scholarly journals Current and Future Systemic Therapies in Biliary Tract Cancer

2021 ◽  
pp. 1-7
Author(s):  
Arndt Vogel ◽  
Anna Saborowski
Keyword(s):  
Biliary Tract ◽  
Treatment Options ◽  
Standard Of Care ◽  
Genetic Diagnostics ◽  
Braf Mutations ◽  
Tract Cancer ◽  
Palliative Situation ◽  
Tumor Entity ◽  
Biliary Malignancies ◽  
Early Tumor

<b><i>Background:</i></b> Despite an increasing incidence, biliary tumors are still considered a rare tumor entity. Due to an often long clinically inapparent course and a lack of early detection strategies, surgical resection is often not possible at the time of diagnosis. Since 2010, chemotherapy with gemcitabine and cisplatin is considered the standard of care in the palliative situation. Only recently, first studies have been published or initiated that expand the treatment options in the first line and, for the first time, also suggest valid systemic approaches in the second line. <b><i>Summary:</i></b> Molecularly targeted therapies in selected patient subgroups are rapidly changing the field. In addition to IDH1 mutations and FGFR2 fusions in patients with intrahepatic tumors, the therapeutic relevance of rare but targetable alterations such as HER2/neu amplification, NTRK fusions, or BRAF mutations should be considered in patients with biliary tract cancers. <b><i>Key Message:</i></b> The current study landscape clearly shows that precision medicine will play an important role in the therapy of biliary malignancies and underlines the importance of early tumor genetic diagnostics. In this article we provide an overview of systemic therapy concepts in the adjuvant and palliative setting.

scholarly journals Biliary Tract Cancers: Molecular Heterogeneity and New Treatment Options

Cancers ◽  
2020 ◽  
Vol 12 (11) ◽  
pp. 3370
Author(s):  
Nicola Personeni ◽  
Ana Lleo ◽  
Tiziana Pressiani ◽  
Francesca Colapietro ◽  
Mark Robert Openshaw ◽  
...  
Keyword(s):  
Biliary Tract ◽  
Advanced Disease ◽  
Treatment Options ◽  
Growth Factor Receptor ◽  
Standard Of Care ◽  
Resistance Mechanisms ◽  
Anatomical Location ◽  
Molecular Heterogeneity ◽  
Isocitrate Dehydrogenase 1 ◽  
Tract Cancer

Most patients with biliary tract cancer (BTC) are diagnosed with advanced disease, relapse rates are high in those undergoing surgery and prognosis remains poor, while the incidence is increasing. Treatment options are limited, and chemotherapy is still the standard of care in both adjuvant and advanced disease setting. In recent years, different subtypes of BTC have been defined depending on the anatomical location and genetic and/or epigenetic aberrations. Especially for intrahepatic cholangiocarcinoma (iCCA) novel therapeutic targets have been identified, including fibroblast growth factor receptor 2 gene fusions and isocitrate dehydrogenase 1 and 2 mutations, with molecularly targeted agents having shown evidence of activity in this subgroup of patients. Additionally, other pathways are being evaluated in both iCCA and other subtypes of BTC, alongside targeting of the immune microenvironment. The growing knowledge of BTC biology and molecular heterogeneity has paved the way for the development of new therapeutic approaches that will completely change the treatment paradigm for this disease in the near future. This review provides an overview of the molecular heterogeneity of BTC and summarizes new targets and emerging therapies in development. We also discuss resistance mechanisms, open issues, and future perspectives in the management of BTC.

scholarly journals Establishment of a Pretreatment Nomogram to Predict the 6-Month Mortality Rate of Patients with Advanced Biliary Tract Cancers Undergoing Gemcitabine-Based Chemotherapy

Cancers ◽  
2021 ◽  
Vol 13 (13) ◽  
pp. 3139
Author(s):  
Chiao-En Wu ◽  
Wen-Kuan Huang ◽  
Wen-Chi Chou ◽  
Chia-Hsun Hsieh ◽  
John Wen-Cheng Chang ◽  
...  
Keyword(s):  
Liver Metastasis ◽  
Mortality Rate ◽  
Biliary Tract ◽  
Mortality Risk ◽  
Treatment Options ◽  
Univariate Analysis ◽  
Cytotoxic Agents ◽  
Response To Treatment ◽  
Tract Cancer ◽  
Additional Information

Background: The estimation of mortality risk among patients diagnosed with advanced cancer provides important information for clinicians and patients in clinical practice. Currently, gemcitabine-based chemotherapy regimens are the standard treatment for patients with advanced biliary tract cancer (BTC). We aimed to develop a nomogram to predict the 6-month mortality rate among patients with advanced BTC to help physicians evaluate treatment options and outcomes. Patients: We conducted a retrospective analysis to evaluate the 6-month mortality rate among patients with advanced BTC who underwent gemcitabine-based chemotherapy from 2012 to 2018. Data regarding pretreatment factors and the clinical response to treatment were collected. Univariate and multivariate analyses were performed to identify independent factors for nomogram creation. Results: A total of 202 advanced BTC patients who were treated with gemcitabine-based chemotherapy were included in this analysis. No difference in survival was identified between patients undergoing gemcitabine monotherapy and those treated with gemcitabine combined with other cytotoxic agents. The univariate analysis revealed 10 significant factors, while the multivariate analysis identified four independent factors, including gender, monocyte to lymphocyte ratio (MLR), alkaline phosphatase (ALP), and liver metastasis, which were used to establish the nomogram. The performance of this nomogram for the prediction of 6-month mortality risk was found to be promising and feasible based on logistic regression. Conclusion: A nomogram based on four independent pretreatment factors, including gender, MLR, ALP, and liver metastasis, was established to predict the 6-month mortality risk in patients with advanced BTC; it can provide clinicians and patients with additional information when evaluating treatment outcomes.

