scholarly journals Impact of red blood cell transfusion dose density on progression-free survival in patients with lower-risk myelodysplastic syndromes

Haematologica ◽  
2019 ◽  
Vol 105 (3) ◽  
pp. 632-639 ◽  
Author(s):  
Louise de Swart ◽  
Simon Crouch ◽  
Marlijn Hoeks ◽  
Alex Smith ◽  
Saskia Langemeijer ◽  
...  
Keyword(s):  
Blood Cell ◽  
Red Blood Cell ◽  
Myelodysplastic Syndromes ◽  
Lower Risk ◽  
Progression Free Survival ◽  
Red Blood Cell Transfusion ◽  
Free Survival

scholarly journals Comparison between 5-day decitabine and 7-day azacitidine for lower-risk myelodysplastic syndromes with poor prognostic features: a retrospective multicentre cohort study

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Byung-Hyun Lee ◽  
Ka-Won Kang ◽  
Min Ji Jeon ◽  
Eun Sang Yu ◽  
Dae Sik Kim ◽  
...  
Keyword(s):  
Adverse Events ◽  
Myelodysplastic Syndromes ◽  
Lower Risk ◽  
Survival Rates ◽  
Progression Free Survival ◽  
Free Survival ◽  
Prognostic Features ◽  
Multicentre Cohort Study ◽  
Treatment Responses ◽  
Grade 3

AbstractNumerous studies have analysed the clinical efficacies of hypomethylating agents (HMAs) in patients with myelodysplastic syndromes (MDS). However, reports that compare the two HMAs, decitabine and azacitidine, in patients with lower-risk (low and intermediate-1) MDS are limited. We compared 5-day decitabine and 7-day azacitidine regimens in terms of treatment responses, survival outcomes, and adverse events in patients with lower-risk MDS with poor prognostic features. The overall response rates (ORRs) were 67.2% and 44.0% in the patients treated with decitabine and azacitidine, respectively (P = 0.014). While the median progression-free survival (PFS) was significantly better in the patients treated with decitabine than in those treated with azacitidine (P = 0.019), no significant differences in event-free and overall survival rates were observed between the two groups. Multivariate analysis revealed that compared with azacitidine treatment, decitabine treatment is significantly associated with a higher ORR (P = 0.026) and longer PFS (P = 0.037). No significant differences were observed in the incidence of grade 3 or higher haematologic adverse events in response to the two HMAs. In conclusion, in lower-risk MDS, especially with poor prognostic features, ORR and PFS were significantly better with 5-day decitabine treatment than with 7-day azacitidine treatment, with comparable safety.

scholarly journals Survival Benefit with Standard-Dose Decitabine Versus Standard-Dose Azacitidine in Patients with Lower-Risk Myelodysplastic Syndromes

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 3099-3099
Author(s):  
Byung-Hyun Lee ◽  
Ka-Won Kang ◽  
Min Ji Jeon ◽  
Eun Sang Yu ◽  
Dae Sik Kim ◽  
...  
Keyword(s):  
Adverse Events ◽  
Clinical Efficacy ◽  
Myelodysplastic Syndromes ◽  
Lower Risk ◽  
Standard Dose ◽  
Multivariable Analysis ◽  
Progression Free Survival ◽  
Significant Prognostic Factor ◽  
Free Survival ◽  
Treatment Responses

