Neoadjuvant cetuximab, twice-weekly gemcitabine, and intensity-modulated radiotherapy (IMRT) in patients with pancreatic adenocarcinoma

Annals of Oncology, 05/10/2012

Neoadjuvant therapy with cetuximab/gemcitabine/intensity–modulated radiotherapy (IMRT) is tolerable and active in pancreatic ductal adenocarcinoma (PDAC). Margin–negative resection rates are high and some locally advanced tumors can be downstaged to allow for complete resection with encouraging survival. Pathological complete responses can occur. This combination warrants further investigation.

Methods

  • Treatment consisted of cetuximab load at 400 mg/m2 followed by cetuximab 250 mg/m2 weekly and gemcitabine 50 mg/m2 twice–weekly given concurrently with IMRT to 54 Gy.
  • Following therapy, patients were considered for resection.

Results

  • Thirty–seven patients were enrolled with 33 assessable for response.
  • Ten patients (30%) manifested partial response and 20 (61%) manifested stable disease by RECIST.
  • Twenty–five patients (76%) underwent resection, including 18/23 previously borderline and 3/6 previously unresectable tumors.
  • Twenty–three (92%) of these had negative surgical margins.
  • Pathology revealed that 24% of resected tumors had grade III/IV tumor kill, including two pathological complete responses (8%).
  • Median survival was 24.3 months in resected patients.
  • Outcome did not vary by epidermal growth factor receptor status.

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