Gynecological cancer requiring management during pregnancy is rare, with an estimated incidence of 2 to 5 per 100,000 pregnancies in the first trimester. Balancing maternal and fetal health in these cases can be difficult, and management strategies differ from nonpregnancy cases. Management strategies are typically determined by maximizing benefit to the mother while minimizing harm to the fetus, considering the extent of the cancer, available treatment options for each type of cancer, and the gestational age of the fetus. This article is a guideline presenting the highest standard of evidence for the management of these cases, although the authors recognize that following these recommendations is not always possible in all areas of the world. These guidelines address imaging, pathology, surgery, medical oncology, obstetrics, radiation therapy, psychology, patient perspective, and pediatric follow-up for ovarian, cervical, and vulvar cancers during pregnancy. The guidelines in this article were developed using the European Society of Gynecological Oncology (ESGO) via the ESGO Guideline Committee. This consists of a multidisciplinary international development group that uses scientific evidence and expert consensus, as well as an external international review process. A systematic review was performed as part of the creation of these guidelines, including relevant studies published between January 2014 and June 2024. In cases where evidence was unclear, professional experience and expertise were used to fill the gap. General guidelines included discussing treatment with a multidisciplinary team, patient and partner counseling being a priority (including diagnostic and treatment plans, potential alternatives, risks and benefits, and side effects), workup and treatment being conducted at a specialized center, patients receiving care as close as possible to nonpregnant patients, taking into account individual modifications as necessary, prioritizing research with these cases, and registration of all cancer cases during pregnancy. The incidence of cancer during pregnancy is not decreasing, and thus, practitioners should be aware of these possible complications of pregnancy. Recommendations include investigating symptoms of cancer immediately and thoroughly, as well as preserving the pregnancy because pregnancy does not worsen the prognosis of gynecological cancers. Imaging guidelines include ultrasound examination for diagnosis, with the reassurance of its safety during pregnancy, magnetic resonance imaging (MRI) for inconclusive ultrasound examination, referral to an experienced radiologist, repeated ultrasound examination for management planning, using ultrasound to evaluate patient response to neoadjuvant chemotherapy, and avoiding the use of gadolinium-based contrast agents, using diffusion-weighted MRI instead. In addition, the use of a lead apron for shielding is not recommended. The recommendations surrounding pathology include recording all relevant information on the pathology request form, referral for specialist opinion, and submission of the placenta for pathological examination after delivery. Surgical recommendations include locoregional anesthesia as a preferred method over general anesthesia and using a left lateral tilt of at least 15 degrees after 20 weeks of gestation. If procedures cannot be postponed, they should be performed during pregnancy even with an elevated risk to the fetus, though trauma to the uterus should be avoided. Minimally invasive procedures are preferred during pregnancy, when possible, though there is little evidence surrounding safe lengths and abdominal pressures; thus, surgical times and abdominal pressure should be minimized. Medical oncology guidelines include assessment of maternal and fetal health before each chemotherapy cycle, choosing a chemotherapy regimen based on cancer type, adapting standard treatment due to anticipated fetotoxic effects, and timing of chemotherapy to be after 12 weeks of gestation and before 35 weeks of gestation. In terms of obstetrics, it is recommended to encourage the use of compression stockings or devices during surgery and prophylactic low-molecular-weight heparin both after surgery and after delivery. Preterm birth should be avoided if possible, and delivery should be timed 2 weeks after the last course of chemotherapy if possible. If preterm delivery is expected, corticosteroids should be administered for fetal lung development in accordance with standard care recommendations. Cesarean delivery is recommended in cases of vulvo-vaginal cancer in situ and invasive cervical cancer, and vaginal delivery can be considered in cases where cancer has been completely removed or is restricted to the ovaries. The effects of radiation should be considered in a risk/benefit assessment for this therapy during pregnancy, and pelvic or groin radiation therapy should not be performed if pregnancy preservation is desired. Limited delay of radiation therapy should be considered if it allows for standard treatment, but minimizing fetal exposure can be considered as well in urgent cases. If pregnancy preservation is not desired, radiation therapy in combination with feticide or uterine evacuation can be proposed. Oncopsychologists should be included in the multidisciplinary team managing cases of gynecological cancer in pregnancy, and regular screening should be performed along with support offered at every stage of treatment during and after pregnancy. Patients and their partners should be included in treatment decisions and educated and consulted about their care. Long-term monitoring is recommended for children exposed to chemotherapy or radiation in utero, including assessments of hearing, cardiotoxicity, and neurodevelopmental delays.
