首页> 外文期刊>Journal of the advanced practitioner in oncology >Gastrointestinal Cancers: 2021 ASCO Annual Meeting Highlights for the Advanced Practitioner: The Advanced Practitioner Perspective: Liposomal Irinotecan With 5-FU and Leucovorin Improves Outcomes for Patients With Biliary Tract Cancer, By JADPRO Staff
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Gastrointestinal Cancers: 2021 ASCO Annual Meeting Highlights for the Advanced Practitioner: The Advanced Practitioner Perspective: Liposomal Irinotecan With 5-FU and Leucovorin Improves Outcomes for Patients With Biliary Tract Cancer, By JADPRO Staff

机译:Gastrointestinal Cancers: 2021 ASCO Annual Meeting Highlights for the Advanced Practitioner: The Advanced Practitioner Perspective: Liposomal Irinotecan With 5-FU and Leucovorin Improves Outcomes for Patients With Biliary Tract Cancer, By JADPRO Staff

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摘要

Liposomal irinotecan (Onivyde) in combination with 5-FU and leucovorin significantly improved progression-free survival and overall survival for patients with advanced biliary tract cancer who have progressed on first-line gemcitabine and cisplatin. The NIFTY study is a multicenter, randomized, open-label phase IIb study that randomized patients with disease progression on first-line gemcitabine and cisplatin 1:1 to liposomal irinotecan (70 mg/m2, 90 minutes) plus 5-FU (2,400 mg/m2, 46 hours)/leucovorin (400 mg/m2, 30 min), every 2 weeks or 5-FU/leucovorin, every 2 weeks until disease progression per investigator review or intolerable toxicities. The primary endpoint was progression-free survival (PFS) per blinded independent central review (BICR). Secondary endpoints were PFS per investigator review, overall survival (OS), overall response rates (ORR), and safety. The Advanced Practitioner Perspective: Biliary tract cancer includes cancers of the gallbladder and bile ducts (cholangiocarcinoma). These cancers are relatively rare and tend to be diagnosed at an advanced stage. Patients diagnosed with advanced biliary tract cancer often have poor survival, and the optimal approach to treatment remains uncertain. Patients may be treated with chemotherapy, enrolled in a clinical trial, or given best supportive care. In this study, patients with progression of disease after first-line chemotherapy of gemcitabine and cisplatin were enrolled and received either liposomal irinotecan and 5-FU and leucovorin (5-FU/LV) or were treated with 5-FU/LV alone. According to data from the phase II NIFTY trial, liposomal irinotecan in combination with 5-FU/LV delayed cancer progression and prolonged survival for patients with metastatic biliary tract cancer whose disease had progressed following first-line gemcitabine/cisplatin. Despite the fact that this study was conducted in Korea only, it was appropriately powered to compare the two treatment groups and was designed for meticulous tumor response evaluation. The combination should be considered as a standard of care for second-line therapy in patients with metastatic biliary tract cancers.

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