In a single-institution retrospective study reported in JAMA Surgery, Perri et al found that first-line FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin) was associated with a higher response rate and subsequent pancreatectomy vs gemcitabine plus nab-paclitaxel in patients with previously untreated localized pancreatic ductal adenocarcinoma. However, overall survival rates between the two regimens were similar.
Study Details
The study included 485 consecutive patients diagnosed between January 2010 and December 2017 at The University of Texas MD Anderson Cancer Center who received at least 3 cycles of first-line FOLFIRINOX (n = 285) or gemcitabine plus nab-paclitaxel (n = 200).
Key Findings
Median follow-up was 33 months.
In the entire cohort, patients treated with FOLFIRINOX were younger (median age at diagnosis = 61 vs 71, P = .001), had better Eastern Cooperative Oncology Group performance status (≤ 2 in 96% vs 82%, P = .001), and had more invasive tumors (resectable tumors in 32% vs 45%, P = .01). Patients treated with FOLFIRINOX were more likely to receive immediate treatment with (chemo)radiation (50% vs 34%, P = .001) and to ultimately undergo pancreatectomy (27% vs 16%, P = .01).
KEY POINTS
- Among all patients, there were no differences between the FOLFIRINOX vs gemcitabine plus nab-paclitaxel groups in response rate, reduction in tumor volume, tumor downstaging, or change in CA19-9.
- In a propensity score–matched analysis including 140 patients in each group, patients in the FOLFIRINOX group were more likely to receive immediate treatment with (chemo)radiation and to ultimately undergo pancreatectomy.
- Among all patients, median overall survival was 21 months with FOLFIRINOX vs 20 months with gemcitabine plus nab-paclitaxel, including a median overall survival of 48 months vs not reached in individuals undergoing resection.
Among all patients, there were no differences between the FOLFIRINOX vs gemcitabine plus nab-paclitaxel groups in response rate (all partial responses; 13% vs 9%, P = .40), reduction in tumor volume (66% vs 67%, P = .80), tumor downstaging (5% vs 6%, P = .60), or change in CA19-9 (overall P = .60).
In a propensity score–matched analysis including 140 patients in each group, patients in the FOLFIRINOX group were more likely to receive immediate treatment with (chemo)radiation (53% vs 34%, P = .001) and to ultimately undergo pancreatectomy (29% vs 18%, P = .02). No significant differences were observed in reduction in tumor volume (71% vs 69%, P = .70), tumor downstaging (8% vs 7%, P = .70), or change in CA19-9 (overall P = .90). The FOLFIRINOX group had a higher response rate (19% vs 6%, P = .001).
Among all patients, median overall survival was 21 months with FOLFIRINOX vs 20 months with gemcitabine plus nab-paclitaxel, including a median overall survival of 48 months vs not reached in individuals undergoing resection. On multivariate analysis of the entire cohort, the hazard ratio for overall survival for gemcitabine plus nab-paclitaxel vs FOLFIRINOX was 1.14 (P = .30). On multivariate analysis in the propensity score–matched cohort, the hazard ratio was 1.48 (P = .07).
The investigators concluded, “In this cohort of patients with localized pancreatic adenocarcinoma who received FOLFIRINOX or gemcitabine plus nab-paclitaxel as their first line of therapy, FOLFIRINOX was associated with higher rates of Response Evaluation Criteria in Solid Tumors partial response and subsequent pancreatectomy than gemcitabine plus nab-paclitaxel, but the overall survival associated with these regimens was similar.”
Matthew H.G. Katz, MD, of the Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, is the corresponding author for the JAMA Surgery article.
Disclosure: The study was supported by a grant from the National Cancer Institute. For full disclosures of the study authors, visit jamanetwork.com.
