Lack of racial and ethnic diversity in pediatric ophthalmology clinical trials from 2000 to 2022.

PURPOSE: To examine the prevalence of and factors associated with racial and ethnic reporting and trends in such reporting and to assess whether categories of race and ethnicity have been under- or over-represented in pediatric ophthalmology randomized control trials (RCTs) in the United States. METHODS: We systematically searched the literature on pediatric ophthalmology RCTs in high-impact factor ophthalmology journals published between 2000 and 2022. Logistic regression was used to assess parameters linked to race/ethnicity reporting; linear regression, to gauge the relationship between publication year and race/ethnicity reporting. The racial and ethnic composition of RCTs was contrasted with 2010 US census data by calculating percentage difference. RESULTS: Of 170 eligible articles, 89 (52.4%) included race/ethnicity data. Multivariable analysis showed that academic (OR = 12.19; 95% CI, 3.34-44.44) and government (OR = 3.91; 95% CI, 1.20-12.72) funding was linked to data reporting. During the study period, publication year and race/ethnicity reporting had a nonstatistically significant 1.0% annual increase (r = 0.29, P = 0.18). White participants were over-represented, with a percentage difference of 16.7% (95% CI, 11.8%-21.7%), whereas Hispanic individuals were under-represented, with a percentage difference of -7.6% (95% CI, -11.2% to -4.1%) compared to the 2010 US census data. CONCLUSIONS: Our results indicate a gradual rise in reported race and/or ethnicity in published pediatric ophthalmology RCTs, though not statistically significant, both in the United States and globally. Notably, under-representation of Hispanic, over-representation of White, and proportional representation of Black and Asian individuals were observed in US-based studies.

Intraoperative Radiation Therapy for Early-Stage Breast Cancer: Updated Outcomes from a Single-Institution Experience.

BACKGROUND: Increasingly, data have supported the use of partial-breast irradiation (PBI) for low-risk patients after breast-conserving surgery, with techniques allowing for completion of treatment in 1-3 weeks. Intraoperative radiation therapy (IORT) is an alternative to PBI. Our institution had used low-energy photon IORT (TARGIT) for more than a decade. The initial results demonstrated a 2% local recurrence rate with a short follow-up period of 2 years. This report presents updated outcomes during with 5-year follow-up. METHODS: A review of an institutional review board (IRB)-approved institutional registry was performed. The review identified 215 patients with early-stage breast cancer (stages 0-IIA) who received IORT. At the time of surgery, IORT was delivered with 20 Gy in a single fraction, with 5.1% (n = 11) of patients receiving additional whole-breast irradiation (WBI). RESULTS: The mean age at diagnosis was 71 years (range, 49-98 years), and the median follow-up was 5.7 years (interquartile range [IQR], 4.2-7.0 years). Of the 215 patients, 2.8% (n = 6) had ductal carcinoma in situ (DCIS), 90.7% (n = 195) had T1 disease, and 6.5% (n = 14) had T2 disease. Endocrine therapy was prescribed for 79% and chemotherapy for 1.4% of the patients. The 5-year rates were 5.3% for local recurrence, 6.4% for locoregional recurrence, and 2.7% for distant metastases. At 5 years, 93% of the patients were alive. CONCLUSIONS: The 5-year outcomes with TARGIT IORT demonstrated high rates of local recurrence, exceeding those seen with alternative modern approaches. The local recurrence outcomes with IORT are more consistent with studies omitting radiation following breast-conserving surgery, using endocrine therapy alone. Consistent with current guidelines and previous data, TARGIT IORT should not be used as monotherapy outside prospective clinical trials.

Five Fraction Accelerated Partial Breast Irradiation Versus Intraoperative Radiation Therapy for Early-Stage Breast Cancer.

