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Evidence based Treatment
Neo-adjuvant therapy for carcinoma rectum
Dr. Harsh Shah
MS, FMAS, DNB MCh (GI)
GI & HPB Surgeon
Kaizen Hospital
Ahmedabad
Level of Evidence
Evolution of rectal cancer treatment
• 3rd MC cancer worldwide
• APR – Miles (1908)
• Invention of circular stapler (1970)
• TME by Heald (1982)
• TEMS Gerhard Buess(1983)
• Neoadjuvant CT-RT(2001)
• Definitive CTRT(2004)
Aim of rectal cancer treatment
• Improve Survival
• Reduce of local recurrence
• Reduce systemic recurrence
• Improve Quality of life
• Sphincter preservation
Classification
• Local – T1,T2 – Surgical resection
• Locally advanced – T3, T4, N+ - Neoadjuvant CTRT f/b surgery
• Advanced- M1
Indications for Neo-adjuvant CT-RT
Stage II:T3/T4, N0
Stage III: Any T, N+
High risk of local recurrence
• Close proximity of the rectum
to pelvic structures and organs
• Absence of a serosa
surrounding the rectum
• Technical difficulties associated
with obtaining wide surgical
margins at resection.
Pre-operative Investigations
• Colonoscopy, Biopsy
• CT chest/abdomen/pelvis
• MRI Pelvis/Endo rectal US
• CEA
T2 tumour
Preserved muscularis propria
T3
Extension beyond muscularis propria
Issues in Rectal cancer treatment
• RT f/b surgery(TME) vs Surgery(TME) alone
• Neo-adjuvant vs adjuvant RT
• Short course vs Long course RT
• RT vs CTRT
• 5FU vs Capecitabine vs +Oxaliplatin
• Role of Definitive CTRT
• Timing of surgery
• Duration & timing of adjuvant therapy
Pre-op RT vs Surgery alone
Lancet Oncology 2011
• 1861 patients
• Short course RT f/b surgery vs surgery
• Median follow up 11 years
• Reduced 10 year local recurrence by 50% in RT group
• Improved disease specific survival
Issues in Rectal cancer treatment
• RT vs Surgery
• Neo-adjuvant vs adjuvant RT
• Short course vs Long course RT
• RT vs CTRT
• 5FU vs Capecitabine vs +Oxaliplatin
• Role of Definitive CTRT
• Timing of surgery
• Duration & timing of adjuvant therapy
Timing of RT : Pre-op vs Post-op
• 823 patients
• Randomly assigned
• Reduced local recurrence
• No difference in overall survival
Advantages of NART
• Surgery-naive tissue are better oxygenated
• Avoid the occurrence of radiation-induced injury to
small bowel
• Avoids irradiating the anastomosis
Sphincter preservation
46 cGy RT
2004
• 10 RCTs
• 4596 patients
• No impact on sphincter preservation
• Cochrane review 2007
• 9 studies comparing neo-adjuvant CTRT vs other NA/A treatment
• No impact on sphincter preservation
Issues in Rectal cancer treatment
• RT vs Surgery
• Neo-adjuvant vs adjuvant RT
• Short course vs Long course RT
• RT vs CTRT
• 5FU vs Capecitabine vs +Oxaliplatin
• Role of Definitive CTRT
• Timing of surgery
• Duration & timing of adjuvant therapy
• 5 cGy x 5 days (Dutch
TME,2001)
• No concurrent chemo(too
toxic)
• Surgery within 7 days before
the inflammation develops
• T3/N+
• Higher long term toxicities
• Better compliance & Cheaper
• 1.8 cGy per day, 5 days a
week, total 50.4 cGy over 5.5
weeks (German Rectal cancer
study,2004)
• Concurrent chemo
• Surgery at 6 weeks after
inflammation subsides &
tumour shrinks
• T3,4/N+
• Higher short term toxicities
Short course RT Long course RT
Short course vs Long course RT
• 326 patients randomly assigned
• Median follow up 5.9 years
• No difference in local recurrence & Overall survival
• LC may be more effective for distal tumours
Issues in Rectal cancer treatment
• RT vs Surgery
• Neo-adjuvant vs adjuvant RT
• Short course vs Long course RT
• RT vs CTRT
• 5FU vs Capecitabine vs +Oxaliplatin
• Role of Definitive CTRT
• Timing of surgery
• Duration & timing of adjuvant therapy
Advantage of CT + RT
• Control of systemic micrometastasis
• Sensitization of local RT
• Increased rate of pathological complete response
• 5 RCTs, 2393 patients, NACTRT vs NART
• Addition of CT to NART improves local control
• Higher toxicity
• 2013 cochrane review
• 5 trials included
• Higher rate of PCR
• Improved local control
• Higher grade 3,4 toxicities
• No benefit in sphincter preservation
Issues in Rectal cancer treatment
• RT vs Surgery
• Neo-adjuvant vs adjuvant RT
• Short course vs Long course RT
• RT vs CTRT
• 5FU vs Capecitabine vs +Oxaliplatin
• Role of Definitive CTRT
• Timing of surgery
• Duration & timing of adjuvant therapy
Which Chemotherapeutic agent ?
