Selective Internal Radiation Therapy (SIRT) with yttrium-90 resin microspheres plus standard systemic chemotherapy regimen of FOLFOX versus FOLFOX alone as first-line treatment of non-resectable liver metastases from colorectal cancer: The SIRFLOX study

BMC Cancer

Volumn 14, Issue 1, 2014, Pages

  Gibbs, Peter ^a,f   Gebski, Val ^b   Van Buskirk, Mark ^c   Thurston, Kenneth ^d   Cade, David N ^d   Van Hazel, Guy A ^e   Amin, Pradip ^g   Angelelli, Bruna ^g   Balosso, Jacques ^g   Beny, Alex ^g   Bloomgarden, Daniel ^g   Boucher, Eveline ^g   Brown, Michael ^g   Bruch, Harald Robert ^g   Bui, James ^g   Burge, Matthew ^g   Cardaci, Giuseppe ^g   Carlisle, James ^g   Chen, Yi Jen ^g   Chevallier, Patrick ^g   Clarke, Stephen ^g   Coveler, Andrew ^g   Craninx, Michel ^g   Delanoit, Thierry ^g   Deleporte, Amélie ^g   Eliadis, Paul ^g   Facchini, Francis ^g   Ferguson, Thomas ^g   Ferrante, Michel ^g   Findlay, Michael ^g   Frenette, Gary ^g   Frick, Jacob ^g   Ganju, Vinod ^g   Garofalo, Michael ^g   Geboes, Karen ^g   Gehbauer, Gerald ^g   George, Benjamin ^g   Geva, Ravit ^g   Gordon, Michael ^g   Gulac, Seza ^g   Hannigan, James ^g   Heinemann, Volker ^g   Helmberger, Thomas ^g   Holtzman, Matthew ^g   Isaacs, Richard ^g   James, Philip ^g   Kaubisch, Andreas ^g   Ko, Yon Dschun ^g   Kooy, Todd ^g   Kröning, Hendrik ^g   Lammert, Frank ^g   Liauw, Winston ^g   Louafi, Samy ^g   de Man, Marc ^g   Margolis, Jeffrey ^g   Martin, Robert ^g   Marx, Gavin ^g   Matos, Marco ^g   Monsaert, Els ^g   Moons, Veerle ^g   Nott, Louise ^g   Nusch, Arnd ^g   O'Donnell, Anne ^g   Ozer, Howard ^g   Padia, Siddarth ^g   Pavlakis, Nick ^g   Peeters, Marc ^g   Perez, David ^g   Pluntke, Stefan ^g   Polus, Marc ^g   Powell, Alex ^g   Price, Timothy ^g   Ransom, David ^g   Rebischung, Christine ^g   Ridwelski, Karsten ^g   Riess, Hanno ^g   Riera, Jorge Ramon ^g   Ricke, Jens ^g   Rilling, William ^g   Robinson, Bridget ^g   Rodríguez, Javier ^g   Sauerbruch, Tilmann ^g   Savin, Michael ^g   Scheidhauer, Klemens ^g   Schneiderman, Elyse ^g   Seeger, Grant ^g   Segelov, Eva ^g   Schmueli, Einat Shaham ^g   Shani, Adi ^g   Shannon, Jenny ^g   Sharma, Navesh ^g   Shibata, Stephen ^g   Singhal, Nimit ^g   Smith, Denis ^g   Smith, Randall ^g   Stemmer, Salomon ^g   Stötzer, Oliver ^g   Strickland, Andrew ^g   Taieb, Julien ^g   Tatsch, Klaus ^g   Terrebonne, Eric ^g   Tichler, Thomas ^g   Vehling Kaiser, Ursula ^g   Vera Garcia, Ruth ^g   Vogl, Thomas ^g   Walpole, Euan ^g   Wang, Eric ^g   Whiting, Samuel ^g   Wolf, Ido ^g   more..

^a ROYAL MELBOURNE HOSPITAL   (Australia)

^b UNIVERSITY OF SYDNEY   (Australia)

^c Data Reduction LLC   (United States)

^d Research and DevelopmentSirtex Medical Limited   (Australia)

^e UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

^f WALTER AND ELIZA HALL INSTITUTE OF MEDICAL RESEARCH   (Australia)

^g NONE   (Israel)

Author keywords

Liver metastases; Metastatic colorectal cancer; Selective Internal Radiation Therapy (SIRT); SIR Spheres microspheres; Systemic chemotherapy

Indexed keywords

BEVACIZUMAB; FLUOROURACIL; FOLINIC ACID; MICROSPHERE; MICROSPHERE Y 90; OXALIPLATIN; RESIN; UNCLASSIFIED DRUG; YTTRIUM 90; ANTINEOPLASTIC AGENT; PLATINUM COMPLEX; YTTRIUM;

