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M. L. Westfal and M. G. Mutch
and this has been studied in clinical trials but remains controversial [28, 40–42].
Taira etal. looked at the prognosis of patients with T1 rectal cancer stratied by
pre-operative chemo-radiation therapy. In 86 patients there was no signicant difference in relapse-free survival but they did nd that in a multivariate analysis,
tumor location within 5cm from the anal verge was a signicant risk factor associated with a poor relapse-free survival [43].
In terms of adjuvant therapy, Minsky etal. concluded that post-operative radiation therapy is not needed after local excision in patients with T1 tumors and negative prognostic features [44]. On the other hand, Taylor etal [45] and Lamont etal.
[46] reported that adjuvant radiation therapy improved both recurrence rate and
survival in their patient cohorts. Paty etal. [47] reported that local recurrence was
delayed in patient that received adjuvant pelvic radiation. Finally, Borstlap et al.
concluded that local recurrence rates in T1 rectal cancer between patients with local
excision with adjuvant therapy and those who underwent radical surgery were comparable [48].
When patients with high-risk T1 lesions refuse radical resection or prioritize
sphincter preservation, adjuvant chemoradiation in combination with local excision
has been considered. A systematic review of patients with T1/T2 rectal lesions
removed by local excision compared the patients who received adjuvant chemoradiation with those that underwent radical resection. The authors report a 10% recurrence rate after local excision with adjuvant therapy versus a 6% recurrence rate
after radical resection of T1 tumors [49]. Oostendorp et al. performed a metaanalysis of 73 studies and showed a local recurrence rate of 6.7% for low risk T1
tumors with local excision alone and no local recurrences in patients treated with
adjuvant pelvic radiation and concurrent chemotherapy. High risk T1 tumors had a
local recurrence rate of 13.6% compared to 3.9% with LE alone versus adjuvant
therapy, therefore the authors concluded that local excision with adjuvant chemoradiation therapy may provide an alternative approach to radical surgery for patients
with high-risk features. In a small study, Balyasnikova etal. found no recurrence at
a median follow-up of 4years in 18 patients with high-risk rectal cancer after undergoing local excision with adjuvant radiotherapy [50]. Al-Sawat etal. concluded that
local excision with adjuvant radiotherapy is a better treatment option to avoid complications and stoma formation compared with radical excision and is a safe alternative for patients with T1 rectal cancer with fewer than three high-risk features [51].
Finally, Swanton etal. found similar results and concluded that local excision followed by adjuvant pelvic radiation is feasible, safe and yields good locoregional
control in T1 rectal cancers, thereby avoiding denitive surgery and the morbidity
associated with LAR or APR. [52]
In summary, the NCCN guidelines8 recommend that for node negative T1 rectal
cancer, lesions can be treated with trans-abdominal resection or trans-anal resection
as appropriate. If pathology review after local excision reveals no high-risk features,
then no further treatment is required. However, if pathology shows poorly differentiated histology, positive margins, invasion into the deepest third of the submucosa
(sm3), LVI or PNI, then additional treatment is required. Trans-abdominal resection
is the preferred next step in management followed by adjuvant therapy based on
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pathologic stage. If patients instead undergo adjuvant chemoradiation therapy after
local excision, additional treatment will be determined by whether there is evidence
of residual disease. If there is no evidence of disease, observation or additional chemotherapy can be considered based the patient’s risk factors. If there is evidence of
disease, then trans-abdominal resection should be performed with or without adjuvant chemotherapy. It is imperative that the patient undergo careful surveillance if
they forego trans-abdominal resection.
249
Surveillance
Whether or not patients with T1N0M0 rectal cancer require further surveillance
remains controversial. ASCRS and NCCN guidelines both recommend surveillance
for stage 1 rectal cancer with a regular history and exam, CEA, exible sigmoidoscopy/proctoscopy and colonoscopy. There is no role for routine imaging for these
patients [1, 8]. On the other hand the Cancer Care Ontario (CCO) and the American
Society of Clinical Oncology (ASCO) do not recommend surveillance for stage I
patients for colon or rectal cancer [53]. The decision regarding surveillance for
patients with T1 rectal cancer should be made on an individual basis based on the
patient’s risk factors.
Outcomes
Local Recurrence
The risk of local recurrence for patients undergoing local excision remains unknown.
One retrospective study by Nash etal. showed that in 282 patients undergoing either
transanal local excision or radical resection for T1 rectal cancer, the respective local
recurrence rates were 13.2% and 2.7% respectively [23]. A similar retrospective
study by You etal. showed local recurrence rates of 12.5% for transanal excision
patients and 6.9% for radical resection patients [27]. Rates of local control following local excision have been shown to be favorable in T1 sm1–2 tumors [54], while
prognostic factors for increased local recurrence rates include high grade tumors,
LVI, PNI, tumor budding, sm3 tumors, mucinous type tumors, and positive resection margins [36, 37, 55]. Overall, several studies have found recurrence rates of
10–30% for patients undergoing local resection for T1 rectal cancer [45, 56–58].
