Role of second-line gemcitabine after FOLFIRINOX failure in advanced pancreatic adenocarcinoma: A retrospective analysis.

Abstract

473 Background: Cancer of the exocrine pancreas is a highly lethal malignancy. Based on a phase III study, FOLFIRINOX regimen became the standard first-line treatment for patients with good performance status. However, the optimal management strategy for patients who fail initial FOLFIRINOX remains undefined. We aim at reporting our experience with single-agent gemcitabine as a second-line treatment for advanced pancreatic cancer patients who progressed on FOLFIRINOX. Methods: Patients with advanced exocrine pancreatic adenocarcinoma who received gemcitabine (1.000 mg/m² on days 1, 8 and 15 every 4 weeks) until disease progression, as second-line therapy after FOLFIRINOX failure at our institution were retrospectively evaluated. Progression-free survival (PFS) and overall survival (OS) were estimated by the Kaplan-Meier method. Results: A total of 20 patients were reviewed. Most of them (60%) had metastatic disease while 40% had locally advanced tumors. Median age was 60 years (range 43–74) and 80% were male. Eastern Cooperative Oncology Group (ECOG) performance status was 0 or 1 in 65% and 2 or 3 in 35% of the patients. Median time on prior FOLFIRINOX therapy was 5 months. Median PFS and OS with gemcitabine were 2,0 (95% CI 1,2-2,8) and 5,7 months (95% CI 3,9-7,4), respectively. There were no deaths due to the treatment. Conclusions: In this study, gemcitabine was a reasonable second-line treatment option for patients with advanced pancreatic adenocarcinoma. Phase III trials are urgently needed exploring the role of gemcitabine in the second-line setting.

Gemcitabine Plus Nab-Paclitaxel as Second-Line Chemotherapy following FOLFIRINOX in Patients with Unresectable Pancreatic Cancer: A Single-Institution, Retrospective Analysis

“…There has been no established standard regimen for second-line treatment of unresectable pancreatic cancer after FFX. Previous retrospective studies reported that median PFS and OS of second-line GEM after FFX were 2.0-2.5 and 3.1-5.7 months, respectively [16,[21][22][23][24][25]. Compared with these results, the PFS and OS in the present study were better.…”

Systematic review and meta-analysis of gemcitabine-based chemotherapy after FOLFIRINOX in advanced pancreatic cancer

“…Supplementary Table S7 illustrates treatment characteristics in the selected studies. Amongst noncomparative studies, five evaluated the activity of single-agent gemcitabine 25–27,33,35 and eight assessed the activity of gemcitabine plus nab-paclitaxel. 12,22,28–32,34 In the three two-arm comparative studies, treatment arms included single-agent gemcitabine and gemcitabine plus nab-paclitaxel.…”

“…A total of 14 studies reported data on OS-GEM (552 patients). 11,12,22–25,27–30,32–35 Supplementary Figure S1 depicts median OS-GEM and actuarial OS-GEM rates at 6 and 12 months according to the treatment regimen used. Median OS times across studies ranged from 3.1 to 12.4 months.…”

“…A total of 13 studies reported data on PFS (541 patients). 12,22–31,34,35 In one study, data were available only for time-to-treatment failure. 32 Figure 5 depicts median PFS and actuarial PFS rates at three and six months according to the treatment regimen used.…”

“…Three studies were two-arm retrospective comparative cohort studies 11,23,24 and the remaining 13 studies were case series. 12,22,25–35 Six studies were multicentric investigations 22,23,26,27,31,34 and seven were available solely as posters or electronic abstracts. 11,24,25,29–31,34…”