scholarly journals Outcome of Standard Induction Therapy with Daunorubicin and Ara-C (3+7) in Acute Myeloid Leukemia

2016 ◽  
Vol 24 (2) ◽  
pp. 141-145
Author(s):  
Mohammad Manirul Islam ◽  
Md Mizanur Rahman ◽  
Jannatul Ferdous ◽  
Mafruha Akter ◽  
Humayra Nazneen ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Induction Therapy ◽  
Significant Influence ◽  
Myeloid Leukemia ◽  
Remission Rate ◽  
Performance Status ◽  
College Hospital ◽  
Medical College ◽  
Hospital Facility ◽  
Acute Myeloid

Acute myeloid leukemia (AML) is a clonal, malignant disease of hematopoietic tissue.Main variables precluding cure are the treatment-related mortality and relapse rates.The most common induction chemotherapy regimens in AML involve the use of cytarabine (Ara-C) and an anthracycline. It was observational study carried out in the inpatient Department of Hematology, Dhaka Medical College Hospital, Dhaka, from July 2009 to June 2014.76 newly diagnosed cases of AML patients between 15 year to 60 yearwere enrolled in this study. All patient received standard induction therapy with Daunorubicin 45mg/m2 I/V for 3 days and Ara-C 100mg/m2 I/V over 24 hours for 7 days. A bone marrow aspirate to assess remission status was carried out at day 28+, after the peripheral recovery.The mean age of the patients were 35.12±12.45 years, ranging from 17 to 55 years. 68% were male and 32% cases were female. Total 34(44.7%) patient achieved complete remission (CR), out of them 17% had t(8:21), 5.8% had inv16 and only 2.9% was FLT3 positive. 26(34%) patient achieved partial remission (PR), 11% had t(8:21) and 3.8% inv16. 13.1% patient failed to achieve any remission (Non responder, NR) and 6 patient (7.8%) died during induction therapy. Age, performance status and cytogenetics had significant influence (P<0.025, P<0.030 and P<0.003 respectively) on the outcome. The presenting peripheral blast percent (%) also had a significant influence (P=0.012) on the outcome after induction therapy.Complete remission rate is significantly lower in our center comparing discussed study. This is probably due to lack of modern hospital facility and socio-economic condition of our patients.Cytogenetic analysis provides the most powerful independent predictor of disease outcome. To improve outcome, all the supportive measures have to be improved and more tools are required in identifying the good prognostic groups.J Dhaka Medical College, Vol. 24, No.2, October, 2015, Page 141-145

Daunorubicine, Cytarabine and Cladribine (DAC) Vs Daunorubicine and Cytarabine (DA) Induction Treatment in Elderly Acute Myeloid Leukemia (AML) Patients – Results of the Prospective, Multicenter, Randomized Trial of the Polish Adult Leukemia Group (PALG)

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 3602-3602
Author(s):  
Agnieszka Pluta ◽  
Tadeusz Robak ◽  
Agata Wrzesien-Kus ◽  
Bozena Katarzyna Budziszewska ◽  
Kazimierz Sulek ◽  
...  
Keyword(s):  
Overall Survival ◽  
Acute Myeloid Leukemia ◽  
Treatment Option ◽  
Induction Therapy ◽  
Myeloid Leukemia ◽  
Performance Status ◽  
Hematological Toxicity ◽  
Proportional Hazard ◽  
Newly Diagnosed ◽  
Acute Myeloid

