Prognostic Value of Baseline ALBI Score Among Patients With Colorectal Liver Metastases: A Pooled Analysis of Two Randomized Trials

doi:10.1016/j.clcc.2018.09.008

Clinical Colorectal Cancer

Volume 18, Issue 1, March 2019, Pages e61-e68

https://doi.org/10.1016/j.clcc.2018.09.008 Get rights and content

Abstract

Background

Baseline albumin-bilirubin (ALBI) score has been shown to be a reliable prognostic predictor among patients with hepatocellular carcinoma. The current study aims at evaluating its prognostic impact among patients with colorectal liver metastases treated with first-line systemic therapy.

Materials and Methods

Through the Project Data Sphere portal, de-identified clinical trial datasets of 2 clinical trials (NCT00115765; PACCE [Panitumumab Advanced Colorectal Cancer Evaluation Study] trial) and (NCT00364013; PRIME [Panitumumab Randomized Trial In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy] trial) were downloaded. Baseline ALBI score was calculated for each included patient in this study. Kaplan-Meier curve/log-rank testing was used to evaluate overall and progression-free survival according to ALBI grades. Additional Cox regression models were run in order to evaluate factors affecting overall and progression-free survival. Factors with P-value < .05 in univariate analysis were included in multivariate analysis.

Results

A total of 1434 patients with colorectal liver metastases were included in this study. Kaplan-Meier survival analysis was conducted to assess the impact of ALBI grade on overall and progression-free survival in the study cohort. For both endpoints, higher ALBI grade was associated with worse overall and progression-free survival (P < .001 for both endpoints). The following factors were significant for overall survival in univariate Cox regression analysis (P < .05): age, Eastern Cooperative Oncology Group (ECOG) score, lactate dehydrogenase (LDH), number of metastatic sites, body mass index, and ALBI score. When these factors were evaluated in multivariate Cox regression analysis, the following factors were predictive of worse overall survival: higher ALBI score (P < .001), higher number of metastatic sites (P < .001), higher LDH (P < .001), higher ECOG score (P < .001), and older age (P < .001). Similarly, the following factors were significant for progression-free survival in univariate Cox regression analysis (P < .05): age, race, ECOG score, LDH, number of metastatic sites, body mass index, type of chemotherapy, and ALBI score. When these factors were evaluated in multivariate Cox regression analysis, the following factors were predictive of worse progression-free survival: higher ECOG score (P < .001), higher LDH level (P < .001), higher number of metastatic sites (P < .001), and higher ALBI score (P < .001).

Conclusions

Higher baseline ALBI score is associated with worse overall and progression-free survival among patients with colorectal liver metastases treated with first-line systemic therapy.

Introduction

Colorectal cancer (CRC) represents one of the most common incident cancers as well as one of the most common causes of cancer deaths worldwide.¹ A considerable proportion of patients with CRC present with de novo metastatic disease. Moreover, many patients with initially localized CRC present later on with distant disease relapse.²

The liver is by far the most common and most prognostically relevant site of metastatic disease. Numerous studies were published to evaluate different prognostic indices/models among patients with colorectal liver metastases.3, 4, 5 However, the impact of baseline functional hepatic status on the outcomes of those patients was not adequately addressed. Moreover, the few studies that tackled the impact of hepatic functional status on the outcomes of those patients were based on retrospectively collected datasets with plenty of potential confounders.⁶

The albumin-bilirubin (ALBI) score is a simplified model that has shown prognostic relevance among patients with newly diagnosed hepatocellular carcinoma.⁷ Its prognostic relevance was proved among patients with early, intermediate, and advanced stages as well as among patients treated with surgery, locoregional treatment, or systemic treatment.8, 9, 10, 11, 12 Moreover, its prognostic value was shown among patients with advanced liver cirrhosis without hepatocellular carcinoma.¹³ It remains to be seen and proven if this score (as a surrogate of the hepatic functional status of patients with colorectal liver metastases) could help predict the outcomes of those patients.

