Incidence and risk factors for cholangitis during systemic chemotherapy among patients with advanced biliary tract cancer.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 313-313 ◽  
Author(s):  
J. Hashimoto ◽  
C. Morizane ◽  
S. Kondo ◽  
H. Ueno ◽  
S. Mitsunaga ◽  
...  
Keyword(s):  
Risk Factors ◽  
Median Time ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Biliary Drainage ◽  
Systemic Chemotherapy ◽  
Sphincter Of Oddi ◽  
Ampullary Cancer ◽  
First Episode ◽  
Tract Cancer

313 Background: Patients with biliary tract cancer (BTC) have a high risk of developing cholangitis. In patients with advanced BTC receiving systemic chemotherapy, cholangitis might interfere with the execution of the treatment. Furthermore, cholangitis during severe immunosuppression might develop into lethal complications such as sepsis or shock. Purpose: To determine the incidence of cholangitis among patients with advanced BTC undergoing systemic chemotherapy and to identify risk factors for the development of cholangitis. Methods: We reviewed the records of 301 patients with advanced BTC who received systemic chemotherapy at our hospital between February 2002 and July 2009. The clinical data of patients treated with gemcitabine monotherapy (GEM) as a first-line chemotherapy was retrieved. Results: One hundred and thirty-one patients were successfully followed up throughout the entire GEM treatment. Forty-three patients had intrahepatic BTC (32.8%), 28 had extrahepatic BTC (21.4%), 11 had hilar BTC (8.4%), 7 had ampullary cancer (5.3%), and 42 had gallbladder cancer (32.1%). Interventional radiological treatment or biliary reconstruction for biliary obstruction was performed in 50 patients (37.9%) prior to the start of chemotherapy. The median time to GEM treatment failure was 126 days. Cholangitis developed in 30 patients (22.9%) during GEM, and severe cholangitis developed in 10 patients (7.6%). The median time to the first episode of cholangitis from the start of chemotherapy was 65 days. Chemotherapy was discontinued because of cholangitis in 4 patients (3.1%), but no deaths as a result of cholangitis occurred. A multivariate analysis using a logistic regression model demonstrated that the presence of hilar obstruction (p=0.0002, OR: 10.748), the loss of sphincter of Oddi function (p=0.0005,OR: 8.960), and the presence of internal biliary drainage (p=0.007, OR: 4.472) were independent risk factors of cholangitis. Conclusions: The incidence of cholangitis during GEM treatment was 22.9% among the advanced BTC patients in this study. Hilar obstruction, the loss of sphincter of Oddi function, and internal biliary drainage may be risk factors of cholangitis. No significant financial relationships to disclose.

A phase II trial of regorafenib as a single agent in patients with advanced and metastatic biliary tract carcinoma and first-line chemotherapy failure.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. TPS498-TPS498
Author(s):  
Anuj Kishor Patel ◽  
Ronald G. Stoller ◽  
John C. Rhee ◽  
Barry C. Lembersky ◽  
James Ohr ◽  
...  
Keyword(s):  
Biliary Tract ◽  
Phase Ii ◽  
Biliary Tract Cancer ◽  
Systemic Chemotherapy ◽  
Single Agent ◽  
Response To Treatment ◽  
Mri Imaging ◽  
First Line ◽  
Tract Cancer ◽  
Line Chemotherapy

TPS498 Background: Biliary tract cancers (including cholangiocarcinomas) are rare but aggressive malignancies with limited options for treatment. Currently, the combination of gemcitabine and cisplatin is considered the upfront systemic chemotherapy for patients with advanced and metastatic diseases. There is no ‘standard’ for second-line treatment. Several signaling pathways have been identified that might play a role in the development of biliary tract cancer and that may represent targets for directed therapies. Overexpression of VEGF and alterations of the Ras/Raf pathway have been identified in the majority of cholangiocarcinoma; some studies have shown these mutations to be associated with metastasis and poorer prognosis. Regorafenib is an oral multikinase inhibitor of multiple angiogenic and oncogenic kinases (VEGFR1-3, TIE2, PDGFR-β, FGFR1, KIT, RET, RAF) which has shown efficacy as a single agent in multiple solid tumors. This study evaluates the efficacy of regorafenib in patients with advanced/metastatic biliary tract cancer following the failure of first-line chemotherapy. Methods: Enrollment in this phase II, single-arm trial is ongoing. Eligible patients have unresectable advanced or metastatic biliary tract adenocarcinoma, and have failed first-line systemic chemotherapy. Patients receive regorafenib 120 mg orally daily in a 21 days on, 7 days off cycle. Tumor measurements take place every 3 cycles by CT or MRI imaging. Patients continue on therapy until disease progression or unacceptable toxicities. The primary end point of this study is median progression-free survival (PFS). To evaluate for evidence of activity, defined as a median PFS of 3.5 months or greater, with 83% power (one-sided test, α=0.10), target enrollment is 37 patients. Secondary endpoints include safety, overall response rate, disease control rate, median overall survival, and changes in biomarker levels. The correlation of these biomarkers and of tumor mutations with response to treatment is built into the study as well. As of September 2014, 9 patients had been enrolled. ClinicalTrials.gov Identifier: NCT02053376. Clinical trial information: NCT02053376.

