Modified FOLFIRINOX versus gemcitabine plus oxaliplatin as first-line chemotherapy for patients with locally advanced or metastatic cholangiocarcinoma: a retrospective comparative study

Abstract

Background Gemcitabine plus platinum as the first-line chemotherapy for cholangiocarcinoma (CCA) has limited efficacy. The aim of this study was to evaluate the effectiveness of modified FOLFIRINOX (mFOLFIRINOX) compared to that of gemcitabine plus oxaliplatin (Gemox) for patients with locally advanced or metastatic CCA. Methods From January 2016 to December 2019, consecutive patients who were diagnosed with locally advanced or metastatic CCA were treated with either mFOLFIRINOX or Gemox as a first-line chemotherapy. The main endpoint was Progression free survival (PFS). The second endpoints were Overall survival (OS), Disease control rate (DCR) and incidence of severe toxicity (grade 3–4). Tumors were evaluated at baseline and thence every 4–6 weeks. The study was designed and carried out in accordance with the principles of the declaration of Helsinki, approved by the Ethics Committee of Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine (XHEC-D-2020-154) and registered with ClinicalTrials.gov, number NCT04305288 (registration date: 12/03/2020). Results Of 49 patients in this study, 27 were in the FOLFIRINOX regimen group and 22 in the Gemox regimen group. There were no significant differences between groups in baseline characteristics. The DCR was 77.8% in the mFOLFIRINOX group and 63.5% in the Gemox group. The corresponding median PFS was 9.9 months (95% confidence interval [CI], 7.3–12.4) in the mFOLFIRINOX group versus 6.4 months (95% CI,3.6–9.2, p = 0.040) in the Gemox group. The corresponding median OS was 15.7 months (95% CI, 12.5–19.0) versus 12.0 months (95% CI, 9.3–14.8, p = 0.099). Significantly more grade 3–4 vomiting occurred in the mFOLFIRINOX than the Gemox groups (7 (25.9%) vs 1 (4.5%), p = 0.044). Conclusions First-line mFOLFIRINOX offered more promising results in patients with advanced or metastatic CCA.

A prospective multicenter phase II study of FOLFIRINOX as a first-line treatment for patients with advanced and recurrent biliary tract cancer

“…Since FOLFIRINOX signi cantly improved the survival in patients with metastatic pancreatic cancer [26], it had been recognized as an attractive regimen worthy of evaluation in BTC. Actually, as shown in Table 5, several retrospective studies reported the promising activity and tolerability of FOLFIRINOX both as rstand second-line treatment, with a median PFS of 5.0-9.9 months, OS of 9.5-15.7 months and an ORR of 16.0%-33.3% [20][21][22]24]. Favorable results were also observed in a prospective study focused on gallbladder cancer which generally harbors worse survival compared with other BTC; a median PFS of 8.3 months, OS of 10.2 months and an ORR of 48.2% [19].…”

“…In addition, liposomal irinotecan combined with uorouracil and leucovorin has also been contributed to increase survival in the second-line setting [17]. Furthermore, FOLFIRINOX comprises uorouracil, leucovorin, irinotecan and oxaliplatin has shown activity and tolerability in retrospective and prospective studies for the rst-or second-line treatment of advanced BTC [18][19][20][21][22][23][24]. Therefore, we designed this prospective study to evaluate safety and e cacy of FOLFIRINOX in patients with chemotherapy-naïve, advanced or recurrent BTC.…”

A prospective multicenter phase II study of FOLFIRINOX as a first-line treatment for patients with advanced and recurrent biliary tract cancer

“…Since FOLFIRINOX significantly improved the survival in patients with metastatic pancreatic cancer [ 26 ], it had been recognized as an attractive regimen worthy of evaluation in BTC. Actually, as shown in Table 5 , several retrospective studies reported the promising activity and tolerability of FOLFIRINOX both as first- and second-line treatment, with a median PFS of 5.0–9.9 months, OS of 9.5–15.7 months and an ORR of 16.0%-33.3% [ 20 – 22 , 24 ]. Favorable results were also observed in a prospective study focused on gallbladder cancer which generally harbors worse survival compared with other BTC; a median PFS of 8.3 months, OS of 10.2 months and an ORR of 48.2% [ 19 ].…”

A Single-Center Retrospective Study to Compare the Efficacy and Safety of Modified FOLFIRINOX with S-1 as Adjuvant Chemotherapy in 71 Patients with Resected Pancreatic Carcinoma

“…The mFOLFIRINOX regimen included oxaliplatin 65 mg/m 2 , leucovorin 400mg/m 2 , irinotecan 150 mg/m 2 , 5-FU 400 mg/m 2 , and continuous 5-FU 2400 m4 2 (for 46 h), in a 2-week schedule. The dose of the mFOLFIRINOX regimen was modified according to physical condition of the Chinese population and previous regimens used in PC4[ 10 ]. The S-1 monochemotherapy (body surface area [BSA] ≥1.5 m 2 , 120 mg/day; 1.25 m 2 ≤BSA <1.5 m 2 , 100 mg/day; BSA <1.25 m 2 , 80 mg/day, in 2 divided doses for 2 weeks) was administrated every 3 weeks.…”