In order to avoid the potential confounding effect of retrospectively collected datasets, the current analysis was based on a number of prospectively collected datasets downloaded from the Project Data Sphere (PDS). The aim of the current study is thus to evaluate the prognostic impact of baseline ALBI score on the outcomes of patients with colorectal liver metastases treated with first-line systemic chemotherapy. The primary hypothesis of this study is that ALBI score – as a measure of liver function – might predict the outcomes of patients with colorectal liver metastases.

Section snippets

About the Project Data Sphere (PDS)

PDS is an international initiative based on a number of stakeholders including governmental agencies and drug companies who work as sponsors for a number of landmark clinical trials.¹⁴ This initiative aims at facilitating the access of interested researchers to de-identified raw data of multiple clinical trials. Such an initiative should hopefully allow making the best use out of previously published clinical trials by asking new research questions on the existing clinical trial datasets.

Clinical Trial Datasets

The

Patients' Characteristics

A total of 1434 patients were included in this study. The median age was 61 years (range, 22-88 years), the median BMI was 25.9 (range, 15.7-58), and the median ALBI score was −2.66 (range, −3.79 to −0.21). Patients with male gender represent 60.2% of the study cohort, patients with white race represent 90.9%, patients with ECOG score of 0 represent 56.2%, and patients with colon as the primary tumor site represent 74.1%. Of the included patients, 32.8% have a single site of metastasis

Discussion

To the best of our knowledge, this is the first study to evaluate the prognostic impact of baseline ALBI score on the outcomes of patients with colorectal liver metastases treated with first-line systemic chemotherapy. This study shows that higher baseline ALBI score is associated with worse overall and progression-free survival outcomes. This prognostic value is independent of other established prognostic factors among patients with metastatic CRC. These findings, coupled with the simplicity

Disclosure

The author has stated that he has no conflicts of interest.

Acknowledgment

This publication is based on research using information obtained from www.projectdatasphere.org, which is maintained by Project Data Sphere, LLC. Neither Project Data Sphere, LLC nor the owner(s) of any information from the website have contributed to, approved, or are in any way responsible for the contents of this publication.

References (18)

R. Labianca et al.
Early colon cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up
Ann Oncol
(2013)
C.H. Lo et al.
Comparison between Child-Turcotte-Pugh and albumin-bilirubin scores in assessing the prognosis of hepatocellular carcinoma after stereotactic ablative radiation therapy
Int J Radiat Oncol Biol Phys
(2017)
J. Hansmann et al.
Albumin-bilirubin and platelet-albumin-bilirubin grades accurately predict overall survival in high-risk patients undergoing conventional transarterial chemoembolization for hepatocellular carcinoma
J Vasc Interv Radiol
(2017)
J.Y. Douillard et al.
Final results from PRIME: randomized phase III study of panitumumab with FOLFOX4 for first-line treatment of metastatic colorectal cancer
Ann Oncol
(2014)
C.R. de Lope et al.
Management of HCC
J Hepatol
(2012)
World Health Organization; International Agency for Research on Cancer. Global Cancer Observatory. Available at:...
J.H. Byun et al.
The impact of primary tumor location in patients with metastatic colorectal cancer: a Korean Cancer Study Group CO12-04 study
Korean J Intern Med
(2017)
S. Karim et al.
Association between prognosis and tumor laterality in early-stage colon cancer
JAMA Oncol
(2017)
O. Abdel-Rahman
Challenging a dogma: five-year survival does not equal cure in all colorectal cancer patients
Expert Rev Anticancer Ther
(2018)

There are more references available in the full text version of this article.

