Outcome and Safety after 103 Radioembolizations with Yttrium-90 Resin Microspheres in 73 Patients with Unresectable Intrahepatic Cholangiocarcinoma—An Evaluation of Predictors
Abstract
:Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. Patient Selection
2.2. Dosimetry for Radioembolization
2.3. Radioembolization Procedure
2.4. Follow-Up: Response, Toxicity, Survival
2.5. Statistical Analyses
3. Results
3.1. Outcome—Treatment Response (RECIST)
3.2. Outcome—Survival
3.3. Safety
4. Discussion
4.1. Outcomes, Previous Results, and Predictors
4.2. Safety of TARE in ICC
4.3. Treatment Alternatives
4.4. Limitations
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Variable | No. of Patients | % |
---|---|---|
Total cohort | 73 | 100 |
Age | ||
<65 years | 31 | 42 |
≥65 years | 42 | 58 |
Male | 40 | 55 |
Previous therapies | ||
Surgery | 23 | 32 |
Radiofrequency ablation | 1 | 1 |
Prior trans-arterial chemoembolization | 4 | 5 |
Prior chemotherapy | 52 | 71 |
Tumor characteristics | ||
Extra-hepatic disease | 37 | 51 |
Tumor burden | ||
≤25% | 44 | 60 |
26–50% | 24 | 33 |
>50% | 5 | 7 |
Laboratory data | ||
Bilirubin (absolute) | ||
≤0.6 mg/dL | 44 | 60 |
0.7–1.2 mg/dL | 29 | 40 |
Cholinesterase (absolute) | ||
Within normal limits (≥4.62 kU/L) | 59 | 81 |
Below normal limits (<4.62 kU/L) | 14 | 19 |
Treatment Concept (Patients) | n (%) | Calculated Dose | Applied Dose | ||
---|---|---|---|---|---|
Median Dose | Interquartile Range | Median Dose | Interquartile Range | ||
Overall | 73 | 1500 | 933–1940 | 1373 | 881–1848 |
Location | |||||
One lobe, single session | 25 (34%) | 1067 | 412–2500 | 1050 | 404–2157 |
Whole liver, single session | 25 (34%) | 1960 | 750–2500 | 1887 | 740–2475 |
Whole liver, two sessions | 17(23%) | 1000 | 400–1500 | 1009 | 390–1512 |
Multiple treatments | 6 (8%) | 966.5 | 560–2000 | 1000.5 | 564–1874 |
Category | n (%) | Overall Survival (Months) | Progression Free Survival (Months) | ||||
---|---|---|---|---|---|---|---|
Median | 95% CI | p-value | Median | 95% CI | p-value | ||
All patients | 11.82 | 7.32–16.32 | 6.41 | 5.20–7.61 | |||
Tumor burden | 11.83 | 7.32–16.32 | 6.40 | 5.2–7.61 | |||
≤25% | 44 (60%) | 15.21 | 8.86–21.56 | (reference) | 6.93 | 3.67–10.19 | (reference) |
26–50% | 24 (33%) | 9.62 | 4.54–14.70 | 0.963 | 4.27 | 0.34–8.19 | 0.515 |
>50% | 5 (7%) | 6.60 | 2.16–11.04 | 0.036 | 2.79 | 2.72–2.86 | 0.143 |
CA-19-9 response | 11.95 | 7.53–16.38 | 6.73 | 5.58–7.88 | |||
Yes | 20 (27%) | 20.96 | 10.44–31.48 | (reference) | 6.93 | 0.0–15.74 | (reference) |
No | 53 (73%) | 10.81 | 7.74–13.88 | 0.098 | 6.21 | 4.38–8.04 | 0.654 |
RECIST response | 11.82 | 7.32–16.32 | 6.40 | 5.20–7.60 | |||
Partial response | 18 (25%) | 15.21 | 10.64–19.77 | (reference) | 10.59 | 5.68–15.47 | (reference) |
Stable disease | 36 (49%) | 20.96 | 13.55–28.37 | 0.637 | 10.05 | 6.54–13.56 | 0.634 |
Progressive disease | 19 (26%) | 6.60 | 3.99–9.21 | <0.001 | 2.76 | 2.28–3.23 | <0.001 |
Bilirubin | 11.46 | 7.94–14.98 | 6.20 | 4.67–7.74 | |||
<0.6 mg/dL | 44 (60%) | 11.95 | 8.75–15.16 | (reference) | 6.76 | 4.83–8.69 | (reference) |
0.7–1.2 mg/dL | 29 (40%) | 8.903 | 4.19–13.61 | 0.419 | 5.55 | 4.40–6.70 | 0.967 |
