A randomized, double-blind, multicenter phase II AIO trial with gemcitabine plus sorafenib versus gemcitabine plus placebo in patients with chemotherapy-naive advanced or metastatic biliary tract cancer: First safety and efficacy data.

Moehler, Markus; Schimanski, Carl Christoph; Kanzler, S; Woerns, Marcus A.; Denzer, U; Kolligs, Frank T.; Ebert, MP; Distelrath, Andrea; Geißler, Michael; Zeuzem, Stefan; Lammert, Frank; Lohse, Ansgar W.; Dollinger, Matthias; Lindig, Udo; Duerr, Eva-Maria; Lubomierski, Nikolaus; Zimmermann, S.J.; Kabisch, Maria; Schadmann-Fischer, S.; Galle, Peter R.; Aio, German

doi:10.1200/jco.2011.29.15_suppl.4077

Cited by 7 publications

(3 citation statements)

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“…A phase II study of gemcitabine, oxaliplatin, and bevacizumab in advanced BTC reported a response rate of 40%, median PFS of 7 months, and OS of 12.7 months (Table 4) [79]. A single-arm phase II trial of erlotinib and bevacizumab without traditional cytotoxic Other antiangiogenic agents such as sorafenib and sunitinib have failed to show efficacy in this disease, either as single agents or in combination with gemcitabine, with response rates ,10% and survival times less than that seen with other regimens [81][82][83][84]. Sorafenib is a multikinase inhibitor of VEGFR-2/-3, PDGFR-b, B-Raf, and C-Raf; it has shown some level of activity in preclinical models of cholangiocarcinoma.…”

Section: Vegfmentioning

confidence: 99%

Molecular Targets in Biliary Carcinogenesis and Implications for Therapy

Oyasiji

Zhang²,

Kuvshinoff³

et al. 2015

The Oncologist

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Biliary tract cancers (BTCs) encompass a group of invasive carcinomas, including cholangiocarcinoma (intrahepatic, perihilar, or extrahepatic), and gallbladder carcinoma. Approximately 90% of patients present with advanced, unresectable disease and have a poor prognosis. The latest recommendation is to treat advanced or metastatic disease with gemcitabine and cisplatin, although chemotherapy has recorded modest survival benefits.Comprehension of the molecular basis of biliary carcinogenesis has resulted in experimental trials of targeted therapies in BTCs, with promising results. This review addresses the emerging role of targeted therapy in the treatment of BTCs. Findings from preclinical studies were reviewed and correlated with the outcomes of clinical trials that were undertaken to translate the laboratory discoveries. The Oncologist 2015;20:742-751

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Section: Vegfmentioning

confidence: 99%

Molecular Targets in Biliary Carcinogenesis and Implications for Therapy

Oyasiji

Zhang²,

Kuvshinoff³

et al. 2015

The Oncologist

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“…Studies of combined sorafenib and gemcitabine, sorafenib, oxaliplatin and capecitabine, or the related antiangiogenic drug sunitinib, also had minimal objective response rates but higher rates of stable disease [46,47,48]. …”

Section: Novel Targets and Therapiesmentioning

confidence: 99%

Current Therapy and Future Directions in Biliary Tract Malignancies

Ciombor

Goff

2013

Curr. Treat. Options in Oncol.

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OPINION STATEMENT Cancers of the biliary tree represent a rare group of diseases with a devastating impact on patients. Gallbladder cancer is often associated with cholelithiasis. Cholangiocarcioma may arise in the setting of biliary inflammation such as primary sclerosing cholangitis but most commonly occurs in patients without a particular risk factor. Surgical removal of biliary cancer is essential for cure, but it is associated with a very high rate of recurrence and for many patients is not possible at the time of diagnosis. Although risk factors differ for each anatomic site, systemic treatment is generally similar. Various adjunctive therapies such as radiation and embolization have been investigated for biliary tract cancers with modest success and efforts are ongoing to understand how to optimize these tools. Retrospective series and pooled analysis suggest a benefit for adjuvant treatment following resection, but prospective data is limited. Ongoing and planned phase 3 trials should help clarify the role of adjuvant chemotherapy and radiation. For advanced disease, chemotherapy improves quality of life and survival, and gemcitabine with cisplatin represents the standard of care. However, all patients ultimately progress on this therapy, so clinical trials of new and better agents are essential to expand the existing treatment options for patients.

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“…In the monotherapy setting, sorafenib has not demonstrated significant clinical activity, with response rates of 0–2% [52, 53]. In the combination chemotherapy setting, sorafenib was paired with gemcitabine in a phase II trial of first‐line chemotherapy in 62 patients with biliary cancers reported at ASCO 2011, demonstrating a response rate of 7%, but stable disease in another 63% of patients [54] The combination appears to have been well tolerated, and suggests the combination of a multitargeted kinase inhibitor might have reasonable activity and be safely paired with cytotoxic chemotherapy. A phase I/II study of gemcitabine/oxaliplatin with sorafenib is currently underway in the United States (Table 2).…”

Section: Angiogenesismentioning

confidence: 99%

Targeted therapy for biliary tract cancers

Faris

Zhu

2012

J Hepato Biliary Pancreat

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Biliary tract cancers (BTCs) are a heterogeneous group of malignancies, with a historically poor prognosis as a whole. Until recently, the development of effective therapeutics was hampered by the relatively low incidence, heterogeneity in patients and tumors, and correspondingly poor clinical trial enrollments. With the publication of the landmark phase III ABC-02 trial demonstrating the superiority of gemcitabine and cisplatin combination chemotherapy, the landscape changed for the development of new agents. Despite this progress, there are currently no approved targeted agents for BTC. This review will focus on recent developments in targeted therapeutics, directed against several key signaling pathways in BTC, including epidermal growth factor receptor, angiogenesis, and the mitogen-activated protein kinase pathway. Data from recent phase I and II trials will be discussed, along with a preview of upcoming trials involving targeted therapies.

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A randomized, double-blind, multicenter phase II AIO trial with gemcitabine plus sorafenib versus gemcitabine plus placebo in patients with chemotherapy-naive advanced or metastatic biliary tract cancer: First safety and efficacy data.

Cited by 7 publications

References 0 publications

Molecular Targets in Biliary Carcinogenesis and Implications for Therapy

Molecular Targets in Biliary Carcinogenesis and Implications for Therapy

Current Therapy and Future Directions in Biliary Tract Malignancies

Targeted therapy for biliary tract cancers

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