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The albumin–bilirubin (ALBI) score evaluates liver dysfunction severity. However, this score had prognostic effects in patients with hepatocellular, pancreatic, and gastric carcinomas. We aimed to assess the predictive value of the ALBI score in patients with esophageal squamous cell carcinoma (ESCC).
Data from 154 patients with ESCC who consecutively underwent neoadjuvant chemotherapy (NAC) and subtotal esophagectomy were retrospectively investigated. The ALBI score was calculated as pre-NAC ALBI and categorized into grades 1, 2a, 2b, and 3; low-ALBI group (n = 134) was assigned with ALBI grade 1 and the other grades were assigned to the high-ALBI group (n = 20).
The pre-NAC ALBI was significantly associated with relapse-free survival (RFS) and overall survival (P = 0.003 and P = 0.014, respectively). Based on multivariate analysis, pre-NAC ALBI, pathological T factor, and N factor were identified as independent prognostic factors for poor RFS. Multivariate and univariate analyses limited to factors were obtained before treatment, indicating high pre-NAC ALBI as an independent prognostic factor of poor overall survival (P = 0.039) and RFS (P = 0.008). With respect to pathological response to NAC, patients in the high pre-NAC ALBI group had a significantly lower response than patients in the low pre-NAC ALBI group (P = 0.010).
Our results suggested that the pre-NAC ALBI marker predicts the long-term outcome and pathological response to NAC in patients with ESCC consecutively undergoing NAC and a subtotal esophagectomy.
Assessment of the albumin-bilirubin score in breast cancer patients with liver metastasis after surgery
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This study aims to investigate the potential prognostic value of albumin-bilirubin (ALBI) score in breast cancer patients with liver metastasis after surgery.
This was a retrospective study of 178 breast cancer patients with liver metastasis after surgery. ALBI score was calculated by the following formula: (log10 bilirubin × 0.66) − (albumin × 0.085). The optimal cutoff value of ALBI score was assessed by X-tile. The clinical influence of ALBI score on survival outcomes using Kaplan-Meier method, Log-rank test, Cox proportional hazards regression model. The calibration curves, decision curve analysis and time-dependent ROC curve were used to assess the predictive performance of the nomogram's models.
The classifications of 178 breast cancer patients with liver metastasis after surgery were as follows: low ALBI score group (＜−3.36) vs. high ALBI score group (≥−3.36). The Cox proportional hazards regression model indicated that ALBI score was a potential predictor. Kaplan-Meier survival curve performed that the median disease free survival (p = 0.0029) and overall survival (p＜0.0001) in low ALBI score group were longer than in high ALBI score group. The ALBI-based nomograms had good predictive performance.
The ALBI score has high prognostic ability for survival time in breast cancer with liver metastasis after surgery. These models will be valuable in discriminating patients at high risks of liver metastasis.
The effect of albumin-bilirubin on colorectal cancer patients: A meta-analysis
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The ALBI score: From liver function in patients with HCC to a general measure of liver function
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Citation Excerpt :
For example, ALBI has been shown to be prognostic in cancers other than HCC, including pancreatic, colon and gastric cancer, intrahepatic cholangiocarcinoma, extrahepatic bile duct cancer, and even brain cancer (glioma and medulloblastoma).114–136 ALBI is likely to be reflective of liver dysfunction in patients undergoing hepatic resection for intrahepatic tumours, such as intrahepatic cholangiocarcinoma or metastatic liver tumours, and tolerance for those undergoing systemic therapy, including chemotherapies, molecular-targeted drugs and immune checkpoint inhibitors.118,123,126-128,131,133,134 Although most authors have attempted to link the association of ALBI with a particular cancer to liver function, we should consider whether its association with mortality is actually through some aspect of liver dysfunction or whether it simply reflects the prognostic power of serum albumin and bilirubin levels, independent of liver function.
