Gynecologic oncology最新文献

{"title":"Molecular classification in fertility-sparing treatment of early-stage endometrial cancer: A potential tool for optimizing patient selection","authors":"","doi":"10.1016/j.ygyno.2024.10.012","DOIUrl":"10.1016/j.ygyno.2024.10.012","url":null,"abstract":"<div><h3>Objective</h3><div>To investigate the prognostic significance of molecular classification on treatment outcomes of fertility-sparing treatment (FST) in early-stage endometrial cancer (EC), and its potential in optimizing fertility-sparing management.</div></div><div><h3>Methods</h3><div>Patients with early-stage EC who received FST with ProMisE classification were investigated. Oncological and reproductive outcomes were compared across four molecular subtypes. Factors influencing complete response (CR) were analyzed.</div></div><div><h3>Results</h3><div>Among 116 molecularly classified patients, 80 were evaluated for therapeutic effects, including 64 (80.0 %) p53wt, 7 (8.7 %) MMR-D, 5 (6.3 %) POLE EDM, and 4 (5.0 %) p53abn. Overall CR rates were comparable across four molecular subtypes, with 92.2 % of p53wt, 71.4 % of MMR-D, 100.0 % of POLE EDM, and 75.0 % of p53abn (<em>P</em> = 0.145). MMR-D patients needed the longest median treatment time to achieve CR (7.9 months, range 3.5–15.9), while POLE EDM required the shortest (3.0 months, range 2.8–6.4), followed by p53abn (3.5 months, range 3.0–3.7) and p53wt (3.7 months, range 2.2–22.8) (<em>P</em> <em>=</em> 0.049). Among 14 p53wt patients with superficial myometrial invasion (MI) or G2 histology, 13 (92.9 %) achieved CR, and of 8 who attempted to conceive,4 delivered. Multivariable analysis identified MMR-D, superficial MI and insulin resistance negatively predicted CR, while POLE EDM was a positive factor.</div></div><div><h3>Conclusions</h3><div>Molecular classification of EC may serve as a tool for predicting response to FST and assist in identifying candidates for FST. POLE EDM patients tended to obtain promising outcomes. MMR-D cases should be cautiously administrated for FST with close surveillance. Patients with p53wt demonstrated favorable outcomes, including those with superficial MI or G2 EC. Patients with endometrium-confined p53abn tumors may benefit from FST. However, given the small sample sizes of certain subtypes, further investigation is necessary to validate these findings.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142499093","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}

{"title":"Safety and tolerability of mirvetuximab soravtansine monotherapy for folate receptor alpha–expressing recurrent ovarian cancer: An integrated safety summary","authors":"","doi":"10.1016/j.ygyno.2024.10.013","DOIUrl":"10.1016/j.ygyno.2024.10.013","url":null,"abstract":"<div><h3>Objective</h3><div>Mirvetuximab soravtansine-gynx (MIRV) is a novel antibody-drug conjugate targeting folate receptor alpha (FRα), which is overexpressed in epithelial ovarian cancer (EOC), with limited expression on normal tissues. This integrated safety summary sought to characterize the safety profile of MIRV monotherapy in participants with FRα-expressing recurrent EOC.</div></div><div><h3>Methods</h3><div>Safety data were retrospectively analyzed from 4 clinical studies (phase 1 trial [<span><span>NCT01609556</span><svg><path></path></svg></span>], phase 3 FORWARD I [<span><span>NCT02631876</span><svg><path></path></svg></span>], phase 2 SORAYA [<span><span>NCT04296890</span><svg><path></path></svg></span>], phase 3 MIRASOL [<span><span>NCT04209855</span><svg><path></path></svg></span>]) that evaluated participants with FRα-expressing recurrent EOC who received ≥1 dose of MIRV 6 mg/kg adjusted ideal body weight every 3 weeks.