Dasatinib or high-dose imatinib for patients with chronic myelogenous leukemia chronic-phase (CML-CP) resistant to standard- dose imatinib: 2-year follow-up data from START-R

Rousselot, P. H.; Facon, T.; Paquette, Ronald; Bleickardt, Eric; Dejardin, David; Kantarjian, Hagop

doi:10.1200/jco.2008.26.15_suppl.7012

Cited by 19 publications

(16 citation statements)

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“…27,28 The MCyR and CCyR rates were consistent whether or not the Ph-negative, BCR-ABL-positive patients were included in the analysis. In this phase 3 study, the inclusion criteria encompassed imatinib-resistant and -intolerant patients, as well as suboptimal responders as defined by the European LeukemiaNet criteria.…”

Section: Discussionmentioning

confidence: 95%

Potent, transient inhibition of BCR-ABL with dasatinib 100 mg daily achieves rapid and durable cytogenetic responses and high transformation-free survival rates in chronic phase chronic myeloid leukemia patients with resistance, suboptimal response or intolerance to imatinib

Shah¹,

Kim²,

Kantarjian³

et al. 2010

Haematologica

220

181

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The online version of this article has a supplementary appendix. BackgroundDasatinib 100 mg once daily achieves intermittent BCR-ABL kinase inhibition and is approved for chronic-phase chronic myeloid leukemia patients resistant or intolerant to imatinib. To better assess durability of response to and tolerability of dasatinib, data from a 2-year minimum follow-up for a dose-optimization study in chronic-phase chronic myeloid leukemia are reported here. Design and MethodsIn a phase 3 study, 670 chronic-phase chronic myeloid leukemia patients with resistance, intolerance, or suboptimal response to imatinib were randomized to dasatinib 100 mg once-daily, 50 mg twice-daily, 140 mg once-daily, or 70 mg twice-daily. ResultsData from a 2-year minimum follow-up demonstrate that dasatinib 100 mg once daily achieves major cytogenetic response and complete cytogenetic response rates comparable to those in the other treatment arms, and reduces the frequency of key side effects. Comparable 2-year progression-free survival and overall survival rates were observed (80% and 91%, respectively, for 100 mg once daily, and 75%-76% and 88%-94%, respectively, in other arms). Complete cytogenetic responses were achieved rapidly, typically by 6 months. In patients treated with dasatinib 100 mg once daily for 6 months without complete cytogenetic response, the likelihood of achieving such a response by 2 years was 50% for patients who had achieved a partial cytogenetic response, and only 8% or less for patients with minor, minimal, or no cytogenetic response. Less than 3% of patients suffered disease transformation to accelerated or blast phase. ConclusionsIntermittent kinase inhibition can achieve rapid and durable responses, indistinguishable from those achieved with more continuous inhibition. Clintrials.gov identifier: NCT00123474.Key words: chronic myeloid leukemia, chronic phase, dasatinib, cytogenetic response, inhibition. Haematologica. 2010; 95:232-240. doi:10.3324/haematol.2009 Citation

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Section: Discussionmentioning

confidence: 95%

Potent, transient inhibition of BCR-ABL with dasatinib 100 mg daily achieves rapid and durable cytogenetic responses and high transformation-free survival rates in chronic phase chronic myeloid leukemia patients with resistance, suboptimal response or intolerance to imatinib

Shah¹,

Kim²,

Kantarjian³

et al. 2010

Haematologica

220

181

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“…[12][13][14]28 Among IRIS patients who achieved an MMR within 12 months, 100% were free from disease progression and loss of complete hematologic response or major cytogenetic response at 24 months, compared with 95% who achieved a CCyR but no MMR (P ¼ 0.007), and 85% who achieved no CCyR (P ¼ 0.013). 11 In addition, 100% of patients with an MMR at 18 months remained free from transformation to acceleratedphase or blast-phase CML at 60 months, compared with 98% of those who achieved a CCyR but no MMR (P ¼ 0.11), and 87% who achieved no CCyR (Po0.001). 12 The results of the landmark analyses presented here show that in patients treated with dasatinib after imatinib failure, MMR or CCyR achieved within 12 months of dasatinib treatment is predictive for favorable outcome.…”

