Rebecca A Previs, Kyle C Strickland, Zachary Wallen, Heidi Ko, Michelle Green, Maureen Cooper, Elizabeth Lyon, Michael Biorn, Jennifer Armetta, Rennie Quarles, Catherine H Watson, Kari Ring, Jonathan L Klein, Brian Caveney, Eric A Severson, Shakti Ramkissoon
{"title":"Analysis of real world FRα testing in ovarian, fallopian tube, and primary peritoneal cancers.","authors":"Rebecca A Previs, Kyle C Strickland, Zachary Wallen, Heidi Ko, Michelle Green, Maureen Cooper, Elizabeth Lyon, Michael Biorn, Jennifer Armetta, Rennie Quarles, Catherine H Watson, Kari Ring, Jonathan L Klein, Brian Caveney, Eric A Severson, Shakti Ramkissoon","doi":"10.1016/j.ygyno.2024.11.010","DOIUrl":"https://doi.org/10.1016/j.ygyno.2024.11.010","url":null,"abstract":"<p><strong>Background: </strong>Epithelial ovarian cancer (EOC) remains a significant challenge in gynecologic oncology, particularly in the context of platinum-resistant disease. Mirvetuximab soravtansine (MIRV), was approved after trials revealed favorable response and survival outcomes. MIRV targets folate receptor alpha (FRα), a cell-surface receptor that is overexpressed in EOC and has been associated with aggressive disease phenotypes.</p><p><strong>Methods: </strong>This retrospective study analyzed 425 patient samples tested for FRα using the VENTANA® FOLR1 RxDx immunohistochemical assay. The patient cohort included cases with high grade serous carcinoma predominantly, tested across various anatomical sites. Statistical analysis examined the correlation between FRα positivity and clinical parameters such as tumor site and histology.</p><p><strong>Results: </strong>FRα was highly expressed in 36.3 % of the cases, with a significant association between FRα positivity and high grade serous ovarian histology. Tumor samples from the ovary, fallopian tube, adnexa, and dominant pelvic masses showed higher FRα positivity compared to metastatic sites (positive rates of 44.4 % vs 32.5 %, p = 0.02), highlighting the potential influence of tumor origin on expression of FRα. Time between sample collection and testing did not impact FRα expression, with sample testing spread over a median of 19.5 months post-collection. Eight patients had more than one specimen tested, of which 3 (37.5 %) had discordant results when a subsequent specimen was tested.</p><p><strong>Conclusion: </strong>Our results highlight a need for standardized protocols for FRα testing to ensure accurate biomarker evaluation across varied clinical settings. The heterogeneity in FRα expression, influenced by tumor histology and anatomical origin, warrant further investigation to optimize therapeutic outcomes.</p><p><strong>Prior presentation: </strong>Preliminary findings from this study were previously presented in poster format at the Society of Gynecologic Oncology 2024 Annual Metting. We confirm that the submission complies with the journal requirements.</p>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"192 ","pages":"102-110"},"PeriodicalIF":4.5,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142779995","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gynecologic oncologyPub Date : 2024-12-01Epub Date: 2024-10-18DOI: 10.1016/j.ygyno.2024.10.010
Emanuele Perrone, Ilaria Capasso, Diana Giannarelli, Rita Trozzi, Luigi Congedo, Elisa Ervas, Vincenzo Tarantino, Giovanni Esposito, Luca Palmieri, Arianna Guaita, Anne-Sophie van Rompuy, Giulia Scaglione, Gian Franco Zannoni, Giovanni Scambia, Frédéric Amant, Francesco Fanfani
