Efficacy and feasibility of stereotactic radiotherapy after folfirinox in patients with locally advanced pancreatic cancer (LAPC-1 trial)

作者：Mustafa Suker, Joost J.M.E. Nuyttens, Ferry A.L.M. Eskens, Brigitte C.M. Haberkorn, Peter‐Paul L. O. Coene, Erwin van der Harst, Bert A. Bonsing, Alexander L. Vahrmeijer, J. Sven D. Mieog, Rutger‐Jan Swijnenburg, Daphne Roos, Bas Groot Koerkamp, Casper H.J. van Eijck · 发表于：EClinicalMedicine · 年份：2019 · DOI：10.1016/j.eclinm.2019.10.013 · 被引用次数：65 · 研究领域：Pancreatic and Hepatic Oncology Research、Neuroendocrine Tumor Research Advances、Renal cell carcinoma treatment

BACKGROUND: We conducted a multicentre phase II trial to investigate feasibility and antitumor activity of sequential FOLFIRINOX and Stereotactic Body Radiotherapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC), (LAPC-1 trial). METHODS: Patients with biopsy-proven LAPC treated in four hospitals in the Netherlands between December 2014 and June 2017. Patients received 8 cycles of FOLFIRINOX followed by SBRT (5 fractions/8 Gy) if no tumour progression after the FOLFIRINOX treatment was observed. Primary outcome was 1-year overall survival (OS). Secondary outcomes were median OS, 1-year progression-free survival (PFS), treatment-related toxicity, and resection rate. The study is registered with ClinicalTrials.gov, NCT02292745, and is completed. FINDINGS: = 1). Thirty-nine (78%) patients received the SBRT treatment. The 1-year OS and PFS were 64% (95% CI: 50%-76%) and 34% (95% CI: 22%-48%), respectively. Thirty grade 3 or 4 adverse events were observed during FOLFIRINOX. Two (5%) grade 3 or 4 adverse events after SBRT were observed. Two (5%) patients died due to a gastro-intestinal bleeding within three months after SBRT were observed. Six (12%) patients underwent a resection, all resulting in a complete (R0) resection. Two patients had a complete pathological response. INTERPRETATION: FOLFIRINOX followed by SBRT in patients with LAPC is feasible and shows relevant antitumor activity. In 6 (12%) patients a potentially curative resection could be pursued followi...