Giorgio Valabrega, Matthew A Powell, Sakari Hietanen, Eirwen M Miller, Zoltan Novak, Robert Holloway, Dominik Denschlag, Tashanna Myers, Anna M Thijs, Kathryn P Pennington, Lucy Gilbert, Evelyn Fleming, Oleksandr Zub, Lisa M Landrum, Beyhan Ataseven, Radhika Gogoi, Iwona Podzielinski, Noelle Cloven, Bradley J Monk, Sudarshan Sharma, Thomas J Herzog, Ashley Stuckey, Bhavana Pothuri, Angeles Alvarez Secord, Dana Chase, Veena Vincent, Oren Meyers, Jamie Garside, Mansoor Raza Mirza, Destin Black
{"title":"Patient-reported outcomes in the subpopulation of patients with mismatch repair-deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer treated with dostarlimab plus chemotherapy compared with chemotherapy alone in the ENGOT-EN6-NSGO/GOG3031/RUBY trial.","authors":"Giorgio Valabrega, Matthew A Powell, Sakari Hietanen, Eirwen M Miller, Zoltan Novak, Robert Holloway, Dominik Denschlag, Tashanna Myers, Anna M Thijs, Kathryn P Pennington, Lucy Gilbert, Evelyn Fleming, Oleksandr Zub, Lisa M Landrum, Beyhan Ataseven, Radhika Gogoi, Iwona Podzielinski, Noelle Cloven, Bradley J Monk, Sudarshan Sharma, Thomas J Herzog, Ashley Stuckey, Bhavana Pothuri, Angeles Alvarez Secord, Dana Chase, Veena Vincent, Oren Meyers, Jamie Garside, Mansoor Raza Mirza, Destin Black","doi":"10.1136/ijgc-2024-005484","DOIUrl":"10.1136/ijgc-2024-005484","url":null,"abstract":"<p><strong>Objective: </strong>In the ENGOT-EN6-NSGO/GOG3031/RUBY trial, dostarlimab+carboplatin-paclitaxel demonstrated significant improvement in progression free survival and a positive trend in overall survival compared with placebo+carboplatin-paclitaxel, with manageable toxicity, in patients with primary advanced or recurrent endometrial cancer. Here we report on patient-reported outcomes in the mismatch repair-deficient/microsatellite instability-high population, a secondary endpoint in the trial.</p><p><strong>Methods: </strong>Patients were randomized 1:1 to dostarlimab+carboplatin-paclitaxel or placebo+carboplatin-paclitaxel every 3 weeks for 6 cycles followed by dostarlimab or placebo monotherapy every 6 weeks for ≤3 years or until disease progression. Patient-reported outcomes, assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and Endometrial Cancer Module, were prespecified secondary endpoints. A mixed model for repeated measures analysis, a prespecified exploratory analysis, was conducted to generate least-squares means to compare between-treatment differences while adjusting for correlations across multiple time points within a patient and controlling for the baseline value. Results are provided with 2-sided, nominal p values.</p><p><strong>Results: </strong>Of 494 patients enrolled, 118 were mismatch repair-deficient/microsatellite instability-high. In this population, mean change from baseline to end of treatment showed visual improvements in global quality of life (QoL), emotional and social function, pain, and back/pelvis pain for dostarlimab+carboplatin-paclitaxel. Meaningful differences (least-squares mean [standard error]) favoring the dostarlimab arm were reported for change from baseline to end of treatment for QoL (14.7 [5.45]; p=0.01), role function (12.7 [5.92]); p=0.03), emotional function (14.3 [4.92]; p<0.01), social function (13.5 [5.43]; p=0.01), and fatigue (-13.3 [5.84]; p=0.03).</p><p><strong>Conclusions: </strong>Patients with mismatch repair-deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer receiving dostarlimab+carboplatin-paclitaxel demonstrated improvements in several QoL domains over patients receiving placebo+carboplatin-paclitaxel. The observed improvements in progression free survival and overall survival while improving or maintaining QoL further supports dostarlimab+carboplatin-paclitaxel as a standard of care in this setting. Trial registration ClinicalTrials.govNCT03981796.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"101852"},"PeriodicalIF":4.1,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142346256","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":"HPV-associated and HPV-independent vulvar squamous cell carcinoma: is there an impact of resection margins on local recurrence?","authors":"Marilyn Boo, Lynn Sadler, Susan Bigby, Lois Eva","doi":"10.1016/j.ijgc.2025.101757","DOIUrl":"10.1016/j.ijgc.2025.101757","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to investigate the impact of resection margins on the first local recurrence of vulvar squamous cell carcinoma, stratified by human papillomavirus (HPV) status: HPV-associated (HPV-A) and HPV-independent (HPV-I). It also investigated the association between precursor lesions of vulvar squamous cell carcinoma at the resection margins and the risk of first local vulvar squamous cell carcinoma recurrence.</p><p><strong>Methods: </strong>This was a retrospective single-center clinicopathological case note review of patients treated with primary surgery for vulvar squamous cell carcinoma between January 1990 and December 2020, with follow-up until February 2024. The impact of pathological margins on first local recurrence was assessed for HPV-A and HPV-I tumors separately in univariable and multi-variable survival analyses.