{"title":"Less is more? Comparison between genomic profiling and immunohistochemistry-based models in endometrial cancer molecular classification: A multicenter, retrospective, propensity-matched survival analysis.","authors":"Emanuele Perrone, Ilaria Capasso, Diana Giannarelli, Rita Trozzi, Luigi Congedo, Elisa Ervas, Vincenzo Tarantino, Giovanni Esposito, Luca Palmieri, Arianna Guaita, Anne-Sophie van Rompuy, Giulia Scaglione, Gian Franco Zannoni, Giovanni Scambia, Frédéric Amant, Francesco Fanfani","doi":"10.1016/j.ygyno.2024.10.010","DOIUrl":"10.1016/j.ygyno.2024.10.010","url":null,"abstract":"<p><strong>Background: </strong>Genomic profiling-based model (GP-M) is the gold-standard for endometrial cancer (EC) molecular classification, but several issues related to the availability of genomic sequencing in low-income settings remain and health disparities in the management are increasing. This study aims to investigate the non-inferiority of the immunohistochemistry-alone model in classifying ECs compared to the standard genomic profiling-based model in terms of oncologic outcomes.</p><p><strong>Methods: </strong>All preoperative uterine-confined ECs undergoing surgical staging were retrospectively included. Patients classified by IHC-M were stratified into: MMR-proficient (MMRp), p53 wild type (p53wt) and estrogen receptor (ER) positive, 2) MMRp, p53wt and ER-negative, 3) MMRd, and 4) p53abn. A case-control comparison was performed between the IHC-M and GP-M cohorts. Then, a propensity-matched analysis was performed: ECs classified by IHC-M were matched in a 3:1 ratio with patients classified by GP-M.</p><p><strong>Results: </strong>1587 patients with EC were included. The Kaplan-Meier survival curves for disease-free survival and overall survival demonstrated that the two models performed similarly in risk-stratifying the study population (p < 0.0001). Moreover, the AUC-ROC showed overlapping results: 0.77 (0.66-0.87) for IHC-M and 0.72 (0.63-0.81) for GP-M, indicating that both models were able to successfully identify patients at high-risk and low-risk of disease recurrence/progression.</p><p><strong>Conclusion: </strong>The IHC-M showed overlapping classification performance compared to the GP-M in terms of oncologic outcomes. This study may lay the basis to further investigate the real-life clinical impact of POLE sequencing in molecular classification and the potential stand-alone prognostic role of ER status for further allocation of EC patients into risk classes.</p>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"191 ","pages":"150-157"},"PeriodicalIF":4.5,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142463325","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Tong Shu , Yiming Liang , Siwen Zhang , Tianqi Sun , Yunong Gao , Chang Guo , Zhe Li , Min Gao , Nan Zhang , Nan Song , Naiyi Zhang , Weijiao Gao , Wei Wang , Hongguo Wang , Yan Cai , Feng Zhang , Xuwo Ji , Yu Dong , Hong Zheng
{"title":"The prognostic value of tumor-informed minimal residual disease detection using circulating tumor DNA in first-line treatment of ovarian cancer","authors":"Tong Shu , Yiming Liang , Siwen Zhang , Tianqi Sun , Yunong Gao , Chang Guo , Zhe Li , Min Gao , Nan Zhang , Nan Song , Naiyi Zhang , Weijiao Gao , Wei Wang , Hongguo Wang , Yan Cai , Feng Zhang , Xuwo Ji , Yu Dong , Hong Zheng","doi":"10.1016/j.ygyno.2024.11.002","DOIUrl":"10.1016/j.ygyno.2024.11.002","url":null,"abstract":"<div><h3>Objective</h3><div>This study aims to assess the application and effectiveness of tumor-informed Minimal Residual Disease (MRD) detection using circulating tumor DNA (ctDNA) for predicting disease recurrence and survival outcomes in ovarian cancer patients.</div></div><div><h3>Methods</h3><div>Between 2020 and 2022, 31 newly diagnosed stage II-IV ovarian cancer patients were enrolled in this retrospective study. All patients completed standard treatment, including cytoreductive surgery and platinum-based chemotherapy, achieving a complete remission (CR) without receiving first-line PARP inhibitor maintenance therapy. Archived tumor tissue, as well as plasma samples collected pre- and post-treatment, were tested using Whole Exome Sequencing (WES) to identify personalized somatic variants for MRD detection.