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Neoadjuvant modified FOLFIRINOX followed by postoperative gemcitabine in borderline resectable pancreatic adenocarcinoma: a Phase 2 study for clinical and biomarker analysis.
- Source :
-
British Journal of Cancer . Aug2020, Vol. 123 Issue 3, p362-368. 7p. - Publication Year :
- 2020
-
Abstract
- <bold>Background: </bold>Patients with borderline resectable pancreatic cancer (BRPC) have poor prognosis with upfront surgery.<bold>Methods: </bold>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).<bold>Results: </bold>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).<bold>Conclusions: </bold>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. [ABSTRACT FROM AUTHOR]
- Subjects :
- *PROTEIN metabolism
*PANCREATIC tumors
*ADENOCARCINOMA
*PILOT projects
*FOLINIC acid
*RESEARCH
*CLINICAL trials
*RESEARCH methodology
*DEOXYCYTIDINE
*ANTINEOPLASTIC agents
*MEDICAL cooperation
*EVALUATION research
*TREATMENT effectiveness
*DRUG administration
*FLUOROURACIL
*COMPARATIVE studies
*SURVIVAL analysis (Biometry)
*RESEARCH funding
*COMBINED modality therapy
*MONOCYTES
*ANTIGENS
*PHARMACODYNAMICS
Subjects
Details
- Language :
- English
- ISSN :
- 00070920
- Volume :
- 123
- Issue :
- 3
- Database :
- Academic Search Index
- Journal :
- British Journal of Cancer
- Publication Type :
- Academic Journal
- Accession number :
- 147249670
- Full Text :
- https://doi.org/10.1038/s41416-020-0867-x