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A. Ostowari and O. S. Eng
closed after 7years due to poor patient accrual with only 48 patients enrolled (24/
arm) [13]. Median OS favored the CRS/IPC arm at 25months versus 18months in
the SCT only arm (p=.04) with a 2-year OS of 54% in the experimental arm versus
38% in the SCT arm (p= .04). There was no signicant difference in PFS, but at
5years 33% of the experimental arm versus 4% of the control arm were still alive
(p=.02) [13]. Therefore, these studies demonstrated some survival benet to the
implementation of CRS with IPC over SCT alone.
The American Society of Peritoneal Surface Malignancies Multi-Institution
(ASPSM) sought to improve patient selection by identifying who would likely benet most from CRS/HIPEC by establishing the Peritoneal Surface Disease Severity
Score (PSDSS). This score was based off of three criteria prior to surgery, which
included the patient’s symptoms, PCI score, and primary tumor histological grade
[14]. A retrospective review of 1013 CRC patients with PC between 1985 and 2012
was performed, comparing survival data from patients who underwent CRS/HIPEC
versus SCT alone. 884 patients had PSDSS scores calculated for, of which 609
patients underwent CRS/HIPEC and 275 patients underwent systemic treatment
alone [14]. Overall median survival favored the CRS/HIPEC group at 41months
versus 10 months (p < 0.001) and 3-year/5-year survival also favored the CRS/
HIPEC group at 66%/58% versus 25%/19%. After multivariate analysis, two factors
identied as independent prognostic factors for survival were the PSDSS and CC
score (P<0.001) [14]. The median survival of patients who underwent CRS/HIPEC
based on their PSDSS (I, II, III, IV) was 86, 43, 29, and 28months, respectively
versus 45, 19, 8, and 6months in patients with systemic therapy alone (P<0.001).
Subgroup analysis of patients that underwent CRS/HIPEC showed improved
median survival in patients undergoing complete cytoreduction (CC-0) versus an
incomplete cytoreduction (51 vs 28months, p< 0.001) [14]. This conrmed the
importance of achieving a complete cytoreduction during CRS for patient survival
and provided data on the use of the PSDSS as a tool to dene CRC patients with PC
with the highest likelihood of long-term survival after undergoing CRS/
HIPEC.Following this, the ASPSM looked further into survival differences based
on the type of HIPEC performed while stratifying patients based on PSDSS. 539
patients were included in this study and underwent complete CRS and HIPEC with
either oxaliplatin or mitomycin C. Median OS was not signicantly different
between the two types of utilized chemoperfusion agents [15]. However, when
patients were stratied by their PSDSS, there was a signicant difference in median
OS in patients with a PSDSS of I or II that favored mitomycin C (54.3 vs 28.2months,
p=0.012). On the other hand, patients with a PSDSS of III or IV showed no signicant difference in median OS between the two agents [15]. This demonstrated that
mitomycin C might be more effective than oxaliplatin in the treatment of patients
with better tumor histology and lower disease burden.
More recently, several studies have been carried out that have looked at the effectiveness of HIPEC in CRC patients with PC or at high risk of developing PC.The
COLOPEC study was a multicenter, open-label, randomized control trial that
looked at the efcacy of adjuvant HIPEC in patients with locally advanced colon
cancer amongst 9 HIPEC specialty hospitals in the Netherlands [16]. Between April
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217
1, 2015 and February 20, 2017, 204 patients were enrolled in a 1:1 fashion to adjuvant HIPEC followed by routine SCT (n=100, 2 patients dropped out) versus SCT
alone (n=102). Patients with primary clinical or pathological stage T4N0-2M0 or
perforated colon cancer were included, while those with metastatic disease were
excluded. Adjuvant HIPEC consisted of a combination of IV uorouracil and leucovorin with intraperitoneal oxaliplatin delivered either simultaneously at the time
of resection or 5–8weeks after resection [16]. All patients received 6months of
adjuvant SCT consisting of capecitabine and oxaliplatin or uorouracil and oxaliplatin ideally started within 6–8weeks of resection, but no later than 12 weeks.
After 18months, every patient without radiographic evidence of recurrence underwent a diagnostic laparoscopy [16]. At 18months, there was no signicant difference seen between the groups in terms of peritoneal metastasis-free survival, overall
survival, and disease-free survival. 14% (n=12) of patients in the adjuvant HIPEC
group developed postoperative complications and 1% (n=1) developed a long-term
morbidity (encapsulating peritoneal sclerosis) requiring a surgical intervention [16].