</div></div><div><h3>Results</h3><div>All pre-treatment (baseline) blood samples showed a 100 % MRD positive rate, demonstrating the high sensitivity of ctDNA-based MRD detection. This rate decreased to 25.8 % in post-treatment (landmark) samples, indicating a significant reduction of ctDNA levels following effective treatment. The median follow-up time until Sep 2023 was 21.4 months, during which 15 patients experienced recurrence. Landmark MRD-positive patients exhibited a markedly shorter median progression-free survival (PFS) compared to MRD-negative patients (5.8 months vs 24.7 months, HR = 6.678, <em>p</em> = 0.01). Furthermore, a strong correlation was observed between post-treatment MRD status and recurrence, with a higher relapse rate in the MRD-positive group.</div></div><div><h3>Conclusion</h3><div>The study establishes MRD detection via ctDNA analysis as a valuable tool for early and accurate prediction of ovarian cancer recurrence, potentially leading to improved clinical outcomes. As a result, integrating MRD detection into routine clinical practice is advocated to enable more effective and personalized treatment strategies for ovarian cancer patients.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"192 ","pages":"Pages 94-101"},"PeriodicalIF":4.5,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142695163","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lauren Borho , Esther Elishaev , Riyue Bao , Emily O'Brien , Kaitlyn Dinkins , Jessica Berger , Michelle Boisen , John Comerci , Madeleine Courtney-Brooks , Robert P. Edwards , Alison Aunkst Garrett , Joseph L. Kelley , Jamie Lesnock , Haider S. Mahdi , Alexander Olawaiye , Shannon Rush , Paniti Sukumvanich , Sarah Taylor , Ritu Aneja , Lyse Norian , Francesmary Modugno
{"title":"Association of neighborhood social vulnerability with ovarian cancer survival","authors":"Lauren Borho , Esther Elishaev , Riyue Bao , Emily O'Brien , Kaitlyn Dinkins , Jessica Berger , Michelle Boisen , John Comerci , Madeleine Courtney-Brooks , Robert P. Edwards , Alison Aunkst Garrett , Joseph L. Kelley , Jamie Lesnock , Haider S. Mahdi , Alexander Olawaiye , Shannon Rush , Paniti Sukumvanich , Sarah Taylor , Ritu Aneja , Lyse Norian , Francesmary Modugno","doi":"10.1016/j.ygyno.2024.10.030","DOIUrl":"10.1016/j.ygyno.2024.10.030","url":null,"abstract":"<div><h3>Objective</h3><div>Social determinants of health (<strong>SDOH</strong>) impact cancer outcomes. The CDC Social Vulnerability Index (<strong>SVI</strong>) integrates scores for four neighborhood-based SDOH domains (socioeconomic status, household characteristics, minority status, and housing type/transportation) to assess neighborhood social vulnerability (<strong>NSV)</strong>. While NSV has been associated with overall cancer mortality and lung, breast, colon, and endometrial cancer-specific mortality, the relationship between NSV as defined by the SVI and ovarian cancer outcomes remains unknown.</div></div><div><h3>Methods</h3><div>We used data from 177 patients enrolled in an observational ovarian cancer cohort study from October 2012 through September 2022. All patients underwent debulking surgery and completed an entire course of standard-of-care platinum-based chemotherapy. Follow-up was completed through May 2024. SVI was calculated using census tract at diagnosis. High NSV was defined as SVI in the top quartile of the cohort. Cox proportional hazard models assessed the association between NSV and progression-free (<strong>PFS</strong>) and overall (<strong>OS</strong>) survival.</div></div><div><h3>Results</h3><div>After accounting for demographic and clinical factors, high NSV was associated with significantly worse PFS (HR:2.31 [95% CI:1.48–3.61]; <em>P</em> < 0.001) and OS (HR:1.79 [95% CI:1.10–2.92]; <em>P</em> = 0.02), with neighborhood socioeconomic status associated with significantly worse PFS (HR:2.29 [95% CI:1.47–3.56]; <em>P</em> < 0.001) and OS (HR:1.71 [95% CI:1.04–2.80]; <em>P</em> = 0.03). Neighborhood housing type/transportation was also associated with significantly worse PFS (HR:1.65 [95% CI:1.07–2.55]; <em>P</em> = 0.02) and trended towards worse OS (HR:1.43 [95% CI: 0.80–2.33]).</div></div><div><h3>Conclusion and relevance</h3><div>Higher neighborhood social vulnerability is associated with worse outcomes among ovarian cancer patients. Validating these results in a population-based cohort and assessing programs to reduce neighborhood social vulnerability to improve ovarian cancer outcomes is warranted.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"192 ","pages":"Pages 32-39"},"PeriodicalIF":4.5,"publicationDate":"2024-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142692905","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Giuseppe Marino , Liliana Marchetta , Serena Negri , Filippo Testa , Daniele Lugotti , Giulia Cavallo , Tommaso Grassi , Marta Jaconi , Elena De Ponti , Maria Cristina Bonazzi , Fabio Landoni , Robert Fruscio
