Prognostic factors for progression-free and overall survival in advanced biliary tract cancer

Bridgewater, John; Lopes, Andre; Wasan, Harpreet; Malka, David; Jensen, Lars Henrik; Okusaka, Takuji; Knox, Jennifer J.; Wagner, Daniel; Cunningham, David; Shannon, Jennifer; Goldstein, David; Moehler, Markus; Bekaii‐Saab, Tanios; McNamara, Mairéad G.; Valle, Juan W.

doi:10.1093/annonc/mdv483

Cited by 85 publications

(81 citation statements)

References 24 publications

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“…(4) Previous studies have identified the role of site of diseases and metastasis in prognosis of BTC treated with GC (4,5,(14)(15)(16). Liver function tests such as ALP and bilirubin have also been included in prognostic models (5,14,15). In our study, we also identified the role of baseline liver function tests in predicting response.…”

Section: Discussionmentioning

confidence: 86%

“…Combining metastatic disease with locally advanced disease may complicate the interpretation, as the outcomes of metastatic disease may be different from locally advanced disease (2,4). As per the SEER database for liver and intrahepatic biliary ductal cancers, the five year survival for distant metastatic disease is 3% compared to 11% for regional disease (2 (3,4,14). Locally advanced disease is also often combined with metastatic disease.…”

Section: Discussionmentioning

confidence: 99%

“…Locally advanced disease is also often combined with metastatic disease. (4) Previous studies have identified the role of site of diseases and metastasis in prognosis of BTC treated with GC (4,5,(14)(15)(16). Liver function tests such as ALP and bilirubin have also been included in prognostic models (5,14,15).…”

Section: Discussionmentioning

confidence: 99%

“…This is suggested by a genomic analysis study of cholangiocarcinoma in which it was shown EHC with mutations in BAP1 and PBRM1 are more likely to be associated with bone metastases and worse survival (13). This was also suggested in the ABC-02 trial where the benefit seen in metastatic disease (HR =0.74) was not as remarkable as in the unresectable locally advanced (HR =0.47) (4,14).…”

Section: Introductionmentioning

confidence: 88%

“…Other studies have suggested prognostic roles for blood counts, bilirubin and gender (14). Data for survival based on prognostic factors is conflicting and there is a critical need to identify clinically reliable biomarkers that could predict response and provide prognostic information allowing informed decision making (5,(14)(15)(16).…”

Section: Introductionmentioning

confidence: 99%

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Advanced biliary tract cancer: clinical outcomes with ABC-02 regimen and analysis of prognostic factors in a tertiary care center in the United States

Agarwal

Sendilnathan

Siddiqi

et al. 2016

J. Gastrointest. Oncol.

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Background: Gemcitabine plus cisplatin (GC) is currently the standard regimen for advanced biliary tract cancers (BTC) based on the outcomes in ABC-02 trial. Multiple factors can affect outcomes in these patients. This retrospective review evaluates the University of Cincinnati experience with GC in advanced intrahepatic (IHC)/ extrahepatic cholangiocarcinoma (EHC) and gall bladder carcinoma (GBC). Methods: In this study approved by University of Cincinnati IRB, retrospective analysis of advanced BTC patients seen between 01/2008 and 01/2015 was done. Kaplan Meyer method was used to calculate progression free survival (PFS), and overall survival (OS). Cox model was used to test the association between baseline variables and OS/PFS, adjusting for gender and age at diagnosis. Patients were identified using ICD code for BT tumors, 26 patients met inclusion criteria: histologically proven advanced BTC that received GC as their initial chemotherapy. GC was given as per ABC-02 protocol with appropriate modifications until disease progression or unacceptable toxicities. Results: Median age at diagnosis was 62 years (range, 31-81 years). Eighteen (69%) were IHC, 5 EHC, 3 GBC, 61% male, 73% whites. Performance status (PS): 0-1: 69%, PS 2: 31%. Baseline CA19-9 data was available for 21 patients, (range 1 to 69,543), and abnormal CA19-9 was seen in 14 patients (54%). PFS was 4.5 months (95% CI: 3.1-8.9 months) and OS was 10.5 months (95 % CI: 7.9-18.8 months). OS at 6 and 12 months was 69% (18/26) and 42% (11/26). Thirty-eight percent (10/26) received 2nd line chemotherapy, of these 9/10 received 5FU based chemotherapy. Eleven percent (3/26) received 3rd line chemotherapy. Increase in baseline carcinoembryonic antigen (CEA), alanine aminotransferase, alkaline phosphatase (ALP) and total bilirubin was associated with increased risk of death while increase in baseline CEA and ALP was associated with increased risk of progression (P valve <0.05). In the group of patients who had all three major risk factors (PS ≥2, CEA >3, and stage IVb), the median survival was 2.9 months (95% CI: 2.6-9.3 months), which was significantly worse compared to rest of the population [median 18 months (95% CI: 5.4-19.5 months), P<0.01]. Conclusions: Our data supports the use of GC as a first line regimen for advance BTC in a non-clinical trial setting. Results are comparable to those reported in ABC-02 trial, despite inclusion of PS 2 patients whom constituted 31% of our population. In the patient population studied, baseline CEA and liver function test appeared able to predict response to GC in advanced BTC. Patients with all three high risk factors (PS ≥2, CEA >3, and stage IVb) did poorly and may need careful selection prior to initiating chemotherapy.

