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CARCINOMA COLON AND IT’S MANAGEMENT Dr. Manoj Kumar B. Moderator: Dr. R. Kapoor 30.10.08
INTRODUCTION ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
CLINICAL  ANATOMY ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Ascending Colon 4% Transverse Colon 8% Descending Colon 14% Sigmoid Colon 35.7% Rectum 39%
 
CLINICAL  RISK FACTORS ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
CARCINOGENESIS: Adenoma to Carcinoma Pathway APC Loss/mutation Ch. 5q Normal Epithelium Early Adenoma Cancer Hyper- proliferation Intermediate Adenoma Late Adenoma K-ras Mutation Ch. 12p (50%) DCC loss Ch. 18q DPC4  Ch. 4 p53 Loss Ch. 17p Loss of DNA methylation
 
PATHOLOGY: WHO  Classification ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
 
SPREAD ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
CLINICAL PRESENTATION ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
DIAGNOSIS ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
BARIUM ENEMA ,[object Object],[object Object],[object Object],[object Object]
FLEXIBLE SIGMOIDOSCOPY ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
COLONOSCOPY ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
 
[object Object],[object Object],[object Object],[object Object]
CECT ABDOMEN/ PELVIS  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
AJCC/ UICC STAGING
 
 
TREATMENT ,[object Object],[object Object],[object Object],[object Object]
SURGERY ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
SURGERY ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
 
ADJUVANT THERAPY ,[object Object],[object Object],[object Object],[object Object],[object Object]
Adjuvant Therapy for Colon Ca ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object]
Stage Mean 5 yr survival rate (%) T 1 N 0 97 T 2 N 0 90 T 3 N 0 78 T 2 N + 74 T 4 N 0 63 T 3 N + 48 T 4 N + 38
RADIATION   ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Failure pattern following curative surgery Series Stage n LF (%) Abdominal failure (%) Distant failure(%) Gunderson et al All  T3-4 and /or N1-2 91 72 22 17 4 6 7 7 Willet et al All  T3-4 and /or N1-2 533 395 6 8 11 14 4 Minsky et al All  T3-4 and /or N1-2 284 229 6 4 8 10 3 5
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Technique ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Caecum and proximal ascending colon
Mid ascending colon
Distal descending colon
Middle sigmoid colon adherent to left pelvic sidewall or proximal sigmoid
Distal ascending colon and hepatic flexure
Splenic flexure and proximal descending   colon
Middle descending colon
Palliative - Sigmoid colon adherent to the UB
[object Object],[object Object],[object Object],[object Object],[object Object]
5 yr Local/Regional failure (%)  DFS (%) Group Stage N Surgery Sx+RT Surgery Sx+RT Adjuvant T3N0(B2) 163 10 9 70 72 T4N0(B2) 83 31 7 63 79 T3N1-2 (C2) 100 35 30 44 47 T4N1-2 (C3) 49 53 28 37 53 Perforation/fistula T4N0 21 48 6 43 91 Residual disease All 47 37
HISTORICAL ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
NEWER RT Techniques ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
CHEMOTHERAPY ,[object Object],[object Object]
 
Historical data in favor of chemotherapy     FU, semustine & VCR (MOF)  NSABP-C-01  randomized N(-), N(+) patients   BCG     Sx alone MOF –  5 yrs DFS 58%, OS – 67%  INT-0035 ,[object Object],DFS(%) OS(%) Stage II Sx alone 71 72 Sx-> 5FU+Levamisole 79 72 Stage III Sx  alone 44 Sx-> 5FU+Levamisole 61 Death rate ↓ 33% Rec. rate  ↓40% Sx-> Levamisole NS
5FU 370-400mg/m 2  + LCV 200mg/m 2  D 1 -D 5 x4 weeklyx6 cycles NCCTG/ NCI 3 yr survival (%) RFS(%) Gr 3 toxicity 5FU+LCV(Mayo)x 6 months 83.2 68.6 High PVI 5FU 200mg/ m 2 /d x 12 weeks 87.9 80 Less
[object Object],[object Object],[object Object],[object Object],[object Object],INT-0089  Treatment duration (weeks) 5 yr DFS(%) 5 yr OS(%) 5-FU +levamisole 52 56 63 5-FU + weekly HDLCV (Roswell park ) 32 59 65 5-FU +LDLCV on d1- 5 (Mayo clinic) 24 60 66 Mayo Clinic schedule of 5-FU/LCV + levamisole. 24 60 67
