Feasibility of HER2-Targeted Therapy in Advanced Biliary Tract Cancer: A Prospective Pilot Study of Trastuzumab Biosimilar in Combination with Gemcitabine Plus Cisplatin

Jeong, Hyehyun; Jeong, Jae Ho; Kim, Kyu-Pyo; Lee, Sang Soo; Oh, Dongwook; Park, Do Hyun; Song, Tae Jun; Park, Yangsoon; Hong, Seung‐Mo; Ryoo, Baek‐Yeol; Yoo, Changhoon

doi:10.3390/cancers13020161

Cited by 19 publications

(9 citation statements)

References 36 publications

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“…The following supporting information can be downloaded at , Table S1 : Overview of current and ongoing clinical trials for therapies targeting IDH1/2 in CCA, Table S2 : Overview of current and ongoing clinical trials for therapies targeting KRAS in CCA, Table S3 : Overview of current and ongoing clinical trials for therapies targeting FGFR in CCA, Table S4 : Overview of current and ongoing clinical trials for therapies targeting EGFR and VEGF in CCA, Table S5 : Overview of current and ongoing clinical trials for targeted therapies including multikinase inhibitors in CCA, Table S6 : Overview of current and ongoing clinical trials for therapies targeting the MET, notch, and chromatin remodeling pathways in CCA, Table S7 : Overview of current and ongoing clinical trials for immunotherapies in CCA. References [ 181 , 182 , 183 , 184 , 185 , 186 , 187 , 188 , 189 , 190 , 191 , 192 , 193 , 194 , 195 , 196 , 197 , 198 , 199 ] are cited in the supplementary materials.…”

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confidence: 99%

Prognostic and Predictive Molecular Markers in Cholangiocarcinoma

Pavicevic

Reichelt

Uluk

et al. 2022

Cancers

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Cholangiocarcinoma (CCA) is the second most common primary liver cancer and subsumes a heterogeneous group of malignant tumors arising from the intra- or extrahepatic biliary tract epithelium. A rising mortality from CCA has been reported worldwide during the last decade, despite significant improvement of surgical and palliative treatment. Over 50% of CCAs originate from proximal extrahepatic bile ducts and constitute the most common CCA entity in the Western world. Clinicopathological characteristics such as lymph node status and poor differentiation remain the best-studied, but imperfect prognostic factors. The identification of prognostic molecular markers as an adjunct to traditional staging systems may not only facilitate the selection of patients who would benefit the most from surgical, adjuvant or palliative treatment strategies, but may also be helpful in defining the aggressiveness of the disease and identifying patients at high-risk for tumor recurrence. The purpose of this review is to provide an overview of currently known molecular prognostic and predictive markers and their role in CCA.

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confidence: 99%

Prognostic and Predictive Molecular Markers in Cholangiocarcinoma

Pavicevic

Reichelt

Uluk

et al. 2022

Cancers

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“…Interestingly, small studies including patients with biliary tract cancer and HER2 mutations or overexpression have suggested promising efficacy with HER2-targeted therapies. 29 , 30 As HER2 overexpression occurs in only around one-quarter of biliary tract cancers, 12 selecting patients with HER2 aberrations may increase the likelihood of observing a therapeutic effect compared with an unselected patient population. In this regard, the SUMMIT basket trial investigated monotherapy with neratinib, a pan-HER kinase inhibitor, in pretreated patients with HER2 -mutated advanced biliary tract cancer.…”

Section: Discussionmentioning

confidence: 99%

Varlitinib plus capecitabine in second-line advanced biliary tract cancer: a randomized, phase II study (TreeTopp)

Javle

Ikeda

et al. 2022

ESMO Open

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Background Patients with advanced biliary tract cancer who progress on first-line therapy have limited treatment options. The TreeTopp study assessed varlitinib, a reversible small molecule pan-human epidermal growth factor receptor inhibitor, plus capecitabine in previously treated advanced biliary tract cancer. Patients and methods This global, double-blind, randomized, placebo-controlled phase II study enrolled patients with confirmed unresectable or metastatic biliary tract cancer and disease progression after one prior line of gemcitabine-containing chemotherapy. Patients received oral varlitinib 300 mg or placebo twice daily (b.i.d.) for 21 days, plus oral capecitabine 1000 mg/m 2 b.i.d. on days 1-14, in 21-day treatment cycles. Co-primary endpoints were objective response rate and progression-free survival (PFS) according to RECIST v1.1 by Independent Central Review. Results In total, 127 patients received varlitinib plus capecitabine ( n = 64) or placebo plus capecitabine ( n = 63). The objective response rate was 9.4% with varlitinib plus capecitabine versus 4.8% with capecitabine alone (odds ratio 2.28; P = 0.42). Median PFS was 2.83 versus 2.79 months [hazard ratio (HR), 0.90; 95% confidence interval (CI), 0.60-1.37; P = 0.63] and overall survival was 7.8 versus 7.5 months (HR, 1.11; 95% CI, 0.69-1.79; P = 0.66), respectively. In a subgroup analysis, the addition of varlitinib appeared to provide a PFS benefit in female patients (median, 4.1 versus 2.8 months; HR, 0.59; 95% CI, 0.28-1.23) and those with gallbladder cancer (median, 2.9 versus 1.6 months; HR, 0.55; 95% CI, 0.26-1.19). Grade ≥3 treatment-emergent adverse events were reported in 65.6% of patients receiving varlitinib plus capecitabine versus 58.7% of those receiving capecitabine alone. Conclusions In patients with advanced biliary tract cancer, second-line treatment with varlitinib plus capecitabine was well tolerated but did not improve efficacy versus capecitabine alone. A PFS benefit was suggested in female patients and those with gallbladder cancer.

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“…Targeting HER2 demonstrated to be a promising strategy using a Trastuzumab biosimilar in a recent study by Jeong et al, that reached a 100% disease control rate (DCR) and a 50% ORR [89].…”

Section: Her2 Blockadementioning

confidence: 99%

Molecular Targets and Emerging Therapies for Advanced Gallbladder Cancer

Canale

Monti

Rapposelli

et al. 2021

Cancers

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Biliary tract cancers (BTCs), for their low incidence, have been often considered together. Gallbladder cancer (GBC) is the most common biliary tract malignancy, characterized by late diagnosis and poor prognosis, and although it is considered a rare tumor in western countries, other areas of the world show considerable incidence rates. In 2010, results from the large phase III ABC-02 clinical trial on GBC identified the gemcitabine and cisplatin combination as the most effective first-line regimen for both GBC and other BTCs. Since then, various systemic therapies have proven active in BTCs in both first- and second-line settings. Molecular profiling has highlighted important genetic differences between GBC and other BTCs, opening new ways for targeted therapy in advanced disease where standard chemotherapies show marginal benefit. Genome-wide data analysis have shown that GBC molecular landscape offer possible strategies for precision medicine approaches, and a better molecular understanding of the GBC is needed to better stratify patients for treatment. In this review, we discuss the molecular targetable agents for GBC, including the results that emerged by clinical trials exploring new treatment strategies.

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Feasibility of HER2-Targeted Therapy in Advanced Biliary Tract Cancer: A Prospective Pilot Study of Trastuzumab Biosimilar in Combination with Gemcitabine Plus Cisplatin

Cited by 19 publications

References 36 publications

Prognostic and Predictive Molecular Markers in Cholangiocarcinoma

Prognostic and Predictive Molecular Markers in Cholangiocarcinoma

Varlitinib plus capecitabine in second-line advanced biliary tract cancer: a randomized, phase II study (TreeTopp)

Molecular Targets and Emerging Therapies for Advanced Gallbladder Cancer

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