A systematic review of patient reported outcomes in phase II or III clinical trials of myelodysplastic syndromes and acute myeloid leukemia

Bryant, Ashley Leak; Drier, Sarah W.; Lee, Se-Jin; Bennett, Antonia V.

doi:10.1016/j.leukres.2018.06.006

Cited by 13 publications

(16 citation statements)

References 42 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…This threshold is based on several studies linking an improvement of QoL and disease-specific outcomes with Hb levels. [11][12][13][14][15][16][17][18][19][20][21] • LTB patients Apart from the definition of transfusion dependence and independence, another major criterion for the assessment of the erythroid response is the baseline Hb level, which according to IWG 2006 has to be ,11 g/dL before treatment in NTD patients.…”

Section: Panel Recommendationmentioning

confidence: 99%

“…On the other hand, treatment of anemia, including its accurate monitoring and assessment, is crucial for both the general improvement of the QoL of the patients as well as disease-specific outcomes. [11][12][13][14][15][16][17][18][19][20][21] and North America followed the procedures used for the development of the current ELN guidelines on MDSs. 22 The consensus development was based on review of recent literature on the topic as well as recent clinical experience, especially in 3 recent randomized trials 9,10,23 using drugs (ESA or lenalidomide) to treat anemia of lower-risk MDSs, which served as a platform to identify pitfalls of current IWG 2006 guidelines.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Proposals for revised IWG 2018 hematological response criteria in patients with MDS included in clinical trials

Platzbecker

Fenaux

Adès

et al. 2019

Blood

117

119

View full text Add to dashboard Cite

The heterogeneity of myelodysplastic syndromes (MDSs) has made evaluating patient response to treatment challenging. In 2006, the International Working Group (IWG) proposed a revision to previously published standardized response criteria (IWG 2000) for uniformly evaluating clinical responses in MDSs. These IWG 2006 criteria have been used prospectively in many clinical trials in MDSs, but proved challenging in several of them, especially for the evaluation of erythroid response. In this report, we provide rationale for modifications (IWG 2018) of these recommendations, mainly for “hematological improvement” criteria used for lower-risk MDSs, based on recent practical and reported experience in clinical trials. Most suggestions relate to erythroid response assessment, which are refined in an overall more stringent manner. Two major proposed changes are the differentiation between “procedures” and “criteria” for hematologic improvement–erythroid assessment and a new categorization of transfusion-burden subgroups.

show abstract

Section: Panel Recommendationmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Proposals for revised IWG 2018 hematological response criteria in patients with MDS included in clinical trials

Platzbecker

Fenaux

Adès

et al. 2019

Blood

117

119

View full text Add to dashboard Cite

show abstract

“…In clinical trial settings, PRO instruments evaluate therapeutic responses, quality of life, and prognosis 10…”

Section: Introductionmentioning

confidence: 99%

<p>Ruxolitinib In The Treatment Of Polycythemia Vera: An Update On Health-Related Quality Of Life And Patient-Reported Outcomes</p>

Cingam¹,

Flatow-Trujillo²,

Andritsos³

et al. 2019

JBM

View full text Add to dashboard Cite

Polycythemia vera (PV) is a rare myeloproliferative neoplasm (MPN) associated with significant impairment in quality of life (QoL) due to disease-related symptoms and complications. Assessment of disease burden constitutes standard monitoring of symptoms and response. Conventional treatments for MPN, such as hydroxyurea, phlebotomy, or interferon, have not shown a significant impact in QoL or patient-reported outcomes (PRO). Ruxolitinib (RUX) is a JAK2 inhibitor approved for patients intolerant or resistant to hydroxyurea (HA). We conducted a systematic review of clinical trials of RUX in patients with PV that incorporated PRO measures to evaluate the effects on PRO and QoL. Three randomized Phase 3 studies reported in four publications were relevant for analysis. Although the small number of trials and potential for treatment bias in the review, treatment with RUX was associated with improved QoL and PRO in PV patients intolerant or resistant to hydroxyurea.

show abstract

“…In our analysis, survivors with diagnoses of acute leukemia (ALL or AML) and diffuse B-cell lymphoma were more likely to be in these classes compared with class 1 (low concerns). Previous studies have demonstrated the high symptom burden experienced by these patients, primarily in the short term after treatment completion 3,4 . Our findings suggest that symptom clusters are also present among hematological cancer survivors, pointing to the need for assessment and management strategies that address these symptoms simultaneously.…”

Section: Discussionmentioning

confidence: 55%

Patterns of Concerns Among Hematological Cancer Survivors

et al. 2022

Self Cite

View full text Add to dashboard Cite

Background: Advances in treatment for hematological cancers warrant greater attention on survivorship concerns. Objective: The aims of this study were to describe survivorship concerns among hematological cancer survivors, identify subgroups of survivors with distinct classes of concerns, and examine sociodemographic and clinical differences across subgroups. Methods: We conducted a cross-sectional analysis of data from 1160 hematological cancer survivors, who rated their degree of concern regarding 20 physical, emotional, and practical changes. Clusters of concerns were identified using latent class analysis. Associations between respondent characteristics and cluster membership were calculated using multinomial logistic regression. Results:Survivors had a mean of 7.5 concerns (SD, 4.6; range, 0-19), the most frequent being fatigue/tiredness (85.4%); anxiety, stress, and worry about cancer returning (70.2%); and changes to concentration/memory (55.4%). Three distinct classes of concerns were identified: class 1 (low, 47.0%), characterized by low endorsement of most concerns, apart from fatigue; class 2 (moderate, 32.3%), characterized by high endorsement of a combination of concerns across domains; and class 3 (high, 20.7%), characterized by the highest number of concerns out of the 3 identified classes, including greater endorsement of concerns relating to sexual well-being. Class membership was differentiated by survivor age, sex, marital status, and diagnosis. Conclusions: Three distinct patterns of concerns were detected in a large sample of hematological cancer survivors. Patterns of concerns could be differentiated by survivor characteristics. Implications for

show abstract

A systematic review of patient reported outcomes in phase II or III clinical trials of myelodysplastic syndromes and acute myeloid leukemia

Cited by 13 publications

References 42 publications

Proposals for revised IWG 2018 hematological response criteria in patients with MDS included in clinical trials

Proposals for revised IWG 2018 hematological response criteria in patients with MDS included in clinical trials

<p>Ruxolitinib In The Treatment Of Polycythemia Vera: An Update On Health-Related Quality Of Life And Patient-Reported Outcomes</p>

Patterns of Concerns Among Hematological Cancer Survivors

Contact Info

Product

Resources

About