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M. D. Mirande and S. R. Kelley
Recommendations Based ontheData
The administration of induction or consolidation CT as part of a TNT regimen
should be considered for all patients with cT3–4 and/or N+ rectal cancer (high quality evidence, strong recommendation).
An oxaliplatin-based CT regimen (FOLFOX, CAPOX, FOLFIRINOX, etc.)
rather than a uoropyrimidine alone is recommended (high quality evidence, strong
recommendation).
To achieve a higher pCR, consolidation rather than induction CT should be considered for treatment of cT3–4 and/or N+ rectal cancer (moderate evidence, moderate recommendation).
Currently there is insufcient evidence to recommend FOLFIRINOX or
FOLFOXIRI over CAPOX or FOLFOX (high quality evidence, strong
recommendation).
Currently, there is insufcient evidence to recommend the addition to bevacizumab to a TNT regimen (high quality evidence, strong recommendation).
A TNT approach increases tolerance and completion rates of CT (high quality
evidence, strong recommendation).
Neoadjuvant radiotherapy (RT) (short or long course) should be offered as part
of a TNT strategy for treatment of cT3–4 and/or N+ rectal cancer (high quality evidence, strong recommendation).
Short and long course RT protocols achieve similar rates of local control, sphincter preservation, DFS, and OS (high quality evidence, strong recommendation).
TNT is associated with higher rates of complete clinical response (cCR) and
pCR (high quality evidence, strong recommendation).
Completion of TNT is associated with higher rates of DFS and lower rates of
DM (high quality evidence, strong recommendation).
Treatment with TNT has not been shown to decrease rates of LR or increase rates
of OS (high quality evidence, strong recommendation).
A Personal View oftheData
At Mayo Clinic, all rectal cancers are reviewed at a multidisciplinary rectal cancer
conference (radiology, pathology, medical oncology, radiation oncology, colon and
rectal surgery). We consider induction or consolidation oxaliplatin-based doublet
CT (CAPOX or FOLFOX) combined with short or long course uoropyrimidinebased (capecitabine or 5-FU) CRT for all patients with MRI cT3–4 and/or N+ rectal
cancers. For lower-risk cancers (i.e., cT3N0 without high-risk features), we typically do not consider TNT since many of those patients will not need AC.For cT4,
we consider triplet CT with FOLFIRINOX.
We typically start with 16weeks of induction CT to treat micrometastatic disease
and test tumor biology. Repeat imaging is performed around 8weeks to determine
response. If response is appropriate, induction CT is completed and followed by
short or long course uoropyrimidine-based CRT. For select patients without
24 Which Patients Are theRight Candidates forTotal Neoadjuvant Therapy (TNT)?
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291
high- risk features (involved or threatened CRM, extramural venous invasion, N+
disease, extramesorectal adenopathy), SCRT followed by immediate surgery is typically pursued. For patients with high-risk features, uoropyrimidine-based LCCRT
is recommended. If the tumor is bulky or there is concern for organ preservation, we
typically start with uoropyrimidine-based LCCRT to shrink the size of the tumor
and follow with consolidation CT.
No single protocol for TNT exists, which can make treatment selection challenging, and there is a risk of overtreatment. All patients should undergo immunohistochemical and microsatellite instability (MSI) testing since a substantial proportion
who do not appropriately express mismatch repair proteins / are MSI-high will not
respond to CT, and other treatment modalities should be considered. These patients
should be reviewed at multidisciplinary tumor conferences and referred to centers
capable of managing them.
Abstracted Recommendations
The administration of induction or consolidation CT as part of a TNT regimen
should be considered for all patients with cT3–4 and/or N+ rectal cancer (high quality evidence, strong recommendation).
An oxaliplatin-based CT regimen (FOLFOX, CAPOX, FOLFIRINOX, etc.)
rather than a uoropyrimidine alone is recommended (high quality evidence, strong
recommendation).
Neoadjuvant RT (short or long course) should be offered as part of a TNT strategy for treatment of cT3–4 and/or N+ rectal cancer (high quality evidence, strong
recommendation).
