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Poster session 13

55P - Final results from the NIFTY trial, a phase IIb, randomized, open-label study of liposomal Irinotecan (nal-IRI) plus fluorouracil (5-FU)/leucovorin (LV) in patients (pts) with previously treated metastatic biliary tract cancer (BTC)


10 Sep 2022


Poster session 13


Tumour Site

Hepatobiliary Cancers


Changhoon Yoo


Annals of Oncology (2022) 33 (suppl_7): S19-S26. 10.1016/annonc/annonc1036


C. Yoo1, K. Kim2, I. Kim3, M.J. Kang4, J. Cheon5, B.W. Kang6, H. Ryu7, J. Jeong8, J.S. Lee9, K.W. Kim10, B. Ryoo8, G.K. Abou-Alfa11

Author affiliations

  • 1 Oncology Dept., Asan Medical Center - University of Ulsan College of Medicine, 138-931 - Seoul/KR
  • 2 Oncology Dept., Asan Medical Center - Asan Institute for Life Science, 138-736 - Seoul/KR
  • 3 Medical Oncology, Inje University Haeundae Paik Hospital, 612-896 - Busan/KR
  • 4 Hematology/oncology, Inje University Haeundae Paik Hospital, 612-030 - Busan/KR
  • 5 Hematology/oncology, Bundang CHA university hospital, 44033 - seongnam/KR
  • 6 Hematology/oncology, KNUH-Kyungpook National University Medical Center Biobank - Chilgok Hospital, 41404 - Daegu/KR
  • 7 Hematooncology Department, Chungnam National University Hospital, 301-721 - Daejeon/KR
  • 8 Department Of Oncology, Asan Medical Center - University of Ulsan College of Medicine, 138-931 - Seoul/KR
  • 9 Clinical Epidemiology And Biostatistics, Asan Medical Center - University of Ulsan, 138-931 - Seoul/KR
  • 10 Radiology, Asan Medical Center - University of Ulsan, 138-931 - Seoul/KR
  • 11 Medicine Department, Memorial Sloan Kettering Evelyn H. Lauder Breast Center, 10065 - New York/US

Abstract 55P


The NIFTY trial showed that nal-IRI plus 5-FU/LV significantly improved the blinded-independent central review (BICR)- and investigator-assessed progression-free survival (PFS) and overall survival (OS) compared with 5-FU/LV. An updated analysis (data cutoff: 31 DEC 2021) was performed to assess the long-term efficacy outcomes (extension follow-up of 1.3 years). As there was a concern about the large discrepancy rates (30%) between BICR and investigator review in the previous analysis, BICR was performed again by three independent radiologists with more experience in clinical trials and also through external monitoring.


Pts with > 19 yrs, ECOG PS 0-1, metastatic BTC, and disease progression on prior GemCis were eligible. Pts were randomized 1:1 to nal-IRI plus 5-FU/LV or 5-FU/LV, every 2 weeks. Tumor response was evaluated per RECIST v1.1, every 6 wks.


Between SEP 2018 and FEB 2020, 88 and 86 pts were included in nal-IRI plus 5-FU/LV and 5-FU/LV groups, respectively. With median follow-up of 6.1 mo (IQR 3.5-12.6), median PFS per BICR in nal-IRI plus 5-FU/LV group and 5-FU/LV group was 3.9 mo (95% CI, 2.6-4.7) and 1.5 mo (1.2-1.9), respectively (HR=0.38 [0.26-0.54], p<0.0001); median PFS per investigator review was 3.9 mo (2.7-5.2) and 1.6 mo (1.3-2.2), respectively (HR=0.51 [0.36-0.71], p<0.0001). Median OS was 8.6 mo (5.4-10.5) and 5.3 mo (4.7-7.2), respectively (HR=0.68 [0.48-0.95], p=0.024). ORR was 12.5% and 3.5% per BICR, respectively (p=0.043) and 19.3% and 2.3% per investigator review, respectively (p=0.0002). The discordance rate for tumor progression date between BICR and investigators was 10.7%. In multivariate analyses for prognostic factors, bone mets was associated with poor PFS; male, CA 19-9 > median, elevated CRP, and albumin > median were associated with poor OS; prior GemCis duration > median was associated with better OS.


The survival benefits of 2nd line nal-IRI plus 5-FU/LV versus 5-FU/LV were maintained over an extended follow-up in BTC pts.

Clinical trial identification

NCT03524508 Release date: May 14, 2018.

Editorial acknowledgement

Legal entity responsible for the study

The authors.


Servier and HK Inno.N.


C. Yoo: Financial Interests, Personal, Invited Speaker: Bayer, Celgene, Eisai, Ipsen, Servier, Roche; Financial Interests, Personal, Advisory Board: AstraZeneca. G.K. Abou-Alfa: Financial Interests, Personal, Advisory Board: Adicet, Alnylam, AstraZeneca, Autem, Beigene, Berry Genomics, Boehringer Ingelheim, Celgene, Cend, CytomX, Eisai, Eli Lilly, Exelixis, Flatiron, Genentech/Roche, Genoscience, Helio, Helsinn, Incyte, Ipsen, Merck, Nerviano, Newbridge, Novartis, QED, Redhill, Rafael, Servier, Silenseed, Sobi, Vector, Yiviva; Financial Interests, Personal, Other, IP License: PCT/US2014/031545 filed on March 24, 2014, and priority application Serial No.: 61/804,907; Filed: March 25, 2013; Financial Interests, Institutional, Research Grant: Arcus, AstraZeneca, BioNtech, BMS, Celgene, Flatiron, Genentech/Roche, Genoscience, Incyte, Polaris, Puma, QED, Silenseed, Yiviva; Non-Financial Interests, Principal Investigator: AstraZeneca, Yiviva, QED. All other authors have declared no conflicts of interest.

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