</p><p><strong>Results: </strong>A total of 360 vulvar squamous cell carcinoma cases were identified. Local recurrences were reported in 12 of 166 (7.2%) HPV-A and 53 of 194 (27.3%) HPV-I tumors (p < .001). Pathological margins <8 mm were significantly associated with increased local recurrence in HPV-I vulvar squamous cell carcinoma, with both univariable (HR 2.34, 95% CI 1.33-4.10, p = .003) and multi-variable analysis (adjusted HR 2.06, 95% CI 1.14 to 3.71, p = .0017) confirming this association. No significant association was observed in HPV-A vulvar squamous cell carcinoma (HR 0.70, 95% CI 0.22 to 2.24, p = .55). The number of HPV-A recurrences precluded multi-variable analysis. After stratifying by HPV sub-type, there was no association between precursors at the margins and local recurrence.</p><p><strong>Conclusions: </strong>Local recurrences are more common in HPV-I than HPV-A vulvar squamous cell carcinoma. Surgical margins may not influence the risk of local recurrence in HPV-A vulvar squamous cell carcinoma. However, in HPV-I vulvar squamous cell carcinoma, narrow resection margins of <8 mm appear to increase the risk of local recurrence. Therefore, HPV status should be incorporated into management protocols to risk-stratify follow-up care.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"101757"},"PeriodicalIF":4.1,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143718830","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":"Comparison of sensitivity for Risk of Ovarian Malignancy Algorithm (ROMA) and Assessment of Different NEoplasias in the adneXa (ADNEX) model for predicting ovarian cancer in a woman with adnexal masses.","authors":"Pakorn Tangjanyatham, Woraphot Chaowawanit","doi":"10.1016/j.ijgc.2025.101827","DOIUrl":"10.1016/j.ijgc.2025.101827","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to compare the diagnostic performance of the Risk of Ovarian Malignancy Algorithm (ROMA) and the Assessment of Different NEoplasias in the adneXa (ADNEX) model in predicting ovarian cancer in women presenting with adnexal masses METHODS: A prospective diagnostic study was conducted at the Faculty of Medicine, Vajira Hospital, Navamindradhiraj University, Thailand. A total of 110 women with adnexal masses confirmed by ultrasound were enrolled. Pre-operative transvaginal ultrasound findings, serum CA125, and HE4 levels were used to evaluate the diagnostic performance of the ROMA and ADNEX models, with histopathological examination as the reference standard. The ADNEX model applied a 10% malignancy risk cutoff.</p><p><strong>Results: </strong>Using a 10% cutoff, the ADNEX model achieved a sensitivity of 91.9% and a specificity of 65.7%. In comparison, ROMA demonstrated a sensitivity of 64.8% and a specificity of 86.3%. The combined use of ADNEX and ROMA did not significantly improve diagnostic specificity. The receiver operating characteristic analysis for the ADNEX model showed an area under the curve of 0.83, indicating good diagnostic accuracy. The optimal threshold for malignancy risk was identified at a 13.8% cutoff, balancing sensitivity and specificity.</p><p><strong>Conclusions: </strong>The ADNEX model, with a 10% malignancy risk cutoff, provides superior sensitivity in diagnosing ovarian cancer in adnexal mass cases and could significantly contribute to early detection strategies. However, its lower specificity highlights the need for cautious interpretation. Further studies are warranted to refine these models and enhance their applicability across diverse clinical environments.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":"35 6","pages":"101827"},"PeriodicalIF":4.1,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143968884","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":"Dermatofibrosarcoma protuberans of the vulva.","authors":"José Antonio Pérez-Álvarez, Félix Boria","doi":"10.1016/j.ijgc.2025.101674","DOIUrl":"10.1016/j.ijgc.2025.101674","url":null,"abstract":"","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"101674"},"PeriodicalIF":4.1,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604944","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}
Giorgio Bogani, Sabrina Croce, Giovanni Scambia, Wouter Froyman, Francesco Raspagliesi, Frederic Amant
{"title":"Fertility-sparing approach for uterine smooth muscle tumors of uncertain malignant potential.","authors":"Giorgio Bogani, Sabrina Croce, Giovanni Scambia, Wouter Froyman, Francesco Raspagliesi, Frederic Amant","doi":"10.1016/j.ijgc.2025.101822","DOIUrl":"10.1016/j.ijgc.2025.101822","url":null,"abstract":"<p><strong>Objective: </strong>Uterine smooth muscle tumors of uncertain malignant potential (STUMP) are a category of tumors that present diagnostic/therapeutic challenges since they cannot be assigned to either a benign or a malignant entity. Hysterectomy is the mainstay of treatment of STUMP. However, in most cases, STUMPs represent an incidental diagnosis following myomectomy. The optimal management of young women having an incidental diagnosis of STUMP following myomectomy is unclear. Only a few experiences are reported. This review focuses on the fertility-sparing treatment of STUMPs.