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26 Rectal Cancer: Neoadjuvant Therapy
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Rectal Cancer: Local Excision
JohnR.T.Monson andRebeccaHoedema
27
Key Concepts
• Local excision of biopsy-proven rectal cancer requires en
bloc full-thickness dissection.
• Predictors of lymph node metastases include tumor depth,
lymphovascular invasion, poor differentiation, and tumor
budding.
• Local recurrence rates for T2 rectal cancers treated with
neoadjuvant therapy and local excision appear similar to
those of T1 cancers treated with local excision alone.
• Transanal endoscopic surgery techniques including transanal endoscopic microsurgery (TEM) and transanal minimally invasive surgery (TAMIS) may improve surgical
outcomes as compared to standard transanal excision
techniques.
Introduction
Local excision for rectal tumors dates back to the early
1800s, with a report by Dr. Jacques Lisfranc describing
excision of a benign rectal mass in the lower rectum [1]. Sir
Alan Parks described a more modern version of transanal
excision in the 1960s [2]. Conventional transanal excision
techniques can be limited by the location of the tumor, anatomy of the rectum, and the tumor characteristics. This
Supplementary Information The online version of this chapter
(https://doi.org/10.1007/978- 3- 030- 66049- 9_27) contains supplementary material, which is available to authorized users.
J. R. T. Monson (*)
Digestive Health and Surgery Institute, AdventHealth, Center for
Colon and Rectal Surgery, Orlando, FL, USA
e-mail: John.Monson.MD@AdventHealth.com
R. Hoedema
Spectrum Health, Department of Colon and Rectal Surgery,
Grand Rapids, MI, USA
approach is ideal for lesions within 8 cm from the anal
verge, <3cm in size and occupying <40% of the rectal circumference [3]. Tumors located more proximally in the rectum can be more challenging. “Transanal endoscopic
microsurgery” (TEM) using an operating proctoscope with
continuous gas insufation was developed by Buess in the
early 1980s to overcome some of these anatomic constraints
[4]. Although there were certainly enthusiasts of the TEM
approach, high capital costs, limited mobility of the operating instruments, a formidable learning curve, and issues
with the insufation system limited enthusiasm. In 2010,
Atallah described the transanal use of a single- port laparoscopic platform with the use of insufation to perform
transanal minimally invasive surgery (TAMIS) which has
overcome some of the limiting factors associated with TEM
and allowed for the utilization of standard laparoscopic
instruments with which surgeons are familiar [5].
Patient Selection
The local excision technique was initially described for presumed benign tumors in the distal rectum, as an alternative to
proctectomy. Local excision allowed the patient to avoid
major abdominal surgery and could be curative, providing
that negative margins could be obtained and there was no
invasive cancer. Local excision for known rectal cancer was
rst described by Morson etal. in 1977 at St. Mark’s Hospital,
who reported a low rate of local recurrence after excision
with negative margins [6].
The typical treatment for locally advanced rectal cancer
includes neoadjuvant treatment followed by proctectomy
using the principles of total mesorectal excision (TME) [7].
Variations in treatment algorithms arise primarily from differences in the sequence and dosing of neoadjuvant/adjuvant therapy elements (radiotherapy and chemotherapy).
Decision-making for patients with clinically staged early
rectal cancers can be more complex, as the best chance for
© Springer Nature Switzerland AG 2022
S. R. Steele et al. (eds.), The ASCRS Textbook of Colon and Rectal Surgery, https://doi.org/10.1007/978-3-030-66049-9_27
479
480
J. R. T. Monson and R. Hoedema
cure (proctectomy, with or without neoadjuvant therapy) is
associated with the greatest morbidity [8], while organ
preservation strategies risk undertreatment and cancerrelated mortality. Reports of reasonable oncologic outcomes following local excision, and patient interest in
rectal preservation has driven the continued enthusiasm for
local excision [9].
Patient selection is critical when patients are being considered for local excision. Current staging modalities include
digital rectal examination to assess tumor character, xation,
and relation to the anorectal muscular ring. Anal sphincter
bulk and tone should also be assessed, as full-thickness local
excision can adversely impact rectal compliance and/or
remove a portion of the internal anal sphincter for very distal
tumors. In addition to baseline carcinoembryonic antigen
level (CEA), patients should be evaluated for distant metastatic spread with computed tomography (CT) of the chest,
abdomen, and pelvis. Local tumor staging can be assessed
with either rectal cancer protocol magnetic resonance imaging (MRI) or transrectal ultrasound (TRUS). MRI is an
important tool to help differentiate cT1/cT2 tumors from
cT3/cT4 tumors, which can signicantly alter initial treatment plans. MRI can also be helpful in assessing the relationship of the tumor to the mesorectal fascia. However, MRI
is less accurate for estimating lymph node status, although
certain ndings (heterogeneous signal intensity and irregular
margins) are usually indicative of lymph node involvement
with tumor [10]. Tang et al. demonstrated that other MRI
ndings, namely, the diameter of the largest lymph node and
the tumor percent enhancement on the arterial phase were
independent risk factors of lymph node positivity in early
rectal cancer patients (p=0.005 vs 0.021, respectively) [11].