Abstract Abstract 3602 Background: AML in elderly patients is associated with very poor prognosis. The best treatment option for this group of patients is not established, yet. The intensity of treatment depends on performance status and comorbidities. The previous PALG AML study showed that addition of cladribine (2CdA) to conventional induction therapy; especially in patients above 40 yrs, is associated with better outcome (Ho3owiecki 2004). Based on this observation we designed a study addressed to newly diagnosed AML patients above 60 yrs old, who were fit enough to intensive treatment. Aim: To verify whether addition of 2CdA has an impact to clinical outcome in newly diagnosed AML patients older than 60 years old. Methods: From October 2004 to November 2011, 178 patients from 16 hematological PALG centers were randomly assigned to DA induction therapy consisting of daunorubicine (DNR) 45mg/m2, intravenously (iv), day 1–3 and cytarabine (AraC) 100 mg/m2, iv, day 1–7 (DA) or DA with addition of 2CdA 5mg/m2, iv, day 1–5 (DAC). Patients, who achieved complete remission (CR), received one course of consolidation with mitoxantron 6mg/m2 iv day1–2 and AraC 100mg/m2 iv day 1–5, followed by six cycles of maintenance consisting of (DNR 30mg/m2 iv day 1–2 with AraC 100mg/m2 sc day 1–5 and tioguanine 100mg/m2, p.o., twice day, day 1–5 with AraC 100mg/m2 s.c. day 1–5, alternately). Response criteria were determined according to revised recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia (Chesson 2003). Statistical analysis: Pairwise comparisons between patient characteristics were performed by the Mann-Whitney U-test for continuous variables and by χ2-statistics or Fisher's exact test for categorical variable. The Kaplan-Meier estimates of survival were calculated and compared using the log-rank test. For multivariate analysis, the Cox proportional hazard regression model was applied. P values < 0.05 were considered significant. Results: 88 pts with median age 66 yrs (range 60–79 yrs) were randomized to DA and 90 pts with median age 64 yrs (range 60–79 yrs) was enrolled to DAC schema. The both groups were comparable in terms of age, sex, performance status, white blood cell count, hemoglobin level, platelets count, tumor burden parameters, cytogenetic, between the both groups. The overall CR rate was 38%. In DA and DAC groups CR was achieved in 33% and 43% pts, respectively (p=0.12). However, in patients under 65 yrs the trend towards higher CR rate in DAC arm than DA group was observed (47% vs. 29%, p=0.09). In pts above 65 yrs the CR rate was comparable (39% vs. 38%, p=0.8). The efficacy and hematological toxicity in DA and DAC groups was similar (Table 1). Also no statistical significant differences in non-hematological toxicity were observed (data not shown). Early deaths in DA and DAC did not differ significantly. Median overall survival (OS) in DA and DAC arm was also similar in both groups (Table 1). In proportional hazard Cox analysis only age under 65yo, CR achievement and WBC above 100G/L were important for better OS (p=0.02, p<0.001 and p=0.09). The presence of dysplastic changes, karyotype, LDH, number of bone marrow blasts did not influenced OS. Conclusions: Our data suggest that prolonged overall survival can be achieved in elderly AML patients mainly till 65yrs. Intensive therapy, especially in patients older than 65yrs, may be associated with high number of complications what results withdrawing from intensive treatment protocol. Hematological and non-hematological toxicity of DA and DAC schema is comparable, however higher CR rate in DAC group in patient till 65yrs may suggest, that addition of 2CdA to DA does not increase toxicity and may be a treatment option in this patient population. Disclosures: Wiktor-Jedrzejczak: Janssen-Cilag: Consultancy; Amgen: Consultancy; Novartis: Consultancy, Speakers Bureau; Pfizer: Consultancy; Bayer: Consultancy; Genopharm: Speakers Bureau; Celgene: Speakers Bureau; Genzyme: Speakers Bureau; Bristol-Myers Squibb: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau.

Acute Myeloid Leukemia (AML). Diagnosis, Therapy and Outcome Results from Tawam Hospital. a Retrospective Review

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 5254-5254
Author(s):  
Arif Alam ◽  
Ali Tahir ◽  
Masood H Syed ◽  
Sabir Hussain ◽  
Amar Lal ◽  
...  
Keyword(s):  
Older Adults ◽  
Acute Myeloid Leukemia ◽  
Supportive Care ◽  
Induction Therapy ◽  
Myeloid Leukemia ◽  
Performance Status ◽  
High Dose ◽  
Lost To Follow Up ◽  
Acute Myeloid

