A randomized two arm phase III study in patients post radical resection of liver metastases of colorectal cancer to investigate bevacizumab in combination with capecitabine plus oxaliplatin (CAPOX) vs CAPOX alone as adjuvant treatment

BMC Cancer

Volumn 10, Issue , 2010, Pages

  Snoeren, Nikol ^a   Voest, Emile E ^a   Bergman, Andre M ^b   Dalesio, Otilia ^b   Verheul, Henk M ^c   Tollenaar, Rob A E M ^c   van der Sijp, Joost R M ^c   Schouten, Sander B ^a   Rinkes, Inne H B ^a   van Hillegersberg, R ^a  

^a UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^b Antonie van Leeuwenhoek Hospital   (Netherlands)

^c Department of Medical Oncology ^*  (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; CAPECITABINE; OXALIPLATIN; ANGIOGENESIS INHIBITOR; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE; DRUG DERIVATIVE; FLUOROURACIL; MONOCLONAL ANTIBODY; PLATINUM COMPLEX;

ADJUVANT THERAPY; ARTICLE; CANCER ADJUVANT THERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER RECURRENCE; CANCER SURVIVAL; CLINICAL TRIAL; COLORECTAL CANCER; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE FREE SURVIVAL; DRUG EFFICACY; DRUG INTERMITTENT THERAPY; DRUG SAFETY; EVENING DOSAGE; HUMAN; HUMAN TISSUE; LIVER METASTASIS; LIVER RESECTION; MONOTHERAPY; MORNING DOSAGE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; QUALITY OF LIFE; RADIOFREQUENCY ABLATION; RANDOMIZED CONTROLLED TRIAL; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT; ADJUVANT CHEMOTHERAPY; COLORECTAL TUMOR; FEMALE; LIVER TUMOR; MALE; METASTASIS; METHODOLOGY; PATHOLOGY; RECURRENT DISEASE; TREATMENT OUTCOME;

ANGIOGENESIS INHIBITORS; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHEMOTHERAPY, ADJUVANT; COLORECTAL NEOPLASMS; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; FEMALE; FLUOROURACIL; HUMANS; LIVER NEOPLASMS; MALE; NEOPLASM METASTASIS; ORGANOPLATINUM COMPOUNDS; QUALITY OF LIFE; RECURRENCE; TREATMENT OUTCOME;

EID: 77957676744     PISSN: None     EISSN: 14712407     Source Type: Journal    
DOI: 10.1186/1471-2407-10-545     Document Type: Article

References (52)