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
MOSAIC Trial:  LV5FU2 vs LV5FU2 + FOLFOX-4  LV5FU2 (n = 1,123) (%) FOLFOX-4 (n = 1,123)   (%) 3 yr DFS stage III 66 72 3 yr DFS stage II 84 87 OS NA NA Grade 3-4 neutropenia 5 41 Neutropenic fever 0 1 Grade 3-4 diarrhea 0 1 Grade 3-4 vomiting 7 11 Neuropathy, any grade 0 92 Neuropathy, grade 3 0 12 Persistent neuropathy, grade 2-3, 1 year after t/t 0 5
Commonly Used Fluorouracil (5-FU) Regimens Regimen   Reference Schedule Mayo clinic Poon et al., 1989 LV 20 mg/m 2 , followed by bolus 5FU, 425  mg/m 2  each daily d1-d5 repeated 4 weekly for 1 st  2 cycles, than  q35d thereafter Roswell Park  Haller et al., 1998  LV 500 mg/m 2  over 2 h; 5-FU 500 mg/m 2   bolus 1 h into LV infusion. weekly x 6 wks, every 8 wks Low-dose weekly LV.,  Jager et al.,  1996  LV 20 mg/m 2  over 5-15 min, followed by bolus 5-FU 500 mg/m 2 ; weekly x 6 wks, every 8 weeks Protracted venous infusion Lokich et al., 1989  5-FU 300 mg/m 2 /day by continuous infusion AIO (weekly 24-h infusion) Kohne et al., 1998 LV 500 mg/m 2  over 2 h, followed by  5-FU 2,600 mg/m 2  over 24 h, weekly LV5FU2 de Gramont et al., 1997 LV 200 mg/m 2  over 2 h days 1, 2, followed by  bolus 5-FU 400 mg/m 2 /day 1 and 2, f/b 5-FU 600 mg/m 2  over 22 h, day 1 and 2: every 14 days  Simplified LV5FU2 Adapted from Andre et al., 1999  LV 400 mg/m 2  over 2 h, followed by bolus 5-FU 400 mg/m 2 , followed by 5-FU 2,400-3,000 mg/m 2  over 46-48 h; cycles repeated every 14 days
Commonly Used Irinotecan/5-FU Combination Regimens Regimen Study  Schedule  IFL Saltz et al; 2000 Irinotecan 125 over 90 min, followed by LV 20 mg/m 2  by brief infusion, followed by bolus 5-FU 500 mg/m 2 ; weekly for 4 weeks , repeated every 6 weeks FOLFIRI Douillard et al., 2000  Irinotecan 180 mg/m 2  over 2 h; LV 200 mg/m 2  concurrently with irinotecan (can be given in same line through Y connector); followed by 5-FU bolus 400 mg/m 2 , followed by 5-FU 600 mg/m 2  infusion over 22 h. Irinotecan given day 1 only. All other meds given days 1 and 2. Cycle repeated every 14 days FOLFIRI (simplified) Andre et al., 1999  Irinotecan 180 mg/m 2  over 2 h; LV 400 mg/m 2  concurrently with irinotecan (can be given in same line through Y connector); followed by 5-FU bolus 400 mg/m 2 , followed by 5-FU 2,400-3,000 mg/m 2  infusion over 46-48 h. Cycle repeated every 14 days FUFIRI  Douillard et al., 2000  Irinotecan 80 mg/m 2 , then LV 500 mg/m 2 , followed by 5-FU 2,300 mg/m 2 ; all drugs given weekly for 6 weeks, repeated every 7 weeks
Selected Commonly Used Oxaliplatin/5-FU Combination Regimens Regimen Study  Schedule  FOLFOX-4 de Gramont et al., 2000  Oxaliplatin 85 mg/m 2  over 2 h; LV 200 mg/m 2  concurrently with oxaliplatin (can be given in same line through Y connector); followed by 5-FU bolus 400 mg/m 2 , followed by 5-FU 600 mg/m 2  infusion over 22 h. Oxaliplatin given day 1 only. All other meds given days 1 and 2. Cycle repeated every 14 days FOLFOX-6 Tournigand et al., 2004  Oxaliplatin 100 mg/m 2  over 2 h; LV 400 mg/m 2  concurrently with oxaliplatin (can be given in same line through Y connector); followed by 5-FU bolus 400 mg/m 2 , followed by 5-FU 2,400-3,000 mg/m 2  infusion over 46-48 h. Cycle repeated every 14 days Modified FOLFOX-6 (mFOLFOX-6) Widely used in current phase III trials, but not published Oxaliplatin 85 mg/m 2  over 2 h; LV 400 mg/m 2  concurrently with oxaliplatin (can be given in same line through Y connector); followed by 5-FU bolus 400 mg/m 2 , followed by 5-FU 2,400-3,000 mg/m 2  infusion over 46-48 h. Cycle repeated every 14 days FUFOX Grothey et al., 2002  Oxaliplatin 50 mg/m 2  over 2 h, followed by LV 500 mg/m 2 , followed by 5-FU 2,000 mg/m 2 over 24 h, weekly for 5 weeks, repeated every 6 weeks.
