Ramucirumab is a human IgG-1 monoclonal antibody that targets the extracellular domain of VEGF receptor 2. We assessed the efficacy of ramucirumab in combination with second-line (2nd-line) or salvage-line (third- line or later) FOLFIRI (leucovorin, fluorouracil [5FU], and irinotecan) in patients with advanced metastatic colorectal cancer (CRC), retrospectively.
Patients who received ramucirumab with FOLFIRI in 2nd-line or salvage-line were enrolled. All patients were initially treated by ramucirumab (8mb/kg), irinotecan (150mg/m2), 5FU bolus (400mg/m2), l-LV (200mg/m2), and 5FU ci (2,400mg/m2). Efficacies were evaluated by progression free survival (PFS), overall survival (OS) after receiving ramucirumab regimens, over all response rate (ORR), and the resection rate of liver metastases (RRLM).
We enrolled 33 patients. RAS mutations were observed in 22 patients (67%) and BRAF V600E mutation was fund in one cases (3%). Among them, 18 patients (55%) received ramucirumab with FOLFIRI in 2nd-line while 15 patients (45%) in salvage line. Median PFS was 5 months (95% CI: 3–10) for patients received ramucirumab in 2nd-line versus 2 months (95% CI: 1–3) for patients in salvage-line. Median overall survival after ramucirumab treatment was 19 months (95% CI: 11–not calculated) for patients received ramucirumab in 2nd-line versus 8 months (95% CI: 5–9) for patients in salvage-line. ORR was observed in 83% (15 patients) of 2nd-line and40% (6 patients) of salvage-line. Interestingly, the patients with BRAF V600E mutation was treated by Ramucirumab with FOLFIRI in salvage-line confirmed as stable disease. Of 18 patients received ramucirumab with FOLFIRI in 2nd-line, 10 patients (56%) had unresectable liver metastases before treatment. Of the 10 patients with liver metastases, 4 patients could be resected liver metastases after ramucirumab treatment (RRLM is 40%). Although, in salvage-line, nine of 15 patients (60%) had unresectable liver metastases before treatment, the nine patients could not have reached liver resection (RRLM is 0%).
Ramucirumab with FOLFIRI in 2nd-line treatment will be effective and tolerable for metastatic CRC patients with a higher liver resection rate.
Clinical trial identification
Legal entity responsible for the study
Kawasaki Medical School.
Has not received any funding.
All authors have declared no conflicts of interest.