Induction chemotherapy, chemoradiotherapy and consolidation chemotherapy in preoperative treatment of rectal cancer - long-term results of phase II OIGIT-01 Trial
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.
Breugom AJ, Swets M, Bosset JF, Collette L, Sainato A, Cionini L, et al. Adjuvant chemotherapy after preoperative (chemo)radiotherapy and surgery for patients with rectal cancer: a systematic review and meta-analysis of individual patient data. Lancet Oncol 2015; 16: 200-7. 10.1016/S1470-2045(14)71199-4BreugomAJSwetsMBossetJFColletteLSainatoACioniniLAdjuvant chemotherapy after preoperative (chemo)radiotherapy and surgery for patients with rectal cancer: a systematic review and meta-analysis of individual patient dataLancet Oncol201516200710.1016/S1470-2045(14)71199-4Open DOISearch in Google Scholar
Martin ST, Heneghan HM, Winter DC. Systematic review and meta-analysis of outcomes following pathological complete response to neoadjuvant chemoradiotherapy for rectal cancer. Br J Surg 2012; 99: 918-28. 10.1002/bjs.8702MartinSTHeneghanHMWinterDC.Systematic review and meta-analysis of outcomes following pathological complete response to neoadjuvant chemoradiotherapy for rectal cancerBr J Surg2012999182810.1002/bjs.870222362002Open DOISearch in Google Scholar
Zorcolo L, Rosman AS, Restivo A, Pisano M, Nigri GR, Fancellu A, et al. Complete pathologic response after combined modality treatment for rectal cancer and long-term survival: a meta-analysis. Ann Surg Oncol 2012; 19: 2822-32. 10.1245/s10434-011-2209-yZorcoloLRosmanASRestivoAPisanoMNigriGRFancelluAComplete pathologic response after combined modality treatment for rectal cancer and long-term survival: a meta-analysisAnn Surg Oncol20121928223210.1245/s10434-011-2209-y22434243Open DOISearch in Google Scholar
Velenik V, Anderluh F, Oblak I, Strojan P, Zakotnik B. Capecitabine as a radiosensitizing agent in neoadjuvant treatment of locally advanced resectable rectal cancer: prospective phase II trial. Croat Med J 2006; 47: 693-700.VelenikVAnderluhFOblakIStrojanPZakotnikB.Capecitabine as a radiosensitizing agent in neoadjuvant treatment of locally advanced resectable rectal cancer: prospective phase II trialCroat Med J200647693700Search in Google Scholar
Gérard JP, Azria D, Gourgou-Bourgade S, Martel-Lafay I, Hennequin C, Etienne PL, et al. Clinical outcome of the ACCORD 12/0405 PRODIGE 2 randomized trial in rectal cancer. J Clin Oncol 2012; 30: 4558-65. 10.1200/JCO.2012.42.8771GérardJPAzriaDGourgou-BourgadeSMartel-LafayIHennequinCEtiennePLClinical outcome of the ACCORD 12/0405 PRODIGE 2 randomized trial in rectal cancerJ Clin Oncol20123045586510.1200/JCO.2012.42.877123109696Open DOISearch in Google Scholar
Aschele C, Cionini L, Lonardi S, Pinto C, Cordio S, Rosati G, et al. Primary tumor response to preoperative chemoradiation with or without oxaliplatin in locally advanced rectal cancer: pathologic results of the STAR-01 Randomized Phase III Trial. J Clin Oncol 2011; 29: 2773-80. 10.1200/JCO.2010.34.4911AscheleCCioniniLLonardiSPintoCCordioSRosatiGPrimary tumor response to preoperative chemoradiation with or without oxaliplatin in locally advanced rectal cancer: pathologic results of the STAR-01 Randomized Phase III TrialJ Clin Oncol20112927738010.1200/JCO.2010.34.491121606427Open DOISearch in Google Scholar
Edge SB, Compton CC. The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual and the future of TNM. Ann SurgOncol 2010; 17: 1471-4. 10.1245/s10434-010-09854EdgeSBComptonCC.The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual and the future of TNMAnn Surg Oncol2010171471410.1245/s10434-010-09854Open DOISearch in Google Scholar