5-FU vs oral Capecitabine vs +Oxaliplatin
• Capecitabine with preoperative RT achieved similar rates of pCR, sphincter-
sparing surgery, and surgical down staging compared with 5FU.
• Adding oxaliplatin did not improve surgical outcomes but added significant
toxicity.
No advantage of following agent when
added to pre-op RT
• Oxaliplatin, Irinotecan
• Cetuximab, Panitimumab
• Bevacizumab
Induction chemotherapy
CapOX or FOLFOX
Possible benefits of using chemotherapy first
• Early prevention or eradication of micro-metastases
• Higher rates of pathologic complete response
• Minimizing the time patients need an ileostomy
• Improving the tolerance and completion rates of chemotherapy
• 108 patients
• Median follow up of 69.5 months
• No difference in 5 year DFS & OS
Issues in Rectal cancer treatment
• RT vs Surgery
• Neo-adjuvant vs adjuvant RT
• Short course vs Long course RT
• RT vs CTRT
• 5FU vs Capecitabine vs +Oxaliplatin
• Role of Definitive CTRT
• Timing of surgery
• Duration & timing of adjuvant therapy
Complete clinical response after NACTRT
• 90 of 183(49%) cCR, 50-54 cGy RT + 5FU
• watch & wait + salvage, median FU 5 years
• 31% developed recurrence, 94% salvaged with surgery
• 78% organ preservation
2014
• 23 studies, 867 patients
• cCR managed by watch & wait approach vs PCR identified at
surgery
• Local recurrences were managed by salvage surgery
• No difference in OS, DFS
• Need for more studies
Lancet Gastro Hepat 2017
Issues in Rectal cancer treatment
• RT vs Surgery
• Neo-adjuvant vs adjuvant RT
• Short course vs Long course RT
• RT vs CTRT
• 5FU vs Capecitabine vs +Oxaliplatin
• Role of Definitive CTRT
• Timing of surgery
• Duration & timing of adjuvant therapy
When to perform surgery following NACTRT ?
• 265 patients
• PCR was equal in both the groups
• Higher morbidity & poor quality of TME in longer waiting group
Issues in Rectal cancer treatment
• RT vs Surgery
• Neo-adjuvant vs adjuvant RT
• Short course vs Long course RT
• RT vs CTRT
• 5FU vs Capecitabine vs +Oxaliplatin
• Role of Definitive CTRT
• Timing of surgery
• Duration & timing of adjuvant therapy
Adjuvant CT after Neo-adjuvant CTRT
• 2 RCTs, 1 pooled analysis of 5RCTs, 10 retrospective studies
• Total 5457 patients
• Better 5year DFS & OS
• FOLFOX preferred over 5FU
Timing & Duration of Adjuvant CT
• Each 4-week delay in chemotherapy results in a 14% decrease in OS
• Adjuvant therapy should be administered as soon as the patient is
medically able
Association between time to initiation of adjuvant chemotherapy and survival in
colorectal cancer: a systematic review and meta-analysis. Biagi et al JAMA 2011
• Adjuvant CT for 4 months
• Total duration of perioperative treatment 6 months
Plan of treatment
T3/T4/N+
• Neoadjuvant CTRT
• 5-FU infusional + RT 50.4 Gy over 5.5
weeks
• Short course RT for T3 tumours
• Surgery
• 5-6 weeks of completion of CTRT
• Adjuvant CT
• FOLFOX for 4 months
Take Home Message
• Pre-op RT f/b surgery vs Surgery  RT improves local control
• Neo-adjuvant vs adjuvant RT  NART preferred
• Short course vs Long course RT Equal results
• RT vs CTRT  CTRT improves PCR
• 5FU vs Capecitabine vs +Oxaliplatin  5FU/Capecitabine
• Role of Definitive CTRT ???
