Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 25, No 18S (June 20 Supplement), 2007: 14544
© 2007 American Society of Clinical Oncology

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Abstract

Phase II comparative study of capecitabine combined with oxaliplatin (XELOX) and CPT-11 (XELIRI) for advanced colorectal cancer patients (p) previously treated with 5-FU-based chemotherapy

Hospital Universitario Germans Trias i Pujol. ICO, Bardelona, Spain; Hospital Virgen de la Arrixaca, Murcia, Spain; Clínica Rotger, Palma de Mallorca, Spain; Hospital Josep Trueta, ICO Girona, Girona, Spain; Policlínica Miramar, Palma de Mallorca, Spain; Creu Roja de Hospitalet, Barcelona, Spain; Hospital Espíritu Santo, Santa Coloma de Gramanet, Barcelona, Spain

14544

Background: Based on the results obtained with Capecitabine (XEL), Oxaliplatin (OX), and CPT-11 (IRI), we proposed this exploratory study to asses the efficacy of XELIRI and XELOX, for advanced colorectal cancer, after a first line treatment with 5 FU plus OX (FOLFOX) or IRI (FOLFIRI). Methods: P aged = 18 with histological diagnosis of metastatic colorectal adenocarcinoma, were assigned to XELOX arm (XEL, 1000 mg/m² BID during 14 d; OX, 130 mg/m² d1; q3w) or XELIRI arm (XEL 1000 mg/m² BID during 14 d; IRI 240 mg/m² d1; q3w), depending on previous treatment (FOLFIRI or FOLFOX, respectively). Although sample size was calculated for 115 p, recruitment was premature closed due to the low inclusion rate related with cetuximab + IRI approval for second line treatment. Results: Forty three p (25 p, XELOX; 18 p, XELIRI) were enrolled: median age 63.2 years; M/F, 40.5%/59.5%; ECOG PS 0–1, 79.1%. All p have been previously treated for metastatic disease and 65.1% had stage IV. Main sites of metastatic disease were liver (71.8%), lymph nodes (7.7%), pelvis (7.7 %) and lung (5.1%). XELOX/XELIRI treatment data: total number of administered cycles was 94/85 and median relative dose intensity 100%(XEL)/99%(OX) and 96%(XEL)/94%(IRI); disease control rate (PR+SD) was 28%/33.3%, median TTP 3.4/4.1 months, median OS 10.3/11.2 months and 1-year survival, 39.1%/44.3%, respectively. Twenty p (46.5%) received further antitumoral treatment. Most frequent G3–4 toxicities per p are detailed in table 1. Conclusions: Capecitabine based combinations show an excellent toxicity profile and good efficacy results, in terms of disease control and survival rates, for advanced colorectal cancer patients previously treated with 5-FU schedules.

No significant financial relationships to disclose.