Chronic Myeloid Leukemia (CML)
Conditions
Keywords
second primary malignancies, imatinib
Brief summary
Imatinib is a tyrosine kinase inhibitor that has improved the prognosis of patients with chronic myeloid leukemia (CML). CML has become a chronic disease requiring long-term administration of imatinib. Late adverse effects were initially unknown. Since 2005, imatinib has been suspected to increase the risk of second primary malignancies (SPM). Through the French STI571 Prospective Randomized Trial (SPIRIT), we studied the incidence of SPM after more than 20 years of exposure, and treatment strategies for CML and SPM at their occurrence.
Interventions
Imatinib-based regimen
Sponsors
Poitiers University Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Included in the French SPIRIT trial
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk of second primary malignancies (SPM) | Through study completion, an average of 20 years | SPM is an invasive primary cancer diagnosed at least 6 months after CML diagnosis. Non-melanoma skin cancers were excluded from the analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment strategies for CML and SPM at their occurrence | At the occurence of SPM. Through study completion, on average 20 years | For treatment strategy of CML: response, modification of treatment (temporary discontinuation, permanent interruption, replace by a new generation TKI), relapse. For treatment strategy of SPM: intent of treatment (curative, palliative, follow without treatment), type of treatment (surgery, radiotherapy, chemotherapy, targeted therapy), atypical adverses events, modification of treatment. |
Countries
France
Outcome results
None listed