1. Ponz D, Marino M, Benatti P, Rossi G, Menigatti M, Pedroni M, et al. Trend of incidence, subsite distribution and staging of colorectal neoplasms in the 15-year experience of a specialised cancer registry. Ann Oncol 2004, 15:940-946. 10.1093/annonc/mdh224, 15151952.
2. Van CE, Nordlinger B, Adam R, Kohne CH, Pozzo C, Poston G, et al. Towards a pan-European consensus on the treatment of patients with colorectal liver metastases. Eur J Cancer 2006, 42(14):2212-21. 10.1016/j.ejca.2006.04.012, 16904315.
3. Boyle P, Ferlay J. Cancer incidence and mortality in Europe, 2004. Ann Oncol 2005, 16:481-488. 10.1093/annonc/mdi098, 15718248.
4. Borner MM. Neoadjuvant chemotherapy for unresectable liver metastases of colorectal cancer--too good to be true?. Ann Oncol 1999, 10:623-626. 10.1023/A:1008353227103, 10442182.
5. Sugarbaker PH. Metastatic inefficiency: the scientific basis for resection of liver metastases from colorectal cancer. J Surg Oncol Suppl 1993, 3:158-160. 10.1002/jso.2930530541, 8503973.
6. Jaffe BM, Donegan WL, Watson F, Spratt JS. Factors influencing survival in patients with untreated hepatic metastases. Surg Gynecol Obstet 1968, 127:1-11.
7. Bengmark S, Hafstrom L. The natural history of primary and secondary malignant tumors of the liver. I. The prognosis for patients with hepatic metastases from colonic and rectal carcinoma by laparotomy. Cancer 1969, 23:198-202. 10.1002/1097-0142(196901)23:1<198::AID-CNCR2820230126>3.0.CO;2-J, 5763253.
8. Abdalla EK, Vauthey JN, Ellis LM, Ellis V, Pollock R, Broglio KR, et al. Recurrence and outcomes following hepatic resection, radiofrequency ablation, and combined resection/ablation for colorectal liver metastases. Ann Surg 2004, 239:818-825. 10.1097/01.sla.0000128305.90650.71, 1356290, 15166961.
9. Choti MA, Sitzmann JV, Tiburi MF, Sumetchotimetha W, Rangsin R, Schulick RD, et al. Trends in long-term survival following liver resection for hepatic colorectal metastases. Ann Surg 2002, 235:759-766. 10.1097/00000658-200206000-00002, 1422504, 12035031.
10. Pawlik TM, Izzo F, Cohen DS, Morris JS, Curley SA. Combined resection and radiofrequency ablation for advanced hepatic malignancies: results in 172 patients. Ann Surg Oncol 2003, 10:1059-1069. 10.1245/ASO.2003.03.026, 14597445.
11. Rees M, Tekkis PP, Welsh FK, O'Rourke T, John TG. Evaluation of long-term survival after hepatic resection for metastatic colorectal cancer: a multifactorial model of 929 patients. Ann Surg 2008, 247:125-135. 10.1097/SLA.0b013e31815aa2c2, 18156932.
12. Scheele J, tendorf-Hofmann A. Resection of colorectal liver metastases. Langenbecks Arch Surg 1999, 384:313-327. 10.1007/s004230050209, 10473851.
13. Fong Y, Cohen AM, Fortner JG, Enker WE, Turnbull AD, Coit DG, et al. Liver resection for colorectal metastases. J Clin Oncol 1997, 15:938-946.
14. Aloia TA, Vauthey JN, Loyer EM, Ribero D, Pawlik TM, Wei SH, et al. Solitary colorectal liver metastasis: resection determines outcome. Arch Surg 2006, 141:460-466. 10.1001/archsurg.141.5.460, 16702517.
15. Berber E, Tsinberg M, Tellioglu G, Simpfendorfer CH, Siperstein AE. Resection versus laparoscopic radiofrequency thermal ablation of solitary colorectal liver metastasis. J Gastrointest Surg 2008, 12:1967-1972. 10.1007/s11605-008-0622-8, 18688683.
16. Gillams AR, Lees WR. Radio-frequency ablation of colorectal liver metastases in 167 patients. Eur Radiol 2004, 14:2261-2267. 10.1007/s00330-004-2416-z, 15599547.
17. Siperstein AE, Berber E, Ballem N, Parikh RT. Survival after radiofrequency ablation of colorectal liver metastases: 10-year experience. Ann Surg 2007, 246:559-565. 10.1097/SLA.0b013e318155a7b6, 17893492.
18. Veltri A, Sacchetto P, Tosetti I, Pagano E, Fava C, Gandini G. Radiofrequency ablation of colorectal liver metastases: small size favorably predicts technique effectiveness and survival. Cardiovasc Intervent Radiol 2008, 31:948-956. 10.1007/s00270-008-9362-0, 18506519.