Treatment with TNT has been shown to be associated with greater tolerance and
completion of CT, more frequent cCR and pCR, less severe toxicity, higher rates of
DM-free survival, longer DFS, and better QOL (high quality evidence, strong
recommendation).
References
1. Heald RJ, Ryall RD.Recurrence and survival after total mesorectal excision for rectal cancer.
Lancet. 1986;1(8496):1479–82.
2. Cedermark B, etal. Improved survival with preoperative radiotherapy in resectable rectal cancer. N Engl J Med. 1997;336(14):980–7.
3. Folkesson J, etal. Swedish rectal cancer trial: long lasting benets from radiotherapy on survival and local recurrence rate. J Clin Oncol. 2005;23(24):5644–50.
4. Kapiteijn E, et al. Preoperative radiotherapy combined with total mesorectal excision for
resectable rectal cancer. N Engl J Med. 2001;345(9):638–46.
5. van Gijn W, et al. Preoperative radiotherapy combined with total mesorectal excision for
resectable rectal cancer: 12-year follow-up of the multicentre, randomised controlled TME
trial. Lancet Oncol. 2011;12(6):575–82.
6. Bosset JF, etal. Chemotherapy with preoperative radiotherapy in rectal cancer. N Engl J Med.
2006;355(11):1114–23.
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7. Gérard JP, etal. Preoperative radiotherapy with or without concurrent uorouracil and leucovorin in T3-4 rectal cancers: results of FFCD 9203. J Clin Oncol. 2006;24(28):4620–5.
8. Sauer R, etal. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl
J Med. 2004;351(17):1731–40.
9. Sauer R, etal. Preoperative versus postoperative chemoradiotherapy for locally advanced rectal cancer: results of the German CAO/ARO/AIO-94 randomized phase III trial after a median
follow-up of 11 years. J Clin Oncol. 2012;30(16):1926–33.
10. André T, et al. Improved overall survival with oxaliplatin, uorouracil, and leucovorin
as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. J Clin Oncol.
2009;27(19):3109–16.
11. Breugom AJ, etal. Adjuvant chemotherapy after preoperative (chemo)radiotherapy and surgery for patients with rectal cancer: a systematic review and meta-analysis of individual patient
data. Lancet Oncol. 2015;16(2):200–7.
12. Zhao L, etal. Oxaliplatin/uorouracil-based adjuvant chemotherapy for locally advanced rectal cancer after neoadjuvant chemoradiotherapy and surgery: a systematic review and metaanalysis of randomized controlled trials. Color Dis. 2016;18(8):763–72.
13. Fernandez-Martos C, etal. Chemoradiation, surgery and adjuvant chemotherapy versus induction chemotherapy followed by chemoradiation and surgery: long-term results of the Spanish
GCR-3 phase II randomized trial†. Ann Oncol. 2015;26(8):1722–8.
14. Bujko K, etal. Long-course oxaliplatin-based preoperative chemoradiation versus 5 × 5Gy
and consolidation chemotherapy for cT4 or xed cT3 rectal cancer: results of a randomized
phase III study. Ann Oncol. 2016;27(5):834–42.
15. Ciseł B, etal. Long-course preoperative chemoradiation versus 5 × 5Gy and consolidation
chemotherapy for clinical T4 and xed clinical T3 rectal cancer: long-term results of the randomized polish II study. Ann Oncol. 2019;30(8):1298–303.
16. Moore J, etal. Prospective randomized trial of neoadjuvant chemotherapy during the ‘wait
period’ following preoperative chemoradiotherapy for rectal cancer: results of the WAIT trial.
Color Dis. 2017;19(11):973–9.
17. Kim SY, et al. A randomized phase 2 trial of consolidation chemotherapy after preoperative
Chemoradiation therapy versus Chemoradiation therapy alone for locally advanced rectal cancer: KCSG CO 14-03. Int J Radiat Oncol Biol Phys. 2018;101(4):889–99.
18. Deng Y, etal. Neoadjuvant modied FOLFOX6 with or without radiation versus uorouracil
plus radiation for locally advanced rectal cancer: nal results of the Chinese FOWARC trial. J
Clin Oncol. 2019;37(34):3223–33.
