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Do we need surgery in all rectal
carcinoma patients?
Mohamed Abdulla M.D.
Prof. of Clinical Oncology
Cairo University
PACC 16th – Cairo
City Stars Intercontinental
Thursday, 28/04/2016
Member of Advisory Board, Consultant, and Speaker for:
• Amgen, Astellas, AstraZeneca, Hoffman la Roche, Janssen Cilag,
Merck Serono, Novartis, Pfizer, Mundipharma
• The content of this presentation does not relate to any product of a
commercial interest
Speaker Disclosures:
Basic Facts:
• 2nd & 3rd most common cancer in females &
males.
• 1.4 million new case and 694000 deaths.
• Males > Females.
• Lowest rates in Africa & South Central Asia.
• Low SES  30% increased risk.
• Rising incidence < 50 years  Left sided colon &
rectal, symptomatic & advanced  Poor
outcome.
• Sporadic > Hereditary.
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin 2016; 66:7.
Ahnen DJ, Wade SW, Jones WF, et al. The increasing incidence of young-onset colorectal cancer: a call to action. Mayo Clin Proc
2014; 89:216.
Principles:
Surgery is the cornerstone in management
However,
Local Recurrence Following Surgery
Alone:
Clinical Colorectal Cancer, Vol. 4, No. 4, 233-240, 2004
Adjuvant Radiation Therapy:
Clinical Colorectal Cancer, Vol. 4, No. 4, 233-240, 2004
Cuthbert Dukes 1932: Nodes as a prognostic factor
Local Recurrence: Better Insight:
Circumferential
Margins
Number Local Recurrence
Rate
P
> 2 mm 987 3.3% < 0.0001
1 – 2 mm 100 8.5% 0.02
< 1 mm 227 13.1 0.08
Int. J. Radiation Oncology Biol. Phys., Vol. 55, No. 5, pp. 1311–1320, 2003
CRM or LNs:
Rectal cancer pacc 16
MURCERY Trial:
Fiona et al. JCO. 2014:1(32). 34-46.
Limitations of the TNM – T3 category forms 80% of rectal cancers
Rectal cancer pacc 16
(J Natl Compr Canc Netw 2015;13:1111–1119)
Total Mesorectal Excision (TME):
• Removal of peri-rectal
tissues involving lateral &
circumferential margins of
mesorectal envelop.
Dis Colon Rectum. 2013 May;56(5):535-50.
Total Mesorectal Excision (TME):
Clinical Colorectal Cancer, Vol. 4, No. 4, 233-240, 2004
N Engl J Med. 2001;345:638 – 646.
Adjuvant
Radiation
Therapy
 LR =
2.4%
Adjuvant Chemoradiation in Stages II
& III Rectal Cancer:
• GITSG.
• NCCTG.
• NSABP R-01.
N Engl J Med 1986; 315:1294.
FJ Natl Cancer Inst 1988; 80:21.
N Engl J Med 1991; 324:709.
Adjuvant
Fluoroupyremidine
X 2 months
CRT – 6 Weeks
Adjuvant
Fluoroupyremidine
X 2 months
Adjuvant Therapy = 6 months
Neoadjuvant Therapy:
The German Study: A Shifting Concept
N Engl J Med 2004;351:1731-40.
Slide 4
Slide 3
Slide 2
Slide 6
Slide 7
Slide 9
Slide 11
Slide 12
Radiation + Chemotherapy are MANDATORY in
Neoadjuvant Therapy:
Gastrointest Cancer Res 1:49-56. ©2007 by International Society of Gastrointestinal Oncology
Neoadjuvant Therapy:
The Use of Capecitabine:
The Cancer Journal • Volume 13, Number 3, May/June 2007
EQUIVALENT
Neoadjuvant Therapy:
Adding Oxaliplatin:
Curr Opin Oncol 2012, 24:441–447
• ++ Toxicity & -- Compliance.
• Did not improve:
1. R0 RR.
2. pCR.
3. Sphincter Preservation
Neoadjuvant Therapy:
Adding EGFR/VEGF Inhibition:
Curr Opin Oncol 2012, 24:441–447
No Significant Added Benefit over
Chemotherapy & Higher G 3 & 4
Adverse Events.
Neoadjuvant Therapy:
Indications:
1. T3 – T4 Lesions: The only definitive indication.
2. cT3N0: Should be treated (understaging).
3. Depth of Extramural Invasion:
– T3 lesions (>5 mm)  ++ LNs involvement  Higher
Cancer Specific Mortality (54% Versus 85%).
– Selection of high risk T3 for treatment.
– Approved outside US.
4. T1 – 2 lesions with Positive Nodes.
5. Low situated lesions.
6. Invasion of mesorectal fascia.
Br J Cancer 2000; 82:1131
www.uptodate.com (September 2015)
Neoadjuvant Therapy:
Treatment Outcome:
Complete
Response
cCRpCR
• 15 – 30%.
• Small & Less
Advanced Lesions
• 10 – 12 Weeks.
• Involution to flat scar.
• DRE & Endoscopy.
• Imaging:
• Endorectal US
• PET-CT
• MRI.
