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Retroperitoneal nodal metastases from colorectal cancer: Curable metastases

with radical retroperitoneal lymphadenectomy in selected patients

Article  in  European journal of surgical oncology: the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology ·
April 2015
DOI: 10.1016/j.ejso.2015.03.229

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Retroperitoneal nodal metastases from colorectal cancer:

Curable metastases with radical retroperitoneal
lymphadenectomy in selected patients
J. Gagni!ere a,b,*, A. Dupr"e b, S. Chabaud c, P. Peyrat b, P. Meeus b,
M. Rivoire b
a
Digestive and Hepatobiliary Surgery Department, Estaing University Hospital, 63000 Clermont-Ferrand,
France
b
Digestive Surgery Department, L"eon B"erard Cancer Center, 69008 Lyon, France
c
Biostatistics Department, L"eon B"erard Cancer Center, 69008 Lyon, France
Accepted 13 March 2015
Available online - - -

Abstract
Background: Retroperitoneal nodal metastases (RNM) represent 1e2% of metastases from colorectal cancer (CRC). Non-surgical treat-
ments achieve 5-year overall survival (OS) of 0e12%. Radical retroperitoneal lymphadenectomy (RRL) in this setting remains controver-
sial, but most published series do not distinguish local retroperitoneal recurrences from RNM. We specifically report outcomes after RRL
for RNM from CRC.
Methods: We analyzed prospectively recorded data from patients who underwent standardized RRL for RNM from CRC between January
1997 and August 2012 in our institution. Local retroperitoneal recurrences were excluded.
Results: Twenty-five patients underwent RRL for synchronous (n ¼ 19) or metachronous (n ¼ 6) RNM from CRC. Fifteen patients had
extra-retroperitoneal metastases. Median hospital stay was 16 [7e23] days. Grade " III morbidity was 8% with no perioperative deaths.
Median follow-up was 85 [4e142] months. Median OS and progression free survival (PFS) were 60 [4e142] and 14 [1e116] months. One,
three- and 5-year OS were 92%, 64% and 47%. One, three- and 5-year PFS were 51%, 26% and 26%. Retroperitoneal nodal metastases
from stage III CRC were associated with better median OS compared to those from stage IV CRC (p ¼ 0.02). This variable did not impact
on PFS. Subject to substantial risk of type II error on small samples data statistical analysis, survivals were not affected by timing and
location of RNM, extra-retroperitoneal metastasis, nodal disruption, neoadjuvant nor adjuvant chemotherapy.
Conclusions: To our knowledge, this is the largest series yet reported which specifically studied outcomes of RRL for RNM from CRC.
RRL allows favorable outcomes in selected patients with acceptable morbidity.
! 2015 Elsevier Ltd. All rights reserved.

Keywords: Colorectal neoplasms; Lymph nodes; Neoplasm metastasis; Lymph node excision; Long-term survival

Introduction

Colorectal cancer (CRC) is the fourth most frequent can-

Abbreviations: RNM, retroperitoneal nodal metastases; CRC, colo-
rectal cancer; RRL, radical retroperitoneal lymphadenectomy; RLR, retro-
peritoneal local recurrence.
* C orrespo ndi ng au tho r. Servi ce de Chiru rgi e Dig estive et
H"epatobiliaire, CHU Estaing 1, place Lucie et Raymond Aubrac, 63000
Clermont-Ferrand, France. Tel.: þ33 4 73 75 04 94; fax: þ33 4 73 75
04 97.
E-mail address: jgagniere@chu-clermontferrand.fr (J. Gagni!ere).
cer worldwide and an estimated 600 000 colorectal cancer
deaths occurred in 2008.1 Over the past twenty years, de-
velopments in diagnosis and the adoption of multimodality
treatments have improved the prognosis of metastatic CRC.
Estimated 5-year overall survival (OS) is now 30e50% af-
ter surgery for liver and/or pulmonary metastases2,3 and
11e32% in patients with peritoneal metastases.4 Surgery
for liver and pulmonary metastases from CRC is now the

http://dx.doi.org/10.1016/j.ejso.2015.03.229
0748-7983/! 2015 Elsevier Ltd. All rights reserved.

