Comprehensive Geriatric Assessment Does Not Predict Overall Survival in Older Patients with Acute Myeloid Leukemia (AML)

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 3689-3689 ◽  
Author(s):  
Ellen K. Ritchie ◽  
Danielle C. Marshall ◽  
Molly D. Greenberg ◽  
Tania J. Curcio ◽  
Ashley E. Giambrone ◽  
...  
Keyword(s):  
Overall Survival ◽  
Acute Myeloid Leukemia ◽  
Geriatric Assessment ◽  
Comprehensive Geriatric Assessment ◽  
Older Patients ◽  
Myeloid Leukemia ◽  
Performance Status ◽  
Newly Diagnosed ◽  
Wbc Count ◽  
Acute Myeloid

Abstract Background Age and cytogenetics are the strongest predictors of overall survival (OS) in older patients with acute myeloid leukemia (AML), but practitioners recognize that outcomes are also affected by medical comorbidities, physical function and a variety of psychosocial factors. Recent data suggest that geriatric assessment, including measures of physical, cognitive and psychological function, may be predictive of OS and helpful for risk stratification in AML (Klepin 2013). We evaluated the ability of a comprehensive geriatric assessment (CGA) to predict overall survival in newly diagnosed older patients with AML. Patients and Methods All newly diagnosed AML patients age ≥60 years treated at Weill Cornell Medical Center and The New York Presbyterian Hospital completed a CGA including the OARS Physical Health Section, Mental Health Inventory (MHI-17), MOS Social Activity Survey, Activities of Daily Living (ADL) subscale of the MOS Physical Health, OARS Instrumental ADL subscale, Timed Up & Go, Blessed-Orientation-Memory-Concentration Test, and Karnofsky Performance Status (KPS). Laboratory data, medications, transfusions and days of hospitalization were also collected. Comorbidities were assessed using the Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI). OS was estimated by the Kaplan-Meier method and the log-rank test was used to compare survival profiles. The independent effects of the CGA and clinical risk factor variables on OS were estimated using hazard ratios in an adjusted Cox regression model. Results In total, 126 patients were evaluated (median age 74, range 60-90). Fifty-one percent of patients had a HCT-CI score >1, with the most common comorbidities being a history of cancer (28.57%), cardiac disease (20.6%), and psychiatric disturbances (17.5%). Half of the patients had prior hematologic disorders and 29% had poor-risk cytogenetics. Most patients (84.9%) received decitabine-based induction strategies; 44 of these patients (34.9%) subsequently received intensive salvage regimens (median age 69). The other 19 patients (15.1%) were treated with standard induction chemotherapy, and 29 patients (21%) underwent allogeneic stem cell transplantation (median age 68). One hundred twenty-three patients (96.6%) completed the CGA with a mean time to completion of 26 minutes (± 8.9 minutes). Thirty-five percent of patients did not complete the entire assessment and only 61.1% completed the follow up CGA. Median OS was 11.1 months (range 0.36-52.64), with 1-year survival of 47.6%, complete remission (CR) rate of 39.8%, and 30-day mortality of 2.4%. In univariate analysis, age (P=0.0289), physician-assigned KPS (P=0.0031), sex (P=0.0074), ELN cytogenetic risk (P=0.0194), creatinine (P=0.027), albumin (P=0.0052), white blood cell (WBC) count (P=0.0135), LDH (P=0.0004), and treatment response (P=0.0001) were significant clinical predictors of OS. Significant CGA variables included Blessed Orientation-Memory-Concentration score (P=0.0035), Bend-Kneel-Stoop (P=0.0239), “someone to prepare your meals” (P=0.0253) and self-reporting of heart disease (P<0.001). In a multivariate analysis controlling for age and cytogenetic risk, physician-assigned KPS (HR, 1.804; 95% CI 1.175 to 2.768), self-reported cardiac history (HR, 2.290; 95% CI 1.383 to 3.794), and WBC count <11.2/ul (HR, 2.360; 95% CI 1.415 to 3.936) were the only independent prognostic factors for overall survival. Conclusion In this study, age and cytogenetics remain the strongest predictors of OS in older patients with AML. While completion of the CGA was feasible, only performance status (KPS) was predictive of OS. Many measures previously reported as significant predictors of outcome, including impaired physical function (Klepin 2013), medication intake (Hurria 2011), pain (Sherman 2013), and HCT-CI score (Sorror 2005, 2009) were not predictive in our study population. The role of the CGA as a predictor of OS in AML requires further evaluation. The utility of the CGA in predicting functional performance and/or quality of life for older AML patients throughout treatment should also be investigated. Disclosures Ritchie: Celgene, Incyte: Speakers Bureau. Feldman:Ariad: Honoraria, Speakers Bureau; Novartis: Honoraria, Research Funding, Speakers Bureau.

