Nimotuzumab Plus Gemcitabine-based Adjuvant Chemotherapy for Resectable Pancreatic Cancer: A Retrospective Observational Study.

BACKGROUND: Adjuvant chemotherapy (AC) provides an improved long-term survival chance for those with R0/R1 resection, following limited survival improvement space, as well as intolerable side effects. There is currently a gap in the use of macromolecule-targeted drugs (nimotuzumab) added to AC, so we developed this study. MATERIALS AND METHODS: Resectable pancreatic cancers (RPC) were treated with surgery and postoperative chemotherapy with or without nimotuzumab. Demographic and clinical data were collected from the electronic medical records of Ruijin Hospital from May 2016 to July 2022. The primary efficacy endpoint was OS. Additional endpoints included disease-free survival (DFS) and adverse reactions (safety). RESULTS: Thirty-six RPC patients who had received AC with nimotuzumab (study arm) or 55 patients who had conducted AC alone (control arm) treatment out of the 795 patients screened. The median age was 61 years. The Barthel score was 99. The study arm demonstrated a prolonged median overall survival (mOS) and median disease-free survival (mDFS) trend compared with the control arm (mOS, 45.1 mo vs. 28.1 mo; mDFS, 20.0 mo vs. 13.0 mo). In the further exploratory analyses of KRAS mutation and KRASG12D types, the study arm also showed a survival benefit trend (mOS, 44.6 mo vs. 25.0 mo, mDFS, 30.9 mo vs. 10.3 mo in KRAS mutation; mOS, 36.2 mo vs. 19.6 mo in KRASG12D type). R0 patients with KRASG12D, the survival benefit on DFS was significantly different (mDFS, 16.0 mo vs. 9.9 mo; P =0.022). For adverse events grade 3 or higher calculated, the highest incidence of adverse reactions was slightly hematologic abnormalities, such as anemia, leukopenia, etc., in both groups. No grade 4 or above adverse reactions were observed. CONCLUSIONS: By adding nimotuzumab to existing gemcitabine-based AC regimens, RPC patients would show a survival benefit trend with a satisfactory safety profile.