Please cite this article in press as: Gagni!ere J, et al., Retroperitoneal nodal metastases from colorectal cancer: Curable metastases with radical retroper-
itoneal lymphadenectomy in selected patients, Eur J Surg Oncol (2015), http://dx.doi.org/10.1016/j.ejso.2015.03.229
2 J. Gagni!ere et al. / EJSO xx (2015) 1e7
gold standard and remains the only treatment that allows
long-term survival and potential cure.5,6
Compared with the sites mentioned above, retroperito-
neal nodal metastases (RNM) from CRC are rare: the esti-
mated incidence of isolated RNM after curative resection is
1e2%.7e9 RNM are often accompanied by extra-
retroperitoneal metastases.10 The estimated delay between
surgery for the primary CRC and diagnosis of retroperito-
neal recurrence is 23e28 months.9,11
Management of RNM from CRC remains controver-
sial.12,13 Central localization of the retroperitoneum, neigh-
boring colorectal tumors and related lymphatic systems can
lead to the development of both retroperitoneal local recur-
rences (RLR) and RNM.7e9,12,14 Indeed, most published ar-
ticles do not distinguish between RLR and RNM when
reporting the outcomes of surgery but present results glob-
ally for retroperitoneal locoregional recurrences associated
with poor prognosis. However, RLR and RNM seem not to
be the same disease. When lymph node and locoregional
retroperitoneal recurrences are distinguished, RLR seems
to have a worse prognosis than RNM11 (estimated 3-year
OS and progression free survival (PFS) for RLR being
27% and 0% versus 81% and 26% for RNM). Management
of these two categories of patients should therefore be
different. The better control of nodal metastasis progression
permitted by effective chemotherapy is one respect in
which treatment might vary.11 Hence, even if distinguishing
between RLR and RNM is sometimes difficult,11,15 it
should be done early so that therapy can be adjusted to
the circumstances of individual patients, with the aim of
improving their survival.
Several studies have suggested that surgery for RNM is
the only potentially curative treatment and can achieve
long-term OS in selected patients with an acceptable post-
operative morbidity.7e9,16e18 Median OS in operated pa-
tients was 34e46 months, compared with 3e33 months
in those who did not have surgery, and five year OS was
15e53% versus 0e12% respectively. Because RNM is
relatively rare, its management is often based on retrospec-
tive studies of small groups of CRC patients which (as
noted above) often included those with RLR.17 Even in
expert centers, whether to perform radical retroperitoneal
lymphadenectomy (RRL) is still discussed on a case by
case basis. With the aim of clarifying the role of surgery
in RNM from CRC, we studied the outcomes of RRL in,
to the best of our knowledge, the largest well-
characterized series yet reported.
Patients and methods
Study population
We retrospectively analyzed data from a prospective
database of all patients who underwent complete surgical
resection of RNM at the L"eon B"erard Cancer Center
(Lyon, France) between January 1997 and August 2012.
Please cite this article in press as: Gagni!ere J, et al., Retroperitoneal nodal metastases from colorectal cancer: Curable metastases with radical retroper-
itoneal lymphadenectomy in selected patients, Eur J Surg Oncol (2015), http://dx.doi.org/10.1016/j.ejso.2015.03.229
RNM was defined as histologically confirmed retroperito-
neal lymph node involvement, without local CRC recur-
rence, in an area limited laterally by the ureters, the
celiac area superiorly and iliac vessels inferiorly.
Preoperative staging included carcinoembryonic antigen
(CEA) determination and a thoraco-abdomino-pelvic
computed tomography (CT) scan. Positron emission to-
mography e CT has also been routine since 2005.
All prognostic factors for RNM found in the literature
were recorded, including patient characteristics, primary
stage according to the 2010 AJCC staging system, timing
of metastasis (synchronous vs metachronous), preoperative
CEA level, chemotherapy, radiotherapy, the size and num-
ber (macroscopically and radiologically) of suspected
involved nodes and their location (supra-renal, infra-renal,
iliac), nodal disruption, histology, presence of extra-
retroperitoneal metastatic sites, postoperative morbidity
and mortality, and long-term patient outcomes.
Treatment and follow-up
Therapeutic management was systematically discussed
for all patients presenting with retroperitoneal nodal metas-
tases (isolated/not isolated, resectable/unresectable) from
CRC in multidisciplinary digestive cancer board meetings
at our institution. Surgery, including RRL, was proposed
with intent to achieve a R0 resection for all metastatic sites.
If indicated, perioperative chemotherapy consisted of infu-
sional fluorouracil and leucovorin (the LV5FU2 regimen)
and, more recently, folinic acid plus oxaliplatin or irinote-
can with or without the addition of cetuximab or bevacizu-
mab. Standardized RRL, including all nodal tissues in the
previously defined retroperitoneal area, was systematically
performed. Infra-renal radical lymphadenectomy consisted
of the resection of the laterocaval, precaval, retrocaval, lat-
eroaortic, preaortic, retroaortic and interaorticocaval nodal
tissues (Fig. 1). A complete resection was defined as no
macroscopic residual tumor. Patients with synchronous
RNM had them resected at the same time as the primary
CRC. When necessary, vascular resection and reconstruc-
tion were performed using a vascular prosthesis. Closed-
suction abdominal drainage was used routinely. All patients
had a postoperative fat-free diet for one month.
Patients were followed up every three months for two
years and every six months thereafter. Physical examina-
tion, CEA level determination and thoraco-abdomino-
pelvic CT-scan were performed at each patient visit.
Statistical analysis
Medians were compared using Wilcoxon non parametric
test. Proportions were compared using the Fisher exact test.
Survival curves were calculated using the KaplaneMeier
method. The Log-rank test was used for univariate analysis.
A p value $0.05 was considered statistically significant.
Hazard ratios were estimated using Cox model and
 J. Gagni!ere et al. / EJSO xx (2015) 1e7 3

