Prognostic factors in patients with advanced biliary tract cancer treated with first-line gemcitabine plus cisplatin: retrospective analysis of 740 patients

Kim, Bum Joon; Hyung, Jaewon; Yoo, Changhoon; Kim, Kyu-Pyo; Park, Seong‐Joon; Lee, Sang Soo; Park, Do Hyun; Song, Tae Jun; Seo, Dong Wan; Lee, Sung Koo; Kim, Myung–Hwan; Park, Jin‐Hong; Cho, Hyungwoo; Ryoo, Baek‐Yeol; Chang, Heung-Moon

doi:10.1007/s00280-017-3353-2

Cited by 69 publications

(74 citation statements)

References 16 publications

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“…9,12,13 However, it has not been evaluated before in prognostication of advanced/ metastaic disease status except in one study which inculded all biliary tract malignancies. 14 In this study, there were about 25% GBC patients and the analysis was not done for these patients separately. In our study, we could not find any significant association between the presence of elevated levels of CA 19-9 and survival.…”

Section: Discussionmentioning

confidence: 96%

Prognostic Value of CA19-9 and CA242 in Gallbladder Cancer - An Exploratory Study

Agarwal¹,

Tiwari²,

Kumari³

et al. 2019

IJCMR

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Introduction: There are, at present, no biomarkers to predict to prognosis of Gallbladder cancer. We conducted a prospective exploratory study to evaluate the role to serum CA 19-9 and CA 242 as prognostic markers. Material and Methods: We enrolled consecutive patients for this study and CA 19-9 and 242 were estimated from venous samples. Association of these markers with clinical variables and median overall survival (OS) difference between patients who has raised versus normal levels of these markers was determined. Results: Sixty-two patients were enrolled for this study. Forty-four (71%) patients had elevated CA19-9. Thirty-nine (62.9%) patients had an raised CA242 levels. CA 19-9 was found to be significantly associated with the presence of jaundice (p=0.038) and advanced stage (p=0.009). Median OS of patients who had elevated CA 19-9 was 5.73 months compared to 8.33 months in patients who had normal CA 19-9. The difference was not statistically different (p= 0.15). Median OS for patients who had elevated CA 242 was 5.53 months, which was inferior to those who had normal levels (9.1 months). This difference approached, but was not statistically significant (p=0.055). Conclusion: This is the first study to show association between CA 19-9 and stage of disease in GBC. At present, CA 19-9 and CA 242 cannot be recommended as prognostic markers. However, role of CA 242 needs to be examined in a larger cohort of patients of GBC to establish its usefulness.

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Section: Discussionmentioning

confidence: 96%

Prognostic Value of CA19-9 and CA242 in Gallbladder Cancer - An Exploratory Study

Agarwal¹,

Tiwari²,

Kumari³

et al. 2019

IJCMR

View full text Add to dashboard Cite

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“…The median OS of patients with unresected nonmetastatic disease without and with chemotherapy (6.7 and 9.9 months) and of patients with metastatic disease without and with chemotherapy (2.8 and 8.2 months) are not in line with results from previous trials. The median OS of unresected biliary tract cancer is typically reported between 8.1 and 12.7 months [7,27,28]. Obviously, patients selected for clinical trials represent a subset of the total population with better performance status and prognosis.…”

Section: Discussionmentioning

confidence: 99%

Treatment and survival of resected and unresected distal cholangiocarcinoma: a nationwide study

