A REAPPRAISAL OF THE AZA TREATMENT OUTCOME: ASSESSING THE VALUE OF DISEASE STABILISATION AND EFFECT OF TREATMENT SCHEDULE MODIFICATION
(Abstract release date: 05/19/16)
EHA Library. Casartelli E. 06/09/16; 134821; PB1921
Dr. Elena Maria Casartelli
Contributions
Contributions
Abstract
Abstract: PB1921
Type: Publication Only
Background
5-Azacytidine is a chemical analog of cytidine used in the treatment of myelodysplastic syndrome. We considered two unanswered questions in the treatment of myelodisplastic syndrome: the significance of stable disease and the impact of dose reduction or treatment delay on the outcome of patients.
Aims
In this study we considered a population of patients affected by myelodysplastic syndrome with IPPS intermediate 2 or high risk treated with 5-Azacytidine. We analysed the prognostic impact of stable disease and treatment schedule modification.
Methods
We retrospectively analysed 57 patients treated with 5-Azacytidine from 2008 to 2015 at San Gerardo Hospital, Hematological Unit (Monza, Italy). We defined the response to treatment according to International Working Group 2006. All patients continued the treatment until loss of response, even if they obtained stable disease. The median number of cycles of drug was 7, from a minimum of 1 to a maximum of 27.
Results
The median time between the start of treatment and the loss of response is 24 months. In the subgroup of patients who did not receive bone marrow transplantation the median time is 20 months. The median survival after loss of response is 4,8 months. We established 3 classes: 20 patients obtained a response to treatment, defined as complete response, partial response, marrow CR, cytogenetical response, hematologic improvement; 15 patients obtained stable disease; 22 patients failed the treatment. The median survival from the diagnosis in responding patients, patients with stable disease, or treatment failure is respectively 27 months, 30 months and 10 months. Similarly the median survival from start of treatment of these 3 classes is respectively 23 months, 27 months and 3,7 months. Fourteen out of 57 patients required, during the treatment, a dose reduction of 5-Azacytidine or treatment delay because of toxicity. Considering the treatment efficacy we deduced that 53% of patients who did not need a treatment schedule modification obtained a response or stable disease (23 of 43). Indeed 85% of patients who required a dose reduction or a treatment delay obtained a response or stable disease (12 of 14). This difference, despite the few cases, appears statistically significant with p value 0,02. In the subgroup of patients who required a dose reduction the median survival from diagnosis is 31 months versus 25 months in patients who do not have dose reduction. Similarly the median survival from start of treatment is respectively 23 months and 16,7 months. The median survival of all patients who required a treatment schedule modification, as dose reduction or treatment delay, is 31 months from the diagnosis and 23 months from the start of treatment, versus 21 months and 16 months in patients who respected the schedule.
Conclusion
This study shows that in patients affected by myelodysplastic syndrome with IPSS intermediate 2 or high risk treated with 5-Azacytidine, the stable disease should be considered response to treatment. The only patients who have low median survival are treatment failures, in fact outcome is similar in responders and in patients with stable disease. Furthermore dose reduction or treatment delay does not seem to adversely affect the therapy efficacy and survival, but they reduce the treatment toxicity.
Session topic: E-poster
Keyword(s): Hypomethylation, Myelodysplasia
Type: Publication Only
Background
5-Azacytidine is a chemical analog of cytidine used in the treatment of myelodysplastic syndrome. We considered two unanswered questions in the treatment of myelodisplastic syndrome: the significance of stable disease and the impact of dose reduction or treatment delay on the outcome of patients.
Aims
In this study we considered a population of patients affected by myelodysplastic syndrome with IPPS intermediate 2 or high risk treated with 5-Azacytidine. We analysed the prognostic impact of stable disease and treatment schedule modification.
