Metastatic gastric cancer: 2nd-line cetuximab + mFOLFIRI shows promise

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  • 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.

Key results

  • 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%).

Study design

  • 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.