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Anticancer Res. 2013 Feb;33(2):717-23.

Phase II trial of erlotinib plus capecitabine as first-line treatment for metastatic pancreatic cancer (XELTA study).

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1
Servicio de Oncología Médica, Complejo Hospitalario Universitario de Santiago de Compostela, Travesía de Choupana s/n. 15706 Santiago de Compostela, Spain. Rafael.Lopez.Lopez@sergas.es

Abstract

AIM:

To evaluate the efficacy and safety of erlotinib plus capecitabine for metastatic pancreatic cancer.

PATIENTS AND METHODS:

This was a multicenter, uncontrolled, phase II trial. Patients with untreated metastatic pancreatic cancer received oral capecitabine at 1,000 mg/m(2) twice daily on days 1-14, of a 21-day treatment cycle; and oral erlotinib at 150 mg daily.

RESULTS:

Thirty-two patients were enrolled. The overall response rate (ORR) was 6%, with a median time to treatment failure of 2.1 months. The median follow-up was 7.6 months. The median progression-free survival was 2.1 months and median overall survival was 4.3 months. The one-year survival rate was 22%. Major grade 1 and 2 non-hematological toxicities were skin rash (34%), asthenia (31%) and diarrhea (31%). Grade 3 hematological toxicity was <13%. No grade 4 toxicities were detected. None of the patients died due to treatment toxicity.

CONCLUSION:

The combination of capecitabine with erlotinib is an active regimen with a favorable safety profile for patients with metastatic pancreatic cancer.

PMID:
23393373
[Indexed for MEDLINE]
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