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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

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Abstract
Background The prognosis of patients with advanced biliary tract cancer who have progressed on gemcitabine plus
cisplatin is dismal. We aimed to investigate the efficacy and safety of second-line liposomal irinotecan plus fluorouracil
and leucovorin in patients with metastatic biliary tract cancer that has progressed on gemcitabine plus cisplatin.
Methods This multicentre, open-label, randomised, phase 2b (NIFTY) study was done at five academic institutions in
South Korea and included patients aged 19 years or older with histologically or cytologically confirmed metastatic
biliary tract cancer that had progressed on first-line gemcitabine plus cisplatin and an Eastern Cooperative Oncology
Group performance status of 0 or 1. By use of an interactive web-based response system integrated with an electronic
data capture system, patients were randomly assigned (1:1) using permuted blocks (block size 4) to receive either
intravenous liposomal irinotecan (70 mg/m² for 90 min) plus intravenous leucovorin (400 mg/m² for 30 min) and
intravenous fluorouracil (2400 mg/m² for 46 h) every 2 weeks or leucovorin and fluorouracil only every 2 weeks, and
were stratified by primary tumour site, previous surgery with curative intent, and participating centre. Study treatment
was continued until the patient had disease progression or unacceptable toxicities, or withdrew consent. The primary
endpoint was blinded independent central review (BICR)-assessed progression-free survival. The primary endpoint
and safety were assessed in the full analysis set and the safety analysis set, respectively, both of which comprised all
randomly assigned patients who received at least one dose of the study treatment. This trial is registered with
ClinicalTrials.gov, NCT03524508, and enrolment is complete.
Findings Between Sept 5, 2018, and Feb 18, 2020, 193 patients were screened for eligibility, of whom 174 (88 in the
liposomal irinotecan plus fluorouracil and leucovorin group and 86 in the fluorouracil plus leucovorin group) were
enrolled and included in the full analysis and safety analysis sets. At a median follow-up of 11·8 months (IQR 7·7?18·7),
the median BICR-assessed progression-free survival was significantly longer in the liposomal irinotecan plus
fluorouracil and leucovorin group (7·1 months, 95% CI 3·6?8·8) than in the fluorouracil and leucovorin group
(1·4 months, 1·2?1·5; hazard ratio 0·56, 95% CI 0·39?0·81; p=0·0019). The most common grade 3?4 adverse events
were neutropenia (21 [24%] of 88 in the liposomal irinotecan plus fluorouracil and leucovorin group vs one [1%] of
86 in the fluorouracil and leucovorin group) and fatigue or asthenia (11 [13%] vs three [3%]). Serious adverse events
occurred in 37 (42%) patients receiving liposomal irinotecan plus fluorouracil and leucovorin and 21 (24%) patients
receiving fluorouracil and leucovorin. There were no treatment-related deaths.
Interpretation Adding liposomal irinotecan to fluorouracil and leucovorin significantly improved BICR-assessed
progression-free survival in patients with advanced biliary tract cancer. Liposomal irinotecan plus fluorouracil and
leucovorin could be considered a standard-of-care second-line therapy for advanced biliary tract cancer.
Author(s)
강명주강병욱김경원김규표김일환류백렬류혜원유창훈이지성정재호천재경Ghassan Abou-Alfa
Issued Date
2021
Type
Article
Keyword
AnalysisAntimitotic agentsAntineoplastic agentsDevelopment and progressionLeucovorinMetastasis
DOI
10.1016/S1470-2045(21)00486-1
URI
https://oak.ulsan.ac.kr/handle/2021.oak/8262
https://ulsan-primo.hosted.exlibrisgroup.com/primo-explore/fulldisplay?docid=TN_cdi_proquest_miscellaneous_2583325289&context=PC&vid=ULSAN&lang=ko_KR&search_scope=default_scope&adaptor=primo_central_multiple_fe&tab=default_tab&query=any,contains,Liposomal%20irinotecan%20plus%20fluorouracil%20and%20leucovorin%20versus%20%20fluorouracil%20and%20leucovorin%20for%20metastatic%20biliary%20tract%20cancer%20%20after%20progression%20on%20gemcitabine%20plus%20cisplatin%20(NIFTY):%20%20a%20multicentre,%20open-label,%20randomised,%20phase%202b%20study&offset=0&pcAvailability=true
Publisher
LANCET ONCOLOGY
Location
영국
Language
영어
ISSN
1470-2045
Citation Volume
22
Citation Number
11
Citation Start Page
1560
Citation End Page
1572
Appears in Collections:
Medicine > Medicine
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