Modified FOLFIRINOX versus S-1 as second-line chemotherapy in gemcitabine-failed metastatic pancreatic cancer patients: A randomised controlled trial (MPACA-3)
- Authors
- Go, S.-I.; Lee, S.-C.; Bae, W.K.; Zang, D.Y.; Lee, H.W.; Jang, J.S.; Ji, J.H.; Kim, J.H.; Park, S.; Sym, S.J.; Yang, Y.; Jeon, S.Y.; Hwang, I.G.; Oh, S.Y.; Kang, J.H.
- Issue Date
- Nov-2021
- Publisher
- Elsevier Ltd
- Keywords
- Gemcitabine; Modified FOLFIRINOX; Pancreatic neoplasms; Randomised controlled trial; S-1; Second-line chemotherapy
- Citation
- European Journal of Cancer, v.157, pp 21 - 30
- Pages
- 10
- Journal Title
- European Journal of Cancer
- Volume
- 157
- Start Page
- 21
- End Page
- 30
- URI
- https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/49388
- DOI
- 10.1016/j.ejca.2021.08.002
- ISSN
- 0959-8049
1879-0852
- Abstract
- Background: The efficacy of modified FOLFIRINOX (mFOLFIRINOX) as a second-line chemotherapy treatment for metastatic pancreatic adenocarcinoma (mPAC), remains unclear. This multi-center randomised phase III trial aimed to elucidate the efficacy of mFOLFIRINOX as a second-line chemotherapy treatment for mPAC patients with good performance status. Patients and methods: Eighty mPAC patients (age, 19–75 years) refractory to first-line gemcitabine-based chemotherapy were randomly selected to receive mFOLFIRINOX or S-1. mFOLFIRINOX comprised oxaliplatin (65 mg/m2), irinotecan (135 mg/m2), and leucovorin (400 mg/m2) on day 1 and continuous 5-FU infusion (1000 mg/m2) over 24 h on days 1–2 every 2 weeks. S-1 comprised body surface area-dependent oral S-1, divided into two doses per day on days 1–28 every 6 weeks. Results: Overall survival was the primary endpoint. The objective response and disease control rates were higher in the mFOLFIRINOX than in the S-1 group (15% versus 2%; p = .04 and 67% versus 37%; p = .007). The median progression-free survival rates were 5.2 and 2.2 months in the mFOLFIRINOX and S-1 groups, respectively (adjusted hazard ratio [HR]: .4; 95% confidence interval [CI]: .2-.6; p < .001). The median overall survival rates were 9.2 and 4.9 months in the mFOLFIRINOX and S-1 groups, respectively (adjusted HR: .4; 95% CI: .2–.7; p = .002). Grade 3-4 adverse events occurred in 56% and 17% of the patients in the mFOLFIRINOX and S-1 groups, respectively (p < .001). Conclusion: Administration of mFOLFIRINOX as a second-line chemotherapy treatment for mPAC patients refractory to gemcitabine-based chemotherapy resulted in increased survival rates than S-1 treatment alone. © 2021 Elsevier Ltd
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