OBJECTIVE:Data on fertility-sparing surgery in advanced borderline ovarian tumors are limited to retrospective series and suggest concerning fertility outcomes. We aimed to study the long-term fertility and reproductive outcomes of patients with stage IIA to IIIC borderline ovarian tumors treated with fertility-sparing surgery. METHODS:This retrospective single-institution study included patients younger than 45 years with stage IIA to IIIC borderline ovarian tumors treated with fertility-sparing surgery from 1985 to 2021. Primary end points were the rates of pregnancies and live births among women attempting to conceive. Logistic regression models were used to evaluate the impact of different covariates on the occurrence of pregnancies. RESULTS:A total of 86 patients were included in the study. The median follow-up was 182 months. Fifty patients (58%) actively attempted to conceive, 5 of whom were referred to a reproductive medicine center. Forty-two patients successfully achieved 76 pregnancies, and 63 live births occurred in 40 women, yielding an overall pregnancy and live birth rates of 84% and 80%, respectively. Of the 76 pregnancies, 40 occurred before any relapse, while 28 and 8 occurred after the first and second recurrences, respectively. Similarly, of the 63 live births, 35 occurred before any relapse, whereas 22 and 6 occurred after the first and second recurrences. Thirty-five (40.7%) patients underwent subsequent radical surgery, 29 for recurrence and 6 as completion surgery, after a median time of 96 months. The median age at radical surgery was 40 years. Among patients who did not undergo radical surgery, 11 experienced spontaneous menopause during follow-up at a median age of 41 years. CONCLUSIONS:Despite high recurrence rates, fertility-sparing surgery yields satisfactory fertility outcomes in patients with advanced borderline ovarian tumors, irrespective of disease stage or surgical approach, and should be considered both as a primary treatment strategy and as a feasible option for recurrent disease.
Importance Young BRCA carriers may undergo breast-conserving surgery (BCS) or mastectomy with or without contralateral risk-reducing mastectomy at the time of an index breast cancer diagnosis. A variety of factors may influence surgical decision-making. Objective To explore surgical patterns of care and factors associated with uptake of bilateral mastectomy among affected BRCA1 or BRCA2 ( BRCA1/2 ) carriers diagnosed with early-onset breast cancer. Design, Setting, and Participants The BRCA BCY Collaboration is an international, hospital-based retrospective cohort study conducted at 109 centers across 5 continents. Women aged 40 years or younger with germline pathogenic or likely pathogenic variants in BRCA1/2 who were diagnosed between January 1, 2000, and December 31, 2020, with invasive stage I to III breast cancer were included. Data were collected between January 2022 and June 2024, and analyses were performed between May 21 and 28, 2025. Main Outcome and Measures The main outcome was the evaluation of surgical management as primary treatment for a first diagnosis of invasive breast cancer, defined as BCS, unilateral mastectomy, or bilateral mastectomy. Results Of 5660 eligible BRCA1/2 carriers, 4715 women (median [IQR] age, 35 [31-38] years) had unilateral stage I to III breast cancer with surgical treatment details