TY - JOUR
T1 - Randomized Multicenter Phase II Trial of Two Different Schedules of Irinotecan Combined with Capecitabine as First-Line Treatment in Metastatic Colorectal Carcinoma
AU - Bajetta, Emilio
AU - Di Bartolomeo, Maria
AU - Mariani, Luigi
AU - Cassata, Antonio
AU - Artale, Salvatore
AU - Frustaci, Sergio
AU - Pinotti, Graziella
AU - Bonetti, Andrea
AU - Carreca, Ignazio
AU - Biasco, Guido
AU - Bonaglia, Luigi
AU - Marini, Giovanni
AU - Iannelli, Antonio
AU - Cortinovis, Diego
AU - Ferrario, Ermina
AU - Beretta, Elena
AU - Lambiase, Antonio
AU - Buzzoni, Roberto
PY - 2004/1/15
Y1 - 2004/1/15
N2 - BACKGROUND. The aim of the current randomized Phase II study was to investigate the efficacy and safety of capecitabine combined with irinotecan as first-line treatment in metastatic colorectal carcinoma (CRC). METHODS. A total of 140 patients received capecitabine at a dose of 1250 mg/m2 twice daily on Days 2-15 and irinotecan at a dose of either 300 mg/m2 on Day 1 (Arm A) or 150 mg/m2 on Days 1 and 8 (Arm B) every 3 weeks. During the course of the study, enrollment was continued using lower doses of capecitabine (1000 mg/m2 twice daily) and irinotecan (Arm A: 240 mg/m2; Arm B: 120 mg/m2) to improve the safety profile of the combinations. RESULTS. Efficacy was evaluable in 134 patients (68 in Arm A, 66 in Arm B). Objective responses were observed in 46% of the patients (8% complete response [CR]), including 47% in Arm A (9% CR; 38% partial response [PR]) and 44% in Arm B (8% CR; 36% PR). The median progression-free survival was 8.3 months in Arm A and 7.6 months in Arm B. Among the first 52 patients treated with the higher doses, the most frequent Grade 3-4 adverse event was diarrhea (27%). The lower doses adopted in the subsequent 88 patients led to better diarrhea control, particularly in Arm A, and significant reductions in the incidence of all-grade hand-foot syndrome and abdominal pain. CONCLUSIONS. The capecitabine and irinotecan combination was a highly active first-line therapy in metastatic CRC. An acceptable safety profile was observed after dose reduction, particularly when irinotecan was administered on 1 day.
AB - BACKGROUND. The aim of the current randomized Phase II study was to investigate the efficacy and safety of capecitabine combined with irinotecan as first-line treatment in metastatic colorectal carcinoma (CRC). METHODS. A total of 140 patients received capecitabine at a dose of 1250 mg/m2 twice daily on Days 2-15 and irinotecan at a dose of either 300 mg/m2 on Day 1 (Arm A) or 150 mg/m2 on Days 1 and 8 (Arm B) every 3 weeks. During the course of the study, enrollment was continued using lower doses of capecitabine (1000 mg/m2 twice daily) and irinotecan (Arm A: 240 mg/m2; Arm B: 120 mg/m2) to improve the safety profile of the combinations. RESULTS. Efficacy was evaluable in 134 patients (68 in Arm A, 66 in Arm B). Objective responses were observed in 46% of the patients (8% complete response [CR]), including 47% in Arm A (9% CR; 38% partial response [PR]) and 44% in Arm B (8% CR; 36% PR). The median progression-free survival was 8.3 months in Arm A and 7.6 months in Arm B. Among the first 52 patients treated with the higher doses, the most frequent Grade 3-4 adverse event was diarrhea (27%). The lower doses adopted in the subsequent 88 patients led to better diarrhea control, particularly in Arm A, and significant reductions in the incidence of all-grade hand-foot syndrome and abdominal pain. CONCLUSIONS. The capecitabine and irinotecan combination was a highly active first-line therapy in metastatic CRC. An acceptable safety profile was observed after dose reduction, particularly when irinotecan was administered on 1 day.
KW - Colorectal carcinoma
KW - First-line treatment
KW - Irinotecan and capecitabine combination
KW - Phase II trial
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U2 - 10.1002/cncr.11910
DO - 10.1002/cncr.11910
M3 - Article
C2 - 14716761
AN - SCOPUS:9144255466
VL - 100
SP - 279
EP - 287
JO - Cancer
JF - Cancer
SN - 0008-543X
IS - 2
ER -