- Cetuximab and modified FOLFIRI (mFOLFIRI) appeared well tolerated and active as second-line treatment for patients with metastatic gastric cancer (MGC); low baseline plasma vascular endothelial growth factor (VEGF) levels were associated with better clinical outcomes.
Why this matters
- MGC has a poor prognosis, with short median OS time.
- Among 54 evaluable patients, response rate (RR) was 33.3%.
- In the intention-to-treat population, median time to progression (TTP) was 4.6 mo; median OS was 8.6 mo.
- Patients with low (≤12.6 pg/mL) vs high (>12.6 pg/mL) baseline plasma VEGF levels had RR of 55.0% and 5.3%, respectively (P=.001).
- Median TTP values were also improved (6.9 vs 2.8 mo, respectively; P=.0005), as was median OS (12 vs 5 mo; P<.0001).
- No KRAS, BRAF, or PIK3CA mutations were found.
- Treatment was generally well tolerated; major reported toxicity was hematologic, including grade 3/4 neutropenia (52.5%), anemia (29.5%), and thrombocytopenia (8.2%).
- Prospective, open-label, single-group, multicenter, phase 2 study evaluated cetuximab plus mFOLFIRI as second-line treatment in 61 patients with MGC.
- Primary endpoint: TTP.
- Funding: Fudan University Shanghai Cancer Center; Merck & Co., Inc., Kenilworth, NJ, USA.
- Small, single-group study; biomarker analysis considered exploratory.