Randomized phase II trial of adjuvant hepatic arterial infusion and systemic chemotherapy with or without bevacizumab in patients with resected hepatic metastases from colorectal cancer

Journal of Clinical Oncology

Volumn 29, Issue 7, 2011, Pages 884-889

  Kemeny, Nancy E ^a   Jarnagin, William R ^a   Capanu, Marinela ^a   Fong, Yuman ^a   Gewirtz, Alexandra N ^a   DeMatteo, Ronald P ^a   D'Angelica, Michael I ^a  

^a WEILL CORNELL MEDICAL COLLEGE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; DEXAMETHASONE; FLOXURIDINE; FLUOROURACIL; FOLINIC ACID; HEPARIN; IRINOTECAN; OXALIPLATIN;

ABDOMINAL PAIN; ADULT; ALKALINE PHOSPHATASE BLOOD LEVEL; ALLERGIC REACTION; ARTICLE; BILIRUBIN BLOOD LEVEL; CANCER ADJUVANT THERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER SURGERY; CANCER SURVIVAL; COLITIS; COLORECTAL ADENOCARCINOMA; COLORECTAL CARCINOMA; DIARRHEA; FEMALE; FEVER; HUMAN; INFECTION; KAPLAN MEIER METHOD; LIVER METASTASIS; LIVER RESECTION; LOG RANK TEST; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MULTIPLE CYCLE TREATMENT; OVERALL SURVIVAL; PARALYTIC ILEUS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECURRENCE FREE SURVIVAL; SCORING SYSTEM; SIDE EFFECT; STENT; SYSTEMIC THERAPY; THROMBOSIS; WOUND INFECTION;

ADENOCARCINOMA; AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHEMOTHERAPY, ADJUVANT; COLORECTAL NEOPLASMS; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HEPATECTOMY; HUMANS; INFUSIONS, INTRA-ARTERIAL; INFUSIONS, INTRAVENOUS; LIVER NEOPLASMS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; PROGNOSIS; SURVIVAL ANALYSIS;

EID: 79952307340     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2010.32.5977     Document Type: Article

References (33)

