Gemcitabine-erlotinib versus gemcitabine-erlotinib-capecitabine in the first-line treatment of patients with metastatic pancreatic cancer: Efficacy and safety results of a phase IIb randomised study from the Spanish TTD Collaborative Group.

Background: Gemcitabine and erlotinib have shown a survival benefit in the first-line setting in metastatic pancreatic cancer (mPC). The aim of this study was to assess whether combining capecitabine (C) with gemcitabine + erlotinib (GE) was safe and effective versus GE in patients with mPC.

Patients And Methods: Previously untreated mPC patients were randomised to receive G (1000 mg/m, days 1, 8, 15) + E (100 mg/day, days 1-28) + C (1660 mg/m, days 1-21) or GE, q4 weeks, until progression or unacceptable toxicity.