Hopefully with improvements in radiographic assessment of
mesorectal lymph node status and the involvement of dedicated radiologists who review all rectal cancer MRIs and
participate in multidisciplinary tumor discussions, the
decision- making process for patients with clinically early
stage rectal cancer will be more rened.
It should be remembered that local staging provides only
estimates of tumor stage, and there is a substantial rate of
inaccuracy with any staging test, especially when estimating
mesorectal nodal involvement. Treatment decisions for
patients with rectal cancer occur in prospective fashion (preoperatively), when stage of the tumor cannot be known with
certainty. In addition, decisions regarding initial treatment
may adversely impact subsequent therapy. For example,
local excision of an anterior tumor may create substantial
scarring and adjacent organ adherence that may compromise
future attempts at proctectomy. Thus, it is critical that the
surgeon consider not only whether local excision is appropriate as the initial mode of treatment but how local excision
may impact subsequent care if the clinical stage was inac-
curate, negative margins were not obtained, or local pelvic
failure occurs.
In the following sections, we discuss outcomes for various stage tumors thought to be suitable for local excision.
This is somewhat disingenuous because, as noted above, histologic stage cannot be known with certainty until after operation. Unfortunately, much of the published literature on
local excision reports outcomes of select patients who meet
certain histologic criteria, rather than including all patients
undergoing local excision on an intention-to-treat basis. This
will obviously bias the results in favor of local excision. In
addition to the aforementioned problem of retrospective
patient selection for inclusion in studies of local excision
outcomes, there are other issues with the published literature
on local excision. Firstly, there has been a paucity of prospective randomized trials (RCTs) comparing local excision
with proctectomy. The vast majority of reports are retrospective analyses, in which selection bias is inherent to the study
design. Secondly, many published studies have heterogeneous study populations. Lastly, many trials do not report
time-to-event (Kaplan-Meier) calculations of survival and/or
recurrence, instead inappropriately using crude fractions,
which may artifactually improve outcomes. These problems
further limit our ability to rigorously compare treatment
outcomes.
T1N0
In general, local excision as a sole denitive treatment for
rectal cancer should be reserved for histologically favorable
T1 cancers, conned to the submucosa. However, T1 cancers
with unfavorable histologic features, i.e., presence of lymphovascular invasion, poor differentiation, and tumor budding, should be strongly considered for proctectomy given
the risk of lymph node metastasis. Adherence to these strict
criteria may produce equivalent survival for local excision
when compared to radical surgery. An analysis of retrospective data from the Surveillance, Epidemiology, and End
Results database reported that local excision of a T1 rectal
cancer produced similar cancer-specic survival when compared to radical surgery [12]. Two meta-analyses, comparing
local excision and radical surgery for T1 rectal cancer, demonstrated similar 5-year overall survival when comparing
outcomes of the TEM subgroup and proctectomy [13, 14].
However, it should be noted that these meta-analyses only
included one underpowered RCT; the remainder of the studies were retrospective cohort studies. In addition, one of the
meta-analyses found inferior oncologic results with local
excision overall [13].
If a patient undergoes local excision and nal pathology
unexpectedly reveals high-risk features, patients should be
27 Rectal Cancer: Local Excision
481
considered for completion proctectomy or adjuvant chemoradiotherapy. As noted above, patients should understand
prior to undergoing local excision that these are potential
scenarios once nal histology is reviewed. Another consideration that may drive shared decision-making preoperatively
is that patients undergoing local excision typically undergo
more frequent surveillance examinations [15]. This may be
of importance to patients with limited resources and/or difculty in traveling to the treating facility.
Predicting Lymph Node Metastasis
The ideal candidate for local excision is a patient who has a
primary tumor that can be excised completely with negative
margins and has no lymph node metastasis. In this ideal
patient, local excision can be curative. However, our ability
to predict lymph node metastasis is not ideal, and occult
lymph node metastases may be the primary driver of the
higher local recurrence rates observed following local excision as compared to radical surgery. Estimates of lymph
node status in rectal cancer patients thus dramatically affect
treatment recommendations.
