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Neoadjuvant Therapy ca rectum
1. Neoadjuvant chemoradiotherapy (CTRT) followed by total mesorectal excision (TME) surgery has become the standard of care for locally advanced rectal cancer based on improved local control and survival outcomes compared to surgery or radiotherapy (RT) alone. 2. The addition of chemotherapy to neoadjuvant RT improves pathological complete response rates and local control compared to RT alone, though it also increases toxicity. 3. For patients who achieve a clinical complete response after neoadjuvant CTRT, a non-operative "watch and wait" approach may be considered given comparable oncologic outcomes when salvage surgery is performed for recurrences.
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Neoadjuvant Therapy ca rectum
- 1. Evidence based Treatment Neo-adjuvanttherapy for carcinoma rectum Dr. Harsh Shah MS, FMAS, DNB MCh (GI) GI & HPB Surgeon Kaizen Hospital Ahmedabad
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- 3. Evolution of rectalcancer 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 rectalcancer 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-adjuvantCT-RT Stage II:T3/T4, N0 Stage III: Any T, N+
- 7. High risk oflocal 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
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- 11. Issues in Rectalcancer 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 vsSurgery 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 Rectalcancer 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
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- 19. • 10 RCTs •4596 patients • No impact on sphincter preservation
- 20. • Cochrane review2007 • 9 studies comparing neo-adjuvant CTRT vs other NA/A treatment • No impact on sphincter preservation
- 21. Issues in Rectalcancer 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 cGyx 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 vsLong 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 Rectalcancer 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 cochranereview • 5 trials included • Higher rate of PCR • Improved local control • Higher grade 3,4 toxicities • No benefit in sphincter preservation
- 28. Issues in Rectalcancer 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 offollowing agent when added to pre-op RT • Oxaliplatin, Irinotecan • Cetuximab, Panitimumab • Bevacizumab
- 31. Induction chemotherapy CapOX orFOLFOX 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 Rectalcancer 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 responseafter 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 Rectalcancer 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 performsurgery following NACTRT ? • 265 patients • PCR was equal in both the groups • Higher morbidity & poor quality of TME in longer waiting group
- 38. Issues in Rectalcancer 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 afterNeo-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 & Durationof 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