Phase III trial comparing protracted intravenous fluorouracil infusion alone or with yttrium-90 resin microspheres radioembolization for liver-limited metastatic colorectal cancer refractory to standard chemotherapy

Journal of Clinical Oncology

Volumn 28, Issue 23, 2010, Pages 3687-3694

  Hendlisz, Alain ^a   Van Den Eynde, Marc ^a   Peeters, Marc ^a   Maleux, Geert ^a   Lambert, Bieke ^a   Vannoote, Jaarke ^a   De Keukeleire, Katrien ^a   Verslype, Chris ^a   Defreyne, Luc ^a   Van Cutsem, Eric ^a   Delatte, Philippe ^a   Delaunoit, Thierry ^a   Personeni, Nicola ^a   Paesmans, Marianne ^a   Van Laethem, Jean Luc ^a   Flamen, Patrick ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; CETUXIMAB; FLUORODEOXYGLUCOSE F 18; FLUOROURACIL; IRINOTECAN; MACROSALB TC 99M; OXALIPLATIN; RADIOACTIVE MICROSPHERE; RESIN MICROSPHERE Y 90; UNCLASSIFIED DRUG; ALKYLATING AGENT; MICROSPHERE; YTTRIUM;

ABDOMINAL PAIN; ADULT; AGED; ANOREXIA; ARTICLE; ASCITES; CANCER CHEMOTHERAPY; CANCER GROWTH; CANCER RADIOTHERAPY; CANCER RECURRENCE; CHEMOEMBOLIZATION; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; COGNITIVE DEFECT; COLORECTAL CANCER; COMBINATION CHEMOTHERAPY; CONSTIPATION; DIARRHEA; DRUG FEVER; DRUG HYPERSENSITIVITY; DRUG SAFETY; DYSPNEA; FATIGUE; FEMALE; GASTROINTESTINAL SYMPTOM; HAND FOOT SYNDROME; HEART ARRHYTHMIA; HUMAN; HUMAN TISSUE; LIVER METASTASIS; LIVER RESECTION; LUNG TOXICITY; MALE; MONOTHERAPY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; OVERALL SURVIVAL; PAIN; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SENSORY DYSFUNCTION; SKIN TOXICITY; STOMACH ULCER; STOMATITIS; THROMBOCYTOPENIA; TREATMENT RESPONSE; ADENOCARCINOMA; ARTIFICIAL EMBOLISM; CLINICAL TRIAL; COLORECTAL TUMOR; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; INTRAARTERIAL DRUG ADMINISTRATION; INTRAVENOUS DRUG ADMINISTRATION; LIVER TUMOR; METASTASIS; MIDDLE AGED; PATHOLOGY; PROSPECTIVE STUDY; TREATMENT OUTCOME;

ADENOCARCINOMA; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS, ALKYLATING; COLORECTAL NEOPLASMS; EMBOLIZATION, THERAPEUTIC; FEMALE; FLUOROURACIL; HUMANS; INFUSIONS, INTRAVENOUS; INJECTIONS, INTRA-ARTERIAL; LIVER NEOPLASMS; MALE; MICROSPHERES; MIDDLE AGED; PROSPECTIVE STUDIES; TREATMENT OUTCOME; YTTRIUM RADIOISOTOPES;

EID: 77957266593     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2010.28.5643     Document Type: Article

References (40)

