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- Title
Neoadjuvant modified FOLFIRINOX followed by postoperative gemcitabine in borderline resectable pancreatic adenocarcinoma: a Phase 2 study for clinical and biomarker analysis.
- Authors
Yoo, Changhoon; Lee, Sang Soo; Song, Ki Byung; Jeong, Jae Ho; Hyung, Jaewon; Park, Do Hyun; Song, Tae Jun; Seo, Dong Wan; Lee, Sung Koo; Kim, Myung-Hwan; Lee, Seung Soo; Kim, Jin Hee; Jin, Hyung-seung; Park, Jin-hong; Hwang, Dae Wook; Lee, Jae Hoon; Lee, Woohyung; Chang, Heung-Moon; Kim, Kyu-pyo; Ryoo, Baek-Yeol
- 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.
- 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
- Publication
British Journal of Cancer, 2020, Vol 123, Issue 3, p362
- ISSN
0007-0920
- Publication type
journal article
- DOI
10.1038/s41416-020-0867-x