Abstract

Simple SummaryBecause FOLFIRINOX shows high prevalence of hematologic toxicity, it is meaningful to investigate of usefulness of primary G-CSF prophylaxis in metastatic pancreatic cancer patients. In this retrospective study, a total of 165 patients were divided into G-CSF user group (n = 57) and non-user group (n = 105). Baseline characteristics were not significantly different between two groups, which included initial absolute neutrophil counts and metastatic burden. Primary G-CSF prophylaxis reduced the risk of neutropenia (55.6% to 31.6%, p = 0.003) and febrile neutropenia (18.5% to 1.8%, p = 0.002) and improved OS (8.8 to 14.7 months; hazard ratio (HR): 1.766, 95% CI: 1.257–2.481, p = 0.001). When administering FOLFIRINOX for MPC, primary G-CSF prophylaxis could be rationalized to reduced AEs and improve survival, and more prospective studies are needed.Although FOLFIRINOX (5-fluorouracil, leucovorin, irinotecan, and oxaliplatin) has been proven efficacious in metastatic pancreatic cancer (MPC), physicians hesitate to administer it due to its hematologic toxicities. We investigated the usefulness of primary granulocyte colony-stimulating factor (G-CSF) prophylaxis. We reviewed electronic medical records of MPC patients with good performance status who were administered FOLFIRINOX as the first-line treatment from 2011 to 2017. The patients were divided into primary G-CSF prophylaxis users (group A) and non-users or therapeutic/secondary users (group B). Cumulative relative dose (cRDI), adverse effects (AEs), and overall survival (OS) were compared. A total of 165 patients (group A (57) vs. group B (108)) were investigated. Intergroup differences in baseline characteristics were not significant, although the cRDI and the number of treatment cycles were both higher in group A than in group B (cRDI: 80.6% vs. 73.9%, p = 0.007; 9 vs. 6 cycles, p = 0.004). Primary G-CSF prophylaxis reduced the risk of neutropenia (55.6% to 31.6%, p = 0.003) and febrile neutropenia (18.5% to 1.8%, p = 0.002) and improved OS (8.8 to 14.7 months; hazard ratio [HR]: 1.766, 95% CI: 1.257–2.481, p = 0.001). When administering FOLFIRINOX for MPC, primary G-CSF prophylaxis could be rationalized to reduced AEs and improve survival; more prospective studies are needed.

Highlights

  • Pancreatic cancer (PC) was the fourth leading cause of death from cancer in both men and women in the United States in 2019 [1]

  • Since 2011, FOLFIRINOX is recommended as the first-line chemotherapy in metastatic PC (MPC) patients with good performance status [3,5]

  • In the present study, we investigated the usefulness of primary granulocyte colony-stimulating factor (G-CSF) prophylaxis in reducing hematologic adverse effects (AEs) and improving survival in MPC patients with good performance status who were treated with FOLFIRINOX

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Summary

Introduction

Pancreatic cancer (PC) was the fourth leading cause of death from cancer in both men and women in the United States in 2019 [1]. Combination chemotherapy regimens such as FOLFIRINOX (5-fluorouracil, leucovorin, irinotecan, and oxaliplatin) have considerably contributed to improvements in the overall survival (OS) of patients with metastatic PC (MPC) since 2011, the overall five-year survival rate is 9%, still indicating an unfavorable prognosis [2,3,4]. Since 2011, FOLFIRINOX is recommended as the first-line chemotherapy in MPC patients with good performance status [3,5]. In 2019, modified FOLFIRINOX became a new a milestone in the adjuvant setting of resectable PC; the regimen is becoming more widely used [6]. FOLFIRINOX was demonstrated to show considerable hematologic and nonhematologic side effects, even with a dose-modified regimen. Modification of the FOLFIRINOX regimen while both maintaining efficacy and reducing toxicity remains an important issue [3,7,8,9,10,11,12,13]

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