TY - JOUR
T1 - Multicenter phase II trial of modified FOLFIRINOX in gemcitabine-refractory pancreatic cancer
AU - Pancreatobiliary Cancer Study Group of Korean Society of Gastrointestinal Cancer
AU - Chung, Moon Jae
AU - Kang, Huapyong
AU - Kim, Ho Gak
AU - Hyun, Jong Jin
AU - Lee, Jun Kyu
AU - Lee, Kwang Hyuck
AU - Noh, Myung Hwan
AU - Kang, Dae Hwan
AU - Lee, Sang Hyub
AU - Bang, Seungmin
N1 - Publisher Copyright:
© The Author(s) 2018.
PY - 2018/12/1
Y1 - 2018/12/1
N2 - 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 GEMbased 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 II study of FOLFIRINOX. The objective response rate (ORR), disease control rate (DCR), progressionfree 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.
AB - 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 GEMbased 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 II study of FOLFIRINOX. The objective response rate (ORR), disease control rate (DCR), progressionfree 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.
KW - Chemotherapy
KW - Clinical Trial
KW - FOLFIRINOX
KW - Gemcitabine refractory
KW - Pancreatic cancer
KW - Phase II
UR - http://www.scopus.com/inward/record.url?scp=85059121005&partnerID=8YFLogxK
U2 - 10.4251/wjgo.v10.i12.505
DO - 10.4251/wjgo.v10.i12.505
M3 - Article
AN - SCOPUS:85059121005
SN - 1948-5204
VL - 10
SP - 505
EP - 515
JO - World Journal of Gastrointestinal Oncology
JF - World Journal of Gastrointestinal Oncology
IS - 12
ER -