National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) Common terminology criteria for adverse events v4.0 (CTCAE). Publish 2009; 2009: 0-71. Available at https://www.eortc.be/services/doc/ctc/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdfNational Cancer InstituteCommon Terminology Criteria for Adverse Events (CTCAE) Common terminology criteria for adverse events v4.0 (CTCAE).Publish20092009071Available athttps://www.eortc.be/services/doc/ctc/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdfSearch in Google Scholar
Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982; 5: 649-56.OkenMMCreechRHTormeyDCHortonJDavisTEMcFaddenETToxicity and response criteria of the Eastern Cooperative Oncology GroupAm J Clin Oncol198256495610.1097/00000421-198212000-00014Search in Google Scholar
Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics 1982; 38: 143-51.FlemingTR.One-sample multiple testing procedure for phase II clinical trialsBiometrics1982381435110.2307/2530297Search in Google Scholar
A’Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med 2001; 20: 859-66. 10.1002/sim.721A’HernRP.Sample size tables for exact single-stage phase II designsStat Med2001208596610.1002/sim.72111252008Open DOISearch in Google Scholar
Velenik V, Oblak I, Anderluh F. Long-term results from a randomized phase II trial of neoadjuvant combined-modality therapy for locally advanced rectal cancer. Radiat Oncol 2010; 5: 88. 10.1186/1748-717X-5-88VelenikVOblakIAnderluhF.Long-term results from a randomized phase II trial of neoadjuvant combined-modality therapy for locally advanced rectal cancerRadiat Oncol201058810.1186/1748-717X-5-88295559420920276Open DOISearch in Google Scholar
Fernández-Martos C, Pericay C, Aparicio J, Salud A, Safont M, Massuti B, et al. Phase II, randomized study of concomitant chemoradiotherapy followed by surgery and adjuvant capecitabine plus oxaliplatin (CAPOX) compared with induction CAPOX followed by concomitant chemoradiotherapy and surgery in magnetic resonance imaging-defined, locally advanced rectal cancer: Grupo cancer de recto 3 study. J Clin Oncol 2010; 28: 859-65. 10.1200/JCO.2009.25.8541Fernández-MartosCPericayCAparicioJSaludASafontMMassutiBPhaseIIrandomized study of concomitant chemoradiotherapy followed by surgery and adjuvant capecitabine plus oxaliplatin (CAPOX) compared with induction CAPOX followed by concomitant chemoradiotherapy and surgery in magnetic resonance imaging-defined, locally advanced rectal cancer: Grupo cancer de recto 3 studyJ Clin Oncol2010288596510.1200/JCO.2009.25.854120065174Open DOISearch in Google Scholar
Marechal R, Vos B, Polus M, Delaunoit T, Peeters M, Demetter P, et al. Short course chemotherapy followed by concomitant chemoradiotherapy and surgery in locally advanced rectal cancer: a randomized multicentric phase II study. Ann Oncol 2012; 23: 1525-30. 10.1093/annonc/mdr473MarechalRVosBPolusMDelaunoitTPeetersMDemetterPShort course chemotherapy followed by concomitant chemoradiotherapy and surgery in locally advanced rectal cancer: a randomized multicentric phase II studyAnn Oncol20122315253010.1093/annonc/mdr47322039087Open DOISearch in Google Scholar