Section: Discussionmentioning

confidence: 96%

Dasatinib-associated major molecular responses in patients with chronic myeloid leukemia in chronic phase following imatinib failure: response dynamics and predictive value

et al. 2009

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“…Finally, Cortes et al 's retrospective cohort study 38 features some participants in CML-AP, although the dosage at which they took dasatinib is not reported. 23 Shah et al 82 Shah et al 83 Cannell (2007) 84 Kantarjian et al 85 Martinelli et al 86 Schiffer (2007) 87 Rousselot et al 88 Rousselot et al 22 Hochhaus et al 90 Hochhaus et al 91 Shah et al 92 Hochhaus et al 93 Hochhaus et al 94 Nicaise et al 95 Porkka et al 96 Shah et al 97 Wang et al 81 Kantarjian et al 99 Pasquini et al 100 Kantarjian et al 101 Saglio et al No treatment for CML other than dasatinib was permitted during the study -except anagrelide and hydroxycarbamide for treatment of elevated platelet counts (higher than 700 × 10 9 /l) and WBC counts (higher than 50 × 10 9 /l), respectively. Use of hydroxycarbamide was limited to a period of 2 weeks.…”

Section: Papers Screenedmentioning

confidence: 99%

Dasatinib and nilotinib for imatinib-resistant or -intolerant chronic myeloid leukaemia: a systematic review and economic evaluation.

Rogers

Hoyle²,

Coon³

et al. 2012

Health Technol Assess

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How to obtain copies of this and other HTA programme reports An electronic version of this title, in Adobe Acrobat format, is available for downloading free of charge for personal use from the HTA website (www.hta.ac.uk). A fully searchable DVD is also available (see below).Printed copies of HTA journal series issues cost £20 each (post and packing free in the UK) to both public and private sector purchasers from our despatch agents.Non-UK purchasers will have to pay a small fee for post and packing. For European countries the cost is £2 per issue and for the rest of the world £3 per issue. How to order:-fax (with credit card details) -post (with credit card details or cheque) -phone during office hours (credit card only).Additionally the HTA website allows you to either print out your order or download a blank order form. Contact details are as follows:Synergie UK (HTA Department) Digital House, The Loddon Centre Wade Road Basingstoke Hants RG24 8QW Email: orders@hta.ac.uk Tel: 0845 812 4000 -ask for 'HTA Payment Services' (out-of-hours answer-phone service) Fax: 0845 812 4001 -put 'HTA Order' on the fax header Payment methods Paying by chequeIf you pay by cheque, the cheque must be in pounds sterling, made payable to University of Southampton and drawn on a bank with a UK address.Paying by credit card You can order using your credit card by phone, fax or post. SubscriptionsNHS libraries can subscribe free of charge. Public libraries can subscribe at a reduced cost of £100 for each volume (normally comprising 40-50 titles). The commercial subscription rate is £400 per volume (addresses within the UK) and £600 per volume (addresses outside the UK). Please see our website for details. Subscriptions can be purchased only for the current or forthcoming volume.How do I get a copy of HTA on DVD?Please use the form on the HTA website (www.hta.ac.uk/htacd/index.shtml). HTA on DVD is currently free of charge worldwide.The website also provides information about the HTA programme and lists the membership of the various committees. HTADasatinib and nilotinib for imatinib-resistant or -intolerant chronic myeloid leukaemia: a systematic review and economic evaluation NIHR Health Technology Assessment programmeThe Health Technology Assessment (HTA) programme, part of the National Institute for Health Research (NIHR), was set up in 1993. It produces high-quality research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS. 'Health technologies' are broadly defined as all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care. The research findings from the HTA programme directly influence decision-making bodies such as the National Institute for Health and Clinical Excellence (NICE) and the National Screening Committee (NSC). HTA findings also help to improve the quality of clinical practice in the NHS indirectly in that they form a key component of the 'National Knowledge Service' . Th...

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Dasatinib or high-dose imatinib for patients with chronic myelogenous leukemia chronic-phase (CML-CP) resistant to standard- dose imatinib: 2-year follow-up data from START-R

Cited by 19 publications

References 0 publications

Potent, transient inhibition of BCR-ABL with dasatinib 100 mg daily achieves rapid and durable cytogenetic responses and high transformation-free survival rates in chronic phase chronic myeloid leukemia patients with resistance, suboptimal response or intolerance to imatinib

Potent, transient inhibition of BCR-ABL with dasatinib 100 mg daily achieves rapid and durable cytogenetic responses and high transformation-free survival rates in chronic phase chronic myeloid leukemia patients with resistance, suboptimal response or intolerance to imatinib

Dasatinib-associated major molecular responses in patients with chronic myeloid leukemia in chronic phase following imatinib failure: response dynamics and predictive value

Dasatinib and nilotinib for imatinib-resistant or -intolerant chronic myeloid leukaemia: a systematic review and economic evaluation.

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