Randomised phase-II trial of CAPIRI (capecitabine, irinotecan) plus bevacizumab vs FOLFIRI (folinic acid, 5-fluorouracil, irinotecan) plus bevacizumab as first-line treatment of patients with unresectable/metastatic colorectal cancer (mCRC)

• Published in: British journal of cancer Vol. 106; no. 3; pp. 453 - 459
• Main Authors: Souglakos, J, Ziras, N, Kakolyris, S, Boukovinas, I, Kentepozidis, N, Makrantonakis, P, Xynogalos, S, Christophyllakis, Ch, Kouroussis, Ch, Vamvakas, L, Georgoulias, V, Polyzos, A
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 31.01.2012; Nature Publishing Group
• Subjects: 692/308/2779/109/1941; 692/699/67/1504/1885; 692/699/67/322; 692/700/565/1436/1437; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Bevacizumab; Biological and medical sciences; Biomedical and Life Sciences; Biomedicine; Camptothecin - administration & dosage; Camptothecin - analogs & derivatives; Cancer Research; Cancer therapies; Capecitabine; Chemotherapy; Clinical Studies; clinical-study; Colorectal cancer; Colorectal Neoplasms - drug therapy; Colorectal Neoplasms - mortality; Colorectal Neoplasms - pathology; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Drug Resistance; Epidemiology; Female; Fluorouracil - administration & dosage; Fluorouracil - analogs & derivatives; Gastroenterology. Liver. Pancreas. Abdomen; Greece - epidemiology; Humans; Leucovorin - administration & dosage; Male; Medical research; Medical sciences; Metastasis; Middle Aged; Molecular Medicine; Neoplasm Metastasis; Neoplasm Recurrence, Local - drug therapy; Neoplasm Recurrence, Local - mortality; Neoplasm Recurrence, Local - pathology; Neutropenia; Oncology; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus; Toxicity; Treatment Outcome; Tumors; CAPIRI; bevacizumab; mCRC; phase-II trial; FOLFIRI; Antineoplastic agent; Rectal disease; Capecitabine; Colorectal cancer; Calcium folinate; Monoclonal antibody; Metastasis; Bevacizumab; Isomerases; Cancerology; Phase II trial; Intestinal disease; Clinical trial; Advanced stage; Antiangiogenic agent; Topoisomerase I inhibitor; Pyrimidine nucleoside; Fluorouracil; Camptothecin derivatives; Human; Folinic acid; Enzyme; Fluoropyrimidine derivatives; Transferases; DNA topoisomerase; Enzyme inhibitor; Malignant tumor; Prodrug; Thymidylate synthase; First line treatment; Colonic disease; Irinotecan; Vascular endothelium growth factor; Antimetabolic; Methyltransferases; Unresectable; Pyrimidine derivatives; Digestive diseases; Comparative study; Cancer
• ISSN: 0007-0920; 1532-1827
• DOI: 10.1038/bjc.2011.594

Background: To compare the efficacy and safety of CAPIRI+bevacizumab (Bev) in comparison with FOLFIRI+Bev as first-line treatment for patients with metastatic colorectal cancer (mCRC). Methods: Patients were randomised to receive either FOLFIRI plus Bev 5 mg kg −1 every 2 weeks (Arm-A) or CAPIRI plus Bev 7.5 mg kg −1 every 3 weeks (Arm-B). Results: Three hundred thirty-three patients (Arm-A=167; Arm-B=166) were enrolled into the study. No difference was observed in median progression-free survival (PFS) (10.0 and 8.9 months; P =0.64), overall survival (25.7 and 27.5 months; P =0.55) or response rates (45.5 and 39.8.7%; P =0.32) for FOLFIRI-Bev and CAPIRI-Bev, respectively. Patients treated with CAPIRI-Bev presented significantly higher incidence of diarrhoea ( P =0.005), febrile neutropenia ( P =0.003) and hand–foot skin reactions ( P =0.02) compared with patients treated with FOLFIRI-Bev. Treatment delays ( P =0.05), dose reduction ( P <0.001) and treatment discontinuation owing to toxicity ( P =0.01) occurred more frequently in the CAPIRI-Bev arm. Conclusion: The PFS of FOLFIRI-BEV is not superior to that observed with the CAPIRI-Bev regimen. CAPIRI-Bev has a less favourable toxicity profile, requiring dose reductions, in order to be considered as an option in first-line treatment of patients with mCRC.