19. Hur H, Ko YT, Min BS, Kim KS, Choi JS, Sohn SK, et al. Comparative study of resection and radiofrequency ablation in the treatment of solitary colorectal liver metastases. Am J Surg 2009, 197:728-736. 10.1016/j.amjsurg.2008.04.013, 18789428.
20. Mulier S, Ni Y, Jamart J, Ruers T, Marchal G, Michel L. Local recurrence after hepatic radiofrequency coagulation: multivariate meta-analysis and review of contributing factors. Ann Surg 2005, 242:158-171. 10.1097/01.sla.0000171032.99149.fe, 1357720, 16041205.
21. Figueras J, Torras J, Valls C, Llado L, Ramos E, Marti-Rague J, et al. Surgical resection of colorectal liver metastases in patients with expanded indications: a single-center experience with 501 patients. Dis Colon Rectum 2007, 50:478-488. 10.1007/s10350-006-0817-6, 17279302.
22. Kemeny MM, Adak S, Gray B, Macdonald JS, Smith T, Lipsitz S, et al. Combined-modality treatment for resectable metastatic colorectal carcinoma to the liver: surgical resection of hepatic metastases in combination with continuous infusion of chemotherapy--an intergroup study. J Clin Oncol 2002, 20:1499-1505. 10.1200/JCO.20.6.1499, 11896097.
23. Langer B, Bleiberg H. Fluorouracil (FU) plus l-leucovorin (l-LV) versus observation after potentially curative resection of liver or lung metastases from colorectal cancer (CRC): results of the ENG (EORTC/NCIC CTG/GIVIO) randomized trial. 2002, Ref Type: Generic.
24. Portier G, Elias D, Bouche O, Rougier P, Bosset JF, Saric J, et al. Multicenter randomized trial of adjuvant fluorouracil and folinic acid compared with surgery alone after resection of colorectal liver metastases: FFCD ACHBTH AURC 9002 trial. J Clin Oncol 2006, 24:4976-4982. 10.1200/JCO.2006.06.8353, 17075115.
25. Panis Y, Ribeiro J, Chretien Y, Nordlinger B. Dormant liver metastases: an experimental study. Br J Surg 1992, 79:221-223. 10.1002/bjs.1800790309, 1555087.
26. Van CE, Hoff PM, Harper P, Bukowski RM, Cunningham D, Dufour P, et al. Oral capecitabine vs intravenous 5-fluorouracil and leucovorin: integrated efficacy data and novel analyses from two large, randomised, phase III trials. Br J Cancer 2004, 90:1190-1197. 10.1038/sj.bjc.6601676, 2409640, 15026800.
27. McDermott WV, Ottinger LW. Elective hepatic resection. Am J Surg 1966, 112:376-381. 10.1016/0002-9610(66)90206-6, 5917305.
28. Monaco AP, Hallgrimsson J, McDermott WV. MULTIPLE ADENOMA (HAMARTOMA) OF THE LIVER TREATED BY SUBTOTAL (90 PERCENT) RESECTION: MORPHOLOGICAL AND FUNCTIONAL STUDIES OF REGENERATION. Ann Surg 1964, 159:513-519. 1408610, 14138195.
29. Bengmark S, Engevik L, Rosengren K. Angiography of the regenerating human liver after extensive resection. Surgery 1969, 65:590-596.
30. Folkman J. Tumor angiogenesis: therapeutic implications. N Engl J Med 1971, 285:1182-1186. 10.1056/NEJM197108122850711, 4938153.
31. Drixler TA, Borel RI, Ritchie ED, van Vroonhoven TJ, Gebbink MF, Voest EE. Continuous administration of angiostatin inhibits accelerated growth of colorectal liver metastases after partial hepatectomy. Cancer Res 2000, 60:1761-1765.
32. Slooter GD, Marquet RL, Jeekel J, Ijzermans JN. Tumour growth stimulation after partial hepatectomy can be reduced by treatment with tumour necrosis factor alpha. Br J Surg 1995, 82:129-132. 10.1002/bjs.1800820144, 7881931.
33. 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, 350:2335-2342. 10.1056/NEJMoa032691, 15175435.
34. Giantonio BJ, Catalano PJ, Meropol NJ, O'Dwyer PJ, Mitchell EP, Alberts SR, 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. 10.1200/JCO.2006.09.6305, 17442997.
35. Hurwitz HI, Fehrenbacher L, Hainsworth JD, Heim W, Berlin J, Holmgren E, et al. Bevacizumab in combination with fluorouracil and leucovorin: an active regimen for first-line metastatic colorectal cancer. J Clin Oncol 2005, 23:3502-3508. 10.1200/JCO.2005.10.017, 15908660.
