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Use of minimal residual disease assessment in the treatment of chronic lymphocytic leukemia

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Pages 2777-2785 | Received 27 Feb 2017, Accepted 07 Apr 2017, Published online: 16 May 2017

References

  • Eichhorst B, Robak T, Montserrat E, et al. Chronic lymphocytic leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015;26(Suppl. 5):v78–v84.
  • Goede V, Fischer K, Busch R, et al. Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions. N Engl J Med. 2014;370:1101–1110.
  • National Cancer Institute. SEER stat fact sheets: chronic lymphocytic leukemia [Internet]. 2016. [cited April 18, 2017]. USA: National Cancer Institute. Available from: https://seer.cancer.gov/statfacts/html/clyl.html
  • European Medicines Agency. Guideline on the use of minimal residue disease as an endpoint in chronic lymphocytic leukaemia studies [Internet]. 2014. London, UK: European Medicines Agency. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/12/WC500179047.pdf.
  • Cramer P, Langerbeins P, Eichhorst B, et al. Advances in first-line treatment of chronic lymphocytic leukemia: current recommendations on management and first-line treatment by the German CLL Study Group (GCLLSG). Eur J Haematol. 2016;96:9–18.
  • Thompson PA, Tam CS, O’Brien SM, et al. Fludarabine, cyclophosphamide, and rituximab treatment achieves long-term disease-free survival in IGHV-mutated chronic lymphocytic leukemia. Blood. 2016;127:303–309.
  • Hoffmann-La Roche Limited. PrGAZYVA®. Product Monograph. December 21, 2015. [cited April 18, 2017]. Canada: Government of Canada. Drug Product Database. Available from: https://health-products.canada.ca/dpd-bdpp/index-eng.jsp
  • Lundbeck Canada Inc. PRTreandaR. Product Monograph. 2016. [cited April 18, 2017]. Canada: Government of Canada. Drug Product Database. Available from: https://health-products.canada.ca/dpd-bdpp/index-eng.jsp
  • Janssen Inc. PRImbruvicaR. Product Monograph. 2017. [cited April 18, 2017]. Canada: Government of Canada. Drug Product Database. Available from: https://health-products.canada.ca/dpd-bdpp/index-eng.jsp
  • U.S. Department of Health and Human Services. Guidance for industry clinical trail endpoints for the approval of cancer agents and biologics. 2007. [cited April 18, 2017]. USA: Food and Drug Administration. Available from: https://www.fda.gov/downloads/drugsGuidanceComplianceRegulatoyInformation/Guidance/UCM071590.pdf
  • McCain J. The ongoing evolution of endpoints in oncology. Managed Care. 2010;19(Suppl.1):11.
  • Hallek M, Fischer K, Fingerle-Rowson G, et al. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. Lancet. 2010;376:1164–1174.
  • Fischer K, Bahlo J, Fink AM, et al. Long-term remissions after FCR chemoimmunotherapy in previously untreated patients with CLL: updated results of the CLL8 trial. Blood. 2016;127:208–215.
  • Dimier N, Delmar P, Ward C, et al. A model for predicting effect of treatment on progression-free survival using minimal residual disease as a surrogate endpoint in chronic lymphocytic leukemia. Blood. 2015;126:720.
  • Bosch F, Ferrer A, Villamor N, et al. Fludarabine, cyclophosphamide, and mitoxantrone as initial therapy of chronic lymphocytic leukemia: high response rate and disease eradication. Clin Cancer Res. 2008;14:155–161.
  • Tam CS, O’Brien S, Wierda W, et al. Long-term results of the fludarabine, cyclophosphamide, and rituximab regimen as initial therapy of chronic lymphocytic leukemia. Blood. 2008;112:975–980.
  • Thompson PA, Wierda WG. Eliminating minimal residual disease as a therapeutic end point: working toward cure for patients with CLL. Blood. 2016;127:279–286.