Abstract Introduction: Hypomethylating agents (HMAs) are used for the treatment of patients with myelodysplastic syndromes (MDS). Two HMAs, decitabine and azacitidine, are currently available for such treatment. Numerous studies have analyzed the clinical efficacy of HMAs in patients with MDS; however, reports directly comparing decitabine and azacitidine in patients with lower-risk (low and intermediate-1) MDS are limited. The clinical efficacy of standard-dose HMA treatment in lower-risk MDS remains controversial. Patients and methods: The Korea University MDS registry is a longitudinal cohort that contains data on 452 patients consecutively diagnosed with MDS from October 2006 to December 2017 in Korea University Medical Center (Korea University Anam, Guro, and Ansan Hospital). In the Korea University MDS registry, 357 patients were classified as having lower-risk MDS. Among them, 115 patients were treated with HMA (decitabine or azacitidine); 111 patients were eligible for the study. We compared treatment responses, survival outcomes, and adverse events between standard-dose decitabine (20 mg/m2 daily for 5 days every 4 weeks) and azacitidine (75 mg/m2 daily for 7 days every 4 weeks) in lower-risk MDS patients. Treatment responses were assessed according to the modified 2006 International Working Group response criteria. Patients who were evaluated received at least one cycle of HMA therapy. The overall response rate (ORR) included complete remission (CR), partial remission, marrow CR, and hematologic improvement. Progression-free survival (PFS) was measured from the time of treatment initiation until disease progression or death from MDS. Results: The CR rates were 16.4% (10/61) in the decitabine group and 6.0% (3/50) in the azacitidine group with borderline significance (P = .090). The ORRs were 67.2% (41/61) and 44.0% (22/50) for decitabine and azacitidine, respectively (P = .014). The erythroid responses for decitabine and azacitidine were 68.3% (41/60) and 44.2% (19/43), respectively (P = .014). In the multivariable analysis, treatment with decitabine (hazard ratio [HR] 2.553; 95% confidence interval [CI] 1.116-5.840; P = .026), hemoglobin (Hb) concentration of <8 g/dL (HR 3.073; 95% CI 1.340-7.048; P = .008), and ≥5% BM blasts (HR 3.739; 95% CI 1.102-12.683; P = .034) were significantly associated with higher ORRs. The median progression-free survival was significantly better in patients treated with decitabine than in those treated with azacitidine (33 vs. 19 months; P = .019). There were no significant differences in the event-free survival and in the overall survival between the two HMAs. In the multivariable analysis, treatment with decitabine (HR 0.496; 95% CI 0.257-0.957; P = .037) and achievement of CR (HR 0.122; 95% CI 0.015-0.993; P = .049) were significant prognostic factors for better survival, whereas ANC below 0.8 × 109/L (HR 1.905; 95% CI 1.032-3.515; P = .039) was a significant prognostic factor for poor prognosis. The poor cytogenetic risk group, as classified by International Prognostic Scoring System (HR 2.136; 95% CI 0.992-4.556; P = .052), also affected the survival unfavorably with borderline significance. There were no significant differences in grade 3 or higher hematologic adverse events between the two HMAs. Conclusions: The standard-dose decitabine therapy showed significantly better ORR, erythroid response, and longer PFS than did standard-dose azacitidine in patients with lower-risk MDS. The frequencies of hematologic adverse events did not differ between the patients who received decitabine and those who received azacitidine. Disclosures No relevant conflicts of interest to declare.

scholarly journals A progressziómentes túlélést befolyásoló tényezők vizsgálata ibrutinibbel kezelt krónikus lymphoid leukémiás betegekben

2021 ◽  
Vol 54 (1) ◽  
pp. 13-20
Author(s):  
László Szerafin ◽  
Péter Takács ◽  
Gabriella Varjasi ◽  
László Rejtő ◽  
Péter Ilonczai ◽  
...  
Keyword(s):  
Blood Cell ◽  
Red Blood Cell ◽  
Progression Free Survival ◽  
Lymphocytic Leukemia ◽  
Cell Distribution ◽  
Lymphoid Leukemia ◽  
Distribution Width ◽  
Free Survival ◽  
Factors Influencing ◽  
Red Blood Cell Distribution

