Phase II Study of Irinotecan in Combination with Capecitabine on a 3-Weekly Schedule as First-Line Chemotherapy for Patients with Metastatic or Locally Advanced Colorectal Cancer
Pages 151-159
Antonieta Salud, Vicente Alonso, Pilar Escudero, Miguel Burillo, Cristina Martín, Fernando Rivera, Alfonso Yubero, Carlos García-Girón and Alberto Muñoz
DOI: http://dx.doi.org/10.6000/1927-7229.2013.02.03.4
Published: 31 July 2013

Abstract: Background: Capecitabine has demonstrated non inferiority efficacy and improved safety compared with 5-fluorouracil (5-FU)/leucovorin (LV) in metastatic colorectal cancer (mCRC) without the inconvenience of an infusional therapy. The aim of the present study was to evaluate the efficacy and safety of capecitabine plus irinotecan (CPT-11) given every 3 weeks (XELIRI regimen) as first-line treatment in locally advanced (LA) or mCRC, in order to improve patient tolerability and quality of life. Patients and methods: Patients with LA or mCRC received CPT-11 225 mg/m² (180 mg/m² if > 65 years old) on day 1 and capecitabine 1000 mg/m² (750 mg/m² if > 65 years old) twice daily on days 2-15 every 3 week. Primary endpoints were objective response rate (ORR) and toxicity of the chemotherapeutic regimen. Secondary endpoints of overall survival (OS), progression-free survival (PFS), response duration and quality of life were also evaluated.

Results: Ninety-one patients were included. In an intention-to-treat analysis, complete response was achieved in 3 patients and partial response in 27, for an ORR of 33%. The disease control rate (ORR + stable disease) was 72.5%. Median time to progression and OS were 9.3 and 17.1 months respectively. Grade 3/4 neutropenia and diarrhea were the most commonly reported adverse vents.

Conclusion: The XELIRI regimen given every 3 weeks, as first-line therapy of LA or mCRC was effective and well tolerated, including elderly patients. Severe gastrointestinal toxicities and hematological events were manageable.