Predicting lymph node metastasis for rectal cancer is a
multifactorial calculation. The use of the preoperative staging workup, imaging modalities, and histologic ndings can
help determine the risk and benet of local excision.
Unfavorable histologic features in the primary tumor can
predict lymph node metastasis and change the direction of
cancer care. Chang etal. found multiple unfavorable histologic features, primarily lymphovascular invasion (LVI), had
an additive risk for lymph node metastasis [16]. According to
the American Society of Colon and Rectal Surgeons practice
parameters for the management of rectal cancer last published in 2013, local excision is an appropriate treatment
modality for carefully selected T1 rectal cancers without
high-risk features [17].
rectal cancers in relation to lymph node metastasis and local
recurrence rates [17].
The T stage and SM level of the tumor are important predictors of lymph node metastasis which in turn, signicantly
affects the risk for local recurrence and the long-term survival in those patients with rectal cancer treated with local
excision. Analysis of the Swedish Rectal Cancer Registry
demonstrated that the risk of lymph node metastasis in T1
lesions is 6% in the absence of adverse histologic features
[22]. It has also been reported that histologically favorable
T1 lesions with a low risk of lymph node metastasis can be
potentially cured with local excision surgery alone.
Unfortunately, SM level can only be accurately assessed
after excision of the tumor, either by full- or partial- thickness
local excision or endoscopic submucosal dissection (ESD).
Although occasionally SM level can be assessed in a routine
polypectomy specimen, this is relatively uncommon, as there
is the need for a signicant portion of the submucosa within
the resected specimen in order to dene the deepest border of
the submucosa. Therefore, SM level calculation is typically
only useful after local excision to make decisions regarding
recommendations for completion proctectomy or adjuvant
chemoradiotherapy.
Lymphovascular Invasion andPoor
Dierentiation
Lymphovascular invasion is found to be the most consistent
histologic feature associated with metastatic disease. Chang
retrospectively reviewed 943 patients with pT1 or pT2 rectal
cancers at a single institution and found lymphovascular
invasion was the variable that was most strongly associated
with the risk of lymph node metastasis, with an odds ratio of
11.5 and risk of 68.8% (Table 27.1) [16]. Lymphovascular
invasion has recently been reported to be associated with
systemic recurrence in rectal cancer patients, which is less
Depth ofInvasion
T1 lesions are further classied according to the depth of
invasion of the tumor by dividing the submucosal layer into
thirds according to Kikuchi [18]. They noted an incremental
increase in risk of lymph node metastasis and/or local recurrences with a deeper depth of invasion. The risk of lymph
node metastasis is 3% for lesions invading the supercial 1/3
of the submucosa (SM1), but it rises up to 23% for deeply
invading lesions (SM3), and therefore local excision should
be reserved for supercial or middle lesions for the best curative and oncologic results [19–21]. Tumors with a depth
invading to the SM3 level were found to be similar to T2
Table 27.1 Lymph node metastasis in relation to risk factors in
patients with pT1–2 rectal cancer
Cancer LV 1 PD LNM, n LNM, %
pT1
pT2
Reused with permission from [16]. Copyright © 2012 Springer Nature
+ presence, absence, LV1 lymphovascular invasion, PD poor differentiation, LNM lymph node metastasis
− −
−
+
+ + 3/3 100
− −
−
+
+ + 6/6 100
+ 1/5 20
−
+ 5/16 31.3
−
18/241 7.5
9/15 60
87/569 15.3
59/88 67.0
482
J. R. T. Monson and R. Hoedema
Table 27.2 Analysis of independent association between LV1+ and
LR/SR in RC
Locoregional recurrence Systemic recurrence
Parameter p HR 95% CI p HR 95% CI
Age 0.37 1.02 0.98–1.07 0.49 0.99 0.95–1.03
Male 0.88 1.09 0.37–3.21 0.42 0.68 0.24–1.80
Stage III 0.05 2.57 1.01–6.93 0.05 1.66 0.69–4.32
Total LN 0.09 0.92 0.83–1.01 0.76 0.99 0.91–1.07
LV1 0.40 1.57 0.55–4.49 0.04 2.57 1.04–6.39
Reused with permission [25]. Copyright © 2015 Wolters Kluwer
Established prognostic factors and LV1 were incorporated into a Cox
proportional hazards multivariate model to evaluate the independent
association between LV1+ and LR/SR
LV1+ was an independent predictor of adverse LR in CC (p=0.02) but
not RC (p=0.40). LV1+ was an independent predictor of adverse SR in
RC (p=0.04) but not CC (p=0.88) and CRC (p=0.31)
CC colon cancer, CRC colorectal cancer, LR locoregional, LN lymph
node, LV1 lymphovascular invasion, LV1+ lymphovascular invasion
positive, LV1- lymphovascular invasion negative, RC rectal cancer, SR
systemic recurrence
amenable to curative surgical interventions and associated
with reduced overall survival [23, 24]. Hogan etal. found
that lymphovascular invasion in rectal cancer patients portended an increase in systemic recurrence and therefore an
adverse effect on survival (Table27.2) [25].
