ASSESSMENT OF MAJOR MOLECULAR RESPONSE (MMR) AND COMPLETE CYTOGENETIC RESPONSE (CCYR) AS SURROGATE OUTCOMES OF SURVIVAL IN CHRONIC MYELOID LEUKEMIA CHRONIC PHASE (CML-CP) PATIENTS

Author(s)

Kwon H, Park J, Shin M, Shin S
National Evidence based Health-care Collaborating Agency, Seoul, South Korea

OBJECTIVES: This study aims to investigate the association of the major molecular response (MMR) and complete cytogenetic response (CCyR) as surrogate outcomes with overall survival (OS) and progression free survival (PFS) in chronic phase of chronic myeloid leukemia (CML-CP) patients using evidence from observational or experimental study. METHODS: We conducted using existing systematic reviews and meta-analysis to quantify the association between CCyR and/or MMR at 12 months and OS and/or PFS. The overall survival rate or progression free survival rate according to the responders or non-responders of MMR or CCyR at 12 months after the initiation of first-line TKI therapy (imatinib, dasatinib or nilotinib) was extracted by two independent reviewers. A weighted average of the OS and PFS at different yearly intervals was estimated respectively for both the responders and non-responders with assumption of no censoring. The analyses were carried out using R package “metafor”. RESULTS: Eleven studies provided data on the association between CCyR or MMR and OS or PFS after imatinib treatment however there were no such studies about dasatinib or nilotinib treatment. Patients who experience CCyR following 12 months’ TKI therapy have better long-term (7 –year) OS and PFS (OS 97.0% vs 82.5; PFS 97.0% vs 69.6%) than patients who are non-responders at 12 months. Patients who experience MMR at 12 months’ TKI therapy have better long-term (5-year) OS and PFS (OS 99.4% vs 93.4%; PFS: 89.9% vs 85.3%). CONCLUSIONS: This study identified evidence of the association between CCyR and/or MMR and survival among the TKI treated CML-CP patients, and this is based entirely on imatinib treatment studies. The evidence of dasatinib and nilotinib is limited by the amount and quality of data available. Therefore further research is needed whether this relationship between the surrogate outcomes and final outcomes are equally applicable to dasatinib and nilotinib.

Conference/Value in Health Info

2015-11, ISPOR Europe 2015, Milan, Italy

Value in Health, Vol. 18, No. 7 (November 2015)

Code

PCN18

Topic

Clinical Outcomes

Topic Subcategory

Comparative Effectiveness or Efficacy

Disease

Oncology, Systemic Disorders/Conditions

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