19. Schrag D, etal. Challenges and solutions in the design and execution of the PROSPECT phase II/
III neoadjuvant rectal cancer trial (NCCTG N1048/Alliance). Clin Trials. 2019;16(2):165–75.
20. Bahadoer RR, etal. Short-course radiotherapy followed by chemotherapy before total mesorectal excision (TME) versus preoperative chemoradiotherapy, TME, and optional adjuvant
chemotherapy inlocally advanced rectal cancer (RAPIDO): a randomised, open-label, phase 3
trial. Lancet Oncol. 2021;22(1):29–42.
21. Conroy T, etal. Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23): a
multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2021;22(5):702–15.
22. Fokas E, et al. Chemoradiotherapy plus induction or consolidation chemotherapy as Total
neoadjuvant therapy for patients with locally advanced rectal cancer: long-term results of the
CAO/ARO/AIO-12 randomized clinical trial. JAMA Oncol. 2022;8(1):e215445.
23. Garcia-Aguilar J, etal. Organ preservation in patients with rectal adenocarcinoma treated with
Total neoadjuvant therapy. J Clin Oncol. 2022;40(23):2546–56.
M. D. Mirande and S. R. Kelley
Management ofthePatient withRectal
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Cancer Presenting withSynchronous
25
Liver Metastases
CimarronE.Sharon andJoshuaI.S.Bleier
Introduction
With the incidence of colorectal (CRC) cancer rising [1, 2], notably among younger
patients [3, 4], up to 25% are presenting with synchronous metastatic disease [5],
most commonly in the liver [6]. Patients with synchronous metastatic disease and a
rectal primary present a therapeutic dilemma, as no conventional approach exists,
and treatment is often individualized.
Question: What is the best way to manage the patient with asymptomatic rec-
tal cancer and synchronous liver metastases?
For patients with asymptomatic rectal cancer and synchronous liver metastases
(SCRLM), treatment is typically multimodal, including a combination of chemotherapy, radiation, and surgical resection. With regards to the surgical strategy
specically, patients can undergo either a staged (i.e., proctectomy rst or hepatectomy rst) or combined approach, dependent on their tumor biology, response
to chemotherapy/radiation, and the burden of metastatic disease. The goal of this
chapter is to provide evidence-based recommendations to assist providers in caring for these complex patients.
C. E. Sharon
Department of Surgery, University of Pennsylvania, Perelman School of Medicine,
Philadelphia, PA, USA
e-mail: Cimarron.sharon@pennmedicine.UPenn.edu
J. I. S. Bleier (*)
Division of Colorectal Surgery, Department of Surgery, University of Pennsylvania, Perelman
School of Medicine, Philadelphia, PA, USA
e-mail: Joshua.bleier@pennmedicine.upenn.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_25
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Table 25.1 PICO table for rectal cancer and synchronous liver metastases
Patient Population
Patients with asymptomatic rectal
cancer and synchronous liver
metastases
Intervention Comparator
Staged liver rst
resection
Combined rectal
and liver resection
C. E. Sharon and J. I. S. Bleier
Outcomes
Morbidity
Overall
survival
Disease-free
survival
Search Strategy
A systematic review of the literature using PubMed was performed using search
terms in various combinations of rectal cancer, liver metastases, hepatic metastases,
synchronous resection, combined resection, staged resection, liver-rst, imaging,
diagnosis, chemotherapy, radiation, guidelines, and management. Articles were
limited to peer reviewed reports in English published between 2010 and 2022, in
order to provide an update to the chapter on this topic published in the 2017 edition
of this textbook. Additional studies were identied from the references of the initial
articles and were included as appropriate. Table 25.1 summarizes the population,
intervention, comparator, and key outcomes (PICO) for the patient population.
Results
Initial Evaluation
Imaging
As discussed in previous chapters, imaging of the primary rectal tumor is best
accomplished with pelvic magnetic resonance imaging (MRI) [7], which can assess
tumor depth, presence of locoregional nodal disease, and the circumferential resection margin (CRM), all critical factors in preoperative planning [8, 9]. If MRI is
contraindicated, then locoregional staging can be performed with an endorectal
ultrasound (EUS) [7].