scholarly journals CPX-351 (cytarabine and daunorubicin) Liposome for Injection Versus Conventional Cytarabine Plus Daunorubicin in Older Patients With Newly Diagnosed Secondary Acute Myeloid Leukemia

2018 ◽  
Vol 36 (26) ◽  
pp. 2684-2692 ◽  
Author(s):  
Jeffrey E. Lancet ◽  
Geoffrey L. Uy ◽  
Jorge E. Cortes ◽  
Laura F. Newell ◽  
Tara L. Lin ◽  
...  
Keyword(s):  
Overall Survival ◽  
Acute Myeloid Leukemia ◽  
Older Patients ◽  
Myeloid Leukemia ◽  
Bone Marrow Cells ◽  
Remission Rate ◽  
Phase Iii ◽  
Newly Diagnosed ◽  
Secondary Acute Myeloid Leukemia ◽  
Acute Myeloid

Purpose CPX-351 is a dual-drug liposomal encapsulation of cytarabine and daunorubicin that delivers a synergistic 5:1 drug ratio into leukemia cells to a greater extent than normal bone marrow cells. Prior clinical studies demonstrated a sustained drug ratio and exposure in vivo and prolonged survival versus standard-of-care cytarabine plus daunorubicin chemotherapy (7+3 regimen) in older patients with newly diagnosed secondary acute myeloid leukemia (sAML). Patients and Methods In this open-label, randomized, phase III trial, 309 patients age 60 to 75 years with newly diagnosed high-risk/sAML received one to two induction cycles of CPX-351 or 7+3 followed by consolidation therapy with a similar regimen. The primary end point was overall survival. Results CPX-351 significantly improved median overall survival versus 7+3 (9.56 v 5.95 months; hazard ratio, 0.69; 95% CI, 0.52 to 0.90; one-sided P = .003). Overall remission rate was also significantly higher with CPX-351 versus 7+3 (47.7% v 33.3%; two-sided P = .016). Improved outcomes were observed across age-groups and AML subtypes. The incidences of nonhematologic adverse events were comparable between arms, despite a longer treatment phase and prolonged time to neutrophil and platelet count recovery with CPX-351. Early mortality rates with CPX-351 and 7+3 were 5.9% and 10.6% (two-sided P = .149) through day 30 and 13.7% and 21.2% (two-sided P = .097) through day 60. Conclusion CPX-351 treatment is associated with significantly longer survival compared with conventional 7+3 in older adults with newly diagnosed sAML. The safety profile of CPX-351 was similar to that of conventional 7+3 therapy.

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.

European Development of Clofarabine as Treatment for Older Patients With Acute Myeloid Leukemia Considered Unsuitable for Intensive Chemotherapy

2010 ◽  
Vol 28 (14) ◽  
pp. 2389-2395 ◽  
Author(s):  
Alan K. Burnett ◽  
Nigel H. Russell ◽  
Jonathan Kell ◽  
Michael Dennis ◽  
Donald Milligan ◽  
...  
Keyword(s):  
Overall Survival ◽  
Acute Myeloid Leukemia ◽  
Complete Remission ◽  
Older Patients ◽  
Myeloid Leukemia ◽  
Performance Status ◽  
Poor Performance Status ◽  
Intensive Chemotherapy ◽  
Phase Ii Studies ◽  
Acute Myeloid

