| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 5883021 | Clinical Lymphoma Myeloma and Leukemia | 2013 | 7 Pages |
IntroductionOutcomes of CML-CP patients treated in clinical trials are frequently perceived to be not representative of those treated outside of clinical trials.Patients and MethodsWe investigated the outcomes of patients receiving imatinib outside of a clinical trial (off protocol) or in a clinical trial (on protocol) for CML-CP.ResultsWe identified 65 patients treated with imatinib off protocol and 71 patients treated on protocol with standard-dose imatinib. The overall complete cytogenetic response (CCyR) rate was 83% for patients treated on and off protocol. CCyR rates 12 months after initiation of imatinib were not statistically different (61% vs. 66%, respectively; PÂ = .15). Patients treated off protocol had similar rates of overall major molecular response (72% vs. 73%) compared with the patients treated on protocol. The 5-year event-free survival rates were 84% and 86% for off and on protocol patients, respectively. There was also no significant difference in 5-year transformation free survival (94% vs. 96%) and overall survival (96% vs. 90%).ConclusionThese results suggest that patients with CML treated outside of a clinical trial might have the same excellent outcome as those treated in a clinical trial provided they are followed with the same rigor.