Összefoglaló. Bevezetés: A krónikus lymphoid leukémia kezelésében jelentős előrelépést eredményezett az ibrutinibterápia bevezetése. A gyógyszer első vonalbeli és többed vonalbeli kezelése is magas remissziós arányt eredményezett, bár a terápia korai bevezetése és a kedvező genetikai eltérések esetén az eredmények jobbak. A progressziómentes túlélést befolyásoló egyéb tényezőkről azonban még kevés adat áll rendelkezésre. Célkitűzés: Krónikus lymphoid leukémiás betegek ibrutinibkezelése során a teljes hematológiai remisszió elérését és a progressziómentes túlélés időtartamát befolyásoló tényezők vizsgálata. Betegek és módszer: 47 krónikus lymphoid leukémiás beteg (életkor: 39–84 év, férfi 27, nő 20, követési idő 5–58 hónap, medián 15 hónap) klinikai és laboratóriumi adatainak retrospektív elemzése. Eredmények: A teljes hematológiai remisszió elérése független volt a betegek nemétől, életkorától, a betegség stádiumától, az immunglobulin gén nehézlánc-variábilis régió státuszától, a genetikai aberrációktól, az abszolút neutrophilszámtól, az abszolút monocytaszámtól és a vörösvértestnagyság-eloszlási görbe szélességétől. A progressziómentes túlélést a komplett remisszió elérése (p = 0,00073) és a magasabb abszolút neutrophilszám (<4 G/l vs. ≥4 G/l, p = 0,022) befolyásolta szignifikánsan, a vörösvértestnagyság-eloszlási görbe szélességértékével való összefüggés pedig statisztikailag határértéken volt (p = 0,065). A Cox-féle regressziós elemzésbe bevont változók közül csak a teljes hematológiai remisszió elérése mutatott szignifikáns hatást a progressziómentes túlélésre (p = 0,0147). Következtetések: A teljes hematológiai remisszió elérése az egyéb vizsgált tényezőktől független, szignifikáns hatással bír a betegek progressziómentes túlélésére. Az abszolút neutrophilszám és a vörösvértestnagyság-eloszlási görbe szélessége szintén hasznos kiegészítő prognosztikus marker lehet. Az elemzett esetek száma még alacsony a komolyabb következtetések levonására, azonban így is elmondható, hogy az eredmények egy része már a szakirodalom korábbi eredményeit tükrözi. Summary. Introduction: The introduction of ibrutinib therapy has led to significant advances in the treatment of chronic lymphocytic leukemia. Both first-line and multiple-lines treatments of the drug resulted in high remission rates, although results were better with early initiation of therapy and favorable genetic abnormalities. However, little data are available on other factors influencing progression-free survival. Objective: To investigate factors influencing the achievement of complete hematological remission and progression-free survival with ibrutinib treatment in patients with chronic lymphocytic leukemia. Patients and metods: Retrospective analysis of clinical and laboratory data from 47 chronic lymphoid leukemia patients (age: 39–84 years, male 27, female 20, follow-up 5–58 months, median 15 months). Results: Achieving complete hematologic remission was independent of patient gender, age, disease stage, immunoglobulin heavy chain variable region status, genetic aberrations, absolute neutrophil count, absolute monocyte count, and red blood cell distribution width. Progression-free survival was significantly affected by complete remission (p = 0.00073), and higher absolute neutrophil counts (<4 G/l vs. ≥ 4 G/l, p = 0.022), the red blood cell distribution width was statistically less significant (p = 0.065). Of the variables included in the Cox regression analysis, only the achievement of complete hematologic remission had a significant effect on progression-free survival (p = 0.0147). Conclusions: Achieving complete hematologic remission, independent of the other factors studied, has a significant effect on patients’ progression-free survival. Absolute neutrophil count and red blood cell distribution width can also be a useful additional prognostic marker. The number of analyzed cases is still low to draw more serious conclusions, but it can still be said that some of the results already reflect previous results in the literature.

A 36-month analysis of treatment patterns and outcomes in patients with lower-risk myelodysplastic syndromes from a prospective observational study.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 7122-7122
Author(s):  
Roger M. Lyons ◽  
Billie J. Marek ◽  
Carole S. Paley ◽  
Jason Esposito ◽  
Lawrence E. Garbo ◽  
...  
Keyword(s):  
Blood Cell ◽  
Iron Overload ◽  
Red Blood Cell ◽  
Myelodysplastic Syndromes ◽  
Lower Risk ◽  
Cardiac Events ◽  
Risk Status ◽  
Red Blood Cell Transfusions ◽  
Lost To Follow Up ◽  
Ophthalmologic Disorders