ARTICLE; AUSTRALIA; CANCER COMBINATION CHEMOTHERAPY; CANCER RADIOTHERAPY; CANCER SURVIVAL; COLORECTAL CANCER; CONTROLLED STUDY; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; EUROPE; HUMAN; ISRAEL; LIVER METASTASIS; LIVER RESECTION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NEW ZEALAND; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SELECTIVE INTERNAL RADIATION THERAPY; SURVIVAL TIME; TREATMENT RESPONSE; TUMOR GROWTH; UNITED STATES; ADULT; CHEMORADIOTHERAPY; CLINICAL TRIAL; COLORECTAL NEOPLASMS; LIVER NEOPLASMS; PATHOLOGY; SECONDARY;

ADULT; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHEMORADIOTHERAPY; COLORECTAL NEOPLASMS; FLUOROURACIL; HUMANS; LEUCOVORIN; LIVER NEOPLASMS; MICROSPHERES; ORGANOPLATINUM COMPOUNDS; YTTRIUM RADIOISOTOPES;

EID: 84924414313     PISSN: None     EISSN: 14712407     Source Type: Journal    
DOI: 10.1186/1471-2407-14-897     Document Type: Article

References (45)

1. Welch JP, Donaldson GA: The clinical correlation of an autopsy study of recurrent colorectal cancer. Ann Surg 1979, 189:496-502.
2. Abbas S, Lam V, Hollands M: Ten-year survival after liver resection for colorectal metastases: systematic review and meta-analysis. ISRN Oncol 2011, 2011:763245.
3. Adam R: Developing strategies for liver metastases from colorectal cancer. Semin Oncol 2007, 34:S7-S11.
4. Fong Y, Fortner J, Sun RL, Brennan MF, Blumgart LH: Clinical score for predicting recurrence after hepatic resection for metastatic colorectal cancer: analysis of 1001 consecutive cases. Ann Surg 1999, 230:309-318. discussion 318-321
5. Choti MA, Sitzmann JV, Tiburi MF, Sumetchotimetha W, Rangsin R, Schulick RD, Lillemoe KD, Yeo CJ, Cameron JL: Trends in long-term survival following liver resection for hepatic colorectal metastases. Ann Surg 2002, 235:759-766.
6. Stangl R, Altendorf-Hofmann A, Charnley RM, Scheele J: Factors influencing the natural history of colorectal liver metastases. Lancet 1994, 343:1405-1410.
7. Rothbarth J, van de Velde CJ: Treatment of liver metastases of colorectal cancer. Ann Oncol 2005,16(Suppl 2):ii144-ii149.
8. Berber E, Pelley R, Siperstein AE: Predictors of survival after radiofrequency thermal ablation of colorectal cancer metastases to the liver: a prospective study. J Clin Oncol 2005, 23:1358-1364.
9. Navarra G, Ayav A, Weber JC, Jensen SL, Smadga C, Nicholls JP, Habib NA, Jiao LR: Short- and-long term results of intraoperative radiofrequency ablation of liver metastases. Int J Colorectal Dis 2005, 20:521-528.
10. Van Cutsem E, Nordlinger B, Adam R, Kohne CH, Pozzo C, Poston G, Ychou M, Rougier P, European Colorectal Metastases Treatment G: Towards a pan-European consensus on the treatment of patients with colorectal liver metastases. Eur J Cancer 2006, 42:2212-2221.
11. de Jong MC, Pulitano C, Ribero D, Strub J, Mentha G, Schulick RD, Choti MA, Aldrighetti L, Capussotti L, Pawlik TM: Rates and patterns of recurrence following curative intent surgery for colorectal liver metastasis: an international multi-institutional analysis of 1669 patients. Ann Surg 2009, 250:440-448.
12. Piedbois P, Rougier P, Buyse M, Pignon J, Ryan L, Hansen R, Zee B, Weinerman B, Pater J, Leichman C, Macdonald J, Benedetti J, Lokich J, Fryer J, Brufman G, Isacson R, Laplanche A, Levy E, Meta-analysis Group In Cancer: Efficacy of intravenous continuous infusion of fluorouracil compared with bolus administration in advanced colorectal cancer. J Clin Oncol 1998, 16:301-308.
13. Saltz LB, Cox JV, Blanke C, Rosen LS, Fehrenbacher L, Moore MJ, Maroun JA, Ackland SP, Locker PK, Pirotta N, Elfring GL, Miller LL: Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. N Engl J Med 2000, 343:905-914.
14. Goldberg RM, Sargent DJ, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Alberts SR: A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 2004, 22:23-30.
