Haller, Daniel G.;
Rothenberg, Mace L.;
Wong, Alfred O.;
Koralewski, Piotr M.;
Miller, Wilson H.;
Bodoky, Gyorgy;
Habboubi, Nassir;
Garay, Carlos;
Olivatto, Luis O.
Oxaliplatin Plus Irinotecan Compared With Irinotecan Alone as Second-Line Treatment After Single-Agent Fluoropyrimidine Therapy for Metastatic Colorectal Carcinoma
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Medientyp:
E-Artikel
Titel:
Oxaliplatin Plus Irinotecan Compared With Irinotecan Alone as Second-Line Treatment After Single-Agent Fluoropyrimidine Therapy for Metastatic Colorectal Carcinoma
Beteiligte:
Haller, Daniel G.;
Rothenberg, Mace L.;
Wong, Alfred O.;
Koralewski, Piotr M.;
Miller, Wilson H.;
Bodoky, Gyorgy;
Habboubi, Nassir;
Garay, Carlos;
Olivatto, Luis O.
Erschienen:
American Society of Clinical Oncology (ASCO), 2008
Beschreibung:
<jats:sec><jats:title>Purpose</jats:title><jats:p> To determine whether irinotecan plus oxaliplatin (IROX) is superior to irinotecan alone in patients with metastatic colorectal cancer (CRC) previously treated with single-agent fluoropyrimidines. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> A phase III, randomized, open-label, multicenter study of patients with metastatic or recurrent CRC that had progressed or recurred during or after adjuvant or first-line fluoropyrimidines (fluorouracil/leucovorin or capecitabine, the latter only for metastatic CRC). Patients received IROX (irinotecan 200 mg/m<jats:sup>2</jats:sup> plus oxaliplatin 85 mg/m<jats:sup>2</jats:sup>) or irinotecan alone (350 mg/m<jats:sup>2</jats:sup>) every 3 weeks. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> At the data cutoff (when 447 of 628 randomly assigned patients had died), median overall survival was 13.4 months (95% CI, 12.4 to 14.7 months) and 11.1 month (95% CI, 10.0 to 12.7 months) in the IROX and irinotecan groups, respectively (hazard ratio = 0.78; 95% CI, 0.65 to 0.94; P = .0072). Overall response rate (22% v 7%, respectively; P < .0001), median time to progression (5.3 v 2.8 months, respectively; P < .0001), and improvement in tumor-related symptoms (32% v 19%, respectively; P = .0072) were also improved with IROX as compared with irinotecan. With the exception of granulocytopenia (25% v 13%), diarrhea (28% v 23%), and sensory disturbances (5% v 0%), grade 3 to 4 toxicities were comparable between the IROX and irinotecan groups, respectively. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> IROX is an effective treatment for metastatic CRC that has progressed after first-line fluoropyrimidine therapy. IROX improves efficacy compared with irinotecan alone, providing an additional option in the postadjuvant or second-line treatment setting for patients who experience treatment failure with single-agent fluoropyrimidine therapy. </jats:p></jats:sec>