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Phase II study of cetuximab in combination with cisplatin and docetaxel in patients with untreated advanced gastric or gastro-oesophageal junction adenocarcinoma
British Journal of Cancer, 09/29/09

Pinto C et al. – The addition of cetuximab to the cisplatin/docetaxel regimen improved the ORR of the cisplatin/docetaxel doublet in the first-line treatment of advanced gastric and gastro-oesophageal junction adenocarcinoma, but this combination did not improve the TTP and OS. The toxicity of cisplatin/docetaxel chemotherapy was not affected by the addition of cetuximab.

Methods

Untreated patients with histologically confirmed advanced gastric or gastro-oesophageal adenocarcinoma
Received cetuximab at initial dose of 400 mg m-2 i.v. followed by weekly doses of 250 mg m-2, cisplatin 75 mg m-2 i.v. on day 1, docetaxel 75 mg m-2 i.v. on day 1, every 3 weeks, for a maximum of 6 cycles
Cetuximab maintenance treatment allowed in patients with complete response, partial response, or stable disease

Results

72 patients (stomach 81.9% and gastro-oesophageal junction 18.1%; locally advanced disease 4.2%; and metastatic disease 95.8%) were enrolled
ORR was 41.2%
Median time to progression 5 mos
Median survival time 9 mos
Most frequent grades 3–4 toxicity was neutropenia (44.4%)
No toxic death observed

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