Prediction Efficacy for Clinical Outcome of Prognostic Nutritional Index in Patients with Resectable Biliary Tract Cancer Depends on Sex and Obstructive Jaundice Status

Abstract Background: The prognostic nutritional index, a marker of nutritional status and systemic inflammation, is a known biomarker for various cancers. However, few studies have evaluated the predictive value of the prognostic nutritional index in patients with biliary tract cancer. Therefore, we investigated the prognostic significance of the prognostic nutritional index and developed a risk-stratification system to identify prognostic factors in patients with biliary tract cancer.Methods: Between July 2010 and March 2021, 117 patients with biliary tract cancer were recruited to this single-center retrospective study. The relationship between clinicopathological variables, including the prognostic nutritional index and overall survival, was analyzed using univariate and multivariate analyses. P < 0.05 was considered statistically significant.Results: The median age was 75 (range, 38–92) years. Thirty patients had intrahepatic cholangiocarcinoma; 29, gallbladder carcinoma; 28, distal cholangiocarcinoma; 16, ampullary carcinoma; and 13, perihilar cholangiocarcinoma. R0 resection was achieved in 99 patients. In univariate analysis, the prognostic nutritional index (< 42), lymph node metastasis, carbohydrate antigen 19-9 level (> 20 U/mL), preoperative cholangitis, tumor differentiation, operation time (≥ 360 minutes), and R1–2 resection were significant risk factors for overall survival. The prognostic nutritional index (P = 0.007), lymph node metastasis (P = 0.024), and tumor differentiation (P = 0.008) were independent prognostic factors in the multivariate analysis. A combined score of the prognostic nutritional index and pathological findings outperformed each marker alone, in terms of discriminatory power.Conclusions: The prognostic nutritional index, lymph node metastasis, and tumor differentiation were independent prognostic predictors after surgical resection in patients with biliary tract cancer. A combined prediction model using the prognostic nutritional index and pathological findings accurately predicted prognosis and can be applied as a novel prognostic indicator for patients with biliary tract cancer.

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A combined prediction model for biliary tract cancer using the prognostic nutritional index and pathological findings: a single-center retrospective study

BMC Gastroenterology ◽

10.1186/s12876-021-01957-5 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Masashi Utsumi ◽

Koji Kitada ◽

Naoyuki Tokunaga ◽

Takamitsu Kato ◽

Toru Narusaka ◽

...

Keyword(s):

Prognostic Factors ◽

Lymph Node ◽

Biliary Tract ◽

Biliary Tract Cancer ◽

Prognostic Nutritional Index ◽

Tumor Differentiation ◽

Pathological Findings ◽

Tract Cancer ◽

Node Metastasis ◽

Nutritional Index

Abstract Background The prognostic nutritional index, a marker of nutritional status and systemic inflammation, is a known biomarker for various cancers. However, few studies have evaluated the predictive value of the prognostic nutritional index in patients with biliary tract cancer. Therefore, we investigated the prognostic significance of the prognostic nutritional index, and developed a risk-stratification system to identify prognostic factors in patients with biliary tract cancer. Methods Between July 2010 and March 2021, 117 patients with biliary tract cancer were recruited to this single-center, retrospective study. The relationship between clinicopathological variables, including the prognostic nutritional index, and overall survival was analyzed using univariate and multivariate analyses. A P < 0.05 was considered statistically significant. Results The median age was 75 (range 38–92) years. Thirty patients had intrahepatic cholangiocarcinoma; 29, gallbladder carcinoma; 27, distal cholangiocarcinoma; 17, ampullary carcinoma; and 13, perihilar cholangiocarcinoma. Curative (R0) resection was achieved in 99 patients. In univariate analysis, the prognostic nutritional index (< 42), lymph node metastasis, carbohydrate antigen 19-9 level (> 20 U/mL), preoperative cholangitis, tumor differentiation, operation time (≥ 360 min), and R1–2 resection were significant risk factors for overall survival. The prognostic nutritional index (P = 0.027), lymph node metastasis (P = 0.040), and tumor differentiation (P = 0.006) were independent prognostic factors in multivariate analysis. A combined score of the prognostic nutritional index and pathological findings outperformed each marker alone, in terms of discriminatory power. Conclusions The prognostic nutritional index, lymph node metastasis, and tumor differentiation were independent prognostic factors after surgical resection in patients with biliary tract cancer. A combined prediction model using the prognostic nutritional index and pathological findings accurately predicted prognosis, and can be used as a novel prognostic factor in patients with biliary tract cancer.

