Analysis of Female Participant Representation in Registered Oncology Clinical Trials in the United States from 2008 to 2020

Perera, Nirosha D.; Bellomo, Tiffany R.; Schmidt, Walker M; Litt, Henry K; Shyu, Margaret; Stavins, MaKenna A.; Wang, Max; Bell, Alexander Melville; Saleki, Massoud; Wolf, Katherine I.; Ionescu, Ruxandra; Tao, Jacqueline J; Ji, Sunjong; O’Keefe, Ryan; Pun, Matthew; Takasugi, Jordan; Steinberg, Jecca R.; Go, Ronald S.; Turner, Brandon E.; Mahipal, Amit

doi:10.1093/oncolo/oyad009

Cited by 7 publications

(3 citation statements)

References 53 publications

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“…This imbalance in gender representation is similar to that reported by the Checkmate-214 trial and it is in line with less than 30% of female patients included in the Keynote-426, Checkmate-9ER, and CLEAR trials [ 5 – 7 ]. Despite the incidence ratio of RCC in males to females of 2:1 [ 46 ] and the implemented cancer clinical trials in the last 20 years, the issue of under-representation of female patients remains to be addressed [ 47 ]. Considering the gender differences in the immune system, behaviors, and lifestyle, as well as the heterogeneity of efficacy and outcomes with ICI treatment [ 48 ], specific measures such as stratifying patients by gender should be promptly applied in clinical trials [ 49 ].…”

Section: Discussionmentioning

confidence: 99%

Sex and survival outcomes in patients with renal cell carcinoma receiving first-line immune-based combinations

Incorvaia,

Monteiro,

Massari

et al. 2024

Cancer Immunol Immunother

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Background There is an ongoing debate as to whether sex could be associated with immune checkpoint inhibitor (ICI) benefit. Existing literature data reveal contradictory results, and data on first-line immune combinations are lacking. Method This was a real-world, multicenter, international, observational study to determine the sex effects on the clinical outcomes in metastatic renal cell carcinoma (mRCC) patients treated with immuno-oncology combinations as first-line therapy. Results A total of 1827 mRCC patients from 71 cancer centers in 21 countries were included. The median OS was 38.7 months (95% CI 32.7–44.2) in the overall study population: 40.0 months (95% CI 32.7–51.6) in males and 38.7 months (95% CI 26.4–41.0) in females (p = 0.202). The median OS was higher in males vs. females in patients aged 18-49y (36.9 months, 95% CI 29.0–51.6, vs. 24.8 months, 95% CI 16.8–40.4, p = 0.426, with + 19% of 2y-OS rate, 72% vs. 53%, p = 0.006), in the clear cell histology subgroup (44.2 months, 95% CI 35.8–55.7, vs. 38.7 months, 95% CI 26.0–41.0, p = 0.047), and in patients with sarcomatoid differentiation (34.4 months, 95% CI 26.4–59.0, vs. 15.3 months, 95% CI 8.9–41.0, p < 0.001). Sex female was an independent negative prognostic factor in the sarcomatoid population (HR 1.72, 95% CI 1.15 − 2.57, p = 0.008). Conclusions Although the female’s innate and adaptive immunity has been observed to be more active than the male’s, women in the subgroup of clear cell histology, sarcomatoid differentiation, and those under 50 years of age showed shorter OS than males.

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Section: Discussionmentioning

confidence: 99%

Sex and survival outcomes in patients with renal cell carcinoma receiving first-line immune-based combinations

Incorvaia,

Monteiro,

Massari

et al. 2024

Cancer Immunol Immunother

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“…Indeed, research reveals a historical underrepresentation, with only 34.7% of participants in cancer preventive and therapy studies from 1990 to 2001 being female [69]. Though a more recent analysis involving data from 2008 to 2020 showed that females constituted 46.9% of participants in oncologic clinical trials, there were concerning proportional participation rates (PPR) of 0.912 across all trials, with women facing significant underrepresentation in surgical (PPR 0.74) and other invasive (PPR 0.69) oncology trials [70]. Further, recent immunotherapy trials such as the AEGEAN and KEYNOTE671, investigating perioperative chemoimmunotherapy in NSCLC, revealed a stark disparity of approximately 70% of participants in both treatment and placebo arms being male [71,72].…”

Section: Lack Of Inclusion In Clinical Trialsmentioning

confidence: 99%

Precision Immuno-Oncology in NSCLC through Gender Equity Lenses

Marks,

Sridhar,

et al. 2024

Cancers

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Precision immuno-oncology involves the development of personalized cancer treatments that are influenced by the unique nature of an individual’s DNA, immune cells, and their tumor’s molecular characterization. Biological sex influences immunity; females typically mount stronger innate and adaptive immune responses than males. Though more research is warranted, we continue to observe an enhanced benefit for females with lung cancer when treated with combination chemoimmunotherapy in contrast to the preferred approach of utilizing immunotherapy alone in men. Despite the observed sex differences in response to treatments, women remain underrepresented in oncology clinical trials, largely as a result of gender-biased misconceptions. Such exclusion has resulted in the development of less efficacious treatment guidelines and clinical recommendations and has created a knowledge gap in regard to immunotherapy-related survivorship issues such as fertility. To develop a more precise approach to care and overcome the exclusion of women from clinical trials, flexible trial schedules, multilingual communication strategies, financial, and transportation assistance for participants should be adopted. The impact of intersectionality and other determinants of health that affect the diagnosis, treatment, and outcomes in women must also be considered in order to develop a comprehensive understanding of the unique impact of immunotherapy in all women with lung cancer.

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“…This is similar to cardiology trials (population prevalence ratio, ∼0.7) but markedly worse than oncology trials (population prevalence ratio, 0.9). 6 , 7 …”

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confidence: 99%