Albumin-Indocyanine Green Evaluation Grading System Predicts Post-Hepatectomy Liver Failure for Biliary Tract Cancer

2018 ◽  
Vol 36 (1) ◽  
pp. 13-19 ◽  
Author(s):  
Yoshihiro Miyazaki ◽  
Takashi Kokudo ◽  
Katsumi Amikura ◽  
Amane Takahashi ◽  
Nobuhiro Ohkohchi ◽  
...  
Keyword(s):  
Risk Factors ◽  
Liver Failure ◽  
Indocyanine Green ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Preoperative Evaluation ◽  
Grading System ◽  
Tract Cancer ◽  
Major Complications ◽  
Independent Risk Factors

Background: In biliary tract cancer treatment, a precise preoperative evaluation of the patient’s liver function is essential to avoid post-hepatectomy liver failure (PHLF) and mortality. The present study aimed to evaluate the role of the Albumin-Indocyanine Green Evaluation (ALICE) grading system in predicting PHLF in biliary tract cancer patients. Methods: Data from 166 patients who underwent hepatectomy for biliary tract cancer between 2000 and 2016 were retrospectively analyzed. Univariate and multivariate analyses were performed to identify the risk factors for PHLF. Results: Among the 166 patients, major hepatectomy was performed in 101 (61%) and bile duct resection was performed in 99 (60%) patients. Thirteen (8%) patients developed PHLF. Furthermore, PHLF, major complications, and mortality were significantly higher in patients with high ALICE grades (≥2b) than in those with low ALICE grades (<2b) (PHLF, 42 vs. 18%, p = 0.002; major complications, 35 vs. 19%, p = 0.036; mortality, 9.3 vs. 0%, p = 0.001). In multivariate analysis, high ALICE grade (p = 0.016) and blood loss ≥1,500 mL (p = 0.009) were identified as independent risk factors for PHLF. Conclusions: The ALICE grading system effectively stratified the risks for PHLF for biliary tract cancer.

scholarly journals NUC-1031/cisplatin versus gemcitabine/cisplatin in untreated locally advanced/metastatic biliary tract cancer (NuTide:121)

2020 ◽  
Vol 16 (16) ◽  
pp. 1069-1081 ◽  
Author(s):  
Mairéad Geraldine McNamara ◽  
Lipika Goyal ◽  
Mark Doherty ◽  
Christoph Springfeld ◽  
David Cosgrove ◽  
...  
Keyword(s):  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Objective Response ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Resistance Mechanisms ◽  
Ampullary Cancer ◽  
Cancer Resistance ◽  
Tract Cancer ◽  
Patient Reported

Gemcitabine/cisplatin is standard of care for first-line treatment of patients with advanced biliary tract cancer (aBTC); new treatments are needed. NUC-1031 is designed to overcome key cancer resistance mechanisms associated with gemcitabine. The tolerability/efficacy signal of NUC-1031/cisplatin in the Phase Ib ABC-08 study suggested that this combination may represent a more efficacious therapy than gemcitabine/cisplatin for patients with aBTC, leading to initiation of the global NuTide:121 study which will include 828 patients ≥18 years with untreated histologically/cytologically-confirmed aBTC (including cholangiocarcinoma, gallbladder or ampullary cancer); randomized (1:1) to NUC-1031 (725 mg/m2)/cisplatin (25 mg/m2) or gemcitabine (1000 mg/m2)/cisplatin (25 mg/m2), on days 1/8, Q21-days. Primary objectives are overall survival and objective response rate. Secondary objectives: progression-free survival, safety, pharmacokinetics, patient-reported quality of life and correlative studies. (Investigational new drug (IND) number: 139058, European Clinical Trials database: EudraCT Number 2019-001025-28, ClinicalTrials.gov identifier: NCT04163900).

scholarly journals Risk factors for occult metastasis detected by inflammation-based prognostic scores and tumor markers in biliary tract cancer

2021 ◽  
Vol 9 (32) ◽  
pp. 9770-9782
Author(s):  
Yu Hashimoto ◽  
Tetsuo Ajiki ◽  
Hiroaki Yanagimoto ◽  
Daisuke Tsugawa ◽  
Kenta Shinozaki ◽  
...  
Keyword(s):  
Risk Factors ◽  
Tumor Markers ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Prognostic Scores ◽  
Occult Metastasis ◽  
Tract Cancer

scholarly journals SEOM clinical guidelines for pancreatic and biliary tract cancer (2020)

