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Ref Type | Journal Article | ||||||||||||
PMID | (39232586) | ||||||||||||
Authors | Chen LT, Vogel A, Hsu C, Chen MH, Fang W, Pangarsa EA, Sharma A, Ikeda M, Park JO, Tan CK, Regala E, Tai D, Tanasanvimon S, Charoentum C, Chee CE, Lui A, Sow J, Oh DY, Ueno M, Ramaswamy A, Jeo WS, Zhou J, Curigliano G, Yoshino T, Bai LY, Pentheroudakis G, Chiang NJ, Cervantes A, Chen JS, Ducreux M | ||||||||||||
Title | Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with biliary tract cancer. | ||||||||||||
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Abstract Text | The European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with biliary tract cancer (BTC), published in late 2022 were adapted in December 2023, according to established standard methodology, to produce the Pan-Asian adapted (PAGA) ESMO consensus guidelines for the management of Asian patients with BTC. The adapted guidelines presented in this manuscript represent the consensus opinions reached by a panel of Asian experts in the treatment of patients with BTC representing the oncological societies of China (CSCO), Indonesia (ISHMO), India (ISMPO), Japan (JSMO), Korea (KSMO), Malaysia (MOS), the Philippines (PSMO), Singapore (SSO), Taiwan (TOS) and Thailand (TSCO), co-ordinated by ESMO and the Taiwan Oncology Society (TOS). The voting was based on scientific evidence and was independent of the current treatment practices, drug access restrictions and reimbursement decisions in the different regions of Asia. Drug access and reimbursement in the different regions of Asia are discussed separately in the manuscript. The aim is to provide guidance for the optimisation and harmonisation of the management of patients with BTC across the different countries and regions of Asia, drawing on the evidence provided by both Western and Asian trials, whilst respecting the differences in screening practices and molecular profiling, as well as age and stage at presentation. Attention is drawn to the disparity in the drug approvals and reimbursement strategies, between the different countries. |
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Therapy Name | Drugs | Efficacy Evidence | Clinical Trials |
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Gene | Variant | Impact | Protein Effect | Variant Description | Associated with drug Resistance |
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Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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RET fusion | biliary tract cancer | sensitive | Selpercatinib | Guideline | Actionable | Retevmo (selpercatinib) is included in the Pan-Asian Guidelines Adaptation (PAGA) for biliary tract cancer patients harboring RET fusions who have progressed on or are intolerant of prior therapies (PMID: 39232586; ESMO.org). | detail... 39232586 |
MSH6 negative | biliary tract cancer | sensitive | Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) is included in the Pan-Asian Guidelines Adaptation (PAGA) for patients with mismatch repair-deficient (dMMR, defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) biliary tract cancer who have progressed on or are intolerant of non-immune checkpoint inhibitor therapies (PMID: 39232586; ESMO.org). | detail... 39232586 |
MLH1 negative | biliary tract cancer | sensitive | Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) is included in the Pan-Asian Guidelines Adaptation (PAGA) for patients with mismatch repair-deficient (dMMR, defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) biliary tract cancer who have progressed on or are intolerant of non-immune checkpoint inhibitor therapies (PMID: 39232586; ESMO.org). | detail... 39232586 |
IDH1 mutant | cholangiocarcinoma | sensitive | Ivosidenib | Guideline | Actionable | Tibsovo (ivosidenib) is included in the Pan-Asian Guidelines Adaptation (PAGA) for cholangiocarcinoma patients harboring IDH1 mutations who have progressed after one or more lines of systemic therapy (PMID: 39232586; ESMO.org). | detail... 39232586 |
BRAF V600E | biliary tract cancer | sensitive | Dabrafenib + Trametinib | Guideline | Actionable | Tafinlar (dabrafenib) in combination with Mekinist (trametinib) is included in the Pan-Asian Guidelines Adaptation (PAGA) for biliary tract cancer patients harboring BRAF V600E who have progressed on one or more lines of systemic therapy (PMID: 39232586; ESMO.org). | 39232586 detail... |
FGFR2 fusion | biliary tract cancer | sensitive | Futibatinib | Guideline | Actionable | Lytgobi (futibatinib) is included in the Pan-Asian Guidelines Adaptation (PAGA) for biliary tract cancer patients harboring FGFR2 fusions who have progressed after one or more lines of systemic therapy (PMID: 39232586; ESMO.org). | detail... 39232586 |
FGFR2 fusion | biliary tract cancer | sensitive | Pemigatinib | Guideline | Actionable | Pemazyre (pemigatinib) is included in the Pan-Asian Guidelines Adaptation (PAGA) for biliary tract cancer patients harboring FGFR2 fusions who have progressed after one or more lines of systemic therapy (PMID: 39232586; ESMO.org). | detail... 39232586 |