Neoadjuvant FOLFIRINOX in patients with borderline resectable pancreatic cancer: a systematic review and patient-level meta-analysis.
Janssen QP, Buettner S, Suker M, Beumer BR, Addeo P, Bachellier P, Bahary N, Bekaii-Saab T, Bali MA, Besselink MG, Boone BA, Chau I, Clarke S, Dillhoff M, El-Rayes BF, Frakes JM, Grose D, Hosein PJ, Jamieson NB, Javed AA, Khan K, Kim KP, Kim SC, Kim SS, Ko AH, Lacy J, Margonis GA, McCarter MD, McKay CJ, Mellon EA, Moorcraft SY, Okada KI, Paniccia A, Parikh PJ, Peters NA, Rabl H, Samra J, Tinchon C, van Tienhoven G, van Veldhuisen E, Wang-Gillam A, Weiss MJ, Wilmink JW, Yamaue H, Homs MYV, van Eijck CHJ, Katz MHG, and Koerkamp BG. Neoadjuvant FOLFIRINOX in patients with borderline resectable pancreatic cancer: a systematic review and patient-level meta-analysis. J Natl Cancer Inst 2019; Epub ahead of print.
Journal of the National Cancer Institute
BACKGROUND: FOLFIRINOX is a standard treatment for metastatic pancreatic cancer patients. The effectiveness of neoadjuvant FOLFIRINOX in patients with borderline resectable pancreatic cancer (BRPC) remains debated.
METHODS: We performed a systematic review and patient-level meta-analysis on neoadjuvant FOLFIRINOX in patients with BRPC. Studies with BRPC patients who received FOLFIRINOX as first-line neoadjuvant treatment were included. Primary endpoint was overall survival (OS). Secondary endpoints were progression-free survival (PFS), resection rate, R0-resection rate, and grade 3-4 adverse events. Patient-level survival outcomes were obtained from authors of the included studies and analyzed using the Kaplan-Meier method.
RESULTS: We included 24 studies (8 prospective, 16 retrospective), comprising 313 (38.1%) BRPC patients treated with FOLFIRINOX. Most studies (n=20) presented intention-to-treat results. The median number of administered neoadjuvant FOLFIRINOX cycles ranged from 4 to 9. The resection rate was 67.8% (95% CI: 60.1 - 74.6), the R0-resection rate was 83.9% (95% CI: 76.8 - 89.1). The median OS varied from 11.0 to 34.2 months across studies. Patient-level survival data was obtained for 20 studies representing 283 BRPC patients. Patient-level median OS was 22.2 months (95% CI: 18.8 - 25.6), patient-level median PFS was 18.0 months (95% CI: 14.5 - 21.5). Pooled event rates for grade 3-4 adverse events were highest for neutropenia (17.5 per 100 patients, 95% CI: 10.3 - 28.3), diarrhea (11.1 per 100 patients, 95% CI: 8.6 - 14.3), and fatigue (10.8 per 100 patients, 95% CI 8.1 - 14.2). No deaths were attributed to FOLFIRINOX.
CONCLUSION: This patient-level meta-analysis of BRPC patients treated with neoadjuvant FOLFIRINOX showed a favorable median OS, resection rate, and R0-resection rate. These results need to be assessed in a randomized trial.
ePub ahead of print