Radiol Oncol 2024; 58(2): 214-220. doi: 10.2478/raon-2024-0023
214
research article
Prognostic factors for overall survival and 
safety of trans-arterial chemoembolization 
(TACE) with irinotecan-loaded drug-eluting 
beads (DEBIRI) in patients with colorectal liver 
metastases
Maja Sljivic1,2, Masa Sever3, Janja Ocvirk1,4,5, Tanja Mesti1,4, Erik Brecelj1,4, Peter Popovic1,2
1 Faculty of Medicine Ljubljana, Ljubljana, Slovenia 
2 Clinical Institute of Radiology, University Medical Centre Ljubljana, Ljubljana, Slovenia
3 Faculty of Medicine Belgrade, Serbia
4 Institute of Oncology, Ljubljana, Slovenia 
5 University of Primorska, Faculty of Health Sciences, Isola, Slovenia
Radiol Oncol 2024; 58(2): 214-220.
Received 13 December 2023 
Accepted 6 March 2024
Correspondence to: Assoc. Prof. Peter Popovič, M.D., Ph.D., University Medical Centre Ljubljana, Clinical Institute of Radiology,  
Zaloška cesta 7, SI-1000 Ljubljana, Slovenia. E-mail: peter.popovic@kclj.si
Maja Sljivic and Masa Sever contributed equally to this work.
Disclosure: No potential conflicts of interest were disclosed.
This is an open access article distributed under the terms of the CC-BY license (https://creativecommons.org/licenses/by/4.0/).
Background. Transarterial chemoembolisation with irinotecan-loaded drug-eluting beads (DEBIRI TACE) can be 
considered in patients with unresectable colorectal cancer liver metastases (CRLM) who progress after all approved 
standard therapies or in patients unsuitable for systemic therapy.
Patients and methods. Between September 2010 and March 2020, thirty patients (22 men and 8 women; mean 
age 66.8 ± 13.2) were included in this retrospective study. DEBIRI TACE was conducted in 43% of patients unsuitable 
for systemic therapy as a first-line treatment and 57% as salvage therapy after the progression of systemic therapy. All 
the patients had liver-limited disease. In the case of unilobar disease, two treatments were performed at four-week 
intervals, and in the case of bilobar disease, four treatments were performed at two-week intervals. All patients were 
premedicated and monitored after the procedure. Adverse events were graded according to the Cardiovascular 
and Interventional Radiological Society of Europe (CIRSE) classification system for complications.
Results. The median overall survival (OS) from the beginning of DEBIRI TACE in the salvage group was 17.4 months; 
in the group without prior systemic therapy, it was 21.6 months. The median overall survival of all patients was 17.4 
months (95% confidence interval [CI]: 10.0–24.7 months), and progression-free survival (PFS) was 4.2 months (95% CI: 
0.9–7.4 months). The one-year survival rate after the procedure was 61%, and the two-year rate was 25%. Univariate 
analysis showed better survival of patients with four or fewer liver metastases (p = 0.002). There were no treatment-
related deaths or grade 4 and 5 adverse events. Nonserious adverse events (Grades 1 and 2) were present in 53% of 
patients, and Grade 3 adverse events were present in 6% of the patients.
Conclusions. DEBIRI TACE is a well-tolerated treatment option for patients with liver metastases of colorectal cancer. 
Patients with four or fewer liver metastases correlated with better survival.
Key words: colorectal cancer; liver metastases; irinotecan; drug-eluting beads; transarterial chemoembolization; 
survival
Radiol Oncol 2024; 58(2): 214-220.
Sljivic M et al. / DEBIRI TACE in patients with colorectal liver metastases 215
Introduction
Colorectal cancer (CRC) is Europe’s second most 
frequently diagnosed malignancy and the second 
most common cause of death due to cancer (ex-
cluding skin carcinomas).1,2 At the time of diagno-
sis, 25% of patients have already developed CRC 
metastases, and 25−35% of patients will develop 
metastases in the later stages of their disease.3 The 
liver is the most common site of CRC metastases 
(CRLM). The disease progression in the liver is a 
significant source of complications and death.4,5 
The only curative treatment option for CRLM is 
surgical resection.4,6 Unfortunately, most (approx. 
