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

Juliusson, Gunnar; Lazarevic, Vladimir; Hörstedt, Ann-Sofi; Hagberg, Oskar; Höglund, Martin

doi:10.1182/blood-2011-12-379008

Cited by 242 publications

(175 citation statements)

References 55 publications

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“…13 The performance status at AML presentation is associated with mortality within 30 days from induction. 1,14 In the panelists' opinion, making a realistic judgment about patient's unfitness requires a careful performance status reassessment after adequate intensive supportive treatment. The threshold of performance status chosen for defining unfitness to intensive chemotherapy was a value 42 and the decision was in accordance with the results of the literature.…”

Section: Editorialmentioning

confidence: 99%

“…The threshold of performance status chosen for defining unfitness to intensive chemotherapy was a value 42 and the decision was in accordance with the results of the literature. 1,15 Patient's financial and socioeconomic status, presence of a caregiver and distance from the caring center are further critical factors allowing care of AML to be delivered and follow-up to be performed. However, our panelists agreed that these dimensions should not entail a relevance, in the frame of the Italian perspective of social security and welfare, in that patients may trust in a number of facilities and supports (that is, home care, free transportation, social assistance).…”

Section: Editorialmentioning

confidence: 99%

See 1 more Smart Citation

Consensus-based definition of unfitness to intensive and non-intensive chemotherapy in acute myeloid leukemia: a project of SIE, SIES and GITMO group on a new tool for therapy decision making

et al. 2013

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Section: Editorialmentioning

confidence: 99%

Section: Editorialmentioning

confidence: 99%

Consensus-based definition of unfitness to intensive and non-intensive chemotherapy in acute myeloid leukemia: a project of SIE, SIES and GITMO group on a new tool for therapy decision making

et al. 2013

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“…In the older segment, median survival generally is short (2.4 months overall); it ranges from 3.9 months among those age 65-74 years to 1.4 months among those age 85 years or older [6][7][8]. Cytogenetic abnormalities represent an important prognostic factor for predicting remission rate, relapse risk, and survival outcome.…”

Section: Introductionmentioning

confidence: 99%

“…Azacitidine is approved in patients with marrow blast percentages between 20% and 30% who fulfill the criteria for AML according to the 2008 World Health Organization (WHO) classification. Despite improvements in outcomes for younger patients in recent decades, there has been little progress in improving prognosis for patients age $60 years [7,8]. AML, especially in older patients, remains an area of significant unmet need.…”

Section: Introductionmentioning

confidence: 99%

The European Medicines Agency Review of Decitabine (Dacogen) for the Treatment of Adult Patients With Acute Myeloid Leukemia: Summary of the Scientific Assessment of the Committee for Medicinal Products for Human Use

et al. 2016

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On September 20, 2012, a marketing authorization valid throughout the European Union (EU) was issued for decitabine for the treatment of adult patients aged 65 years and older with newly diagnosed de novo or secondary acute myeloid leukemia (AML) who are not candidates for standard induction chemotherapy. Decitabine is a pyrimidine analog incorporated into DNA, where it irreversibly inhibits DNA methyltransferases through covalent adduct formation with the enzyme.The use of decitabine was studied in an open-label, randomized, multicenter phase III study (DACO-016) in patients with newly diagnosed de novo or secondary AML. Decitabine (n 5 242) was compared with patient's choice with physician's advice (n 5 243) of low-dose cytarabine or supportive care alone. The primary endpoint of the study was overall survival. The median overall survival in the intent-to-treat (ITT) population was 7.7 months among patients treated with decitabine compared with 5.0 months for those in the control arm (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.69-1.04; p 5 .1079). Mature survival data after an additional year of follow-up were consistent with these results, with a median overall survival of 7.7 months in patients treated with decitabine and 5.0 months in the control arm (HR, 0.82; 95% CI, 0.68-0.99; p 5 .0373). Secondary endpoints, including response rates, progressionfree survival, and event-free survival, were increased in favor of decitabine when compared with control treatment. The most common adverse drug reactions reported during treatment with decitabine are pyrexia, anemia, thrombocytopenia, febrile neutropenia, neutropenia, nausea, and diarrhea. This paper summarizes the scientific review of the application leading to approval of decitabine in the EU. The detailed scientific assessment report and product information (including the summary of product characteristics) for this product are available on the EMA website (http://www.ema.europa.eu). The Oncologist 2016;21:692-700

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“…7 Lower CR rates result from intrinsic biological AML-related factors, including a higher frequency of multi-drug resistance (MRD) gene overexpression, higher frequency of secondary or treatment-related AML, 8 and higher frequency of poor molecular and cytogenetic risks compared to younger patients. [8][9][10][11] Lower CR rates can also be contributed by patient-related factors increasing TRM, 9 including lower performance status, 7 greater co-morbidities and lesser physiologic resilience compared to younger AML patients. Reported studies indicate that although age is important, performance status, associated comorbidities and impairment of functional status have a greater impact on survival.…”

Section: Induction Therapymentioning

confidence: 99%

To transplant or not: a dilemma for treatment of elderly AML patients in the twenty-first century

Üstün

Lazarus

Weisdorf

2013

Bone Marrow Transplant

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AML treatment presents significant challenges in the elderly, who more often have poor risk cytogenetic and molecular markers, comorbidities and compromised performance status. Although population-based studies indicate that treated patients' survival is better than those who are not treated, there is an understandable reluctance of physicians to choose aggressive therapy. Even in this older population 40-60% CR rates are achievable. Several scoring systems and web-based programs help to predict TRM and CR rates. These sources can assist physicians in the difficult decision-making process of aggressive therapy in an individual patient. Clofarabine and hypomethylating agents are reasonable options and can induce CR in patients who cannot receive standard induction with anthracyclines and cytarabine. Despite encouraging CR rates, median survival remains short (o12 months) in elderly AML patients. Even those patients achieving CR have limited long-term survival (B20% at 3 years) without allogeneic hematopoietic cell transplantation (alloHCT). AlloHCT is feasible and can provide approximately 40% survival at 2 years in appropriately selected patients. Although increased age is associated with poorer survival, higher comorbidities and poor performance status have more negative impact than age per se. The short duration of CR demands that leukemia and transplant physicians collaborate immediately after diagnosis to move quickly toward alloHCT. This collaboration is also essential to choosing the right individuals to transplant and to bridging post-remission therapy (intermediate-dose cytarabine, a hypomethylating agent or FLT-3 inhibitor) in this sometimes frail population. Future studies should be designed not only to address who should receive alloHCT, but also to improve our understanding of AML biology and the process of its cure.

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

Cited by 242 publications

References 55 publications

Consensus-based definition of unfitness to intensive and non-intensive chemotherapy in acute myeloid leukemia: a project of SIE, SIES and GITMO group on a new tool for therapy decision making

Consensus-based definition of unfitness to intensive and non-intensive chemotherapy in acute myeloid leukemia: a project of SIE, SIES and GITMO group on a new tool for therapy decision making

The European Medicines Agency Review of Decitabine (Dacogen) for the Treatment of Adult Patients With Acute Myeloid Leukemia: Summary of the Scientific Assessment of the Committee for Medicinal Products for Human Use

To transplant or not: a dilemma for treatment of elderly AML patients in the twenty-first century

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