1. The document discusses treatment options and strategies for rectal cancer patients who achieve a clinical complete response after neoadjuvant chemoradiation therapy. 2. Key points discussed include patient selection criteria for active surveillance versus surgery, optimal timing of response assessment, and surveillance schedules for patients undergoing a watch-and-wait approach. 3. Studies presented showed that outcomes for complete responders managed non-operatively can be comparable to those having surgery, though local recurrence rates are higher with the non-operative approach. Strict patient selection and close surveillance are important.

1. DR KANHU CHARAN PATRO
MD,DNB [RADIATION ONCOLOGY], MBA. PDCR. CEPC, FAROI
HOD, RADIATION ONCOLOGY. MGCHRI. VISAKHAPATNAM
1
drkcpatro@gmail.com
M-9160470564
Clinical and radiological CR after
NACTRT in Rectal Cancer- What next?

2. ESMO ALGORITHM

3. OPTIONS
• Active surveillance
• Limited surgery at cCR
• Surgery after recurrence
• Complete CHEMO

4. • “Planned” Organ Preservation or “Incidental” cCR?
• How to Select Patients for a “Watch and Wait”
Strategy? And When Is the Optimal Time Point for
Response Assessment?
• What Is the Optimal Surveillance Strategy?
• Is Limited Surgery an Option?
• Could We Harm Our Patients?
Questions?

6. RESPONSE ASSEMENT
• DRE
• PROCTOSCOPY
• REIMAGING BY MRI
• CEA

8. Habr-Gama definition of cCR
• Whitening of the mucosa in an area of the rectal wall may be frequently observed in
patients with cCR; if this is the only finding, patients may be monitored by monthly
follow-up visits including digital rectal examination and rigid proctoscopy. It is usually
possible to identify the whitening on subsequent visits .
• Association of any teleangiectasia, i.e, small derogative blood vessels seen on the
rectal mucosa at the area previously harboring the primary cancer, is also frequently
observed in complete clinical responders. This finding is seen even in long-term follow-
up of patients with complete clinical response managed by observation alone .
• Another feature that is also seen or felt in these patients is a subtle loss of pliability of
the rectal wall harboring the scar; this is usually observed during manual insufflations
at proctoscopy with light stiffness of the wall. In the context of no additional positive
findings of residual cancer, this may also be considered as a feature of cCR; it should not
be mistaken for rectal stenosis or wall nodularity that clearly should be considered as
incomplete clinical response
• Whenever a tumor cannot be felt or seen, patients should be considered as complete
clinical responders

9. The cCR

10. Habr-Gama definition of residual
• Any residual deep ulceration with or without a necrotic
center should be considered as a positive sign for incomplete
clinical response.
• Any superficial ulcer, irregularity, even in the presence of only
mucosal ulceration, should be regarded as a positive sign of
incomplete clinical response
• Any palpable nodule, easily defined by digital rectal
examination, even in the presence of mucosal complete
integrity should be considered as incomplete clinical response
• Any significant stenosis impeding the rigid proctoscope from
sliding through should be considered as incomplete clinical
response

11. The nodularity-residual

12. The superficial ulcer-residual

13. The deep ulcer-residual

14. DEFINITION OF cCR
• A cCR is defined as the absence of any palpable tumour
or irregularity at DRE
• No visible lesion at rectoscopy except a flat scar,
telangiectasia or whitening of the mucosa.
• These minimal criteria can be complemented by
absence of any residual tumour in the primary site and
draining lymph nodes on imaging with MRI or ERUS,
• Negative biopsies from the scar.
• An initially raised CEA level which returns to normal (<
5 ng/ml) after CRT is associated with an increased
likelihood of cCR and pCR, and hence supports the
opinion that a cCR has been achieved

15. cCR-ypT0N0
Flat whitish scar with some
telangiectasis
Fibrotic
changes
Diffusion-weighted Imaging
Shows A Complete Disappearance Of Tumor Signal

16. Local excision

17. • 1990 and June 2002, 431 patients with clinically staged T3
rectal cancer were treated with preoperative chemoradiation
followed by surgical resection
• Full-thickness local excision (n 3) or a transanal excision (n
23)] was performed in 26 patients because of patient refusal
of abdominoperineal resection (APR) (n 13), medical
comorbidity (n 4), physician preference after a complete
clinical response (n 6), and other reasons (n 3)
• Actuarial overall survival at 5 years was 86% in the local-
excision group compared with 81% among mesorectal-
excision patients (p NS), and 85% in patients with a complete
clinical response to chemoradiation followed by mesorectal
excision by APR or LAR (p NS).
Local excision

18. PATIENT REFUSAL OF APR, HIGHLY SELECTED PATIENTS WHO RESPONDED WELL TO
CONVENTIONAL EXTERNAL-BEAM RADIOTHERAPY (CXRT) WERE SELECTED TO UNDERGO
LOCAL EXCISION. MOST OF THESE PATIENTS HAD PATHOLOGIC COMPLETE RESPONSE.
LOCAL CONTROL AND SURVIVAL RATES ARE COMPARABLE TO THOSE ACHIEVED WITH
CHEMORADIATION FOLLOWED BY MESORECTAL EXCISION
Local excision

19. What we need?
• Patients should be informed that the strategy
• Standardized protocol for intensive
surveillance
• Such patients have been subjected to rigorous
and meticulous follow up, where MRI
surveillance is available
• More frequent than routine surveillance to
ensure that surgical salvage is feasible and
timely

20. What we need?
• Patient selection,
• Treatment sequencing,
• Optimal assessment of response,
• Long-term surveillance strategies

21. NOMOGRAM?

23. • Mucinous adenocarcinoma,
• Positive pre-treatment serum CEA
• Clinical T4 and N2 stages may impart
difficulty for patients to achieve pCR
ODD THINGS?