Purpose Treatment options for older patients with acute myeloid leukemia (AML) who are not considered suitable for intensive chemotherapy are limited. We assessed the second-generation purine nucleoside analog, clofarabine, in two similar phase II studies in this group of patients. Patients and Methods Two consecutive studies, UWCM-001 and BIOV-121, recruited untreated older patients with AML to receive up to four or six 5-day courses of clofarabine. Patients in UWCM-001 were either older than 70 years or 60 to 69 years of age with poor performance status (WHO > 2) or with cardiac comorbidity. Patients in BIOV-121 were ≥ 65 years of age and deemed unsuitable for intensive chemotherapy. Results A total of 106 patients were treated in the two monotherapy studies. Median age was 71 years (range, 60 to 84 years), 30% had adverse-risk cytogenetics, and 36% had a WHO performance score ≥ 2. Forty-eight percent had a complete response (32% complete remission, 16% complete remission with incomplete peripheral blood count recovery), and 18% died within 30 days. Interestingly, response and overall survival were not inferior in the adverse cytogenetic risk group. The safety profile of clofarabine in these elderly patients with AML who were unsuitable for intensive chemotherapy was manageable and typical of a cytotoxic agent in patients with acute leukemia. Patients had similar prognostic characteristics to matched patients treated with low-dose cytarabine in the United Kingdom AML14 trial, but had significantly superior response and overall survival. Conclusion Clofarabine is active and generally well tolerated in this patient group. It is worthy of further evaluation in comparative trials and might be of particular use in patients with adverse cytogenetics.

A Scoring System for Prediction of FLT3-ITD Positivity in Patients with Newly Diagnosed Acute Myeloid Leukemia.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2590-2590
Author(s):  
Fabiana Ostronoff ◽  
Megan Othus ◽  
Hagop M. Kantarjian ◽  
Soheil Meshinchi ◽  
Farhad Ravandi ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Scoring System ◽  
Myeloid Leukemia ◽  
Conflicts Of Interest ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Cancer Center ◽  
Newly Diagnosed ◽  
Wbc Count ◽  
Acute Myeloid

Abstract Abstract 2590 Background FLT3-internal tandem duplication (ITD) is found in about 30% of patients with acute myeloid leukemia (AML) at diagnosis and confers a high risk of relapse. Thus allogeneic hematopoietic transplant (HCT) is recommended for these patients in first complete remission (CR) and after HCT they become candidates for trials of FLT3-ITD inhibitors (such as quizartinib) to prevent relapse. However at referral to tertiary centers after reaching CR, FLT3-ITD status at diagnosis is often unknown, complicating decisions about HCT. FLT3-ITDs are known to be associated with a normal karyotype (NK), translocation 6;9 and a high white blood cell (WBC) count, and we hypothesized that assessment of likely FLT3-ITD status at diagnosis in patients presenting in CR not tested at diagnosis would be improved by examining these covariates simultaneously. Methods Our initial analysis included 434 adult patients with newly diagnosed AML (excluding APL) treated on three SWOG trials (S9031, S9333, and S0106) in whom FLT3-ITD status (positive/negative) was established at diagnosis. Univariate and then multivariate analyses were used to identify covariates independently associated with FLT3-ITD positivity. The relative abilities of these to predict FLT3-ITD positivity were quantified using the area under the receiver operator characteristic curve (AUC); an AUC of 1.0 denotes perfect prediction, whereas an AUC of 0.5 is analogous to a coin flip. The log odds ratios (ORs) from the multivariate models were used to assign a score to each covariate and scores were summed; such that the higher the score, the greater is the likelihood of the FLT3-ITD positivity at diagnosis. We tested the performance of the scoring system in 2 newly-diagnosed populations that had not contributed to the system's development and in whom FLT3-ITD status at diagnosis was known: (a) 210 patients treated at FHCRC (Fred Hutchinson Cancer Research Center) and (b) 1,401 patients treated at MDACC (M.D. Anderson Cancer Center). Covariates examined were: age, sex, performance status (PS), WBC count, platelet count, bone marrow blast percentage, secondary AML, and cytogenetic risk (using SWOG/Eastern Cooperative Oncology Group criteria). Results FLT3- ITD was present in 101 of the 434 SWOG patients (23%) in the scoring system development population. The log OR were rounded to the nearest half point to create the scoring system. Only WBC > 20,000 (reference, WBC < 20,000) and cytogenetics (reference, normal) had non-zero scores, which are summarized below: Scores less than −0.5 were called low, ≥−0.5 and <0.5 intermediate, ≥ 0.5 high. The AUC was 0.75 and contrasted with 0.66 and 0.69 when only WBC or cytogenetics were considered. However when this system was tested in the FHCRC population (16% FLT3-ITD positive) its AUC was only 0.58, not better than when each covariate was examined separately (AUC 0.54 and 0.6 for WBC and cytogenetics, respectively). Similarly at MDACC (17% FLT3-ITD positive) the system's AUC was 0.68 vs. 0.59 and 0.68 for WBC and cytogenetics, respectively. Conclusion Although this scoring system seemed useful tool within the population it was developed (SWOG), such was not the case in two independent cohorts of AML patients with known FLT3-ITD status (FHCRC and MDACC). This indicates that there is no obvious substitute for actual data on FLT3-ITD status. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Epigenetic therapy is associated with similar survival compared with intensive chemotherapy in older patients with newly diagnosed acute myeloid leukemia

