British journal of cancer, 2020-08, Vol.123 (3), p.362-368
2020
Details
- Autor(en) / Beteiligte
- Titel
- Neoadjuvant modified FOLFIRINOX followed by postoperative gemcitabine in borderline resectable pancreatic adenocarcinoma: a Phase 2 study for clinical and biomarker analysis
- Ist Teil von
- British journal of cancer, 2020-08, Vol.123 (3), p.362-368
- Ort / Verlag
- England: Nature Publishing Group
- Erscheinungsjahr
- 2020
- Link zum Volltext
- Quelle
- MEDLINE
- Beschreibungen/Notizen
- Patients with borderline resectable pancreatic cancer (BRPC) have poor prognosis with upfront surgery. 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). 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). 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.
- Sprache
- Englisch
- Identifikatoren
- ISSN: 0007-0920eISSN: 1532-1827DOI: 10.1038/s41416-020-0867-xTitel-ID: cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7403346
- Format
- –
- Schlagworte
- Adenocarcinoma, Adenocarcinoma - drug therapy, Adenocarcinoma - immunology, Adenocarcinoma - surgery, Adult, Aged, Antigens, CD - metabolism, Antigens, Differentiation, T-Lymphocyte - metabolism, Antineoplastic Combined Chemotherapy Protocols - administration & dosage, Antineoplastic Combined Chemotherapy Protocols - pharmacology, Biomarkers, Biomarkers, Tumor - immunology, CD14 antigen, CD4 Antigens - metabolism, CD69 antigen, Chemotherapy, Deoxycytidine - administration & dosage, Deoxycytidine - analogs & derivatives, Deoxycytidine - pharmacology, Drug Administration Schedule, Feasibility Studies, Female, Fluorouracil - administration & dosage, Fluorouracil - pharmacology, Gemcitabine, Humans, Intraepithelial Lymphocytes - immunology, Irinotecan - administration & dosage, Irinotecan - pharmacology, Lectins, C-Type - metabolism, Leucovorin - administration & dosage, Leucovorin - pharmacology, Lymphocytes T, Male, Medical prognosis, Middle Aged, Monocytes, Monocytes - immunology, Neoadjuvant Therapy, Oxaliplatin - administration & dosage, Oxaliplatin - pharmacology, Pancreatic cancer, Pancreatic Neoplasms - drug therapy, Pancreatic Neoplasms - immunology, Pancreatic Neoplasms - surgery, Patients, Radiation therapy, Surgery, Survival Analysis, T-cell receptor, Treatment Outcome