  • Kovacs G, Robrecht S, Fink AM, et al. Minimal residual disease assessment improves prediction of outcome in patients with chronic lymphocytic leukemia (CLL) who achieve partial response: comprehensive analysis of two phase III studies of the German CLL study group. J Clin Oncol. 2016;34:3758–3765.
  • Brown JR, Byrd JC, Coutre SE, et al. Idelalisib, an inhibitor of phosphatidylinositol 3-kinase p110delta, for relapsed/refractory chronic lymphocytic leukemia. Blood. 2014;123:3390–3397.
  • Byrd JC, Brown JR, O’Brien S, et al. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014;371:213–223.
  • Rawstron AC, Fazi C, Agathangelidis A, et al. A complementary role of multiparameter flow cytometry and high-throughput sequencing for minimal residual disease detection in chronic lymphocytic leukemia: an European Research Initiative on CLL study. Leukemia. 2016;30:929–936.
  • Wierda WG. Minimal residual disease provides treatment focus for next chronic lymphocytic leukemia advances. J Clin Oncol 2016;34:3722–3723.
  • Food and Drug Administration. Minimal residual disease (MRD) as a surrogate endpoint in chronic lymphocytic leukemia (CLL) workshop [Internet]. 2013. [cited April 18, 2017]. USA: US Departmetn of Health and Human Services, FDA. Available from: https://www.fda.gov/downloads/drugs/guidances/ucm351261.pdf
  • Food and Drug Administration. Minimal residual disease as a surrogate endpoint in hematologic cancer trials [Internet]. 2016. [cited April 18, 2017]. Duke Margolis center for Health Policy. Available from: https://healthpolicy.duke.edu/events/minimal-residual-disease-surrogate-endpoint-hematologic-cancer-trials
  • Serrati S, De Summa S, Pilato B, et al. Next-generation sequencing: advances and applications in cancer diagnosis. Onco Targets Ther. 2016;9:7355–7365.
  • Avet-Loiseau H. Minimal residual disease by next-generation sequencing: pros and cons. Am Soc Clin Oncol Educ Book. 2016;35:e425–e430.
  • Rawstron AC, Villamor N, Ritgen M, et al. International standardized approach for flow cytometric residual disease monitoring in chronic lymphocytic leukaemia. Leukemia. 2007;21:956–964.
  • Rawstron AC, Böttcher S, Letestu R, et al. Improving efficiency and sensitivity: European Research Initiative in CLL (ERIC) update on the international harmonised approach for flow cytometric residual disease monitoring in CLL. Leukemia. 2013;27:142–149.
  • de Tute RM, Jack AS, Child JA, et al. A single-tube six-colour flow cytometry screening assay for the detection of minimal residual disease in myeloma [letter to the editor]. Leukemia. 2007;21:2046–2049.
  • Logan AC, Zhang B, Narasimhan B, et al. Minimal residual disease quantification using consensus primers and high-throughput IGH sequencing predicts post-transplant relapse in chronic lymphocytic leukemia. Leukemia. 2013;27:1659–1665.
  • Fraser G, Cramer P, Demirkan F, Silva RS, Pylypenko H, Grosicki S. Ibrutinib (I) plus bendamustine and rituximab (BR) in previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): a 2-year follow-up of the HELIOS study. J Clin Oncol. 2016;34(Suppl):abstr 7525.
  • Abrisqueta P, Villamor N, Terol MJ, et al. Rituximab maintenance after first-line therapy with rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) for chronic lymphocytic leukemia. Blood. 2013;122:3951–3959.
  • Strati P, Keating MJ, O’Brien SM, et al. Eradication of bone marrow minimal residual disease may prompt early treatment discontinuation in CLL. Blood. 2014;123:3727–3732.
  • Santacruz R, Villamor N, Aymerich M, et al. The prognostic impact of minimal residual disease in patients with chronic lymphocytic leukemia requiring first-line therapy. Haematologica. 2014;99:873–880.