In high-risk patients the risk of local recurrence is higher. One meta-analysis
looking at local recurrence in patients with high-risk T1 and T2 rectal cancer who
did not receive additional therapy showed a substantial risk of local recurrence.
Completion TME or adjuvant chemoradiation for T1 patient was found to mitigate
that risk. This provides support for using full thickness local excision as a guide to
denitive management. Another meta-analysis reported a substantial risk of local
recurrence in patients with high-risk T1 and T2 rectal cancer who received no additional therapy following local excision. The authors conclude that neo-adjuvant
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chemoradiation therapy followed by local excision may be safe and effective alternative for patients with any T stage of cancer who refuse or are unt for transabdominal resection but understand that further studies are needed to explore this
management suggestion [59].
Finally, Madbouly etal [60] showed that the 5-year recurrence rate after transanal excision was 29.4%. 5-year cancer specic and overall survival were 89% and
75% respectively. Nearly all patients with a recurrence underwent salvage treatment
with a 56.3% ve-year survival rate. They concluded that although overall cancer
survival rates might be regarded as satisfactory, the high recurrence and low salvage
rate raises the issue about the role of transanal excision alone for early rectal cancer
and the potential need to consider adjuvant therapy for these patients.
M. L. Westfal and M. G. Mutch
Metastasis
Lymph node (LN) metastasis occurs in 2–35% of T1 lesions. When looking at the
depth of tumor involvement into the submucosa and LN metastasis in T1 rectal
cancer, the rates of LN metastasis for sm1, sm2 and sm3 tumors was 2%, 9%, and
35% respectively [25]. Additionally, Kitajima etal. established the method for measuring submucosal invasion depth (SID) and found that lesions with SID less than
1000 micrometers had no evidence of lymph node metastasis. The clinical guidelines of the Japanese Society for Cancer of the Colon and Rectum describe the
method of measuring an SID and advise additional surgical resection with lymph
node dissection after endoscopic treatment for lesions with SID greater than 1000
micrometers. This “1000 micrometer rule” is recommended as a criterion for additional resection in many previous papers [34, 61, 62] and is used as a gold-standard
indicator for endoscopic diagnoses, such as magnifying endoscopy or imageenhanced endoscopy [63]. As endoscopic techniques progress, endoscopic treatment is becoming more widely acceptable for lesions with SID greater than or equal
to 1000 micrometers [61, 64, 65].
Disease Free andOverall Survival
Although limited, some data suggests that TEM may have similar oncologic outcomes
in patients with T1N0M0 rectal cancer compared with radical resection, while additionally offering patients the benets of local resection [66, 67]. Additionally, Lu etal.
showed that although the local recurrence rate after TEM was higher than that after
TME, distant metastasis, overall survival and disease-free survival rates did not differ
between these groups [68]. Clancy etal. performed a meta-analysis in 2015 and found
that TEM provides superior oncologic outcomes compared to transanal local excision
as it had a higher rate of negative microscopic margins, reduced rate of specimen
fragmentation, and reduced rate of lesion recurrence [69]. Endreseth etal. completed
a prospective study from the Norwegian Rectal Cancer Project looking at 291 patients
with T1 rectal cancer treated with radical resection or trans-anal excision. They found
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that the 5-year survival for trans-anal excision was 70% compared to 80% in the radical resection group [55]. Hyun etal. performed a retrospective review from multicenter data and used propensity score matching to form two groups of patients who
underwent local excision and compared them to patients who underwent TME for T1
rectal cancer. They found that although patients who underwent local excision had
higher local recurrence rates, there was no difference in disease-free survival or overall survival [70]. Several other studies found that there was not a signicant difference
in overall survival rate between patients undergoing local excision versus TME with
T1 rectal cancer [27, 57, 71].
251
Quality ofLife
Local excision is associated with improved quality of life secondary to overall decreased
morbidity in terms of bowel function, sexual function, and micturition function. In the
NSABP R-04 trial, patients who had an APR reported worse body image, worse micturition symptoms, and less sexual enjoyment at 1year post- surgery compared to those
who had sphincter-sparing surgery [8]. An extra-levator APR may have benets over a
conventional APR approach, including lower rates of intra-operative perforation, CRM
involvement and local recurrence although the data remains varied [72, 73]. Further
studies comparing the quality of life of patients after radical resection and local excision are needed to further delineate these outcomes in more detail.
Conclusion
In patients found to have T1 rectal cancer, a careful review of the pathology as well
was local and distant staging is necessary in order to determine if a local excision or
a radical resection is appropriate. All resected specimens should undergo pathologic
review to assess for high-risk features because presence of these features are associated with an increased likelihood of mesorectal lymph node involvement and therefore a radical resection with TME would be warranted in this setting. If the patient
has signicant co-morbidities and is not a candidate for radical resection, then a
local excision should be considered. Although this is the safer approach from an
operative standpoint in terms of morbidity, mortality and sphincter function, there is
a possible increased risk of local and distant failure. For patients that opt for a local
excision, close surveillance is necessary in order to identify local recurrence quickly
should it occur. The use of either neo-adjuvant and/or adjuvant chemoradiation
therapy remains controversial but may provide better outcomes for patients opting
to undergo local excision. A multi-disciplinary clinical team should be utilized in
order to review each case on an individual basis and provide the patient with all possible options for the management of T1 rectal cancer. Overall, it is important to
match the treatment plan approach to the individual patient and all risk factors must
be explained to the patient in order to allow them to make an informed decision that
considers short and long-term risks and benets.