Single Agents: 5FU/Leucovorin (Mayo, Roswell, DeGramont)‏ Capecitabine Oxaliplatin Irinotecan Combinations: Oxaliplatin + 5FU (FOLFOX)‏ Irinotecan/5FU/Leuco (IFL, Saltz)‏ Irinotecan + 5FU (FOLFIRI)‏ Capecitabine + Oxaliplatin (Capox)‏ Capecitabine + Irinotecan (Capiri)‏ Chemotherapy in CRC
5-Fluorouracil + Leucovorin (Mayo Clinic Schedule) NCCTG 5-FU: 425 mg/m2 IV on d1 – 5 LCV : 20 mg/m 2  IV on d1 – 5 before 5 - FU Repeat cycle every 4 – 5 weeks for a total of 6 cycles Oxaliplatin + 5-Fluorouracil  + Leucovorin (FOLFOX4) Oxaliplatin: 85 mg/m 2  IV on day 1 5-Fluorouracil  400 mg/m 2  IV bolus, followed by 600 mg/m 2  IV continuous infusion  for 22 hours on days 1 and 2 Leucovorin: 200 mg/m 2  IV on days 1 and 2 as a 2-hour infusion before  5-Fluorouracil Repeat cycle every 2 weeks Chemotherapy as adjuvant in CRC
Stage IV/ Metastatic Ca Colon ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Oxaliplatin + 5-Fluorouracil  + Leucovorin (mFOLFOX7) Oxaliplatin: 100 mg/m 2  IV on day 1 5-Fluorouracil: 3000 mg/m 2  IV continuous infusion on days 1 and 2 for 46 hours Leucovorin: 400 mg/m 2  IV on day 1 as a 2-hour infusion before 5-fluorouracil Repeat cycle every 2 weeks Irinotecan + 5-Fluorouracil + Leucovorin (FOLFIRI Regimen) Irinotecan: 180 mg/m2 IV on day 1 5-Fluorouracil: 400 mg/m 2  IV bolus on day 1, followed by 2400 mg/m2 IV  continuous infusion for 46 hours Leucovorin: 200 mg/m 2  IV on day 1 as a 2-hour infusion prior to 5-fluorouracil on days 1 – 5 administered before 5 - Fluorouracil  Repeat cycle every 2 weeks  Capecitabine Capecitabine: 1250 mg/m 2  PO bid on days 1 – 14 Repeat cycle every 21 days for a total of 8 cycles. Dose may be decreased to 850-1000 mg/m 2  PO bid on days 1-14 to reduce the risk of toxicity without compromising clinical efficacy  Chemotherapy as adjuvant in CRC
Capecitabine + Oxaliplatin (XELOX) Capecitabine: 1000 mg/m 2  PO bid on days 1 - 14 Oxaliplatin: 130 mg/m 2  IV on day 1 Repeat cycle every 21 days. May decrease dose of capecitabine to 850 mg/m 2  PO bid and dose of oxalioplatin to 100 mg/m 2  IV to reduce the risk of toxicity without compromising clinical efficacy Capecitabine + Irinotecan (XELIRI) Capecitabine: 1000 mg/m 2  PO bid on days 1 - 14 Irinotecan: 250 mg/m 2  IV on day 1  Repeat cycle every 21 days. May decrease dose of capecitabine to 850 mg/m 2  PO bid and dose of irinotecan to 200 mg/m 2  IV to reduce the risk of toxicity without compromising clinical efficacy Chemotherapy as adjuvant in CRC
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Investigational adjuvant approaches ,[object Object],[object Object],[object Object],[object Object],[object Object]
Targeted agents in  CRC
[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object]
Bevacizumab Anti – VEGF monoclonal antibody
Bevacizumab ,[object Object],[object Object],[object Object],[object Object]
