Long-Term Quality of Life in Patients With Acute Promyelocytic Leukemia

Study Overview
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Brief Summary
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This study will focus on acute promyelocytic leukemia patients who have been diagnosed more than 5 years ago and their present quality of life. The possible late effects of cancer treatment can include several issues and, thus, there has been an increasing interest worldwide in studying the long-term impact of these in patients' life.

Detailed Description
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This study will focus on long-term survivors as defined by the America Cancer Society, that is surviving the initial diagnosis for more than 5 years. Previous research has investigated long-term Health Related Quality of Life (HRQOL) in patients with acute myeloid leukemia, however, this will be the first research conducted to investigate long-term HRQOL outcomes in patients with acute promyelocytic leukemia (APL). The potential late effects of cancer treatment can include second malignancies or other chronic conditions affecting physical and emotional well-being. Therefore, there has been an increasing interest worldwide in evaluating the longer-term impact of cancer and its treatment. Currently large cohort of patients enjoys disease-free survival of 5 years or longer. However, a disease-free status is not synonymous with a life free of physical and psychological health related to the cancer and/or its treatment. Research shows that cancer related health concerns persist long after initial treatment and this has been shown in several cancer populations including prostate, testicular, breast cancer and lymphoma patients. Long-term cancer survivors can experience treatment-induced morbidity (e.g. cardiovascular damage due to chemotherapy or radiotherapy; infertility and second tumors), chronic disease and treatment-related symptoms, functional impairment, psychosocial problems, and practical problems. Since the introduction of the vitamin A derivative all-trans retinoic acid (ATRA) as front-line therapy for APL, the outcome of this acute leukemia subtype has changed from the state of a most frequently fatal leukemia to the condition of a highly curable disease. The Italian cooperative group GIMEMA designed in 1993 the AIDA (Atra plus IDArubicin) trial for newly diagnosed APL. Results on over 800 patients showed a complete remission (CR) rate > 90% and an overall survival of 76% and confirmed that the concomitant administration of ATRA and chemotherapy is more effective than the sequential administration. Following the identification of distinct prognostic categories among APL patients, the GIMEMA group designed a new trial (AIDA2000) in which the intensity of post-remission treatment was adapted to the relapse risk and 498 patients were enrolled since January 2000. The results recently published showed a CR rate >90% with molecular remission rate after third consolidation of 98%. The new schedule allowed a Disease Free Survival (DFS) of 86% and showed that a risk-adapted strategy including ATRA for consolidation provides an outcome improvement in newly diagnosed patients. As reported by an international panel of experts, simultaneous ATRA and anthracycline chemotherapy schedules such as those used in the AIDA protocols represent the state of the art therapy for newly diagnosed APL.

Official Title
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Long-Term Quality of Life in Patients With Acute Promyelocytic Leukemia: a Follow-up Observational Study of Patients Enrolled in the GIMEMA AIDA 0493 and AIDA 200

Conditions
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Acute Promyelocytic Leukemia

Intervention / Treatment
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* Other: Health Related Quality of Life (HRQOL) measures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: APL patients previously enrolled in the studies GIMEMA AIDA0493 and AIDA2000 surviving the initial diagnosis for more than 5 years and are in CR. Written informed consent provided. Adult patients at the time of registration onto this study. Exclusion Criteria: Concomitant major psychiatric disorders or cognitive dysfunctions that would interfere with a self-reported evaluation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients being studied<br>APL patients previously enrolled in GIMEMA AIDA 0493 and AIDA 2000 studies. | Other: Health Related Quality of Life (HRQOL) measures<br> <br> * Other names: MD Anderson Symptom Inventory (MDASI).;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical significance on each of the SF-36 questionnaire scales. | This will be performed by using HRQOL scores available for the Italian population. This will help identify which specific areas are mostly impaired and to what extent these patients recover in terms of HRQOL over the long run. This kind of comparison, which is only possible when HRQOL cultural-based norms are available, is largely used when investigating long-term HRQOL in cancer survivors and it is widely recognized as one of the most valuable approach in this kind of research setting. | One month from study entry. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of EORTC-QLQC30 scales with social-demographic and clinical treatment related variables. |  | One month from study entry. | 
| Association of MDASI scales (i.e., symptom severity and symptom interference) with different treatment strategies tested in the two GIMEMA trials. |  | One month from study entry. | 
| Association of EORTC-QLQC30 scales with different treatment strategies tested in the two GIMEMA trials. |  | One month from study entry. | 
| Association of rate of secondary malignancies with different treatment strategies tested in the two GIMEMA trials. |  | One month from study entry | 
| Possible differences in EORTC-QLQC30, MDASI and SF-36 scales between patients who were less than eighteen years old at the time of diagnosis and patients who were at least eighteen years old at the time of diagnosis. |  | One month from study entry | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life, Health related quality of life outcomes, Long-term, Aida 0493, AIDA 2000