Methods
We retrospectively analysed 57 patients treated with 5-Azacytidine from 2008 to 2015 at San Gerardo Hospital, Hematological Unit (Monza, Italy). We defined the response to treatment according to International Working Group 2006. All patients continued the treatment until loss of response, even if they obtained stable disease. The median number of cycles of drug was 7, from a minimum of 1 to a maximum of 27.
Results
The median time between the start of treatment and the loss of response is 24 months. In the subgroup of patients who did not receive bone marrow transplantation the median time is 20 months. The median survival after loss of response is 4,8 months. We established 3 classes: 20 patients obtained a response to treatment, defined as complete response, partial response, marrow CR, cytogenetical response, hematologic improvement; 15 patients obtained stable disease; 22 patients failed the treatment. The median survival from the diagnosis in responding patients, patients with stable disease, or treatment failure is respectively 27 months, 30 months and 10 months. Similarly the median survival from start of treatment of these 3 classes is respectively 23 months, 27 months and 3,7 months. Fourteen out of 57 patients required, during the treatment, a dose reduction of 5-Azacytidine or treatment delay because of toxicity. Considering the treatment efficacy we deduced that 53% of patients who did not need a treatment schedule modification obtained a response or stable disease (23 of 43). Indeed 85% of patients who required a dose reduction or a treatment delay obtained a response or stable disease (12 of 14). This difference, despite the few cases, appears statistically significant with p value 0,02. In the subgroup of patients who required a dose reduction the median survival from diagnosis is 31 months versus 25 months in patients who do not have dose reduction. Similarly the median survival from start of treatment is respectively 23 months and 16,7 months. The median survival of all patients who required a treatment schedule modification, as dose reduction or treatment delay, is 31 months from the diagnosis and 23 months from the start of treatment, versus 21 months and 16 months in patients who respected the schedule.
Conclusion
This study shows that in patients affected by myelodysplastic syndrome with IPSS intermediate 2 or high risk treated with 5-Azacytidine, the stable disease should be considered response to treatment. The only patients who have low median survival are treatment failures, in fact outcome is similar in responders and in patients with stable disease. Furthermore dose reduction or treatment delay does not seem to adversely affect the therapy efficacy and survival, but they reduce the treatment toxicity.
Session topic: E-poster
Keyword(s): Hypomethylation, Myelodysplasia
Abstract: PB1921
Type: Publication Only
Background
5-Azacytidine is a chemical analog of cytidine used in the treatment of myelodysplastic syndrome. We considered two unanswered questions in the treatment of myelodisplastic syndrome: the significance of stable disease and the impact of dose reduction or treatment delay on the outcome of patients.
Aims
In this study we considered a population of patients affected by myelodysplastic syndrome with IPPS intermediate 2 or high risk treated with 5-Azacytidine. We analysed the prognostic impact of stable disease and treatment schedule modification.
Methods
We retrospectively analysed 57 patients treated with 5-Azacytidine from 2008 to 2015 at San Gerardo Hospital, Hematological Unit (Monza, Italy). We defined the response to treatment according to International Working Group 2006. All patients continued the treatment until loss of response, even if they obtained stable disease. The median number of cycles of drug was 7, from a minimum of 1 to a maximum of 27.
Results
The median time between the start of treatment and the loss of response is 24 months. In the subgroup of patients who did not receive bone marrow transplantation the median time is 20 months. The median survival after loss of response is 4,8 months. We established 3 classes: 20 patients obtained a response to treatment, defined as complete response, partial response, marrow CR, cytogenetical response, hematologic improvement; 15 patients obtained stable disease; 22 patients failed the treatment. The median survival from the diagnosis in responding patients, patients with stable disease, or treatment failure is respectively 27 months, 30 months and 10 months. Similarly the median survival from start of treatment of these 3 classes is respectively 23 months, 27 months and 3,7 months. Fourteen out of 57 patients required, during the treatment, a dose reduction of 5-Azacytidine or treatment delay because of toxicity. Considering the treatment efficacy we deduced that 53% of patients who did not need a treatment schedule modification obtained a response or stable disease (23 of 43). Indeed 85% of patients who required a dose reduction or a treatment delay obtained a response or stable disease (12 of 14). This difference, despite the few cases, appears statistically significant with p value 0,02. In the subgroup of patients who required a dose reduction the median survival from diagnosis is 31 months versus 25 months in patients who do not have dose reduction. Similarly the median survival from start of treatment is respectively 23 months and 16,7 months. The median survival of all patients who required a treatment schedule modification, as dose reduction or treatment delay, is 31 months from the diagnosis and 23 months from the start of treatment, versus 21 months and 16 months in patients who respected the schedule.