Abstract Introduction Acute Myeloid leukemia (AML) is a heterogeneous group of malignant disorders of myeloid hematopoetic cells. These cells have a maturation arrest in different stages of development leading to accumulation of immature cells. This gives rise to the different symptoms and signs of disease secondary to anemia, thrombocytopenia and neutropenia. The current WHO classification broadly divides AML into 4 main groups based on morphology, immunophenotyping, genetics and clinical features. These include AML with recurrent genetic abnormalities, AML with myelodysplasia related changes; therapy related AML and AML not otherwise specified (NOS). Therapeutically AML can be divided into 2 main groups; Acute promyelocytic leukemia (APML) and non APML. Methods Tawam Tumor registry was searched for patients with diagnosis of AML from January 2010 till December 2012. Patient records were then reviewed and data was collected. Results We identified 49 patients with pathologically confirmed diagnosis of AML. 19/49 patients were diagnosed with AML with recurrent cytogenetic, 5/49 with MDS related or therapy related and 25 with AML NOS Cytogenetic Analysis of this cohort of 49 patients with AML showed that 15 patients (30%) had APML with 15;17 translocation, 4 patients had 8;21 translocation, 5 had complex or poor risk cytogenetic while 13 had normal karyotype. In 12/49 patients Karyotyping failed due to growth failure. Status of FLT3 and NPM1 are not known for the entire cohort. Demographics The median age of the cohort was 38 years (range 20 to 84 years). Older adults (age 65 years or more) make a minority of this cohort (8%). Male to female ration was 3.5:1. Treatment In patients with Non APML Induction therapy was a combination of Cytarabine and Idarubicin for adults < 65 years of age and with good performance status. Older adults or adults with poor performance status or co-morbidities were either given hypomehtylating agents, Clofarabine or supportive care. Patients achieving complete remission (CR) were given consolidation with High Dose Cytarabine (HIDAC) as per CALGB protocol. Only a minority of patients were able to go for allogeneic stem cell transplantation in CR1 Patients with APML were treated with ATRA, Idarubicin/Mitoxantrone and Cytarabine as per PETHEMA protocol on a risk adjusted plan. This was followed by 2 year maintenance with ATRA, 6 MP and Methotrexate. Outcome of Treatment In non APML patients 62 % (17) achieved CR with induction therapy. Induction therapy failure was observed in 18 % (5) while there were 5 early deaths observed (during aplasia). 7 patients were treated with hypomethylating agents or best supportive care. Only 1patient was able to achieve CR (after cycle 4 of 5-azacitidine). Consolidation therapy was given to 17 patients achieving CR. With a median follow up of 15 months (range 9-24 months) 9 patients are alive and disease free while 17 patients have been lost to follow up. 8 out of these 17 patients were in remission at their last follow up. In APML patients the CR rate was 93%. There were no cases of induction failure and only 1 case of early death (7%) due to hemorrhage. With a median follow up of 17 months (range 11-41 months) 11 patients are in molecular CR while 3 have been lost to follow up. Conclusion This is the first analysis of patients who were diagnosed with AML in a tertiary care center in UAE. The results show that the median age of patients our cohort is low as compared to international reports (approximately 38 vs. 65 years). Older adults (> 65 years of age) make only a minority of the AML cohort in Tawam Hospital. Response to induction therapy is comparable to international standards (60-80%) for AML and > 90% for APML. We also report a twofold higher incidence of APML as compared to internationally reported data (30% vs.12%). This has a very significant diagnostic and therapeutic impact on the management of AML patients at our institute leading to increase vigilance and institution of ATRA at the earliest clinical suspicion of APML. Disclosures Alam: BMS: Consultancy, Honoraria; Novartis: Consultancy, Honoraria. Hussain:BMS: Honoraria; Novartis: Honoraria. Lal:BMS: Honoraria; novartis: Honoraria.