</div></div><div><h3>Results</h3><div>In this analysis of 682 participants, 94 % had platinum-resistant ovarian cancer (PROC). Blurred vision (43 %), nausea (41 %), diarrhea (39 %), and fatigue (35 %) were the most common treatment-emergent adverse events (TEAEs) and were primarily grade 1–2 in severity. Grade ≥ 3 TEAEs occurred in 48 % of participants, with the most common being keratopathy and blurred vision (5 % each). Most TEAEs were managed with supportive care and dose modifications, and only 12 % of participants experienced a TEAE leading to discontinuation (1 % due to ocular events). No corneal ulcerations or perforations have been reported. Median time to onset of blurred vision and keratopathy was 5.9 and 6.7 weeks, respectively. Most blurred vision events and keratopathy events resolved completely (71 % and 66 %, respectively) or partially (15 % and 14 %, respectively).</div></div><div><h3>Conclusions</h3><div>As demonstrated among 682 participants, the safety profile of MIRV is well tolerated and consists primarily of low-grade gastrointestinal, fatigue, headache, peripheral neuropathy, and resolvable ocular adverse events.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142499096","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}

{"title":"Phase II clinical trial assessing the efficacy of enzalutamide in advanced non-resectable granulosa cell ovarian tumors: The GREKO III study (GETHI2016–01)","authors":"","doi":"10.1016/j.ygyno.2024.10.019","DOIUrl":"10.1016/j.ygyno.2024.10.019","url":null,"abstract":"<div><h3>Background</h3><div>Granulosa cell ovarian tumors (GCT) are orphan disease with limited treatments. Hormone therapy is a potential treatment, due to the overexpression of hormone receptors in most tumors. This study explores the activity of the antiandrogen, enzalutamide, in metastatic cases.</div></div><div><h3>Methods</h3><div>We designed a phase II clinical trial under the Spanish Collaborative Group for Transversal Oncology and Rare and Orphan Tumors (GETTHI). Eligible participants were adult women with advanced GCT. Primary endpoint was objective response rate. Secondary endpoints included clinical benefit rate, progression-free survival, overall survival, and safety profile. Patients received enzalutamide 160 mg once daily.</div></div><div><h3>Results</h3><div>From April 2018 to March 2020, eighteen patients were screened, and sixteen were included across nine institutions. Median age was 56.4 years (range 45–71), and most were Caucasian (14 cases), one Arabian and one Latin. ECOG performance status was zero in 13 cases (81 %) and one in three (19 %). Six patients (38 %) had previously received hormone therapy as adjuvant treatment or for advanced disease, and 15 (94 %) chemotherapy. Median time from metastasis to study entry was 96 months (range 4.5–198).</div><div>No objective response was observed, but the clinical benefit rate reached 68.8 % (95 % CI [46 %–91.5 %]). Median progression-free survival was 3.8 months (95 % CI [1.36–6.14]). Median overall survival was not reached, with a median follow-up of 6 months (range 2.2–19).</div><div>At the time of database closure, 14 patients had discontinued treatment, 13 due to disease progression and one by personal choice. Two deaths attributed to disease progression were recorded.</div><div>Five grade 3 adverse events were reported, with only one (asthenia) deemed related to the therapy.</div></div><div><h3>Conclusions</h3><div>Although enzalutamide demonstrated modest activity in GCT, durable stabilization was observed in some cases.</div><div><em>Trial Registration:</em> <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> Identifier: <span><span>NCT03464201</span><svg><path></path></svg></span></div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142499094","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}