In addition, poor differentiation on histology is associated
with lymph node metastasis in rectal cancer [16, 21, 26, 27].
Bosch etal. performed a meta-analysis of 17 studies and further conrmed that poor differentiation, among other adverse
histologic ndings, is a strong predictor of lymph node
metastasis with a relative risk of 4.9 (95% condence interval 3.3–6.9) [28].
Tumor Budding
Tumor budding was initially described by Hase in 1993 and
dened as small clusters of undifferentiated cancer cells
ahead of the invasive front of the lesion [29]. A review of 663
patients who underwent curative resection of colorectal cancer found that tumors with substantial budding had more
aggressive behavior than tumors without budding. Initially
reported primarily in the Japanese literature as a predictor
and prognostic indicator of lymph node metastasis [30, 31],
more recent reports from Western centers have supported
this concept [28, 32]. It has now been adopted in the reporting system and is well-established as an independent adverse
prognostic factor in colorectal carcinoma that can then allow
for stratication of patients into risk categories more meaningful than just the TNM staging and potentially help guide
treatment decisions, especially in early rectal cancers.
Consensus statements and recommendations have been put
forth by the International Tumor Budding Consensus
Conference (ITBCC) that support tumor budding as an inde-
Table 27.3 Statements of the ITBCC 2016 based on the GRADE
System
Statement Recommendation Evidence
1 Tumor budding is dened as
a single tumor cell or a cell
cluster consisting of four
tumor cells or less
2 Tumor budding is an
independent predictor of
lymph node metastasis in
pT1 colorectal cancer
3 Tumor budding is an
independent predictor of
survival in stage II
colorectal cancer
4 Tumor budding should be
taken into account along
with other
clinicopathological features
in a multidisciplinary
setting
5 Tumor budding is counted
on H&E
6 Intramural budding exits in
colorectal cancer and has
been shown to be related to
lymph node metastasis
7 Tumor budding is assessed
in one hotspot (in a eld
measuring 0.785mm
the invasive front
8 For tumor budding
assessment in colorectal
cancer, the hotspot method
is recommended
9 A three-tier system should
be used along with the
budding count in order to
facilitate risk stratication
in colorectal cancer
10 Tumor budding should be
included in guidelines/
protocols for colorectal
cancer reporting
11 Tumor budding and tumor
grade are not the same
Reused with permission from [33]. Copyright © 2017 Springer Nature
2
) at
Strong vote: 22/22
(100%)
Strong vote: 23/23
(100%)
Strong vote: 23/23
(100%)
Strong vote: 23/23
(100%)
Strong vote: 19/22 Moderate
Strong vote: 22/22 Low
Strong vote: 22/22
(100%)
Strong vote: 22/22
(100%)
Strong vote: 23/23
(100%)
Strong vote: 23/23
(100%)
Strong vote: 23/23
(100%)
High
High
High
High
Moderate
Moderate
Moderate
High
High
pendent predictor of lymph node metastasis in T1 colorectal
cancer. The authors clarify that tumor budding and tumor
grade are not the same and that tumor budding should be
included in synoptic reporting, guidelines and protocols for
colorectal cancer reporting (Table27.3) [33].
T2
To date, local excision has been a plausible option in early
rectal cancers, namely, T1 tumors, but what about T2 lesions?
Proctectomy for patients with T2 rectal cancers is associated
27 Rectal Cancer: Local Excision
with high cure rates at the cost of high morbidity, risk of
permanent colostomy, and signicant impairment to anorectal, sexual, and urinary function with an associated effect on
quality of life [34–37]. However, the standard recommendation for T2 lesions remains radical resection due to the high
risk of lymph node metastases, unless patient comorbidities
are prohibitive or the patient refuses radical surgery and/or
the possibility of a colostomy. Locoregional recurrence rates
for T2 tumors after local excision alone are unacceptably
high, ranging from 13% to 30%, which may be partially due
to the 30–40% incidence of occult nodal involvement [9, 38,
39]. However, recent evidence suggests that local excision
with adjuvant chemoradiotherapy may be effective in treating occult nodal disease and minimize recurrence [40, 41].