E3200: Response Rates 0.7% 3.0% 9.2% 21.8% OR* 0 1.9% CR 29.1% 3.0% 230 Bevacizumab 45.0% 51.7% SD 8.5% 19.9% PR 271 271 FOLFOX4 FOLFOX4 + bevacizumab Giantonio BJ, et al. ASCO 2005 *FOLFOX+B vs FOLFOX:  P < 0.0001
The importance of EGFR in metastatic colorectal cancer ,[object Object],[object Object],[object Object]
Cetuximab (C225) ‏ ,[object Object],[object Object],[object Object],[object Object],O‘Dwyer PJ, Benson AB III. Semin Oncol. 2002;29(suppl 14):10 .
Cetuximab ,[object Object],[object Object],[object Object],[object Object]
Cetuximab in EGFR expressing metastatic CRC: first line trials Hoehler T. et al. Proc ESMO 2004 Van Cutsem E. et al. Proc ESMO 2004 Reference 21% resection of livermetastases remarks 21 % 2% PD 24 % 17% SD 55 % 81% (74% conf.)‏ (61-88)‏ CR + PR (95% CI)‏ 38 43 Total patients FUFOX + cetuximab FOLFOX + cetuximab
FOLFIRI 5-FU bolus 400 mg/m 2 , infusion 2400 mg/m 2  +  Irinotecan 180 mg/m 2  + Leucovorin 400 mg/m 2 every 2 wks (n = 609) Patients with previously untreated EGFR-expressing metastatic colorectal cancer, stratified by geographical region, ECOG PS  (N = 1217)‏ FOLFIRI + Cetuximab 5-FU  bolus 400 mg/m 2 , infusion 2400 mg/m 2  +  Irinotecan  180 mg/m 2  + Leucovorin  400 mg/m 2   every 2 wks Cetuximab  400 mg/m 2  initial dose,  then 250 mg/m 2  wkly (n = 608)‏ Van Cutsem E, et al. ASCO 2007. Abstract 4000. CRYSTAL Trial FOLFIRI ± Cetuximab
PROGNOSITC FACTORS ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Rational post therapy surveillance programme ,[object Object],[object Object],[object Object],[object Object],[object Object]
NORMAL  CXR  RISING  CEA COLONOSCOPY FDG-PET CECT
ACS colorectal cancer screening guidelines * ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
 
THANK YOU
Population Screening ,[object Object],[object Object],[object Object],[object Object],[object Object],CRC fulfills many of these criteria for effective screening

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Carcinoma Colon And Management

  • 1. CARCINOMA COLON AND IT’S MANAGEMENT Dr. Manoj Kumar B. Moderator: Dr. R. Kapoor 30.10.08
  • 2.
  • 3.
  • 4. Ascending Colon 4% Transverse Colon 8% Descending Colon 14% Sigmoid Colon 35.7% Rectum 39%
  • 5.  
  • 6.
  • 7. CARCINOGENESIS: Adenoma to Carcinoma Pathway APC Loss/mutation Ch. 5q Normal Epithelium Early Adenoma Cancer Hyper- proliferation Intermediate Adenoma Late Adenoma K-ras Mutation Ch. 12p (50%) DCC loss Ch. 18q DPC4 Ch. 4 p53 Loss Ch. 17p Loss of DNA methylation
  • 8.  
  • 9.
  • 10.  
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  • 12.
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  • 15.
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  • 17.
  • 18.  
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  • 20.
  • 21.
  • 23.  
  • 24.  
  • 25.
  • 26.
  • 27.
  • 28.
  • 29.  
  • 30.