7122 Background: Many patients (pts) with lower-risk myelodysplastic syndromes (MDS) require chronic red blood cell transfusions for symptomatic anemia, which can result in iron overload. We present a 36-month interim analysis of a 5-year US registry that prospectively collected data on clinical events and survival in chelated vs non-chelated, transfused, lower-risk MDS pts. Methods: This multicenter, non-interventional registry enrolled 600 pts ≥18 yr old with lower-risk MDS (WHO, FAB, and/or IPSS risk stratification criteria) and transfusional iron overload (serum ferritin ≥1,000 ng/mL and/or ≥20 packed red blood cell units and/or ≥6 units every 12 wks). The chelated group included pts who had received any chelation. Results: Median age was 76 yr (range, 21–99), 57.8% were male, and risk status was 38.6% IPSS low risk and 61.4% IPSS INT-1 risk. Baseline demographics and IPSS risk status were similar between groups, although transfusion burden trended higher in chelated pts. As of April 30, 2012, 169 pts continued on the registry, and 431 discontinued (345 died, 57.5%; 61 lost to follow-up, 10.2%; and 25 other, 4.2%). In all, 264 pts (44%) received chelation therapy; 200 had ≥6 mos chelation. Overall survival (OS) and time to acute myeloid leukemia (AML) transformation were significantly longer, and the percentage of deaths was significantly lower, in chelated ≥6 mos vs non-chelated pts (P<0.0001, P=0.011 [median not reached in either group], P=0.0002, respectively. AML transformations appeared to be lower in chelated ≥6 mos pts (not significant [NS]). At baseline in non-chelated vs chelated ≥6 mos pts, there was a higher prevalence of vascular, cardiac, endocrine, and ophthalmologic disorders; this trend continued at 36 mos. Most frequent causes of death were MDS/AML, cardiac events, and infection. Use of MDS therapy was lower among non-chelated pts (non-chelated, 88.4%; ≥6 mos chelation, 93.5%; NS). Conclusions: At 36 mos,chelated pts had significantly longer OS and time to AML, as well as significantly fewer deaths. Trends toward fewer AML transformations and fewer vascular, cardiac, endocrine, and ophthalmologic disorders were observed in chelated pts.

Evaluation of Cardial Iron Deposition by T2* MRI in Transfusion Dependent Patients with Myelodysplastic Syndromes.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 2663-2663
Author(s):  
Simona Deplano ◽  
Anna Di Tucci ◽  
Gildo Matta ◽  
Annalisa Agus ◽  
Attilio Gabbas ◽  
...  
Keyword(s):  
Blood Cell ◽  
Serum Ferritin ◽  
Red Blood Cell ◽  
Myelodysplastic Syndromes ◽  
Cardiac Mri ◽  
Clinical Signs ◽  
Left Ventricular ◽  
Iron Deposition ◽  
Red Blood Cell Transfusion ◽  
Myocardial Iron

Abstract Cardiac T2* Magnetic Resonance Imaging (MRI) has been recently used to evaluate myocardial iron deposition in patients with transfusion dependent beta-thalassemia major. No comparable studies have been published for patients with myelodysplastic syndromes receiving chronic red blood cell transfusion. Therefore we measured cardiac-MRI T2* in 16 patients (10 male, 6 female) with myelodysplastic syndromes (aged 54 – 82 years, median age 67). All of them were transfusion dependent having received a median number of 60 (range 16–225) packed red blood cell transfusion equivalent to 3.2 – 45 (median 12) grams of iron. Nine have been irregularly and sporadically chelated by deferoxamine, seven were unchelated. Serum ferritin levels ranged from 1163 to 6241 mg/dl (median value 2086). None of the patients presented signs or symptoms of cardiac dysfunction at the time of the study. Cardiac-MRI T2*values obtained ranged from 5.6 to 80 (median value 46.5) milliseconds (ms). Correlation between serum ferritin and cardiac T2* value was weak ( r= 0.43, r2 =0.18). According to D. Pennel we considered as significant of myocardial iron deposition a relaxation time ≤ 20ms. Cardiac T2* was < 20ms in 3 patients who had never used iron chelators (5.6, 12.4 and 8.5 ms, respectively). They had received 39, 101 and 200 units of red blood cell transfusion, corresponding to 7.8, 20 and 40 grams of iron, respectively. Of relevance 2 of them died within few months after the end of the study and one showed early signs of left ventricular dysfunction. None of the patients with a cardiac T2* value >20 ms showed instrumental nor clinical signs of cardiac deterioration in six months follow up. No patient who had received less than 39 transfusions presented cardiac T2* value ≤20 ms. Evaluation of myocardial iron deposition by T2* cardiac MRI could be recommendable in myelodyplasia patients who had received more than 30 packed red blood cells transfusisions.

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