Techniques
Transanal Excision
483
A thorough surgical history and physical examination including bowel function and continence are important prior to
scheduling. The examination includes a digital rectal examination along with ofce proctoscopy to determine the location and characteristics of the mass. Standard transanal
excision technique can be a viable option if the rectal cancer
is palpable with digital examination and specically if the
top of the mass can be palpated. Optimal visualization during surgery is imperative, so a mechanical bowel preparation
is recommended in most circumstances, but a simple enema
preparation may sufce in the appropriate patient. Typically,
preoperative intravenous antibiotics are given within 1hour
of the start of the surgery. General anesthesia is most commonly used for these cases, although spinal anesthesia and
MAC sedation can also be viable options in the appropriate
patient.
Patient positioning is based on the location of the tumor
and surgeon preference. Many surgeons would want the
tumor in the dependent position. For example, if the tumor is
anteriorly based, the patient would be in the prone position.
A myriad of anoscopes, retractors, proctoscopes, and other
self-retaining tools can be used for optimal exposure.
Electrocautery is then used to mark approximately 5–10mm
around the tumor. Stay sutures can be helpful in these circumstances and dissection continues with a combination of
both sharp dissection and electrocautery. For known or
strongly suspected cancer, a full-thickness dissection is typically performed. For benign appearing lesions, partialthickness resection is usually the best option, as it can be
curative if the tumor is benign, damage to the rectal wall is
avoided, and all future treatment options are preserved if
indeed an occult carcinoma is found. Partial-thickness resec-
Fig. 27.1 Transanal endoscopic microsurgery defect
tion can also be performed using endoscopic ESD techniques
(see Chap. 23). Closure of the defect should be completed in
a transverse fashion to avoid stricture formation. If closure is
not possible and the peritoneal cavity has not been entered,
then leaving the wound open to heal by secondary intention
can be considered (Fig.27.1).
Transanal Endoscopic Microsurgery
Preoperative preparation is similar as for standard local excision, with the exception that some surgeons prefer the patient
be positioned so that the tumor is “towards the sky,” so that
is naturally falls away from the rectal wall during dissection.
The operating proctoscope is gently inserted into the anal
canal and then attached to the table mount (Fig. 27.2).
Pneumorectum is established allowing the proctoscope to
visualize the target tumor. Three instrument ports are placed,
and electrocautery is used to demarcate 5–10mm around the
target tumor. The tumor is removed and the defect closed. If
intraperitoneal entry occurs or is suspected during a TEM
procedure, laparoscopic assistance may be necessary for closure of the defect and to perform pneumatic leak testing, as
one would perform following colorectal anastomosis.
Implementation of the TEM technique has broadened the
application of local excision for rectal cancers and has
allowed for removal of more proximal tumors compared to
the standard transanal technique. As noted above, there are
several limitations associated with the TEM technique,
namely, cost and a steep learning curve, and many surgeons
have migrated to the TAMIS technique for mid and proximal
rectal tumors.
484
J. R. T. Monson and R. Hoedema
Fig. 27.3 Insufation occurs and the tumor marking occurs in a similar way using cautery. https://doi.org/10.1007/000-33e
Fig. 27.2 Transanal endoscopic microsurgery device
Transanal Minimally Invasive Surgery (TAMIS)
TAMIS was rst introduced in 2009 as an alternative to
TEM, offering similar visibility and versatility but at a signicant cost advantage [5]. Dissection can be performed in
multiple quadrants, and there are fewer restrictions on patient
positioning. This technique uses a exible, disposable singleport minimally invasive platform placed transanally.
Laparoscopic insufation, camera, and tools are utilized.
Dissection occurs in a similar fashion to TEM.Insufation
occurs and the tumor marking occurs in a similar way using
cautery (Fig.27.3). Closure of the defect occurs with varying
techniques [42]. If the tumor is near the top of the anal
sphincter, a hybrid approach using TAMIS and transanal
approaches may be necessary. As noted above for TEM, if
intraperitoneal entry occurs or is suspected during a TAMIS
procedure, laparoscopic assistance may be necessary for closure of the defect and to perform pneumatic leak testing, as
one would perform following colorectal anastomosis.
