Investigating the Prevalence and Prognostic Importance of Polypharmacy in Adults Treated for Newly Diagnosed Acute Myelogenous Leukemia (AML)
調査の概要
詳細な説明
The incidence of acute myelogenous leukemia (AML) increases with age. Older AML patients, generally defined by age 60 years and above, have worse treatment outcomes than younger patients. While selected older patients can benefit from standard therapies, as a group they experience increased treatment-related toxicity, decreased remission rates, decreased disease-free survival and decreased overall survival. Outcome disparity is in part explained by age related biologic features. Older patients are more likely to present with unfavorable cytogenetic abnormalities, multidrug resistance phenotypes, and secondary AML. However, even older adults with favorable tumor biology have a worse prognosis compared to younger patients. Patient-specific factors including impaired physical function and comorbidity independently predict increased treatment toxicity and decreased survival. Improving patient assessment strategies is critical to identify those patients who are most likely to benefit from induction and post-remission therapies.
Treatment decision-making for older adults is hampered by the difficulty of accurately predicting vulnerability to toxicity. Increasing age alone is a risk factor for poor response to therapy. Older adults of the same chronologic age represent a heterogeneous population. Multiple patient-specific factors may impact an older adult's ability to tolerate tumor burden and treatments. Comorbid disease, functional status and cognitive status are examples of factors that reflect an individual patient's reserve capacity; none of these can be adequately assessed with chronologic age alone.
Translating geriatric assessment strategies into the evaluation of older patients with acute leukemia should help refine the treatment approach to this population. One strategy commonly used in geriatric medicine is the comprehensive geriatric assessment (CGA). CGA refers to a multidisciplinary evaluation of geriatric domains, including comorbid disease, physical function, cognitive function, psychological state, nutritional status, and medication management. In older cancer patients CGA can identify problems that may interfere with cancer treatment and is recommended by the NCCN Guidelines for "Senior Adult Oncology". The optimal measures to use and how to change management based on results are less clear.
Medication management may be of particular importance for older adults with AML due to the potentially high prevalence of polypharmacy in this population. Studies of older adults with cancer report average numbers of medications ranging from 4-9. These numbers may be higher for patients being actively treated for acute leukemia. Polypharmacy is associated with increased adverse drug reactions and increased risk of drug-drug interactions. Careful medication review with discontinuation of potentially unnecessary or inappropriate medications may minimize negative consequences of polypharmacy.
To date, however, prevalence and prognostic significance of polypharmacy has not been evaluated in adults undergoing treatment for AML. Investigating the significance of polypharmacy in this population may help improve patient assessment and provide an opportunity to design simple interventions to minimize unnecessary morbidity associated with treatment.
研究の種類
入学 (実際)
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Hospitalized between January 2004 and December 2009 with newly diagnosed AML
- Age ≥60 years at the time of diagnosis
- Received treatment while hospitalized for AML
Exclusion Criteria:
- 30-day mortality data unavailable
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:コホート
- 時間の展望:回顧
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Prevalence of polypharmacy in adults ≥60 years of age hospitalized for treatment of newly diagnosed AML
時間枠:Day 1 (admission)
|
Number of medications at baseline
|
Day 1 (admission)
|
Prevalence of polypharmacy in adults ≥60 years of age hospitalized for treatment of newly diagnosed AML
時間枠:Through hospitilization, an average of 30 days
|
Number of medications at discharge
|
Through hospitilization, an average of 30 days
|
協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRB00014134
- CCCWFU 22410 (その他の識別子:Wake Forest University Health Sciences)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
介入なしの臨床試験
-
University of California, San FranciscoSan Francisco Veterans Affairs Medical Center; Tobacco Related Disease Research Program完了
-
University of MichiganNational Institute on Drug Abuse (NIDA)募集
-
University of PittsburghCenters for Disease Control and Preventionまだ募集していません暴力, ドメスティック | 思春期の暴力 | 暴力、性的 | 暴力、身体的 | 暴力, 偶然ではない | 社会的結束 | 暴力、構造 | コミュニティ内暴力アメリカ
-
University of Southern CaliforniaNational Institutes of Health (NIH)積極的、募集していない
-
Massachusetts General HospitalNational Institutes of Health (NIH); Samaritans of Bostonまだ募集していません自殺念慮 | 自殺未遂 | 自殺