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

Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • 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.

Limitations

  • Small, single-group study; biomarker analysis considered exploratory.