Complications
Each of the described techniques for local excision of early
distal rectal cancers has limitations: incomplete resection,
conversion to an alternative approach, or the need for staged
procedures to name a few. These events are more likely to
occur if the tumor is too bulky or if the working environment/space is too tight, incomplete visualization of the entire
tumor due to a fold, uncontrolled bleeding occurs, or poor
bowel preparation.
Overall, the complication rate for local excision, regardless of the technical approach, is lower than for radical surgery [9, 43]. Common complications after local excision
include urinary retention/urinary tract infections, bleeding,
and other gastrointestinal complaints. Uncommon complications include wound infections, thromboembolic events, rectal strictures, or rectovaginal stulas [9]. The most common
complication with local excision is postsurgical urinary
retention. This can occur up to 5% of patients and secondary
to pressure on the urethra, anal stretch, edema, and pain [44].
This is usually self-limited and treated by either selfcatheterization or placement of an indwelling catheter.
Postoperative bleeding can also occur up to 5% and tends
to occur several days post-op and usually corresponds to a
suture line dehiscence if the wound was closed, sloughing of
any scab formation, or anticoagulation medication. Minor
bleeding can oftentimes be self-limited, but frank hemorrhage warrants resuscitation, endoscopic evaluation, and
treatment. After stabilization, it can usually be addressed
with monopolar cautery, sutures, and/or epinephrine injection. Major intraoperative bleeding, however, is a rare event.
Pelvic abscess can also occur. It is unclear whether
abscess is more frequent when an extraperitoneal defect is
left open versus closed, and this is the subject of much
debate. Tumors that cause a defect breaching the peritoneum
necessitate closure, but there is conicting evidence for those
lesions located in the extraperitoneal rectum that do not vio-
27 Rectal Cancer: Local Excision
485
late the peritoneal cavity. A single randomized trial showed
no difference in early or late complications and determined
that there is no difference in the approach to the open wound
[45]. However, there were only 44 patients randomized, and
the study may have been underpowered to detect a true difference. Other observational studies have equivocal outcomes. Some surgeons favor defect closure; others favor
leaving the defect open [46–48]. A recent multi-institutional
matched analysis at a high-volume center consisting of 991
eligible patients found no difference in 30-day postoperative
morbidity in those undergoing closure of the defect versus
leaving the defect open after local excision [49]. Thus, the
management of the rectal wall defect after local excision is at
the surgeon’s discretion.
Oncologic Results
Local excision is an acceptable oncologic treatment strategy
for patients with T1 rectal cancers, and local excision with
chemoradiation treatment has gained some interest and can
be an acceptable oncologic treatment for certain patients
with T2 distal rectal cancers.
T1 Cancer
Approximately 15% of rectal cancers present at stage I.Since
the rst report of local excision as an acceptable alternative
to radical resection, local excision without additional therapy
has been offered as a treatment alternative for early distal T1
tumors [6]. This oncologic approach can be a viable option
in appropriately selected patients with favorable clinical and
histological features. Local excision can also be viewed as a
palliative treatment for patients with more advanced disease
who are medically unt for radical surgery. The main drawback of local excision as curative therapy is the inability to
excise and accurately stage mesorectal lymph nodes. T1 rectal tumors have a 6–11% risk of nodal metastasis overall,
pending additional histologic information [38].
Criteria for local excision include well to moderately differentiated T1 cancer, the absence of lymphovascular or perineural invasion, and tumors less than 3 cm in diameter
occupying less than one-third of the circumference of the
bowel lumen [38]. In order to achieve a good oncologic outcome, optimal surgical technique is imperative. It has been
shown that a positive margin following local excision of a T1
rectal cancer is associated with a higher risk of recurrence
and concomitant lower 5-year overall survival [9, 50].
Hopefully, advancements and improvements in surgical
techniques will greatly improve the rates of en bloc resection
with negative margins in rectal cancer patients treated with
local excision. As noted previously, this has been a substantial problem in prior trials of local excision. Even using more
modern techniques, achieving negative margins can be challenging. Prospectively collected data from a 21-center collaborative in the United Kingdom regarding 424 patients
undergoing TEM +/− adjuvant/neoadjuvant radiotherapy
revealed that positive margins were found in 11%, 23%, and
42% of patients with pT1, pT2, and pT3 tumors.
Data from that same report revealed that local recurrence
rates following local excision by TEM in patients with T1
rectal cancer were 10%, 13%, and 19% at years 2, 3, and 5
[51]. Local recurrence was found to be associated with three
histopathologic factors: depth of invasion, tumor maximum
diameter, and lymphovascular invasion. For favorable
tumors (no lymphovascular invasion, SM1), local recurrence rates ranged from 3% to 8% depending on tumor size.