Conclusion
This study shows that in patients affected by myelodysplastic syndrome with IPSS intermediate 2 or high risk treated with 5-Azacytidine, the stable disease should be considered response to treatment. The only patients who have low median survival are treatment failures, in fact outcome is similar in responders and in patients with stable disease. Furthermore dose reduction or treatment delay does not seem to adversely affect the therapy efficacy and survival, but they reduce the treatment toxicity.
Session topic: E-poster
Keyword(s): Hypomethylation, Myelodysplasia
Type: Publication Only
Background
5-Azacytidine is a chemical analog of cytidine used in the treatment of myelodysplastic syndrome. We considered two unanswered questions in the treatment of myelodisplastic syndrome: the significance of stable disease and the impact of dose reduction or treatment delay on the outcome of patients.
Aims
In this study we considered a population of patients affected by myelodysplastic syndrome with IPPS intermediate 2 or high risk treated with 5-Azacytidine. We analysed the prognostic impact of stable disease and treatment schedule modification.
Methods
We retrospectively analysed 57 patients treated with 5-Azacytidine from 2008 to 2015 at San Gerardo Hospital, Hematological Unit (Monza, Italy). We defined the response to treatment according to International Working Group 2006. All patients continued the treatment until loss of response, even if they obtained stable disease. The median number of cycles of drug was 7, from a minimum of 1 to a maximum of 27.
Results
The median time between the start of treatment and the loss of response is 24 months. In the subgroup of patients who did not receive bone marrow transplantation the median time is 20 months. The median survival after loss of response is 4,8 months. We established 3 classes: 20 patients obtained a response to treatment, defined as complete response, partial response, marrow CR, cytogenetical response, hematologic improvement; 15 patients obtained stable disease; 22 patients failed the treatment. The median survival from the diagnosis in responding patients, patients with stable disease, or treatment failure is respectively 27 months, 30 months and 10 months. Similarly the median survival from start of treatment of these 3 classes is respectively 23 months, 27 months and 3,7 months. Fourteen out of 57 patients required, during the treatment, a dose reduction of 5-Azacytidine or treatment delay because of toxicity. Considering the treatment efficacy we deduced that 53% of patients who did not need a treatment schedule modification obtained a response or stable disease (23 of 43). Indeed 85% of patients who required a dose reduction or a treatment delay obtained a response or stable disease (12 of 14). This difference, despite the few cases, appears statistically significant with p value 0,02. In the subgroup of patients who required a dose reduction the median survival from diagnosis is 31 months versus 25 months in patients who do not have dose reduction. Similarly the median survival from start of treatment is respectively 23 months and 16,7 months. The median survival of all patients who required a treatment schedule modification, as dose reduction or treatment delay, is 31 months from the diagnosis and 23 months from the start of treatment, versus 21 months and 16 months in patients who respected the schedule.
Conclusion
This study shows that in patients affected by myelodysplastic syndrome with IPSS intermediate 2 or high risk treated with 5-Azacytidine, the stable disease should be considered response to treatment. The only patients who have low median survival are treatment failures, in fact outcome is similar in responders and in patients with stable disease. Furthermore dose reduction or treatment delay does not seem to adversely affect the therapy efficacy and survival, but they reduce the treatment toxicity.
Session topic: E-poster
Keyword(s): Hypomethylation, Myelodysplasia
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