Adding ramucirumab to first-line chemotherapy does not improve outcomes in patients with advanced pancreatic ductal adenocarcinoma, according to research published in the European Journal of Cancer.
Patients who received ramucirumab in combination with oxaliplatin, irinotecan, and fluorouracil (modified FOLFIRINOX) had similar progression-free survival (PFS) and overall survival (OS) as patients who received only modified FOLFIRINOX.
This phase 2 trial (ClinicalTrials.gov Identifier: NCT02581215) enrolled patients with recurrent or metastatic pancreatic ductal adenocarcinoma.
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The intention-to-treat population included 82 patients — 42 who received ramucirumab plus modified FOLFIRINOX and 40 who received modified FOLFIRINOX alone. Baseline characteristics were similar between the treatment arms.
The objective response rate was 17.7% in the ramucirumab arm and 22.6% in the chemotherapy-alone arm (P =.88). One patient in the chemotherapy arm achieved a complete response. All other responses were partial responses.
The median PFS was 5.6 months in the ramucirumab arm and 6.7 months in the chemotherapy arm (P =.322). The 12-month PFS rate was 10.8% and 16.3%, respectively.
The median OS was 10.3 months in the ramucirumab arm and 9.7 months in the chemotherapy arm (P =.094). The 12-month OS rate was 27.7% and 38.9%, respectively.
In a multivariate analysis, the risk of progression or death was not significantly different between the ramucirumab arm and the chemotherapy arm (hazard ratio [HR], 1.25; 95% CI, 0.73-2.13; P =.410). In addition, the risk of death alone was not significantly different between the arms (HR, 1.55; 95% CI, 0.87-2.77; P =.138).
There were no treatment-related deaths. The most common adverse events in both arms were gastrointestinal events — 19.52% in the ramucirumab arm and 21.9% in the chemotherapy arm. The rate of grade 3-4 adverse events was 23.08% and 29.41%, respectively.
Disclosures: This research was supported by Eli Lilly.
Reference
Shaib WL, Manali R, Liu Y, et al. Phase II randomized, double-blind study of mFOLFIRINOX plus ramucirumab versus mFOLFIRINOX plus placebo in advanced pancreatic cancer patients (HCRN GI14-198). Eur J Cancer. Published online March 10, 2023. doi:10.1016/j.ejca.2023.02.030