The median time to diagnosis of peritoneal metastasis was 9months in the experimental group versus 14months in the control group (p=.059). Of those with peritoneal metastases, 68% (13/19) of patients in the experimental group underwent
CRS/HIPEC and 65% (15/23) in the control group. Overall, there was a 21% peritoneal recurrence amongst all patients in this study [16]. This study showed no
benet in peritoneal metastasis-free survival, overall survival, or disease-free survival at 18months in patients undergoing adjuvant HIPEC after resection even
though we did see a trend of earlier diagnosis of peritoneal metastasis. Some of the
limitations of this study included later administration of adjuvant chemotherapy in
the experimental group versus the control group though this still occurred within
12weeks. Furthermore, 37% (n=74) of patients did not agree to undergo diagnostic laparoscopy at 18months, possibly due to the invasiveness of undergoing a second procedure [16].
After the COLOPEC trial, the PROPHYLOCHIP study evaluated survival benets in undergoing a second-look surgery and HIPEC versus standard surveillance
in CRC patients with high risk of developing PC.This was an open-label, phase 3
study among 23 hospitals in France. 150 patients were enrolled from June 11, 2010
to March 31, 2015 in a 1:1 fashion to a second-look surgery and HIPEC group
(n=75) versus a standard surveillance group (n=75) [17]. Patients included in this
study had CRC with either synchronous/localized PC removed during the operation,
resection of ovarian metastasis or a perforated tumor and underwent 6months of
adjuvant chemotherapy following resection without evidence of tumor recurrence,
while patients with cancer other than CRC, and detectable recurrence or metastasis
other than to the peritoneum or ovaries were excluded from the study [17].
Chemoperfusion agents consisted of oxaliplatin, oxaliplatin/irinotecan or mitomycin C.Every patient in this study received adjuvant SCT and those in the experimental group without signs of disease recurrence underwent second-look surgery/
HIPEC 6 months afterwards [17]. At a median follow up of 50.8months, 47%
(n=35) of patients in the experimental group and 48% (n=36) in the control group
experienced recurrence. There was no signicant difference seen in 3-year
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A. Ostowari and O. S. Eng
disease- free survival or peritoneal recurrence-free survival between the two groups
[17]. In addition, there were no treatment related deaths reported, but 41% (n=29)
of patients in the experimental group had grade 3–4 complications most commonly
being an intra-abdominal event such as hemorrhage or GI leak followed by a hematologic adverse event. 3-year OS was 79% in the experimental group and 80% in the
control group, while 5-year OS was 68% in the experimental group and 72% in the
control group [17]. Similar to the COLOPEC trial, this study showed that a secondlook surgery and HIPEC does not improve disease-free or overall survival compared to standard surveillance. However, this study brought up the importance of
identifying CRC patients with high risk of developing PC to potentially diagnose
and treat them at an earlier stage [17].
The HIPECT4 study is a multicenter, randomized control trial among 15 Spanish
HIPEC specialty centers that looked at the effectiveness and safety of adjuvant
HIPEC in preventing PC development in CRC patients with high risk of PC recurrence. Between November 2015 and January 2021, 184 patients with locally
advanced colon cancer were enrolled and randomly assigned to an adjuvant HIPEC
group followed by SCT (n=89) versus SCT alone (n=95) [18]. Adjuvant HIPEC
consisted of mitomycin and was performed simultaneously with tumor resection. At
a median follow-up of 36months, there was no difference seen in DFS, OS, or morbidity between the two groups, but loco-regional control was improved in the experimental arm (35.3 versus 33.2 months) with a 3-year loco-regional rate of 97%
versus 87% (p = 0.025). Additionally, subgroup analysis showed a clear benet
inloco-regional control in the adjuvant HIPEC arm among patients with T4 disease
[18]. This study showed that while the addition of mitomycin HIPEC to surgical
resection did not lead to improved DFS and OS in patients with locally advanced
colon cancer, it does improve loco-regional control rate especially in patients with
T4 colon cancer.
