Health-Related Quality-of-Life Measurement in Randomized Clinical Trials in Breast Cancer--Taking Stock

Abstract

Measurement of health-related quality-of-life (HRQOL) in randomized clinical trials in breast cancer has become common. In this review, we take stock of the contribution that HRQOL measurement in breast cancer clinical trials makes to clinical decision making regarding selection of optimal treatment. A series of MEDLINE searches was conducted to identify all randomized trials in breast cancer that included self-reported HRQOL or psychosocial outcomes. A total of 256 citations were identified that included HRQOL or psychosocial outcomes in breast cancer patients, and 66 of these involved randomized clinical trials of treatment. These 66 reports of breast cancer clinical trials of treatment are discussed in this review. Forty-six of the trials evaluated biomedical interventions, and 20 evaluated psychosocial interventions. Among the biomedical trials, eight trials evaluated HRQOL in primary management of breast cancer, seven trials evaluated HRQOL in adjuvant therapy of breast cancer patients, 20 trials involved metastatic breast cancer, eight trials involved symptom control/supportive care, and three trials evaluated different approaches to investigation or follow-up of breast cancer patients. Among the psychosocial trials, 13 trials evaluated HRQOL in adjuvant therapy of breast cancer patients, and their partners or spouses, six trials involved metastatic breast cancer, and one trial focused on symptom control. We found that the contribution of HRQOL measurement to clinical decision making depended on the clinical setting. In primary management of breast cancer, where medical outcomes of several treatment options are equivalent, HRQOL measurement provided added information for clinical decision making beyond that of traditional medical outcomes. In trials in the adjuvant setting, HRQOL measurement did not influence clinical decision making. In metastatic disease, HRQOL outcomes provided little information beyond that obtained from traditional medical outcomes, including toxicity. In the symptom control/supportive care setting, results of HRQOL questionnaires targeting specific symptoms (e.g., emesis) guided treatment decisions. In psychosocial intervention trials, psychosocial and/or HRQOL measurements often provided the only outcome information; therefore, selection of instruments that captured attributes likely to be altered by the intervention was essential. Until results of ongoing trials in breast cancer are available, caution is recommended in initiating new HRQOL studies unless treatment equivalency is expected, or unless the HRQOL questions target unique or specific issues that can only be addressed through patient self-report, including outcomes of psychosocial interventions.

Support groups in advanced breast cancer

“…These observations highlight the need for researchers to select instruments that address domains likely to be influenced by the interventions that have shown significant sensitivity in detecting small but clinically important changes. 26 Taken together, the current results provide strong evidence for a psychologic benefit for group support of various types in the setting of metastatic breast cancer. Questions that arise from these observations include whether all women (or only distressed women) benefit from such interventions and what should be the optimal duration of the intervention (long-term vs. short-term).…”

Health‐related quality of life during neoadjuvant treatment and surgery for localized esophageal carcinoma

“…A recent review of HRQL trials in breast carcinoma has found that HRQL assessments provide little contribution to clinical decision-making about treatment alternatives except in certain clinical situations (e.g., trials of treatment equivalency and trials with special HRQL end points). 21 It is currently not known whether this finding is similar for other cancer sites. For patients with esophageal carcinoma, HRQL measures may guide treatment decisions because of the magnitude of negative impact that potentially curative treatment has on HRQL and because survival benefits related to combination treatment are fairly small.…”

Recommendations for research priorities in breast cancer by the Coalition of Cancer Cooperative Groups Scientific Leadership Council: systemic therapy and therapeutic individualization

“…A systematic analysis of BC CTs concluded that the utility of HRQOL analyses depended on the setting, but in some scenarios provided added information for clinical decision-making beyond that of traditional medical outcomes [145]. For example, Table 5 Research recommendations and high priority studies in pharmacogenomics…”

“…HRQOL measurement did not influence clinical decisionmaking in adjuvant therapy and provided little information beyond that obtained from traditional medical outcomes such as toxicity in metastatic trials. However, results of HRQOL questionnaires targeting specific symptoms (e.g., emesis) guided treatment decisions when evaluating symptom control and was the only measure in psychosocial intervention trials [145]. In order to address some of the challenges of measuring the outcomes and provide guidance regarding the settings in which they should be measured, efforts are underway to standardize effective patientreported outcomes (PRO).…”