Gender disparities in head and neck cancer chemotherapy clinical trials participation and treatment

Benchetrit, Liliya; Torabi, Sina J.; Tate, Janet P.; Mehra, Saral; Osborn, Heather A.; Young, Melissa R.; Burtness, Barbara; Judson, Benjamin L.

doi:10.1016/j.oraloncology.2019.05.009

Cited by 28 publications

(21 citation statements)

References 46 publications

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“…These findings suggest that despite increasing awareness of sex disparity and numerous policy statements from organizations such as the FDA, little has changed in the past 20 years, and disparity in trial enrollment is still an important area for improvement in our society. This finding is consistent with recent data on representation of women in lung and colorectal trials, as well as less common solid organ cancers [26][27][28][29]. We also show that a significant number of trial publications do not consider sex in their analysis of treatment efficacy, with this omission occurring more frequently in the hematological trials in this cohort.…”

Section: Discussionsupporting

confidence: 92%

Sex Representation in Clinical Trials Associated with FDA Cancer Drug Approvals Differs Between Solid and Hematologic Malignancies

Mendis¹,

Anand

Karasinska

et al. 2020

The Oncologist

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Background. Proportionate female representation in health research is necessary for scientific rigor and health equity. We aimed to assess the representation of women in clinical trials leading to U.S. Food and Drug Administration (FDA) cancer drug approvals. Materials and Methods. Trials supporting FDA cancer drug approvals between July 2008 and June 2018 were sourced from PubMed and ClinicalTrials.gov. The ratio of female to male trial enrollment was compared with cancer incidence and mortality in the U.S. using International Agency for Research on Cancer data. Reproductive tract and breast cancers were excluded. Odds ratios (ORs) and 95% confidence intervals (CIs) comparing trial enrollment with population incidence and mortality were calculated. Results. A total of 186 trials leading to 170 FDA cancer drug approvals showed slight female underrepresentation compared with overall cancer incidence in the U.S. (OR, 0.97; 95% CI, 0.95-0.98, p < .0001).

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Section: Discussionsupporting

confidence: 92%

Sex Representation in Clinical Trials Associated with FDA Cancer Drug Approvals Differs Between Solid and Hematologic Malignancies

Mendis¹,

Anand

Karasinska

et al. 2020

The Oncologist

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“…An acknowledged limitation of our study was that gender and BMI were significantly different between comparison groups (Table 1 ). From an epidemiological perspective, HNSCC predominantly affects the male population 21 and weight loss is a well-documented hallmark sign of malignancy and a marker of poor prognosis. 22 We used univariate statistical comparisons prior to classifier selection to ensure the variables used in model generation were not associated with gender or BMI.…”

Section: Discussionmentioning

confidence: 99%

Development of a non-invasive exhaled breath test for the diagnosis of head and neck cancer

et al. 2020

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Background Improving the ability to identify early-stage head and neck squamous cell carcinoma (HNSCC) can improve treatment outcomes and patient morbidity. We sought to determine the diagnostic accuracy of breath analysis as a non-invasive test for detecting HNSCC. Methods Standardised breath samples were collected from 181 patients suspected of HNSCC prior to any treatment. A selected ion flow-tube mass spectrometer was used to analyse breath for volatile organic compounds. Diagnosis was confirmed by histopathology. A binomial logistic regression model was used to differentiate breath profiles between cancer and control (benign disease) patients based on mass spectrometry derived variables. Results In all, 66% of participants had early-stage primary tumours (T1 and T2) and 58% had regional node metastasis. The optimised logistic regression model using three variables had a sensitivity and specificity of 80% and 86%, respectively, with an AUC for ROC curve of 0.821 (95%CI 0.625–1.0) in the testing cohort. Conclusions Breath analysis for non-invasive diagnosis of HNSCC appears to be practical and accurate. Future studies should be conducted in a primary care setting to determine the applicability of breath analysis for early identification of HNSCC.

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“…Similarly, the rates of oral and esophageal cancer mortality are also decreasing in Nevada, mainly among females-which further demonstrates the strong links observed between cancer incidence and mortality [1,5,6]. However, the lack of available data regarding incidence and mortality among minorities is concerning, given that previous observations have revealed that non-White (minority) populations may be more vulnerable to, and more likely to suffer from health disparities in general, and more specifically from smoking-related cancers-such as oral and pharyngeal, esophageal, and lung cancers [20,21].…”

Section: Discussionmentioning

confidence: 91%

Surveillance of the Incidence and Mortality of Oral and Pharyngeal, Esophageal, and Lung Cancer in Nevada: Potential Implications of the Nevada Indoor Clean Air Act

Foote

Kingsley

2021

IJERPH

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Reviews of national and state-specific cancer registries have revealed differences in rates of oral, esophageal, and lung cancer incidence and mortality that have implications for public health research and policy. Many significant associations between these types of cancers and major risk factors, such as cigarette usage, may be influenced by public health policy such as smoking restrictions and bans—including the Nevada Clean Indoor Air Act (NCIAA) of 2006 (and subsequent modification in 2011). Although evaluation of general and regional advances in public policy have been previously evaluated, no recent studies have focused specifically on the changes to the epidemiology of oral and pharyngeal, esophageal, and lung cancer incidence and mortality in Nevada. Methods: Cancer incidence and mortality rate data were obtained from the National Cancer Institute (NCI) Division of Cancer Control and Population Sciences (DCCPS) Surveillance, Epidemiology and End Results (SEER) program. Most recently available rate changes in cancer incidence and mortality for Nevada included the years 2012–2016 and are age-adjusted to the year 2000 standard US population. This analysis revealed that the overall rates of incidence and mortality from these types of cancer in Nevada differs from that observed in the overall US population. For example, although the incidence rate of oral cancer is decreasing in the US overall (0.9%), it is stable in Nevada (0.0%). However, the incidence and mortality rates from esophageal cancer are also decreasing in the US (−1.1%, −1.2%, respectively), and are declining more rapidly in Nevada (−1.5%, −1.9%, respectively). Similarly, the incidence and mortality rates from lung are cancer are declining in the US (−2.5%, −2.4%, respectively) and are also declining more rapidly in Nevada (−3.2%, −3.1%, respectively). Analysis of previous epidemiologic data from Nevada (1999–2003) revealed the highest annual percent change (APC) in oral cancer incidence in the US was observed in Nevada (+4.6%), which corresponded with the highest APC in oral cancer mortality (+4.6%). Subsequent studies regarding reduced rates of cigarette use due to smoking restrictions and bans have suggested that follow up studies may reveal changes in the incidence and mortality rates of oral and other related cancers. This study analysis revealed that oral cancer incidence rates are no longer increasing in Nevada and that mortality rates have started to decline, although not as rapidly as the overall national rates. However, rapid decreases in both the incidence and mortality from esophageal and lung cancer were observed in Nevada, which strongly suggest the corresponding changes in oral cancer may be part of a larger epidemiologic shift resulting from improved public health policies that include indoor smoking restrictions and bans.

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Gender disparities in head and neck cancer chemotherapy clinical trials participation and treatment

Cited by 28 publications

References 46 publications

Sex Representation in Clinical Trials Associated with FDA Cancer Drug Approvals Differs Between Solid and Hematologic Malignancies

Sex Representation in Clinical Trials Associated with FDA Cancer Drug Approvals Differs Between Solid and Hematologic Malignancies

Development of a non-invasive exhaled breath test for the diagnosis of head and neck cancer

Surveillance of the Incidence and Mortality of Oral and Pharyngeal, Esophageal, and Lung Cancer in Nevada: Potential Implications of the Nevada Indoor Clean Air Act

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