Attenuated FOLFIRINOX in the salvage treatment of gemcitabine-refractory advanced pancreatic cancer: a phase II study
- Abstract
- BACKGROUND: Combination therapy with oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) chemotherapy drastically improves survival of advanced pancreatic cancer patients. However, the efficacy of FOLFIRINOX as a second-line treatment after gemcitabine failure has not been tested prospectively. We investigated the feasibility and safety of attenuated FOLFIRINOX in patients with gemcitabine-refractory advanced pancreatic cancer. METHODS: A multicenter phase II prospective open-label, single-arm study was conducted at 14 hospitals. Patients with histologically proven invasive ductal pancreatic adenocarcinoma, a measurable or evaluable lesion, Eastern Cooperative Oncology Group performance status 0 or 1, adequate organ function, and aged 19years or older were eligible. Attenuated FOLFIRINOX consisted of oxaliplatin 65mg/m(2), irinotecan 135mg/m(2), and leucovorin 400mg/m(2) injected intravenously on day 1 and 5-fluorouracil 2000mg/m(2) continuously infused intravenously over 46h on days 1-2, repeated every 2weeks. The primary endpoint was progression-free survival from the initiation of FOLFIRINOX. Secondary endpoints were the objective response rate, disease control rate, overall survival, safety, and tolerability. We estimated overall survival and progression-free survival using the Kaplan-Meier methods. RESULTS: We enrolled 39 patients from 14 institutions. The objective response rate was 10.3%, while the disease control rate was 64.1%. The 6-month and 1-year overall survival rates were 59.0% and 15.4%, respectively. Median progression-free survival and overall survival were 3.8months (95% confidence interval [CI] 1.5-6.0months) and 8.5months (95% CI 5.6-11.4months), respectively. Grade 3 or 4 adverse events were neutropenia (41.0%), nausea (10.3%), anorexia (10.3%), anemia (7.7%), mucositis (7.7%), pneumonia/pleural effusion (5.1%), and fatigue (5.1%). One treatment-related death attributable to septic shock occurred. CONCLUSION: Attenuated FOLFIRINOX may be promising as a second-line therapy for gemcitabine-refractory pancreatic cancer.
- All Author(s)
- J. H. Kim
; S. C. Lee
; S. Y. Oh
; S. Y. Song
; N. Lee
; E. M. Nam
; S. Lee
; I. G. Hwang
; H. R. Lee
; K. T. Lee
; S. B. Bae
; H. J. Kim
; J. S. Jang
; D. H. Lim
; H. W. Lee
; S. Y. Kang
; J. H. Kang
- Issued Date
- 2018
- Type
- Article
- Keyword
- Attenuated FOLFIRINOX; Second‑line; Pancreatic cancer; Gemcitabine
- Publisher
- US Chinese Anti-Cancer Association
- ISSN
- 2523-3548
- Citation Title
- Cancer Communications
- Citation Volume
- 38
- Citation Number
- 1
- Citation Start Page
- 32
- Citation End Page
- 32
- Language(ISO)
- eng
- DOI
- 10.1186/s40880-018-0304-1
- URI
- http://schca-ir.schmc.ac.kr/handle/2022.oak/1709
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