  • Böttcher S, Ritgen M, Fischer K, et al. Minimal residual disease quantification is an independent predictor of progression-free and overall survival in chronic lymphocytic leukemia: a multivariate analysis from the randomized GCLLSG CLL8 trial. JCO. 2012;30:980–988.
  • Fischer K, Cramer P, Busch R, et al. Bendamustine in combination with rituximab for previously untreated patients with chronic lymphocytic leukemia: a multicenter phase II trial of the German Chronic Lymphocytic Leukemia Study Group. JCO. 2012;30:3209–3216.
  • Pettitt AR, Jackson R, Carruthers S, et al. Alemtuzumab in combination with methylprednisolone is a highly effective induction regimen for patients with chronic lymphocytic leukemia and deletion of TP53: final results of the national cancer research institute CLL206 trial. JCO. 2012;30:1647–1655.
  • Lamanna N, Jurcic JG, Noy A, et al. Sequential therapy with fludarabine, high-dose cyclophosphamide, and rituximab in previously untreated patients with chronic lymphocytic leukemia produces high-quality responses: molecular remissions predict for durable complete responses. JCO. 2009;27:491–497.
  • Maloum K, Settegrana C, Chapiro E, et al. IGHV gene mutational status and LPL/ADAM29 gene expression as clinical outcome predictors in CLL patients in remission following treatment with oral fludarabine plus cyclophosphamide. Ann Hematol. 2009;88:1215–1221.
  • Moreton P, Kennedy B, Lucas G, et al. Eradication of minimal residual disease in B-cell chronic lymphocytic leukemia after alemtuzumab therapy is associated with prolonged survival. JCO. 2005;23:2971–2979.
  • Kwok M, Rawstron AC, Varghese A, et al. Minimal residual disease is an independent predictor for 10-year survival in CLL. Blood. 2016;128:2770–2773.
  • Farren TW, Giustiniani J, Fanous M, et al. Minimal residual disease detection with tumor-specific CD160 correlates with event-free survival in chronic lymphocytic leukemia. Blood Cancer J. 2015;5:e273.
  • van Dongen JJ, van der Velden VH, Brüggemann M, et al. Minimal residual disease diagnostics in acute lymphoblastic leukemia: need for sensitive, fast, and standardized technologies. Blood. 2015;125:3996–4009.
  • Health Quality Ontario. Minimal residual disease evaluation in childhood acute lymphoblastic leukemia: an economic analysis. Ontario Health Technology Assessment Series 2016;16:1–83.
  • Thompson P, Strati P, Keating M, O’Brien SM. Early achievement of MRD-negativity in IGHV-mutated (IGHV-M) patients portends highly favorable outcomes after first-line treatment of CLL with fludarabine, cyclophosphamide and rituximab (FCR). Serial monitoring for minimal residual disease (MRD) in blood after achieving MRD-negativity predicts subsequent clinical relapse. Blood. 2016;128:232.
  • Appleby N, Quinn FM, O’Brien D, et al. Minimal residual disease (MRD) status in FCR-treated CLL patients at the end of treatment influences progression free survival (PFS), results of the Ctrial-IE (ICORG) 07-01/CLL Ireland Study, with mutational analysis providing additional insight. Paper presented at: 58th Annual Meeting & Exposition. American Society of Hematology Meeting; 2016 Dec 3–6; abstract 3237; San Diego, CA.
  • Schweighofer CD, Ritgen M, Eichhorst BF, et al. Consolidation with alemtuzumab improves progression-free survival in patients with chronic lymphocytic leukaemia (CLL) in first remission: long-term follow-up of a randomized phase III trial of the German CLL Study Group (GCLLSG). Br J Haematol. 2009;144:95–98.
  • Varghese AM, Howard DR, Pocock C, et al. Eradication of minimal residual disease improves overall and progression-free survival in patients with chronic lymphocytic leukaemia, evidence from NCRN CLL207: a phase II trial assessing alemtuzumab consolidation. Br J Haematol. 2017;176:573–582.

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