A phase 3 study of three induction regimens and of priming with GM-CSF in older adults with acute myeloid leukemia: a trial by the Eastern Cooperative Oncology Group

Blood ◽  
2004 ◽  
Vol 103 (2) ◽  
pp. 479-485 ◽  
Author(s):  
Jacob M. Rowe ◽  
Donna Neuberg ◽  
William Friedenberg ◽  
John M. Bennett ◽  
Elisabeth Paietta ◽  
...  
Keyword(s):  
Older Adults ◽  
Acute Myeloid Leukemia ◽  
Growth Factor ◽  
Complete Remission ◽  
Induction Chemotherapy ◽  
Induction Therapy ◽  
Myeloid Leukemia ◽  
Remission Rate ◽  
Gm Csf ◽  
Acute Myeloid

Abstract The optimal induction for older adults with acute myeloid leukemia (AML) is unknown. Several anthracyclines have been proposed, but the data remain equivocal. Additionally, few prospective trials of priming with hematopoietic growth factors to cycle leukemia cells prior to induction chemotherapy have been conducted. Three hundred and sixty-two older adults with previously untreated AML were randomized to either daunorubicin, idarubicin or mitoxantrone with a standard dose of cytarabine as induction therapy. In addition, 245 patients were also randomized to receive granulocyte-macrophage colony-stimulating factor (GM-CSF) or placebo beginning 2 days prior to induction chemotherapy and continuing until marrow aplasia. No difference was observed in the disease-free overall survival or in toxicity among patients receiving any of the 3 induction regimens or among those receiving growth factor or placebo for priming. However, the complete remission rate for the first 113 analyzable patients, who did not participate in the priming study and started induction therapy 3 to 5 days earlier than those who did, was significantly higher (50% versus 38%; P = .03). None of the anthracyclines is associated with improved outcome in older adults. Priming with hematopoietic growth factor did not improve response when compared with placebo. Furthermore, delaying induction therapy in older adults may lead to a lower complete remission rate.

Outcome after induction chemotherapy for older patients with acute myeloid leukemia is not improved with mitoxantrone and etoposide compared to cytarabine and daunorubicin: a Southwest Oncology Group study

Blood ◽  
2002 ◽  
Vol 100 (12) ◽  
pp. 3869-3876 ◽  
Author(s):  
Jeanne E. Anderson ◽  
Kenneth J. Kopecky ◽  
Cheryl L. Willman ◽  
David Head ◽  
Margaret R. O'Donnell ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Complete Remission ◽  
Induction Chemotherapy ◽  
Induction Therapy ◽  
Older Patients ◽  
Myeloid Leukemia ◽  
Remission Rate ◽  
P Value ◽  
Term Survival ◽  
Acute Myeloid

Complete remission and long-term survival rates are low for older adults treated for acute myeloid leukemia (AML). Because of favorable phase 2 data using mitoxantrone and etoposide, we conducted a phase 3 study (SWOG-9333) in which patients over 55 years of age with previously untreated AML were randomized to receive mitoxantrone (10 mg/m2 per day × 5) and etoposide (100 mg/m2per day × 5) [ME], or cytarabine (200 mg/m2 per day × 7) and daunorubicin (45 mg/m2 per day × 3) [AD] as induction therapy. The randomization was stratified by age, onset of leukemia, and multidrug resistance phenotype. Over a 4-year period, 328 eligible patients from 66 institutions were enrolled. The complete remission rate was 34% (95% confidence interval [CI] 26%-41%) for patients in the ME and 43% (CI 35%-51%) for patients in the AD treatment arm (one-tailedP value .96). The rates of resistant disease were 43% (CI 35%-51%) and 34% (CI 27%-42%), respectively, for the 2 treatment arms (one-tailed P value .95). The estimated overall survival at 2 years was 11% (CI 6%-15%) and 19% (CI 12%-25%) for patients randomized to ME and to AD induction therapy, respectively (one-tailed P value .99). After accounting for the independent prognostic factors associated with survival (karyotype, performance status, age, white blood cell count), exploratory analysis suggested there was a worse survival for patients who received ME compared with AD induction therapy (2-tailed P value .0066). We conclude that the results of our study do not demonstrate any benefit to the use of ME induction chemotherapy instead of AD in older patients with AML.

scholarly journals Clinical outcome of management of acute myeloid leukemia with idarubicin plus cytarabine

