Patient- versus physician-reporting of symptoms and health status in chronic myeloid leukemia

Efficace, Fabio; Rosti, Gianantonio; Aaronson, Neil K.; Cottone, Francesco; Angelucci, Emanuele; Molica, Stefano; Vignetti, Marco; Mandelli, Franco; Baccarani, Michele

doi:10.3324/haematol.2013.093724

Cited by 86 publications

(68 citation statements)

References 29 publications

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“…19 Also, a recent CML study has shown that physicians tend to under-estimate symptom severity and over-estimate the overall health status of their patients. 20 This evidence underscores the need for directly asking patients themselves about their disease and treatment burden, and also confirms, with empirical data, the previously raised concerns about the current practice of assessing intolerance to TKIs (i.e. not patient-reported).…”

Section: © F E R R a T A S T O R T I F O U N D A T I O Nsupporting

confidence: 72%

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Moving towards patient-centered decision-making in chronic myeloid leukemia: assessment of quality of life and symptom burden

2014

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F e r r a t a S t o r t i F o u n d a t i o n Editorials and Perspectives 206haematologica | 2014; 99 (2) response and on treatment recommendations. 7-9 While biochemical or laboratory abnormalities can be recorded objectively, clinical side-effects, for example, are typically recorded and collected by health care professionals (HCPs) who interpret and evaluate reports from the patients themselves. Probably only a few side-effects, like skin rash, alopecia, edema and fluid retention, can really be evaluated directly and, to a certain extent, objectively by the investigators. All available TKIs for first-line therapy, that is imatinib (i.e. 1st-generation TKIs) and dasatinib or nilotinib (i.e. 2nd-generation TKIs), have sideeffects that one should consider when deciding which therapy is best for the individual patient. However, some side-effects can be more frequent with a given TKI. As an example, while fatigue has been reported to be similar amongst the three TKIs, 10 others, such as rash, have been reported to be worse with both 2nd-generation TKIs. 11,12 In any case, in most studies, recording and assessing the type, the intensity and the duration of the side-effects are not planned, apart from formal reference to some internationally recognized scoring systems (e.g. NCI, SWOG). The data obtained with this methodology can be very different, even in company-sponsored, registrative studies.Just to illustrate how challenging it is to draw conclusions with regards to toxicity data, we report (for descriptive purposes only) five studies, [12][13][14][15][16] all in newly diagnosed, chronic phase, CML patients treated with imatinib 400 mg once daily (Table 1). Interestingly, the reported proportion of patients with any grade fatigue and muscle pain ranged from 8% and 34% (ENESTnd) 14 to 50% and 95% (IRIS), 13 respectively. Similarly, marked differences were also reported for all the other major groups of sideeffects (Table 1). The purpose of these studies, that tested imatinib versus other drugs, was to compare the type and Table 1. Percentage of newly diagnosed, chronic phase, CML patients who were reported to complain of the listed side-effects with imatinib. Side-effects (all grades)Pivotal trials comparing imatinib (400 mg once daily) © F e r r a t a S t o r t i F o u n d a t i o nseverity of the side-effects, but not the duration, between two different drugs. However, the reported data in the imatinib arm differed so greatly that it was difficult to assess the imatinib-related burden of symptoms, and can raise doubts as to the value of the comparison. Limitations of standard physician-reported toxicity with regards to the documentation of drug safety have been acknowledged 17 and have prompted the National Cancer Institute (NCI) to create a version of the NCI's Common Terminology Criteria for Adverse Events (PRO-CTCAE) that can be completed by patients themselves, providing direct patient feedback on their experience of their symptoms during treatment. 18In the context of CML treated with long-term TKI the...

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Section: © F E R R a T A S T O R T I F O U N D A T I O Nsupporting

confidence: 72%

“…20 This evidence underscores the need for directly asking patients themselves about their disease and treatment burden, and also confirms, with empirical data, the previously raised concerns about the current practice of assessing intolerance to TKIs (i.e. not patient-reported).…”

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confidence: 72%

Moving towards patient-centered decision-making in chronic myeloid leukemia: assessment of quality of life and symptom burden

2014

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“…Следует отметить, что в последнее время в между-народном гематологическом сообществе при оценке эффекта и безопасности лечения ХМЛ все большее внимание уделяется оценкам самих пациентов [15][16][17][18][19][20], которые содержат информацию о заболевании и лечении, полученную непосредственно от больного и позволяющую судить об эффекте проводимого ле-чения, а также о его рисках с точки зрения самого па-циента. Таким образом, при комплексной оценке эф-фекта и безопасности терапии ХМЛ, помимо определения клинического эффекта и побочных ре-акций, важными составляющими являются качество жизни и профиль симптомов больного [15, [21][22][23][24][25].…”

Section: контакты: татьяна ивановна ионова Tation16@gmailcom в статьunclassified

Quality of life, symptom profile and clinical efficacy of second-line treatment with dasatinib in patients with imatinib-resistant or -intolerant chronic myeloid leukemia: results of 2-year follow-up

Ионова¹,

Никитина²,

Ломаиа³

et al. 2015

Onkogematologiâ

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“…The impact of comorbidities was studied during imatinib treatment in the German CML IV study which enrolled patients between 16 and 88 years old (median, 53 years). 6,7,35 In a recent report, 1519 of these patients were analyzed by cohorts according to their Charlson Comorbidity Index (CCI) at diagnosis. 35 Higher CCI was significantly associated with lower OS.…”

Section: Side Effectsmentioning

confidence: 99%

“…6,7,35 In a recent report, 1519 of these patients were analyzed by cohorts according to their Charlson Comorbidity Index (CCI) at diagnosis. 35 Higher CCI was significantly associated with lower OS. At 8 years, the probabilities for OS for CCI 2, 3-4, 5-6, and .7 were approximately 94%, 89%, 78%, and 46%.…”

Section: Side Effectsmentioning

confidence: 99%

Is there a best TKI for chronic phase CML?

Larson

2015

Blood

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The development of BCR/ABL1 tyrosine kinase inhibitors (TKIs) over the past 20 years has dramatically improved the outcomes for patients with every stage of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML). Clinicians now have access to 5 oral, generally well-tolerated, and highly effective TKIs. How should these agents be used for an individual patient to ensure the best possible duration and quality-of-life, to avoid treatment-related complications, and potentially to achieve a cure at an affordable cost? Because CML patients may need to continue TKI therapy indefinitely, the long-term safety of each treatment option must be considered. Evidence-based care requires an understanding of the optimal use of these drugs, their specific early and late toxicities, the prognostic significance of achieving treatment milestones, and the critical importance of molecular monitoring. Efficacy is important, but treatment choice does not depend only on efficacy. Choosing among various treatment options is informed by understanding the distinct benefits and risks of each agent, along with careful consideration of patient-specific factors, such as risk status, age, and comorbidities.

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Patient- versus physician-reporting of symptoms and health status in chronic myeloid leukemia

Cited by 86 publications

References 29 publications

Moving towards patient-centered decision-making in chronic myeloid leukemia: assessment of quality of life and symptom burden

Moving towards patient-centered decision-making in chronic myeloid leukemia: assessment of quality of life and symptom burden

Quality of life, symptom profile and clinical efficacy of second-line treatment with dasatinib in patients with imatinib-resistant or -intolerant chronic myeloid leukemia: results of 2-year follow-up

Is there a best TKI for chronic phase CML?

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