NEW ORLEANS—A new, simple, comprehensive health status assessment scale may lead to improved clinical decision-making in older patients with hematologic malignances, according to a study presented here at the American Society of Hematology Annual Meeting (Abstract 2979).
Santiago Bonanad, MD, of Hospital Universitario de la Ribera in Spain, noted that older patients represent the most prevalent population in oncological practice and their shortened life-expectancy and the presence of comorbidities or disabilities can complicate the process of decision-making. “They may be undertreated, mainly because of their advanced age, regardless of whether they are highly functional patients, do not present comorbidities, or could benefit from oncological therapies,” he said in an interview.
Although both the U.S. National Comprehensive Cancer Network and the International Society of Geriatric Oncology have recommended that some form of geriatric assessment be conducted to help hematologists and oncologists identify current health problems, guide interventions to reduce adverse outcomes, and optimize functional status, neither organization has as yet determined the best form of such an assessment.
Currently, the main tool for assessing older patients is a comprehensive geriatric assessment, although its complexity and duration may hinder regular use in daily practice as a tool for clinical decision-making, he continued. Several attempts have been made to assess comorbidities in myelodysplasia, but those have focused mainly on organic damage rather than global assessment. “Most of the available instruments are complex and time-consuming, which may hinder their regular use in daily practice as a tool for correct clinical decision-making,” he said.
Bonanad and his Spanish colleagues aimed to develop and validate a new comprehensive health status assessment scale, the Geriatric Assessment in Hematology (GAH Scale), in patients at least 65 years old with myelodysplastic syndromes (MDS), acute myeloblastic leukemia (AML), or multiple myeloma.
The GAH scale was developed by hematologists and geriatricians as a thorough evaluation of older patients with hematologic malignancies, encompassing several validated clinical dimensions. The researchers created a brief scale of eight dimensions with selected items: the number of drugs, gait speed, mood, activities of daily living, subjective health status, nutrition, mental status, and comorbidity.
In an attempt to test this initial brief scale, the researchers conducted an exploratory study of 83 patients. This multicenter, observational, prospective study was carried out at 20 hospitals in Spain, enrolling elderly patients who were not previously treated. After a psychometric validation phase, further studies will be carried out in order to evaluate clinical use for prognosis and clinical decision-making, Bonanad said.
The plan is to eventually enroll 360 patients, and so far, 254 evaluable patients have been enrolled. Bonanad presented preliminary results of 189 patients with a median age of 76. Slightly more than half of the patients had MDS or AML, and the rest had multiple myeloma.
The mean amount of time needed to fill out the questionnaire was 12 minutes. Almost 84 percent of patients answered all of the questions of the scale, leading to a mean percentage of unanswered questions per patient of one percent.
A visual analog assessment (VAS) was used to measure the physician's perception of the patient's health status, which showed a median VAS of 7.0 for MDS/AML and multiple myeloma. Content validity was established between the eight dimensions of the GAH Scale and external variables, including ECOG, Karnofsky, and Physicians VAS scores.
A test-retest was completed by 112 patients, and the GAH Scale showed satisfactory reliability. The results indicate that the GAH Scale is independent of the observer and is stable in clinically stable patients, he said.
In conclusion, Bonanad said, “These preliminary data of the GAH Scale show the scale is a valid, reliable, and consistent tool, simple enough to assess health status in older patients with hematological malignancies. There was a good correlation between the scale dimensions and external variables.”
Comorbidities do not seem to correlate with the ECOG or VAS scores, he noted.
Further clinical studies are still needed to establish whether the GAH Scale may be a tool to improve clinical decision making in these groups of patients, he added.
‘In Making Decisions, Oncologists Need to Consider Everyday Things’
Asked for his opinion, Fabio Efficace, MD, Head of the Outcomes Research Program for the Italian Group for Adult Hematologic Diseases (GIMEMA), said, “This study is important because physicians often overlook quality-of-life and daily living issues. A patient may have good cytogenetics and no comorbidity, but if the patient's fatigue level is high, and he is unable to care for himself, then he may not be a good candidate for transplant.
“This kind of health-assessment scale comes the closest to getting to true decision making.”
Quality of life needs to be included in the decisions oncologists make—for example, to choose a patient to go to transplant and to have donors give blood, he continued. “Right now, most decisions are made through cytogenetics, blood type, and whether a patient has a matched or unmatched donor available. Oncologists need to consider everyday things. Can the patient feed herself? Is she able to shop by herself?”
Fatigue levels are often ignored when physicians discuss if a patient is a good candidate for transplant, Efficace noted. “Some kind of intervention may be necessary for fatigue. Once fatigue has been assessed, it can be dealt with. For example, patients who are anemic can receive a blood transfusion or treatment with hypomethylating agents to raise the red blood cell count to reduce fatigue levels.”
Efficace's message to oncologists is simple: “The human aspect—not just molecular values, cytogenetics, and biological criteria—needs to be included in clinical decisions.”
Quality of Life in MDS
The issue of anemia in myelodysplastic syndromes is of particular interest to Fabio Efficace, MD, Head of the Outcomes Research Program for the Italian Group for Adult Hematologic Diseases (GIMEMA), who presented a study himself at the meeting about the first test with the iron-chelator deferasirox on quality of life in transfusion-dependent patients with MDS (Abstract 2980).
“Anemia is a common symptom in patients with MDS, and although erythropoietic agents are often active, it is frequently treated with red blood cell transfusions. A substantial proportion of patients might also eventually become transfusion-dependent, and iron-chelating therapies might be important to minimize complications of iron overload,” he said.
He and his colleagues conducted an open-label, single-arm, multicenter, prospective study of the impact of deferasirox therapy on health-related quality of life of lower-risk transfusion-dependent MDS patients over a period of one year, which included 159 adult patients from 37 centers. The patients were diagnosed with transfusional siderosis following a minimum of 20 blood transfusions, and received daily oral deferasirox at a dose between 10 and 30 mg/kg of body weight for one year.
Health-related quality of life was assessed at baseline and at three, six, nine, and 12 months after treatment started. The scale consisted of 30 items and included five functional scales (physical, role, emotional, social, and cognitive); three symptoms (fatigue, nausea and vomiting, and pain); and a global health status/quality of life scale, as well as six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).
The results suggest that deferasirox therapy does not decrease health-related quality of life in these lower-risk transfusion-dependent MDS patients, he reported. “Iron chelation provides a benefit in this population. We would expect that quality of life would decline over one year with transfusions, but the drug is safe and does not worsen quality of life.”
Patients with higher baseline pain severity seem more likely to achieve transfusion independence. “Pain seems to be a prognostic factor for transfusion independence,” he explained. “We believe that at the beginning of therapy, patients who are in pain may be frailer, and iron chelation can have more chances of being effective.
“It is crucial now in this population of MDS patients to look at how to complement what we know from clinical parameters and classical data collected on efficacy and toxicity. We know deferasirox is safe and effective in these patients. We need the patient's perspective on the impact of therapy. We assessed quality of life only to get the patient's voice and to find out if it makes a difference in their lives.
“This is useful information clinicians need to be made aware of.”