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Chapter 5 : A Novel DBA Algorithm Design

5.5 The Novel Algorithm Design

5.5.2 The new polling scheme

Nombre Apellido Especialidad Institución Conflictos de Interés Declarados

1 Arcuri Jorge Oncólogo Tucumán Ninguno

2 Blajman Cesar Oncólogo Santa Fe Ninguno

3 Lirussi Mauricio Oncólogo San Juan Ninguno

4 Marmisole Fabiana Oncóloga La Plata Ninguno

5 Ortiz Eduardo Oncólogo La Pampa Ninguno

6 Rusz Maidana Cristina Oncóloga Santiago del Estero Ninguno 7 Zwenger Ariel Oncólogo Hospital Castro Rendón

Neuquén Ninguno

8 Romera Alvaro Oncólogo Rosario Ninguno

9 Lingua Alejo Oncólogo Córdoba

Remuneración por protocolo de investigación en cáncer de colon: Merck 2013

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BIBLIOGRAFIA

1

Cirocchi R, Trastulli S, Abraha I, Vettoretto N, Boselli C, Montedori A, Parisi A, Noya G, PlatellC.Non-resection versus resection for an asymptomatic primary tumour in patients with unresectable stage IV colorectal cancer.Cochrane Database Syst Rev. 2012 Aug 15;8:CD008997. Review. PMID: 22895981

2

Falcone A, Ricci S, Brunetti I, Pfanner E, Allegrini G, Barbara C, Crinò L, Benedetti G, Evangelista W, Fanchini L, Cortesi E, Picone V, Vitello S, Chiara S, Granetto C, Porcile G, Fioretto L, Orlandini C, Andreuccetti M, Masi G; GruppoOncologico Nord Ovest. Phase III trial of infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) compared with infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI) as first-line treatment for metastatic colorectal cancer: the GruppoOncologico Nord Ovest. J ClinOncol. 2007 May 1;25(13):1670-6. PMID: 17470860 3 http://www.msal.gov.ar/images/stories/bes/graficos/0000000032cnt-19- Guia%20de%20Procedimientos%20para%20la%20Conserjeria%20de%20Evaluacion%20de%20Antecedentes%2 0y%20Riesgo.pdf 4 http://www.msal.gov.ar/inc/images/stories/downloads/publicaciones/equipo_medico/Cancer_colorrectal/Diagnsti co_situacional_del_cncer_colorrectal_en_Argentina.pdf 5

Scheithauer W, Rosen H, Kornek GV, Sebesta C, DepischD.Randomised comparison of combination chemotherapy plus supportive care with supportive care alone in patients with metastatic colorectal cancer.BMJ. 1993 Mar 20;306(6880):752-5.PMID: 7683942

6

Di Nicolantonio F, Martini M, Molinari F, Sartore-Bianchi A, Arena S, Saletti P, De Dosso S, Mazzucchelli L, Frattini M, Siena S, Bardelli A. Wild-type BRAF is required for response to panitumumab or cetuximab in metastatic colorectal cancer. J Clin Oncol. 2008 Dec 10;26(35):5705-12. PMID: 19001320

7

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, KabbinavarF.Bevacizumab plus Irinotecan, fluorouracil and Leucovorin for metastatic colorectal cancer. N Engl J Med. 2004 Jun 3;350(23):2335-42. PMID: 15175435

8

Kabbinavar F, Hurwitz HI, Fehrenbacher L, Meropol NJ, Novotny WF, Lieberman G, Griffing S, Bergsland E. Phase II, randomized trial comparing bevacizumab plus fluorouracil (FU)/leucovorin (LV) with FU/LV alone in patients with metastatic colorectal cancer. J ClinOncol. 2003 Jan 1;21(1):60-5. PMID: 12506171

9

Kabbinavar FF, Schulz J, McCleod M, Patel T, Hamm JT, Hecht JR, Mass R, Perrou B, Nelson B, Novotny WF. Addition of bevacizumab to bolus fluorouracil and leucovorin in first-line metastatic colorectal cancer: results of a randomized phase II trial. J ClinOncol. 2005 Jun 1;23(16):3697-705. PMID: 15738537

10

Saltz LB, Clarke S, Díaz-Rubio E, Scheithauer W, Figer A, Wong R, Koski S, Lichinitser M, Yang TS, Rivera F, Couture F, Sirzén F, Cassidy J. Bevacizumab in combination with Oxaliplatin-Based Chemotherapy as First-Line Therapy in Metastatic Colorectal Cancer: A Randomized Phase III Study. JClinOncol. 2008 Apr 20;26(12):2013-9. Erratum in: J ClinOncol. 2008 Jun; 26(18):3110. J ClinOncol. 2009 Feb 1;27(4):653. PMID: 18421054

