A multicenter phase Ib-IIR trial assessing the activity of regorafenib combined with modified gemcitabine: Oxaliplatin (mGEMOX) in patients with advanced biliary tract cancer (aBTC).

Assenat, Eric; Guimbaud, Rosine; Fraisse, Julien; Samalin, Emmanuelle; Portalès, Fabienne; Mazard, Thibault; Rifai, Lobna; Delord, Jean‐Pierre; Ychou, Marc

doi:10.1200/jco.2018.36.15_suppl.e16134

Cited by 3 publications

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“…Recently, a French random-ized Phase II study reported data on the activity of regorafenib in combination with GEMOX in advanced BTC. Regorafenib showed acceptable tolerability when combined with GEMOX with toxicities mainly imputable to conventional CT 63. A randomized Phase II double-blind trial tested the combination of ramucirumab or merestinib ( MET inhibitor) or placebo in addition to GEMCIS 64…”

Section: Future Prospectsmentioning

confidence: 99%

Biliary tract cancer: current challenges and future prospects

Ghidini¹,

Pizzo²,

Botticelli³

et al. 2018

CMAR

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PurposeIncidence and mortality of biliary tract carcinoma (BTC) are increasing, especially in South America and Asia. Such a disease often bears a dismal prognosis because of diagnosis occurring at late stages and for the frequent relapses after surgery. The aims of this review were to summarize the state of the art of the treatment of BTC and give a view at possible future prospects linked with molecular profiling, immunotherapy, and targeted therapies.DesignWe conducted a systematic literature search using MEDLINE and the 2018 ASCO Meeting abstract databases to identify published clinical trials, translational series, and meeting abstracts. All significant papers and abstracts available to date were included.ResultsFor resected BTC, thanks to the BILCAP study, adjuvant chemotherapy (CT) with capecitabine should be regarded as the new standard of care. For locally advanced inoperable and metastatic diseases, the use of chemoradiotherapy and radioembolization has not been supported by any randomized Phase III study. The standard of care remains the combination of CT with gemcitabine and cisplatin, as reported by the ABC-02 trial. All targeted therapies have failed to improve the survival outcomes, either in combination with CT or as single agents and are not recommended in the treatment of BTC. Whole-exome sequencing and molecular profiling have helped in identifying genetic signatures typical of different BTC subtypes. With this support, new trials with targeted agents and immunotherapy have been designed, and results are awaited.ConclusionBTC still remains a disease with very few treatment options. Different BTC subtypes own peculiar gene mutations and pathways alterations. Therefore, molecular profiling may be the only key to enable new tailored strategies with targeted agents and immunotherapy.

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Section: Future Prospectsmentioning

confidence: 99%