Figure 1. Intraoperative view after standardized infra-renal radical retroperitoneal lymphadenectomy for nodal metastases from colorectal cancer.

presented with their 95% confidence interval. Statistical an-
alyses were performed using SAS version 9.3" (SAS Insti-
tute Inc, Cary, NC).
Results
Clinicopathological and therapeutic features
neoadjuvant chemotherapy. Both received preoperative
chemotherapy with oxaliplatin plus cetuximab.
Median hospital stay was 16 days [range 7e23]. Severe
(grade IIIeIV) morbidity was experienced by 8%
(n ¼ 2):this consisted of pulmonary embolism in one pa-
tient and right ureteral injury in the other. Importantly, there
were no cases of symptomatic lymphocele and there was no
90-day mortality.

Twenty-five consecutive patients underwent RRL be-

tween January 1997 and August 2012. All resections
were macroscopically complete. Patient’s demographic
and clinical characteristics, treatment history, and the na-
ture of their RNM are summarized in Table 1.
All patients had $5 cm RNM. Sixty percent (n ¼ 15)
had extra-retroperitoneal metastases that were not neces-
sarily resected at the same time as the RNM:pulmonary
metastasis (n ¼ 3), liver metastasis (n ¼ 13), and peritoneal
metastasis (n ¼ 2). Radical retroperitoneal lymphadenec-
tomy was the only operative procedure in 3 patients
(12%). The remainder had associated surgical procedures:
colectomy (n ¼ 9); proctectomy (n ¼ 9); liver resection
(n ¼ 6) including 1 left hepatectomy, 1 left lobectomy, 3
wedge resections and 1 cryotherapy ablation; and cytore-
ductive surgery with hyperthermic intraperitoneal chemo-
therapy was used in one patient.
All patients with metachronous RNM had perioperative
chemotherapy. Fifty-three percent (n ¼ 10) of patients with
synchronous RNM did not receive neoadjuvant chemo-
therapy because preoperative diagnosis was uncertain in 3
cases and because diagnosis was intraoperative in 7. All
four patients who did not receive adjuvant chemotherapy
had 12 cycles of chemotherapy preoperatively. Two patients
had retroperitoneal pathological complete response to
Recurrence and survival
Median follow-up after RRL was 85 months [range
4e142]. Ten patients had less than two years of follow-
up. Among them, 6 patients died because of a disseminated
disease progression and 1 patient died of an acute cardiac
disease 4 months after surgery. The other 3 patients have
been operated on less than two years before closing accrual.
No patients were thus lost to follow-up. Median OS and
PFS were 60 months [range 4e142] and 14 months [range
1e116]. One-year, 3-year and 5-year OS were respectively
92%, 64% and 47% (Fig. 2a). One-year, 3-year and 5-year
PFS were respectively 51%, 26% and 26% (Fig. 2b).
One-year, 3-year and 5-year OS and PFS in patients
without extra-retroperitoneal metastases were respectively
90%, 68%, 56% and 93%, 61%, 51%. These survivals
were respectively 93%, 61%, 51% and 47%, 13%, 13%
in patients presenting with extra-retroperitoneal metastases
from CRC.
Thirteen patients (52%) developed a nodal retroperito-
neal recurrence within a median of 14 months [range
4e33]. Among the twelve patients who did not develop a
nodal retroperitoneal recurrence, the median follow-up af-
ter RRL was 85 months [range 8e116]. The main site of