Assessment of distant metastatic disease should include a contrast-enhanced
computed tomography (CT) scan of the chest, abdomen, and pelvis [7, 10]. In the
assessment of liver metastases, specically, a multiphasic CT scan (non-contrast
followed by arterial, venous, and delayed phase intravenous contrast) is the diagnostic modality of choice [7, 11, 12]. For sub-centimeter liver lesions, and for evalu-
ation after neoadjuvant chemotherapy, magnetic resonance imaging (MRI) is
superior to CT [12, 13]. The role of positron emission tomography (PET)-CT in the
evaluation of colorectal cancer metastases is to assess for extra-hepatic sites of disease, which if present, would preclude curative surgical resection [12, 14, 15].
Goals
Imaging evaluation of the rectal primary and the hepatic metastases assists in determining the resectability of the lesions. With regards to the hepatic lesions, knowledge of the number and size of the metastases, in addition to their lobar distribution
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and relationship to the vasculature, is imperative [7]. For hepatic metastases to be
resectable, the liver remnant must encompass approximately 25% of the total liver
volume, for patients without inherent liver disease [16]. Ascertaining resectability
also drives the goals of treatment, whether curative or palliative in nature.
295
Multidisciplinary Team
Patient evaluation by a multidisciplinary team (MDT) assists in identifying treatment goals, in addition to course and strategy. Prior to initiation of therapy, whether
in the form of systemic therapy or surgical resection, patients with SCRLM should
be evaluated by an MDT [17]. This MDT typically consists of radiation and medical
oncologists, pathologists, palliative care clinicians, and colorectal and hepatobiliary
surgeons, who can jointly determine a patient’s optimal rst-line treatment [7, 12,
18, 19]. Patients with SCRLM who are evaluated by an MDT including a hepatobi-
liary surgeon have a higher resection rate and improved overall survival (OS)
[18, 20].
Treatment
Neoadjuvant Treatment
While perioperative chemotherapy has notable advantages to resection alone [21],
there is no consensus on timing, and the routine use of neoadjuvant chemotherapy
(NCT) for patients with SCRLM is controversial. The advantage to NCT in these
patients lies in the ability to downstage hepatic lesions to facilitate curative-intent
surgical resection. However, the risks of NCT include chemotherapy-induced toxicities, most notably liver injury, which would complicate hepatic resection and
increase the size of the required functional liver remnant (FLR) [22]. Further complications of NCT include disease progression during treatment which would prevent surgical resection, and disappearing liver lesions, wherein the macroscopic
disease has regressed but the possibility of microscopic disease remains [22]. As
such, the main advantage of NCT is for patients with unresectable hepatic disease
to allow for tumor downstaging and conversion to resectability. For patients with
unresectable or borderline resectable hepatic metastases, upfront resection of an
asymptomatic rectal primary is not recommended due to the risk of perioperative
morbidity which would delay necessary systemic therapy [7, 12, 23].
The NCT administered typically consists of a combination of systemic therapy
and targeted biologic treatments, as recommended by the MDT. Current National
Comprehensive Cancer Network (NCCN) guidelines [23] list FOLFIRI
(5- uorouracil, leucovorin, and irinotecan), FOLFOX (5-uorouracil, leucovorin,
and oxaliplatin), CAPEOX (capecitabine and oxaliplatin), or FOLFIRINOX
(5- uorouracil, leucovorin, irinotecan, and oxaliplatin) with or without bevacizumab (VEGF inhibitor) as treatment options for rectal cancer patients with initially
unresectable liver metastases. Regardless of the type of NCT administered, patients
should be re-evaluated every 2months to assess tumor response/resectability and
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avoid any liver toxicity or disease progression which would render the metastases
unresectable [24].