{"title":"Oncologic and fertility outcomes in patients with juvenile granulosa cell tumor - a retrospective single centre analysis","authors":"Giuseppe Marino , Liliana Marchetta , Serena Negri , Filippo Testa , Daniele Lugotti , Giulia Cavallo , Tommaso Grassi , Marta Jaconi , Elena De Ponti , Maria Cristina Bonazzi , Fabio Landoni , Robert Fruscio","doi":"10.1016/j.ygyno.2024.11.007","DOIUrl":"10.1016/j.ygyno.2024.11.007","url":null,"abstract":"<div><h3>Background</h3><div>Granulosa cell tumors (GCTs) are rare neoplasia that account for less than 5 % of all the ovarian tumors. Juvenile GCT histotype is generally observed in adolescent and young women, representing a very rare disease, so only a paucity of data are present in literature. The aim of this study is to analyse the oncologic and fertility outcome in our case series of juvenile GCTs.</div></div><div><h3>Methods</h3><div>Clinicopathological data were retrospectively collected and analysed from a cohort of 30 patients ovarian juvenile GCTs treated at IRCCS San Gerardo dei Tintori Hospital, Monza, between 1980 and 2024.</div></div><div><h3>Results</h3><div>The median age of disease onset was 21.5. Among patients enrolled in the study, 80.0 % (24/30) were stage I (16/26, 1/26 and 7/26 of stage IA, IB and IC, respectively), 6.7 % (2/30) were stage II and 13.3 % stage III (4/30). In 86.7 % (26/30) of patients, a fertility-sparing surgery was carried out, while 13.3.% (4/30) of patients underwent radical surgery. Adjuvant chemotherapy was administered in 20.0 % (6/30) of cases, while 80.0 % (24/30) were followed only with surveillance. Three patients in thirty (10.0 %) relapsed and died of disease despite multi-therapeutic approaches. All of them had advanced stages of disease at time of diagnosis.</div></div><div><h3>Conclusions</h3><div>Juvenile GCT appears to have a good prognosis at stage I disease. However, advanced stage represents a hard challenge for clinicians, showing a high rate of relapse and mortality.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"192 ","pages":"Pages 89-93"},"PeriodicalIF":4.5,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142675293","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Andreas Kleppe , Kristina Lindemann , Wanja Kildal , Kari Anne R. Tobin , Manohar Pradhan , Ljiljana Vlatkovic , Maria X. Isaksen , Håvard E. Danielsen , Hanne A. Askautrud , Gunnar B. Kristensen
{"title":"Prognostic and therapeutic implication of molecular classification including L1CAM expression in high-risk endometrial cancer","authors":"Andreas Kleppe , Kristina Lindemann , Wanja Kildal , Kari Anne R. Tobin , Manohar Pradhan , Ljiljana Vlatkovic , Maria X. Isaksen , Håvard E. Danielsen , Hanne A. Askautrud , Gunnar B. Kristensen","doi":"10.1016/j.ygyno.2024.11.005","DOIUrl":"10.1016/j.ygyno.2024.11.005","url":null,"abstract":"<div><h3>Introduction</h3><div>The role of molecular classification and L1CAM in high-risk endometrial cancer is uncertain. We aimed to determine the association of molecular profiling and L1CAM with patterns of relapse and survival.</div></div><div><h3>Material and methods</h3><div>This retrospective cohort study included patients referred to Department for Gynecologic Oncology, Oslo University Hospital between January 1, 2006 and December 31, 2017. L1CAM expression and molecular profiling according to ProMisE was performed. Main outcome was time to recurrence (TTR) and cancer specific survival (CSS).