11

Saltz L, Clarke C, Diaz Rubio E, Scheithauer W, Figer A, Wong R, Koski S, Lichinitser M, Yang T and Cassidy J. Bevacizumab (Bev) in combination with XELOX or FOLFOX 4: Updated efficacy results from XELOX-1/NO16966, a randomized phase III trial in first-line metastatic colorectal cancer [slideset]. J Clin Oncol 25:18s, 2007 (suppl; abstr 4028)

12

Hochster HS, Hart LL, Ramanathan RK, Childs BH, Hainsworth JD, Cohn AL, Wong L, Fehrenbacher L, Abubakr Y, Saif MW, Schwartzberg L, Hedrick E. Safety and Efficacy of Oxaliplatin and Fluoropyrimidine Regimens With or Without Bevacizumab as First –Line Treatment of Metastatic Colorectal Cancer: Results of the TREE Study. J ClinOncol. 2008 Jul 20;26(21):3523-9. Erratum in: J ClinOncol. 2008 Oct 1;26(28): 4697.PMID: 18640933

13

Tebbutt NC, Wilson K, Gebski VJ, Cummins MM, Zannino D, van Hazel GA, Robinson B, Broad A, Ganju V, Ackland SP, Forgeson G, Cunningham D, Saunders MP, Stockler MR, Chua Y, Zalcberg JR, Simes RJ, Price TJ. 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 ClinOncol. 2010 Jul 1;28(19):3191-8. PMID: 20516443

DROGAS DE ALTO COSTO EN EL TRATAMIENTO DEL CÁNCER COLORRECTAL AVANZADO

71

14

Stathopoulos GP, Batziou C, Trafalis D, Koutantos J, Batzios S, Stathopoulos J, Legakis J, Armakolas A. Treatment of Colorectal Cancer with and without Bevacizumab: A Phase III Study. Oncology. 2010;78(5-6):376-81. PMID: 20798560

15

Bendell JC, Bekaii-Saab TS, Cohn AL, Hurwitz HI, Kozloff M, Tezcan H, Roach N, Mun Y, Fish S, Flick ED, Dalal D, Grothey A. Treatment patterns and clinical outcomes in patients with metastatic colorectal cancer initially treated with FOLFOX-bevacizumab or FOLFIRI-bevacizumab: results from ARIES, a bevacizumab observational cohort study. Oncologist. 2012;17(12):1486-95. PMID: 23015662

16

Kabbinavar FF, Hambleton J, Mass RD, Hurwitz HI, Bergsland E, Sarkar S. Combined analysis of efficacy: The addition of Bevacizumab to fluorouracil/leucovorin improves survival for patients with metastatic colorectal cancer. J ClinOncol. 2005 Jun 1;23(16):3706-12. PMID: 15867200

17

Macedo LT, da Costa Lima AB, SasseAD.Addition of bevacizumab to first-line chemotherapy in advanced colorectal cancer: a systematic review and meta-analysis, with emphasis on chemotherapy subgroups. BMC Cancer. 2012 Mar 13;12:89. Review. PMID: 22414244

18

Wagner AD, Arnold D, Grothey AA, Haerting J, Unverzagt S. Anti-angiogenic therapies for metastatic colorectal cancer. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD005392. Review. PMID: 19588372

19

Loupakis F, Bria E, Vaccaro V, Cuppone F, Milella M, Carlini P, Cremolini C, Salvatore L, Falcone A, Muti P, Sperduti I, Giannarelli D, Cognetti F. Magnitude of benefit of the addition of bevacizumab to first-line chemotherapy for metastatic colorectal cancer: meta-analysis of randomized clinical trials. J Exp Clin Cancer Res. 2010 May 26;29:58. PMID: 20504361

20

Galfrascoli E, Piva S, Cinquini M, Rossi A, La Verde N, Bramati A, Moretti A, Manazza A, Damia G, Torri V, Muserra G, Farina G, Garassino MC; ORION CollaborativeGroup. Risk/benefit profile of bevacizumab in metastatic colon cancer: a systematic review and meta-analysis. Dig Liver Dis. 2011 Apr;43(4):286-94. Review. PMID: 21146479

21

Welch S, Spithoff K, Rumble RB, Maroun J; Gastrointestinal Cancer Disease Site Group. Bevacizumab combined with chemotherapy for patients with advanced colorectal cancer: a systematic review. Ann Oncol. 2010Jun;21(6):1152-62. Review. PMID: 19942597