{"title":"Trends in brachytherapy in utilization for vaginal cancer in the United States from 2004 to 2021","authors":"","doi":"10.1016/j.ygyno.2024.10.014","DOIUrl":"10.1016/j.ygyno.2024.10.014","url":null,"abstract":"<div><h3>Purpose</h3><div>Brachytherapy (BT) is recommended for vaginal cancer treatment, particularly cases of bulky and/or recurrent disease. However, previous studies noted a decline in utilization rates. This study examines recent trends in BT utilization to assess for reversal in trends.</div></div><div><h3>Material and methods</h3><div>This study analyzed the National Cancer Database (NCDB) of patients with FIGO stage I to IVA vaginal cancer treated between 2004 and 2021. A log binomial regression with robust variance was used to estimate incidence rate ratios (IRRs) of BT utilization over time and identify potential factors associated with receipt.</div></div><div><h3>Results</h3><div>Brachytherapy use increased from 48.0 % in 2004 to 63.3 % in 2021. Factors associated with increased brachytherapy use included, receiving care at an academic/research program (IRR: 1.35 95 % CI: 1.18–1.55), integrated cancer program (1.22 [1.06–1.41]), and diagnosis after 2018 (1.31 [1.21–1.42]). Factors associated with decreased use included American Indian or Alaskan Native race (0.55 [0.31–0.97]) when compared to white race, age over 70 (≥ 70–79 years: 0.91 [0.83–0.99]; ≥ 80 years: 0.68 [0.61–0.76]) when compared to age less than 50, and stage II (0.91 [0.86–0.96]), III (0.71 [0.67–0.75]), or IVA (0.43 [0.37–0.50]) disease when compared to stage I. Finally, geographic differences were also observed in BT use.</div></div><div><h3>Conclusions</h3><div>In patients with stage I – IVA vaginal cancer from 2004 to 2021, brachytherapy utilization has significantly increased. These results indicate a recent start of the reversal of previously identified declining use of brachytherapy. However, more work is needed to ensure equitable use across demographic strata.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142499097","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}

{"title":"Adjuvant therapy de-escalation for stage I uterine leiomyosarcoma: A systematic review and meta-analysis","authors":"","doi":"10.1016/j.ygyno.2024.10.018","DOIUrl":"10.1016/j.ygyno.2024.10.018","url":null,"abstract":"<div><h3>Objective</h3><div>To examine the association between adjuvant chemotherapy and survival outcomes in patients with stage I uterine leiomyosarcoma (uLMS).</div></div><div><h3>Methods</h3><div>This comprehensive systematic review and meta-analysis through December 31, 2023 (PROSPERO registration number: CRD42024504776) investigated studies that examined survival outcomes in patients with stage I uLMS using 4 public search engines (PubMed, Scopus, Web of Science, and the Cochrane Central Register of Controlled Trials). Two investigators searched the studies independently, and survival outcomes (overall survival [OS] and disease-free survival [DFS]) were compared between the adjuvant chemotherapy and observation groups. Utilization rate of adjuvant chemotherapy and the regimens used were also assessed. Kaplan-Meier survival curves in the two treatment groups were evaluated using ImageJ software.</div></div><div><h3>Results</h3><div>From 1988 to 2022, 16 eligible studies including a total of 5690 patients met the inclusion criteria and evaluated the effect of adjuvant chemotherapy on survival outcomes in patients with stage I uLMS. Adjuvant chemotherapy was utilized in 38.5 % of patients (range, 14.8 % to 70.0 %). Eight studies from 2017 to 2022 compared the survival outcomes between adjuvant chemotherapy and observation. OS was comparable between the two groups in both unadjusted (<em>n</em> = 6, hazard ratio [HR] 1.02, 95 % confidence interval [CI] 0.77–1.35, <em>P =</em> 0.88) and adjusted (<em>n</em> = 4, HR 0.90, 95 %CI 0.56–1.43, <em>P =</em> 0.65) pooled analyses. DFS was also similar between adjuvant chemotherapy and observation in both unadjusted (<em>n</em> = 4, HR 0.78, 95 %CI 0.53–1.13, <em>P =</em> 0.18) and adjusted (<em>n</em> = 2, HR 1.14, 95 %CI 0.67–1.94, <em>P =</em> 0.64) pooled analyses. Adjuvant chemotherapy regimens utilized included doxorubicin, ifosfamide, cisplatin, gemcitabine, and docetaxel as monotherapies or combination therapies.</div></div><div><h3>Conclusions</h3><div>In this contemporaneous systematic review and meta-analysis, less than 40 % of patients received adjuvant chemotherapy for stage I uLMS and adjuvant chemotherapy which was not associated with improved survival. These results support the current National Comprehensive Cancer Network clinical practice guidelines that recommends de-escalating adjuvant chemotherapy in stage I uLMS after complete resection.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142499076","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}