The (albumin-bilirubin) ‘ALBI’ score is an index of ‘liver function’ that was recently developed to assess prognosis in patients with hepatocellular carcinoma, irrespective of the degree of underlying liver fibrosis. Other measures of liver function, such as model for end-stage liver disease (MELD) and Child-Pugh score, which were introduced for specific clinical scenarios, have seen their use extended to other areas of hepatology. In the case of ALBI, its application has been increasingly extended to chronic liver disease in general and in some instances to non-liver diseases where it has proven remarkably accurate in terms of prognosis. With respect to chronic liver disease, numerous publications have shown that ALBI is highly prognostic in patients with all types and stages of chronic liver disease. Outside of liver disease, ALBI has been reported as being of prognostic value in conditions ranging from chronic heart failure to brain tumours. Whilst in several of these reports, explanations for the relationship of liver function to a clinical condition have been proposed, it has to be acknowledged that the specificity of ALBI for liver function has not been clearly demonstrated. Nonetheless, and similar to the MELD and Child-Pugh scores, the lack of any mechanistic basis for ALBI’s clinical utility does not preclude it from being clinically useful in certain situations. Why albumin and bilirubin levels, or a combination thereof, are prognostic in so many different diseases should be studied in the future.
Assessment of the albumin-bilirubin grade as a prognostic factor in patients with non-small-cell lung cancer receiving anti-PD-1-based therapy
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Citation Excerpt :
The ALBI score is calculated from albumin and bilirubin values as continuous variables, allowing an accurate evaluation of the liver function.27 Previous studies have suggested the prognostic role of the ALBI score in patients with colorectal liver metastasis, liver cirrhosis, and hepatocellular carcinoma.38-40 Moreover, Matsukane et al.41 recently demonstrated that pretreatment ALBI grade was an independent prognostic factor for both PFS and OS in 140 patients with NSCLC receiving ICIs.
The albumin-bilirubin (ALBI) grade is a novel indicator of the liver function. Some studies showed that the ALBI grade was a prognostic and predictive biomarker for the efficacy of chemotherapy in cancer patients. The association between the ALBI grade and outcomes in patients with non-small-cell lung cancer (NSCLC) treated with cancer immunotherapy, however, is poorly understood.
We retrospectively enrolled 452 patients with advanced or recurrent NSCLC who received anti-programmed cell death protein 1 (PD-1)-based therapy between 2016 and 2019 at three medical centers in Japan. The ALBI score was calculated from albumin and bilirubin measured at the time of treatment initiation and was stratified into three categories, ALBI grade 1-3, with reference to previous reports. We examined the clinical impact of the ALBI grade on the outcomes of NSCLC patients receiving anti-PD-1-based therapy using Kaplan–Meier survival curve analysis with log-rank test and Cox proportional hazards regression analysis.
The classifications of the 452 patients were as follows: grade 1, n = 158 (35.0%); grade 2, n = 271 (60.0%); and grade 3, n = 23 (5.0%). Kaplan–Meier survival curve analysis showed that the ALBI grade was significantly associated with progression-free survival and overall survival. Moreover, Cox regression analysis revealed that the ALBI grade was an independent prognostic factor for progression-free survival and overall survival.
The ALBI grade was an independent prognostic factor for survival in patients with advanced or recurrent NSCLC who receive anti-PD-1-based therapy. These findings should be validated in a prospective study with a larger sample size.
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Original StudyPrognostic Value of Baseline ALBI Score Among Patients With Colorectal Liver Metastases: A Pooled Analysis of Two Randomized Trials

Abstract

Background

Materials and Methods

Results

Conclusions

Introduction

Section snippets

About the Project Data Sphere (PDS)

Clinical Trial Datasets

Patients' Characteristics

Discussion

Disclosure

Acknowledgment

Ann Oncol

Int J Radiat Oncol Biol Phys

J Vasc Interv Radiol

Ann Oncol

J Hepatol

The impact of primary tumor location in patients with metastatic colorectal cancer: a Korean Cancer Study Group CO12-04 study

Korean J Intern Med

Association between prognosis and tumor laterality in early-stage colon cancer

JAMA Oncol

Challenging a dogma: five-year survival does not equal cure in all colorectal cancer patients

Expert Rev Anticancer Ther

Original Study
Prognostic Value of Baseline ALBI Score Among Patients With Colorectal Liver Metastases: A Pooled Analysis of Two Randomized Trials