More recently, the PRODIGE 7 trial has brought into question whether the addition of HIPEC to CRS adds survival benet compared to CRS alone. This was a
phase 3, randomized control trial across 17 centers in France. Between February 11,
2008 and January 6, 2014, 265 patients were enrolled and randomized into the CRS/
HIPEC arm (n=133) and CRS only arm (n = 132) [19]. The HIPEC component
included intravenous 5-FU/Leucovorin with 30minutes of intraperitoneal oxaliplatin, and all patients either received neoadjuvant and/or adjuvant systemic chemotherapy. After a median follow-up period of 63.8months, no signicant difference
was seen in median OS and RFS between the two groups. However, a post-hoc
subgroup analysis of patients with a PCI of 11–15 did show a signicant improvement in OS and RFS in the CRS/HIPEC arm versus CRS alone [19]. When looking
at the frequency of grade 3 or worse adverse events, there was no signicant difference at 30days, but between 30 and 60days there was a higher rate in the CRS/
HIPEC group versus CRS alone group at 26% versus 15% [19]. This study showed
that there was no survival benet with the addition of HIPEC to CRS aside from
possibly a small subset of patients with a PCI of 11–15 [19].
As more data emerges on the efcacy and survival benets of CRS and HIPEC
in the management of CRC patients with PC or high risk of developing PC, we
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continue to optimize this treatment modality for our patients. Factors associated
with survival along with patient selection criteria have been described and give us
insight on which population of patients might benet the most from CRS and
HIPEC.The Chicago Consensus Working Group currently provides us with multidisciplinary recommendations incorporating all of those factors on the management
of CRC with both synchronous and metachronous peritoneal metastasis. [20] Novel
approaches are always being studied, which include modied/improved techniques
of administering intraperitoneal or system chemotherapy, immunotherapy, monoclonal antibodies, and others [4]. As the treatment paradigm to CRC with PM continues to evolve over time, the management of these patients should always be a
multidisciplinary collaboration to provide patients with the best treatments available to them.
219
Expert Opinion
Based on the data presented, we would strongly recommend the practice of CRS
alone in patients with CRC and PC in the context of multidisciplinary evaluation at
an expert center. We would provide a moderate to strong recommendation for the
practice of CRS/HIPEC in CRC patients with PC under certain clinical scenarios
(PSDSSI/II with mitomycin C and PCI 11–15 with Oxaliplatin) in the context of
multidisciplinary evaluation at an expert center. Based on the results of recent studies, we would not recommend the prophylactic or adjuvant use of HIPEC at this
time for patients with CRC and high risk of PC.
Personal View
Colorectal cancer with peritoneal carcinomatosis was at one time a diagnosis without surgical treatment options and consisted of systemic palliative chemotherapy as
the mainstay in management. Over time, the management of CRC with PC has
evolved with now established cytoreductive surgery techniques along with intraperitoneal chemotherapy, to supplement the practice of systemic chemotherapy. As
described above, various studies have shown survival benets with the use of CRS
and HIPEC in the management of CRC patients with PC resulting in this becoming
an increasingly accepted treatment modality in this patient population. However,
many questions remain, including whether certain HIPEC regimens add survival
benet versus CRS alone and their use as an adjuvant/prophylactic option in patients
with high risk to develop PC.Yet given the vast heterogeneity of disease processes
and clinical practice patterns, some open questions may remain as such, thus emphasizing the importance of coordinated multidisciplinary decision-making. What
appears most apparent though is that survival is consistently related to achieving a
complete cytoreduction and having a lower burden of disease. Our ability to intervene during times of lower disease burdens may perhaps be better informed by
improvement in detection and surveillance in the future. In addition, the
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A. Ostowari and O. S. Eng
ever- evolving landscape of novel therapeutics likewise provides the prospect of
future treatments such as targeted therapies and/or enhanced drug delivery systems
which may be utilized in these patients. While CRC with PC is undoubtedly a challenging disease process, the increasing momentum in improving outcomes is apparent and has been a long time coming.