70−80%) metastases are unresectable.7,8 The ther-
apy of choice for non-resectable CRLM is multia-
gent systemic chemotherapy, such as FOLFOX or 
FOLFIRI, and targeted agents, including epider-
mal growth factor receptor (EGFR) and vascular 
endothelial growth factor (VEGF) inhibitor.7,8 The 
median overall survival of first-line chemotherapy 
ranges from 12 to 23 months, which is further in-
creased by another two months with the addition 
of anti-VEGF agent bevacizumab. Median overall 
survival (OS) reaches around 30 months with a 
multi-line treatment plan.7,8
Conventional transarterial chemoembolisation 
(TACE) is a selective intraarterial administration 
of chemotherapeutic agents in combination with 
Lipiodol. The newer method uses drug-eluting 
beads (DEB) that cause embolisation and release 
chemotherapeutic agents into the targeted tissue. 
The most used chemotherapeutic agent in TACE 
for CRLM is irinotecan (transarterial chemoembo-
lisation with irinotecan-loaded drug-eluting beads, 
DEBIRI TACE).9 Based on current European Society 
for Medical Oncology (ESMO) guidelines, TACE 
should be considered a possible treatment option 
when patients with metastatic liver-limited disease 
do not respond to systemic chemotherapy.7,8 Studies 
have shown that DEBIRI TACE is an effective and 
safe procedure, with serious high-grade adverse 
reaching up to 11%.9-14 On the other hand, getting as 
much data as possible on how DEBIRI TACE works 
in real life and finding a group of patients who 
would benefit the most from this type of treatment 
is essential. Studies examining prognostic factors 
for determining survival and treatment efficacy in 
patients with CRLM treated with DEBIRI TACE are 
rare.11,12,13 Research is ongoing, and most authors 
suggest that further research is needed. Therefore, 
additional clinical and radiological prognostic fac-
tors are required to choose the appropriate patient 
profile for treatment with DEBIRI TACE. 
This retrospective study investigated the safety 
and prognostic factors in predicting overall sur-
vival in patients with CRLM treated with DEBIRI 
TACE. 
Patients and methods
Study design and patient selection
This single-centre retrospective study was ap-
proved by the Republic of Slovenia National 
Medical Ethics Committee (0120-115/2020/9). The 
study complied with the protocol and principles 
in the Declaration of Helsinki. Between September 
2010 and March 2020, 30 patients with unresect-
able liver metastases of colorectal cancer who did 
not respond to systemic therapy, had contraindi-
cation to systemic therapy or non-tolerance to sys-
temic chemotherapy underwent treatment with 
DEBIRI TACE after a tumour board review. All the 
patients had liver-limited disease. The presence of 
metastases that exceeded 70% of the liver volume 
and the occurrence of metastases outside the liver 
were considered exclusion criteria. All patients 
had a life expectancy longer than three months 
and an Eastern Cooperative Oncology Group 
(ECOG) score equal to 2 or lower before the first 
DEBIRI TACE treatment.
Data analysis
All data were obtained by reviewing patient files. 
The following variables were collected – baseline 
demographic and clinical data (age, sex, ECOG 
performance status, tumour location), peripro-
cedural complications, duration of hospital stay, 
previous cycles of systemic therapy, number of 
metastases, type of liver impairment (unilobar or 
bilobar), values of tumour markers carcinoembry-
onic antigen (CEA) and cancer antigen 19-9 (CA 19-
9) before and after treatment, radiological tumour 
progression, and survival. Limit values for tumour 
markers were used based on estimated upper nor-
mal plasma levels (for CEA ≤ 5 µg/L, CA19-9 ≤ 37 
kU/L). Variables assessed as possible prognostic 
factors were age, ECOG status, tumour location, 
previous systemic therapy, number of metastases, 
uni- or bilobar disease, CEA and CA 19-9 before 
the first treatment, and rise or fall of tumour mark-
ers after the first treatment.
