A Phase II study of bevacizumab, oxaliplatin, and capecitabine in patients with previously untreated metastatic colorectal cancer: A prospective, multicenter trial of the korean cancer study group

American Journal of Clinical Oncology: Cancer Clinical Trials

Volumn 37, Issue 1, 2014, Pages 19-23

  Hong, Yong Sang ^a,e   Lee, Sung Sook ^a   Kim, Kyu Pyo ^a   Lee, Jae Lyun ^a   Kang, Yoon Koo ^a   Shin, Sang Joon ^b   Ahn, Joong Bae ^b   Jung, Kyung Hae ^a,e   Im, Seock Ah ^c   Kim, Tae You ^c   Kim, Jee Hyun ^f   Park, Young Suk ^d   Kim, Tae Won ^a  

^a University of Ulsan College of Medicine   (South Korea)

^b Yonsei University College of Medicine   (South Korea)

^c Seoul National University Hospital   (South Korea)

^d Sungkyunkwan University School of Medicine   (South Korea)

^e National Cancer Center   (South Korea)

^f Seoul National University Bundang Hospital   (South Korea)

Author keywords

bevacizumab; capecitabine; metastatic colorectal cancer; oxaliplatin

Indexed keywords

BEVACIZUMAB; CAPECITABINE; OXALIPLATIN; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE; FLUOROURACIL; MONOCLONAL ANTIBODY; PLATINUM COMPLEX;

ADULT; AGED; ANEMIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; CLINICAL ARTICLE; CONFIDENCE INTERVAL; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; HAND FOOT SYNDROME; HEART ARREST; HUMAN; HYPERTENSION; INTESTINE PERFORATION; KOREA; LIVER METASTASIS; LUNG METASTASIS; LYMPH NODE METASTASIS; MAINTENANCE THERAPY; MALE; METASTATIC COLORECTAL CANCER; MIDDLE AGED; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROPATHY; NEUTROPENIA; OVERALL SURVIVAL; PERITONEUM METASTASIS; PHASE 2 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; PROSPECTIVE STUDY; PROTEINURIA; SENSORY NEUROPATHY; STATISTICAL ANALYSIS; STOMATITIS; SUDDEN CARDIAC DEATH; THROMBOCYTOPENIA; TREATMENT OUTCOME; TREATMENT RESPONSE; VOMITING; ADENOCARCINOMA; ANALOGS AND DERIVATIVES; CHEMICALLY INDUCED; CLINICAL TRIAL; COLORECTAL NEOPLASMS; DRUG ADMINISTRATION; KAPLAN MEIER METHOD; MAINTENANCE CHEMOTHERAPY; MORTALITY; PATHOLOGY; PERIPHERAL NEUROPATHY; SOUTH KOREA;

ADENOCARCINOMA; ADULT; AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; COLORECTAL NEOPLASMS; DEOXYCYTIDINE; DIARRHEA; DRUG ADMINISTRATION SCHEDULE; FEMALE; FLUOROURACIL; HUMANS; KAPLAN-MEIER ESTIMATE; MAINTENANCE CHEMOTHERAPY; MALE; MIDDLE AGED; NEUTROPENIA; ORGANOPLATINUM COMPOUNDS; PERIPHERAL NERVOUS SYSTEM DISEASES; PROSPECTIVE STUDIES; REPUBLIC OF KOREA; THROMBOCYTOPENIA; TREATMENT OUTCOME;

EID: 84893766724     PISSN: 02773732     EISSN: 1537453X     Source Type: Journal    
DOI: 10.1097/COC.0b013e31826b9c94     Document Type: Article

References (24)