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Section: Discussionmentioning

confidence: 86%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 88%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Advanced biliary tract cancer: clinical outcomes with ABC-02 regimen and analysis of prognostic factors in a tertiary care center in the United States

Agarwal

Sendilnathan

Siddiqi

et al. 2016

J. Gastrointest. Oncol.

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Pretreatment direct bilirubin and total cholesterol are significant predictors of overall survival in advanced non‐small‐cell lung cancer patients with EGFR mutations

Zhang

Lou

et al. 2017

Intl Journal of Cancer

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This study was designed to examine the prediction of pretreatment circulating bilirubin and cholesterol for overall survival in 459 advanced non-small-cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations. Circulating total bilirubin, direct bilirubin (DB), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) levels were measured at baseline. The mean age (standard deviation) of all study patients was 58.7 (10.5) years, and 42.9% of them was males. Ever smokers accounted for 27.0% and lung adenocarcinoma for 90.4%. The median follow-up time and survival time were 29.5 and 34.9 months, respectively. Patients with higher DB had a 1.68-fold increased risk of death compared with patients with lower DB (hazard ratio [HR] = 1.68, 95% confidence interval [CI]: 1.22-2.30, p = 0.001), while patients with higher TC were at a 63% reduced risk of death compared with patients with lower TC (HR = 0.37, 95% CI: 0.20-0.67, p = 0.001). As for HDL-C, patients with higher levels had the risk of death reduced by 46% (HR = 0.54, 95% CI: 0.29-1.00, p = 0.049) compared with patients with lower levels. After the Bonferroni correction, only DB and TC were significantly associated with NSCLC survival. Our findings demonstrate for the first time that pretreatment DB was identified as a significant risk factor, yet TC as a protective factor, for overall survival in NSCLC patients with EGFR mutations.

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Pan‐cancer efficacy and safety of anlotinib plus PD‐1 inhibitor in refractory solid tumor: A single‐arm, open‐label, phase II trial

Qin

Jiao

Wang

et al. 2023

Intl Journal of Cancer

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The combination of immunotherapy and antiangiogenic agents for the treatment of refractory solid tumor has not been well investigated. Thus, our study aimed to evaluate the efficacy and safety of a new regimen of anlotinib plus PD‐1 inhibitor to treat refractory solid tumor. APICAL‐RST is an investigator‐initiated, open‐label, single‐arm, phase II trial in patients with heavily treated, refractory, metastatic solid tumor. Eligible patients experienced disease progression during prior therapy without further effective regimen. All patients received anlotinib and PD‐1 inhibitor. The primary endpoints were objective response and disease control rates. The secondary endpoints included the ratio of progression‐free survival 2 (PFS2)/PFS1, overall survival (OS) and safety. Forty‐one patients were recruited in our study; 9 patients achieved a confirmed partial response and 21 patients had stable disease. Objective response rate and disease control rate were 22.0% and 73.2% in the intention‐to‐treat cohort, and 24.3% and 81.1% in the efficacy‐evaluable cohort, respectively. A total of 63.4% (95% confidence interval [CI]: 46.9%‐77.4%) of the patients (26/41) presented PFS2/PFS1 >1.3. The median OS was 16.8 months (range: 8.23‐24.4), and the 12‐ and 36‐month OS rates were 62.8% and 28.9%, respectively. No significant association was observed between concomitant mutation and efficacy. Thirty‐one (75.6%) patients experienced at least one treatment‐related adverse event. The most common adverse events were hypothyroidism, hand‐foot syndrome and malaise. This phase II trial showed that anlotinib plus PD‐1 inhibitor exhibits favorable efficacy and tolerability in patients with refractory solid tumor.

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Prognostic factors for progression-free and overall survival in advanced biliary tract cancer

Cited by 85 publications

References 24 publications

Advanced biliary tract cancer: clinical outcomes with ABC-02 regimen and analysis of prognostic factors in a tertiary care center in the United States

Advanced biliary tract cancer: clinical outcomes with ABC-02 regimen and analysis of prognostic factors in a tertiary care center in the United States

Pretreatment direct bilirubin and total cholesterol are significant predictors of overall survival in advanced non‐small‐cell lung cancer patients with EGFR mutations

Pan‐cancer efficacy and safety of anlotinib plus PD‐1 inhibitor in refractory solid tumor: A single‐arm, open‐label, phase II trial

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