• ypT0N0
Martin R. et al. Surg Oncol Clin N Am 23 (2014) 113–125
Neoadjuvant Therapy:
Treatment Outcome in Relation to pCR:
German Study:
Neoadjuvant Therapy:
Impact of Pathological CR:
British Journal of Surgery 2012; 99: 918–928
Can we Avoid Surgery?
Can we Avoid Surgery?
Can we Avoid Surgery?
JCO. VOLUME 29 􏰉 NUMBER 35 􏰉 DECEMBER 10 2011
21 Patients
pCR
Neoadjuvant CRT
For Stages II & III
Wait & See
MRI, Endoscopy &
Biopsy
Median Follow up
=25 months
1 Patient  LR
 Surgery
20 Pts, Stages II & III
 NAT  pCR
Median Follow up
=35 months
2 – Year DFS: 91%
2 – Year OAS: 93%
Rectal cancer pacc 16
Rectal cancer pacc 16
Habr-Gama A, São Julião GP, Perez RO. Nonoperative manage ment of rectal cancer: identifying the ideal
patients. Hematol Oncol Clin North Am 2015; 29: 135151 [PMID: 25475576 DOI: 10.1016/j.hoc.2014.09.004]
Predicting Pathologic CR:
Questions & Debates:
• DRE: Under estimation.
• CT and ERUS : Residual disease & nodes (ypT0 
LN +ve = 2 – 9%)
• Timing of Assessment: 6 or 12 or 6 & 12 months?
• CEA: Cutoff Point = 2.7 ng/ml at 4 or 8 weeks?
• Diffusion Weighted MRI: Higher sensitivity and
specificity.
• Full Thickness Excision Biopsy.
• PET CT Scan: 6 and 12 months.
• Molecular Signature: 33 & 54 genes signatures.
Chawla et al. Am J Clin Oncol 2015;38:534–540
Neoadjuvant Therapy:
Problems with Current Practice:
CRT
5.5 Weeks 6 wks
TME
1 – 2 weeks
4-6 wks Adjuvant Cth
18 weeks
• Delayed.
• Reduced.
• Omitted
CRT TME
Neodjuvant
Chemoth.
Neodjuvant
Chemoth.
CRT TME
Adopted from Deborah Schrag’s Presentation at 2015 ASCO Annual Meeting
The Art of Today:
• Radical resection remains the cornerstone in
management regardless the achieved response.
• The identification of patients with pCR is challenging,
however, patients should be informed about watch and
wait strategy.
• Data showed higher incidence of relapse during the 1st
year then becoming comparable to those following
radical surgery  intensive follow up during the 1st
year.
• Adoption of MDT should be encouraged.
• The need for more clinical trials is highly appreciated.
Thank You

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Rectal cancer pacc 16

  • 1. Do we need surgery in all rectal carcinoma patients? Mohamed Abdulla M.D. Prof. of Clinical Oncology Cairo University PACC 16th – Cairo City Stars Intercontinental Thursday, 28/04/2016
  • 2. Member of Advisory Board, Consultant, and Speaker for: • Amgen, Astellas, AstraZeneca, Hoffman la Roche, Janssen Cilag, Merck Serono, Novartis, Pfizer, Mundipharma • The content of this presentation does not relate to any product of a commercial interest Speaker Disclosures:
  • 3. Basic Facts: • 2nd & 3rd most common cancer in females & males. • 1.4 million new case and 694000 deaths. • Males > Females. • Lowest rates in Africa & South Central Asia. • Low SES  30% increased risk. • Rising incidence < 50 years  Left sided colon & rectal, symptomatic & advanced  Poor outcome. • Sporadic > Hereditary. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin 2016; 66:7. Ahnen DJ, Wade SW, Jones WF, et al. The increasing incidence of young-onset colorectal cancer: a call to action. Mayo Clin Proc 2014; 89:216.
  • 4. Principles: Surgery is the cornerstone in management However,
  • 5. Local Recurrence Following Surgery Alone: Clinical Colorectal Cancer, Vol. 4, No. 4, 233-240, 2004
  • 6. Adjuvant Radiation Therapy: Clinical Colorectal Cancer, Vol. 4, No. 4, 233-240, 2004
  • 7. Cuthbert Dukes 1932: Nodes as a prognostic factor
  • 8. Local Recurrence: Better Insight: Circumferential Margins Number Local Recurrence Rate P > 2 mm 987 3.3% < 0.0001 1 – 2 mm 100 8.5% 0.02 < 1 mm 227 13.1 0.08 Int. J. Radiation Oncology Biol. Phys., Vol. 55, No. 5, pp. 1311–1320, 2003
  • 11. MURCERY Trial: Fiona et al. JCO. 2014:1(32). 34-46.
  • 12. Limitations of the TNM – T3 category forms 80% of rectal cancers
  • 14. (J Natl Compr Canc Netw 2015;13:1111–1119)
  • 15. Total Mesorectal Excision (TME): • Removal of peri-rectal tissues involving lateral & circumferential margins of mesorectal envelop. Dis Colon Rectum. 2013 May;56(5):535-50.