There is no clear consensus on the utility of pelvic radiation for patients with
metastatic rectal cancer, despite its widespread use for locally advanced rectal cancer. Past studies have shown that for patients with metastatic rectal cancer the use of
radiotherapy is associated with improved overall and disease-specic survival [25,
26]. According to NCCN guidelines, short course pelvic radiation should be consid-
ered in the setting of resectable liver metastases or after downstaging of initially
unresectable lesions [23]. The main utility in radiotherapy lies in increased local
control. However, most patients with SCRLM who develop recurrent disease do so
distantly, indicating that radiation may be safely omitted in select patients [27]. For
patients with lesions in the upper rectum or with a wide circumferential margin on
imaging, either short course radiation can be utilized, or radiotherapy may be omitted [7, 28]. The choice to administer or omit radiotherapy is highly individualized
and should be made in consultation with an MDT.
C. E. Sharon and J. I. S. Bleier
Surgery Summary
For the patient with asymptomatic rectal cancer and resectable synchronous liver
metastases, three surgical options exist: the “classic” (rectal primary is resected
rst), the “reverse” (liver metastases are resected rst), and the “synchronous”
approach (rectal primary and liver metastases resected simultaneously) [7, 29, 30].
The goal of surgical resection is complete removal of disease while minimizing
morbidity so as to not cause a delay in the initiation or resumption of systemic
therapy [31]. As such, both patient comorbidities and the complication prole of the
required procedure are taken into consideration when planning the optimal surgical
approach. As with most treatment for patients with SCRLM, surgical planning is
highly individualized and should include discussion with an MDT that includes a
hepatobiliary surgeon. This chapter will address the three main surgical approaches
and highlight patients who are the optimal candidates for each.
Notably, studies investigating the outcomes of the aforementioned surgical
approaches include patients with synchronous liver metastases from both colon and
rectal cancers, and the majority combine these patients when reporting outcomes.
Additionally, the majority of reported data is retrospective in nature. Table25.2
summarizes the results of notable publications, while also highlighting whether
patients with rectal cancer were analyzed separately with regards to post-operative
morbidity and long-term survival.
Rectum First
The “classic” approach where the rectal primary is resected rst is rarely utilized for
patients with asymptomatic rectal tumors, and its application has decreased overall
in favor of the “reverse” or “synchronous” approach [30]. The rectum rst strategy
is more commonly used for patients with larger symptomatic primaries who also
have a high burden of metastatic disease [7, 24]. When compared to the reverse
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297
(continued)
Quality of
Evidence
Rectal cancer
analyzed
separately
(Y/N)
Morbidity (%)
p value OS (p value) DFS (p value)
N Low
35% overall
cohort
Between groups:
PF [ref.]
SR [HR 1.40,
95% CI
SR vs. ST
p=0.66
p=0.45
0.55–3.55,
p=0.78]
LF [HR 0.87,
95% CI
N Moderate
2-year DFS
2-year OS
0.32–2.34,
p=0.78]
SR (18%)
SR (36%)
PF (17%)
P=0.05
SR (87%)
PF (70%)
P=0.05
PF (22%)
p=0.70
Low
N– OS
– Y– Morbidity
5-year OS
PF [ref.]