Dewdney A, Cunningham D, Tabernero J, Capdevila J, Glimelius B, Cervantes A, et al. Multicenter randomized phase II clinical trial comparing neoadjuvant oxaliplatin, capecitabine, and preoperative radiotherapy with or without cetuximab followed by total mesorectal excision in patients with high-risk rectal cancer (EXPERT-C). J Clin Oncol 2012; 30: 1620-7. 10.1200/JCO.2011.39.6036DewdneyACunninghamDTaberneroJCapdevilaJGlimeliusBCervantesAMulticenter randomized phase II clinical trial comparing neoadjuvant oxaliplatin, capecitabine, and preoperative radiotherapy with or without cetuximab followed by total mesorectal excision in patients with high-risk rectal cancer (EXPERT-C)J Clin Oncol2012301620710.1200/JCO.2011.39.603622473163Open DOISearch in Google Scholar
Sclafani F, Peckitt C, Cunningham D, Tait D, Giralt J, Glimelius B, et al. Short- and long-term quality of life and bowel function in patients with MRI-defined, high-risk, locally advanced rectal cancer treated with an intensified neoadjuvant strategy in the randomized phase 2 EXPERT-C Trial. Int J RadiatOncol 2015; 93: 303-12. 10.1016/j.ijrobp.2015.03.038SclafaniFPeckittCCunninghamDTaitDGiraltJGlimeliusBShort- and long-term quality of life and bowel function in patients with MRI-defined, high-risk, locally advanced rectal cancer treated with an intensified neoadjuvant strategy in the randomized phase 2 EXPERT-C TrialInt J Radiat Oncol2015933031210.1016/j.ijrobp.2015.03.03826031368Open DOISearch in Google Scholar
Sclafani F, Brown G, Cunningham D, Wotherspoon A, Tait D, Peckitt C, et al. PAN-EX: a pooled analysis of two trials of neoadjuvant chemotherapy followed by chemoradiotherapy in MRI-defined, locally advanced rectal cancer. Ann Oncol 2016; 27: 1557-65. 10.1093/annonc/mdw215SclafaniFBrownGCunninghamDWotherspoonATaitDPeckittCPAN-EX: a pooled analysis of two trials of neoadjuvant chemotherapy followed by chemoradiotherapy in MRI-defined, locally advanced rectal cancerAnn Oncol20162715576510.1093/annonc/mdw21527217542Open DOISearch in Google Scholar
Teo MTW, McParland L, Appelt AL, Sebag-Montefiore D. Phase 2 neoadjuvant treatment intensification trials in rectal cancer: a systematic review. Int J Radiat Oncol 2018; 100: 146-58. 10.1016/j.ijrobp.2017.09.042TeoMTWMcParlandLAppeltALSebag-Montefiore D. Phase 2 neoadjuvant treatment intensification trials in rectal cancer: a systematic reviewInt J Radiat Oncol20181001465810.1016/j.ijrobp.2017.09.04229254769Open DOISearch in Google Scholar
Fokas E, Liersch T, Fietkau R, Hohenberger W, Beissbarth T, Hess C, et al. Tumor regression grading after preoperative chemoradiotherapy for locally advanced rectal carcinoma revisited: updated results of the CAO/ARO/AIO-94 trial. J Clin Oncol 2014; 32: 1554-62. 10.1200/JCO.2013.54.3769FokasELierschTFietkauRHohenbergerWBeissbarthTHessCTumor regression grading after preoperative chemoradiotherapy for locally advanced rectal carcinoma revisited: updated results of the CAO/ARO/AIO-94 trialJ Clin Oncol20143215546210.1200/JCO.2013.54.376924752056Open DOISearch in Google Scholar
Biagi JJ, Raphael MJ, Mackillop WJ, Kong W, King WD, Booth CM. Association between time to initiation of adjuvant chemotherapy and survival in colorectal cancer. JAMA 2011; 305: 2335. 10.1001/jama.2011.749BiagiJJRaphaelMJMackillopWJKongWKingWDBoothCM.Association between time to initiation of adjuvant chemotherapy and survival in colorectal cancerJAMA2011305233510.1001/jama.2011.74921642686Open DOISearch in Google Scholar
Bosset JF, Collette L, Calais G, Mineur L, Maingon P, Radosevic-Jelic L, et al. Chemotherapy with preoperative radiotherapy in rectal cancer. N Engl J Med 2006; 355: 1114-23. 10.1056/NEJMoa060829BossetJFColletteLCalaisGMineurLMaingonPRadosevic-JelicLChemotherapy with preoperative radiotherapy in rectal cancerN Engl J Med200635511142310.1056/NEJMoa06082916971718Open DOISearch in Google Scholar