Please cite this article in press as: Gagni!ere J, et al., Retroperitoneal nodal metastases from colorectal cancer: Curable metastases with radical retroper-
itoneal lymphadenectomy in selected patients, Eur J Surg Oncol (2015), http://dx.doi.org/10.1016/j.ejso.2015.03.229
4 J. Gagni!ere et al. / EJSO xx (2015) 1e7

Table 1
Clinicopathological and treatment features of patients operated on for nodal retroperitoneal recurrence was both supra- and infra-
RNMa from CRCb. renal (n ¼ 7). Other sites were infra-renal (n ¼ 3) and
Characteristics Total (n ¼ 25)
supra-renal (n ¼ 3).
After RRL, metastatic recurrence at extra-
No./median [Range] %
retroperitoneal sites occurred in 15 patients (60%). The
Male 9 36 main sites were lung (n ¼ 13; 87%), liver (n ¼ 7; 47%),
Median age (years) 55 [31e69]
Median body mass index (kg/m2) 25 [18e33] mediastinum (n ¼ 5; 33%), peritoneum (n ¼ 2; 13%), brain
ASAc score " 3 2 8 (n ¼ 2; 13%), ovary (n ¼ 2; 13%), bone (n ¼ 1 7%), and
Location of primary supra-clavicular nodes (n ¼ 1; 7%). The median interval
Right colon 4 16 between RRL and extra-retroperitoneal recurrence was 9
Left colon 8 32 months [range 4e20].
Rectum 13 52
TNM stage
III 5 20
Prognostic factors
IV 20 80
Timing of RNMa
Synchronous 19 76 Univariate analyses on small samples incur a substantial
Metachronous 6 24 risk of type II error. However prognostic factors for OS and
Median disease-free interval 12 [5e42] PFS are summarized in Table 2.
when metachronous (months) Retroperitoneal nodal metastases from stage III CRC (at
Preoperative CEAd level (mg/L)
< 10 15 60 initial diagnosis) were associated with better median OS
" 10 6 24 compared to those from stage IV CRC (p ¼ 0.02). Howev-
Unknown 4 16 er, this variable did not have an impact on PFS. Survivals
Location of RNMa seemed not to be affected by age, timing of metastases,
Supra- þ/% infra-renal 4 16
location of RNM, presence of extra-retroperitoneal metas-
Infra-renal 21 84
Laterocaval 7 28
tasis, preoperative CEA level, nodal disruption, and neoad-
Retrocaval 10 40 juvant nor adjuvant chemotherapy.
Lateroaortic 24 96
Retroaortic 12 48
Interaorticocaval 14 56 Discussion
Vascular involvement
Yes 3 12 Retroperitoneal nodal metastases are rare compared with
No 22 88
liver metastases and confer a poor prognosis. Because of
Number of radiologic retroperitoneal supra-centimetric nodes
<3 13 52 their rarity, the literature contains little information, and
"3 12 48 there has been no consensus on therapeutic strategy. A
Median number of harvested lymph nodes 21 [4e56] recent review published by Ho et al.17 emphasized the
Median number of positive lymph nodes 4 [1e41] need for prospective trials (which would be difficult to
Size of the largest node (cm)
conduct) or, in their absence, large observational studies.
<5 25 100
"5 0 0 We report our series of patients operated on for RNM.
Nodal micrometastases The number (n ¼ 25) would be considered small in many
Yes 7 28 contexts but is large in the setting of RNM and represents
No 18 72 one of the biggest series along with the study of Dumont
Nodal disruption
et al. (n ¼ 23).11 However, results of univariate analysis
Yes 15 60
No 9 36 should take into account a substantial type II error risk
Unknown 1 4 due to small samples.
Extra-retroperitoneal metastases We report median OS of 60 months and PFS of 14
Yes 10 40 months, which are consistent with results in the literature.11
No 15 60
However, our study differs from others in important re-
Neoadjuvant chemotherapy
Yes 15 60 spects. Firstly, the fact that the majority of patients (76%)
No 10 40 presented with synchronous RNM eliminates the possibility
Adjuvant chemotherapy of confounding them with RLR. All patients with synchro-
Yes 21 84 nous RNM should have had preoperative chemotherapy but
No 4 16
almost a half did not receive it because retroperitoneal in-
Perioperative retroperitoneal radiotherapy
Yes 1 4 vasion (often minor and not evident on CT) was discovered
No 24 96 macroscopically only during surgery for the primary tumor.
a
Retroperitoneal nodal metastases. A strength of this study is that patients operated on for RRL
b
Colorectal cancer. were recorded systematically and had a long median
c
American Society of Anesthesiology. follow-up.
d
Carcinoembryonic antigen.
Please cite this article in press as: Gagni!ere J, et al., Retroperitoneal nodal metastases from colorectal cancer: Curable metastases with radical retroper-
itoneal lymphadenectomy in selected patients, Eur J Surg Oncol (2015), http://dx.doi.org/10.1016/j.ejso.2015.03.229
 J. Gagni!ere et al. / EJSO xx (2015) 1e7 5