22

Cao Y, Tan A, Gao F, Liu L, Liao C, Mo Z. A meta-analysis of randomized controlled trials comparing chemotherapy plus bevacizumab with chemotherapy alone in metastatic colorectal cancer.Int J Colorectal Dis. 2009 Jun;24(6):677-85. PMID: 19184059

23

Kabbinavar FF, Hurwitz HI, Yi J, Sarkar S, Rosen O. Addition of Bevacizumab to Fluorouracil-Based First-Line Treatment of Metastatic Colorectal Cancer: Pooled Analysis of Cohorts of Older Patients From Two Randomized Clinical Trials. J ClinOncol. 2009 Jan 10;27(2):199-205. PMID: 19064978

24

Hershman DL, Wright JD, Lim E, Buono DL, Tsai WY, NeugutAI.Contraindicated use of bevacizumab and toxicity in elderly patients with cancer. J Clin Oncol. 2013 Oct 1;31(28):3592-9. PMID: 24002522

25

Whyte S, Pandor A, Stevenson Bevacizumab for metastatic colorectal cancer for the first line therapy: a NICE single technology appraisal. Researcher, ScHARR, University of Sheffield Pharmacoeconomics. 2012 Dec 1;30(12):1119-32. Review. PMID: 23058097

26

NICE Technology Appraisal Guidance 212. Bevacizumab in combination with oxaliplatin and either fluorouracil plus folinic acid or capecitabine for the treatment of metastatic colorectal cancer. Issued: December 2010

27

NICE Technology Appraisal Guidance 118. Bevacizumab and Cetuximab for the treatment of metastatic colorectal cancer.Issued: January 2007

28

Disponible en: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines

29

Tournigand C, Cervantes A, Figer A, Lledo G, Flesch M, Buyse M, Mineur L, Carola E, Etienne PL, Rivera F, Chirivella I, Perez-Staub N, Louvet C, André T, Tabah-Fisch I, de Gramont A. OPTIMOX1: a randomized study of FOLFOX4 or FOLFOX7 with oxaliplatin in a stop-and-Gofashion in advanced colorectal cancer-a GERCOR study. J ClinOncol. 2006 Jan 20;24(3):394-400. PMID: 16421419

DROGAS DE ALTO COSTO EN EL TRATAMIENTO DEL CÁNCER COLORRECTAL AVANZADO

72

30

Chibaudel B, Maindrault-Goebel F, Lledo G, Mineur L, André T, Bennamoun M, Mabro M, Artru P, Carola E, Flesch M, Dupuis O, Colin P, Larsen AK, Afchain P, Tournigand C, Louvet C, de Gramont A. Can chemotherapy be discontinued in unresectable metastatic colorectal cancer? The GERCOR OPTIMOX2 Study.J ClinOncol. 2009 Dec 1;27(34):5727-33. PMID: 19786657

31

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 fi rst-line combination chemotherapy for treatment of advanced colorectal cancer: results of the randomised phase 3 MRC COIN trial. Lancet. 2011 Jun 18;377(9783):2103-14. PMID: 21641636

32

Labianca R, Sobrero A, Isa L, Cortesi E, Barni S, Nicolella D, Aglietta M, Lonardi S, Corsi D, Turci D, Beretta GD, Fornarini G, Dapretto E, Floriani I, Zaniboni A; Italian Group for the Study of Gastrointestinal Cancer-GISCAD. Intermittent versus continuous chemotherapy in advanced colorectal cancer: a randomised 'GISCAD'trial. Ann Oncol. 2011 May;22(5):1236-42. PMID: 1078826

33

Hochster HS, Grothey A, Hart L, Rowland K, Ansari R, Alberts S, Chowhan N, Ramanathan RK, Keaton M, Hainsworth JD, Childs BH. Improved time to treatment failure with an intermittent oxaliplatin strategy: results of CONcePT. Ann Oncol. 2014 Jun;25(6):1172-8. PMID: 24608198

34

Díaz-Rubio E, Gómez-España A, Massutí B, Sastre J, Abad A, Valladares M, Rivera F, Safont MJ, Martínez de Prado P, Gallén M, González E, Marcuello E, Benavides M, Fernández-Martos C, Losa F, Escudero P, Arrivi A, Cervantes A, Dueñas R, López-Ladrón A, Lacasta A, Llanos M, Tabernero JM, Antón A, Aranda E; Spanish Cooperative Group for the Treatment of Digestive Tumors. First-line XELOX plus bevacizumab followed by XELOX plus bevacizumab or single-agent bevacizumab as maintenance therapy in patients with metastatic colorectal cancer: the phase III MACRO TTD study.Oncologist. 2012;17(1):15-25. PMID: 22234633

