Capecitabine and irinotecan with bevacizumab 2-weekly for metastatic colorectal cancer: The phase II AVAXIRI study

BMC Cancer

Volumn 15, Issue 1, 2015, Pages

  Garcia Alfonso, Pilar ^a   Chaves, Manuel ^b   Muñoz, Andrés ^a   Salud, Antonieta ^c   García Gonzalez, Maria ^d   Grávalos, Cristina ^e   Massuti, Bartomeu ^f   González Flores, Encarna ^g   Queralt, Bernardo ^h   López Ladrón, Amelia ⁱ   Losa, Ferran ^j   Gómez, Maria Jose ^k   Oltra, Amparo ^l   Aranda, Enrique ^m  

^a HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑÓN   (Spain)

^b HOSPITAL UNIVERSITARIO VIRGEN DEL ROCÍO   (Spain)

^c Hospital Lleida Arnau de Vilanova   (Spain)

^d HOSPITAL UNIVERSITARIO DE BURGOS   (Spain)

^e HOSPITAL UNIVERSITARIO 12 DE OCTUBRE   (Spain)

^f HOSPITAL GENERAL UNIVERSITARIO DE ALICANTE   (Spain)

^g HOSPITAL UNIVERSITARIO VIRGEN DE LAS NIEVES   (Spain)

^h HOSPITAL JOSEP TRUETA   (Spain)

ⁱ HOSPITAL UNIVERSITARIO DE VALME   (Spain)

^j HOSPITAL GENERAL DE CATALUNYA   (Spain)

^k HOSPITAL UNIVERSITARIO PUERTA DEL MAR   (Spain)

^l HOSPITAL VIRGEN DE LOS LIRIOS   (Spain)

^m UNIVERSITY OF CÓRDOBA   (Spain)

more..

Author keywords

Bevacizumab; Capecitabine; Chemotherapy; Irinotecan; Metastatic colorectal cancer

Indexed keywords

BEVACIZUMAB; CAPECITABINE; CETUXIMAB; IRINOTECAN; OXALIPLATIN; PANITUMUMAB; ANTINEOPLASTIC AGENT; CAMPTOTHECIN;

ADULT; AGED; ALOPECIA; ANXIETY; ARTICLE; ASTHENIA; CANCER COMBINATION CHEMOTHERAPY; CANCER MORTALITY; CANCER PAIN; CANCER SURGERY; CANCER SURVIVAL; CAUSE OF DEATH; DEPRESSION; DIARRHEA; DIGESTIVE SYSTEM PERFORATION; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; FEBRILE NEUTROPENIA; FEMALE; FISTULA; HAND FOOT SYNDROME; HUMAN; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; METASTATIC COLORECTAL CANCER; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MULTIPLE ORGAN FAILURE; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; SURVIVAL TIME; THROMBOEMBOLISM; TIME TO TREATMENT; VISUAL ANALOG SCALE; VOMITING; WOUND HEALING IMPAIRMENT; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; COLORECTAL NEOPLASMS; DISEASE FREE SURVIVAL; METASTASIS; MIDDLE AGED; PATHOLOGY; TREATMENT OUTCOME; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BEVACIZUMAB; CAMPTOTHECIN; CAPECITABINE; COLORECTAL NEOPLASMS; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; TREATMENT OUTCOME;

EID: 84928884120     PISSN: None     EISSN: 14712407     Source Type: Journal    
DOI: 10.1186/s12885-015-1293-y     Document Type: Article

References (31)

