Continuation of bevacizumab after first progression in metastatic colorectal cancer (ML18147): A randomised phase 3 trial

The Lancet Oncology

Volumn 14, Issue 1, 2013, Pages 29-37

  Bennouna, Jaafar ^a   Sastre, Javier ^b   Arnold, Dirk ^c   Österlund, Pia ^d   Greil, Richard ^e   Van Cutsem, Eric ^f   von Moos, Roger ^g   Viéitez, Jose Maria ^h   Bouché, Olivier ⁱ   Borg, Christophe ^j   Steffens, Claus Christoph ^k   Alonso Orduña, Vicente ^l   Schlichting, Christoph ^m   Reyes Rivera, Irmarie ⁿ   Bendahmane, Belguendouz ^o   André, Thierry ^p   Kubicka, Stefan ^q  

^a Cancérologie de l'Ouest Institute   (France)

^b HOSPITAL CLÍNICO SAN CARLOS   (Spain)

^c UNIVERSITY MEDICAL CENTER HAMBURG EPPENDORF   (Germany)

^d HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

^e PARACELSUS MEDICAL UNIVERSITY   (Austria)

^f UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^g Kantonal Hospital of Graubunden   (Switzerland)

^h HOSPITAL UNIVERSITARIO CENTRAL DE ASTURIAS   (Spain)

ⁱ SERVICE DE DERMATOLOGIE   (France)

^j UNIVERSITY HOSPITAL OF BESANÇON   (France)

^k Medizinisches Versorgungszentrum Hämatologie Onkologie Klinik Dr Hancken   (Germany)

^l HOSPITAL UNIVERSITARIO MIGUEL SERVET   (Spain)

^m Diakoniekrankenhaus Rotenburg ^*  (Germany)

ⁿ GENENTECH INC   (United States)

^o F HOFFMANN LA ROCHE LTD   (Switzerland)

^p SORBONNE UNIVERSITÉ   (France)

^q Cancer Center Reutlingen   (Germany)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; CAPECITABINE; FLUOROURACIL; FOLINIC ACID; IRINOTECAN; OXALIPLATIN;

ABDOMINAL PAIN; ADULT; AGED; ARTERIAL THROMBOEMBOLISM; ARTICLE; ASTHENIA; CANCER CHEMOTHERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER CONTROL; CANCER GROWTH; CANCER SURVIVAL; CEREBROVASCULAR ACCIDENT; COLORECTAL CANCER; COMPARATIVE STUDY; CONTINUOUS INFUSION; CONTROLLED STUDY; DECREASED APPETITE; DIARRHEA; DIGESTIVE SYSTEM PERFORATION; DRUG EFFECT; DRUG FATALITY; DRUG FEVER; DRUG HYPERSENSITIVITY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; DYSPNEA; FATIGUE; FEMALE; FOLLOW UP; GASTROINTESTINAL HEMORRHAGE; GENE MUTATION; HEART INFARCTION; HUMAN; HYPERTENSION; HYPOKALEMIA; ILEUS; LEUKOPENIA; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; METASTASIS; MUCOSA INFLAMMATION; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; ONCOGENE K RAS; OVERALL SURVIVAL; PERIPHERAL NEUROPATHY; PHASE 3 CLINICAL TRIAL; POLYNEUROPATHY; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION; VENOUS THROMBOEMBOLISM; VOMITING;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; COLORECTAL NEOPLASMS; DISEASE-FREE SURVIVAL; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; VASCULAR ENDOTHELIAL GROWTH FACTOR A;

EID: 84871720057     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(12)70477-1     Document Type: Article

References (26)