  • 31.
  • 32.
  • 33. Stage Mean 5 yr survival rate (%) T 1 N 0 97 T 2 N 0 90 T 3 N 0 78 T 2 N + 74 T 4 N 0 63 T 3 N + 48 T 4 N + 38
  • 34.
  • 35.
  • 36. Failure pattern following curative surgery Series Stage n LF (%) Abdominal failure (%) Distant failure(%) Gunderson et al All T3-4 and /or N1-2 91 72 22 17 4 6 7 7 Willet et al All T3-4 and /or N1-2 533 395 6 8 11 14 4 Minsky et al All T3-4 and /or N1-2 284 229 6 4 8 10 3 5
  • 37.
  • 38.
  • 39.
  • 40. Caecum and proximal ascending colon
  • 43. Middle sigmoid colon adherent to left pelvic sidewall or proximal sigmoid
  • 44. Distal ascending colon and hepatic flexure
  • 45. Splenic flexure and proximal descending colon
  • 47. Palliative - Sigmoid colon adherent to the UB
  • 48.
  • 49. 5 yr Local/Regional failure (%) DFS (%) Group Stage N Surgery Sx+RT Surgery Sx+RT Adjuvant T3N0(B2) 163 10 9 70 72 T4N0(B2) 83 31 7 63 79 T3N1-2 (C2) 100 35 30 44 47 T4N1-2 (C3) 49 53 28 37 53 Perforation/fistula T4N0 21 48 6 43 91 Residual disease All 47 37
  • 50.
  • 51.
  • 52.
  • 53.  
  • 54.
  • 55. 5FU 370-400mg/m 2 + LCV 200mg/m 2 D 1 -D 5 x4 weeklyx6 cycles NCCTG/ NCI 3 yr survival (%) RFS(%) Gr 3 toxicity 5FU+LCV(Mayo)x 6 months 83.2 68.6 High PVI 5FU 200mg/ m 2 /d x 12 weeks 87.9 80 Less
  • 56.
  • 57.
  • 58. MOSAIC Trial: LV5FU2 vs LV5FU2 + FOLFOX-4 LV5FU2 (n = 1,123) (%) FOLFOX-4 (n = 1,123) (%) 3 yr DFS stage III 66 72 3 yr DFS stage II 84 87 OS NA NA Grade 3-4 neutropenia 5 41 Neutropenic fever 0 1 Grade 3-4 diarrhea 0 1 Grade 3-4 vomiting 7 11 Neuropathy, any grade 0 92 Neuropathy, grade 3 0 12 Persistent neuropathy, grade 2-3, 1 year after t/t 0 5
  • 59. Commonly Used Fluorouracil (5-FU) Regimens Regimen Reference Schedule Mayo clinic Poon et al., 1989 LV 20 mg/m 2 , followed by bolus 5FU, 425 mg/m 2 each daily d1-d5 repeated 4 weekly for 1 st 2 cycles, than q35d thereafter Roswell Park Haller et al., 1998 LV 500 mg/m 2 over 2 h; 5-FU 500 mg/m 2 bolus 1 h into LV infusion. weekly x 6 wks, every 8 wks Low-dose weekly LV., Jager et al., 1996 LV 20 mg/m 2 over 5-15 min, followed by bolus 5-FU 500 mg/m 2 ; weekly x 6 wks, every 8 weeks Protracted venous infusion Lokich et al., 1989 5-FU 300 mg/m 2 /day by continuous infusion AIO (weekly 24-h infusion) Kohne et al., 1998 LV 500 mg/m 2 over 2 h, followed by 5-FU 2,600 mg/m 2 over 24 h, weekly LV5FU2 de Gramont et al., 1997 LV 200 mg/m 2 over 2 h days 1, 2, followed by bolus 5-FU 400 mg/m 2 /day 1 and 2, f/b 5-FU 600 mg/m 2 over 22 h, day 1 and 2: every 14 days Simplified LV5FU2 Adapted from Andre et al., 1999 LV 400 mg/m 2 over 2 h, followed by bolus 5-FU 400 mg/m 2 , followed by 5-FU 2,400-3,000 mg/m 2 over 46-48 h; cycles repeated every 14 days