{"title":"What happens after menopause? (WHAM): A prospective controlled study of vasomotor symptoms and menopause-related quality of life 24 months after premenopausal risk-reducing salpingo-oophorectomy (RRSO)","authors":"","doi":"10.1016/j.ygyno.2024.10.007","DOIUrl":"10.1016/j.ygyno.2024.10.007","url":null,"abstract":"<div><h3>Objective</h3><div>To measure vasomotor symptoms and menopause-related quality of life up to 24 months after RRSO, and the effects of Menopausal Hormone Therapy (MHT).</div></div><div><h3>Methods</h3><div>Prospective observational study of 104 premenopausal women at elevated risk of ovarian cancer planning RRSO and age-matched comparators (<em>n</em> = 102) who retained their ovaries. Vasomotor symptoms and quality of life were measured using the Menopause-specific QoL Intervention (MENQOL-I) scale. Changes in QoL were examined using a population-averaged linear regression model. The study was registered with the Australian and New Zealand Clinical Trials Registry, ACTRN12615000082505.</div></div><div><h3>Results</h3><div>At 24 months after RRSO the prevalence of vasomotor symptoms had increased from 6 % at baseline to 59 % and night sweats from 21 % to 39 %. There was a clinically and statistically significant difference of 1.14 points in MENQOL score (95 % CI 0.71, 1.57, <em>p</em> &lt; 0.001) in the change from baseline to 24 months in vasomotor symptoms between the RRSO vs comparison group. Following RRSO, 61 % started MHT, most (79 %) within 3 months. At 24 months, 54 % of MHT users reported vasomotor symptoms of which around half (52 %) categorized these as “mild”. Amongst non-MHT users, 88 % reported vasomotor symptoms at 24 months of which 72 % categorized these as “mild”. Menopause-related QoL decreased after RRSO but was stable in comparators. Menopause related quality of life was higher in MHT users vs non-users.</div></div><div><h3>Conclusions</h3><div>Vasomotor symptoms peak by 3 months after RRSO and are stable over 24 months. MHT mitigates but does not fully resolve vasomotor symptoms and improves menopause-related QoL.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142499098","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}

{"title":"Phase II study of enlonstobart (SG001), a novel PD-1 inhibitor in patients with PD-L1 positive recurrent/metastatic cervical cancer","authors":"","doi":"10.1016/j.ygyno.2024.10.001","DOIUrl":"10.1016/j.ygyno.2024.10.001","url":null,"abstract":"<div><h3>Background</h3><div>Platinum-based chemotherapy with or without bevacizumab is the first-line treatment for patients with recurrent or metastatic cervical cancer (r/mCC), and the treatment options are limited for r/mCC after first-line treatment. Enlonstobart (SG001) is a fully humanized and high-affinity anti-PD-1 immunoglobulin G4 monoclonal antibody. Previous phase Ib study demonstrated that SG001 had a promising efficacy in patients with PD-L1 positive r/mCC.</div></div><div><h3>Methods</h3><div>In this multicenter, single-arm, open-label, phase II study, eligible patients were ≥ 18 years with PD-L1-positive cervical cancer who had progression on or intolerance to the first-line platinum-based chemotherapy. Patients received SG001 240 mg every two weeks for 24 months or until disease progression, intolerable toxicities, or other study discontinuation criteria were met. The primary endpoint was confirmed objective response rate (ORR) assessed by RECIST version 1.1 by independent review committee.