Measuring the symptom burden associated with the treatment of chronic myeloid leukemia

Williams, Loretta A.; Gonzalez, Araceli Garcia; Ault, Patricia; Mendoza, Tito R.; Sailors, Mary L; Williams, Janet L.; Huang, Furong; Nazha, Aziz; Kantarjian, Hagop M.; Cleeland, Charles S.; Cortes, Jorge

doi:10.1182/blood-2013-01-477687

Cited by 94 publications

(82 citation statements)

References 32 publications

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“…13 Importantly, the severity of TKI side effects tended to remain relatively constant over time. A study undertaken in imatinibtreated patients showed impaired physical and mental health status in patients ,60 years of age, whereas older CML patients on average had a health status comparable to age-matched controls.…”

Section: Problems With Ongoing Tki Therapymentioning

confidence: 99%

Moving treatment-free remission into mainstream clinical practice in CML

Hughes

Ross

2016

Blood

290

260

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The dramatic success of tyrosine kinase inhibitors (TKIs) has led to the widespread perception that chronic myeloid leukemia (CML) has become another chronic disease, where lifelong commitment to pharmacologic control is the paradigm. Recent trials demonstrate that some CML patients who have achieved stable deep molecular response can safely cease their therapy without relapsing (treatment free remission [TFR]). Furthermore, those who are unsuccessful in their cessation attempt can safely re-establish remission after restarting their TKI therapy. Based on the accumulated data on TFR, we propose that it is now time to change our approach for the many CML patients who have achieved a stable deep molecular response on long-term TKI therapy. Perhaps half of these patients could successfully achieve TFR if offered the opportunity. For many of these patients ongoing therapy is impairing quality of life and imposing a heavy financial burden while arguably achieving nothing. This recommendation is based on the evident safety of cessation attempts and TFR in the clinical trial setting. We acknowledge that there are potential risks associated with cessation attempts in wider clinical practice, but this should not deter us. Instead we need to establish criteria for safe and appropriate TKI cessation. Clinical trials will enable us to define the best strategies to achieve TFR, but clinicians need guidance today about how to approach this issue with their patients. We outline circumstances in which it would be in the patient's best interest to continue TKI, as well as criteria for a safe TFR attempt.

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Section: Problems With Ongoing Tki Therapymentioning

confidence: 99%

Moving treatment-free remission into mainstream clinical practice in CML

Hughes

Ross

2016

Blood

290

260

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“…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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“…26 Unlike the EORTC QLQ CML-24, this questionnaire has been devised to evaluate symptom burden (rather than QoL). The strength of this tool was the longitudinal analysis performed in the development process, which further supported validity data.…”

Section: Use and Area Of Applications Of Pro Instruments In CMLmentioning

confidence: 99%

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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Measuring the symptom burden associated with the treatment of chronic myeloid leukemia

Cited by 94 publications

References 32 publications

Moving treatment-free remission into mainstream clinical practice in CML

Moving treatment-free remission into mainstream clinical practice in CML

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

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

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