available. In the cohort, 1805 patients (38.3%) underwent BCS, 1752 (37.2%) underwent unilateral mastectomy, and 1158 (24.6%) underwent bilateral mastectomy. The proportion of BRCA1/2 carriers undergoing BCS decreased over the study period (55.7% [49 of 88] in 2000 vs 27.0% [82 of 304] in 2020), whereas the use of bilateral mastectomy significantly increased (8.0% [7 of 88] in 2000 vs 44.4% [135 of 304] in 2020). Bilateral mastectomy was more common in women who had genetic testing performed before (248 of 435 [57.0%]) or within 6 months (729 of 1892 [38.5%]) of a breast cancer diagnosis compared with those tested after diagnosis (111 of 2167 [5.1%]). On multivariable analysis, compared with those tested after diagnosis, earlier genetic testing was the factor most strongly associated with bilateral mastectomy receipt (testing prior to diagnosis: adjusted odds ratio, 20.72 [95% CI, 15.27-28.13]; testing at diagnosis: adjusted odds ratio, 6.83 [95% CI, 5.39-8.66]). In subgroup analyses, including 2327 patients who had genetic testing performed before or within 6 months of diagnosis, 977 (42.0%) underwent bilateral mastectomy, with the lowest rates reported in Asia and Africa (130 of 499 [26.1%]) and the highest rates reported in North America (233 of 351 [66.4%]). Conclusions and Relevance The findings of this cohort study of young BRCA1/2 carriers suggest that geographic region and timing of genetic testing were the factors most strongly associated with surgical management.
BACKGROUND:Evidence to guide (neo)adjuvant chemotherapy choices in carriers of germline BRCA1/BRCA2 pathogenic variants (BRCA carriers) with early breast cancer (BC) is limited. We evaluated the association of different chemotherapy regimens with survival outcomes in this population. METHODS:The BRCA BCY Collaboration (NCT03673306) is an international, multicenter, retrospective cohort study of BRCA carriers diagnosed with stage I-III BC at age ≤ 40 years, between 2000 and 2020. Disease-free survival (DFS) and overall survival (OS) were assessed among patients with HER2-negative disease treated with anthracycline-taxane, anthracycline-no-taxane, or non-anthracycline (neo)adjuvant chemotherapy. The association of platinum use with outcomes was evaluated in triple-negative breast cancer (TNBC). RESULTS:Among 4200 young BRCA carriers from 109 centres who received (neo)adjuvant chemotherapy for HER2-negative BC, 58.7% had TNBC. Median follow-up was 8.1 years (IQR, 4.7-12.6 years). Anthracycline-taxane, anthracycline-no-taxane, and non-anthracycline regimens were used in 74.4%, 19.3%, and 6.3% of patients, respectively. Platinum agents were administered in 19.8% of TNBC cases. After multivariable adjustment, no significant differences in DFS or OS were observed between anthracycline-no-taxane and anthracycline-taxane regimens (DFS adjusted hazard ratio [aHR] 0.88, 95% CI 0.73-1.05; OS aHR 1.20, 95% CI 0.87-1.67) or non-anthracycline regimens (DFS aHR 1.07, 95% CI 0.82-1.38; OS aHR 1.16, 95% CI 0.68-2.0). In TNBC, platinum use was not associated with improved outcomes. CONCLUSIONS:In young BRCA carriers with HER2-negative early BC, no statistically significant differences in survival outcomes were detected across different chemotherapy regimens. Our findings may inform future prospective studies evaluating chemotherapy de-escalation strategies in this genetically defined population.