2016 ◽  
Vol 11 (4) ◽  
Author(s):  
Muhammad Hafeez ◽  
Shaharyar , ◽  
Khalid Shabbir ◽  
Zafar Alauddin ◽  
Muhammad Farooq ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Complete Remission ◽  
Induction Therapy ◽  
Myeloid Leukemia ◽  
Bone Marrow Examination ◽  
Remission Induction ◽  
High Dose ◽  
Medical College ◽  
A Prospective Study ◽  
Acute Myeloid

A prospective study was conducted at Department of Clinical Oncology, King Edward Medical College / Mayo Hospital, Lahore from July 2003 to June 2004 to evaluate the effect of Idarubicin plus Cytarabine in chemo naive Acute Myeloid Leukemia (AML) patients. A total of 15 consecutive patients were enrolled with age group 15-58 years. Patients were classified according to French American British (FAB) classification. Induction therapy with Cytarabine as continuous infusion for 7 days and Idarubicin was given on day 1-3. For assessment of response, all patients were subjected to bone marrow examination fifteen days after completion of Induction chemotherapy. Consolidation Therapy with high dose Cytarabine was given on days 1, 3 and 5. Cytarabine was repeated after 28 days for 4 cycles in patients with complete remission after induction therapy. A remission induction rate of 66.7% was observed. Four patients died because of complications. One patient lost to follow up. Idarubicine and cytarabine is effective r egimen for achieving complete remission in AML Chemo-naive patients.

Comparison of Outcome and Prognosis of 248 Elderly Patients with Acute Myeloid Leukemia Treated with Standard-Dose or Low-Intensity Induction Therapy

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 2540-2540
Author(s):  
Jianda Hu ◽  
Yi Chen ◽  
Xiaoyun Zheng ◽  
Zhihong Zheng ◽  
Ting Yang ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Prognostic Factors ◽  
Elderly Patients ◽  
Induction Therapy ◽  
Myeloid Leukemia ◽  
Standard Dose ◽  
Performance Status ◽  
Low Intensity ◽  
Induction Cycle ◽  
Acute Myeloid