All adverse events were graded according to the 
Cardiovascular and Interventional Radiological 
Society of Europe (CIRSE) classification system for 
complications.15 Tumour response was assessed 
Radiol Oncol 2024; 58(2): 214-220.
Sljivic M et al. / DEBIRI TACE in patients with colorectal liver metastases216
using the Response Evaluation Criteria in Solid 
Tumours (RECIST) and modified RECIST (mRE-
CIST) criteria. 
Survival was calculated as the time from the 
first DEBIRI to death or to the end of follow-up 
(July 20, 2020). Survival analysis was performed by 
using the Kaplan-Meier method. Progression-free 
survival (PFS) was calculated from the date of the 
first DEBIRI to disease progression or death from 
any cause. Survival endpoints for each factor were 
estimated according to Kaplan-Meier analysis and 
compared with the log-rank test. The p-values are 
two-sided and considered statistically significant 
at ≤ 0.05. Data were analysed using the statistical 
software SPSS 25 for Windows (IBM Corp., NY, 
USA).
Treatment 
Premedication included intravenous hydration, 
opioid analgesic, corticosteroid, antiemetic, and 
antibiotic prophylaxis. Intraprocedural pain was 
managed by a continuous intravenous infusion 
containing morphine (20 mg) combined with the 
nonsteroidal anti-inflammatory agent ketorolac 
(20 mg), starting two hours before the procedure 
for 24 hours. The procedure was performed in an 
angiography suite in local anaesthesia through 
the femoral approach. First, preliminary diagnos-
tic angiography was performed to evaluate hepat-
ic arterial supply. Then, a microcatheter (Progreat, 
Terumo Europe N.V, Belgium) was introduced in-
to the left or right hepatic artery, followed by 2−4 
mL intraarterial application of 1% lidocaine and 2 
ml solution of microparticles loaded with 100 mg 
of irinotecan, respectively. Over time, the size of 
microparticles has changed noticeably. Initially, 
DC beads (Boston Scientific, Marlborough, 
Massachusetts) ranging between 100 and 300 
micrometres in size were used. Later, there was 
a move towards using smaller particles, such as 
DC beads M1 ranging from 75 to 100 microme-
tres, and Tandem 100 micrometre beads (Tandem, 
Boston Scientific, Marlborough, Massachusetts) in 
the following years. The procedure was consid-
ered successful if at least 50% of the planned dose 
(50 mg of irinotecan-loaded beads) was delivered. 
In the case of unilobar disease, two treatments 
were performed at four-week intervals, and in the 
case of bilobar disease, four treatments were per-
formed at two-week intervals. The patient’s vital 
signs and femoral access site were monitored after 
the procedure.
Results
Between September 2010 and March 2020, 30 pa-
tients with histologically confirmed colorectal 
adenocarcinoma with liver-only metastases (22 
men and 8 women; mean age 66,8 ± 13,2) were in-
cluded in the study. DEBIRI TACE was conducted 
as a first-line treatment in 43% of patients unsuit-
able for systemic therapy and as salvage therapy 
after systemic therapy in 57%. In the second group, 
100% (17 patients) were treated with the first line, 
71% (12 patients) additionally with the second 
line and 47% (8 patients) with third-line systemic 
therapy. Eighty two percent of patients on sys-
temic chemotherapy were treated in combination 
with targeted therapies. Patient characteristics are 
shown in Table 1. 
Treatment compliance and safety 
113 DEBIRI procedures were performed with a me-
dian of 4 treatments per patient (ranging from 2 
to 8). All procedures were technically successful. 
After the procedure, patients were hospitalised 
TABLE 1. Patient demographics and clinicopathological 
features
Age in years
Median (range) 68 (34–85)
Sex n (%) 
Male 22 (73)
Female 8 (27)
Primary tumour
Colon 16 (53)
Rectum 14 (47)
ECOG performance status
0 18 (60)
1 9 (30)
2 3 (10)
Liver metastases  
Unilobar 17 (57)
Bilobar 13 (43)
≤ 4 lesions 19 (63)
> 4 lesions 11 (37)
Previous chemotherapy  
Yes 17 (57)
No 13 (43)
Radiol Oncol 2024; 58(2): 214-220.
