TABLE 5Details of interventions: RCTs

StudyArm no.DrugDosage notesNotes
Kantarjian et al. (2007)231Dasatinib70 mg b.i.d.

Escalated to 180 mg b.i.d for participants with inadequate response at 12 weeks or progression

Reduced to 100 mg or 80 mg b.i.d for participants experiencing toxicity
Crossover to the alternative treatment was permitted after confirmed progression, lack of MCyR at the week 12 cytogenetic evaluation or intolerance

This is study 017 in the BMS submission184 to NICE
2Imatinib400 mg b.i.d.

Reduction to 600 mg b.i.d was permitted for toxicity in participants who had not previously received 600 mg b.i.d imatinib
Shah et al. (2008)221Dasatinib100 mg q.d.

Escalation to 140 mg q.d. allowed for suboptimal response

Reduction to 80 mg q.d. allowed for toxicity
This is study 034 in the BMS submission184 to NICE
2Dasatinib50 mg b.i.d.

Escalation to 70 mg b.i.d. allowed for suboptimal response

Reduction to 40 mg b.i.d. allowed for toxicity
3Dasatinib140 mg q.d.

Escalation to 180 mg q.d. allowed for suboptimal response

Reduction to 80 mg q.d. allowed for toxicity
4Dasatinib70 mg b.i.d.

Escalation to 90 mg b.i.d. allowed for suboptimal response

Reduction to 40 mg b.i.d. allowed for toxicity
Kantarjian et al. (2009)811Dasatinib140 mg q.d.

Escalation to 180 mg q.d. was allowed for inadequate response (rising percentage of blasts or loss of HR in two consecutive assessments at least 1 week apart; absence of CHR, NEL, or minor HR within 4 weeks; no MCyR after 3 months or no CCyR after 6 months)

Interruption or reduction to 80 mg q.d. was allowed in cases of drug toxicity (grade 2 or greater, non-haematological toxicity considered related to dasatinib; ANC 0.5 × 109/l and/or platelets < 100 × 109/l for > 6 weeks with BM cellularity < 10% with blasts < 5% or BM cellularity > 10% with blasts > 5%; or febrile neutropenia with signs of septicaemia)
This is study 035 in the BMS submission184 to NICE
2Dasatinib70 mg b.i.d.

Escalation to 90 mg b.i.d. or reduction to 40 mg b.i.d. permitted; criteria as per arm 1

NEL, no evidence of leukaemia.

From: 2, Assessment of clinical effectiveness

Cover of Dasatinib and Nilotinib for Imatinib-Resistant or -Intolerant Chronic Myeloid Leukaemia: A Systematic Review and Economic Evaluation
Dasatinib and Nilotinib for Imatinib-Resistant or -Intolerant Chronic Myeloid Leukaemia: A Systematic Review and Economic Evaluation.
Health Technology Assessment, No. 16.22.
Rogers G, Hoyle M, Thompson Coon J, et al.
Southampton (UK): NIHR Journals Library; 2012 Apr.
© 2012, Crown Copyright.

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