Liposomal irinotecan plus fluorouracil and leucovorin versus fluorouracil and leucovorin for metastatic biliary tract cancer after progression on gemcitabine plus cisplatin (NIFTY): a multicentre, open-label, randomised, phase 2b study

Yoo, Changhoon; Kim, Kyu-Pyo; Jeong, Jae Ho; Kim, Il-Hwan; Kang, Myoung Joo; Cheon, Jaekyung; Kang, Byung Woog; Ryu, Hyewon; Lee, Ji Sung; Kim, Kyung Won; Abou‐Alfa, Ghassan K.; Ryoo, Baek‐Yeol

doi:10.1016/s1470-2045(21)00486-1

Cited by 153 publications

(128 citation statements)

References 30 publications

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“… [33] , [34] , [35] , [36] , [37] , [38] , [39] Therefore, a variety of new treatment regimens, such as triple therapies like FOLFIRINOX ( NCT02591030 ) or gemcitabine/cisplatin/nab-paclitaxel ( NCT03768414 ) are currently being investigated in clinical trials. 16 , 20 , 40 …”

Section: Discussionmentioning

confidence: 99%

“… [12] , [13] , [14] After failure of GemCis, recent studies recommend the use of FOLFOX as second-line treatment of ABTC. 2 , 15 In addition, triple therapies such as gemcitabine + cisplatin + nab-paclitaxel 16 or FOLFIRINOX [17] , [18] , [19] , novel regimens such as liposomal irinotecan + fluorouracil + leucovorin, 20 checkpoint inhibitors alone or in combination with chemotherapy, 21 and molecular targeted therapies such as the inhibition of fibroblast growth factor receptor (FGFR) 1-4 [22] , [23] , [24] , [25] , [26] or isocitrate dehydrogenase (IDH) 1 27 are currently being investigated in clinical trials (reviewed in 21 , 28 ). However, most patients with ABTC will receive established treatments, and for them and their treating physicians real-world data on their prognosis can present valuable information.…”

Section: Introductionmentioning

confidence: 99%

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Outcomes in patients receiving palliative chemotherapy for advanced biliary tract cancer

Thol¹,

Gairing²,

Czauderna³

et al. 2022

JHEP Reports

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This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Outcomes in patients receiving palliative chemotherapy for advanced biliary tract cancer

Thol¹,

Gairing²,

Czauderna³

et al. 2022

JHEP Reports

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“…Following progression on gemcitabine/cisplatin, patients were randomized to either liposomal irinotecan/5-FU or 5-FU alone. Overall response rates (ORR) were higher in the arm containing liposomal irinotecan (15% vs. 6%) as was PFS, the primary endpoint of the study (7.1 vs. 1.4 months; HR 0.56, 95% CI 0.39–0.81; p = 0.0019) [ 18 ].…”

Section: Cytotoxic Chemotherapymentioning

confidence: 99%

Advanced Bile Duct Cancers: A Focused Review on Current and Emerging Systemic Treatments

Cowzer

Harding

2022

Cancers

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Cancers arising in the biliary tract are rare, with varied incidence depending on geographical location. As clinical presentation is typically vague with non-specific symptoms, a large proportion of patients present with unresectable or metastatic disease at diagnosis. When unresectable, the mainstay of treatment is cytotoxic chemotherapy; however, despite this, 5-year overall survival remains incredibly poor. Diagnostic molecular pathology, using next-generation sequencing, has identified a high prevalence of targetable alterations in bile duct cancers, which is transforming care. Substantial genomic heterogeneity has been identified depending on both the anatomical location and etiology of disease, with certain alterations enriched for subtypes. In addition, immune checkpoint inhibitors with anti-PD-1/PD-L1 antibodies in combination with chemotherapy are now poised to become the standard first-line treatment option in this disease. Here, we describe the established role of cytotoxic chemotherapy, targeted precision treatments and immunotherapy in what is a rapidly evolving treatment paradigm for advanced biliary tract cancer.

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“…In a multicenter, open-label, randomized, phase 2b study performed in South Korea (NIFTY), 174 patients were enrolled (88 treated with liposomal irinotecan plus 5-FU/leucovorin, and 86 in the 5-FU/leucovorin group). At a median follow-up of 11.8 months, the median PFS was significantly longer in the liposomal irinotecan plus 5-FU/leucovorin group (7.1 months, 95% CI 3.6–8.8) compared to 5-FU/leucovorin group (1.4 months, 1.2–1.5; hazard ratio 0.56, 95% CI 0.39–0.81; p = 0.0019) [ 63 ]. As expected, patients treated with liposomal irinotecan plus 5-FU/LV experienced more side effects, including neutropenia and fatigue.…”

Section: Treatment Optionsmentioning

confidence: 99%

Evolving Paradigms in the Systemic Treatment of Advanced Gallbladder Cancer: Updates in Year 2022

Lim

2022

Cancers

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Gallbladder cancer (GBC) is a biological, anatomical, and clinically distinct subset of biliary tract cancers (BTC), which also include extra- and intra-hepatic cholangiocarcinoma. The advent of next-generation sequencing (NGS) clearly shows that GBC is genetically different from cholangiocarcinoma. Although GBC is a relatively rare cancer, it is highly aggressive and carries a grave prognosis. To date, complete surgical resection remains the only path for cure but is limited to patients with early-stage disease. The majority of the patients are diagnosed at an advanced, inoperable stage when systemic treatment is administered as an attempt to enable surgery or for palliation. Gemcitabine and platinum-based chemotherapies have been the main treatment modality for unresectable, locally advanced, and metastatic gallbladder cancer. However, over the past decade, the treatment paradigm has evolved. These include the introduction of newer chemotherapeutic strategies after progression on frontline chemotherapy, incorporation of targeted therapeutics towards driver mutations of genes including HER2, FGFR, BRAF, as well as approaches to unleash host anti-tumor immunity using immune checkpoint inhibitors. Notably, due to the rarity of BTC in general, most clinical trials included both GBC and cholangiocarcinomas. Here, we provide a review on the pathogenesis of GBC, past and current systemic treatment options focusing specifically on GBC, clinical trials tailored towards its genetic mutations, and emerging treatment strategies based on promising recent clinical studies.

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Liposomal irinotecan plus fluorouracil and leucovorin versus fluorouracil and leucovorin for metastatic biliary tract cancer after progression on gemcitabine plus cisplatin (NIFTY): a multicentre, open-label, randomised, phase 2b study

Cited by 153 publications

References 30 publications

Outcomes in patients receiving palliative chemotherapy for advanced biliary tract cancer

Outcomes in patients receiving palliative chemotherapy for advanced biliary tract cancer

Advanced Bile Duct Cancers: A Focused Review on Current and Emerging Systemic Treatments

Evolving Paradigms in the Systemic Treatment of Advanced Gallbladder Cancer: Updates in Year 2022

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