15. Tournigand C, Andre T, Achille E, Lledo G, Flesh M, Mery-Mignard D, Quinaux E, Couteau C, Buyse M, Ganem G, Landi B, Colin P, Louvet C, de Gramont A: FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol 2004, 22:229-237.
16. Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E, Ferrara N, Fyfe G, Rogers B, Ross R, Kabbinavar F: Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 2004, 350:2335-2342.
17. Saltz LB, Clarke S, Diaz-Rubio E, Scheithauer W, Figer A, Wong R, Koski S, Lichinitser M, Yang TS, Rivera F, Couture F, Sirzen F, Cassidy J: 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.
18. Folprecht G, Grothey A, Alberts S, Raab HR, Kohne CH: Neoadjuvant treatment of unresectable colorectal liver metastases: correlation between tumour response and resection rates. Ann Oncol 2005, 16:1311-1319.
19. Adam R, Delvart V, Pascal G, Valeanu A, Castaing D, Azoulay D, Giacchetti S, Paule B, Kunstlinger F, Ghemard O, Levi F, Bismuth H: Rescue surgery for unresectable colorectal liver metastases downstaged by chemotherapy: a model to predict long-term survival. Ann Surg 2004, 240:644-657. discussion 657-648
20. Louvet C, de Gramont A: Colorectal cancer: integrating oxaliplatin. Curr Treat Options Oncol 2003, 4:405-411.
21. Giantonio BJ, Catalano PJ, Meropol NJ, O'Dwyer PJ, Mitchell EP, Alberts SR, Schwartz MA, Benson AB 3rd, Eastern Cooperative Oncology Group Study E: 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.
22. Van Hazel G, Blackwell A, Anderson J, Price D, Moroz P, Bower G, Cardaci G, Gray B: Randomised phase 2 trial of SIR-Spheres plus fluorouracil/leucovorin chemotherapy versus fluorouracil/leucovorin chemotherapy alone in advanced colorectal cancer. J Surg Oncol 2004, 88:78-85.
23. Sharma RA, Van Hazel GA, Morgan B, Berry DP, Blanshard K, Price D, Bower G, Shannon JA, Gibbs P, Steward WP: Radioembolization of liver metastases from colorectal cancer using yttrium-90 microspheres with concomitant systemic oxaliplatin, fluorouracil, and leucovorin chemotherapy. J Clin Oncol 2007, 25:1099-1106.
24. Gray B, Van Hazel G, Hope M, Burton M, Moroz P, Anderson J, Gebski V: Randomised trial of SIR-Spheres plus chemotherapy vs. chemotherapy alone for treating patients with liver metastases from primary large bowel cancer. Ann Oncol 2001, 12:1711-1720.
25. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG: New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000, 92:205-216.
26. Kosmider S, Tan TH, Yip D, Dowling R, Lichtenstein M, Gibbs P: Radioembolization in combination with systemic chemotherapy as first-line therapy for liver metastases from colorectal cancer. J Vasc Interv Radiol 2011, 22:780-786.
27. Hendlisz A, Van den Eynde M, Peeters M, Maleux G, Lambert B, Vannoote J, De Keukeleire K, Verslype C, Defreyne L, Van Cutsem E, Delatte P, Delaunoit T, Personeni N, Paesmans M, Van Laethem JL, Flamen P: 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. J Clin Oncol 2010, 28:3687-3694.
28. Bester L, Meteling B, Pocock N, Pavlakis N, Chua TC, Saxena A, Morris DL: Radioembolization versus standard care of hepatic metastases: comparative retrospective cohort study of survival outcomes and adverse events in salvage patients. J Vasc Interv Radiol 2012, 23:96-105.
29. Seidensticker R, Denecke T, Kraus P, Seidensticker M, Mohnike K, Fahlke J, Kettner E, Hildebrandt B, Dudeck O, Pech M, Amthauer H, Ricke J: Matched-pair comparison of radioembolization plus best supportive care versus best supportive care alone for chemotherapy refractory liver-dominant colorectal metastases. Cardiovasc Intervent Radiol 2012, 35:1066-1073.
30. Khushalani NI, Leichman CG, Proulx G, Nava H, Bodnar L, Klippenstein D, Litwin A, Smith J, Nava E, Pendyala L, Smith P, Greco W, Berdzik J, Douglass H, Leichman L: Oxaliplatin in combination with protracted-infusion fluorouracil and radiation: report of a clinical trial for patients with esophageal cancer. J Clin Oncol 2002, 20:2844-2850.