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M. L. Westfal and M. G. Mutch
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Can Total Mesorectal Excision
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BeAvoided inT2 Rectal Cancer?
AnthonyLoria andFergalJ.Fleming
Introduction
In 2020, there were approximately 43,000 incident cases of rectal cancer in the
United States and over 700,000 incident cases worldwide [1, 2]. Patients with clinical stage one rectal cancer (T1–2N0) represent approximately 25–30% of incident
cases at the population level [3]. For patients with T2N0 disease, total mesorectal
excision (TME) is the standard of care due to durable oncologic outcomes [4].
However TME can be associated with considerable morbidity. Balancing the risk of
undertreatment with minimizing surgical morbidity has prompted a growing interest in using local excision among patients with T2N0 rectal cancer. Moreover,
recent data on neoadjuvant chemoradiation followed by local excision is challenging the paradigm that TME is associated with superior oncologic outcomes in
patients with T2N0 disease. This chapter aims to articulate the rationale for seeking
alternatives to TME, weigh the contemporary evidence, and provide expert opinion
on the rapidly advancing management of early (T1-T2, node-negative) rectal cancer.
22
Search Strategy
For this narrative review, a comprehensive literature search of PubMed identied
studies comparing local excision with TME published between 2002 and 2023
(Table22.1). Local excision in the context of early rectal (T1–2N0) cancer refers to
transanal endoscopic microsurgery (TEMS) or transanal minimally invasive surgery
A. Loria · F. J. Fleming (*)
Division of Colorectal Surgery, Department of Surgery, University of Rochester Medical
Center, Rochester, NY, USA
e-mail: anthony_loria@urmc.rochester.edu; fergal_eming@urmc.rochester.edu
© The Author(s), under exclusive license to Springer Nature
Switzerland AG 2023
K. Umanskiy, N. Hyman (eds.), Difcult Decisions in Colorectal Surgery,
Difcult Decisions in Surgery: An Evidence-Based Approach,
https://doi.org/10.1007/978-3-031-42303-1_22
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Table 22.1 PICO
P (patients)
T2N0 rectal cancer TME Local excision
I (intervention) C (comparison)
(TEMS, TAMIS)
A. Loria and F. J. Fleming
O (outcomes)
Morbidity (short-term)
Survival (overall, disease free)
Patient reported
(TAMIS). The search included “rectal neoplasms,” “natural orice endoscopic surgery,” “microsurgery,” “minimally invasive surgical procedures,” or “watchful waiting” [5]. Representative title or abstract limited terms included “early rectal cancer,”
“T1 rectal cancer,” “T2 rectal cancer,” “TEM,” “local excision,” “TAMIS,” “EMR,”
among others. Non-English and non-comparative studies were excluded. The references were reviewed to identify additional studies not captured in the primary search.
Results
Difculties in accurately staging early rectal cancer must be acknowledged. Tumor
invasion (T) and nodal involvement (N) are assessed by either endorectal ultrasound
(EUS) or magnetic resonance imaging (MRI) [4]. Unfortunately, for T2 lesions,
MRI over stages 42% and EUS over stages 18% [6–8]. Similarly, accurately detecting nodal involvement is a diagnostic challenge. A meta-analysis found that the
sensitivity and specicity for accurately detecting nodal involvement of EUS were
67% and 78%, and for MRI, they were 66% and 76% [6]. Consequently, European
guidelines focus heavily on the area where MRI excels, tumor involvement of the
circumferential resection margin [9].
TME Works: Why Replace it?
Benchmarking the short-term morbidity, functional, and oncologic outcomes associated with TME and local excision is essential. Expectedly, the short-term morbidity prole favors local excision. In a large retrospective study of 2124 patients with
Stage I (T1–2N0) disease, 5.6% of patients who underwent local excision experienced a 30-day complication compared to 14.6% following TME (p<0.001) [10].
Neoadjuvant therapy was less common in the era of those retrospective data, however, multi-institutional, randomized controlled trials suggest the postoperative
morbidity following TME alone is higher than patients who receive neoadjuvant
chemoradiation and local excision (50.6% vs. 20.7%, p<0.001) [11]. Similarly, in
a trial comparing neoadjuvant short-course radiation (SCRT) followed by local
excision to TME alone, the rates of serious adverse events among the TME group
were signicantly higher than those who had SCRT followed by local excision
(39% vs. 15%) [12]. Contemporary 30-day mortality rates following TME are low
(approximately 1–1.5%), but it is notable that at 3-months post-TME, the mortality
rate in four European nations ranged from 5.6–8.3% among patients 80years or
older with stage I rectal cancer [13, 14].
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