35

Yalcin S, Uslu R, Dane F, Yilmaz U, Zengin N, Buyukunal E, Buyukberber S, Camci C, Sencan O, Kilickap S, Ozdener F, CevikD. Bevacizumab + capecitabine as maintenance therapy after initial bevacizumab + XELOX treatment in previously untreated patients with metastatic colorectal cancer: phase III 'Stop and Go' study results-- a Turkish Oncology Group Trial.Oncology. 2013;85(6):328-35. doi: 10.1159/000355914. Epub 2013 Nov 12.PMID: 24247559

36

Koeberle D, Betticher D, von Moos R, Dietrich D, Brauchli P, Baertschi, Matter-Walstra K, Winterhalder R, BornerM,Anchisi S, Moosmann P, Kollar A, Saletti P, Roth A, FruehM, Kueng M, Popescu R, Schacher S, Hess V, Herrmann R. Bevacizumab continuation versus no continuation after first-line chemo-bevacizumab therapy in patients with metastatic colorectal cancer: A randomized phase III noninferiority trial (SAKK 41/06) J ClinOncol 31, 2013 (suppl; abstr 3503)

37

Koopman M, Simkens LH, Ten Tije AJ. Maintenance treatment with capecitabine and bevacizumab versus observation after induction treatment with chemotherapy and bevacizumab in metastatic colorectal cancer (mCRC): The phase III CAIRO3 study of the Dutch Colorectal Cancer Group (DCCG) [ASCO abstract 3502]. J ClinOncol. 2013;31(15)(suppl)

38

UllrichGraeven AD, Lerchenmuller CA, Killing B, Depenbusch R, Steffens CC, Al-Batran SE, Lange T, Dietrich G, Stoehlmacher J, Tannapfel A, Schmoll HJ, Reinacher-Schick A, Hegewisch-BeckerS. Maintenance strategy with fluoropyrimidines (FP) plus Bevacizumab (Bev), Bev alone, or no treatment, following a standard combination of FP, oxaliplatin (Ox), and Bev as first-line treatment for patients with metastatic colorectal cancer (mCRC): A phase III non-inferiority trial (AIO KRK 0207). J ClinOncol 32:5s, 2014 (suppl; abstr 3503)

39

Allegra CJ, Jessup JM, Somerfield MR, Hamilton SR, Hammond EH, Hayes DF, McAllister PK, Morton RF and Schilsky RL. American Society of Clinical Oncology Provisional Clinical Opinion: Testing for KRAS Gene Mutations in Patients With Metastatic Colorectal Carcinoma to Predict Response to Anti–Epidermal Growth Factor Receptor Monoclonal Antibody Therapy. J Clin Oncol. 2009 Apr 20;27(12):2091-6 PMID: 19188670

40

Behl AS, Goddard KA, Flottemesch TJ, Veenstra D, Meenan RT, Lin JS, Maciosek MV. Cost-effectiveness analysis of screening for KRAS and BRAF mutations in metastatic colorectal cancer. J Natl Cancer Inst. 2012 Dec 5; 104(23):1785-95. PMID: 23197490

DROGAS DE ALTO COSTO EN EL TRATAMIENTO DEL CÁNCER COLORRECTAL AVANZADO

73

41

De Roock W, Claes B, Bernasconi D, De Schutter J, Biesmans B, Fountzilas G, Kalogeras KT, Kotoula V, Papamichael D, Laurent-Puig P, Penault-Llorca F, Rougier P, Vincenzi B, Santini D, Tonini G, Cappuzzo F, Frattini M, Molinari F, Saletti P, De Dosso S, Martini M, Bardelli A, Siena S, Sartore-Bianchi A, Tabernero J, Macarulla T, Di Fiore F, Gangloff AO, Ciardiello F, Pfeiffer P, Qvortrup C, Hansen TP, Van Cutsem E, Piessevaux H, Lambrechts D, Delorenzi M, Tejpar S. Effects of KRAS, BRAF, NRAS, and PIK3CA mutations on the efficacy of cetuximab plus chemotherapy in chemotherapy-refractory metastatic colorectal cancer: a retrospective consortium analysis. LancetOncol. 2010 Aug;11(8):753-62. PMID: 20619739

42

Douillard JY, Oliner KS, Siena S, Tabernero J, Burkes R, Barugel M, Humblet Y, Bodoky G, Cunningham D, Jassem J, Rivera F, Kocákova I, Ruff P, Błasińska-Morawiec M, Šmakal M, Canon JL, Rother M, Williams R, Rong A, Wiezorek J, Sidhu R, Patterson SD. Panitumumab-FOLFOX4 treatment and RAS mutations incolorectal cancer. N Engl J Med. 2013 Sep 12;369(11):1023-34. PMID: 24024839