PURPOSE:BRCA carriers face high risks of developing both breast and ovarian/fallopian tube cancers (hereafter referred to as ovarian). Among BRCA carriers with ovarian cancer, it is not clear whether the risk of breast cancer is sufficiently high that risk-reducing mastectomy should be offered. This study aimed to assess the risk of breast cancer BRCA carriers after a diagnosis of ovarian cancer. METHODS:We included women with a pathogenic/likely pathogenic variant in BRCA1 or BRCA2, a diagnosis of ovarian cancer, and no other cancer history and no risk-reducing bilateral mastectomy. Women were followed for incident breast cancer from the date of ovarian cancer diagnosis or the date of baseline questionnaire, whichever came last. The 5-, 10-, and 15-year cumulative risks of breast cancer were compared for women with ovarian cancer and an age-matched set of control women without ovarian cancer. RESULTS:A total of 960 participants with ovarian cancer were identified (814 BRCA1 and 146 BRCA2 carriers). After a mean follow-up of 4.9 years, 41 women (4.3%) developed breast cancer, at a mean age at diagnosis of 57.5 years (range, 39-74). Actuarial cumulative breast cancer risks after ovarian cancer were 4.4%, 8.9%, and 11.5% at 5, 10, and 15 years, respectively. Only three breast cancer-related deaths occurred. Among 741 age-matched BRCA carriers without ovarian cancer, actuarial cumulative risks of breast cancer were 20.9%, 38.6%, and 47.2% at 5, 10, and 15 years, respectively. The hazard ratio for breast cancer, after an ovarian cancer diagnosis, compared with no ovarian cancer, was 0.18 ([95% CI, 0.12 to 0.27]; P < .0001). CONCLUSION:After ovarian cancer, BRCA carriers have a relatively low risk of breast cancer. Risk-reducing mastectomy should not be recommended routinely, but might be considered for long-term survivors. Magnetic resonance imaging surveillance and/or mammography is a realistic alternative.
Objective The updated European Society of Gynaecological Oncology guidelines recommend routine molecular classification to refine risk assessment and guide adjuvant treatment. However, the prognostic impact of sentinel lymph node involvement and molecular classification in apparent early-stage endometrial cancer remains incompletely defined. Methods PROMISE-EC is a multi-center retrospective study including patients with apparently uterine-confined endometrial cancer who underwent surgical staging with sentinel lymph node biopsy at 16 European institutions (January 2014-February 2024). Clinicopathologic characteristics, sentinel lymph node status, and Cancer Genome Atlas-based molecular classification were collected and analyzed. The primary endpoint was progression-free survival. Results Among 2732 records, 2003 patients met inclusion criteria. International Federation of Gynecology and Obstetrics 2009 stage I was observed in 1585 patients (79.4%). Sentinel lymph node involvement was present in 282 patients (14.1%). p53-abnormal tumors were associated with poorer progression-free survival (p <.0001), whereas patients with POLE-mutated tumors showed excellent outcomes, with no significant difference compared with non-specific molecular profile (p =.103). Patients with deficient mismatch repair tumors showed intermediate outcomes (p =.484). In unadjusted Kaplan-Meier analysis, progression-free survival worsened with increasing sentinel lymph node tumor burden (p =.047). In multi-variable analysis, high-grade disease (p =.003) and p53 abnormal status (p <.001) remained independent predictors of recurrence. The association between sentinel lymph node tumor burden and recurrence was attenuated, with only macrometastatic involvement retaining independent prognostic significance. In multi-variable logistic regression, lymphovascular space invasion was the strongest predictor of sentinel lymph node metastases (p <.00001), while patients with POLE-mutated tumors were less likely to harbor clinically relevant nodal involvement (p =.032). Conclusions Our study supports the prognostic relevance of both sentinel lymph node assessment and molecular classification in early-stage endometrial cancer, with potential implications for post-operative risk stratification and management.
Complete hydatidiform mole and coexistent live fetus (CHMCF) is a rare form of twin pregnancy with significant obstetric and oncological implications. Historically, termination of pregnancy (TOP) was the preferred approach due to associated risks. However, recent evidence suggests that, with appropriate management, continuation of pregnancy may be a viable option. We report four cases of CHMCF managed at our institution between 2012 and 2026, two of which resulted in continued pregnancy, while two patients opted for TOP. CHMCF poses substantial diagnostic and management challenges, underscoring the necessity of referral to specialized centers. The decision to continue or terminate pregnancy should be individualized, balancing maternal and fetal risks. Angiogenic biomarkers, particularly soluble fms-like tyrosine kinase-1 (sFlt-1) and placental growth factor (PlGF), may represent promising complementary prognostic tools for risk stratification beyond human chorionic gonadotropin (β-hCG). Further research is needed to validate their potential role and optimize management strategies for CHMCF.