Abstract Recommendations
– Patients with CRC and PC should undergo CRS alone after multidisciplinary
evaluation at an expert center (evidence quality moderate to high; strong
recommendation)
– Patients with CRC and PC under certain clinical scenarios (PSDSSI/II with mito-
mycin C and PCI 11–15 with Oxaliplatin) should undergo CRS/HIPEC after
multidisciplinary evaluation at an expert center (evidence quality moderate to
high; moderate to strong recommendation)
– Patients with CRC and high risk of PC should not undergo prophylactic or adju-
vant HIPEC (evidence quality moderate to high; strong recommendation)
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Colorectal Cancer Management inOlder
https://t.me/medicina_free
Adults: Use ofGeriatric Assessment
19
toGuide Patient-Centered Care
JeffreyL.Roberson andNicoleM.Saur
Introduction
Age and/or physician-perceived frailty have historically been inappropriately used
as relative contraindications to abdominal surgery in geriatric patients. Specic to
colorectal cancer, 56% of new diagnoses in the United States occur in patients over
65years of age [1]. Currently, a 75-year-old American man in good health has a life
expectancy of 18years with his 82-year-old counterpart has a 10-year life expectancy. However, the presence of any severe comorbidity decreases their expectancies to 6 and 2 years respectively [2, 3]. While the denition and cutoff age for
geriatrics remains debated, it is generally agreed upon that patients should not be
treated solely on chronological age [4]. Despite this, however, many elderly colorectal cancer patients are either undertreated based on age or over-treated despite their
frailty [5, 6]. Therefore, the approach to elderly patients with colorectal cancer
should include comprehensive evaluation for and optimization of frailty with a
focus on patient-centered outcomes.
PICO Table
Formatted for: Difcult Decisions in Colorectal Surgery
J. L. Roberson
Department of Surgery, Hospital of the University of Pennsylvania, Philadelphia, PA, USA
e-mail: jeffrey.roberson@pennmedicine.upenn.edu
N. M. Saur (*)
Division of Colon and Rectal Surgery, Department of Surgery, Hospital of the University of
Pennsylvania, Philadelphia, PA, USA
e-mail: Nicole.Saur@uphs.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_19
223
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J. L. Roberson and N. M. Saur
Patient
Elderly
patients with
colorectal
cancer
Intervention Comparator
Prehabilitation or geriatric
assessment prior to surgical
or chemotherapeutic
intervention
Patients without
prehabilitation or
assessment
Outcome
Perioperative and/or
chemotherapeutic
outcomes
Search Strategy
Comprehensive literature searches of the Cochrane Database, EMBASE, MEDLINE,
and PubMed was performed to identify all of the English-language publications
related to geriatric colorectal cancer patients with or without geriatric assessments
and prehabilitation and their subsequent perioperative/chemotherapeutic outcomes
from 1985 to 2022. Key search terms included “geriatric,” “colorectal cancer,” “prehabilitation,” “perioperative,” “perioperative outcomes,” “outcomes,” and “elderly.”
Studies were excluded if they did not focus on geriatric patients with colorectal
cancer and/or discuss prehabilitation or if the full texts were not available in English.
Only the most recent study was included if similar studies from the same institution
were encountered. All references of the included studies were subsequently reviewed
to identify any additional studies that were appropriate for inclusion.
Results
Of the 145 potential studies, seven independent studies were identied for inclusion.
To date, a variety of methods have been utilized to attempt to quantify frailty and
inuence perioperative management in colorectal cancer. Of the seven studies, three
utilized scoring systems, three performed comprehensive geriatric assessments
(CGA), and one was intervention-based with respect to patients’ frailty assessments.
A variety of scoring systems were utilized to investigate patients’ frailty. Li etal.
[8] performed a subgroup analysis of patients enrolled in a multicenter study for
gastrointestinal malignancy prior to chemotherapy initiation. They utilized serial
measures of the Cooperative Oncology Group score, Barthel’s ADL scale, Lawton’s
IADL scale, the G-8 questionnaire, and the QLQ-C30 questionnaire. Of the 20 analyzed patients, most were receiving palliative chemotherapy. Patients with unstable
ADL and IADL scores had signicantly shorter overall survival (OS) than those
without changes in their scores. However, there was no difference in progression- free
survival. IADL instability was also correlated with QoL deterioration. Bessems etal.
[11], however, was a retrospective study comparing G8 and 4MGST scores with
postoperative complications. Of the 132 patients screened for frailty, a higher complication rate was seen in patients with G8 less than or equal to 14 and/or 4MGST
under 1m/s. Pneumonia and cardiac complications were most prevalent among these
patients. Souwer etal. [10] utilized a geriatric sumscore comprised of undernutrition,
physical impairment, risk for delirium, and fall risk to retrospectively investigate an
association between score and perioperative morbidity of 555 patients undergoing
elective CRC surgery. One point was awarded per criteria with intermediate being
19 Colorectal Cancer Management in Older Adults: Use of Geriatric Assessment…
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1–2 and high being 3–4. Ultimately, intermediate and high scores were associated
with lower OS and presence of a postoperative complication.