43

Seymour MT, Brown SR, Middleton G, Maughan T, Richman S, Gwyther S, Lowe C, Seligmann JF, Wadsley J, Maisey N, Chau I, Hill M, Dawson L, Falk S, O'Callaghan A, Benstead K, Chambers P, Oliver A, Marshall H, Napp V, Quirke P. Panitumumab and irinotecan versus irinotecan alone for patients with KRAS wild-type, fluorouracil- resistant advanced colorectal cancer (PICCOLO): a prospectively stratified randomised trial. Lancet Oncol. 2013 Jul; 14(8):749-59. PMID: 23725851

44

Peeters M, Oliner KS, Parker A, Siena S, Van Cutsem E, Huang J, Humblet Y, Van Laethem JL, André T, Wiezorek J, Reese D, Patterson SD. Massively parallel tumor multigene sequencing to evaluate response to panitumumab in a randomized phase III study of metastatic colorectal cancer. Clin Cancer Res. 2013 Apr 1;19(7):1902-12. doi: 10.1158/1078-0432.CCR-12-1913. Epub 2013 Jan 16. PubMed PMID: 23325582.

45

Bokemeyer C, Van Cutsem E, Rougier P, Ciardiello F, Heeger S, SchlichtingM,Celik I, Köhne CH. Addition of cetuximab to chemotherapy as first-line treatment for KRAS wild-type metastatic colorectal cancer: pooled analysis of the CRYSTAL and OPUS randomised clinical trials. Eur J Cancer. 2012 Jul;48(10):1466-75. PMID: 22446022

46

Tol J, Koopman M, Cats A, Rodenburg CJ, Creemers GJ, Schrama JG, Erdkamp FL, Vos AH, van Groeningen CJ, Sinnige HA, Richel DJ, Voest EE, Dijkstra JR, Vink-Börger ME, Antonini NF, Mol L, van Krieken JH, Dalesio O, Punt CJ.Chemotherapy, bevacizumab, and cetuximab in metastatic colorectal cancer.NEngl J Med. 2009 Feb 5;360(6):563-72. Erratum in: N Engl J Med. 2010 Dec 23;363(26):2573.PMID: 19196673

47

Folprecht G, Gruenberger T, Bechstein WO, Raab HR, Lordick F, Hartmann JT, Lang H, Frilling A, Stoehlmacher J, Weitz J, Konopke R, Stroszczynski C, Liersch T, Ockert D, Herrmann T, Goekkurt E, Parisi F, Köhne CH. Tumour response and secondary resectability of colorectal liver metastases following neoadjuvant chemotherapy with cetuximab: the CELIM randomised phase 2 trial. LancetOncol. 2010 Jan;11(1):38-47. PMID: 19942479

48

Van Cutsem E, Köhne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D'HaensG, Pintér T, Lim R, Bodoky G, Roh JK, Folprecht G, Ruff P, Stroh C, Tejpar S,Schlichting M, Nippgen J, Rougier P. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009 Apr2;360(14):1408-17. PMID: 19339720

49

Van Cutsem E, Köhne CH, Láng I, Folprecht G, Nowacki MP, CascinuS,Shchepotin I, Maurel J, Cunningham D, Tejpar S, Schlichting M, Zubel A, CelikI,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 ClinOncol. 2011 May 20;29(15):2011-9. PMID: 21502544

50

Bokemeyer C, Bondarenko I, Hartmann JT, de Braud F, Schuch G, Zubel A, Celik I, Schlichting M, Koralewski P. Efficacy according to biomarker status of cetuximab plus FOLFOX-4 as first-line treatment for metastatic colorectal cancer: the OPUS study. Ann Oncol. 2011 Jul;22(7):1535-46. PMID: 21228335

51

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, BirkemeyerE,Johnsson A, Starkhammar H, Yilmaz MK, Keldsen N, Erdal AB, Dajani O, Dahl O,ChristoffersenT.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 ClinOncol. 2012 May 20;30(15):1755-62. PMID: 22473155

52

Stintzing S, Junga, Rossius L, Modest DP, Fischer von Weikersthal L and Decker T. Analysis of KRAS/NRAS and BRAF mutations in FIRE-3: a randomized phase III study of FOLFIRI plus cetuximab or bevacizumab as first-line

DROGAS DE ALTO COSTO EN EL TRATAMIENTO DEL CÁNCER COLORRECTAL AVANZADO

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