妇科癌症首个疗程期间的临床试验注册与生存率。

IF 4.5 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Gynecologic oncology Pub Date : 2024-11-15 DOI:10.1016/j.ygyno.2024.11.003

Wafa Khadraoui , Jennifer A. Sinnott , Caitlin E. Meade , Jesse Plascak , Autumn Carey , Floor J. Backes , Robert L. Dood , Britton Trabert , Ashley S. Felix

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引用次数: 0

摘要

目的：在妇科癌症患者中，参与临床试验是否会影响生存结果尚不清楚。此外，鉴于妇科癌症试验注册中已知的种族和民族差异，评估临床试验注册是否与少数种族和民族的总生存率有类似关系也很重要。因此，我们研究了妇科癌症患者中临床试验注册与总生存率之间的关系，以及不同种族/民族和癌症部位可能产生的影响：我们使用国家癌症数据库来识别 2004 年至 2020 年期间确诊为宫颈癌、卵巢癌或子宫癌的女性（N = 861,817 人）。种族/族裔类别包括美国印第安人/阿拉斯加原住民、亚裔、黑人、西班牙裔（任何种族）、夏威夷原住民/太平洋岛民和白人。我们使用分层考克斯比例危险回归来估算临床试验入组与总生存率相关性的单变量和多变量调整危险比及 95% 置信区间。在单独的模型中使用乘法交互项评估了种族/人种和癌症部位的效应修正：中位随访时间为 56.0 个月（0.03-229.4 个月）。在整个研究人群中，参加临床试验与妇科癌症患者总生存率的提高有关（危险比 = 0.90，95% 置信区间 = 0.82-0.99）。种族/民族（P = 0.34）和癌症部位（P = 0.09）都不会改变这种关联：结论：参加临床试验与妇科癌症患者预后的改善有关。这些研究结果非常重要，表明无论治疗方案如何分配，参与临床试验都与更好的预后有关。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Clinical trial enrollment during first course of gynecologic cancer treatment and survival

Objective

Among gynecologic cancer patients, it is unclear whether participation in clinical trials impacts survival outcomes. In addition, given the known racial and ethnic disparities in gynecologic cancer trial enrollment, it is important to assess whether clinical trial enrollment is similarly related to overall survival among racial and ethnic minorities. Therefore, we examined associations between clinical trial enrollment and overall survival and potential effect modification by race/ethnicity and cancer site among gynecologic cancer patients.

Methods

We used the National Cancer Database to identify women diagnosed with a cervical, ovarian, or uterine cancer from 2004 to 2020 (N = 861,817). Race/ethnicity categories included American Indian/Alaska Native, Asian, Black, Hispanic (any race), Native Hawaiian/Pacific Islander, and White. We used stratified Cox proportional hazards regression to estimate univariable and multivariable-adjusted hazard ratios and 95% confidence intervals for associations of clinical trial enrollment and overall survival. Effect modification by race/ethnicity and cancer site was assessed with multiplicative interaction terms in separate models.

Results

Median follow-up was 56.0 months (range 0.03–229.4 months). Clinical trial enrollment was related to improved overall survival among gynecologic cancer patients in the overall study population (hazard ratio = 0.90, 95% confidence interval = 0.82–0.99). Neither race/ethnicity (p = 0.34) nor cancer site (p = 0.09) modified the association.

Conclusion

Clinical trial enrollment was associated with improved outcomes for gynecologic cancer patients. These findings are important in demonstrating that participation in clinical trials, regardless of therapeutic treatment assignment, is related to better outcomes.

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来源期刊

Gynecologic oncology 医学-妇产科学

CiteScore

8.60

自引率

6.40%

发文量

1062

审稿时长

37 days

期刊介绍： Gynecologic Oncology, an international journal, is devoted to the publication of clinical and investigative articles that concern tumors of the female reproductive tract. Investigations relating to the etiology, diagnosis, and treatment of female cancers, as well as research from any of the disciplines related to this field of interest, are published. Research Areas Include: • Cell and molecular biology • Chemotherapy • Cytology • Endocrinology • Epidemiology • Genetics • Gynecologic surgery • Immunology • Pathology • Radiotherapy