  • 16. Total Mesorectal Excision (TME): Clinical Colorectal Cancer, Vol. 4, No. 4, 233-240, 2004 N Engl J Med. 2001;345:638 – 646. Adjuvant Radiation Therapy  LR = 2.4%
  • 17. Adjuvant Chemoradiation in Stages II & III Rectal Cancer: • GITSG. • NCCTG. • NSABP R-01. N Engl J Med 1986; 315:1294. FJ Natl Cancer Inst 1988; 80:21. N Engl J Med 1991; 324:709. Adjuvant Fluoroupyremidine X 2 months CRT – 6 Weeks Adjuvant Fluoroupyremidine X 2 months Adjuvant Therapy = 6 months
  • 18. Neoadjuvant Therapy: The German Study: A Shifting Concept N Engl J Med 2004;351:1731-40.
  • 27. Radiation + Chemotherapy are MANDATORY in Neoadjuvant Therapy: Gastrointest Cancer Res 1:49-56. ©2007 by International Society of Gastrointestinal Oncology
  • 28. Neoadjuvant Therapy: The Use of Capecitabine: The Cancer Journal • Volume 13, Number 3, May/June 2007 EQUIVALENT
  • 29. Neoadjuvant Therapy: Adding Oxaliplatin: Curr Opin Oncol 2012, 24:441–447 • ++ Toxicity & -- Compliance. • Did not improve: 1. R0 RR. 2. pCR. 3. Sphincter Preservation
  • 30. Neoadjuvant Therapy: Adding EGFR/VEGF Inhibition: Curr Opin Oncol 2012, 24:441–447 No Significant Added Benefit over Chemotherapy & Higher G 3 & 4 Adverse Events.
  • 31. Neoadjuvant Therapy: Indications: 1. T3 – T4 Lesions: The only definitive indication. 2. cT3N0: Should be treated (understaging). 3. Depth of Extramural Invasion: – T3 lesions (>5 mm)  ++ LNs involvement  Higher Cancer Specific Mortality (54% Versus 85%). – Selection of high risk T3 for treatment. – Approved outside US. 4. T1 – 2 lesions with Positive Nodes. 5. Low situated lesions. 6. Invasion of mesorectal fascia. Br J Cancer 2000; 82:1131 www.uptodate.com (September 2015)
  • 32. Neoadjuvant Therapy: Treatment Outcome: Complete Response cCRpCR • 15 – 30%. • Small & Less Advanced Lesions • 10 – 12 Weeks. • Involution to flat scar. • DRE & Endoscopy. • Imaging: • Endorectal US • PET-CT • MRI. • ypT0N0 Martin R. et al. Surg Oncol Clin N Am 23 (2014) 113–125
  • 33. Neoadjuvant Therapy: Treatment Outcome in Relation to pCR: German Study:
  • 34. Neoadjuvant Therapy: Impact of Pathological CR: British Journal of Surgery 2012; 99: 918–928 Can we Avoid Surgery?
  • 35. Can we Avoid Surgery?
  • 36. Can we Avoid Surgery? JCO. VOLUME 29 􏰉 NUMBER 35 􏰉 DECEMBER 10 2011 21 Patients pCR Neoadjuvant CRT For Stages II & III Wait & See MRI, Endoscopy & Biopsy Median Follow up =25 months 1 Patient  LR  Surgery 20 Pts, Stages II & III  NAT  pCR Median Follow up =35 months 2 – Year DFS: 91% 2 – Year OAS: 93%
  • 39. Habr-Gama A, São Julião GP, Perez RO. Nonoperative manage ment of rectal cancer: identifying the ideal patients. Hematol Oncol Clin North Am 2015; 29: 135151 [PMID: 25475576 DOI: 10.1016/j.hoc.2014.09.004]
  • 40. Predicting Pathologic CR: Questions & Debates: • DRE: Under estimation. • CT and ERUS : Residual disease & nodes (ypT0  LN +ve = 2 – 9%) • Timing of Assessment: 6 or 12 or 6 & 12 months? • CEA: Cutoff Point = 2.7 ng/ml at 4 or 8 weeks? • Diffusion Weighted MRI: Higher sensitivity and specificity. • Full Thickness Excision Biopsy. • PET CT Scan: 6 and 12 months. • Molecular Signature: 33 & 54 genes signatures. Chawla et al. Am J Clin Oncol 2015;38:534–540
  • 41. Neoadjuvant Therapy: Problems with Current Practice: CRT 5.5 Weeks 6 wks TME 1 – 2 weeks 4-6 wks Adjuvant Cth 18 weeks • Delayed. • Reduced. • Omitted CRT TME Neodjuvant Chemoth. Neodjuvant Chemoth. CRT TME Adopted from Deborah Schrag’s Presentation at 2015 ASCO Annual Meeting
  • 42. The Art of Today: • Radical resection remains the cornerstone in management regardless the achieved response. • The identification of patients with pCR is challenging, however, patients should be informed about watch and wait strategy. • Data showed higher incidence of relapse during the 1st year then becoming comparable to those following radical surgery  intensive follow up during the 1st year. • Adoption of MDT should be encouraged. • The need for more clinical trials is highly appreciated.