LF [HR 1.06
(95% CI
0.63–1.78,
SR (53%)
LF (33%)
PF (8%)
p=0.033
p=0.83]
SR [HR 1.10,
95% CI
0.65–1.84,
p=0.72]
SR [16]LF [18]
PF (75)
Interventions
Table 25.2 Literature search results for studies comparing staged vs. combined liver resection for patients with rectal cancer and synchronous liver metastases
Study
(N)
Patients (N)
Author (year)
No surgery [16]
CRC w/
SCRLM (125)
Chan (2022)
[32]
SR [39]
PF (46)
CRC w/
SCRLM (85)
Boudjema
(2021) [33]
SR (60)
LF (89)
PF (51)
CRC w/
SCRLM (238)
Båverud Olsson
(2021) [34]
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Quality of
Evidence
C. E. Sharon and J. I. S. Bleier
Rectal cancer
analyzed
separately
(Y/N)
Morbidity (%)
p value OS (p value) DFS (p value)
Interventions
(N)
N Low
5-year DFS
SR (38%)
PF (35%)
LF (38%)
5-year OS
LF [ref] (51%)
PF [HR 1.21,
95% CI
a
SR (40%)
PF (30%)
LF (31%)
p=0.016
SR (2393)
PF (4415)
LF (522)
p=0.043
0.96–1.52,
p=0.10] (47%)
SR [HR 1.30
(95% CI
– N Low
5-year OS
1.02–1.66,
SR (37.2%)
p=0.04] (45%)
SR (28%)
ST (23%)
SR (442)
PF (619)
N Low
5-year DFS
ST (54.8%)
p<0.001
– 5-year OS
p=0.067
PF (587)
LF (157)
PF (24%)
LF (33%)
p=0.01
PF (75%)
LF (62%)
p=0.77
LF (66)
N Low
5-year DFS
After PSM
P=0.62
After PSM
p=0.35
– 5-year OS
SR (320)
SR (25.3%)
ST (24.3%)
p=0.09
SR (38.5%)
ST
(38.9%)
p=0.52
ST (109)
CRC w/
SCRLM
(12,744)
Giuliante (2021)
[35]
Table 25.2 (continued)
Patients (N)
Study
Author (year)
CRC w/
SCRLM (1168)
Bogach (2020)
[42]
CRC w/
SCRLM (653)
Esposito [36]
(2018)
CRC w/
SCRLM (429)
Silberhumer [37]
(2016)
CI condence intervals, CRC colorectal cancer, DFS disease-free survival, HF hazard ratio, LF liver rst, N no, OS overall survival, PF primary rst, PSM
propensity score matching, SCRLM synchronous colorectal liver metastases, SR synchronous resection, ST staged resection, Y yes
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method, resection of the primary tumor rst is not associated with advantages in
morbidity or overall survival (OS) [30, 32–37]. Additionally, a retrospective multicenter study by Esposito etal. [36] of 653 patients with SCRLM who underwent
staged resection found no difference in recurrence-free survival between the patients
who had the primary or the liver resected rst following propensity score matching.
Overall, patient selection for the rectum rst strategy largely depends on the size
and symptoms of the primary in addition to the burden of metastatic disease.
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Liver First
When discussing the liver-rst strategy, it should be put in the context that nearly all
patients receive neoadjuvant chemotherapy. Resection of the liver rst decreases the
possibility that the metastases would progress to a degree that would preclude
resectability, either due to the nature of the disease or from complications of the
classic approach (e.g., anastomotic leaks) that would postpone the second procedure [38]. Additionally, it is hypothesized that further progression of metastatic disease originates from the liver [39], so it is advantageous to resect the metastases rst
to prevent further cancer spread. Thus, this strategy is best suited for patients with a
higher metastatic burden or independently requiring a major hepatectomy [7] based
on anatomic location of metastases. There is evidence that resection of the liver rst
is increasing in popularity [30, 40], which may be due to the increasing efcacy of
systemic therapies, rendering more patients’ metastases as resectable [14]. Conrad
etal. [30] performed a single-center retrospective study of 268 patients with rectal
cancer and SLM between 1999–2014, and they found that the proportion of patients
undergoing the reverse approach increased from 6% from 1999–2003 and 38%
from 2009–2014.
Synchronous Resection
Simultaneous resection of the rectal primary and hepatic metastases may be a safe
option for patients who require low risk hepatectomies and proctectomies. Proper
patient selection is critical, as patients who undergo synchronous resections have
higher rates of post-operative morbidity compared to individual staged procedures
[34, 35]. A study by Shubert etal. [41] utilized the American College of Surgeons
National Surgical Quality Improvement Database (ACS NSQIP) to identify patients
with SCRLM and classied their hepatectomies and colorectal resections as either
low or high risk based on the rates of post-operative morbidity and mortality. Low
risk procedures included partial and left hepatectomies and low anterior resections,
while right hepatectomies, trisegmentectomies (extended right hepatectomies), and
abdominal perineal resections were classied as high risk. They found that among
patients who underwent a synchronous resection, the lowest risk of post-operative
morbidity occurred in patients who received both a low risk hepatectomy and proctectomy. As such, optimal patient selection for a synchronous resection includes
patients with a small burden of metastatic disease and a high rectal tumor.
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