Long‐term safety and efficacy of imatinib mesylate (Gleevec®) in elderly patients with chronic phase chronic myelogenous leukemia: Results of the AFR04 study

Abstract

Data from registries suggest that the median age of chronic myelogenous leukemia (CML) patients is 10–15 years older than that of clinical trials. We conducted a prospective phase II study to evaluate imatinib mesylate (IM, 400 mg daily) in newly diagnosed chronic phase CML (CP‐CML) patients. Patients aged 70 years and over diagnosed with CP‐CML within 12 months were eligible. Thirty patients were enrolled from April 2002 to October 2004. Median age was 74.8 years (range, 70–90). Male/female ratio was 1.72. At inclusion, comorbidities were reported in all but one patient, Cumulative Illness Rating Scale for Geriatrics comorbidity mean index was 1.47, and 66% of patients had cardiovascular disease. The median daily IM dose was 392 mg (range, 256–445). IM was interrupted in patients with severe comorbidities. Treatment discontinuation was observed in 36.6% of patients. Cumulative incidence of complete cytogenetic response was 71.4 and 78.5% at 12 and 24 months, respectively. A high level of sustained responses was observed in patients with mild or moderate comorbidities. Seven‐year estimated overall survival was 80.8% (95% CI: 59.0–91.7). Two‐thirds of the patients were still on long‐term therapy at cut‐off, and no patients had died from progression. This trial was registered at http://www.clinicaltrials.gov as # NCT00219765. Am. J. Hematol. 2013. © 2012 Wiley Periodicals, Inc.

Determinants of survival in patients with chronic myeloid leukaemia treated in the new era of oral therapy: findings from a UK population-based patient cohort

“…This suggests that the much poorer outcome recorded in the USA reflects financial barriers to accessing TKI therapy. Furthermore, our data confirm the inferences from clinical trials that TKI treatment is equally effective at all ages, eliminating the impact of age in traditional prognostic scores 33 34. Indeed, the prospects for most of the patients are excellent, raising questions about the continuing relevance of such scoring systems.…”

Clinical characteristics and therapeutic outcomes of elderly patients with chronic myeloid leukemia: A retrospective multicenter study

“…In the present patient population, the median overall survival and progression‐free survival rates were 35 months (range 1–95 months) and 17 months (range 0.8–95 months), respectively. These results were in concordance with previous studies …”

“…Also, Rousselot et al . stated that imatinib is the choice of treatment for elderly patients with CML . At the same time, second‐generation TKI are currently considered options for first‐line treatment of newly diagnosed patients with CML .…”

Changes in the survival of older patients with hematologic malignancies in the early 21st century

“…However, despite evidence showing that newer medications are well tolerated and effective in older patients with a number of hematologic malignancies, population‐level survival has not improved as might be expected . In particular, survival for older patients with chronic myelocytic leukemia (CML) has lagged behind survival in clinical trials despite evidence showing that tyrosine kinase inhibitors (TKIs) are tolerable for older patients and provide benefits to these patients, although higher doses may be required for the full benefit to be seen . Researchers in Sweden found lower rates of prescription of TKIs for older patients, especially those who were 80 years old or older, in that country, and this suggests either the undertreatment or inability of relatively large numbers of real‐world patients to tolerate therapy.…”