Background: For patients with chronic lymphocytic leukemia (CLL)-the most common form of leukemia in older adults-equitable access to care is particularly challenging, as the disease is often diagnosed in community cancer centers encumbered by regional disparities. Therefore, identifying and understanding regional barriers to care is essential. In 2020, the Association of Community Cancer Centers (ACCC) developed a heat map detailing the incidence rate of CLL diagnoses across the country (Fig.1), overlayed with the locations of CLL “expert” providers, revealing the areas in the US most in need of additional CLL clinical expertise (Fig. 2). In 2022, these incidence rates were stratified by race, ethnicity, and metropolitan statistical area to identify disparities Building on these maps, ACCC set out to identify specific regional challenges to appropriate, equitable care for patients with CLL. Methods: As part of an independent education program, ACCC initiated conversations with providers about the regional barriers that patients with CLL face. Through 4 webinars in February 2023, participants from 4 regions-Northeast (New York and Maine), Northwest (Montana and Idaho), Midwest (Wisconsin, Illinois, and Iowa), and Southwest (Texas)-shared insights on challenges and exchanged ideas on strategies to improve care for patients with CLL. In addition, ACCC interviewed 3 regionally diverse cancer programs (from the US Northwest, South, and Southwest regions) that are effectively overcoming regional challenges to reach their patient populations and provide equitable care. These interviews highlighted barriers and challenges, showcased effective outreach campaigns, and explored how the outreach improved the patient journey. Findings: The following themes emerged as key challenges and potential solutions throughout all regions studied: (1) Comprehensive Diagnostic Work-up Before Treatment Initiation: A key component in caring for patients with CLL is identifying certain disease related criteria prior to formulating a treatment plan. This includes determining the disease burden, disease-related symptoms, and if the patient meets certain active disease criteria (eg, Binet Stage C or Rai Stage III or IV). Further, by utilizing genetic testing, such as the TP53 gene mutation and IGHV mutation tests, physicians can estimate time to treatment and choice of specific novel targeted therapies. (2) Understanding Patient Population Needs: Cancer programs must understand the needs of their unique patient populations to effectively address them. For example, in the Northwest, as mountainous passes can make travel dangerous at times, one local program utilizes near-campus housing/hotel space for patients for the duration of their intensive treatment. In the Southwest, addressing health insurance coverage, low health literacy, language barriers, patient-provider mistrust, and culturally competent care for undocumented individuals presents challenges to equitable care delivery. Therefore, cancer programs in this region have implemented protocols to utilize community and social services to help support these patients. (3) Developing Community Partnerships: As the median age of diagnosis with CLL is approximately 70 years old, barriers such as transportation availability, caregiver support and financial constraints could be magnified. Building trust, particularly among vulnerable communities, also presents a significant challenge. By partnering with community outreach organizations, programs can help address these issues through community resources such as ride share programs, transportation vouchers, and financial assistance programs. (4) Provider Education and Learning: Because many patients are diagnosed in community cancer programs and smaller practices where physicians do not often have experience with CLL, nationally available provider education on new developments in testing and treatments is key. Conclusions: ACCC identified regional challenges and solutions to appropriate and equitable care for patients with CLL, including the importance of comprehensive diagnostic work-up before treating, understanding the regional needs of patient populations (particularly underserved populations), building community partnerships, and engaging in targeted provider education.
Docetaxel As Monotherapy or Combined With Ramucirumab or Icrucumab in Second-Line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma: An Open-Label, Three-Arm, Randomized Controlled Phase II Trial
Purpose This trial assessed the efficacy and safety of docetaxel monotherapy or docetaxel in combination with ramucirumab (vascular endothelial growth factor receptor 2 antibody) or icrucumab (vascular endothelial growth factor receptor 1 antibody) after progression during or within 12 months of platinum-based regimens for patients with locally advanced or metastatic urothelial carcinoma. Patients and Methods Patients were randomly assigned (1:1:1) to receive docetaxel 75 mg/m2 intravenously (IV) on day 1 of a 3-week cycle (arm A), docetaxel 75 mg/m2 IV plus ramucirumab 10 mg/kg IV on day 1 of a 3-week cycle (arm B), or docetaxel 75 mg/m2 IV on day 1 plus icrucumab 12 mg/kg IV on days 1 and 8 of a 3-week cycle (arm C). Treatment continued until disease progression or unacceptable toxicity. The primary end point was investigator-assessed progression-free survival (PFS). Results A total of 140 patients were randomly assigned and treated in arms A (n = 45), B (n = 46), or C (n = 49). PFS was significantly longer in arm B compared with arm A (median, 5.4 months; 95% CI, 3.1 to 6.9 months v 2.8 months; 95% CI, 1.9 to 3.6 months; stratified hazard ratio, 0.389; 95% CI, 0.235 to 0.643; P = .0002). Arm C did not experience improved PFS compared with arm A (1.6 months; 95% CI, 1.4 to 2.9; stratified hazard ratio, 0.863; 95% CI, 0.550 to 1.357; P = .5053). The most common grade 3 or worse adverse events (arms A, B, and C) were neutropenia (36%, 33%, and 39%), fatigue (13%, 30%, and 20%), febrile neutropenia (13%, 17%, and 6.1%), and anemia (6.7%, 13%, and 14%, respectively). Conclusion The addition of ramucirumab to docetaxel met the prespecified efficacy end point for prolonging PFS in patients with locally advanced or metastatic urothelial carcinoma receiving second-line treatment and warrants further investigation in the phase III setting.