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Multicenter phase II trial of modified FOLFIRINOX in gemcitabine-refractory pancreatic cancer

Authors
 Moon Jae Chung  ;  Huapyong Kang  ;  Ho Gak Kim  ;  Jong Jin Hyun  ;  Jun Kyu Lee  ;  Kwang Hyuck Lee  ;  Myung Hwan Noh  ;  Dae Hwan Kang  ;  Sang Hyub Lee  ;  Seungmin Bang  ;  Pancreatobiliary Cancer Study Group of Korean Society of Gastrointestinal Cancer 
Citation
 WORLD JOURNAL OF GASTROINTESTINAL ONCOLOGY, Vol.10(12) : 505-515, 2018 
Journal Title
WORLD JOURNAL OF GASTROINTESTINAL ONCOLOGY
Issue Date
2018
Keywords
Chemotherapy ; Clinical Trial, Phase II ; FOLFIRINOX ; Gemcitabine refractory ; Pancreatic cancer
Abstract
AIM: To evaluate the efficacy and safety of modified FOLFIRINOX as a second-line treatment for gemcitabine (GEM)-refractory unresectable pancreatic cancer (PC). METHODS: This study was a prospective, multicenter, one-arm, open-label, phase II trial. Patients with unresectable PC, who showed disease progression during GEM-based chemotherapy were enrolled. All patients were administered FOLFIRINOX with reduced irinotecan and oxaliplatin (RIO; irinotecan 120 mg/m2 and oxaliplatin 60 mg/m2), which was set according to the phase I study of FOLFIRINOX. The objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), adverse events were evaluated. Additionally, changes in quality of life (QoL) were assessed using a questionnaire on QoL. RESULTS: Between August 2015 and May 2016, a total of 48 patients were enrolled. The median follow-up time was 259 d with a median of 8.5 cycles. The ORR and DCR were 18.8% and 62.5%, respectively, including one patient who showed complete remission. The median PFS was 5.8 mo [95% confidence interval (CI): 3.7-7.9] and median OS was 9.0 mo (95%CI: 6.4-11.6). Neutropenia (64.6%) was the most common grade 3-4 adverse event, followed by febrile neutropenia (16.7%). Although 14.6% of patients experienced grade 3 fatigue, most non-hematologic AEs were under grade 2. In the QoL analysis, the global health status score before treatment was not different from the score at the last visit after treatment (45.43 ± 22.88 vs 48.66 ± 24.14, P = 0.548). CONCLUSION: FOLFIRINOX with RIO showed acceptable toxicity and promising efficacy for GEM-refractory unresectable PC. However, this treatment requires careful observation of treatment-related hematologic toxicities.
Files in This Item:
T201805429.pdf Download
DOI
10.4251/wjgo.v10.i12.505
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kang, Huapyong(강화평) ORCID logo https://orcid.org/0000-0003-1790-0809
Bang, Seungmin(방승민) ORCID logo https://orcid.org/0000-0001-5209-8351
Chung, Moon Jae(정문재) ORCID logo https://orcid.org/0000-0002-5920-8549
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/167262
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