785 - Efficacy of Ramucirumab in combination with second-line or salvage-line FOLFIRI in patients with metastatic colorectal cancer.

Background

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 (2^nd-line) or salvage-line (third- line or later) FOLFIRI (leucovorin, fluorouracil [5FU], and irinotecan) in patients with advanced metastatic colorectal cancer (CRC), retrospectively.

Methods

Patients who received ramucirumab with FOLFIRI in 2^nd-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).

Results

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 2^nd-line while 15 patients (45%) in salvage line. Median PFS was 5 months (95% CI: 3–10) for patients received ramucirumab in 2^nd-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 2^nd-line versus 8 months (95% CI: 5–9) for patients in salvage-line. ORR was observed in 83% (15 patients) of 2^nd-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 2^nd-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%).

Conclusions

Ramucirumab with FOLFIRI in 2^nd-line treatment will be effective and tolerable for metastatic CRC patients with a higher liver resection rate.

Editorial acknowledgement

Clinical trial identification

Legal entity responsible for the study

Kawasaki Medical School.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.