Cholinesterase | 10.87 | 7.88–13.86 | 6.40 | 5.08–7.73 | |||
≥4.62 kU/L | 59 (81%) | 14.0 | 8.59–19.59 | (reference) | 6.93 | 3.56–10.30 | (reference) |
<4.62 kU/L | 14 (19%) | 5.52 | 3.51–7.52 | <0.001 | 3.22 | 2.68–3.76 | 0.001 |
Treatment cycles | 11.83 | 7.33–16.30 | 6.41 | 5.20–7.61 | |||
One | 67 (92%) | 10.81 | 7.78–13.84 | (reference) | 5.78 | 4.69–6.88 | (reference) |
Multiple | 6 (8%) | 28.35 | 9.74–46.97 | 0.156 | 24.44 | 0.0–52.067 | 0.04 |
Laboratory Value | Baseline | Follow-Up (Discharge) | Follow-Up (3 Months Post Radioembolization) | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Median | IQR | Median | IQR | Change from Baseline | Median | IQR | Change from Baseline | |||
Abs. | Rel. in % | Abs. | Rel. in % | |||||||
Bilirubin (mg/dL) | 0.60 | 0.5–0.8 | 0.7 | 0.55–1.0 | 0.1 | 11.81 | 0.7 | 0.6–1.2 | 0.1 | 25 |
Serum cholinesterase (kU/L) | 6.62 | 5.27–7.58 | 5.79 | 4.55–6.85 | −0.85 | −12.8 | 5.90 | 4.54–6.89 | −0.87 | −11.03 |
Albumin (g/dL) | 4.25 | 4.0–4.5 | 3.8 | 3.5–4.0 | −0.40 | −9.64 | 4.1 | 3.3–4.4 | −0.2 | −4.13 |
Thrombocytes (Thousand/µL) | 197 | 150.5–253.0 | 160.0 | 114.0–197.5 | −39.0 | −22.06 | 147.5 | 116.25–191.25 | −36.5 | −20.04 |
C-reactive protein (mg/dL) | 0.9 | 0.5–1.85 | 1.8 | 0.8–5.2 | 0.4 | 50 | 1.25 | 0.6–2.7 | 0.3 | 36.67 |
Symptoms | No Events | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | |
---|---|---|---|---|---|---|---|
Acute | Nausea | 51 (70%) | 8 (11%) | 11 (15%) | 3 (4%) | 0 | 0 |
Vomiting | 65 (89%) | 8 (11%) | 0 | 0 | 0 | 0 | |
Pain | 52 (71%) | 11 (15%) | 8 (11%) | 2 (3%) | 0 | 0 | |
Fever | 67 (92%) | 5 (7%) | 1 (1%) | 0 | 0 | 0 | |
Late | Gastritis | 66 (90%) | 0 | 3 (4%) | 4 (5%) | 0 | 0 |
Pancreatitis | 71 (97%) | 2 (3%) | 0 | 0 | 0 | 0 | |
Cholecystits | 73 (100%) | 0 | 0 | 0 | 0 | 0 | |
Up to 3 months after radioembolization | REILD | 73 (100%) | 0 | 0 | 0 | 0 | 0 |
Skin necrosis | 73 (100%) | 0 | 0 | 0 | 0 | 0 |
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Paprottka, K.J.; Galiè, F.; Ingrisch, M.; Geith, T.; Ilhan, H.; Todica, A.; Michl, M.; Nadjiri, J.; Paprottka, P.M. Outcome and Safety after 103 Radioembolizations with Yttrium-90 Resin Microspheres in 73 Patients with Unresectable Intrahepatic Cholangiocarcinoma—An Evaluation of Predictors. Cancers 2021, 13, 5399. https://doi.org/10.3390/cancers13215399
Paprottka KJ, Galiè F, Ingrisch M, Geith T, Ilhan H, Todica A, Michl M, Nadjiri J, Paprottka PM. Outcome and Safety after 103 Radioembolizations with Yttrium-90 Resin Microspheres in 73 Patients with Unresectable Intrahepatic Cholangiocarcinoma—An Evaluation of Predictors. Cancers. 2021; 13(21):5399. https://doi.org/10.3390/cancers13215399
Chicago/Turabian StylePaprottka, Karolin J., Franziska Galiè, Michael Ingrisch, Tobias Geith, Harun Ilhan, Andrei Todica, Marlies Michl, Jonathan Nadjiri, and Philipp M. Paprottka. 2021. "Outcome and Safety after 103 Radioembolizations with Yttrium-90 Resin Microspheres in 73 Patients with Unresectable Intrahepatic Cholangiocarcinoma—An Evaluation of Predictors" Cancers 13, no. 21: 5399. https://doi.org/10.3390/cancers13215399