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Clinical Outcome of Patients with Advanced Biliary Tract Cancer in a Dedicated Phase I Unit

Clinical Oncology ◽

10.1016/j.clon.2017.11.011 ◽

2018 ◽

Vol 30 (3) ◽

pp. 185-191

Author(s):

R. Sundar ◽

A. Custodio ◽

A. Petruckevich ◽

M. Chénard-Poirier ◽

M. Ameratunga ◽

...

Keyword(s):

Clinical Outcome ◽

Phase I ◽

Biliary Tract ◽

Biliary Tract Cancer ◽

Tract Cancer

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Influence of obstructive jaundice on chemotherapy in patients with unresectable biliary tract cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2014.32.3_suppl.336 ◽

2014 ◽

Vol 32 (3_suppl) ◽

pp. 336-336

Author(s):

Satoshi Shimizu ◽

Shuichi Mitsunaga ◽

Izumi Ohno ◽

Hideaki Takahashi ◽

Hiroyuki Okuyama ◽

...

Keyword(s):

Overall Survival ◽

Obstructive Jaundice ◽

Biliary Tract ◽

Biliary Tract Cancer ◽

Biliary Obstruction ◽

Chief Complaint ◽

Tract Cancer ◽

Group 2 ◽

Line Chemotherapy ◽

Group 1

336 Background: The aim of this study was to investigate the influences of obstructive jaundice (OJ) in unresectable biliary tract cancer (BTC) patients. Methods: Data of a total of 200 patients who were newly diagnosed as having unresectable BTC and received chemotherapy between July 2006 and December 2012 were retrospectively reviewed. Patients were divided into two groups according to whether or not they presented with OJ as the incipient chief complaint (Group 1, patients with OJ; Group 2, patients without OJ). Results: There were 81 patients in Group 1 and 119 patients in Group 2. In regard to the primary site (Group 1/Group 2), 29 had perihilar (27/2), 7 had distal (7/0), 68 had intrahepatic (15/53), 92 had gallbladder (31/61) and 4 had ampulla of vater (1/3) (p<0.01). The rate of distant metastasis was 60% in Group 1 and 76% in Group 2 (p=0.02). The performance status was good (0 or 1) in 96% of cases of both the groups. There were no significant differences in the median survival time between Group 1 and Group 2 (9.0 months vs. 9.0 months, p=0.42) or in the progression free survival of 1st line chemotherapy between the two groups (4.1 months vs. 3.7 months, p=0.08). The rate of development of biliary obstruction in Group 1 was significantly high during the first line chemotherapy (56% vs. 10%, p<0.01). Discontinuation of 1st line chemotherapy was necessitated due to biliary obstruction in 9 patients (10%) of Group 1 and none of the patients (0%) of Group 2. Multivariate analysis showed that absence of metastasis and use of a doublet chemotherapy regimen were significantly correlated with the overall survival, but not the presence of OJ as the incipient chief complaint (HR, 0.772; 95% CI, 0.532-1.119). Conclusions: Patients with OJ as the incipient chief complaint showed high rate of recurrent biliary obstruction and discontinuation chemotherapy due to biliary obstruction. However, OJ may not disadvantage for overall survival in BTC.