  • 60. Commonly Used Irinotecan/5-FU Combination Regimens Regimen Study Schedule IFL Saltz et al; 2000 Irinotecan 125 over 90 min, followed by LV 20 mg/m 2 by brief infusion, followed by bolus 5-FU 500 mg/m 2 ; weekly for 4 weeks , repeated every 6 weeks FOLFIRI Douillard et al., 2000 Irinotecan 180 mg/m 2 over 2 h; LV 200 mg/m 2 concurrently with irinotecan (can be given in same line through Y connector); followed by 5-FU bolus 400 mg/m 2 , followed by 5-FU 600 mg/m 2 infusion over 22 h. Irinotecan given day 1 only. All other meds given days 1 and 2. Cycle repeated every 14 days FOLFIRI (simplified) Andre et al., 1999 Irinotecan 180 mg/m 2 over 2 h; LV 400 mg/m 2 concurrently with irinotecan (can be given in same line through Y connector); followed by 5-FU bolus 400 mg/m 2 , followed by 5-FU 2,400-3,000 mg/m 2 infusion over 46-48 h. Cycle repeated every 14 days FUFIRI Douillard et al., 2000 Irinotecan 80 mg/m 2 , then LV 500 mg/m 2 , followed by 5-FU 2,300 mg/m 2 ; all drugs given weekly for 6 weeks, repeated every 7 weeks
  • 61. Selected Commonly Used Oxaliplatin/5-FU Combination Regimens Regimen Study Schedule FOLFOX-4 de Gramont et al., 2000 Oxaliplatin 85 mg/m 2 over 2 h; LV 200 mg/m 2 concurrently with oxaliplatin (can be given in same line through Y connector); followed by 5-FU bolus 400 mg/m 2 , followed by 5-FU 600 mg/m 2 infusion over 22 h. Oxaliplatin given day 1 only. All other meds given days 1 and 2. Cycle repeated every 14 days FOLFOX-6 Tournigand et al., 2004 Oxaliplatin 100 mg/m 2 over 2 h; LV 400 mg/m 2 concurrently with oxaliplatin (can be given in same line through Y connector); followed by 5-FU bolus 400 mg/m 2 , followed by 5-FU 2,400-3,000 mg/m 2 infusion over 46-48 h. Cycle repeated every 14 days Modified FOLFOX-6 (mFOLFOX-6) Widely used in current phase III trials, but not published Oxaliplatin 85 mg/m 2 over 2 h; LV 400 mg/m 2 concurrently with oxaliplatin (can be given in same line through Y connector); followed by 5-FU bolus 400 mg/m 2 , followed by 5-FU 2,400-3,000 mg/m 2 infusion over 46-48 h. Cycle repeated every 14 days FUFOX Grothey et al., 2002 Oxaliplatin 50 mg/m 2 over 2 h, followed by LV 500 mg/m 2 , followed by 5-FU 2,000 mg/m 2 over 24 h, weekly for 5 weeks, repeated every 6 weeks.
  • 62. Single Agents: 5FU/Leucovorin (Mayo, Roswell, DeGramont)‏ Capecitabine Oxaliplatin Irinotecan Combinations: Oxaliplatin + 5FU (FOLFOX)‏ Irinotecan/5FU/Leuco (IFL, Saltz)‏ Irinotecan + 5FU (FOLFIRI)‏ Capecitabine + Oxaliplatin (Capox)‏ Capecitabine + Irinotecan (Capiri)‏ Chemotherapy in CRC
  • 63. 5-Fluorouracil + Leucovorin (Mayo Clinic Schedule) NCCTG 5-FU: 425 mg/m2 IV on d1 – 5 LCV : 20 mg/m 2 IV on d1 – 5 before 5 - FU Repeat cycle every 4 – 5 weeks for a total of 6 cycles Oxaliplatin + 5-Fluorouracil + Leucovorin (FOLFOX4) Oxaliplatin: 85 mg/m 2 IV on day 1 5-Fluorouracil 400 mg/m 2 IV bolus, followed by 600 mg/m 2 IV continuous infusion for 22 hours on days 1 and 2 Leucovorin: 200 mg/m 2 IV on days 1 and 2 as a 2-hour infusion before 5-Fluorouracil Repeat cycle every 2 weeks Chemotherapy as adjuvant in CRC
  • 64.