PURPOSE/OBJECTIVE(S): Accelerated partial breast irradiation (PBI) delivered in 5 fractions with intensity modulated radiation therapy (IMRT) has been shown to have comparable clinical outcomes to whole breast irradiation with reduced toxicity profiles. In contrast, intraoperative radiation therapy (IORT) offers patients the potential to complete adjuvant radiation therapy in a single treatment. While early data were promising, concerns exist regarding long-term rates of local recurrence after IORT. We present a comparison of 5 fraction PBI versus IORT. MATERIALS/METHODS: We performed a retrospective review of 473 patients with early-stage breast cancer treated at a single institution from 2011 to 2021 with 258 receiving PBI and 215 receiving IORT. PBI patients received 30 Gy in 5 fractions delivered with IMRT. IORT patients received 20 Gy in 1 fraction prescribed to the applicator surface at surgery using the low-energy TARGIT technique. RESULTS: Mean age was 71 years old (IQR:67-74) for IORT patients and 67 years old (IQR:62-72) for PBI patients. Median follow up was 5.7 years (IQR:4.2-7.0) for IORT patients and 2.4 years (IQR:1.8-3.3) for PBI patients (P < .001). Recurrence at any time (locoregional and distant) was seen in 7.9% (n = 17) of patients receiving IORT as compared to 0.8% (n = 2) of patients receiving PBI. IORT was associated with reduced rates of locoregional relapse free survival at 5 years (93.6% vs. 99.4%, P = .05) with no difference in overall survival(92.8% vs. 95.1%, P = .99). CONCLUSION: Low-energy TARGIT IORT was associated with higher rates of locoregional recurrence compared to PBI. These outcomes, consistent with other series and current guidelines, suggest a limited role for low-energy IORT as monotherapy.

Asian American and Pacific Islander patients with melanoma have increased odds of treatment delays: A cross-sectional study.

BACKGROUND: Asian American and Pacific Islander (AAPI) melanoma patients have higher mortality than non-Hispanic White (NHW) patients. Treatment delays may contribute, but whether AAPI patients have longer time from diagnosis to definitive surgery (TTDS) is unknown. OBJECTIVES: Investigate TTDS differences between AAPI and NHW melanoma patients. METHODS: Retrospective review of AAPI and NHW melanoma patients in the National Cancer Database (NCD) (2004-2020). The association of race with TTDS was evaluated by multivariable logistic regression, controlling for sociodemographic characteristics. RESULTS: Of 354,943 AAPI and NHW melanoma patients identified, 1155 (0.33%) were AAPI. AAPI patients had longer TTDS for stage I, II, and III melanoma (P < .05 for all). Adjusting for sociodemographic factors, AAPI patients had 1.5 times the odds of a TTDS between 61 and 90 days and twice the odds of a TTDS >90 days. Racial differences in TTDS persisted in Medicare and private insurance types. Uninsured AAPI patients had the longest TTDS (mean, 53.26 days), while those with private insurance had the shortest TTDS (mean, 34.92 days; P < .001 for both). LIMITATION: AAPI patients comprised 0.33% of the sample. CONCLUSIONS: AAPI melanoma patients have increased odds of treatment delays. Associated socioeconomic differences should inform efforts to reduce disparities in treatment and survival.

Dermatological Autoimmune Considerations of Immune Checkpoint Therapy.

The most common immune-related adverse events (irAEs) involve the skin, and several serve as predictors of response to immune checkpoint inhibitor (ICI) therapy, especially in melanoma. Patients with pre-existing skin autoimmune diseases (ADs) have been excluded from ICI studies for safety concerns, yet recent research has shown that dermatological ADs can be managed without discontinuing ICI therapy. Patients with ADs respond as well or better to ICIs and can be included as candidates in clinical trials. Frequently taken during ICI therapy, steroids impair immunotherapy efficacy in certain anatomical sites of tumors but not others, including the brain. ICI efficacy can be enhanced by radiotherapy without increasing adverse events, as neoadjuvant radiotherapy is thought to sensitize tumors to ICIs. This perspective highlights clinical autoimmune considerations of ICI therapy in melanoma and discusses important areas for future exploration.

Breast Cancer Disparities in Asian Women: The Need for Disaggregated Research.

Asian (AZN) women are a heterogeneous group, comprising a wide array of cultural beliefs, languages, and healthcare needs. Yet, studies of breast cancer (BCa) risks and outcomes predominately consider AZNs in aggregate, assuming that the distinct ethnicities have similar disease profiles and homogeneous responses to treatment. This stereotypical portrayal of AZNs as a homogenous group tends to mask disparities. For example, healthcare-seeking behaviors and attitudes of medical providers toward AZN BCa patients frequently differ within this group and from other races. Misconceptions may arise that significantly influence the prevention, detection, treatment, and post-therapeutic care of AZN women. In addition to low BCa screening rates among AZN women, disparities also exist in various stages of BCa treatment-omission of radiation after breast-conserving surgery, less access to hypofractionation, underutilization of hormonal therapy, and higher-cost treatment owing to high HER2+ incidence. In this perspective, we highlight the need for disaggregated research of BCa among AZN women and advocate for comprehensive, culturally sensitive strategies to address health disparities in this priority population. Improving BCa literacy and awareness, access to care, and equitable recruitment into clinical trials are a few amelioratory goals to consider in the future.