1. Parkin DM, Bray F, Ferlay J, et al: Global cancer statistics, 2002. CA Cancer J Clin 55:74-108, 2005
2. Nagorney DM, Gigot JF: Primary epithelial hepatic malignancies: Etiology, epidemiology, and outcome after subtotal and total hepatic resection. Surg Oncol Clin N Am 5:283-300, 1996 (Pubitemid 26132351)
3. Cunningham D, Pyrhönen S, James RD, et al: Randomized trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. Lancet 352:1413-1418, 1998 (Pubitemid 28510874)
4. de Gramont A, Figer A, Seymour M, et al: Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol 18:2938-2947, 2000 (Pubitemid 30644117)
5. Douillard JY, Cunningham D, Roth AD, et al: Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: A multicentre randomised trial. Lancet 355:1041-1047, 2000 (Pubitemid 30162806)
6. 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)
7. Giantonio JB, 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 25:1539-1544, 2007 (Pubitemid 46733080)
8. Cunningham D, Humblet Y, Siena S, et al: Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med 351:337-345, 2004 (Pubitemid 38944402)
9. Van Cutsem E, Peeters M, Siena S, et al: Open-label phase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapy-refractory metastatic colorectal cancer. J Clin Oncol 25:1658-1664, 2007 (Pubitemid 46797944)
10. Van Cutsem E, Kodie;hne CH, Hitre E, et al: Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med 360:1408-1417, 2009
11. 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)
12. Khatri VP, Chee KG, Petrelli NJ: Modern multimodality approach to hepatic colorectal metastases: Solutions and controversies. Surg Oncol 16:71-83, 2007 (Pubitemid 46880341)
13. Kennedy A, Nag S, Salem R, et al: Recommendations for radioembolization of hepatic malignancies using yttrium-90 microsphere brachytherapy: A consensus panel report from the Radioembolization Brachytherapy Oncology Consortium (REBOC). Int J Radiat Oncol Biol Phys 68:13-23, 2007 (Pubitemid 46589861)
14. Lau WY, Leung TW, Ho S, et al: Diagnostic pharmaco-scintigraphy with hepatic intra-arterial technetium-99m macroaggregated albumin in the determination of tumour to non-tumour uptake ratio in hepatocellular carcinoma. Br J Radiol 67:136-139, 1994 (Pubitemid 24054366)
15. Campbell AM, Bailey IH, Burton MA: Tumour dosimetry in human liver following hepatic yttrium-90 microsphere therapy. Phys Med Biol 46: 487-498, 2001 (Pubitemid 32148511)
16. Kennedy AS, Nutting C, Coldwell D, et al: Pathologic response and microdosimetry of 90Y microspheres in man: Review of four explanted whole livers. Int J Radiat Oncol Biol Phys 60:1552-1563, 2004 (Pubitemid 39601873)
17. Stuart JE, Tan B, Myerson RJ, et al: Salvage radioembolization of liver-dominant metastases with a resin-based microsphere: Initial outcomes. J Vasc Interv Radiol 19:1427-1433, 2008
18. Jakobs TF, Hoffmann RT, Poepperl G, et al: Mid-term results in otherwise treatment refractory primary or secondary liver confined tumours treated with selective internal radiation therapy (SIRT) using 90Yttrium resin-microspheres. Eur Radiol 17:1320-1330, 2007 (Pubitemid 46691963)
19. Gulec SA, Mesoloras G, Dezarn WA, et al: Safety and efficacy of Y-90 microsphere treatment in patients with primary and metastatic liver cancer: The tumor selectivity of the treatment as a function of tumor to liver flow ratio. J Transl Med 5:15, 2007
20. 90Y microspheres in patients with hepatocellular cancer. J Nucl Med 50:688-692, 2009
21. Flamen P, Vanderlinden B, Delatte P, et al: Multimodality imaging can predict the metabolic response of unresectable colorectal liver metastases to radioembolization therapy with yttrium-90labeled resin microspheres. Phys Med Biol 53:6591-6603, 2008