  • 65.
  • 66. Oxaliplatin + 5-Fluorouracil + Leucovorin (mFOLFOX7) Oxaliplatin: 100 mg/m 2 IV on day 1 5-Fluorouracil: 3000 mg/m 2 IV continuous infusion on days 1 and 2 for 46 hours Leucovorin: 400 mg/m 2 IV on day 1 as a 2-hour infusion before 5-fluorouracil Repeat cycle every 2 weeks Irinotecan + 5-Fluorouracil + Leucovorin (FOLFIRI Regimen) Irinotecan: 180 mg/m2 IV on day 1 5-Fluorouracil: 400 mg/m 2 IV bolus on day 1, followed by 2400 mg/m2 IV continuous infusion for 46 hours Leucovorin: 200 mg/m 2 IV on day 1 as a 2-hour infusion prior to 5-fluorouracil on days 1 – 5 administered before 5 - Fluorouracil Repeat cycle every 2 weeks Capecitabine Capecitabine: 1250 mg/m 2 PO bid on days 1 – 14 Repeat cycle every 21 days for a total of 8 cycles. Dose may be decreased to 850-1000 mg/m 2 PO bid on days 1-14 to reduce the risk of toxicity without compromising clinical efficacy Chemotherapy as adjuvant in CRC
  • 67. Capecitabine + Oxaliplatin (XELOX) Capecitabine: 1000 mg/m 2 PO bid on days 1 - 14 Oxaliplatin: 130 mg/m 2 IV on day 1 Repeat cycle every 21 days. May decrease dose of capecitabine to 850 mg/m 2 PO bid and dose of oxalioplatin to 100 mg/m 2 IV to reduce the risk of toxicity without compromising clinical efficacy Capecitabine + Irinotecan (XELIRI) Capecitabine: 1000 mg/m 2 PO bid on days 1 - 14 Irinotecan: 250 mg/m 2 IV on day 1 Repeat cycle every 21 days. May decrease dose of capecitabine to 850 mg/m 2 PO bid and dose of irinotecan to 200 mg/m 2 IV to reduce the risk of toxicity without compromising clinical efficacy Chemotherapy as adjuvant in CRC
  • 68.
  • 69.
  • 71.
  • 72.
  • 73. Bevacizumab Anti – VEGF monoclonal antibody
  • 74.
  • 75. E3200: Response Rates 0.7% 3.0% 9.2% 21.8% OR* 0 1.9% CR 29.1% 3.0% 230 Bevacizumab 45.0% 51.7% SD 8.5% 19.9% PR 271 271 FOLFOX4 FOLFOX4 + bevacizumab Giantonio BJ, et al. ASCO 2005 *FOLFOX+B vs FOLFOX: P < 0.0001
  • 76.
  • 77.
  • 78.
  • 79. Cetuximab in EGFR expressing metastatic CRC: first line trials Hoehler T. et al. Proc ESMO 2004 Van Cutsem E. et al. Proc ESMO 2004 Reference 21% resection of livermetastases remarks 21 % 2% PD 24 % 17% SD 55 % 81% (74% conf.)‏ (61-88)‏ CR + PR (95% CI)‏ 38 43 Total patients FUFOX + cetuximab FOLFOX + cetuximab
  • 80. FOLFIRI 5-FU bolus 400 mg/m 2 , infusion 2400 mg/m 2 + Irinotecan 180 mg/m 2 + Leucovorin 400 mg/m 2 every 2 wks (n = 609) Patients with previously untreated EGFR-expressing metastatic colorectal cancer, stratified by geographical region, ECOG PS (N = 1217)‏ FOLFIRI + Cetuximab 5-FU bolus 400 mg/m 2 , infusion 2400 mg/m 2 + Irinotecan 180 mg/m 2 + Leucovorin 400 mg/m 2 every 2 wks Cetuximab 400 mg/m 2 initial dose, then 250 mg/m 2 wkly (n = 608)‏ Van Cutsem E, et al. ASCO 2007. Abstract 4000. CRYSTAL Trial FOLFIRI ± Cetuximab
  • 81.
  • 82.
  • 83. NORMAL CXR RISING CEA COLONOSCOPY FDG-PET CECT
  • 84.
  • 85.  
  • 87.