Sarah S. Lee

Factors associated with treatment delay for cervical cancer patients treated with definitive chemoradiation and brachytherapy

This study aimed to explore the demographic and clinical factors associated with delayed initiation of treatment for patients with cervical cancer treated with chemoradiation and brachytherapy and determine its impact on oncologic outcomes. Patients with stage IB2 to IVA cervical cancer who were treated with definitive chemoradiation therapy and brachytherapy from 2009 to 2019 were included. Patients who initiated treatment within 8 weeks of diagnosis (early) were compared with those who initiated treatment after 8 weeks (delayed). Time intervals at each stage of care and reasons for delay were evaluated. Logistic regression was performed to identify factors associated with delayed treatment initiation. Cox regression analyzed factors associated with progression-free and overall survival. Of 122 patients, 76 (62%) initiated early treatment, with a median time to treatment of 35 days, and 46 (38%) underwent delayed treatment initiation, with 76 median days to treatment. Patients referred from the public hospital were more likely to experience delayed treatment than those referred from the private hospital (odds ratio 4.31, 95% confidence interval [CI] 1.31 to 14.07). Most delays were due to system factors (85%). Each 10-day increase in time to treatment initiation was associated with worsened overall survival (hazard ratio [HR] 1.07, 95% CI 1.01 to 1.13). Public hospital patients were more likely to experience delays but were less likely to present with advanced stage (29% vs 50%, p = .031) and had improved overall survival compared with patients referred from the private hospital (HR 0.37, 95% CI 0.16 to 0.87). Treatment initiation delays were associated with a decrement in survival. In this cohort, public hospital patients were more likely to have a favorable stage and improved survival than those from the private hospital but also were more likely to experience treatment initiation delays. Referral patterns and delays related to diagnostic workup were the most common factors contributing to delays in care establishment. Improving care coordination may ensure equitable access to timely staging and treatment. Further studies are needed to determine whether treatment initiation delays impact cancer outcomes.

Demographic reporting and language exclusion in gynecologic oncology clinical trials

Participation in clinical trials may help mitigate disparate cancer outcomes. Thus, ensuring equitable access to clinical trials is a major priority for national cancer organizations. This study aimed to examine clinical trial eligibility criteria that may adversely affect the enrollment of underrepresented groups and assess the availability of demographic information in published gynecologic oncology studies. ClinicalTrials.gov was searched for gynecologic oncology studies conducted between 1997 and 2021. Each study's inclusion and exclusion criteria were reviewed to determine whether demographic factors were used for enrollment screening. For published studies, demographic variables that were reported were identified. The expected clinical trial enrollment based on disease incidence and mortality was compared with the observed trial enrollment based on race. There were 1597 gynecologic oncology studies: 883 (55%) from ovarian cancer studies, 336 (21%) from cervical cancer studies, 262 (17%) from uterine cancer studies, and 116 (7%) from multisite gynecologic oncology studies. Of the 581 published studies, 554 (95%) reported age, 363 (63%) reported race, and 171 (29%) reported ethnicities. Cervical cancer studies were most likely to report demographic information, including race (P=.026) and ethnicity (P<.001). During the study period, 189 studies (12%) excluded patients based on the language spoken. Industry-sponsored trials (odds ratio, 0.07; 95% confidence interval, 0.02-0.30) and organization-sponsored trials (odds ratio, 0.40; 95% confidence interval, 0.22-0.73) were less likely to exclude patients because of language than investigator-initiated trials. A minority of patients (37%) in cervical cancer trials were of White race, compared with 85% of patients in uterine cancer trials and 82% of patients in ovarian cancer trials. Over the last 3 decades, 1 in 10 gynecologic oncology trials excluded patients because of language. Race and ethnicity were reported in more than half of the available studies. Initiatives to increase transparency in recruiting underrepresented patients and reporting demographic data are urgently needed.