1. 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.
2. Saltz LB, Clarke S, Díaz-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.
3. Tebbutt NC, Wilson K, Gebski VJ, et al. Capecitabine, bevacizumab, and mitomycin in first-line treatment of metastatic colorectal cancer: results of the Australasian Gastrointestinal Trials Group randomized phase III MAX study. J Clin Oncol 2010, 28:3191-3198.
4. Giantonio BJ, Catalano PJ, Meropol NJ, et al. 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 2007, 25:1539-1544.
5. Kozloff M, Yood MU, Berlin J, et al. Clinical outcomes associated with bevacizumab-containing treatment of metastatic colorectal cancer: the BRiTE observational cohort study. Oncologist 2009, 14:862-870.
6. 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.
7. Clinical practice guidelines in oncology. Colon cancer version 2.2012, 2011 National Comprehensive Cancer Network, (accessed June 21, 2012). http://www.nccn.org/professionals/physician_gls/pdf/colon.pdf.
8. Tournigand C, André 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.
9. Cunningham D, Humblet Y, Siena S, et al. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med 2004, 351:337-345.
10. Peeters M, Price TJ, Cervantes A, et al. Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer. J Clin Oncol 2010, 28:4706-4713.
11. Wu H-C, Li P-C Proteins expressed on tumor endothelial cells as potential targets for anti-angiogenic therapy. J Cancer Molec 2008, 4:17-22.
12. Giantonio BJ Targeted therapies: Goldie-Coldman and bevacizumab beyond disease progression. Nat Rev Clin Oncol 2009, 6:311-312.
13. Melnyk O, Zimmerman M, Kim KJ, Shuman M Neutralizing anti-vascular endothelial growth factor antibody inhibits further growth of established prostate cancer and metastases in a pre-clinical model. J Urol 1999, 161:960-963.
14. Mesiano S, Ferrara N, Jaffe RB Role of vascular endothelial growth factor in ovarian cancer: inhibition of ascites formation by immunoneutralization. Am J Pathol 1998, 153:1249-1256.
15. Klement G, Baruchel S, Rak J, et al. Continuous low-dose therapy with vinblastine and VEGF receptor-2 antibody induces sustained tumor regression without overt toxicity. J Clin Invest 2000, 105:R15-R24.
16. Klement G, Huang P, Mayer B, et al. Differences in therapeutic indexes of combination metronomic chemotherapy and an anti-VEGFR-2 antibody in multidrug-resistant human breast cancer xenografts. Clin Cancer Res 2002, 8:221-232.
17. 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.
18. Cohn AL, Bekaii-Saab TS, Bendell JC, et al. Clinical outcomes in bevacizumab (BV)-treated patients (pts) with metastatic colorectal cancer (mCRC): results from ARIES observational cohort study (OCS) and confirmation of BRiTE data on BV beyond progression (BBP). Proc Am Soc Clin Oncol 2010, 28(suppl). abstr 3596.
19. Köhne C-H, Cunningham D, Di Constanzo F, et al. Clinical determinants of survival in patients with 5-fluorouracil-based treatment for metastatic colorectal cancer: results of a multivariate analysis of 3825 patients. Ann Oncol 2002, 13:308-317.
20. Pocock SJ, Simon R Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 1975, 31:102-115.
21. Mellor HR, Callaghan R Resistance to chemotherapy in cancer: a complex and integrated cellular response. Pharmacology 2008, 81:275-300.
22. Bergers G, Hanahan D Modes of resistance to anti-angiogenic therapy. Nat Rev Cancer 2008, 8:592-603.
23. Allegra C, Lakomy R, Tabernero J, et al. Effects of prior bevacizumab (B) use on outcomes from the VELOUR study: A phase III study of aflibercept (Afl) and FOLFIRI in patients (pts) with metastatic colorectal cancer (mCRC) after failure of an oxaliplatin regimen. Proc Am Soc Clin Oncol 2012, 30(suppl). abstr 3505.
24. Van Cutsem E, Tabernero J, Lakomy R, et al. Addition of aflibercept to fluorouracil, leucovorin, and irinotecan improves survival in a phase III randomized trial in patients with metastatic colorectal cancer previously treated with an oxaliplatin-based regimen. J Clin Oncol 2012, 30:3499-3506.
25. Kabbinavar F, Hurwitz HI, Fehrenbacher L, et al. Phase II, randomized trial comparing bevacizumab plus fluorouracil (FU)/leucovorin (LV) with FU/LV alone in patients with metastatic colorectal cancer. J Clin Oncol 2003, 21:60-65.
26. Grothey A, Sobrero AF, Siena S, et al. Results of a phase III randomized, double-blind, placebo-controlled, multicenter trial (CORRECT) of regorafenib plus best supportive care (BSC) versus placebo plus BSC in patients (pts) with metastatic colorectal cancer (mCRC) who have progressed after standard therapies. Proc Am Soc Clin Oncol 2012, 30(suppl). abstr LBA385.