• Timing of surgery 5-6 weeks
• Timing & Duration of adjuvant therapy Early, 4 months

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Neoadjuvant Therapy ca rectum

  • 1. Evidence based Treatment Neo-adjuvant therapy for carcinoma rectum Dr. Harsh Shah MS, FMAS, DNB MCh (GI) GI & HPB Surgeon Kaizen Hospital Ahmedabad
  • 3. Evolution of rectal cancer treatment • 3rd MC cancer worldwide • APR – Miles (1908) • Invention of circular stapler (1970) • TME by Heald (1982) • TEMS Gerhard Buess(1983) • Neoadjuvant CT-RT(2001) • Definitive CTRT(2004)
  • 4. Aim of rectal cancer treatment • Improve Survival • Reduce of local recurrence • Reduce systemic recurrence • Improve Quality of life • Sphincter preservation
  • 5. Classification • Local – T1,T2 – Surgical resection • Locally advanced – T3, T4, N+ - Neoadjuvant CTRT f/b surgery • Advanced- M1
  • 6. Indications for Neo-adjuvant CT-RT Stage II:T3/T4, N0 Stage III: Any T, N+
  • 7. High risk of local recurrence • Close proximity of the rectum to pelvic structures and organs • Absence of a serosa surrounding the rectum • Technical difficulties associated with obtaining wide surgical margins at resection.
  • 8. Pre-operative Investigations • Colonoscopy, Biopsy • CT chest/abdomen/pelvis • MRI Pelvis/Endo rectal US • CEA
  • 11. Issues in Rectal cancer treatment • RT f/b surgery(TME) vs Surgery(TME) alone • Neo-adjuvant vs adjuvant RT • Short course vs Long course RT • RT vs CTRT • 5FU vs Capecitabine vs +Oxaliplatin • Role of Definitive CTRT • Timing of surgery • Duration & timing of adjuvant therapy
  • 12. Pre-op RT vs Surgery alone Lancet Oncology 2011 • 1861 patients • Short course RT f/b surgery vs surgery • Median follow up 11 years • Reduced 10 year local recurrence by 50% in RT group • Improved disease specific survival
  • 13. Issues in Rectal cancer treatment • RT vs Surgery • Neo-adjuvant vs adjuvant RT • Short course vs Long course RT • RT vs CTRT • 5FU vs Capecitabine vs +Oxaliplatin • Role of Definitive CTRT • Timing of surgery • Duration & timing of adjuvant therapy
  • 14. Timing of RT : Pre-op vs Post-op • 823 patients • Randomly assigned • Reduced local recurrence • No difference in overall survival
  • 15. Advantages of NART • Surgery-naive tissue are better oxygenated • Avoid the occurrence of radiation-induced injury to small bowel • Avoids irradiating the anastomosis
  • 18. 2004
  • 19. • 10 RCTs • 4596 patients • No impact on sphincter preservation
  • 20. • Cochrane review 2007 • 9 studies comparing neo-adjuvant CTRT vs other NA/A treatment • No impact on sphincter preservation
  • 21. Issues in Rectal cancer treatment • RT vs Surgery • Neo-adjuvant vs adjuvant RT • Short course vs Long course RT • RT vs CTRT • 5FU vs Capecitabine vs +Oxaliplatin • Role of Definitive CTRT • Timing of surgery • Duration & timing of adjuvant therapy
  • 22. • 5 cGy x 5 days (Dutch TME,2001) • No concurrent chemo(too toxic) • Surgery within 7 days before the inflammation develops • T3/N+ • Higher long term toxicities • Better compliance & Cheaper • 1.8 cGy per day, 5 days a week, total 50.4 cGy over 5.5 weeks (German Rectal cancer study,2004) • Concurrent chemo • Surgery at 6 weeks after inflammation subsides & tumour shrinks • T3,4/N+ • Higher short term toxicities Short course RT Long course RT
  • 23. Short course vs Long course RT • 326 patients randomly assigned • Median follow up 5.9 years • No difference in local recurrence & Overall survival • LC may be more effective for distal tumours
  • 24. Issues in Rectal cancer treatment • RT vs Surgery • Neo-adjuvant vs adjuvant RT • Short course vs Long course RT • RT vs CTRT • 5FU vs Capecitabine vs +Oxaliplatin • Role of Definitive CTRT • Timing of surgery • Duration & timing of adjuvant therapy
  • 25. Advantage of CT + RT • Control of systemic micrometastasis • Sensitization of local RT • Increased rate of pathological complete response
  • 26. • 5 RCTs, 2393 patients, NACTRT vs NART • Addition of CT to NART improves local control • Higher toxicity
  • 27. • 2013 cochrane review • 5 trials included • Higher rate of PCR • Improved local control • Higher grade 3,4 toxicities • No benefit in sphincter preservation
  • 28. Issues in Rectal cancer treatment • RT vs Surgery • Neo-adjuvant vs adjuvant RT • Short course vs Long course RT • RT vs CTRT • 5FU vs Capecitabine vs +Oxaliplatin • Role of Definitive CTRT • Timing of surgery • Duration & timing of adjuvant therapy
  • 29. Which Chemotherapeutic agent ? 5-FU vs oral Capecitabine vs +Oxaliplatin • Capecitabine with preoperative RT achieved similar rates of pCR, sphincter- sparing surgery, and surgical down staging compared with 5FU. • Adding oxaliplatin did not improve surgical outcomes but added significant toxicity.