24. ODDS RATIO FOR ODD THINGS?
Mucinous adenocarcinoma and clinical N2 stage might be indicative of a
prognostically unfavorable biological tumor profile with a greater
propensity for local or distant recurrence and decreased survival.

25. Indian study-TMH

26. • 64 patients achieving pathological complete response from
2010 to 2013.
• Disease-free survival (DFS), overall survival (OS), and
locoregional and systemic recurrence rates were evaluated
for these patients.
• Results. After a median follow-up of 30.5 months (range
11–59 months), the 3-year (OS) was 94.6% and the 3-year
(DFS) was 88.5%.
• The locoregional and systemic recurrence rates were 4.7%
and 3.1%, respectively.
• Conclusion. In the Indian subcontinent, despite younger
patients with aggressive tumor biology, outcome in
complete responders is good
Indian study

27. American study

28. • cT2-4N0-2 rectal adenocarcinoma were treated with nCRT
from 2015 through 2016
• Treatment consisted of 50.4 to 54 Gy with concurrent
fluoropyrimidine-based chemotherapy
• A cCR was defined as the absence of mass or ulceration
and the presence of flat mucosa or scar only.
• In addition, (MRI) showed no evidence of residual mass.
• Watchful waiting patients were followed with MRI every 3-
6 months for 2 years then every 6 months up to 5 years.
• Exam with rigid proctoscopy was performed every 3
months for 2 years and every 6 months up to 5 years.
American study

29. • 251 patients were treated with nCRT. 64 (25%) achieved a cCR
• 32 (50%) patients with cCR had surgery at a median time from
nCRT completion to surgery of 81 days.
• 14 (44%) patients with cCR undergoing surgery were found to have
pathologic complete response
• Overall, outcomes were favorable in patients with cCR after nCRT
undergoing watchful waiting with high rates of local control,
disease-free survival, and overall survival.
• Although all local recurrences were surgically resectable, local
recurrence was associated with a poor overall outcome with a
majority of these patients developing distant metastases
• Only N-stage was predictive of distant recurrence on multivariate
analysis
American study

30. 1. The two patient groups did not differ in distant metastasis rates or disease-
free and overall survival, but the nonsurgical group had a higher risk of 1, 2, 3,
and 5-year local recurrence.
2. Hence, we concluded that for rectal cancer patients achieving a cCR after
NCRT, a wait-and-see strategy with strict selection criteria, an appropriate
follow-up schedule, and salvage treatments achieved outcomes at least as
good as radical surgery

31. Important points
• First
– Clinicians should select patients
• Second
– Early identification of cCR
• Third
– The time interval between NCRT and response
assessment is critical
• Fourth
– Success of the wait-and-see strategy

32. FOLLOWUP SCHEDULE IN ACTIVE SURVILLANCE

33. IS RAPIDO NEW STANDARD OF CARE FOR RECTUM?
Renu R Bahadoer/LANCET ONCOLOGY/2020 10th MAY 2021/RECTUM
Rectal cancer And
Preoperative Induction
therapy followed by
Dedicated Operation
(RAPIDO)
SHORT COURSE
RT CHEMOTME
LONG COURSE RT
TMEADJ.
CHEMO
• The observed decreased probability of disease-related treatment failure in
the experimental group is probably indicative of the increased efficacy of
preoperative chemotherapy as opposed to adjuvant chemotherapy in this
setting.
• Therefore, the experimental treatment can be considered as a new standard
of care in high-risk locally advanced rectal cancer
• Median follow-up was 4·6 years .At 3 years after randomization, the cumulative
probability of disease-related treatment failure was 23·7% (95% CI 19·8–27·6) in the
experimental group versus 30·4% (26·1–34·6) in the standard of care group (HR 0·75,
p=0·019)
CHEMO
PROTOCOL
6 CYCLES OF
CAPOX
OR
9 CYCLES OF
FOLFOX
CHEMO
PROTOCOL
8 CYCLES OF
CAPOX
OR
12 CYCLES OF
FOLFOX

34. Summary

35. • Molecular analysis
• Nomograms
• More prospective studies
I wish

36. Observation or local excision for
patients thought to be complete
responders should be undertaken
with caution.

37. NOW cCR

38. Patient emotion

39. DOCTOR-What should I do?
• Organ preservation,
• Deferred surgery
• Conservative surgery
• Watch and wait
NO EVIDENCE

40. My algorithm
POST NACTRT
DRE,MRI,CEA,PROCOTSCOPY
cCR ODDS
ACTIVE
SURVILLENCE/CHEMO
ODDS
PR
MUCINOUS
CEA>5
TAKE ACTION
<PR
MORE CHEMO
SUSPICIOUS
LOCAL EXCISION IS AN OPTION

41. 1. The Bar Rectum was an actual bar built
inside a giant anatomical model
representing the human digestive system,
from tongue to anus.
2. Dutch design firm Atelier Van Lieshout
created it several years ago for the Vienna
Museum Quarter
3. Bar Rectum, Arsch Bar, Asshole Bar, Bar
Anus.
4. While the translations sound different, the
form is universally recognizable.
5. The bar takes its shape from the human
digestive system: starting with the tongue,
continuing to the stomach, moving through
the small and the large intestines and
exiting through the anus.
6. While Bar Rectum is anatomically correct,
the last part of the large intestine has been
inflated to a humongous size to hold as
many drinking customers at the bar as
possible.
RECTUM BAR