Figure 2. KaplaneMeier a) overall survival and b) progression free survival curves after radical retroperitoneal lymphadenectomy for nodal metastases from
colorectal cancer.

We had encouraging outcomes regarding OS and PFS,
especially so given the poor initial prognosis of patients,
the majority of whom had synchronous metastases and pre-
sented with at least one extra -retroperitoneal metastatic
site.
In the majority of reported studies, retroperitoneal lym-
phadenectomy is not well defined. Surgery is incomplete:-
frequently, certain nodes in the macroscopically involved
areas are removed while others remain. A strength of this
study is that we systematically performed a standardized
RRL covering in particular the resection of the retrocaval
and retroaortic nodal areas that were involved in almost
half of our patients. The case for a systematic RRL is
strengthened by the fact that 28% (n ¼ 7) of our patients
had nodal micrometastases, and these were not confined
to the areas macroscopically involved. In surgery for
RNM from CRC, RRL including retrocaval and retroaortic
areas is probably needed.
Radical retroperitoneal lymphadenectomy is considered
a difficult procedure carrying a substantial risk of postoper-
ative morbidity and mortality. In this paper, we report grade
IIIeIV morbidity of 8% and no mortality, but in a small
number of patients. The largest series of retroperitoneal
lymphadenectomies are reported in gynecological

Please cite this article in press as: Gagni!ere J, et al., Retroperitoneal nodal metastases from colorectal cancer: Curable metastases with radical retroper-
itoneal lymphadenectomy in selected patients, Eur J Surg Oncol (2015), http://dx.doi.org/10.1016/j.ejso.2015.03.229
6 J. Gagni!ere et al. / EJSO xx (2015) 1e7

Table 2
Univariate analysis of OSa and PFSb in patients operated on for RNMc from CRCd.
Studied factors OSa Hazard ratio [CI 95%] pf PFSb Hazard ratio [CI 95%] pf
Patient age (years) 0.15 0.95
<60 vs "60 2.50 [0.73e8.65] 0.97 [0.35e2.74]
Primary location 0.59 0.80
Colon vs Rectum 1.37 [0.44e4.33] 1.13 [0.45e2.87]
Primary TNM stage 0.02 0.66
g
III vs IV 1.68 [0.48e5.84]
Timing of RNM 0.18 0.76
Synchronous vs Metachronous 2.83 [0.61e13.08] 0.85 [0.30e2.39]
Preoperative CEAe level (mg/L) 0.15 0.98
<10 vs "10 4.65 [0.57e38.10] 1.01 [0.32e3.25]
Location of RNMc 0.23 0.12
Supra- vs Infra-renal 2.81 [0.92e10.12] 1.15 [0.37e6.32]
Number of radiologic retroperitoneal supra-centimetric nodes 0.12 0.94
<3 vs "3 2.67 [0.79e9.04] 0.96 [0.38e2.44]
Nodal disruption 0.31 0.70
2.0 [0.52e7.63] 0.82 [0.30e2.26]
Extra retroperitoneal metastases 0.43 0.11
1.64 [0.49e5.50] 2.29 [0.80e6.53]
Neoadjuvant chemotherapy 0.46 0.31
1.53 [0.49e4.77] 0.60 [0.22e1.61]
Adjuvant chemotherapy 0.57 0.45
1.56 [0.34e7.22] 0.57 [0.13e2.50]
a
Overall survival.
b
Progression free survival.
c
Retroperitoneal nodal metastases.
d
Colorectal cancer.
e
Carcinoembryonic antigen.
f
Log-rank test.
g
As all death were observed for grade IV stage, Hazard Ratio can’t be obtained.

