disease Adenomatous Polyps Ulcerative Colitis Genetic Risk Familial Adenomatous Polyp Syndrome (FAP) Lynch Syndrome (HNPCC) Familial Adenomatous Polyposis (FAP) Autosomal Dominant High Penetrance (~100%) Genetic Testing Avialable for the APC gene Average Age of Colon Cancer= 39 Prophylactic Colectomy now routine Patients require lifetime screening Chemoprevention strategies in development Affected Individuals and families should be referred for counseling, testing, and screening

2 Hereditary Nonpolyposis Colorectal Cancer (HNPCC, Lynch Syndrome) Autosomal Dominant defect in Mismatch Repair Genes Genetic Testing available for MLH1, MSH2, MSH6 Incomplete penetrance (~80%) Variable expression Mean age of Colon Cancer= 46 Increased risk of Endometrial Cancer ~70% Affected Individuals and families should be referred for counseling, testing, and screening Screening Colonoscopy: Now covered by Medicare and most health plans Frequency: One very 10 years beginning age 50 for average risk individuals, or One between 55 and 65. Surgery Colectomy Extent of Lymph Node Dissection Laparoscopic Surgery Improved short term Quality of Life for selected patients Total Mesorectal Excision (TME) Reduced Rates of Pelvic Failure in Rectal Cancer Resections. Lymph Node Staging Lymph Node Status is a Powerful Predictor of Prognosis and a Cornerstone of Colo-rectal Cancer Staging. Local (N0) disease: 90% 5 year survival IIIA (T1-2N1): 60% 5 year survival IIIB (T3-4N1): 42% 5 year survival IIIC (T1-4N2): 27% 5 year survival Number of Negative Nodes: Laparoscopic vs. Open Colectomy Reduced Hospital Length of Stay Reduced need for analgesics Equivalent Complication rate, 30-day mortality, re-operation rate Equivalent Survival, Recurrence Rates Total Mesorectal Excision (TME) Utilizes sharp dissection of the entire mesorectum rather than blunt dissection of rectum in conventional surgery Local Recurrence Rates Conventional: 16% TME: 9% TME + Radiation 2.4%» Clinical Outcomes of Surgical Therapy Study Group, N Engl J Med 2004; 350;2050-9» Kapiteijn E, et al, Br J Surg 2002; 89:

3 Adjuvant Chemotherapy--Colon Pivotal Studies Demonstrated superior survival of 5FU-based adjuvant chemotherapy to Surgery alone Current State-of-the-Art MOSAIC Trial: Demonstrated survival superiority of FOLFOX (Oxlaliplatin regimen) over 5FU alone Current Trials NSABP C-08: FOLFOX + Avastin vs FOLFOX NCCTG: FOLFOX vs. Cetuximab vs. FOLFOX Adjuvant Chemoradiotherapy-- Rectal Pivotal Trials: 1980 s Demonstrated reduction in local recurrence risk and improved survival with chemoradiation and adjuvant chemotherapy Preoperative Chemoradiation Allows down-staging Improved tolerance compared to post-op chemoradiation Current Trials NSABP R-04 Capcitabine vs. 5FU inusion during radiation Addition of Oxaliplatin during radiation Addition of Avastin to post-op adjuvant chemotherapy Advanced Colorectal Cancer Approved Agents: 5FU: 1950 s Leucovorin (Folinic Acid):1980 s Irinotecan (Camptosar): 1998 s Capcitabine (Xeloda): 2001 Oxaliplatin (Eloxatin): 2002 Bevacizumab (Avastin): 2004 Cetuximab (Erbitux): 2004 Panitumumab (Vectibix): 9/27/ Flourouricil Purine Analog Inhibitor of Thymidalate Synthase Common Toxicities: Stomatitis Diarrhea Leukopenia Toxicity Pattern dependent upon dose/schedule. Current regimens prefer infusional schedules over bolus schedules. Leucovorin Enhances Effectiveness of 5FU Now routinely adminstered with 5FU regimens Irinotecan (Camptosar) Derivitive of Camptothecan Dose Limiting toxicity: Diarrhea Variable metabolism by Liver to active metabolite SN-38. Effective as Single agent in FU-refractory patients. More effective than FU in first line treatment, alone or in combination with FU. Less toxicity with infusional FU combinations compared to bolus FU regimens.

4 IFL (Saltz Regimen) N Engl J Med 2000; 343: Oxaliplatin (Eloxatin) Platinum Salt derivitive Dose limiting toxicity: cumulative sensory neuropathy: Generally limits courses to 6 months or less Most effective in combination with 5FU Most commonly used 1 st line or adjuvant regimen: FOLFOX : Oxaliplatin with Leucovorin and 46 hour infusion of 5FU Fig 2. Overall survival. rifl, reduced-dose fluorouracil, leucovorin, and irinotecan; FOLFOX4, infused fluorouracil, leucovorin, and oxaliplatin Capecitabine (Xeloda) Goldberg, R. M. et al. J Clin Oncol; 24: Oral Prodrug of 5FU Enzymaticaly converted in 3 steps: Selective concentration in tumor cells Dose Limiting Toxicity: Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome) At least equivalent to 5FU, more convenient, oral dosing Copyright American Society of Clinical Oncology Bevacizumab (Avastin) Avastin Pivotal Trial N Engl J Med 2004; 350: Humunized Monoclonal Antibody to Vascular Endothelial Growth Factor (VEGF) Depletion of VEGF reduces neovascular blood vessel growth (angiogenic switch) Low single agent activity, but significant activity in combination with chemotherapy Toxicities: Hypertension, Proteinuria, Impaired wound healing, GI Perforations Rare: Arterial Ischemic Events (MI, Stroke); Rapidly Progressive Leukoencephalopathy Syndrome (RPLS), Nasal Septum perforation

5 Cetuximab (Erbitux) Chimeric Monoclonal Antibody to EGFR (Epidermal Growth Factor Receptor) Major Toxicities Rash Diarrhea Infrequent Infusion Reactions (2-4%) Active single agent Enhances effectiveness of Irinotecan Panitumumab (Vectibix) Fully human monoclonal antibody to EGFR Similar Toxicities to cetuximab Currently approved as single agent Given every 2 weeks Low incidence of infusion reactions Improvement in Survival: Introduction of New Agents 5FU/ LV Irinotecan Oxaliplatin Bevacizumab Median Survival (months) Current Therapy 1 st Line: FOLFOX (5FU + Leucovorin + Oxaliplatin) + Avastin FOLFIRI (5FU + Leucovorin + Irinotecan) + Avastin 2 nd Line: Irinotecan Irinotecan + Erbitux 3 rd Line: Irinotecan + Erbitux Erbitux Vectibix» NCCN Guidelines Surgical Metastatectomy Resection of oligometastatic disease Single organ (Lung or Liver) 3 or fewer mets Evolving role of Neoadjuvant Chemotherapy Conclusions The incidence of Colorectal Cancer can be reduced by dietary modification, screening, and identification of high-risk individuals. There has been significant improvement in the treatment, survival, and quality of life of patients with colorectal cancer in the past decade. Screening Advances: Coverage of Colonoscopy Risk Assessment: Genetic Testing for FAP, Lynch Syndrome

6 Conclusions (2) Surgical Advances Laparoscopic Colectomy; extent of node dissection Total Mesorectal Excision (TME) for Rectal Cancer Chemotherapy Advances Adjuvant Chemotherapy New Drugs New Combinations

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