BACKGROUND:Women with a pathogenic variant in BRCA1 or BRCA2 are at high risk of developing ovarian cancer, and it is often recommended that they undergo bilateral salpingo-oophorectomy at an early age, resulting in surgical menopause. Menopausal hormone replacement therapy (HRT) is an effective way to mitigate the adverse outcomes of early menopause; however, the safety of menopausal HRT on breast cancer risk in this population has not been established. METHODS:We conducted a prospective matched analysis of HRT use following menopause and breast cancer risk in BRCA carriers. Women who initiated HRT were matched one-to-one with women who had not initiated menopausal HRT by gene, year of birth, and age at menopause, resulting in 676 matched pairs. Menopausal HRT use collected by questionnaire included formulation and mode of administration. RESULTS:After a mean of 5.6 years, there were 87 (12.9%) incident breast cancer cases in the 676 exposed women and 128 (18.9%) cases in the 676 unexposed women (P = .002). Compared with unexposed matched control individuals, women who used estrogen alone experienced a statistically significantly decreased risk of breast cancer (hazard ratio = 0.37, 95% CI = 0.24 to 0.57). No protective or adverse effect was associated with the use of estrogen plus progestogen (hazard ratio = 0.94, 95% CI = 0.54 to 1.63). CONCLUSIONS:Our findings suggest no substantial increase in the risk of breast cancer in BRCA carriers with the use of HRT and that estrogen alone might be protective.
Tumor cell fraction (TCF) estimation is an essential step in homologous recombination deficiency (HRD) testing of tubo-ovarian high-grade serous carcinoma (HGSC). However, it is prone to variability and observer dependence. Here, we assess the reliability of the QuANTUM computational pipeline for TCF estimation (cTCF) in HGSC samples. 70 HGSC cases were retrospectively collected and the AmoyDx HRD Focus Panel was employed for DNA extraction and sequencing. TCF estimates were obtained from multiple pathologists, along with the TCF calculated by the proprietary AmoyDx algorithm. The QuANTUM pipeline-derived cTCF and a manually calculated ground truth (GT) were obtained on the same slides, and concordance analyses were performed. Weighted kappa (Wk) values for the agreement among the various pathologists ranged from 0.28 to 0.63, reflecting low to substantial concordance. The QuANTUM algorithm showed substantial and better agreement with the GT and the AmoyDx tool (Wk = 0.73 and 0.63, respectively) as compared to the pathologists’ estimates. No significant differences were observed between QuANTUM, the GT and the AmoyDx tool in identifying cases with tumor cellularity above or below the method-defined 30% cutoff. Considering its high reliability, the QuANTUM algorithm may serve as a robust tool for ensuring adequate TCF evaluation in HGSC.
