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Erschienen in: International Journal of Clinical Oncology 7/2021

11.04.2021 | Original Article

Association of albumin–bilirubin score in patients with colorectal cancer receiving later-line chemotherapy with regorafenib

verfasst von: Daichi Watanabe, Hironori Fujii, Yunami Yamada, Nobuhisa Matsuhashi, Akitaka Makiyama, Hirotoshi Iihara, Takao Takahashi, Shigeru Kiyama, Ryo Kobayashi, Kazuhiro Yoshida, Akio Suzuki

Erschienen in: International Journal of Clinical Oncology | Ausgabe 7/2021

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Abstract

Background

Regorafenib is recognized as a later-line standard treatment in patients with metastatic colorectal cancer (mCRC). In this study, we examined the association of the albumin–bilirubin (ALBI) score in patients with mCRC receiving later-line chemotherapy with regorafenib.

Patients and methods

We retrospectively analyzed data from patients with mCRC treated with regorafenib in a later line between January 2013 and December 2019. Patients were divided into a Normal-ALBI group (ALBI grade 1) and a High-ALBI group (ALBI grades 2 and 3). Primary endpoint was median overall survival (OS) and secondary endpoints were median time to treatment failure (TTF) and incidence of adverse events (AEs).

Results

Data from 60 patients were analyzed (Normal-ALBI group: 32 patients and High-ALBI group: 28 patients). Median OS [10.23 vs. 3.70 months, hazard ratio (HR): 1.79, 95% confidence interval (CI) 1.02–3.13, p = 0.041] and median TTF (2.27 vs. 1.78 months, HR: 1.78, 95%CI 1.02–3.09, p = 0.042) were significantly longer in the Normal-ALBI group than High-ALBI group. On Cox proportional hazard analysis, ALBI score was significantly correlated with OS. The incidence of liver dysfunction (grade ≥ 2) was significantly higher in the High-ALBI than the Normal-ALBI group (42.9% vs. 15.6%, p = 0.041), whereas other AEs were comparable between the two groups.