</p><p><strong>Methods: </strong>This is a systematic review of studies comparing outcomes of patients undergoing hysterectomy and myomectomy. For this review, we included studies reporting outcomes of patients with STUMPs undergoing myomectomy. Studies reporting data only on radical treatment for STUMPs or focusing on conservative management of other uterine malignancies (including leiomyosarcoma) were excluded.</p><p><strong>Results: </strong>Pooled data of 327 patients (from 9 retrospective studies) were evaluated. Overall, the study included 159 (48.6%) and 168 (51.4%) patients who had myomectomy and hysterectomy, respectively. No differences in recurrence rates were observed after myomectomy and hysterectomy (13.2% vs 9.5%, OR 0.69, 95% CI 0.35 to 1.38, p = .30), after a median follow-up of 44 and 48 months, respectively. Patients treated with myomectomy were more likely to develop STUMP recurrences than patients treated with hysterectomy (11.9% vs 4.1%, OR 2.38, 95% CI 1.04 to 5.44, p = .046). Among 103 patients desiring to conceive, 40 (38.8%) patients achieved at least 1 pregnancy. Pregnancy was not associated with an increased risk of recurrence.</p><p><strong>Conclusions: </strong>These cumulative data suggest that myomectomy might be considered a safe and effective alternative for women who wish to preserve their childbearing potential. Centralization, pathology review based on clinic-pathologic and molecular integration, and multidisciplinary discussion in referral centers are of paramount importance. Multicenter prospective registries are needed.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":"35 6","pages":"101822"},"PeriodicalIF":4.1,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143999508","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":"INTERLACE in practice.","authors":"Gemma Eminowicz, Patricia Diez, Mary McCormack","doi":"10.1136/ijgc-2024-006098","DOIUrl":"10.1136/ijgc-2024-006098","url":null,"abstract":"","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"101835"},"PeriodicalIF":4.1,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142499935","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}
Koji Matsuo, Joel Agarwal, Ling Chen, Christian Pino, Mihiri S Karunaratne, Katelyn B Furey, Maximilian Klar, Lynda D Roman, Jason D Wright
{"title":"Modified radical hysterectomy for stage IB1 (≤2 cm) cervical cancer: assessment of temporal trends and oncologic outcomes in the United States.","authors":"Koji Matsuo, Joel Agarwal, Ling Chen, Christian Pino, Mihiri S Karunaratne, Katelyn B Furey, Maximilian Klar, Lynda D Roman, Jason D Wright","doi":"10.1016/j.ijgc.2025.101676","DOIUrl":"10.1016/j.ijgc.2025.101676","url":null,"abstract":"<p><strong>Objective: </strong>The oncologic safety of less-radical surgery for early-stage cervical cancer is currently being actively investigated. Given the paucity of data, this study assessed the temporal trends and oncologic outcomes associated with modified radical hysterectomy for stage IB1 (≤2 cm) cervical cancer in the United States.</p><p><strong>Methods: </strong>This retrospective cohort study used data from the Commission-on-Cancer's National Cancer Database. The study population was 2902 patients with clinical stage IB1 (≤2 cm) cervical cancer from 2010 to 2020. Temporal trends based on hysterectomy modality (radical hysterectomy, modified radical hysterectomy, and simple hysterectomy) were assessed using linear segmented regression with log-transformation, and the overall survival was assessed using a multivariable Cox proportional hazard regression model.</p><p><strong>Results: </strong>There was a statistically significant increase in modified radical hysterectomy from 2013 to 2020 (annual percentage rate increase 4.4, 95% CI 0.7 to 16.0, p=.040) and a decrease in simple hysterectomy from 2012 to 2020 (-2.3, 95% CI -3.7 to -1.3, p<.001). The lymphovascular space invasion rates (26.8%, 26.8%, and 23.1% for the radical, modified radical, and simple hysterectomy groups, respectively, p=.10) and pathological nodal metastasis rates (5.0%, 4.4%, and 4.0%, respectively, p=.54) were similar among the 3 groups. The use of adjuvant radiotherapy was higher in the simple hysterectomy group (13.0%, 13.0%, and 18.2% in the radical, modified radical, and simple hysterectomy groups, respectively, p<.001). The 5-year overall survival rates for radical hysterectomy, modified radical hysterectomy, and simple hysterectomy were 96.6%, 96.3%, and 95.8%, respectively (p=.66). In multivariable analysis, modified radical hysterectomy (adjusted HR 1.23, 95% CI 0.73 to 2.06) and simple hysterectomy (adjusted HR 1.02, 95% CI 0.70 to 1.48) were not associated with decreased overall survival compared with radical hysterectomy.</p><p><strong>Conclusions: </strong>The results of this cohort study in the United States suggest that modified radical hysterectomy for stage IB1 (≤2 cm) may not be associated with overall survival. This observed survival association warrants further investigation for stage IB1 (≤2 cm) cervical cancer that does not meet the low-risk criteria.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"101676"},"PeriodicalIF":4.1,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143630417","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}