The rates of local recurrence were found to be 18–42% for
unfavorable tumors (lymphovascular invasion positivity,
SM2–3).
Junginger etal. published their long-term oncologic outcomes for T1 rectal cancers after local excision [52]. Median
follow-up was 8.6 years. Low-risk tumors compared with
high-risk tumors had 5- and 10-year local recurrence rates of
7% and 12% versus 32% and 35%, respectively. In addition,
the 5- and 10-year cancer-specic survival rates for low-risk
patients were 98% and 91% compared with high-risk patients
at 84.3% and 74.3% (p=0.05). These studies have shown
that to minimize the risk of local recurrence, it is advisable to
limit local excision to T1 rectal cancers with favorable histology as mentioned previously [17, 25, 28].
T2 Cancer
Traditionally, the substantial rates of metastatic nodal disease associated with T2 rectal cancers have swayed most surgeons from treating T2 rectal cancers with local excision
alone as this approach can lead to local recurrence rates of
10–66% [51]. High rates of local failure and compromise in
survival outcomes have been shown, with 5-year local recurrence rates of 47% in patients undergoing local excision
alone compared to 6% with proctectomy and overall survival
of 65% versus 81%, respectively [53]. Despite these sobering numbers, there has been increasing emphasis on organ
preservation techniques, and some surgeons have recommended expanding the indications for local excision to
include some T2 rectal cancers.
Data and evidence from the Surveillance, Epidemiology,
and End Results program reveal that more than 20% of
patients with T2 cancer are being treated by local excision,
although those treated with local excision alone had a suboptimal overall survival [54]. In an attempt to improve outcomes following local excision for T2 tumors, recent clinical
trials have evaluated local excision combined with neoadjuvant or adjuvant treatment with the hope of improving outcomes and expanding eligibility for organ-sparing surgery.
486
J. R. T. Monson and R. Hoedema
Local Excision andAdjuvant Therapy
The Cancer and Leukemia Group B 8984 trial (CALGB
8984) compared oncologic outcomes in patients with T1 rectal cancer treated with local excision alone and T2 rectal cancer treated with local excision followed by adjuvant
chemoradiotherapy [50]. They found that despite adjuvant
therapy, the T2 group experienced worse 10-year overall survival and disease-free survival and were at higher risk of
local recurrence (18% vs. 8%). A meta- analysis of oncologic outcomes for patients with T1 or T2 rectal cancers
undergoing local excision followed by either adjuvant
chemoradiotherapy or completion surgery included 14 studies [55]. It was found that, among patients originally undergoing local excision for T2 tumors, local recurrence occurred
in 15% (range: 11–21%) of patients treated with adjuvant
chemoradiation and 10% (range: 4–22%) of patients treated
with completion proctectomy.
A systematic review by Cutting etal. found local recurrence rates of 6% for T1, 14% for T2, and 34% for T3 rectal
cancers [56]. These studies suggest that adjuvant therapy
after local excision for T2 or greater rectal cancers is inferior
Neoadjuvant Therapy andLocal Excision
Traditionally, locally advanced rectal cancer was treated
with chemoradiotherapy followed by radical surgery with
the benet of tumor downsizing and improvement inlocal
recurrence rates in large randomized controlled trials [57,
58]. It has been shown that up to 30% of patients will experi-
ence a complete pathologic response after neoadjuvant
chemoradiation [59]. In the hope that occult tumor in mesorectal nodes could be sterilized with neoadjuvant chemoradiotherapy, some surgeons explored the concept of local
excision following neoadjuvant therapy in select patients.
The American College of Surgeons Oncology Group
Z6041 study was a phase II trial by Garcia-Aguilar etal. with
a single arm of 84 patients with T2 rectal cancer that were
treated with neoadjuvant chemoradiation and local excision
[60]. Downstaging occurred in 64% of patients. Lezoche
et al. compared local excision with laparoscopic proctectomy in a randomized controlled trial [61]. All patients had
an R0 resection, and local recurrence rates were similar for
the local excision and proctectomy groups, 8% versus 6%,
respectively. The cancer-related survival rate was 89% for
local excision and 94% for proctectomy (p=0.609).
Another randomized controlled trial, GRECCAR 2,
published in 2017 by Rullier et al. investigated patients
with cT2–3 rectal cancer treated with neoadjuvant chemoradiation and then randomized to either local excision or
radical surgery [62]. In a total of 145 patients, there were
no statistically signicant differences in oncologic out-
comes between the groups, and 3-year local recurrence
rates were similar for the local excision group and the proctectomy group (6% vs. 3%, p=0.63). Overall survival rates
were 89% and 95% respectively (p= 0.40). Only 8% of
patients treated by completion radical surgery had nodal
involvement, suggesting that radical surgery may have been
unnecessary for most of them.
