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J Natl Cancer Inst. 2019 May 14. pii: djz073. doi: 10.1093/jnci/djz073. [Epub ahead of print]

Neoadjuvant FOLFIRINOX in patients with borderline resectable pancreatic cancer: a systematic review and patient-level meta-analysis.

Author information

1
Department of Surgery, Erasmus MC University Medical Center, Rotterdam, the Netherlands.
2
Hepato-Pancreato-Biliary Surgery and Liver Transplantation, Pôle des Pathologies Digestives, Hépatiques et de la Transplantation, Hôpital de Hautepierre-Hôpitaux Universitaires de Strasbourg, France.
3
Department of Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
4
Department of Oncology, Mayo Clinic, Phoenix, AZ, USA.
5
Radiology Department, Royal Marsden NHS Foundation Trust, Sutton, UK.
6
Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, the Netherlands.
7
Department of Surgery, West Virginia University, Morgantown, WV, USA.
8
Department of Medicine, The Royal Marsden NHSFoundation Trust, London and Surrey, UK.
9
Department of Oncology, Royal North Shore Hospital, Sydney, NSW, Australia; Sydney Medical School (Northern), The University of Sydney, Australia; Northern Cancer Institute, Sydney, NSW, Australia.
10
Division of Surgical Oncology, the Ohio State University Wexner Medical Center and James Comprehensive Cancer Center, Columbus, OH, USA.
11
Winship Cancer Institute, Emory University, Atlanta, GA, USA.
12
Department of Radiation Oncology, H Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA.
13
West of Scotland Pancreatic Unit, Glasgow Royal Infirmary, Glasgow, UK.
14
Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.
15
Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, UK.
16
Department of Surgery, Johns Hopkins Hospital, Baltimore, MD, USA.
17
Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
18
Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
19
Division of Hematology and Oncology, University of California, San Francisco, California, USA.
20
Department of Medicine, Yale Cancer Center, Yale School of Medicine, New Haven, CT, USA.
21
Department of Surgery, University of Colorado School of Medicine, Aurora, CO, USA.
22
Department of Radiation Oncology, University of Miami, Miller School of Medicine, Sylvester Comprehensive Cancer Center, Miami, FL, USA.
23
Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.
24
Department of Radiation Oncology, Henry Ford Cancer Institute, Detroit, MI, USA.
25
Department of Surgery, LKH Hochsteiermark-Leoben, Austria.
26
Upper GI Surgical Unit, Department of Gastrointestinal Surgery, Royal North Shore Hospital, Sydney, NSW, Australia; Sydney Medical School (Northern), The University of Sydney, Australia.
27
Department of Hemato-Oncology, LKH Hochsteiermark-Leoben, Austria.
28
Department of Radiotherapy, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, the Netherlands.
29
Department of Oncology, Washington University, St. Louis, MO, USA.
30
Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, the Netherlands.
31
Department of Medical Oncology, Erasmus MC University Medical Center, Rotterdam, the Netherlands.
32
Department of Surgery, MD Anderson Cancer Center, Houston, TX, USA.

Abstract

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.

KEYWORDS:

FOLFIRINOX; borderline resectable; neoadjuvant; pancreatic cancer; patient-level meta-analysis

PMID:
31086963
PMCID:
PMC6695305
[Available on 2020-05-14]
DOI:
10.1093/jnci/djz073

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