Neoadjuvant modified FOLFIRINOX followed by postoperative gemcitabine in borderline resectable pancreatic adenocarcinoma: a Phase 2 study for clinical and biomarker analysis.

Abstract:

BACKGROUND:Patients with borderline resectable pancreatic cancer (BRPC) have poor prognosis with upfront surgery. METHODS:This was a single-arm Phase 2 trial for clinical and biomarker analysis. The primary endpoint is 1-year progression-free survival (PFS) rate. Patients received 8 cycles of neoadjuvant modified (m) FOLFIRINOX. Up to 6 cycles of gemcitabine were given for patients who underwent surgery. Plasma immune cell subsets were measured for analysing correlations with overall survival (OS). RESULTS:Between May 2016 and March 2018, 44 chemotherapy- and radiotherapy-naïve patients with BRPC were included. With neoadjuvant mFOLFIRINOX, the objective response rate was 34.1%, and curative-intent surgery was done in 27 (61.4%) patients. With a median follow-up duration of 20.6 months (95% confidence interval [CI], 19.7-21.6 months), the median PFS and OS were 12.2 months (95% CI, 8.9-15.5 months) and 24.7 months (95% CI, 12.6-36.9), respectively. The 1-year PFS rate was 52.3% (95% CI, 37.6-67.0%). Higher CD14+ monocyte (quartile 4 vs 1-3) and lower CD69+ γδ T cell (γδ TCR+/CD69+) levels (quartiles 1-3 vs 4) were significantly associated with poor OS (p = 0.045 and p = 0.043, respectively). CONCLUSIONS:Neoadjuvant mFOLFIRINOX followed by postoperative gemcitabine were feasible and effective in BRPC patients. Monocyte and γδ T cells may have prognostic implications for patients with pancreatic cancer. ClinicalTrials.gov identifier: NCT02749136.

journal_name

Br J Cancer

authors

Yoo C,Lee SS,Song KB,Jeong JH,Hyung J,Park DH,Song TJ,Seo DW,Lee SK,Kim MH,Lee SS,Kim JH,Jin HS,Park JH,Hwang DW,Lee JH,Lee W,Chang HM,Kim KP,Ryoo BY,Kim SC

doi

10.1038/s41416-020-0867-x

subject

Has Abstract

pub_date

2020-08-01 00:00:00

pages

362-368

issue

3

eissn

0007-0920

issn

1532-1827

pii

10.1038/s41416-020-0867-x

journal_volume

123

pub_type

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