malignancies and germ cell tumors.19,20 In these settings,
severe (grade IIIeIV) complications occur in fewer than
10% of patients, even after chemotherapy and in cases of
bulky disease.19e22 The most frequent severe complications
reported are ileus (3%), symptomatic lymphocysts (2e3%)
and ureteral injuries ($2%). Major vascular injuries do not
exceed 1%. The particular concern with retroperitoneal
lymphadenectomy is the occurrence of late complications
such as ureteral stenosis ("3% in repeated surgery) or sec-
ondary renal infarction (0.3e2%).
This study is retrospective and inevitably associated with
selection biases since some patients with RNM may not
have been screened, and an intention-to-treat analysis was
not possible. Another factor that needs to be taken into ac-
count is the long period of the study. During this time,
chemotherapy regimens evolved considerably. However,
in our hands, RRL for RNM in selected patients had
good outcomes for OS and PFS. These were similar to out-
comes obtained with the surgical management of other
resectable metastatic CRC disease such as liver metastases.
Given our results, we suggest that RNM should be consid-
ered in the same way as other resectable metastases and
treated with curative intent, even when synchronous.
The potential benefit of perioperative chemotherapy in
this setting remain controversial and there is a need for pro-
spective studies.9,16,17 However, we extrapolated tech-
niques successfully used in the management of CRC liver
metastases2 to the perioperative management of RNM,
with the aim of improving PFS and selecting patients likely
to respond well. Pre-operative chemotherapy is useful for
patients’ selection in surgical oncology, in a general
manner. It allows considering all therapeutic options. For
well-responding patients, neoadjuvant chemotherapy is
associated with downsizing, which facilitates tumor
removal. It has also been hypothesized that neoadjuvant
chemotherapy minimizes micrometastases development
risk. In this study, most of patients received neoadjuvant
chemotherapy and surgery was discussed only when meta-
static disease was at least stable. Among the patients with
response to chemotherapy, two had complete pathological
response and had thus probably favorable tumor biology.
Good results have been reported using a multimodality
approach including preoperative radiotherapy followed by
surgery and adjuvant chemotherapy,13 with a reported me-
dian OS of 33 months and a 5-year OS of 24%. Kim et al.23
reported a median OS of 37 months and a 3-year PFS of
71% with radiotherapy alone in cases of chemoresistance,
but with a high morbidity and a recurrence rate of 100%.
Standardized radical retroperitoneal lymphadenectomy
for RNM from CRC probably allows favorable outcomes
in highly selected patients. As is the case with liver metas-
tases from CRC, a multimodality approach including peri-
operative chemotherapy may be needed to improve PFS.
Patients with associated lymph node metastases in the

Please cite this article in press as: Gagni!ere J, et al., Retroperitoneal nodal metastases from colorectal cancer: Curable metastases with radical retroper-
itoneal lymphadenectomy in selected patients, Eur J Surg Oncol (2015), http://dx.doi.org/10.1016/j.ejso.2015.03.229
 J. Gagni!ere et al. / EJSO xx (2015) 1e7
hepatic pedicle are probably poor candidates for RRL due
to inherent poor prognosis. In patients who have had previ-
ous retroperitoneal lymphadenectomy or multiple previous
laparotomy, RRL can be challenging because technical
problems arise due to morbid adhesions, which are associ-
ated with increased risk of organ damage and postoperative
complications.
We reported herein a study on small sample, and
because of the rarity of RNM and the lack of published in-
formation, more research, including prospective trials or
large observational studies, are needed to better define the
role of surgery in the management of these patients.
Conflict of interest statement
All authors declared no potential conflicts of interest or
financial disclosures.
Funding
None.
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