Cellular Biotechnologies and Hematology
Contributions
Type: Publication Only
Background
Dasatinib has been recently licensed for first line treatment of patients with chronic myeloid leukemia (CML). However, very few data are available as to toxicity and efficacy of dasatinib in unselected elderly CML patients.
Aims
To address this issue, we revised a “real-life” cohort of 54 CML patients in chronic phase aged > 65 years treated with frontline dasatinib in 24 Italian Centers from 6/2012 to 12/2014 focusing on toxicity and efficacy data.
Methods
The main clinical features of the patients at diagnosis were as follows: M/F 27/27, median age 75.4 years [interquartile range (IQR) 70.6 – 79.5), median Hb 12.3 g/dl (IQR 11.1 – 13.6), median WBC 51.5 x 109/l (IQR 28.1 – 100.0), median PLTS 430 x 109/l (IQR 233 – 770). According to Sokal risk classification, 2 patients (3.7%) were low risk, 32 (59.3%) intermediate risk, 15 (27.8%) high risk while 5 (9.2%) were not classificable. 30/54 patients (55.5%) had ≥ 2 comorbidities requiring concomitant therapies: according to ECOG scale, performance status at baseline was 0 – 1 in 46 patients (85.1%) and 2 in 8 patients (14.9%).
Results
Median interval from diagnosis to dasatinib start was 23 days (IQR 14 – 35). Dasatinib starting dose was 140 mg/day in 1 patient (1.8%), 100 mg/day in 40 patients (74.1%) and < 100 mg/day in 13 patients (24.1%), respectively. After a median period of treatment of 13.7 months (IQR 6.4 – 20,6) all patients were evaluable for toxicity; on the whole, grade 3 – 4 hematological and extra-hematological toxicities were reported in 5 (9.2%) and 9 (16.6%) patients, respectively. Overall, 9 patients (16.6%) permanently discontinued dasatinib due to toxicity (2 patients in the first 3-month period of treatment and 7 beyond that period). Pleural effusions of all WHO grades occurred in 10 patients (18.5%): in 4 of them the pleural effusion occurred during the first 3-month period of treatment. As to treatment efficacy, 5 patients were considered too early to be evaluated (< 3 months of treatment) and 49 were evaluable for cumulative response; on the whole, 45/49 patients (91.8%) achieved complete cytogenetic response (CCyR) and 33/49 (67.3%) also a major molecular response (MMolR). Response to treatment at different time-points is shown on Table.
| 3rd month | 6th month | 12th month |
Not evaluable: | 12 5 7 | 15 6 9 | 16 16 0 |
Evaluable | 42 | 39 | 38 |
Discontinuation | 2 (4.7%) | 4 (10.2%) | 7 (18.4%) |
Less than CCyR | 6 (14,3%) | 2 (5.1%) | 2 (5.2%) |
CCyR only | 21 (50.0%) | 10 (25.7%) | 9 (23.6%) |
MMolR | 13 (31.0%) | 23 (59.0%) | 20 (52.6%) |
After a median period of observation from dasatinib initiation of 15,5 months (IQR 9.2 – 24.7), only 1 patient died from unrelated cause (senectus) while in MMolR: cumulative event-free survival (EFS) at 12 months was 82.4% (95%CI 71.3 – 93.5).
Summary
Present data shows that dasatinib could have a major role in the treatment of unselected patients aged > 65 years; indeed, dasatinib seems very effective and has a favourable safety profile also in elderly subjects with comorbidities.
Keyword(s): Chronic myeloid leukemia, Elderly
Session topic: Publication Only
Type: Publication Only
Background
Dasatinib has been recently licensed for first line treatment of patients with chronic myeloid leukemia (CML). However, very few data are available as to toxicity and efficacy of dasatinib in unselected elderly CML patients.
Aims
To address this issue, we revised a “real-life” cohort of 54 CML patients in chronic phase aged > 65 years treated with frontline dasatinib in 24 Italian Centers from 6/2012 to 12/2014 focusing on toxicity and efficacy data.
Methods
The main clinical features of the patients at diagnosis were as follows: M/F 27/27, median age 75.4 years [interquartile range (IQR) 70.6 – 79.5), median Hb 12.3 g/dl (IQR 11.1 – 13.6), median WBC 51.5 x 109/l (IQR 28.1 – 100.0), median PLTS 430 x 109/l (IQR 233 – 770). According to Sokal risk classification, 2 patients (3.7%) were low risk, 32 (59.3%) intermediate risk, 15 (27.8%) high risk while 5 (9.2%) were not classificable. 30/54 patients (55.5%) had ≥ 2 comorbidities requiring concomitant therapies: according to ECOG scale, performance status at baseline was 0 – 1 in 46 patients (85.1%) and 2 in 8 patients (14.9%).
Results
Median interval from diagnosis to dasatinib start was 23 days (IQR 14 – 35). Dasatinib starting dose was 140 mg/day in 1 patient (1.8%), 100 mg/day in 40 patients (74.1%) and < 100 mg/day in 13 patients (24.1%), respectively. After a median period of treatment of 13.7 months (IQR 6.4 – 20,6) all patients were evaluable for toxicity; on the whole, grade 3 – 4 hematological and extra-hematological toxicities were reported in 5 (9.2%) and 9 (16.6%) patients, respectively. Overall, 9 patients (16.6%) permanently discontinued dasatinib due to toxicity (2 patients in the first 3-month period of treatment and 7 beyond that period). Pleural effusions of all WHO grades occurred in 10 patients (18.5%): in 4 of them the pleural effusion occurred during the first 3-month period of treatment. As to treatment efficacy, 5 patients were considered too early to be evaluated (< 3 months of treatment) and 49 were evaluable for cumulative response; on the whole, 45/49 patients (91.8%) achieved complete cytogenetic response (CCyR) and 33/49 (67.3%) also a major molecular response (MMolR). Response to treatment at different time-points is shown on Table.
| 3rd month | 6th month | 12th month |
Not evaluable: | 12 5 7 | 15 6 9 | 16 16 0 |
Evaluable | 42 | 39 | 38 |
Discontinuation | 2 (4.7%) | 4 (10.2%) | 7 (18.4%) |
Less than CCyR | 6 (14,3%) | 2 (5.1%) | 2 (5.2%) |
CCyR only | 21 (50.0%) | 10 (25.7%) | 9 (23.6%) |
MMolR | 13 (31.0%) | 23 (59.0%) | 20 (52.6%) |
After a median period of observation from dasatinib initiation of 15,5 months (IQR 9.2 – 24.7), only 1 patient died from unrelated cause (senectus) while in MMolR: cumulative event-free survival (EFS) at 12 months was 82.4% (95%CI 71.3 – 93.5).
Summary
Present data shows that dasatinib could have a major role in the treatment of unselected patients aged > 65 years; indeed, dasatinib seems very effective and has a favourable safety profile also in elderly subjects with comorbidities.
Keyword(s): Chronic myeloid leukemia, Elderly
Session topic: Publication Only