PURPOSE: As outcomes improve in early-stage breast cancer, clinical trials are undergoing a paradigm shift from intensification trials (more therapy) to improve survival to optimization trials, which assess the potential for using less toxic therapy while preserving survival outcomes. However, little is known about physician perspectives in community and academic settings about possible barriers and facilitators that could affect accrual to optimization clinical trials and the generalizability of future findings. METHODS: We conducted a qualitative study with semistructured interviews of medical oncologists from different academic and community practices to assess their perspectives on optimization trials. Interviews were audio-recorded and transcribed. Three independent coders used a content analysis approach to analyze transcripts using NVivo. Major themes and exemplary quotes were extracted. RESULTS: All 39 physicians reported that they would enroll patients in optimization clinical trials. Oncologists highlighted specific reasons to consider optimization trials. These included quality-of-life improvement by reducing toxicity, reduction in financial toxicity, fertility preservation, ability to avoid chemotherapy, minimization of overtreatment in patients with comorbid conditions, personalized treatment, opportunities to test novel therapies, and leveraging the availability of targeted therapies. Oncologists also identified accrual barriers, such as tumor-specific biology, individual (host) factors, prognostic markers of risk, access to therapies, provider experience, and system constraints. They voiced recommendations regarding preliminary data, trial design, and tools to support enrollment in optimization trials. CONCLUSION: Although oncologists are generally willing to enroll patients on optimization clinical trials, barriers affect their acceptance. A scientific focus on overcoming these barriers is needed to support future enrollment on trials tailoring therapy on the basis of risk and potential benefit to allow true personalization of treatment.

BACKGROUND: Parathyroidectomy (PTx) is the most effective treatment for secondary hyperparathyroidism. Literature regarding the effect of surgical approaches on postoperative hypocalcemia is limited and mainly focuses on postoperative calcium levels. This study aims to evaluate the association of subtotal PTx and total PTx with autotransplantation for secondary hyperparathyroidism with postoperative hypocalcemia. STUDY DESIGN: We reviewed all dialysis patients who underwent PTx (n = 143) at our institution from 2010 to 2021. Postoperative hypocalcemia adverse events were defined as postoperative intravenous calcium requirement or 30-day readmission due to hypocalcemia. Postoperative hypocalcemia adverse events, length of stay, and oral calcium requirement at 1-month follow-up were compared between the 2 groups. RESULTS: Of the 143 patients, 119 (83.2%) underwent total PTx with autotransplantation, and 24 (16.8%) underwent subtotal PTx. Patients who underwent subtotal PTx had shorter mean ± SD length of stay (1.8 ± 1.7 vs 3.5 ± 3.2, p = 0.002), were less likely to develop hypocalcemia adverse events (8.3% vs 47.1%, p < 0.001), and required less median elemental calcium supplementation at 1-month follow-up (1,558 vs 3,193 mg, p < 0.001). There was no significant difference in surgical success between the 2 groups (91.7% vs 89.1%, p = 0.706). Stepwise multivariable regression demonstrated that patients who underwent total PTx with autotransplantation were 11.9 times more likely to develop hypocalcemia adverse events (adjusted odds ratio 11.9, 95% CI 2.2 to 66.2, p = 0.004), had 1.24 days longer length of stay (95% CI 0.04 to 2.44, p = 0.044), and required 1,776.1 mg more elemental calcium (95% CI 661.5 to 2,890.6 mg, p = 0.002). CONCLUSIONS: Subtotal parathyroidectomy is associated with less postoperative hypocalcemia and provides similar surgical cure for dialysis patients with secondary hyperparathyroidism.

99 Background: Optimization clinical trials testing less intense treatments are becoming more prominent in oncology due to the availability of better prognostic tools and targeted therapies. In addition to previously documented barriers, these trials are likely to face new barriers from engaging racially diverse populations due to the potential of an increased recurrence risk with reducing treatment. However, little is known about the role of race in decision-making for optimization clinical trials amongst physicians and patients. Methods: This qualitative study included a subset analysis on the influence of race in decision-making for participation in trials testing less chemotherapy. This analysis is part of a larger study, which included semi-structured interviews with patients, patient advocates, and physicians assessing barriers and facilitators to trial participation. Interviews were transcribed, and four coders evaluated transcripts for key themes and exemplary quotes using NVivo. Results: 79 participants (24 patients with breast cancer, 16 patient advocates, and 39 physicians) participated; 30% of patients and patient advocates and 26% of physicians were BIPOC (Black, Indigenous, and People of Color). Several key barriers traditionally associated with Black race were noted amongst both patients and physicians, including aggressive biology (e.g. triple negative breast cancer), younger age, socioeconomic challenges, and lack of trust in physicians and clinical trials. One physician noted, “Taking someone who already has a mistrust of medical care and talking to them about a trial of cutting medical care back, it’s challenging.” While some physicians explicitly acknowledged the role of race in decision-making, often linking race to these barriers, the majority of physicians independently highlighted these barriers while denying the explicit impact of race. Black patients noted similar barriers including emphasizing the role of having triple negative breast cancer, being young, the influence of financial strain, and medical mistrust. One Black patient commented, “I was a triple negative, and that kind was more prone to African American women, usually we don’t really survive from it as well as other races do.” Another Black woman commented, “I had a lot of family and friends that were worried that I was going to be a “guinea pig”. In contrast, White patients heavily emphasized the role of trust in their physicians when making decisions. A White woman stated the following, “I would have done whatever they (doctors) told me was the best thing to do.”. Conclusions: Factors associated with Black race can play both an overt and subconscious role in patient and provider decision-making about participation in optimization clinical trials. Multi-level interventions are needed to address these specific barriers to ensure representative participation in clinical trials for all patient populations.

Background Historically, clinical trials involved adding novel agents to standard of care to improve survival. There has been a shift to an individualized approach with testing less intense treatment, particularly in breast cancer where risk of recurrence is low. Little is known about physician perspectives on delivering less intense treatment for patients who are not well represented in clinical trials. Methods Open-ended, individual qualitative interviews with medical oncologists explored their perspectives on trials that test less intense treatment for patients with cancer, with a focus on breast cancer. Interviews were audio-recorded and transcribed. Four independent coders utilized a content analysis approach to analyze transcripts using NVivo. Major themes and exemplary quotes were extracted. Results Of the 39 participating physicians, 61.5% felt comfortable extrapolating, 30.8% were hesitant, and 7.7% would not feel comfortable extrapolating trial outcomes to underrepresented populations. Facilitators of comfort included the sentiment that “biology is biology” (such that the cancer characteristics were what mattered), the strength of the evidence, inclusion of subset analysis on underrepresented populations, and prior experience making decisions with limited data. Barriers to extrapolation included potential harm over the patient’s lifetime, concerns about groups that had minimal participants, application to younger patients, and extending findings to diverse populations. Universally, broader inclusion in trials testing lowering chemotherapy was desired. Conclusions The majority (92%) of physicians reported that they would de-implement treatment for patients poorly represented in clinical trials testing less treatment, while expressing concerns about applicability to specific subpopulations. Further work is needed to increase clinical trial representation of diverse populations to safely and effectively optimize treatment for patients with cancer. Trial registration NCT03248258