</div></div><div><h3>Results</h3><div>107 patients were enrolled with median age of 53 years (range 26–72). 64.5 % of patients had a ECOG of 1. After a median follow-up of 14.0 months (range 0.4–21.9), confirmed ORR was 29.0 %, with two complete responses and twenty-nine partial responses. The disease control rate was 54.2 %. Median duration of response was 16.6 months (95 % CI 10.8-NA), median progression free survival was 3.1 months (95 % CI 2.2–6.9). Median overall survival was not reached. 104 patients (97.2 %) experienced at least one treatment emergent adverse events TEAEs, of which 38 patients (35.5 %) had grade 3 or higher TEAEs. The most common treatment-related adverse events were leukopenia (19.6 %), increased aspartate aminotransferase (18.7 %), anemia (17.8 %), increased alanine aminotransferase (15.9 %), hypothyroidism (15.0 %), neutropenia (15.0 %), and hyperthyroidism (11.2 %).</div></div><div><h3>Conclusion</h3><div>SG001 monotherapy demonstrated durable anti-tumor activity with acceptable safety in patients with PD-L1 positive r/mCC with progression on or intolerance to the first-line platinum-based chemotherapy.</div></div><div><h3>Trial registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (<span><span>NCT04886700</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142499095","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}

{"title":"Cold ischemia time and formalin fixation time in endometrial cancer: Should breast cancer guidelines for preanalytical variables be applied to hysterectomy specimens?","authors":"","doi":"10.1016/j.ygyno.2024.10.015","DOIUrl":"10.1016/j.ygyno.2024.10.015","url":null,"abstract":"<div><h3>Objectives</h3><div>The American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) recommend cold ischemia time (cIT) be &lt;60 min, and formalin fixation time (FFT) 6–72 h, to optimize immunohistochemistry (IHC) based on breast cancer data. We assessed whether cIT and FFT impact IHC in endometrial cancer (EC), and determined which factors affect cIT and FFT.</div></div><div><h3>Methods</h3><div>Surgical EC cases from 2019 to 2023 were reviewed. cIT was calculated by subtracting time of tissue devascularization intra-operatively from time the specimen was placed in formalin. Demographics, clinicopathologic and peri-operative factors, and IHC for estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor 2 (HER2), and mismatch repair (MMR) proteins were compared between patients with cIT &lt;60 min versus ≥60 min (prolonged), and compliant FFT (6–72 h) versus non-compliant FFT (&lt;6 or &gt; 72 h). Categorical variables were compared using χ² tests.</div></div><div><h3>Results</h3><div>941 patients were included in the analysis. Median cIT was 33 min. Prolonged cIT occurred in 95 (10 %) cases. African American/Black race (<em>p</em> &lt; 0.001), advanced stage (p &lt; 0.001), mini-laparotomy (p &lt; 0.001), performance of surgical procedures beyond standard EC staging (p &lt; 0.001), longer surgical length (p &lt; 0.001), and increased uterine weight (p &lt; 0.001) were independently associated with prolonged cIT. There were no significant differences in ER, PR, HER2, or MMR protein expression based on cIT or FFT.</div></div><div><h3>Conclusion</h3><div>Prolonged cIT was not associated with differences in biomarker expression via IHC at time of surgical staging for EC. Despite variability in cIT, which is largely due to non-modifiable factors, tumor molecular features remain consistent and can reliably be utilized for prognostic and therapeutic decision-making.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142499077","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}