Abstract Acute myeloid leukemia (AML) is a disease of older adults, with a median onset age at about 65-70 years. The treatment outcome of AML appears to be poorer with the age increasing, in part due to the poor performance status, concomitant end-organ dysfunction, higher incidence of unfavorable cytogenetic findings, frequent involvement of a more immature leukemic precursor clone, multidrug resistance mediated by MDR1/P-glycoprotein, and the presence of antecedent hematopoietic disorders. Treatment of elderly patients with AML remains highly challenging and controversial. The overall survival rates at 5-year of ≥ 60 years old AML patients are still less than 20% by now. At present, standard-dose induction chemotherapy using a cytarabine plus idarubicin(IA regimen) or daunorubicin (DA regimen) was considered by most to be the most effective upfront AML induction therapy. However, there are still quite a number of elderly patients could not tolerate because of poor performance status and complications. Therefore, low-intensity chemotherapy, including CAG regimen, which combine low-dose cytarabine, aclacinomycin and granulocyte colony-stimulating factor(G-CSF), was used for those were not appropriate for receiving standard-dose chemotherapy. Here we retrospectively analyzed the outcome and prognosis of elderly patients with AML treated with standard-dose or low-intensity induction therapy. 248 elderly patients with acute myeloid leukemia(AML) who received standard-dose or low-intensity induction therapy were enrolled in this retrospective clinical study, 186 patients in standard-dose group with 144 in IA and 42 in DA, 62 cases in low-intensityCAG group. The maininclusion criteria included age ≥ 60 years old, ECOG performance status ≤ 2, without severe complication of heart, liver, kidney or other important organ. The patients received standard-dose or low-intensity induction regimen according to their performance status and patient preference. 144 patients received IA regimen(idarubicin 10mg/m2/d ,d1-3; cytarabine 100mg/m2, q12h, d1-5 or 7), 42 patients received DA regimen(daunorubicin 60mg/m2/d, d1-3; cytarabine 100mg/m2 q12h, d1-5 or 7), and 62 patients received CAG regimen (cytarabine 10mg/m2 q12h, d1-14; aclacinomycin 20mg qd, d1-4; G-CSF 200ug/m2 qd, d0-14, or until bone marrow recover). The median survival time was 9.2 months. 1-year , 3-year and 5-year overall survival(OS) were 42.2%, 18.9% and 13.5%, respectively. After first induction cycle, complete remission(CR) rate was 49.3% in IA group, 35.7% in DA group and 32.3% in CAG group (P = 0.046). The median OS for IA, DA and CAG group were 10.0 months, 9.7months and 7.5 months, respectively. The early mortality of induction therapy and recurrence rate of three regimens showed no difference. IA could improve the long term survival compared to CAG and DA, with 3-year OS: 23.5%,15.9% and 8.3%, respectively; 5-year OS: 19.4%, 6.3%, and 0, respectively (P<0.01). The 67.0% patients relapsed within 24 months, with median relapse time of 8.4 months, 14.6 months and 8.3 months for IA, DA and CAG regimen, respectively. Moreover, Kaplan-Meier analysis showed that 7 parameters were adverse prognostic factors for OS, including age ≥ 70 years old, poor ECOG performance status, unfavorable cytogenetics, non-remission after first induction cycle, white blood cell (WBC) counts ≥ 50×10^9/L, percentage of bone marrow (BM) blast ≥ 80% and higher lactic dehydrogenase (LDH) . Multivariable analysis identified non-remission after first induction cycle (HR = 6.141, 95%CI: 3.585-10.52, P = 0.000) and LDH ≥ 490 IU/L(HR = 1.001, 95%CI: 1.000-1.001, P = 0.000) as independent significantly prognostic factors for OS. In conclusion, Our present data showed that standard-dose IA regimen could improve CR rate and prolong the survival time compared to low-intensity CAG regimen, and CAG regimen still has a certain therapeutic effect for those unfit for intensive chemotherapy. Recurrence is still a serious problem for those who do not receive Allo-HSCT for consolidation after CR. All prognostic factors should be considered before induction therapy to make sure the patients receive the best individualized treatment. Disclosures No relevant conflicts of interest to declare.

scholarly journals Dataset of Two-Dimensional Gel Electrophoresis Images of Acute Myeloid Leukemia Patients before and after Induction Therapy

Data ◽  
2021 ◽  
Vol 6 (2) ◽  
pp. 20
Author(s):  
Juan E. Urrea ◽  
Luisa F. Restrepo ◽  
Jeanette Prada-Arismendy ◽  
Erwing Castillo ◽  
Manuel M. Goez ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Induction Therapy ◽  
Peripheral Blood ◽  
Gel Electrophoresis ◽  
Myeloid Leukemia ◽  
Performance Status ◽  
Two Dimensional ◽  
Two Dimensional Gel Electrophoresis ◽  
Hematopoietic Stem ◽  
Acute Myeloid

Acute myeloid leukemia (AML) is a malignant disorder of the hematopoietic stem and progenitor cells, which results in the build-up of immature blasts in the bone marrow and eventually in the peripheral blood of affected patients. Accurately assessing a patient´s prognosis is very important for clinical management of the disease, which is why there are several prognostic factors such as age, performance status at diagnosis, platelet count, serum creatinine and albumin that are taken into account by the clinician when deciding the course of treatment. However, proteomic changes related to treatment response in this patient group have not been widely explored. Here, we make available a set of 22 two-dimensional gel electrophoresis (2DGE) images obtained from the peripheral blood samples of 11 patients with AML, taken at the time of diagnosis and after induction therapy (approximately 21–28 days after starting treatment). The same set of 2DGE images is also made available after a preprocessing stage (an additional 22 2DGE pre-processed images), which was performed using algorithms developed in Python, in order to improve the visualization of characteristic spots and facilitate proteomic analysis of this type of images.