1. Jemal A, Siegel R, Xu J, et al: Cancer statistics, 2010. CA Cancer J Clin 60:277-300, 2010
2. Weiss L, Grundmann E, Torhorst J, et al: Haematogenous metastatic patterns in colonic carcinoma: An analysis of 1541 necropsies. J Pathol 150:195-203, 1986 (Pubitemid 17181753)
3. Fong Y, Cohen AM, Fortner JG, et al: Liver resection for colorectal metastases. J Clin Oncol 15:938-946, 1997 (Pubitemid 27106275)
4. Choti MA, Sitzmann JV, Tiburi MF, et al: Trends in long-term survival following liver resection for hepatic colorectal metastases. Ann Surg 235:759-766, 2002 (Pubitemid 34547293)
5. Hughes KS, Simon R, Songhorabodi S, et al: Resection of the liver for colorectal carcinoma metastases: A multi-institutional study of patterns of recurrence. Surgery 100:278-284, 1986 (Pubitemid 16070861)
6. Portier G, Elias D, Bouche O, 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, 24:4976-4982, 2006 (Pubitemid 46631399)
7. Mitry E, Fields A, Bleiberg H, et al: Adjuvant chemotherapy after potentially curative resection of metastases from colorectal cancer: A meta-analysis of two randomized trials. J Clin Oncol 24:152s, 2006 (suppl; abstr 3524)
8. Nordlinger B, Sorbye H, Glimelius B, 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 371:1007-1016, 2008 (Pubitemid 351392040)
9. Kemeny N, Huang Y, Cohen AM, et al: Hepatic arterial infusion of chemotherapy after resection of hepatic metastases from colorectal cancer. N Engl J Med 341:2039-2048, 1999 (Pubitemid 30035952)
10. Lygidakis NJ, Sgourakis G, Vlachos L, et al: Metastatic liver disease of colorectal origin: The value of locoregional immunochemotherapy combined with systemic chemotherapy following liver resection - Results of a prospective randomized study. Hepatogastroenterology 48:1685-1691, 2001 (Pubitemid 34003504)
11. Lorenz M, Müller HH, Schramm H, et al: Randomized trial of surgery versus surgery followed by adjuvant hepatic arterial infusion with 5-fluorouracil and folinic acid for liver metastases of colorectal cancer: German Cooperative on Liver Metastases (Arbeitsgruppe Lebermetastasen). Ann Surg 228:756-762, 1998 (Pubitemid 30191686)
12. Kemeny MM, Adak S, Gray B, et al: Combinedmodality 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 20:1499-1505, 2002 (Pubitemid 34260528)
13. Kemeny NE, Gonen M: Hepatic arterial infusion after liver resection. N Engl J Med 352:734-735, 2005 (Pubitemid 40239230)
14. Hurwitz H, Fehrenbacher L, Novotny W, et al: Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 350:2335-2342, 2004 (Pubitemid 38702844)
15. Kemeny N, Daly J, Oderman P, et al: Hepatic artery pump infusion: Toxicity and results in patients with metastatic colorectal carcinoma. J Clin Oncol 2:595-600, 1984 (Pubitemid 14025614)
16. Common Terminology Criteria for Adverse Events v 3.0 (CTCAE), 9 August 2006. http://ctep.cancer.gov/protocoldevelopment/electronic-applications/docs/ ctcaev3.pdf
17. Kemeny N, Capanu M, D'Angelica M, et al: Phase I trial of adjuvant hepatic arterial infusion (HAI) with floxuridine (FUDR) and dexamethasone plus systemic oxaliplatin, 5-fluorouracil and leucovorin in patients with resected liver metastases from colorectal cancer. Ann Oncol 20:1236-1241, 2009
18. Fong Y, Fortner J, Sun RL, et al: Clinical score for predicting recurrence after hepatic resection for metastatic colorectal cancer: Analysis of 1001 consecutive cases. Ann Surg 230:309-318, 1999
19. Benoist S, Brouquet A, Penna C, et al: Complete response of colorectal liver metastases after chemotherapy: Does it mean cure? J Clin Oncol 24:3939-3945, 2006 (Pubitemid 46630742)
20. Ychou M, Hohenberger W, Thezenas S, et al: A randomized phase III study comparing adjuvant 5-fluorouracil/folinic acid with FOLFIRI in patients following complete resection of liver metastases from colorectal cancer. Ann Oncol 20:1964-1970, 2009
21. Charnley RM, Hardcastle JD: Intraoperative abdominal ultrasound. Gut 31:368-369, 1990 (Pubitemid 20129429)
22. Ackerman NB: The blood supply of experimental liver metastases: IV. Changes in vascularity with increasing tumor growth. Surgery 75:589-596, 1974
23. Kemeny N, Jarnagin W, Gonen M, et al: Phase I/II study of hepatic arterial therapy with floxuridine and dexamethasone in combination with intravenous irinotecan as adjuvant treatment after resection of hepatic metastases from colorectal cancer. J Clin Oncol 21:3303-3309, 2003 (Pubitemid 46606264)
24. Alberts SR, Roh MS, Mahoney MR, et al: Alternating systemic and hepatic artery infusion therapy for resected liver metastases from colorectal cancer: A North Central Cancer Treatment Group (NCCTG)/ National Surgical Adjuvant Breast and Bowel Project (NSABP) phase II intergroup trial, N9945/CI-66. J Clin Oncol 28:853-858, 2010
25. Wolmark N, Yothers G, O'Connell MJ, et al: A phase III trial comparing mFOLFOX6 to mFOLFOX6 plus bevacizumab in stage II or III carcinoma of the colon: Results of NSABP Protocol C-08. J Clin Oncol 27:6s, 2009 (suppl; abstr LBA4)
26. Roche: Investor Update, September 18, 2010. http://www.roche.com/ investors/ir-update/inv-update-2010-09-18b.htm
27. Sargent DJ, Wieand HS, Haller DG, et al: Disease-free survival versus overall survival as a primary end point for adjuvant colon cancer studies: Individual patient data from 20,898 patients on 18 randomized trials. J Clin Oncol 23:8664-8670, 2005 (Pubitemid 46211509)
28. Power DG, Capanu M, Patel D, et al: Unexpected increased biliary toxicity when systemic bevacizumab is added to hepatic arterial infusion. J Clin Oncol 28:275s, 2010 (suppl; abstr 3559)
29. Eremina V, Jefferson JA, Kowalewska J, et al: VEGF inhibition and renal thrombotic microangiopathy. N Engl J Med, 358:1129-1136, 2008 (Pubitemid 351398487)
30. Estilo CL, Fornier M, Farooki A, et al: Osteonecrosis of the jaw related to bevacizumab. J Clin Oncol 26:4037-4038, 2008
31. Traina TA, Norton L, Drucker K, et al: Nasal septum perforation in a bevacizumab-treated patient with metastatic breast cancer. Oncologist 11:1070-1071, 2006 (Pubitemid 44788397)
32. Spigel DR, Hainsworth JD, Yardley DA, et al: Tracheoesophageal fistula formation in patients with lung cancer treated with chemoradiation and bevacizumab. J Clin Oncol 28:43-48, 2010
33. Wagner AD, Arnold D, Grothey AA, et al: Antiangiogenic therapies for metastatic colorectal cancer. Cochrane Database Syst Rev 3:CD005392, 2009