Sljivic M et al. / DEBIRI TACE in patients with colorectal liver metastases 217
for a median of 4 days (ranging from 2 to 10 days). 
There were no treatment-related deaths or grade 4 
and 5 adverse events. Non-serious adverse events 
were present in 53% of patients. Most of them 
were minor (grades 1 and 2). They contributed to 
post-embolic syndrome (PES) with significant ab-
dominal pain in 43% of patients, vomiting in 6% of 
patients, nausea in 16%, diarrhoea in 3%, acute hy-
pertension in 10%, and fever in 6% of patients. The 
PES symptoms were managed conservatively with 
hydration and non-steroidal anti-inflammatory 
drugs. The majority resolved in 48 hours. Seven 
(6%) high-grade adverse events (grade 3) occurred, 
including longer stay for pain management (n = 2), 
prolongation of hospitalisation due to the manage-
ment of PES (n = 4) and PES requiring readmission 
(n = 1). 
Survival and prognostic factors
During the follow-up time, 26 of the patients died, 
and 4 remained alive. The median OS from the 
first DEBIRI TACE procedure was 17.4 months 
(95% confidence interval [CI]: 10,0–24,7 months) 
(Figure 1). The 1-year survival rate from the first 
DEBIRI TACE procedure was 61%, and 2-year 
survival rate was 25%. The median PFS from the 
first DEBIRI TACE was 4.2 months (95% CI: 0,9–7.4 
months) (Figure 2). The most common site of pro-
gression was the liver (20 patients), with the lungs 
being the second (6 patients). Other progression 
sites included adrenal glands, lymph nodes, the 
primary tumour site and the vertebrae. 
In 17 patients treated with systemic therapy and 
DEBIRI TACE, median OS and PFS from the be-
ginning of systemic therapy were 44.6 months and 
37.0 months, respectively (Figures 3 and 4).
The median OS from the beginning of DEBIRI 
TACE in the 17 patients where DEBIRI TACE was 
used as salvage therapy was 17.4 months (95% CI: 
11.0–23.7 months), and in the group without prior 
systemic therapy, the median OS was 21.6 months 
(95% CI: 3.8–39.4 months) (Table 2).  
Results from the univariate analysis between 
10 clinical and radiological characteristics and 
OS are reported in Table 2. There were no data 
on levels of CEA and CA 19-9 for three patients 
before DEBIRI TACE treatment. Further, four pa-
tients had no data on CEA and CA 19-9 levels after 
the treatment. Univariate analysis showed better 
survival of patients with four or fewer liver me-
tastases (p = 0.002). Age (p = 0.284), ECOG status 
(p = 0.805), tumour location (p = 0.145), previous 
systemic chemotherapy (p = 0.472), uni- or bilobar 
disease (p = 0.106), CEA and CA 19-9 before (p = 
0.591;0.393) and after (p = 0.037;0.583) the treatment 
did not prove to be statistically significant predic-
tors of survival.
Discussion
The first-line treatment for patients with unresect-
able CRLM is chemotherapy with consideration of 
additional targeted therapies, usually anti-VEGF or 
anti-EGFR antibodies – a regimen usually well tol-
erated, even in elderly patients.8¸16 When the liver is 
the sole or predominant site of metastases, and the 
response to systemic therapy is insufficient or sys-
temic therapy is contraindicated or unsuitable, lo-
coregional treatment options such as TACE should 
FIGURE 1. Overall survival (OS) from the beginning of irinotecan-loaded drug-
eluting beads (DEBIRI) treatment.
FIGURE 2. Progression-free survival (PFS) from the beginning of irinotecan-loaded 
drug-eluting beads (DEBIRI) treatment.
Radiol Oncol 2024; 58(2): 214-220.