BackgroundSentinel lymph node (SLN) mapping has increasingly replaced systematic lymphadenectomy in apparent uterine-confined endometrial cancer (EC). However, concerns persist regarding the risk of recurrence following nodal surgical de-escalation, particularly in patients with aggressive histologic subtypes. We aimed to evaluate the oncologic safety of SLN-based nodal de-escalation by analyzing recurrence patterns and recurrence-free survival in patients with apparent early-stage EC.MethodsWe conducted a retrospective multi-institutional study including women with apparent uterine-confined EC who underwent primary surgery including SLN mapping, with or without pelvic and/or para-aortic lymphadenectomy. Patients were grouped according to nodal staging strategy: SLN-only, SLN plus pelvic lymphadenectomy (PLND), and SLN plus PLND plus para-aortic lymphadenectomy (PALND). The primary endpoints were progression-free survival (PFS) and patterns of recurrence.ResultsWe included 2123 patients from 15 centers in six countries. SLN-only staging was performed in 1,341 patients (63.2%), SLN+PLND in 483 (22.8%), and SLN+PLND+PALND in 299 (14.1%). With a median follow-up of 44.9 months (IQR 19.1–73.4), 121 recurrences were observed (5.6%). No statistically significant differences in PFS were observed among nodal staging groups. On multivariable Cox analysis, SLN-only staging was not associated with inferior PFS compared with SLN+PLND (HR 1.12, p=0.61), and the addition of PALND did not confer a significant benefit. Endometrioid high-grade histology, non-endometrioid high-risk histotypes, deep myometrial invasion, and lymphovascular space invasion were independently associated with recurrence. Isolated nodal relapse was uncommon (14.9%) and similarly distributed across groups. Exploratory molecular analysis did not show statistically significant differences in PFS across molecular subgroups, although expected survival trends were observed.ConclusionsIn apparent uterine-confined EC, no significant differences in recurrence or nodal relapse were observed across nodal staging strategies. These findings support the use of SLN mapping as an adequate staging approach within a biology-driven framework, although they should be interpreted in light of the retrospective design.
BackgroundThe POLE-mutated molecular subtype of endometrial carcinoma is characterized by an ultramutated genomic profile, high tumor mutational burden, and a favorable prognosis. The clinical behavior of advanced-stage POLE-mutated endometrial carcinoma remains poorly defined due to its rarity. While most cases retain an indolent course, emerging evidence suggests that a subset may develop aggressive disease, including atypical metastatic patterns such as brain dissemination.MethodsA multi-center retrospective analysis was performed on 14 patients with advanced (International Federation of Gynecology and Obstetrics Stage III-IV) POLE-mutated endometrial carcinoma. Data on the clinico-pathological characteristics and treatment outcomes were collected.ResultsThe cohort consisted exclusively of high-grade tumors (100% Grade 3), with the majority being endometrioid (86.7%). Lymphovascular space invasion was ubiquitous (100%). The detected POLE mutations were: p.V411L (37%), p.P286A (14%), p.S459F (14%), p.G433A (7%), p.M444L (7%), p.S297P (7%), p.P286R (14%). Most tumors were mismatch repair-proficient (64%) and p53 wild-type (79%). Co-mutations in the PI3K/AKT pathway were detected in 29% of cases, while 43% of patients harbored at least one additional oncogenic driver. Data were interpreted according to variant allele frequency, in order to differentiate biologically relevant clonal alterations from subclonal or passenger events. Three patients (21%) underwent surgery followed by adjuvant radiotherapy and chemotherapy, three (21%) received surgery followed by chemotherapy alone, and four (29%) were treated with surgery alone; treatment data were unavailable for one patient (7%). One patient (7%) presented with brain metastases at diagnosis.ConclusionThis study provides a detailed descriptive characterization of a rare endometrial carcinoma patient population and highlights the emergence of atypical metastatic patterns, including cerebral involvement. Although observed in a very limited number of cases, the recurrent identification of the V411L variant among patients with advanced disease raises hypotheses and requires validation in larger cohorts. These findings underscore the need for nuanced risk stratification that goes beyond POLE mutation status alone.