31. Freyer G, Bossard N, Romestaing P, Mornex F, Chapet O, Trillet-Lenoir V, Gerard JP: Addition of oxaliplatin to continuous fluorouracil, l-folinic acid, and concomitant radiotherapy in rectal cancer: the Lyon R 97-03 phase I trial. J Clin Oncol 2001, 19:2433-2438.
32. Aschele C, Friso ML, Pucciarelli S, Lonardi S, Sartor L, Fabris G, Urso ED, Del Bianco P, Sotti G, Lise M, Monfardini S: A phase I-II study of weekly oxaliplatin, 5-fluorouracil continuous infusion and preoperative radiotherapy in locally advanced rectal cancer. Ann Oncol 2005, 16:1140-1146.
33. Cheeseman SL, Joel SP, Chester JD, Wilson G, Dent JT, Richards FJ, Seymour MT: A 'modified de Gramont' regimen of fluorouracil, alone and with oxaliplatin, for advanced colorectal cancer. Br J Cancer 2002, 87:393-399.
34. Cersosimo RJ: Oxaliplatin-associated neuropathy: a review. Ann Pharmacother 2005, 39:128-135.
35. Van Cutsem E, Rivera F, Berry S, Kretzschmar A, Michael M, DiBartolomeo M, Mazier MA, Canon JL, Georgoulias V, Peeters M, Bridgewater J, Cunningham D, BEAT investigators: 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.
36. Nasti G, Ottaiano A, Berretta M, Delrio P, Izzo F, Cassata A, Romano C, Facchini G, Scala D, Mastro A, Romano G, Perri F, Iaffaioli RV: Pre-operative chemotherapy for colorectal cancer liver metastases: an update of recent clinical trials. Cancer Chemother Pharmacol 2010, 66:209-218.
37. Van Cutsem E, Kohne CH, Lang I, Folprecht G, Nowacki MP, Cascinu S, Shchepotin I, Maurel J, Cunningham D, Tejpar S, Schlichting M, Zubel A, Celik I, Rougier P, Ciardiello F: Cetuximab plus irinotecan, fluorouracil, and leucovorin as first-line treatment for metastatic colorectal cancer: updated analysis of overall survival according to tumor KRAS and BRAF mutation status. J Clin Oncol 2011, 29:2011-2019.
38. Bokemeyer C, Bondarenko I, Makhson A, Hartmann JT, Aparicio J, de Braud F, Donea S, Ludwig H, Schuch G, Stroh C, Loos AH, Zubel A, Koralewski P: Fluorouracil, leucovorin, and oxaliplatin with and without cetuximab in the first-line treatment of metastatic colorectal cancer. J Clin Oncol 2009, 27:663-671.
39. Maughan TS, Adams RA, Smith CG, Meade AM, Seymour MT, Wilson RH, Idziaszczyk S, Harris R, Fisher D, Kenny SL, Kay E, Mitchell JK, Madi A, Jasani B, James MD, Bridgewater J, Kennedy MJ, Claes B, Lambrechts D, Kaplan R, Cheadle JP, MRC COIN Trial Investigators: Addition of cetuximab to oxaliplatin-based first-line combination chemotherapy for treatment of advanced colorectal cancer: results of the randomised phase 3 MRC COIN trial. Lancet 2011, 377:2103-2114.
40. Tveit KM, Guren T, Glimelius B, Pfeiffer P, Sorbye H, Pyrhonen S, Sigurdsson F, Kure E, Ikdahl T, Skovlund E, Fokstuen T, Hansen F, Hofsli E, Birkemeyer E, Johnsson A, Starkhammar H, Yilmaz MK, Keldsen, Erdal AB, Dajani O, Dahl O, Christoffersen T': Phase III trial of cetuximab with continuous or intermittent fluorouracil, leucovorin, and oxaliplatin (Nordic FLOX) versus FLOX alone in first-line treatment of metastatic colorectal cancer: the NORDIC-VII study. J Clin Oncol 2012, 30:1755-1762.
41. Zhou SW, Huang YY, Wei Y, Jiang ZM, Zhang YD, Yang Q, Xie DR: No survival benefit from adding cetuximab or panitumumab to oxaliplatin-based chemotherapy in the first-line treatment of metastatic colorectal cancer in KRAS wild type patients: a meta-analysis. PLoS One 2012, 7:e50925.
42. Peeters M, Price T: Biologic therapies in the metastatic colorectal cancer treatment continuum-applying current evidence to clinical practice. Cancer Treat Rev 2012, 38:397-406.
43. Chu E: An update on the current and emerging targeted agents in metastatic colorectal cancer. Clin Colorectal Cancer 2012, 11:1-13.
44. Schwarz RE, Berlin JD, Lenz HJ, Nordlinger B, Rubbia-Brandt L, Choti MA: Systemic cytotoxic and biological therapies of colorectal liver metastases: expert consensus statement. HPB 2013, 15:106-115.
45. Clary BM, Grothey A, Kopetz S, Marsh RD: Systemic cytotoxic and biologic therapies for colorectal cancer liver metastases: expert consensus statement. HPB 2013, 15:116-118.