Sljivic M et al. / DEBIRI TACE in patients with colorectal liver metastases218
be considered.7,8 The introduction of DEBIRI TACE 
improved the ability to administer higher con-
centrations of irinotecan to liver metastases while 
reducing the systemic peaks of irinotecan, thus 
minimising side - effects. DEBIRI TACE has been 
proven safe and effective in treating CRLM and is 
more frequently used than in the past.11,12,13
In our study, DEBIRI TACE was conducted in 
43% of patients as a first-line treatment and 57% 
as salvage therapy for patients who had received 
previous lines of systemic therapy (patients who 
did not tolerate more cycles of chemotherapy). Our 
study’s median OS from the beginning of DEBIRI 
TACE was 17.4 months, with progression-free sur-
vival of 4.2 months. This aligns with the previ-
ously reported trials with median OS and PFS for 
DEBIRI TACE of 18 months (ranging from 7.3 to 25) 
and 6.7 months (ranging from 4 to 11), respective-
ly.9,11 In the salvage therapy group, the median OS 
was 44,6 months from the beginning of treatment 
with systemic therapy, confirming the usefulness 
of DEBIRI TACE as salvage therapy.
In our study, not all patients received sys-
temic therapy before DEBIRI TACE treatment. 
Interestingly, the group without previous systemic 
therapy had longer OS from the start of DEBIRI 
TACE treatment than the previously treated 
group. Although the difference in survival is not 
statistically significant, it does raise a question as 
to whether TACE should be implemented sooner. 
One such study was done by Martin et al., com-
paring OS, PFS and tumour response between 
patients who underwent concurrent systemic 
therapy (FOLFOX and bevacizumab) and DEBIRI 
TACE and patients who were treated with sys-
temic therapy alone. The group simultaneously 
TABLE 2. Univariate analysis – influence of probable prognostic factors on overall survival
Characteristics n (%) OS 95 % CI p-value
Age ≤ 65 years 11 (37) 15.2 8.5–21.8
0.284
Age > 65 years 19 (63) 21.6 4.7–38.4.
Colon 16 (53) 23.7 16.8–30.5
0.145
Rectum 14 (47) 14.1 6.8–21.4
ECOG 0 18 (60) 19.8 11.3–28.4
0.805
ECOG 1 or 2 12 (40) 17.4 10.0–29.7
Previous chemotherapy 17 (57) 17.4 11.0–23.7
0.472
No previous chemotherapy 13 (43) 21.6 3.8–39.4
Unilobar disease 17 (57) 23.5 7.4–39.6
0.106
Bilobar disease 13 (43) 15.2 1.9–28.4
≤ 4 liver lesions 19 (63) 23.5 15.5–31.5
0.002
> 4 liver lesions 11 (37) 10.8 0.3–21.3
CEA ≤ 5 µg/L before the first DEBIRI TACE 5 (27) 17.4 5.9–28.9
0.591
CEA > 5 µg/L before the first DEBIRI TACE 22 (73) 15.2 9.2–21.1
Increase of serum CEA after first DEBIRI TACE 10 (33) 14.1 7.3–20.9
0.037Decrease of serum CEA after first DEBIRI TACE 12 (40) 24.7 7.0–42.4
CEA stayed the same 1 (3) 25.5
CA 19-9 ≤ 37 kU/L before first DEBIRI TACE 16 (53) 15.2 10.1–20.2
0.393
CA 19-9 > 37 kU/L before first DEBIRI TACE 11 (47) 17.4 0.5–34.2
Increase of serum CA 19-9 after first DEBIRI TACE 11 (48) 15.2 11.7–18.7
0.583Decrease of serum CA 19-9 after first DEBIRI TACE 10 (43) 19.8 0.0–44.9
CA 19-9 stayed the same 2 (9) 7.4
CA 19-9 = cancer antigen 19-9; CEA = carcinoembryonic antigen; DEBIRI TACE = irinotecan-loaded drug-eluting beads transarterial 
chemoembolization; ECOG = Eastern Cooperative Oncology Group preformance status; OS = overall survival
Radiol Oncol 2024; 58(2): 214-220.