Conclusion

ALBI was strongly associated with the prognosis of patients with mCRC treated with regorafenib and with the occurrence of liver-related adverse events. These findings may imply that patients with a high ALBI score should not be treated with regorafenib.
Literatur
1.
Zurück zum Zitat Grothey A, Van Cutsem E, Sobrero A et al (2013) Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet 381:303–312CrossRef Grothey A, Van Cutsem E, Sobrero A et al (2013) Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet 381:303–312CrossRef
2.
Zurück zum Zitat Moriwaki T, Fukuoka S, Masuishi T et al (2020) Prognostic scores for evaluating the survival benefit of regorafenib or trifluridine/tipiracil in patients with metastatic colorectal cancer: an exploratory analysis of the REGOTAS study. Int J Clin Oncol 25:614–621CrossRef Moriwaki T, Fukuoka S, Masuishi T et al (2020) Prognostic scores for evaluating the survival benefit of regorafenib or trifluridine/tipiracil in patients with metastatic colorectal cancer: an exploratory analysis of the REGOTAS study. Int J Clin Oncol 25:614–621CrossRef
3.
Zurück zum Zitat Aljubran A, Elshenawy MA, Kandil M et al (2019) Efficacy of regorafenib in metastatic colorectal cancer: a multi-institutional retrospective study. Clin Med Insights Oncol 13:1179554918825447CrossRef Aljubran A, Elshenawy MA, Kandil M et al (2019) Efficacy of regorafenib in metastatic colorectal cancer: a multi-institutional retrospective study. Clin Med Insights Oncol 13:1179554918825447CrossRef
4.
Zurück zum Zitat Del Prete M, Giampieri R, Loupakis F et al (2015) Prognostic clinical factors in pretreated colorectal cancer patients receiving regorafenib: implications for clinical management. Oncotarget 6:33982–33992CrossRef Del Prete M, Giampieri R, Loupakis F et al (2015) Prognostic clinical factors in pretreated colorectal cancer patients receiving regorafenib: implications for clinical management. Oncotarget 6:33982–33992CrossRef
5.
Zurück zum Zitat Adenis A, de la Fouchardiere C, Paule B et al (2016) Survival, safety, and prognostic factors for outcome with Regorafenib in patients with metastatic colorectal cancer refractory to standard therapies: results from a multicenter study (REBACCA) nested within a compassionate use program. BMC Cancer 16:412CrossRef Adenis A, de la Fouchardiere C, Paule B et al (2016) Survival, safety, and prognostic factors for outcome with Regorafenib in patients with metastatic colorectal cancer refractory to standard therapies: results from a multicenter study (REBACCA) nested within a compassionate use program. BMC Cancer 16:412CrossRef
6.
Zurück zum Zitat US Food and Drug Administration. Clinical pharmacology and biopharmaceutics review(s) (2014). Accessed 30 Aug 2020 US Food and Drug Administration. Clinical pharmacology and biopharmaceutics review(s) (2014). Accessed 30 Aug 2020
7.
Zurück zum Zitat European Medicines Agency. Summary of product characteristics (2014). Accessed 30 Aug 2020 European Medicines Agency. Summary of product characteristics (2014). Accessed 30 Aug 2020
8.
Zurück zum Zitat Kim HD, Bang Y, Lee MA et al (2020) Regorafenib in patients with advanced Child-Pugh B hepatocellular carcinoma: a multicentre retrospective study. Liver Int 40:2544–2552CrossRef Kim HD, Bang Y, Lee MA et al (2020) Regorafenib in patients with advanced Child-Pugh B hepatocellular carcinoma: a multicentre retrospective study. Liver Int 40:2544–2552CrossRef
9.
Zurück zum Zitat Moriwaki T, Fukuoka S, Taniguchi H et al (2018) Propensity score analysis of regorafenib versus trifluridine/tipiracil in patients with metastatic colorectal cancer refractory to standard chemotherapy (REGOTAS): A Japanese society for cancer of the colon and rectum multicenter observational study. Oncologist 23:7–15CrossRef Moriwaki T, Fukuoka S, Taniguchi H et al (2018) Propensity score analysis of regorafenib versus trifluridine/tipiracil in patients with metastatic colorectal cancer refractory to standard chemotherapy (REGOTAS): A Japanese society for cancer of the colon and rectum multicenter observational study. Oncologist 23:7–15CrossRef
10.
Zurück zum Zitat Seo AN, Kim H (2014) Sinusoidal obstruction syndrome after oxaliplatin-based chemotherapy. Clin Mol Hepatol 20:81–84CrossRef Seo AN, Kim H (2014) Sinusoidal obstruction syndrome after oxaliplatin-based chemotherapy. Clin Mol Hepatol 20:81–84CrossRef
11.
Zurück zum Zitat Bethke A, Kühne K, Platzek I et al (2011) Neoadjuvant treatment of colorectal liver metastases is associated with altered contrast enhancement on computed tomography. Cancer Imaging 11:91–99CrossRef Bethke A, Kühne K, Platzek I et al (2011) Neoadjuvant treatment of colorectal liver metastases is associated with altered contrast enhancement on computed tomography. Cancer Imaging 11:91–99CrossRef