</div></div><div><h3>Results</h3><div>Of 489 patients, 486 could be molecular classified. Thirty-seven (8 %) had <em>POLE</em> mutated tumors, 148 (30 %) had MMRd tumors, 189 (39 %) had p53 abnormal tumors, and 112 (23 %) had NSMP tumors. High L1CAM expression was observed in 256 (53 %), low in 227 (46 %) tumors (6 (1 %) missing). ProMisE was significant for TTR but not for CSS in multivariable analysis. L1CAM was significant in multivariable analysis for both TTR and CSS. In a multivariable model with ProMisE and L1CAM expression in the same multivariable model, ProMisE lost significance while L1CAM remained significant. Patients with <em>POLE</em> mutated tumors entailed an excellent prognosis while patients with p53 abnormal or L1CAM overexpressing tumors entailed a poor prognosis with a high frequency of distant recurrences. Patients with MMRd tumors, NSMP and p53 abnormal tumors with low L1CAM had an intermediate prognosis.</div></div><div><h3>Conclusions</h3><div>L1CAM is an additional adverse factor in the p53 abnormal and NSMP groups. These groups need special attention in studies intensifying adjuvant treatment.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"192 ","pages":"Pages 80-88"},"PeriodicalIF":4.5,"publicationDate":"2024-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142643953","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Wafa Khadraoui , Jennifer A. Sinnott , Caitlin E. Meade , Jesse Plascak , Autumn Carey , Floor J. Backes , Robert L. Dood , Britton Trabert , Ashley S. Felix
{"title":"Clinical trial enrollment during first course of gynecologic cancer treatment and survival","authors":"Wafa Khadraoui , Jennifer A. Sinnott , Caitlin E. Meade , Jesse Plascak , Autumn Carey , Floor J. Backes , Robert L. Dood , Britton Trabert , Ashley S. Felix","doi":"10.1016/j.ygyno.2024.11.003","DOIUrl":"10.1016/j.ygyno.2024.11.003","url":null,"abstract":"<div><h3>Objective</h3><div>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.</div></div><div><h3>Methods</h3><div>We used the National Cancer Database to identify women diagnosed with a cervical, ovarian, or uterine cancer from 2004 to 2020 (<em>N</em> = 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.</div></div><div><h3>Results</h3><div>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 (<em>p</em> = 0.34) nor cancer site (<em>p</em> = 0.09) modified the association.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"192 ","pages":"Pages 59-64"},"PeriodicalIF":4.5,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142638693","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Catherine C. Classen , Meredith L. Chivers , Lori A. Brotto , Lisa Barbera , Jeanne Carter , John Koval , John W. Robinson , Sarah E. Ferguson
{"title":"A randomized controlled trial of an online support group addressing psychosexual distress among women treated for gynecologic cancer","authors":"Catherine C. Classen , Meredith L. Chivers , Lori A. Brotto , Lisa Barbera , Jeanne Carter , John Koval , John W. Robinson , Sarah E. Ferguson","doi":"10.1016/j.ygyno.2024.10.032","DOIUrl":"10.1016/j.ygyno.2024.10.032","url":null,"abstract":"<div><h3>Objective</h3><div>To assess whether a 12-week, professionally facilitated, asynchronous online support group would reduce sexual distress (primary outcome) and improve sexual function, body image, depression symptoms, relationship satisfaction, and social support (secondary outcomes) in women treated for gynecologic cancer.</div></div><div><h3>Methods</h3><div>Participants were 398 women recruited from three Canadian provinces and one American cancer center in cohorts of 40. Participants were randomized (50:50 odds) to either the immediate treatment condition (ITC) or the waitlist control condition (WCC). Eligibility included: completed treatment for gynecologic cancer, disease-free for at least 3 months, no more than 5 years post-diagnosis, met criteria for psychosexual distress, willing to discuss sexual concerns, 18 years or older, English speaking, and access to a computer. Participants in the ITC received a 12-week online group along with psychoeducational material each week to stimulate discussion. Two 90-min synchronous sessions were offered in weeks 4 and 8.