Reporting of older subgroups in registration breast cancer trials 2012-2021.

INTRODUCTION: Adequate reporting of data specific to older populations enrolled to breast cancer trials is critical, given the high incidence of the disease among this demographic. This study aimed to examine the completeness of reporting of older subgroups among patients recruited to registration clinical trials investigating systemic treatments for breast cancer. METHODS: Clinical trials leading to a US food and drug administration (FDA) approval in breast cancer between 2012 and 2021 were included. Primary study reports and and all available secondary publications were systematically and objectively assessed with regard to the availability of data regarding efficacy, baseline characteristics, safety, and health-related quality of life (HRQOL) outcomes among older subgroups. RESULTS: 27 trials and 216 publications were assessed. 20.3% of patients were aged ≥65. 70.0% of patients had an eastern cooperative oncology group (ECOG) performance status of 0. Although complete reporting of primary endpoints was adequate (72.7%), most protocol-defined primary endpoints were surrogate endpoints (84.8%). Overall survival data among older populations was unavailable in 50.0% of studies. Reporting was poor for secondary efficacy endpoints (81.8% unreported), baseline characteristics (70.4% unreported), toxicity (55.6% unreported), and health-related quality of life outcomes (87.5% unreported). CONCLUSION: The findings underline significant deficits in the reporting of age-specific data in breast cancer registration trials. The underreporting of key efficacy, safety, and HRQOL outcomes highlights the need for mandatory reporting standards and a dedicated emphasis on older populations' priorities and needs in the reporting of registration clinical trials.

Associations Among Physical Activity, Skeletal Related Events, and Patient Reported Outcomes in Patients with Bone Metastases.

OBJECTIVES: Emerging evidence supports exercise as a therapeutic intervention for patients with bone metastases. However, exercise prescription in practice is limited by concerns regarding skeletal-related events (SREs). This study examined associations among habitual physical activity levels, history of SREs, and patient reported outcomes in patients with bone metastases. DATA SOURCES: A total of 58 patients with bone metastases (n = 45 breast cancer; n = 13 prostate cancer; mean time since cancer diagnosis 5.8 [4.7] years) were assessed. Habitual physical activity levels were collected by accelerometry. Standardized subjective assessment collected history of SREs, quality of life (EORTC-QLQ-C30 and EORTC-BM22), pain (Brief Pain Inventory), sleep quality (Pittsburgh Sleep Quality Questionnaire), and perceptions about exercise (Exercise Benefits/Barriers Scale). Participants spent a mean of 77.37% (standard deviation 14.3)% of waking hours sedentary and a mean of 20.14% (standard deviation 13.4)% of waking hours in light intensity activity. Almost half (n = 28) completed ≥150 min/wk moderate-to-vigorous intensity activity. Higher levels of moderate-to-vigorous intensity activity were associated with lower pain scores, better perceived physical function, lower functional interference scores, and better quality of life. Patients with a history of fracture since diagnosis spent more time sedentary and in light intensity activity in comparison to those with no fracture history (P < .05). CONCLUSION: Moderate-to-vigorous intensity physical activity may have multiple benefits for patients with bone metastases. Reducing sedentary behavior may be a key target for patients with a history of fracture. IMPLICATIONS FOR NURSING PRACTICE: Oncology nurses play a key role in providing education on the benefits of exercise, overcoming barriers to physical activity and timely referrals.