scholarly journals A systematic review and network meta-analysis of adjuvant therapy for curatively resected biliary tract cancers

2020 ◽  
Vol 27 (1) ◽  
Author(s):  
M. Kish ◽  
K. Chan ◽  
K. Perry ◽  
Y.J. Ko
Keyword(s):  
Systematic Review ◽  
Adjuvant Therapy ◽  
Biliary Tract ◽  
Meta Analysis ◽  
Indirect Comparison ◽  
Standard Of Care ◽  
Phase Iii ◽  
Quality Data ◽  
Qualitative Synthesis ◽  
Tract Cancer

Background Recent randomized controlled trials (rcts) have contributed high-quality data about adjuvant therapy in curatively resected biliary tract cancer (btc); however, a standard approach to treating those patients still has not been developed.Methods We conducted a systematic review of published studies and abstracts up to and including June 2018, choosing rcts involving patients with btc receiving adjuvant chemotherapy after complete surgical resection. Network meta-analysis methods were used for indirect comparisons of overall survival (os) and relapse-free survival (rfs) for various adjuvant therapies.Results Five rcts were included in qualitative synthesis, and three rcts (bilcap, prodige 12–accord 18, and bcat) had data sufficient for inclusion in the meta-analysis. Results from the indirect comparison demonstrated no significant improvement in os for capecitabine compared with gemcitabine or with gemcitabine–oxaliplatin (gemox), the hazard ratios (hrs) being 0.82 [95% confidence interval (ci): 0.53 to 1.27] and 0.86 (95% ci: 0.56 to 1.34) respectively. Similarly, no significant improvement in rfs was observed for capecitabine compared with gemcitabine or gemox.Conclusions Although in the present analysis, we found no statistically significant improvements in os or rfs for capecitabine compared with gemox or gemcitabine, capecitabine can—until further prospective trials are completed— be considered the standard of care in the adjuvant setting based on a single randomized phase iii study.

Pharmacotherapeutic options for biliary tract cancer: current standard of care and new perspectives

2019 ◽  
Vol 20 (17) ◽  
pp. 2121-2137 ◽  
Author(s):  
Roberto Filippi ◽  
Pasquale Lombardi ◽  
Virginia Quarà ◽  
Elisabetta Fenocchio ◽  
Giacomo Aimar ◽  
...  
Keyword(s):  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Standard Of Care ◽  
Current Standard ◽  
Tract Cancer

Randomized phase III study of gemcitabine plus S-1 combination therapy versus gemcitabine plus cisplatin combination therapy in advanced biliary tract cancer: A Japan Clinical Oncology Group study (JCOG1113, FUGA-BT).

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 205-205 ◽  
Author(s):  
Chigusa Morizane ◽  
Takuji Okusaka ◽  
Junki Mizusawa ◽  
Hiroshi Katayama ◽  
Makoto Ueno ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Standard Of Care ◽  
Phase Iii ◽  
Appetite Loss ◽  
Eligibility Criteria ◽  
Good Tolerability ◽  
Tract Cancer ◽  
Phase Iii Study

205 Background: Gemcitabine (GEM) plus cisplatin (GC) is the standard of care for advanced biliary tract cancer (BTC). However, GC is considered to be toxic because of nausea, vomiting, and appetite loss, and inconvenient due to requiring hydration before and after administration. GEM plus S-1 (GS) was reported to be promising with preferable efficacy and acceptable toxicity profile (UMIN000001685). This phase III study aimed to confirm the non-inferiority of GS to GC in terms of overall survival (OS). Methods: Eligibility criteria included chemotherapy-naïve patients with recurrent or unresectable biliary tract adenocarcinoma (gallbladder, intrahepatic biliary tract, extrahepatic biliary tract, or ampulla of Vater), an ECOG-PS of 0–1, and adequate organ function. In the GC arm, 1 g/m2 of GEM and 25 mg/m2 of cisplatin was infused on days 1 and 8 of a 21-day cycle. In the GS arm, 1 g/m2 of GEM was infused on days 1 and 8, and S-1 60, 80, or 100 mg/day according to body-surface area was administered from days 1 to 14 of a 21-day cycle. The primary endpoint was OS and the secondary endpoints included progression-free survival (PFS), response rate (RR), adverse events (AEs), clinically relevant AEs defined as any of grade 2 or more fatigue, appetite loss, nausea, vomiting, oral mucositis, and diarrhea. The sample size was calculated to be 350 with a one-sided alpha of 5%, a power of 80%, non-inferiority margin of 1.155 in terms of hazard ratio (HR). Results: From May 2013 to March 2016, 354 patients were enrolled. The non-inferiority of GS to GC was demonstrated (median OS: 13.4 months (m) in GC and 15.1 m in GS, HR 0.95; 90% confidence interval (CI), 0.78 to 1.15; P = 0.046 for non-inferiority). Median PFS was 5.8 m in GC and 6.8 m in GS (HR 0.86, 95% CI, 0.70-1.07). RR was 32.4% in GC and 29.8% in GS. Preliminary AEs data demonstrated that both treatments were generally well tolerated, although clinically relevant AEs were observed 34.7% in GC and 31.2 % in GS. Conclusions: GS demonstrated non-inferiority to GC in OS with good tolerability and was considered as new convenient option of standard of care without hydration for advanced BTC. Clinical trial information: UMIN000010667.

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