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6639 POSTER Polymorphisms Associated With the Clinical Outcome of Biliary Tract Cancer (BTC) Patients Treated With the Epirubicin, Cisplatin and Capecitabine (ECX) Regimen

European Journal of Cancer ◽

10.1016/s0959-8049(11)71950-5 ◽

2011 ◽

Vol 47 ◽

pp. S483

Author(s):

P. Pacetti ◽

E. Giovannetti ◽

A. Mambrini ◽

E. Zaccarelli ◽

M. Orlandi ◽

...

Keyword(s):

Clinical Outcome ◽

Biliary Tract ◽

Biliary Tract Cancer ◽

Tract Cancer

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Results of biomarker analysis from phase II trial of nivolumab in refractory biliary tract cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.3_suppl.338 ◽

2021 ◽

Vol 39 (3_suppl) ◽

pp. 338-338

Author(s):

Elaine Tan ◽

Dae Won Kim ◽

Junmin Zhou ◽

Michael J. Schell ◽

Vincent Chung ◽

...

Keyword(s):

Clinical Outcome ◽

Disease Control ◽

Disease Progression ◽

Biliary Tract ◽

Biliary Tract Cancer ◽

Rapid Disease Progression ◽

Mrna Sequencing ◽

Tract Cancer ◽

Biomarker Analysis ◽

Pre Treatment

338 Background: Our previous phase II study demonstrated that nivolumab provides modest but durable clinical efficacy in patients (pts) with refractory biliary tract cancer (BTC), suggesting the significant clinical benefit of nivolumab in selected pts and identification of potential predictive biomarkers. Here, we report outcomes from the biomarker analysis. Methods: Pre-treatment tumor samples were obtained and assessed for immunohistochemistry (IHC) with PD-1 and PDL-1 antibodies, mRNA sequencing (RNAseq), and whole exome sequencing (WES). Clinical efficacy was correlated with the molecular analysis. Prior cisplatin exposure was reviewed to evaluate the impact of cisplatin on the tumor mutational burden (TMB) and clinical outcome. Results: Among 46 pts who had tumor response evaluation, 31 pts received cisplatin prior to nivolumab, and 15 were cisplatin-naive. Pre-treatment tumor samples were assessed for IHC (n = 42), RNAseq (n = 11), and WES (n = 11) based on tissue availability. There was no statistically significant correlation between prior cisplatin exposure and clinical outcome. Among 42 available tumor samples, 18 (43%) expressed PD-L1 positivity ( > 1%), which was associated with a statistically significant prolonged progression free survival (PFS). Median PFS was 10.4 months for PD-L1 positive vs 2.4 months for PD-L1 negative (HR 0.23, 95% CI 0.10-0.51; P < 0.001), while there was no statistically significant correlation between PD-1 expressing tumor infiltrating lymphocytes and clinical outcome. There was also no statistically significant difference in TMB of cisplatin-exposed (n = 8) vs. cisplatin-naïve tumor samples (n = 3) (9162, SD = 150 vs. 8898, SD = 806, p = 0.62). In comparing the group with prolonged disease control of at least 16 weeks (n = 4) to those with rapid disease progression (n = 7) who had mRNA sequencing performed, levels of AC005609.1, FAT3, TMEM151A, ADARB2, FAM153A were all significantly upregulated (p < 0.01), while levels of CLCA1, MUC2, IGHV3-43, SWORA6, and CRISP3 were all significantly downregulated (p < 0.01). Conclusions: Prior cisplatin exposure did not lead to statistically significant differences in clinical outcome or TMB in advanced BTC pts treated with nivolumab. However, PD-L1 expression > 1% correlated with improved PFS, and variations in level of certain mRNA sequences were noted when comparing pts who had rapid disease progression vs. prolonged disease control with nivolumab. This suggests that BTC pts with positive PD-L1 expression and a particular mRNA profile may have a favorable response to nivolumab. Further studies are needed to confirm these findings. Clinical trial information: NCT02829918.

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