The recently published CARTS study investigated oncologic and functional outcomes of patients with T1–3 rectal
cancers treated with neoadjuvant chemoradiation followed
by local excision [63]. Of those patients recruited, 35 patients
underwent local excision, and 16 patients underwent radical
resection. Results showed a 5-year local recurrence rate of
8%, with 5-year disease-free survival and overall survival
rates of 82% and 83%, respectively. These reports suggest
that local excision after completion of chemoradiation may
be an option in selected patients.
One of the major downsides of local excision following
neoadjuvant radiotherapy is the problem of wound healing,
as it is not uncommon for the rectal wall closure to break
down in the radiated eld. There is also the question as to
whether local excision is even necessary in complete clinical responders (see Chap. 28). Local excision would only be
helpful if there were viable tumor remaining in the rectal
wall, but not in the mesorectal nodes. If there is no remaining tumor in either location, or in both locations, then local
excision would not be anticipated to be of benet to the
patient.
Quality ofLife
One of the goals of organ preservation with local excision is
better functional outcomes with a better quality of life.
Although resection of the rectal wall can have functional
consequences, several studies have shown that those patients
with early rectal cancers who undergo local excision compared with those who undergo radical resection have a better
quality of life and better bowel function overall [64].
Pucciarelli etal. found that anorectal function 1 year after
local excision with neoadjuvant chemoradiation had minimal impact on function and overall quality of life [65, 66].
As reported in the CARTS study, health-related quality of
life was equal to that at baseline, with improved emotional
well-being for patients treated with local excision compared
to radical surgery [63].
Salvage Surgery
Population-based studies have shown that the treatment of
early distal rectal cancers by various local excision techniques has more than doubled over the last two decades [9,
54]. This is likely due to advancements inlocal excision sur-
27 Rectal Cancer: Local Excision
487
gical platforms, patient preference, and publication of outcome data. The increase in the use of local excision
techniques for early stage rectal cancer relies on the desire
for sphincter preservation and maintaining bowel continuity
if the risk of lymph node metastasis is low. Local recurrence
is the most common pattern of failure, ranging from 20% to
30% [43, 51, 67–70]. When patients develop a local recurrence, what surgical options are available and what are the
prognosis and long-term oncologic outcomes?
Bikhchandani etal. reported an R0 resection rate of 93%
on 27 patients who underwent multimodal salvage surgery
for local recurrence of rectal cancer after local excision [71].
The 5-year recurrence-free survival rate was 47%, and the
5-year overall survival rate was 50%. The majority of rerecurrences were distant metastases. The long-term survival
rates were disappointing and grim compared with published
rates of 92–97% disease-free survival at 5years after radical
surgery for early rectal cancer [9]. This was consistent with
other previously published studies that found that salvage
resection for recurrence after local excision is associated
with only modest success [72, 73].
You etal. performed extended resections for patients suffering local failure after local excision, with an R0 resection
rate of only 80% [72]. With a median follow-up of 33months,
3-year re-recurrence-free survival was 43%, and 5-year overall survival was 63%. Friel etal. reported outcomes following salvage surgery for recurrence after local excision and
found that the results were inferior to those of initial radical
treatment [74]. They stressed the importance of appropriate
patient selection for local excision and cautioned against
assuming that salvage surgery would be successful for
patients with local failure.
The practice of local excision seems to exchange the
increased risk of disease recurrence for the benet of
improved function and sphincter preservation. It is imperative to counsel patients regarding the oncologic risks of local
excision and explain that salvage therapy is not always associated with good outcome.
Conclusion
Local excision alone can be offered to patients with early T1
rectal cancers in the absence of adverse histopathologic features, such as poor differentiation, lymphovascular invasion,
tumor budding, or close margins. Patients with low-risk T2
tumor should be considered for local excision only in the
context of palliative intent or enrolment in a clinical trial.
Patients with T3 tumors should only undergo local excision
as palliation (usually for bleeding). Salvage surgery for local
recurrence in those treated initially by local excision is possible in some patients, but oncologic results appear to be
inferior to those that would be obtained by proctectomy at
initial diagnosis. All patients managed with organ preserva-
tion usually undergo intensive posttreatment multimodality
surveillance, as it is assumed (but not proven) that identifying local failure early will lead to improved outcomes (See
Chap. 30).
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