Perez K, Safran H, Sikov W, Vrees M, Klipfel A, Shah N, et al. Complete neoadjuvant treatment for rectal cancer: the Brown University Oncology Group CONTRE Study. Am J Clin Oncol 2017; 40: 283-7. 10.1097/COC.0000000000000149PerezKSafranHSikovWVreesMKlipfelAShahNComplete neoadjuvant treatment for rectal cancer: the Brown University Oncology Group CONTRE StudyAm J Clin Oncol201740283710.1097/COC.000000000000014925374145Open DOISearch in Google Scholar
Nogue M, Salud A, Vicente P, Arrivi A, Roca JM, Losa F, et al. Addition of bevacizumab to XELOX induction therapy plus concomitant capecitabine-based chemoradiotherapy in magnetic resonance imaging-defined poor-prognosis locally advanced rectal cancer: the AVACROSS Study. Oncologist 2011; 16: 614-20. 10.1634/theoncologist.2010-0285NogueMSaludAVicentePArriviARocaJMLosaFAddition of bevacizumab to XELOX induction therapy plus concomitant capecitabine-based chemoradiotherapy in magnetic resonance imaging-defined poor-prognosis locally advanced rectal cancer: the AVACROSS StudyOncologist2011166142010.1634/theoncologist.2010-0285322819821467148Open DOISearch in Google Scholar
O’Connell MJ, Colangelo LH, Beart RW, Petrelli NJ, Allegra CJ, Sharif S, et al. Capecitabine and oxaliplatin in the preoperative multimodality treatment of rectal cancer: surgical end points from National Surgical Adjuvant Breast and Bowel Project trial R-04. J Clin Oncol 2014; 32: 1927-34. 10.1200/JCO.2013.53.7753O’ConnellMJColangeloLHBeartRWPetrelliNJAllegraCJSharifSCapecitabine and oxaliplatin in the preoperative multimodality treatment of rectal cancer: surgical end points from National Surgical Adjuvant Breast and Bowel Project trial R-04J Clin Oncol20143219273410.1200/JCO.2013.53.7753405020524799484Open DOISearch in Google Scholar
Schou J V, Larsen FO, Rasch L, Linnemann D, Langhoff J, Høgdall E, et al. Induction chemotherapy with capecitabine and oxaliplatin followed by chemoradiotherapy before total mesorectal excision in patients with locally advanced rectal cancer. Ann Oncol 2012; 23: 2627-33. 10.1093/annonc/mds056SchouJ VLarsenFORaschLLinnemannDLanghoffJHøgdallEInduction chemotherapy with capecitabine and oxaliplatin followed by chemoradiotherapy before total mesorectal excision in patients with locally advanced rectal cancerAnn Oncol20122326273310.1093/annonc/mds05622473488Open DOISearch in Google Scholar
Fernandez-Martos C, Garcia-Albeniz X, Pericay C, Maurel J, Aparicio J, Montagut C, et al. Chemoradiation, surgery and adjuvant chemotherapy versus induction chemotherapy followed by chemoradiation and surgery: long-term results of the Spanish GCR-3 phase II randomized trial. Ann Oncol 2015; 26: 1722–8. 10.1093/annonc/mdv223Fernandez-MartosCGarcia-AlbenizXPericayCMaurelJAparicioJMontagutCChemoradiation, surgery and adjuvant chemotherapy versus induction chemotherapy followed by chemoradiation and surgery: long-term results of the Spanish GCR-3 phase II randomized trialAnn Oncol2015261722810.1093/annonc/mdv22325957330Open DOISearch in Google Scholar
Zampino MG, Magni E, Leonardi MC, Petazzi E, Santoro L, Luca F, et al. Capecitabine initially concomitant to radiotherapy then perioperatively administered in locally advanced rectal cancer. Int J Radiat Oncol Biol Phys 2009; 75: 421-7. 10.1016/j.ijrobp.2008.11.002ZampinoMGMagniELeonardiMCPetazziESantoroLLucaFCapecitabine initially concomitant to radiotherapy then perioperatively administered in locally advanced rectal cancerInt J Radiat Oncol Biol Phys200975421710.1016/j.ijrobp.2008.11.00219211200Open DOISearch in Google Scholar