22. van Hazel G, Blackwell A, Anderson J, et al: Randomised phase II trial of SIR-Spheres plus fluorouracil/ leucovorin chemotherapy versus fluorouracil/ leucovorin chemotherapy alone in advanced colorectal cancer. J Surg Oncol 88:78-85, 2004 (Pubitemid 39536508)
23. Sharma RA, Van Hazel GA, Morgan B, et al: Radioembolization of liver metastases from colorectal cancer using yttrium-90 microspheres with concomitant systemic oxaliplatin, fluorouracil, and leucovorin chemotherapy. J Clin Oncol 25:1099-1106, 2007 (Pubitemid 46596762)
24. van Hazel GA, Pavlakis N, Goldstein D, et al: Treatment of fluourouracil-refractory patients with liver metastases from colorectal cancer using yttrium-90 resin microspheres plus concomitant systemic irinotecan chemotherapy. J Clin Oncol 27:4089-4095, 2009
25. Gray B, Van Hazel G, Hope M, et al: Randomised trial of SIR-spheres plus chemotherapy vs. chemotherapy alone for treating patients with liver metastases from primary large bowel cancer. Ann Oncol 12:1711-1720, 2001 (Pubitemid 34105661)
26. 90Y- micropshere brachytherapy for unresectable colorectal liver metastases: Modern USA experience. Int J Radiat Oncol Biol Phys 65:412-425, 2006
27. Cosimelli M, Mancini R, Carpanese L, et al: Clinical safety and efficacy of 90yttrium resin microspheres alone in unresectable, heavily pre-treated colorectal liver metastases: Results of a phase II trial. J Clin Oncol 26:197s, 2008 (suppl; abstr 4078)
28. Jakobs TF, Hoffmann RT, Dehm K, et al: Hepatic yttrium-90 radioembolization of chemotherapy-refractory colorectal cancer liver metastases. J Vasc Interv Radiol 19:1187-1195, 2008
29. Therasse P, Arbuck S, Eisenhauer E, et al: New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 92:205-216, 2000 (Pubitemid 30099779)
30. Cancer Therapy Evaluation Program: Common Terminology Criteria for Adverse Events, version 3.0. http://ctep.cancer.gov
31. Jonker DJ, O'Callaghan CJ, Karapetis CS, et al: Cetuximab for the treatment of colorectal cancer. N Engl J Med 357:2040-2048, 2007 (Pubitemid 350106711)
32. Kopetz S, Chang GJ, Overman MJ, et al: Improved survival in metastatic colorectal cancer is associated with adoption of hepatic resection and improved chemotherapy. J Clin Oncol 27:3677-3683, 2009
33. Marn CS, Andrews JC, Francis IR, et al: Hepatic parenchymal changes after intraarterial Y-90 therapy: CT findings. Radiology 187:125-128, 1993 (Pubitemid 23097872)
34. Murthy R, Nunes R, Szklaruk J, et al: Y-90 microspheres therapy for hepatic malignancy: Devices, indications, technical considerations and potential complications. Radiographics 25:S41-S55, 2005 (Pubitemid 41686061)
35. Szyszko T, Al-Nahhas A, Canelo R, et al: Assessment of response to treatment of unresectable liver tumours with Y90 microspheres: Value of FDG-PET versus computed tomography. Nucl Med Commun 28:15-20, 2007 (Pubitemid 44949683)
36. 18F-FDG PET. J Nucl Med 45:1892-1897, 2004
37. 90Y-glass microsphere treatment response of unresectable colorectal liver metastases by (18F)FDG PET: A comparison with CT or MRI. Eur J Nucl Med Mol Imaging 29:815-820, 2002
38. Stubbs RS, Cannan RJ, Mitchell AW: Selective internal radiation therapy (SIRT) with 90Yttrium microspheres for extensive colorectal liver metastases. Hepatogastroenterology 48:333-337, 2001 (Pubitemid 32391561)
39. Chun YS, Laurent A, Maru D, et al: Management of chemotherapy-associated hepatotoxicity in colorectal liver metastases. Lancet Oncol 10:278-286, 2009
40. Sharma RA, Wasan HS, Love SB, et al: FOXFIRE Trial Management Group. FOXFIRE: A phase III clinical trial of chemo-radio-embolisation as first-line treatment of liver metastases in patients with colorectal cancer. Clin Oncol (R Coll Radiol) 20:261-263, 2008