1. Ferlay J, Shin H, Bray F, Forman D, C Mathers, Parkin D. GLOBOCAN 2008 v2.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 10. 2010. Lyon, France: International Agency for Research on Cancer. Available from: http://globocan.iarc.fr. Accessed on 10 November 2013.
2. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (2013) Colon cancer Version 3. Available at http://www.nccn.org/professionals/physician_gls/pdf/colon.pdf. Accessed on 6 March 2013.
3. Schmoll HJ, Van Cutsem E, Stein A, Valentini V, Glimelius B, Haustermans K, et al. ESMO Consensus Guidelines for management of patients with colon and rectal cancer. a personalized approach to clinical decision making. Ann Oncol Off J Eur Soc Med Oncol ESMO. 2012;23:2479-516.
4. Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004;350:2335-42.
5. Saltz LB, Clarke S, Díaz-Rubio E, Scheithauer W, Figer A, Wong R, et al. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. J Clin Oncol Off J Am Soc Clin Oncol. 2008;26:2013-9.
6. Giantonio BJ, Catalano PJ, Meropol NJ, O'Dwyer PJ, Mitchell EP, Alberts SR, et al. Eastern Cooperative Oncology Group Study E3200: Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: results from the Eastern Cooperative Oncology Group Study E3200. J Clin Oncol Off J Am Soc Clin Oncol. 2007;25:1539-44.
7. Bennouna J, Sastre J, Arnold D, Osterlund P, Greil R, Van Cutsem E, et al. ML18147 Study investigators: continuation of bevacizumab after first progression in metastatic colorectal cancer (ML18147): a randomised phase 3 trial. Lancet Oncol. 2013;14:29-37.
8. Fuchs CS, Marshall J, Mitchell E, Wierzbicki R, Ganju V, Jeffery M, et al. Randomized, controlled trial of irinotecan plus infusional, bolus, or oral fluoropyrimidines in first-line treatment of metastatic colorectal cancer: results from the BICC-C Study. J Clin Oncol Off J Am Soc Clin Oncol. 2007;25:4779-86.
9. Köhne C-H, De Greve J, Hartmann JT, Lang I, Vergauwe P, Becker K, et al. Irinotecan combined with infusional 5-fluorouracil/folinic acid or capecitabine plus celecoxib or placebo in the first-line treatment of patients with metastatic colorectal cancer. EORTC study 40015. Ann Oncol Off J Eur Soc Med Oncol ESMO. 2008;19:920-6.
10. Tewes M, Schleucher N, Achterrath W, Wilke HJ, Frings S, Seeber S, et al. Capecitabine and irinotecan as first-line chemotherapy in patients with metastatic colorectal cancer: results of an extended phase I study. Ann Oncol Off J Eur Soc Med Oncol ESMO. 2003;14:1442-8.
11. Borner MM, Bernhard J, Dietrich D, Popescu R, Wernli M, Saletti P, et al. A randomized phase II trial of capecitabine and two different schedules of irinotecan in first-line treatment of metastatic colorectal cancer: efficacy, quality-of-life and toxicity. Ann Oncol Off J Eur Soc Med Oncol ESMO. 2005;16:282-8.
12. Bajetta E, Di Bartolomeo M, Mariani L, Cassata A, Artale S, Frustaci S, et al. Randomized multicenter Phase II trial of two different schedules of irinotecan combined with capecitabine as first-line treatment in metastatic colorectal carcinoma. Cancer. 2004;100:279-87.
13. Garcia-Alfonso P, Muñoz-Martin A, Mendez-Ureña M, Quiben-Pereira R, Gonzalez-Flores E, Perez-Manga G. Capecitabine in combination with irinotecan (XELIRI), administered as a 2-weekly schedule, as first-line chemotherapy for patients with metastatic colorectal cancer: a phase II study of the Spanish GOTI group. Br J Cancer. 2009;101:1039-43.
14. Kolinsky K, Zhang Y-E, Dugan U, Heimbrook D, Packman K, Higgins B. Novel regimens of capecitabine alone and combined with irinotecan and bevacizumab in colorectal cancer xenografts. Anticancer Res. 2009;29:91-8.
15. García-Alfonso P, Muñoz-Martin AJ, Alvarez-Suarez S, Jerez-Gilarranz Y, Riesco-Martinez M, Khosravi P, et al. Bevacizumab in combination with biweekly capecitabine and irinotecan, as first-line treatment for patients with metastatic colorectal cancer. Br J Cancer. 2010;103:1524-8.
16. Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228-47.
17. National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) v3.0. 2006. Available at: http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf. Accessed 10 November 2013.
18. Oemar M, Oppe M. EQ-5D-3L User Guide: Basic information on how to use the EQ-5D-3L instrument. Version 5.0. 2013. Available at: http://www.euroqol.org/fileadmin/user_upload/Documenten/PDF/Folders_Flyers/EQ-5D-3L_UserGuide_2013_v5.0_October_2013.pdf. Accessed on 11 November 2013.
19. Pectasides D, Papaxoinis G, Kalogeras KT, Eleftheraki AG, Xanthakis I, Makatsoris T, et al. XELIRI-bevacizumab versus FOLFIRI-bevacizumab as first-line treatment in patients with metastatic colorectal cancer: a Hellenic Cooperative Oncology Group phase III trial with collateral biomarker analysis. BMC Cancer. 2012;12:271.
20. Souglakos J, Ziras N, Kakolyris S, Boukovinas I, Kentepozidis N, Makrantonakis P, et al. 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). Br J Cancer. 2012;106:453-9.
21. Renouf DJ, Welch S, Moore MJ, Krzyzanowska MK, Knox J, Feld R, et al. A phase II study of capecitabine, irinotecan, and bevacizumab in patients with previously untreated metastatic colorectal cancer. Cancer Chemother Pharmacol. 2012;69:1339-44.
22. Ducreux M, Adenis A, Pignon J-P, François E, Chauffert B, Ichanté JL, et al. Efficacy and safety of bevacizumab-based combination regimens in patients with previously untreated metastatic colorectal cancer: final results from a randomised phase II study of bevacizumab plus 5-fluorouracil, leucovorin plus irinotecan versus bevacizumab plus capecitabine plus irinotecan (FNCLCC ACCORD 13/0503 study). Eur J Cancer Oxf Engl 1990. 2013;49:1236-45.
23. White RH. The epidemiology of venous thromboembolism. Circulation. 2003;107(23 suppl 1):I-4-I-8.
24. Stein PD, Hull RD, Kayali F, Ghali WA, Alshab AK, Olson RE. Venous thromboembolism according to age: the impact of an aging population. Arch Intern Med. 2004;164:2260-5.
25. Kozloff M, Yood MU, Berlin J, Flynn PJ, Kabbinavar FF, Purdie DM, et al. Clinical outcomes associated with bevacizumab-containing treatment of metastatic colorectal cancer: the BRiTE observational cohort study. Oncologist. 2009;14:862-70.
26. Ardavanis A, Kountourakis P, Mantzaris I, Malliou S, Doufexis D, Sykoutri D, et al. Bevacizumab added to the irinotecan and capecitabine combination for advanced colorectal cancer: a well-tolerated, active and convenient regimen. Anticancer Res. 2008;28:3087-92.
27. Hurwitz HI, Yi J, Ince W, Novotny WF, Rosen O. The clinical benefit of bevacizumab in metastatic colorectal cancer is independent of K-ras mutation status: analysis of a phase III study of bevacizumab with chemotherapy in previously untreated metastatic colorectal cancer. Oncologist. 2009;14:22-8.
28. Price TJ, Hardingham JE, Lee CK, Weickhardt A, Townsend AR, Wrin JW, et al. Impact of KRAS and BRAF gene mutation status on outcomes from the phase III AGITG MAX trial of capecitabine alone or in combination with bevacizumab and mitomycin in advanced colorectal cancer. J Clin Oncol Off J Am Soc Clin Oncol. 2011;29:2675-82.
29. Bruera G, Cannita K, Di Giacomo D, Lamy A, Troncone G, Dal Mas A, et al. Prognostic value of KRAS genotype in metastatic colorectal cancer (MCRC) patients treated with intensive triplet chemotherapy plus bevacizumab (FIr-B/FOx) according to extension of metastatic disease. BMC Med. 2012;10:135.
30. Pickard AS, De Leon MC, Kohlmann T, Cella D, Rosenbloom S. Psychometric comparison of the standard EQ-5D to a 5 level version in cancer patients. Med Care. 2007;45:259-63.
31. Janssen MF, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, et al. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res Int J Qual Life Asp Treat Care Rehabil. 2013;22:1717-27.