2021 ◽  
Author(s):  
Mª A. Gómez-España ◽  
A. F. Montes ◽  
R. Garcia-Carbonero ◽  
T. M. Mercadé ◽  
J. Maurel ◽  
...  
Keyword(s):  
Biliary Tract ◽  
Adjuvant Treatment ◽  
Biliary Tract Cancer ◽  
Systemic Chemotherapy ◽  
Initial Period ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Locoregional Therapy ◽  
R0 Resection ◽  
Tract Cancer

AbstractPancreatic cancer (PC) and biliary tract cancer (BTC) are both aggressive and highly fatal malignancies. Nowadays we have a profound knowledge about the molecular landscape of these neoplasms and this has allowed new therapeutic options. Surgery is the only potentially curative therapy in both cancers, but disease recurrence is frequent. In PC, adjuvant treatment with mFOLFIRINOX has improved overall survival (OS) and in BTC adjuvant treatment with capecitabine seems to improve OS and relapse-free survival. Concomitant radio-chemotherapy could also be considered following R1 surgery in both neoplasms. Neoadjuvant treatment represents the best option for achieving an R0 resection in borderline PC. Upfront systemic chemotherapy is the treatment of choice in unresectable locally advanced PC and BTC; then locoregional therapy could be considered after an initial period of at least 3–4 months of systemic chemotherapy. In metastatic PC, FOLFIRINOX or Gemcitabine plus nab-paclitaxel have improved OS compared with gemcitabine alone. In metastatic BTC, cisplatin plus gemcitabine constitute the standard treatment. Progress in the knowledge of molecular biology has enabled the identification of new targets for therapy with encouraging results that could in the future improve the survival and quality of life of patients with PC and BTC.

scholarly journals Benefit of second-line systemic chemotherapy for advanced biliary tract cancer: A propensity score analysis

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Florian Moik ◽  
Jakob M. Riedl ◽  
Thomas Winder ◽  
Angelika Terbuch ◽  
Christopher H. Rossmann ◽  
...  
Keyword(s):  
Propensity Score ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Systemic Chemotherapy ◽  
Propensity Score Analysis ◽  
Second Line ◽  
Tract Cancer ◽  
Score Analysis

scholarly journals Predictive Factors of Chemotherapy Initiation after Biliary Drainage for Advanced Biliary Tract Cancer: A Retrospective Multicenter Study

2021 ◽  
Author(s):  
Miloud Azarfane ◽  
Astrid Lievre ◽  
Helene Senellart ◽  
Beatrice Desomme ◽  
Pauline Guillouche ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Biliary Tract ◽  
Predictive Factors ◽  
Biliary Tract Cancer ◽  
Biliary Drainage ◽  
Biliary Obstruction ◽  
Male Gender ◽  
Biliary Tract Cancers ◽  
Tract Cancer ◽  
Chemotherapy Initiation

Background and Aims: In unresectable biliary tract cancers, the management of biliary obstruction is often the first step before introduction of chemotherapy. Our aim was to study the predictive factors of chemotherapy initiation after biliary drainage in a series of patients presenting with advanced biliary tract cancer and obstructive jaundice. Methods: Data of all patients treated for unresectable biliary tract cancer with initial biliary obstruction requiring a drainage in six institutions, from January 2009 to January 2019, were retrospectively collected. Results: Among 82 patients included in this study (median age 68 years, men 61%), 48 (59%) received chemotherapy. Median overall survival was 4.9 months (0.2-38.7) in the group of patients who did not receive chemotherapy and 12.2 months (1.9-61.0) in chemotherapy group (HR=2.93; 95%CI: 1.6-5.3; p<0.0001). In univariate analysis, younger age, male gender, Eastern Cooperative Oncology Group (ECOG) score ≤2, high albumin level, low C-reactive protein level, and endoscopic drainage were significantly associated with introduction of chemotherapy. In multivariate analysis, only ECOG score ≤2 at diagnosis (HR=70.4; 95%CI: 4.6-1097.6; p=0.002) and male gender (HR=5; 95%CI: 1.5-16.5; p=0.009), were significant independent predictive factors of chemotherapy introduction. Age and bilirubin level at diagnosis were not significant factors in multivariate analysis. Conclusions: ECOG score ≤ 2 and male gender were the only independent predictive factors of chemotherapy introduction in unresectable biliary tract cancers. Age or initial bilirubin level were not predictors for chemotherapy introduction. These results might help defining the initial therapeutic strategy.

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