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

Changhoon Yoo, Sang Soo Lee, Ki Byung Song, Jae Ho Jeong, Jaewon Hyung, Do Hyun Park, Tae Jun Song, Dong Wan Seo, Sung Koo Lee, Myung-Hwan Kim, Seung Soo Lee, Jin Hee Kim, Hyung-Seung Jin, Jin-Hong Park, Dae Wook Hwang, Jae Hoon Lee, Woohyung Lee, Heung-Moon Chang, Kyu-Pyo Kim, Baek-Yeol Ryoo, Song Cheol Kim

Journal: British journal of cancer 2021;123(3):362-368

PMID: 32433600

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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.

Address: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.; Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.; Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.; Department of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.; Department of Convergence Medicine, Asan Institute for Life Sciences, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.; Department of Radiation Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.; Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. [email protected].; Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. [email protected].

DOI: 10.1038/s41416-020-0867-x

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MeSH Terms: Adenocarcinoma, Adult, Aged, Antigens, CD, Antigens, Differentiation, T-Lymphocyte, Antineoplastic Combined Chemotherapy Protocols, Biomarkers, Tumor, CD4 Antigens, Deoxycytidine, Drug Administration Schedule, Feasibility Studies, Female, Fluorouracil, Humans, Intraepithelial Lymphocytes, Irinotecan, Lectins, C-Type, Leucovorin, Male, Middle Aged, Monocytes, Neoadjuvant Therapy, Oxaliplatin, Pancreatic Neoplasms, Survival Analysis, Treatment Outcome, Gemcitabine