BACKGROUND:The oncological safety of breast-conserving surgery followed by radiation therapy (BCS + RT) in young women carrying pathogenic or likely pathogenic BRCA1/2 variants remains debated, with mastectomy (MS) often favoured despite limited comparative real-world evidence. We evaluated survival and recurrence outcomes associated with different loco-regional strategies in a large international cohort of young BRCA carriers. METHODS:The BRCA BCY Collaboration (NCT03673306) is a retrospective, multicentre cohort including women aged ≤ 40 years with invasive breast cancer and confirmed germline BRCA1/2 variants treated between 2000 and 2020. Outcomes were compared between patients treated with BCS + RT, MS alone, or MS plus RT (MS + RT). Endpoints were overall survival (OS), breast cancer-free interval (BCFI), and second primary breast cancer events, defined as ipsilateral breast recurrence (IBR) or contralateral breast cancer (CBC). Multivariable Cox models were used for OS and BCFI. Competing-risks models were used for IBR/CBC. Models were adjusted for prespecified prognostic factors, and subgroup analyses were conducted by BRCA gene, stage, and tumour grade. RESULTS:Among 4,837 patients, 1,704 (35.2%) received BCS + RT, 1,488 (30.8%) MS alone, and 1,645 (34.0%) MS + RT. After a median follow-up of 8.2 years (IQR 4.8-12.7), OS did not differ between BCS + RT and MS alone (adjusted hazard ratio [aHR] 1.02, 95% CI 0.78-1.34). BCFI was comparable across groups. BCS + RT was associated with a higher risk of second primary breast cancer events compared with MS alone (aHR 1.33, 95% CI 1.07-1.66), particularly in patients with BRCA1 variants and stage III disease. CONCLUSION:In young BRCA1/2 carriers, BCS + RT was not associated with worse OS compared with MS alone, despite a higher risk of second primary breast events. Differences in second primary breast cancer events should be interpreted cautiously given differences in BRCA testing timing and treatment era across groups. These data support individualised loco-regional management within a multidisciplinary framework.
OBJECTIVE:Silva pattern is associated with higher risk of lymph node metastasis in cervical adenocarcinoma. However, no study specifically assessed the correlation between Silva pattern and sentinel lymph node (SLN) metastasis after ultrastaging. The primary aim of this study was to assess the incidence of low volume metastases in SLN of patients undergoing primary surgery with SLN biopsy for cervical adenocarcinoma, according to Silva pattern. Secondary aims were to assess risk factors for lymph node metastasis and prognosis. METHODS:Retrospective, multi-center study. Patients with cervical adenocarcinoma clinical FIGO stage IA1 to IIA2, treated with primary surgery between 04/2015 and 12/2023 and undergoing SLN mapping attempt, were included. Low volume metastases were defined as any tumor deposit ≤2 mm (ITC as <0.2 mm, micro-metastasis as 0.2-2 mm). Appropriate statistical analysis was performed to assess study endpoints. RESULTS:153 patients were included. Bilateral SLN mapping was achieved in 133 (86.9%) women. Silva pattern A was present in 47 (30.7%), B in 51 (33.3%) and C in 55 (35.9%) patients. 14 (9.1%) patients had metastatic SLN and 2 (1.4%) had metastatic non-SLN. The incidence of low-volume metastasis was 10/133 (7.5%) in patients with bilateral SLN mapping: 7 (5.3%) in Silva C, 1 (0.7%) in Silva B, and 2 (1.5%) in Silva A, while macro-metastases occurred in 4/133 (3.0%): 3 (2.2%), 0 and 1 (0.7%) cases, respectively (p = 0.027). Silva pattern C was the only factor independently associated to lymph node metastasis at multivariable analysis (OR: 9.724; 95%CI: 1.468-64.402; p = 0.018). No difference in disease-free survival and overall survival was evident when comparing Silva patterns (p = 0.210 versus p = 0.305, respectively). CONCLUSION:Low-volume metastases are more frequent than macro-metastases in patients with cervical adenocarcinoma undergoing SLN biopsy. Silva pattern C was associated with higher incidence of low volume lymph node metastasis, and it was the only factor independently associated with lymph node metastasis. Lymph node macro- and low-volume metastases were found also in Silva pattern A and B, highlighting the potential need for nodal assessment by SLN biopsy also in these sub-groups of patients.
