FOLFIRINOX versus gemcitabine nab-paclitaxel for advanced pancreatic cancer: KU Cancer Center experience.

Abstract

e15744 Background: FOLFIRINOX (FFN) and Gemcitabine plus nab-paclitaxel (GN) have been established as first line chemotherapy in advanced pancreatic cancer (PC). But there is no head-to-head randomized trial data available to support preferable first line choice between these two regimens. Methods: We retrospectively evaluated 154 chemotherapy-naïve locally advanced and metastatic PC patients treated with FFN or GN at KU Cancer Center between January 2011 and November 2016. FFN consisted of Oxaliplatin 85mg/m2, Irinotecan 180mg/m2, 5-FU 400mg/m2 as a bolus and 2,400 mg/m2over 46 hour on days 1 and 15 every 4 weeks. GN consisted of Gemcitabine 1000mg/m2 plus nab-paclitaxel 125mg/m2 day1,8,15 every 4 weeks. We compared characteristics, efficacy and adverse events between FFN and GN. Results: 107 patients were treated with FFN and 47 patients with GN as first line therapy. Demographic and baseline characteristics (FFN/GN) were as follows: Median age 61/63 years, ECOG performance status (0-1): 90% / 83%, Gender (male): 57% / 54%, distant metastases: 52%/70%, biliary stenting: 41%/20%, locally advanced tumor: 48%/30%, pancreatic head tumors: 63%/55%, median number of cycles: 4/4 respectively. Objective response rate (13% vs. 10%), Stable disease rate (76% vs 82%) and disease control rate (89% vs. 92%, p = 0.5) were similar in FFN and in GN. Median PFS was 11.7 months (95% CI: 7.2-16.1) in FFN and 5.7 months (95% CI: 2.7-8.8) in GN [p = 0.07]. Median OS was 15.9 months (95% CI: 13.7-18.1) in FFN and 10.8 months (95% CI: 7.1 – 14.5) in GN [p = 0.17]. Incidences of grade 3 or higher adverse effects were neutropenia (33% vs. 17%), anemia (14% vs 31%), thrombocytopenia (28% vs 6%), elevated creatinine (2.8% vs 4%), elevated transminases (3.7% vs 6%), diarrhea (5% vs. 0%), and peripheral neuropathy (6% vs. 6%) respectively. Conclusions: Patients treated with FFN showed statistically better PFS compared to GN. However this difference in PFS did not translate into statistically significant difference in OS. Response rates were similar. Incidences of adverse events were relatively more with FFN compared to GN as expected.

Real-world comparative effectiveness of nab-paclitaxel plus gemcitabine versus FOLFIRINOX in advanced pancreatic cancer: a systematic review

“…In five of these studies, the DCR was numerically greater with nab-P/G. 25,29,37,39,46 Overall, one study (patients with mPC) reported numerically greater DCR with FOLFIRINOX. 19…”

“…Patients who received nab-P/G were treated for a median of 95 to 261 days versus 91 to 252 days with FOLFIRINOX. 11,20,23,28,29,37,39,40,42,47…”

“…In five of these studies, the DCR was numerically greater with nab-P/G. 25,29,37,39,46 Overall, one study (patients with mPC) reported numerically greater DCR with FOLFIRINOX. 19 aPC, advanced pancreatic cancer; FFX, FOLFIRINOX; mPC, metastatic pancreatic cancer; nab-P/G, nab-paclitaxel/ gemcitabine.…”

“…25,29 In four studies that reported response data for patients with aPC, the ORR was greater with nab-P/G or with FOLFIRINOX in two studies each. 37,39,46,47 A total of six studies reported disease control rates (DCRs; three each in mPC and aPC). In five of these studies, the DCR was numerically greater with nab-P/G.…”

Comparative Effectiveness of Gemcitabine plus Nab-Paclitaxel and FOLFIRINOX in the First-Line Setting of Metastatic Pancreatic Cancer: A Systematic Review and Meta-Analysis

“…We found a total of 493 publications in the electronic databases. A total of 16 studies including 3813 patients (2123 and 1690 of whom were treated with GEM-NAB and FOLFIRINOX respectively), were finally selected for inclusion after exclusion of duplicates and other non-pertinent papers [3,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20]. Fourteen were retrospective case series and two were cohort-studies.…”