1. Tournigand C, Andre T, Achille E, et al. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol. 2004;22:229-237.
2. Hoff PM, Ansari R, Batist G, et al. Comparison of oral capecitabine versus intravenous fluorouracil plus leucovorin as first-line treatment in 605 patients with metastatic colorectal cancer: results of a randomized phase III study. J Clin Oncol. 2001;19:2282-2292.
3. Twelves C, Wong A, Nowacki MP, et al. Capecitabine as adjuvant treatment for stage III colon cancer. N Engl J Med. 2005;352: 2696-2704.
4. Hochster HS, Hart LL, Ramanathan RK, et al. Safety and efficacy of oxaliplatin and fluoropyrimidine regimens with or without bevaci-zumab as first-line treatment of metastatic colorectal cancer: results of the TREE Study. J Clin Oncol. 2008;26:3523-3529.
5. Rothenberg ML, Cox JV, Butts C, et al. Capecitabine plus oxaliplatin (XELOX) versus 5-fluorouracil/folinic acid plus oxaliplatin (FOLFOX-4) as second-line therapy in metastatic colorectal cancer: a randomized phase III noninferiority study. Ann Oncol. 2008;19:1720-1726.
6. Giantonio BJ, Catalano PJ, Meropol NJ, et al. Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOL-FOX4) for previously treated metastatic colorectal cancer: results from the Eastern Cooperative Oncology Group Study E3200. J Clin Oncol. 2007;25:1539-1544.
7. Grothey A, Sugrue MM, Purdie DM, et al. Bevacizumab beyond first progression is associated with prolonged overall survival in metastatic colorectal cancer: results from a large observational cohort study (BRiTE). J Clin Oncol. 2008;26:5326-5334.
8. Hurwitz H, Fehrenbacher L, Novotny W, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004;350:2335-2342.
9. Van Cutsem E, Rivera F, Berry S, et al. Safety and efficacy of first-line bevacizumab with FOLFOX, XELOX, FOLFIRI and fluoropyrimidines in metastatic colorectal cancer: the BEAT study. Ann Oncol. 2009;20:1842-1847.
10. Saltz LB, Clarke S, Diaz-Rubio E, 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. 2008;26:2013-2019.
11. Tol J, Koopman M, Rodenburg CJ, et al. A randomised phase III study on capecitabine, oxaliplatin and bevacizumab with or without cetuximab in first-line advanced colorectal cancer, the CAIRO2 study of the Dutch Colorectal Cancer Group (DCCG). An interim analysis of toxicity. Ann Oncol. 2008;19: 734-738.
12. Doi T, Boku N, Kato K, et al. Phase I/II study of capecitabine plus oxaliplatin (XELOX) plus bevacizumab as first-line therapy in Japanese patients with metastatic colorectal cancer. Jpn J Clin Oncol. 2010;40:913-920.
13. Diaz-Rubio E, Gomez-Espana A, Massuti B, et al. First-line XELOX plus bevacizumab followed by XELOX plus bevacizu-mab or single-agent bevacizumab as maintenance therapy in patients with metastatic colorectal cancer: the phase III MACRO TTD study. Oncologist. 2012;17:15-25.
14. Adam R, Wicherts DA, de Haas RJ, et al. Patients with initially unresectable colorectal liver metastases: is there a possibility of cure? J Clin Oncol. 2009;27:1829-1835.
15. Abdalla EK, Eng C, Madary A, et al. Southwest Oncology Group 0408: Phase II trial of neoadjuvant capecitabine/oxaliplatin/bevacizumab for resectable colorectal metastases in the liver. Clin Colorectal Cancer. 2006;5:436-439.
16. Gruenberger B, Tamandl D, Schueller J, et al. Bevacizumab, capecitabine, and oxaliplatin as neoadjuvant therapy for patients with potentially curable metastatic colorectal cancer. J Clin Oncol. 2008;26:1830-1835.
17. Rubbia-Brandt L, Lauwers GY, Wang H, et al. Sinusoidal obstruction syndrome and nodular regenerative hyperplasia are frequent oxaliplatin- associated liver lesions and partially prevented by bevacizumab in patients with hepatic colorectal metastasis. Histopathology. 2010;56:430-439.
18. Klinger M, Eipeldauer S, Hacker S, et al. Bevacizumab protects against sinusoidal obstruction syndrome and does not increase response rate in neoadjuvant XELOX/FOLFOX therapy of colorectal cancer liver metastases. Eur J Surg Oncol. 2009;35: 515-520.
19. Ohtsu A, Shah MA, Van Cutsem E, et al. Bevacizumab in combination with chemotherapy as first-line therapy in advanced gastric cancer: a randomized, double-blind, placebo-controlled phase III study. Clin Oncol. 2011;29:3968-3976.
20. Culy CR, Clemett D, Wiseman LR. Oxaliplatin. A review of its pharmacological properties and clinical efficacy in metastatic colorectal cancer and its potential in other malignancies. Drugs. 2000;60:895-924.
21. Yalcin S, Uslu R, Dane F, et al. Bevacizumab plus capecitabine as maintenance treatment after initial treatment with bevacizumab plus XELOX in previously untreated metastatic colorectal cancer: updated findings from a randomized, multicenter phase III trial. J Clin Oncol. (Meeting Abstracts). 2011;29:3579.
22. Simkens LH, Tol J, Terstappen LW, et al. The predictive and prognostic value of circulating endothelial cells in advanced colorectal cancer patients receiving first-line chemotherapy and bevacizumab. Ann Oncol. 2010;21:2447-2448.
23. Ronzoni M, Manzoni M, Mariucci S, et al. Circulating endothelial cells and endothelial progenitors as predictive markers of clinical response to bevacizumab-based first-line treatment in advanced colorectal cancer patients. Ann Oncol. 2010;21:2382-2389.
24. Hong YS, Cho HJ, Kim SY, et al. Carbonic anhydrase 9 is a predictive marker of survival benefit from lower dose of bevacizumab in patients with previously treated metastatic colo-rectal cancer. BMC Cancer. 2009;9:246.