RESUMEN
The treatment of metastatic renal cell carcinoma (mRCC) has rapidly evolved; however, the progress made in the field is heavily contingent upon timely and efficient accrual to clinical trials. While a substantial proportion of accrual occurs at tertiary care centers, community sites are playing an increasing role in patient recruitment. In this article, we discuss strategies to optimize collaborations between academic and community sites to facilitate clinical research. Further, as the role of biomarker discovery has become increasingly important in tailoring therapy, we will discuss opportunities to bridge diverse accrual sites for the purpose of translational research.
RESUMEN
Cancer is a disease associated with aging. As the US population ages, the number of older adults with cancer is projected to dramatically increase. Despite this, older adults remain vastly underrepresented in research that sets the standards for cancer treatments and, consequently, clinicians struggle with how to interpret data from clinical trials and apply them to older adults in practice. A combination of system, clinician, and patient barriers bar opportunities for trial participation for many older patients, and strategies are needed to address these barriers at multiple fronts, five of which are offered here. This review highlights the need to (1) broaden eligibility criteria, (2) measure relevant end points, (3) expand standard trial designs, (4) increase resources (e.g., institutional support, interdisciplinary care, and telehealth), and (5) develop targeted interventions (e.g., behavioral interventions to promote patient enrollment). Implementing these solutions requires a substantial investment in engaging and collaborating with community-based practices, where the majority of older patients with cancer receive their care. Multifaceted strategies are needed to ensure that older patients with cancer, across diverse healthcare settings, receive the highest-quality, evidence-based care.
RESUMEN
BACKGROUND: Skeletal-related events cause significant morbidity in patients with metastatic castration-resistant prostate cancer. In the ALSYMPCA study, radium-223 (Ra223) was found to provide pain palliation in addition to prolonged survival and reduced skeletal-related events (SREs). Given previous evidence that bisphosphonates impacted pain relief from the radiopharmaceutical samarium-153, we evaluated whether the timing of bone supportive therapy (BST) such as zoledronic acid or denosumab affected pain palliation from Ra223. METHODS: We identified patients who received Ra223 at University of Southern California or Mayo Clinic Arizona. Patients were evaluable for pain response if they had baseline pain scoreâ¯>â¯0 and at least 1 pain score documented after Ra223 with pain medication use data. Patients were evaluable for pain flare if they had known baseline pain score and at least 2 pain scores documented after Ra223. Pain response was defined asâ¯>â¯2 point decrease in pain on a 10-point scale; flare was defined asâ¯>â¯2 point increase followed by return to baseline or lower. RESULTS: Of 65 patients, 22 (34%) received BST. Median number of doses Ra223 was 5 (range 2-6). Fourteen patients were evaluable for pain response and 34 for pain flare. Eighteen patients received concurrent abiraterone (abi) or enzalutamide (enza), and 16 did not. Pain response occurred in 6/6 (100%) patients who received BST within 1 month prior to first Ra223 dose and 4/8 (50%) patients who did not receive BST. Pain flare occurred in 6/21 patients (29%) without BST and 2/13 (15%) with BST (pâ¯=â¯0.44). 6/10 (60%) patients with pain response had a decline in alkaline phosphatase (ALP) level, but there was no consistent pattern of ALP changes in patients with flare. 8/8 patients with pain response had no PSA decline. 6/8 (75%) and 2/18 (11%) patients on abi/enza had pain response and flare respectively, and 4/6 (67%) and 6/16 (38%) patients without concurrent abi/enza had response/flare. CONCLUSIONS: BST within 1 month prior to first Ra223 dose was associated with increased likelihood of pain palliation and might prevent pain flare. Concurrent use of abi/enza was not associated with increased likelihood of pain response but was associated with decreased likelihood of pain flare.