Blood ◽  
2012 ◽  
Vol 120 (24) ◽  
pp. 4840-4845 ◽  
Author(s):  
Alfonso Quintás-Cardama ◽  
Farhad Ravandi ◽  
Theresa Liu-Dumlao ◽  
Mark Brandt ◽  
Stefan Faderl ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Older Patients ◽  
Myeloid Leukemia ◽  
Performance Status ◽  
Survival Rates ◽  
Epigenetic Therapy ◽  
Intensive Chemotherapy ◽  
Newly Diagnosed ◽  
Similar Survival ◽  
Acute Myeloid

Abstract We reviewed the outcome of 671 patients 65 years of age or older with newly diagnosed acute myeloid leukemia (AML) treated at our institution between 2000 and 2010 with intensive chemotherapy (n = 557) or azacitidine- or decitabine-based therapy (n = 114). Both groups were balanced according to cytogenetics and performance status. The complete response rates with chemotherapy and epigenetic therapy were 42% and 28%, respectively (P = .001), and the 8-week mortality 18% and 11%, respectively (P = .075). Two-year relapse-free survival rates (28% vs 39%, P = .843) and median survival (6.7 vs 6.5 months, P = .413) were similar in the 2 groups. Multivariate analysis identified older age, adverse cytogenetics, poor performance status, elevated creatinine, peripheral blood and BM blasts, and hemoglobin, but not type of AML therapy, as independent prognostic factors for survival. No outcome differences were observed according to cytogenetics, FLT3 mutational status, age, or performance status by therapy type. Decitabine was associated with improved median overall survival compared with azacitidine (5.5 vs 8.8 months, respectively, P = .03). Survival after failure of intensive chemotherapy, azacitidine, or decitabine was more favorable in patients who had previously received decitabine (1.1 vs 0.9 vs 3.1 months, respectively, P = .109). The results of the present study show that epigenetic therapy is associated with similar survival rates as intensive chemotherapy in older patients with newly diagnosed AML. The studies reviewed are registered at www.clinicaltrials.gov as 2009-0172 (NCT00926731) and 2009-0217 (NCT00952588).