</div></div><div><h3>Results</h3><div>Reductions in sexual distress for ITC were not significantly different compared to WCC. Similarly, no treatment effects were observed for body image, depression, relationship satisfaction, or social support. ITC showed statistically significant improvements in sexual functioning compared to WCC, but these gains were not retained at 4-month follow-up.</div></div><div><h3>Conclusion</h3><div>Treatment effects were modest, although in the expected direction. As this study was underpowered, it offers preliminary evidence that an asynchronous, online psychoeducational support group may confer positive benefits for women's sexual functioning. The efficiency, convenience, and accessibility of online interventions has significant potential to close gaps in women's access to evidence-based sexual health care.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"192 ","pages":"Pages 73-79"},"PeriodicalIF":4.5,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142638688","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Manoj Sonavane , Jenna Hedlich-Dwyer , Valeria L. Dal Zotto , Min Tang , John Nemunaitis , Laura Stanbery , Adam Walter , Ernest Bognar , Rodney P. Rocconi , Natalie R. Gassman
{"title":"Repair Assisted Damage Detection (RADD) as a predictive biomarker for immunotherapy response in ovarian cancer","authors":"Manoj Sonavane , Jenna Hedlich-Dwyer , Valeria L. Dal Zotto , Min Tang , John Nemunaitis , Laura Stanbery , Adam Walter , Ernest Bognar , Rodney P. Rocconi , Natalie R. Gassman","doi":"10.1016/j.ygyno.2024.11.006","DOIUrl":"10.1016/j.ygyno.2024.11.006","url":null,"abstract":"<div><h3>Objective</h3><div>Genomic instability has been proposed as a predictive biomarker for immunotherapy in ovarian cancer. We tested a method for measuring DNA damage, a direct measure of genomic instability, in ovarian tumors and its ability to predict immunotherapy response to Vigil (gemogenovatucel-T).</div></div><div><h3>Methods</h3><div>Eighty-two formalin-fixed paraffin-embedded tumors from the VITAL trial (<span><span>NCT02346747</span><svg><path></path></svg></span>) underwent DNA damage assessment using Repair Assisted Damage Detection (RADD). VITAL tested maintenance Vigil therapy vs. placebo for stage IIIB-IV newly diagnosed ovarian cancer in clinical complete response. DNA lesion levels determined by RADD were scored and assessed against patient survival outcomes, expression of CD39, and gene expression signatures.</div></div><div><h3>Results</h3><div>A graduated distribution of RADD scores occurred across all 82 ovarian samples. RADD scores were able to predict HR status (<em>p</em> < 0.001). RADD demonstrated a significant Pearson's correlation with suggested Vigil biomarker CD39 (<em>r</em> = 0.473; p < 0.001), specifically within HRP tumors (<em>r</em> = 0.57; <em>p</em> = 0.002). High RADD scores correlated with worse recurrent free survival (RFS) in the placebo arm of the trial (7.9 vs. 14.7 months, high vs. low; <em>p</em> = 0.066). High RADD scores were also predictive of significant RFS over 39.4 months with Vigil compared to placebo (25.1 vs. 11.7 months, <em>p</em> = 0.005) and improved, but not significantly, OS with 38.8 vs. 31.8 months.</div></div><div><h3>Conclusions</h3><div>RADD revealed DNA repair proficiency without mutation signatures or expression profiling. High DNA damage levels show improved survival for Vigil maintenance therapies and are correlated with immune evasion proteins. The persistence of DNA lesions in the genomic DNA offers a new biomarker for immunotherapy patient stratification.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"192 ","pages":"Pages 65-72"},"PeriodicalIF":4.5,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142638702","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}