12.
Zurück zum Zitat Johnson PJ, Berhane S, Kagebayashi C et al (2015) Assessment of liver function in patients with hepatocellular carcinoma: a new evidence-based approach-the ALBI grade. J Clin Oncol 33:550–558CrossRef Johnson PJ, Berhane S, Kagebayashi C et al (2015) Assessment of liver function in patients with hepatocellular carcinoma: a new evidence-based approach-the ALBI grade. J Clin Oncol 33:550–558CrossRef
13.
Zurück zum Zitat Toyoda H, Lai PB, O’Beirne J et al (2016) Long-term impact of liver function on curative therapy for hepatocellular carcinoma: application of the ALBI grade. Br J Cancer 114:744–750CrossRef Toyoda H, Lai PB, O’Beirne J et al (2016) Long-term impact of liver function on curative therapy for hepatocellular carcinoma: application of the ALBI grade. Br J Cancer 114:744–750CrossRef
14.
Zurück zum Zitat Wang YY, Zhong JH, Su ZY et al (2016) Albumin–bilirubin versus Child-Pugh score as a predictor of outcome after liver resection for hepatocellular carcinoma. Br J Surg 103:725–734CrossRef Wang YY, Zhong JH, Su ZY et al (2016) Albumin–bilirubin versus Child-Pugh score as a predictor of outcome after liver resection for hepatocellular carcinoma. Br J Surg 103:725–734CrossRef
15.
Zurück zum Zitat Ogasawara S, Chiba T, Ooka Y et al (2015) Liver function assessment according to the Albumin–bilirubin (ALBI) grade in sorafenib-treated patients with advanced hepatocellular carcinoma. Invest New Drugs 33:1257–1262CrossRef Ogasawara S, Chiba T, Ooka Y et al (2015) Liver function assessment according to the Albumin–bilirubin (ALBI) grade in sorafenib-treated patients with advanced hepatocellular carcinoma. Invest New Drugs 33:1257–1262CrossRef
16.
Zurück zum Zitat Abdel-Rahman O (2019) Prognostic value of baseline ALBI score among patients with colorectal liver metastases: a pooled analysis of two randomized trials. Clin Colorectal Cancer 18:e61–e68CrossRef Abdel-Rahman O (2019) Prognostic value of baseline ALBI score among patients with colorectal liver metastases: a pooled analysis of two randomized trials. Clin Colorectal Cancer 18:e61–e68CrossRef
17.
Zurück zum Zitat Eisenhauer EA, Therasse P, Bogaerts J et al (2009) New response evaluation criteria in solid tumours: revised RECIST guideline (Version 1.1). Eur J Cancer 45:228–247CrossRef Eisenhauer EA, Therasse P, Bogaerts J et al (2009) New response evaluation criteria in solid tumours: revised RECIST guideline (Version 1.1). Eur J Cancer 45:228–247CrossRef
18.
19.
Zurück zum Zitat Zopf D, Fichtner I, Bhargava A et al (2016) Pharmacologic activity and pharmacokinetics of metabolites of regorafenib in preclinical models. Cancer Med 5:3176–3185CrossRef Zopf D, Fichtner I, Bhargava A et al (2016) Pharmacologic activity and pharmacokinetics of metabolites of regorafenib in preclinical models. Cancer Med 5:3176–3185CrossRef
20.
Zurück zum Zitat Uetake H, Sugihara K, Muro K et al (2018) Clinical features of regorafenib-induced liver injury in japanese patients from postmarketing experience. Clin Colorectal Cancer 17:e49–e58CrossRef Uetake H, Sugihara K, Muro K et al (2018) Clinical features of regorafenib-induced liver injury in japanese patients from postmarketing experience. Clin Colorectal Cancer 17:e49–e58CrossRef
21.
Zurück zum Zitat Weng Z, Luo Y, Yang X et al (2015) Regorafenib impairs mitochondrial functions, activates AMP-activated protein kinase, induces autophagy, and causes rat hepatocyte necrosis. Toxicology 327:10–21CrossRef Weng Z, Luo Y, Yang X et al (2015) Regorafenib impairs mitochondrial functions, activates AMP-activated protein kinase, induces autophagy, and causes rat hepatocyte necrosis. Toxicology 327:10–21CrossRef
22.
Zurück zum Zitat Taguchi D, Inoue M, Fukuda K et al (2020) Therapeutic drug monitoring of regorafenib and its metabolite M5 can predict treatment efficacy and the occurrence of skin toxicities. Int J Clin Oncol 25:531–540CrossRef Taguchi D, Inoue M, Fukuda K et al (2020) Therapeutic drug monitoring of regorafenib and its metabolite M5 can predict treatment efficacy and the occurrence of skin toxicities. Int J Clin Oncol 25:531–540CrossRef
Metadaten
Titel
Association of albumin–bilirubin score in patients with colorectal cancer receiving later-line chemotherapy with regorafenib
verfasst von
Daichi Watanabe
Hironori Fujii
Yunami Yamada
Nobuhisa Matsuhashi
Akitaka Makiyama
Hirotoshi Iihara
Takao Takahashi
Shigeru Kiyama
Ryo Kobayashi
Kazuhiro Yoshida
Akio Suzuki
Publikationsdatum
11.04.2021
Verlag
Springer Singapore
Erschienen in
International Journal of Clinical Oncology / Ausgabe 7/2021
Print ISSN: 1341-9625
Elektronische ISSN: 1437-7772
DOI
https://doi.org/10.1007/s10147-021-01910-2

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