Untreated Patients with Acute Myeloid Leukemia, Age 50–59 Years and Performance Status 2 Should Be as Eligible for Targeted Therapy as Older Patients.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 2864-2864
Author(s):  
Apostolia M. Tsimberidou ◽  
Hagop M. Kantarjian ◽  
Stefan Faderl ◽  
Sherry Pierce ◽  
Emil J. Freireich ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Older Patients ◽  
Myeloid Leukemia ◽  
Performance Status ◽  
Newly Diagnosed ◽  
Death Rates ◽  
Targeted Treatments ◽  
High Death ◽  
And Performance ◽  
Acute Myeloid

Abstract Background: The early mortality rates in older patients (generally defined as those > 60 years) following standard therapy for acute myeloid leukemia (AML), has spurred numerous trials of “targeted” treatments, typically limited to this age group. Here we examine whether younger patients with Zubrod performance status (PS) 2 might also be candidates for these therapies. Patients and Methods: We reviewed the records of 1841 patients 40 years or older with newly diagnosed AML (no acute promyelocytic leukemia) who received cytarabine-containing therapy at M. D. Anderson from 1980 to 2007. We chose patients with the following pretreatment characteristics because they are conventional criteria for entry onto trials of new therapies: PS 0–2, bilirubin < 2 mg/dL, and creatinine < 2 mg/dL. We calculated death rates by age and PS at 28 and 42 days after initiation of induction therapy. Results: Induction death rates in patients with AML by age and performance status The 28-day death rates in patients age 50–59 years with PS 2 were similar to those in patients ≥ 60 years with PS 0–1, and the 42-day death rates in the patients age 50–59 years with PS 2 were similar to those in patients age 60–79 with PS 0–1. Conclusion: Because of the high death rates following AML therapy in patients age 50–59 with PS 2, these patients should be eligible for targeted treatments now limited to older patients. Age, yrs Performance Status No. of Patients Dead by day 28, % Dead by day 42 % 40–49 0–1 288 7 9 40–49 2 38 5 5 50–59 0–1 405 4 6 50–59 2 85 14 15 60–69 0–1 423 8 11 60–69 2 111 17 17 70–79 0–1 301 12 16 70–79 2 124 23 33 ≥80 0–1 45 13 20 ≥ 80 2 21 38 43

Sequential Combination of Gemtuzumab Ozogamicin and Standard Chemotherapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia: Results of a Randomized Phase III Trial by the EORTC and GIMEMA Consortium (AML-17)

2013 ◽  
Vol 31 (35) ◽  
pp. 4424-4430 ◽  
Author(s):  
Sergio Amadori ◽  
Stefan Suciu ◽  
Roberto Stasi ◽  
Helmut R. Salih ◽  
Dominik Selleslag ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Older Patients ◽  
Myeloid Leukemia ◽  
Gemtuzumab Ozogamicin ◽  
Phase Iii ◽  
Newly Diagnosed ◽  
Standard Chemotherapy ◽  
Sequential Combination ◽  
Grade 3 ◽  
Acute Myeloid

Purpose This randomized trial evaluated the efficacy and toxicity of sequential gemtuzumab ozogamicin (GO) and standard chemotherapy in older patients with newly diagnosed acute myeloid leukemia (AML). Patients and Methods Patients (n = 472) age 61 to 75 years were randomly assigned to induction chemotherapy with mitoxantrone, cytarabine, and etoposide preceded, or not, by a course of GO (6 mg/m2 on days 1 and 15). In remission, patients received two consolidation courses with or without GO (3 mg/m2 on day 0). The primary end point was overall survival (OS). Results The overall response rate was comparable between the two arms (GO, 45%; no GO, 49%), but induction and 60-day mortality rates were higher in the GO arm (17% v 12% and 22% v 18%, respectively). With median follow-up of 5.2 years, median OS was 7.1 months in the GO arm and 10 months in the no-GO arm (hazard ratio, 1.20; 95% CI, 0.99 to 1.45; P = .07). Other survival end points were similar in both arms. Grade 3 to 4 hematologic and liver toxicities were greater in the GO arm. Treatment with GO provided no benefit in any prognostic subgroup, with the possible exception of patients age < 70 years with secondary AML, but outcomes were significantly worse in the oldest age subgroup because of a higher risk of early mortality. Conclusion As used in this trial, the sequential combination of GO and standard chemotherapy provides no benefit for older patients with AML and is too toxic for those age ≥ 70 years.

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