{"title":"Imlunestrant, an oral selective estrogen receptor degrader, as monotherapy and combined with abemaciclib, in recurrent/advanced ER-positive endometrioid endometrial cancer: Results from the phase 1a/1b EMBER study","authors":"","doi":"10.1016/j.ygyno.2024.10.006","DOIUrl":"10.1016/j.ygyno.2024.10.006","url":null,"abstract":"<div><h3>Objective</h3><div>Imlunestrant is a next-generation oral selective estrogen receptor degrader designed to deliver continuous estrogen receptor (ER) target inhibition. EMBER is a phase 1a/b trial of imlunestrant, as monotherapy and combined with targeted therapy, in patients with ER+ advanced breast cancer or endometrioid endometrial cancer (EEC). This report focuses on patients with ER+ EEC.</div></div><div><h3>Methods</h3><div>EMBER used an i3 + 3 dose-escalation design to determine the recommended phase 2 dose (RP2D) followed by dose-expansion cohorts (1:1 randomization): imlunestrant monotherapy and imlunestrant plus abemaciclib (150 mg twice daily). Eligible patients had measurable disease and progression or recurrence after platinum-containing chemotherapy. Prior fulvestrant or aromatase inhibitor was not allowed. Secondary endpoints included safety, pharmacokinetics and antitumor activity.</div></div><div><h3>Results</h3><div>In total, 72 patients with a median of 2 prior anticancer therapies were treated. Among the 39 patients who received imlunestrant (400 mg [RP2D], <em>n</em> = 33; 800 mg, <em>n</em> = 6), the most common treatment-emergent adverse events (TEAEs) were grade 1–2 nausea (35.9 %), diarrhea (25.6 %), urinary tract infection (25.6 %), and abdominal pain (20.5 %). Overall response rate (ORR) was 10.3 %, clinical benefit rate (CBR) was 33.3 %, and median progression-free survival (mPFS) was 3.8 months (95 % CI, 1.8–6.7). Among the 33 patients who received imlunestrant (400 mg [RP2D], <em>n</em> = 29; 800 mg, <em>n</em> = 4) plus abemaciclib, the most common TEAEs were diarrhea (87.9 %), nausea (66.7 %), fatigue (48.5 %), and anemia (45.5 %). ORR was 18.2 %, CBR was 42.4 %, and mPFS was 6.8 months (95 % CI, 2.1–12).</div></div><div><h3>Conclusion</h3><div>Imlunestrant, as monotherapy and combined with abemaciclib, has a manageable safety profile with preliminary evidence of antitumor activity in patients with ER+ EEC.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142499079","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}

{"title":"Five-year quality-of-life assessment by urinary diversion type after pelvic Exenterations","authors":"","doi":"10.1016/j.ygyno.2024.10.016","DOIUrl":"10.1016/j.ygyno.2024.10.016","url":null,"abstract":"<div><h3>Objective</h3><div>To determine whether urinary diversion procedures performed at time of pelvic exenteration affect quality of life in patients with recurrent gynecologic malignancies.</div></div><div><h3>Methods</h3><div>We performed a retrospective secondary longitudinal analysis of quality of life according to type of urinary diversion patients received. Participants completed a series of validated questionnaires at various time points. We allocated patients based on urinary diversion type to either the continent group (CD; 29 [55 %]) or noncontinent group (NCD; 24 [45 %]).</div></div><div><h3>Results</h3><div>We noted a significant improvement in global health scores from baseline over time (time <em>p</em> = 0.027). Physical functioning scores showed a statistically significant difference over time (at 24 months: NCD, −4.3 [95 % CI, −14.1 to 5.4]; CD, 0.4 [95 % CI, −7.1 to 7.9]. <em>p</em> &lt; 0.001). Social functioning scores were persistently higher for the CD vs NCD group at all time points but did not differ significantly between the groups at baseline (<em>p</em> = 0.75) or over time within the same group (time <em>p</em> = 0.122). Body image scores significantly decreased (reduced burden) over time for both groups (<em>p</em> = 0.044) and were consistently higher in the NCD vs CD group.</div></div><div><h3>Conclusions</h3><div>Patients experienced a return to their baseline quality of life within a year of surgery. Clinicians should prioritize and improve identifying and discussing postoperative challenges such as changes in physical and social functioning and body image.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142499078","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}