et al. 2019

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Background: Population-based data on distal cholangiocarcinoma (DCC) from the Western world are not available, albeit essential to identify areas for improvement. This study investigated the incidence, treatment and outcomes, including time trends and predictors for survival, in a nationwide cohort of DCC. Methods: This is a retrospective cohort study of patients diagnosed with DCC (2009-2016) derived from the Netherlands Cancer Registry. Overall survival (OS) and its predictors were analyzed using Kaplan-Meier and Cox regression analysis. Time trends (2009-2012 versus 2013-2016) were assessed. Results: Overall, 1338 patients with DCC were included, with 1-, 3-and 5-year OS of 46%, 18%, and 11%. Incidence of DCC was 0.55-0.90 per 100.000 per year. Median OS was 10.4 months across all stages; 21.9 months for resected (n ¼ 620, 46.3%), 6.7 months for unresected nonmetastatic (n ¼ 445, 33.3%), and 3.6 months for metastatic DCC (n ¼ 273, 20.4%) (p < .001). After resection, 30-day mortality was 4.8% and 90-day mortality 7.7%. Patients with metastatic DCC who received chemotherapy (n ¼ 78, 28.6%) had a median OS of 8.2 versus 2.8 months for those not treated (p < .001). Over time, resection rates (53.6% to 61.7%, p ¼ .008) and use of palliative chemotherapy in metastatic DCC (22.3% to 32.9%, p ¼ .05) increased, without improvement in OS (10.3 vs 10.6 months, p ¼ .55). Independent poor prognostic factors for OS in resected disease were increasing age, pT3/T4 stage, higher lymph node ratio, poor differentiation, and R1 resection. Conclusions: In a nationwide cohort of DCC, resection rates and the use of chemotherapy increased whereas OS remained stable at 10.4 months.

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“…For patients with advanced BTC, the phase III ABC-02 and ABC-06 trials showed the clinical efficacy of gemcitabine plus cisplatin (GemCis) and oxaliplatin plus fluoropyrimidine (mFOLFOX) as first-line therapy and second-line therapy, respectively [5,6]. However, the survival outcomes remain dismal with a median overall survival (OS) of < 1 year, and none of the targeted agents have been approved for treatment of BTC [7][8][9].…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of Pembrolizumab in Patients with Refractory Advanced Biliary Tract Cancer: Tumor Proportion Score as a Potential Biomarker for Response

et al. 2020

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Purpose The current standard chemotherapy for advanced biliary tract cancer (BTC) has limited benefit, and novel therapies need to be investigated. Materials and MethodsIn this prospective cohort study, programmed death ligand-1 (PD-L1)–positive BTC patients who progressed on first-line gemcitabine plus cisplatin were enrolled. Pembrolizumab 200 mg was administered intravenously every 3 weeks. ResultsBetween May 2018 and February 2019, 40 patients were enrolled. Pembrolizumab was given as second-line (47.5%) or ≥ third-line therapy (52.5%). The objective response rate was 10% and 12.5% by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 and immune- modified RECIST (imRECIST) and median duration of response was 6.3 months. Among patients with progressive disease as best response, one patient (1/20, 5.0%) achieved complete response subsequently. The median progression-free survival (PFS) and overall survival (OS) were 1.5 months (95% confidence interval [CI], 0.0 to 3.0) and 4.3 months (95% CI, 3.5 to 5.1), respectively, and objective response per imRECIST was significantly associated with PFS (p < 0.001) and OS (p=0.001). Tumor proportion score ≥ 50% was significantly associated with higher response rates including the response after pseudoprogression (vs. < 50%; 37.5% vs. 6.5%; p=0.049). Conclusion Pembrolizumab showed modest anti-tumor activity in heavily pretreated PD-L1–positive BTC patients. In patients who showed objective response, durable response could be achieved.

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Prognostic factors in patients with advanced biliary tract cancer treated with first-line gemcitabine plus cisplatin: retrospective analysis of 740 patients

Abstract: Our retrospective analysis of a large number of patients in a real-world setting found comparable efficacy outcomes to the ABC-02 trial. The prognostic factors identified here may help to predict clinical outcomes and design future clinical trials for advanced BTC.

Cited by 69 publications

References 16 publications

Prognostic Value of CA19-9 and CA242 in Gallbladder Cancer - An Exploratory Study

Prognostic Value of CA19-9 and CA242 in Gallbladder Cancer - An Exploratory Study

Treatment and survival of resected and unresected distal cholangiocarcinoma: a nationwide study

Efficacy and Safety of Pembrolizumab in Patients with Refractory Advanced Biliary Tract Cancer: Tumor Proportion Score as a Potential Biomarker for Response

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