36. Kabbinavar F, Irl C, Zurlo A, Hurwitz H. Bevacizumab improves the overall and progression-free survival of patients with metastatic colorectal cancer treated with 5-fluorouracil-based regimens irrespective of baseline risk. Oncology 2008, 75:215-223. 10.1159/000163850, 18852492.
37. Miwa M, Ura M, Nishida M, Sawada N, Ishikawa T, Mori K, et al. Design of a novel oral fluoropyrimidine carbamate, capecitabine, which generates 5-fluorouracil selectively in tumours by enzymes concentrated in human liver and cancer tissue. Eur J Cancer 1998, 34:1274-1281. 10.1016/S0959-8049(98)00058-6, 9849491.
38. Reigner B, Blesch K, Weidekamm E. Clinical pharmacokinetics of capecitabine. Clin Pharmacokinet 2001, 40:85-104. 10.2165/00003088-200140020-00002, 11286326.
39. Raymond E, Chaney SG, Taamma A, Cvitkovic E. Oxaliplatin: a review of preclinical and clinical studies. Ann Oncol 1998, 9:1053-1071. 10.1023/A:1008213732429, 9834817.
40. Achen MG, Jeltsch M, Kukk E, Makinen T, Vitali A, Wilks AF, et al. Vascular endothelial growth factor D (VEGF-D) is a ligand for the tyrosine kinases VEGF receptor 2 (Flk1) and VEGF receptor 3 (Flt4). Proc Natl Acad Sci USA 1998, 95:548-553. 10.1073/pnas.95.2.548, 18457, 9435229.
41. Ferrara N. Vascular endothelial growth factor and the regulation of angiogenesis. Recent Prog Horm Res 2000, 55:15-35.
42. Ferrara N. Role of vascular endothelial growth factor in regulation of physiological angiogenesis. Am J Physiol Cell Physiol 2001, 280:C1358-C1366.
43. Shibuya M. Structure and function of VEGF/VEGF-receptor system involved in angiogenesis. Cell Struct Funct 2001, 26:25-35. 10.1247/csf.26.25, 11345501.
44. Ferrara N. VEGF and the quest for tumour angiogenesis factors. Nat Rev Cancer 2002, 2:795-803. 10.1038/nrc909, 12360282.
45. Neufeld G, Kessler O, Vadasz Z, Gluzman-Poltorak Z. The contribution of proangiogenic factors to the progression of malignant disease: role of vascular endothelial growth factor and its receptors. Surg Oncol Clin N Am 2001, 10:339-56. ix.
46. Jain RK. Normalizing tumor vasculature with anti-angiogenic therapy: a new paradigm for combination therapy. Nat Med 2001, 7:987-989. 10.1038/nm0901-987, 11533692.
47. Nordlinger B, Sorbye H, Glimelius B, Poston GJ, Schlag PM, Rougier P, et al. Perioperative chemotherapy with FOLFOX4 and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC Intergroup trial 40983): a randomised controlled trial. Lancet 2008, 371:1007-1016. 10.1016/S0140-6736(08)60455-9, 2277487, 18358928.
48. Adam R, Wicherts DA, de Haas RJ, Aloia T, Levi F, Paule B, et al. Complete pathologic response after preoperative chemotherapy for colorectal liver metastases: myth or reality?. J Clin Oncol 2008, 26:1635-1641. 10.1200/JCO.2007.13.7471, 18375892.
49. Scappaticci FA, Fehrenbacher L, Cartwright T, Hainsworth JD, Heim W, Berlin J, et al. Surgical wound healing complications in metastatic colorectal cancer patients treated with bevacizumab. J Surg Oncol 2005, 91:173-180. 10.1002/jso.20301, 16118771.
50. Gruenberger B, Tamandl D, Schueller J, Scheithauer W, Zielinski C, Herbst F, et al. Bevacizumab, capecitabine, and oxaliplatin as neoadjuvant therapy for patients with potentially curable metastatic colorectal cancer. J Clin Oncol 2008, 26:1830-1835. 10.1200/JCO.2007.13.7679, 18398148.
51. Morris-Stiff G, Tan YM, Vauthey JN. Hepatic complications following preoperative chemotherapy with oxaliplatin or irinotecan for hepatic colorectal metastases. Eur J Surg Oncol 2008, 34:609-614.
52. Ribero D, Wang H, Donadon M, Zorzi D, Thomas MB, Eng C, et al. Bevacizumab improves pathologic response and protects against hepatic injury in patients treated with oxaliplatin-based chemotherapy for colorectal liver metastases. Cancer 2007, 110:2761-2767. 10.1002/cncr.23099, 17960603.