Sljivic M et al. / DEBIRI TACE in patients with colorectal liver metastases 219
treated with TACE had better tumour response in 
the first six months and longer PFS (15.3 months in 
the TACE arm versus 7.6 months in the arm with 
chemotherapy alone).14 These results require fur-
ther exploration into the viability of DEBIRI TACE 
treatment not only as salvage therapy but also as 
consolidation treatment in combination with sys-
temic therapy for unresectable CRLM. One of the 
potential reasons for better survival in patients 
without previous systemic therapy may be irinote-
can resistance. Some authors report that DEBIRI 
TACE shows less efficacy if applied after previous 
systemic therapy due to irinotecan resistance.11 
The reason for irinotecan resistance could be in-
creased expression of EGFR receptors or active 
efflux, reducing the drug’s intracellular accumu-
lation after the previously used chemotherapeutic 
agent irinotecan.10,11,17 
Clinical and radiological factors that affect sur-
vival have yet to be determined. Our study is one 
of the first to ascertain prognostic factors affecting 
the survival of patients with CRLM treated with 
DEBIRI TACE. We found that patients with four or 
fewer liver metastases survived better than those 
with more. However, the size of lesions varies con-
siderably; therefore, the number of lesions usu-
ally doesn’t give an accurate assessment of liver 
impairment. Thus, the metastatic volume would 
probably be a better predictive factor in further 
studies. One study where they used DEBIRI and 
capecitabine in heavily pre-treated patients found 
a statistically significant correlation between the 
decrease in CEA after the first DEBIRI treatment 
and survival.18,19 Another study found that patients 
with an ECOG of 0 had better survival than those 
with an ECOG of 1 or 2.20 While no such correlation 
was found in our research, more extensive studies 
should be performed to confirm these findings.
Safety of the procedure is also a primary con-
cern, and we have shown that the number of sig-
nificant adverse events (grade 3) is low, with only 
6%. This is similar to recently published evidence 
on the CIREL registry, with 10% of grade 3 and 
4% of grade 4 adverse events.21 The most com-
mon mild AE (grades 1 and 2) after the procedure 
is post-embolic syndrome (PES). The incidence of 
PES after DEBIRI TACE varies between studies, 
with a median incidence of 57%.9 Our study shows 
that 53% of patients had nonserious mild adverse 
events that contributed to PES, which is compa-
rable to other studies.9,21 We assume that the low 
percentage of serious adverse effects is due to good 
premedication with antibiotics, antiemetic and in-
travenous hydration before and during the proce-
dure and peri-procedural pain management with 
morphine and intra-arterial lidocaine. 
DEBIRI TACE is a relatively new procedure in 
interventional oncology, performed primarily in 
larger centres on a specific group of patients; there-
fore, data from the literature are usually based on 
small populations. Such studies have difficulty 
recognising any essential prognostic factors that 
could affect survival, yet the lack of such clinical 
and radiological markers makes patient selection 
difficult. 
The limitations of this study were retrospective 
design, the small number of patients evaluated, 
data on biomarkers and molecular targets not be-
FIGURE 3. Overall survival (OS) of patients with prior systemic chemotherapy from 
the beginning of systemic treatment.
FIGURE 4. Progression-free survival (PFS) of patients with prior systemic 
chemotherapy from the beginning of systemic treatment.
Radiol Oncol 2024; 58(2): 214-220.
Sljivic M et al. / DEBIRI TACE in patients with colorectal liver metastases220
ing collected, and the heterogeneity of the patient 
population.
In conclusion, DEBIRI TACE is a safe and effec-
tive treatment option for patients with CRLM re-
fractory to systemic therapy. Our research found 
that four or fewer liver metastases correlated with 
better survival. Further studies are required to 
determine the role of DEBIRI TACE in treatment 
strategies for CRLM, as well as to recognise prog-
nostic factors that would make patient selection 
easier.
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