Importance Accurate histologic diagnosis of pelvic tumors is essential for guiding appropriate management but often requires diagnostic surgery, which is associated with morbidity and treatment delays. Ultrasonography-guided core needle biopsy offers a minimally invasive alternative that may reduce surgical risks while providing reliable diagnostic information. Objective To assess the safety and diagnostic adequacy of ultrasonography-guided core needle biopsy in patients with pelvic tumors and to evaluate diagnostic accuracy, patient experience, and pain levels associated with the procedure. Design, Setting, and Participants This prospective, multicenter cohort study was performed from May 26, 2021, to December 31, 2024, at 4 high-volume gynecologic oncology centers (Leuven, Belgium; Rome, Italy; Prague, Czech Republic; and Stockholm, Sweden), with follow-up at 6 weeks after the procedure. Consecutive patients aged 18 years or older with a pelvic tumor undergoing ultrasonography-guided core needle biopsy for diagnostic purposes or inclusion in academic trials were included, and follow-up data were available for all participants. Exposure Ultrasonography-guided core needle biopsy performed via transvaginal, transrectal, or percutaneous approaches according to lesion location and clinical indication. Main Outcomes and Measures The primary outcomes were safety, as assessed by procedure-related complication rates within 6 weeks, and diagnostic adequacy of biopsy specimens. Secondary outcomes included diagnostic accuracy compared with subsequent surgical histology when available, patient-reported pain measured using a numeric rating scale (0-100), and overall patient experience assessed within 72 hours post procedure. Descriptive statistical and multivariable regression analyses were performed. Results Among 461 patients prospectively enrolled in the study, biopsies were performed on 463 lesions (transvaginal: 422 patients; median [IQR] age, 64 [53-73] years; transrectal: 11 patients; median [IQR] age, 78 [59-80] years; percutaneous: 30 patients; median [IQR] age, 58 [51-71] years). Procedure-related complications occurred in 60 patients (13.0%), all of which were minor; no patients required surgery or blood transfusion due to complications. Biopsy specimens were diagnostically adequate in 95.7% (95% CI, 93.4%-97.4%) of cases. In 166 cases with available subsequent surgical histology, diagnostic accuracy was 97.6% (95% CI, 93.9%-99.3%). Patient experience was favorable, with 378 of 402 patients (94.0%) rating their experience in the upper half of the scale. The median pain score was 20 (IQR, 10-50). Conclusions and Relevance This cohort study of patients undergoing ultrasonography-guided core needle biopsy of pelvic lesions found the procedure to be safe, diagnostically adequate, and well-tolerated. These findings support the procedure’s broader implementation in selected patients to reduce the need for diagnostic surgery and associated morbidity.
OBJECTIVE:Early adverse outcomes after treatment for advanced ovarian cancer are often grouped as early relapse or death, although these events may reflect distinct mechanisms. We aimed to characterize early failure phenotypes and develop pragmatic clinical tools to stratify the risk of early death and early relapse. METHODS:This international multi-center real-world study included 3286 patients with advanced ovarian cancer treated within the SUROVA network. Early death was defined as death within 12 months and early relapse as recurrence within 12 months. Baseline, surgical, and post-operative variables were analyzed. Two clinical scores were developed: the Early Lethality Risk Score and the Early Relapse Risk Score. Discrimination was assessed using areas under the curve and compared descriptively with corresponding multi-variable logistic regression models. RESULTS:Within 12 months, 193 patients (5.9%) died; among patients alive at 12 months, 441 (15.8%) experienced early relapse and 2357 (84.2%) had no early adverse event. Early death and documented early relapse showed partial overlap: 45.6% of early deaths occurred without documented progression. Early death was associated with older age, impaired performance status, advanced stage, incomplete cytoreduction, and major post-operative complications. Early relapse among patients who survived 12 months was mainly associated with tumor burden and residual disease. The Early Lethality Risk Score showed acceptable discrimination (area under the curve 0.709, 95% confidence interval 0.666 to 0.752), with modest discrimination for the Early Relapse Risk Score (area under the curve 0.636, 95% confidence interval 0.609 to 0.662). CONCLUSIONS:Early failure in advanced ovarian cancer comprises clinically distinguishable early outcome patterns, with early death more strongly associated with vulnerability and post-operative morbidity, and early relapse among patients who survived 12 months more closely associated with disease burden and residual disease.