Modified FOLFIRINOX versus S-1 as second-line chemotherapy in gemcitabine-failed metastatic pancreatic cancer patients: A randomised controlled trial (MPACA-3). (November 2021)

• Record Type: Journal Article
• Authors: Go, Se-Il; Lee, Sang-Cheol; Bae, Woo Kyun; Zang, Dae Young; Lee, Hyun Woo; Jang, Joung Soon; Ji, Jun Ho; Kim, Jung Hoon; Park, Sanggon; Sym, Sun Jin; Yang, Yaewon; Jeon, So Yeon; Hwang, In Gyu; Oh, Sung Yong; Kang, Jung Hun
• Is Part Of: European journal of cancer. Volume 157(2021)
• Page Start: 21
• Page End: 30
• Publication Date: 2021-11
• Subjects: Pancreatic neoplasms -- Modified FOLFIRINOX -- S-1 -- Second-line chemotherapy -- Gemcitabine -- Randomised controlled trial; Cancer -- Periodicals; Neoplasms -- Periodicals; Cancer -- Périodiques; Cancer; Tumors; Electronic journals; Periodicals; Electronic journals; 616.994
• DOI: 10.1016/j.ejca.2021.08.002
• Languages: English
• ISSNs: 0959-8049

Abstract

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/m 2 ), irinotecan (135 mg/m 2 ), and leucovorin (400 mg/m 2 ) on day 1 and continuous 5-FU infusion (1000 mg/m 2 ) 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. Highlights: mPAC patients with good PS refractory to gemcitabine-based therapy were enrolled. Compared with S-1, mFOLFIRINOX significantly prolonged OS and PFS. ORR and DCR were higher in the mFOLFIRINOX group than in the S-1 group. Grade 3–4 toxicities were more common in the mFOLFIRINOX group than in the S-1 group.