Research biopsies in patients with gynecologic cancers: patient-reported outcomes, perceptions, and preferences

Madariaga, Ainhoa; Bhat, Gita; Wilson, Michelle; Li, Xuan; Cyriac, Sunu; Bowering, Valerie; Hunt, Wendy; Gutierrez, David; Bonilla, Luisa; Kasherman, Lawrence; McMullen, Michelle; Wang, Lisa; Ghai, Sangeet; Dhani, Neesha C.; Oza, Amit M.; Lheureux, Stéphanie

doi:10.1016/j.ajog.2021.06.071

Cited by 3 publications

(4 citation statements)

References 14 publications

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“…Although these surgical procedures are considered to be minimally invasive and generally safe, they still carry risks of complications, including uterine perforation, uterine infection, and hemorrhage. In addition, current sampling methods for EC diagnosis can cause anxiety, physical discomfort and/or pain [15][16][17][18], which impact acceptability and accessibility. Thus, there is a need to develop a noninvasive and low-cost method for early EC detection.…”

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confidence: 99%

Protein biomarkers in cervicovaginal lavages for detection of endometrial cancer

et al. 2022

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Background Rates of endometrial cancer (EC) are increasing. For a definitive diagnosis, women undergo various time-consuming and painful medical procedures, such as endometrial biopsy with or without hysteroscopy, and dilation and curettage, which may create a barrier to early detection and treatment, particularly for women with inadequate healthcare access. Thus, there is a need to develop robust EC diagnostics based on non- or minimally-invasive sampling. The objective of this study was to quantify a broad range of immuno-oncology proteins in cervicovaginal lavage (CVL) samples and investigate these proteins as predictive diagnostic biomarkers for EC. Methods One hundred ninety-two women undergoing hysterectomy for benign or malignant indications were enrolled in this cross-sectional study. Classification of women to four disease groups: benign conditions (n = 108), endometrial hyperplasia (n = 18), low-grade endometrioid carcinoma (n = 53) and other EC subtypes (n = 13) was based on histopathology of biopsy samples collected after the surgery. CVL samples were collected in the operating room during the standard-of-care hysterectomy procedure. Concentrations of 72 proteins in CVL samples were evaluated using multiplex immunoassays. Global protein profiles were assessed using principal component and hierarchical clustering analyses. The relationships between protein levels and disease groups and disease severity were determined using Spearman correlation, univariate and multivariate receiver operating characteristics, and logistic regression analyses. Results Women with EC and benign conditions exhibited distinctive cervicovaginal protein profiles. Several proteins in CVL samples (e.g., an immune checkpoint protein, TIM-3, growth factors, VEGF, TGF-α, and an anti-inflammatory cytokine, IL-10) discriminated EC from benign conditions, particularly, when tested in combinations with CA19–9, CA125, eotaxin, G-CSF, IL-6, MCP-1, MDC, MCP-3 and TRAIL (sensitivity of 86.1% and specificity of 87.9%). Furthermore, specific biomarkers (e.g., TIM-3, VEGF, TGF-α, TRAIL, MCP-3, IL-15, PD-L2, SCF) associated with histopathological tumor characteristics, including histological type and grade, tumor size, presence and depth of myometrial invasion or mismatch repair protein status, implying their potential utility for disease prognosis or monitoring therapies. Conclusions This proof-of-principle study demonstrated that cervicovaginal sampling coupled with multiplex immunoassay technology can offer a minimally to non-invasive method for EC detection.

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confidence: 99%

Protein biomarkers in cervicovaginal lavages for detection of endometrial cancer

et al. 2022

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“…A prospective study in patients with gynecologic malignancies showed that research biopsies were generally well accepted in research study participants, and most patients would accept serial biopsies (83%). 74 In a recent phase I study of patients with multimetastatic solid tumors (including three with ovarian cancer) who were treated with a combination of radiation and immunotherapy, mandatory biopsies were performed without major complications and allowed for the detection of efficacy surrogate markers. 75 Yet, psychosocial factors may be important determinants in patients' and physicians' experience and willingness to undergo research biopsies.…”

Section: Patients' Perspective On Clinical Trials and Endpoint Relevancementioning

confidence: 99%

“…75 Yet, psychosocial factors may be important determinants in patients' and physicians' experience and willingness to undergo research biopsies. 74…”

Section: Patients' Perspective On Clinical Trials and Endpoint Relevancementioning

confidence: 99%

Outcomes and endpoints of relevance in gynecologic cancer clinical trials

Madariaga

Sánchez-Bayona

Herrera

et al. 2023

Int J Gynecol Cancer

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Drug development is paramount to improve outcomes in patients with gynecologic cancers. A randomized clinical trial should measure whether a clinically relevant improvement is detected with the new intervention compared with the standard of care, using reproductible and appropriate endpoints. Clinically meaningful improvements in overall survival and/or quality of life (QoL) are the gold standards to measure benefit of new therapeutic strategies. Alternative endpoints, such as progression-free survival, provide an earlier measure of the effect of the new therapeutic drug, and are not confounded by the effect of subsequent lines of therapy. Yet, its surrogacy with improved overall survival or QoL is unclear in gynecologic malignancies. Of relevance to studies assessing maintenance strategies are other time-to-event endpoints, such as progression-free survival two and time to second subsequent treatment, which provide valuable information on the disease control in the longer term. Translational and biomarker studies are increasingly being incorporated into gynecologic oncology clinical trials, as they may allow understanding of the biology of the disease, resistance mechanisms, and enable a better selection of patients who might benefit from the new therapeutic strategy. Globally, the endpoint selection of a clinical trial will differ according to the type of study, population, disease setting, and type of therapeutic strategy. This review provides an overview of primary and secondary endpoint selection of relevance for gynecologic oncology clinical trials.

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“…Several published studies [12,17] have investigated the safety of CNBs for clinical trials when compared to biopsies performed as clinically indicated. Others have examined a general oncology population or a younger patient group [18,19]. To our knowledge, this is the first study to investigate the safety of research-only core needle biopsies in thoracic malignancies where patients may have lung biopsies and have underlying lung disease.…”

Section: Fig 1 Characteristics Of Biopsies In People With Thoracic Ca...mentioning

confidence: 99%

Safety of image guided research biopsies in patients with thoracic malignancies

Soosman¹,

Schenker²,

Mazzola³

et al. 2022

Lung Cancer

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Research biopsies in patients with gynecologic cancers: patient-reported outcomes, perceptions, and preferences

Cited by 3 publications

References 14 publications

Protein biomarkers in cervicovaginal lavages for detection of endometrial cancer

Protein biomarkers in cervicovaginal lavages for detection of endometrial cancer

Outcomes and endpoints of relevance in gynecologic cancer clinical trials

Safety of image guided research biopsies in patients with thoracic malignancies

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