Comparison of 2 doses of daunorubicin(45mg/m2 vs 60mg/m2) in induction therapy of patients of de novo acute myeloid leukemia

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6581-6581
Author(s):  
N. Khattry ◽  
L. Kumar ◽  
R. Kumar ◽  
C. Patel ◽  
V. Raina ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Induction Therapy ◽  
Myeloid Leukemia ◽  
Performance Status ◽  
Remission Induction ◽  
Study Results ◽  
Significant Difference ◽  
Group A ◽  
Group B ◽  
Acute Myeloid

6581 Background: Standard induction regimen for the management of acute myeloid leukemia (AML) includes 45 mg/m2 of daunorubicin (DNR) × 3 days and 100 mg/m2 of ara-c × 7 days. Recent studies suggest that higher doses of DNR may have better outcome. Randomized studies to objectively authenticate these observations to the best of our knowledge are not available. This study was undertaken as a preliminary trial to compare the induction remission rates and toxicity of 60 mg/m2 of DNR with standard dose of 45 mg/m2. Methods: Sixty newly diagnosed AML patients, except AML—M3, from January 2003—May 2005 were randomized to either 45mg/m2 (group A ) or 60 mg/m2 (group B) of DNR for three days. The dose of ara-c was 100mg/m2 for 7 days in both groups. All denovo AML patients with 0–2 performance status (ECOG) were included in the study. Results: Fifty six patients were evaluable, 30 in group A and 26 in group B. The baseline demographic and clinical characteristics were comparable. Twenty (67%) patients in group A and 23 (88%) in group B (p=0.05) achieved complete remission (CR). Fifteen (50%) patients in group A and 22 (84.6%) in group B (p=0.006) achieved remission after single course of induction chemotherapy. Nine patients (30%) in group A and 3 (11.5%) in group B died due to uncontrolled sepsis (p=0.09). Five patients, all belonging to Group A, had persistent disease at the time of death. Though there was no significant difference with respect to major organ toxicities in both the groups, duration of grade 4 thrombocytopenia and duration of admission were significantly greater in group A (P=0.02 and P=0.005 respectively). Conclusions: This study indicates that daunorubicin in the dose of 60 mg/m2 is superior to 45mg/m2 as a remission induction therapy for AML patients with good performance status. Further follow up is required to ascertain whether higher remission rate leads to higher disease free and over all survival. No significant financial relationships to disclose.

scholarly journals Acute myeloid leukemia in the real world: why population-based registries are needed

Blood ◽  
2012 ◽  
Vol 119 (17) ◽  
pp. 3890-3899 ◽  
Author(s):  
Gunnar Juliusson ◽  
Vladimir Lazarevic ◽  
Ann-Sofi Hörstedt ◽  
Oskar Hagberg ◽  
Martin Höglund
Keyword(s):  
Acute Myeloid Leukemia ◽  
Real World ◽  
Myeloid Leukemia ◽  
Remission Rate ◽  
Performance Status ◽  
Population Based ◽  
Dynamic Graph ◽  
The Real ◽  
The Impact ◽  
Acute Myeloid

Abstract Population-based registries may provide data complementary to that from basic science and clinical intervention studies, all of which are essential for establishing recommendations for the management of patients in the real world. The same quality criteria apply for the evidence-based label, and both high representation and good data quality are crucial in registry studies. Registries with high coverage of the target population reduce the impact of selection on outcome and the subsequent problem with extrapolating data to nonstudied populations. Thus, data useful for clinical decision in situations not well covered by clinical studies can be provided. The potential clinical impact of data from population-based studies is exemplified with analyses from the Swedish Acute Leukemia Registry containing more than 3300 acute myeloid leukemia (AML) patients diagnosed between 1997 and 2006 with a median follow-up of 6.2 years on (1) the role of intensive combination chemotherapy for older patients with AML, (2) the impact of allogeneic stem cell transplantation on survival of younger patients with AML, and (3) the continuing problem with early deaths in acute promyelocytic leukemia. We also present the first Web-based dynamic graph showing the complex interaction between age, performance status, the proportion of patients given intensive treatment, early death rate, complete remission rate, use of allogeneic transplants, and overall survival in AML (non-AML).

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