A comprehensive geriatric assessment (CGA) was performed in three of the studies.
The aim of CGA is to assess comorbidity, polypharmacy, functional status, geriatric
syndromes, mood, cognition, and social support. CGA typically classies patients into
three groups: t, medium-t, or unt. Antonio etal. [7] prospectively enrolled 195
patients with stage II and stage III colorectal cancer. 43% were deemed t, 29%
medium-t, and 28% unt with 5-year survival rates of 74%, 52%, and 27% respectively. Fit and medium-t patients were more likely to die due to cancer progression,
and unt patients were at a signicantly greater risk of a non-cancer related cause of
death. Decoster etal. [9] performed CGA in 193 patients with colorectal cancer, identifying at least one abnormality or area for improvement in 75%. Treatment was modied in 37% of patients based on this assessment. Baseline IADL, depression, fatigue,
and cognition were all predictors for ADL decline. Verweij etal. [11] analyzed 168
geriatric consultations for patients with colorectal cancer. 93% of these patients were
found to have some sort of geriatric impairment with the main recommendation for
improvement being addressing nutritional status. In regards to oncologic treatment, the
geriatrician ultimately recommended the “more intensive treatment” in 69% and “less
intensive” in 31%, 63% of whom were recommended for “supportive care” alone.
Finally, the GERICO study [13] is a randomized phase 3 trial of 142 patients
receiving adjuvant or rst-line palliative chemotherapy for colorectal cancer. Prior to
study initiation, a G8 questionnaire was performed with vulnerability being dened as
a score less than or equal to 14. These patients were subsequently randomized to
CGA-based interventions or standard care, along with guideline based chemotherapy.
Of the enrolled patients, 58% were receiving adjuvant therapy and 42% rst-line palliative chemotherapy. In the intervention group, 62% of patients had medication
changes, 51% received nutritional therapy, and 39% engaged in physical therapy.
There was no difference in severe treatment toxicity; however, signicantly more
interventional patients completed their full chemotherapy (45% vs. 28%, p=0.0366)
than the standard care patients. Additionally, the interventional patients had signicantly improved QoL compared to standard care patients, most notably with decreased
burden of illness (p=0.048 and improved mobility (p=0.008).
225
Recommendations
Depending upon the clinical encounter and the resources available, frailty can be
assessed in a variety of ways in older adults with colorectal cancer. In regions without readily accessible geriatric consultation, the G8 and 4MGST scales can provide
important insight about expected perioperative and/or chemotherapeutic morbidity.
However, if the resource is available, a CGA referral to a geriatric specialist should
be pursued as it provides much more information about a patients’ overall functional status and can inuence treatment plans, ultimately enhancing outcomes of
older adults with colorectal cancer (strong recommendation, moderate evidence).
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Quality
of
evidence
Moderate
CGA can predict survival
and assist in the decision-
74% 5-year survival
− 43% classied as t;
Low
making process of elderly
CRC management.
medium-t; 52% 5-year
survival
− 29% classied as
survival
− 27% as unt; 27% 5-year
-deterioration of functional
status during
progression
- Most patients received
palliative chemotherapy
− 31% died due to cancer
Moderate
chemotherapy negatively
impacted overall survival
and quality of life
-GA identies previously
had shorter OS
- unstable ADL and IADL
− 75% had an abnormal
J. L. Roberson and N. M. Saur
unknown problems but has
limited impact on
interventions and
treatment decisions
GA
discovered in 40%
- unknown problems were
- GA led to intervention in 5%- baseline IADL,
depression, fatigue, and
cognition predict ADL
decline
Comprehensive geriatric
Assessment (CGA)
195 patients over age 74
with high-risk stage II and
III CRC
Study design Patients Measure Results Conclusion
Prospective
cohort
Study
Antonio
[7]
oncology group score
- eastern cooperative
- Barthel’s ADL scale
- Lawton’s IADL scale
-G8 questionnaire
-QLQ-C30 questionnaire
20 patients over 74years
of age with
gastrointestinal(GI)
malignancy
analysis,
prospective
multicenter
Li [8] Subgroup
-geriatric assessment
193 patients over age 69
with colorectal cancer
Prospective
cohort
Decoster
[9]
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