  • 30. No advantage of following agent when added to pre-op RT • Oxaliplatin, Irinotecan • Cetuximab, Panitimumab • Bevacizumab
  • 31. Induction chemotherapy CapOX or FOLFOX Possible benefits of using chemotherapy first • Early prevention or eradication of micro-metastases • Higher rates of pathologic complete response • Minimizing the time patients need an ileostomy • Improving the tolerance and completion rates of chemotherapy
  • 32. • 108 patients • Median follow up of 69.5 months • No difference in 5 year DFS & OS
  • 33. Issues in Rectal cancer treatment • RT vs Surgery • Neo-adjuvant vs adjuvant RT • Short course vs Long course RT • RT vs CTRT • 5FU vs Capecitabine vs +Oxaliplatin • Role of Definitive CTRT • Timing of surgery • Duration & timing of adjuvant therapy
  • 34. Complete clinical response after NACTRT • 90 of 183(49%) cCR, 50-54 cGy RT + 5FU • watch & wait + salvage, median FU 5 years • 31% developed recurrence, 94% salvaged with surgery • 78% organ preservation 2014
  • 35. • 23 studies, 867 patients • cCR managed by watch & wait approach vs PCR identified at surgery • Local recurrences were managed by salvage surgery • No difference in OS, DFS • Need for more studies Lancet Gastro Hepat 2017
  • 36. Issues in Rectal cancer treatment • RT vs Surgery • Neo-adjuvant vs adjuvant RT • Short course vs Long course RT • RT vs CTRT • 5FU vs Capecitabine vs +Oxaliplatin • Role of Definitive CTRT • Timing of surgery • Duration & timing of adjuvant therapy
  • 37. When to perform surgery following NACTRT ? • 265 patients • PCR was equal in both the groups • Higher morbidity & poor quality of TME in longer waiting group
  • 38. Issues in Rectal cancer treatment • RT vs Surgery • Neo-adjuvant vs adjuvant RT • Short course vs Long course RT • RT vs CTRT • 5FU vs Capecitabine vs +Oxaliplatin • Role of Definitive CTRT • Timing of surgery • Duration & timing of adjuvant therapy
  • 39. Adjuvant CT after Neo-adjuvant CTRT • 2 RCTs, 1 pooled analysis of 5RCTs, 10 retrospective studies • Total 5457 patients • Better 5year DFS & OS • FOLFOX preferred over 5FU
  • 40. Timing & Duration of Adjuvant CT • Each 4-week delay in chemotherapy results in a 14% decrease in OS • Adjuvant therapy should be administered as soon as the patient is medically able Association between time to initiation of adjuvant chemotherapy and survival in colorectal cancer: a systematic review and meta-analysis. Biagi et al JAMA 2011 • Adjuvant CT for 4 months • Total duration of perioperative treatment 6 months
  • 41. Plan of treatment T3/T4/N+ • Neoadjuvant CTRT • 5-FU infusional + RT 50.4 Gy over 5.5 weeks • Short course RT for T3 tumours • Surgery • 5-6 weeks of completion of CTRT • Adjuvant CT • FOLFOX for 4 months
  • 42. Take Home Message • Pre-op RT f/b surgery vs Surgery  RT improves local control • Neo-adjuvant vs adjuvant RT  NART preferred • Short course vs Long course RT Equal results • RT vs CTRT  CTRT improves PCR • 5FU vs Capecitabine vs +Oxaliplatin  5FU/Capecitabine • Role of Definitive CTRT ??? • Timing of surgery 5-6 weeks • Timing & Duration of adjuvant therapy Early, 4 months