Journal of Gynecologic Oncology最新文献

Objective: The phase 2, open-label, randomized, 3-arm study (NCT03776812) found that intermittently dosed relacorilant + nab-paclitaxel improved progression-free survival, duration of response, and overall survival compared with nab-paclitaxel monotherapy with minimal additional toxicity. This study analyzed the cost-effectiveness of intermittent relacorilant + nab-paclitaxel (IN), continuous relacorilant + nab-paclitaxel (CN) and nab-paclitaxel monotherapy (N) from the payer's perspective over a 5-year time horizon.

Methods: The health outcome is expressed in quality-adjusted life years (QALYs). IN, CN and N were evaluated using QALYs and incremental cost-effectiveness ratio (ICER). The data for this model come from the NCT03776812 trial and other published literature. The impact of the variables is studied using a one-way deterministic sensitivity analysis and a probabilistic sensitivity analysis based on a second-order Monte Carlo simulation.

Results: N was the least costly strategy, at $ 4606.05, followed by IN ($22,597.75) and CN ($44,276.86). Based on a willingness-to-pay threshold of $100,000/QALY, IN was cost-effective compared with N, with an ICER of $21,418.69 per QALY gained for N, whereas CN was ruled out by extended dominance (less effective, more costly), compared with N. The incremental benefits of IN compared to CN and N were 0.72 QALYs and 0.84 QALYs.

Conclusion: From a US health care system perspective, IN may be cost-effective compared to CN for patients with recurrent platinum-resistant ovarian cancer, and IN is also better than CN and N in terms of efficacy. Therefore, IN is a high-quality regimen for clinicians to treat patients with recurrent platinum-resistant ovarian cancer.

Trial registration: ClinicalTrials.gov Identifier: NCT03776812.

Objective: To determine if preoperative Patient-Reported Outcome Measures (PROMs) can be used to predict post-operative health care utilization in gynecology oncology patients.

Methods: A retrospective study was performed after Institutional Review Board approval. PROMs were collected pre-operatively from all patients undergoing surgery for gynecologic malignancy between 1/1/18 and 9/1/19 at a tertiary academic medical center. Patients received the EORTC QLQ-C30 and Patient-Reported Outcomes Measure Information System emotional and instrumental support questionnaires along with a disease specific PROM. Charts were reviewed to ascertain healthcare utilization ("touches") in the 90-day postoperative period defined as phone calls, emails or portal messages, office visits, emergency department (ED) encounters, and hospital admissions. Linear regression was used to identify PROMs associated with postoperative healthcare utilization.

Results: Three hundred seventy-one patients were administered questionnaires of which 307 (82.7%) completed PROMs and were included for analysis. A significant association was noted between adverse responses on many EORTC QLQ-C30 domains and increased postoperative healthcare utilization. Of all questions, "difficulty remembering things" was most strongly associated with both overall utilization (total touches p=0.01) and utilization in multiple domains. After forward selection against other significant PROMs, as difficulty with memory increased, both overall healthcare utilization (adjusted regression coefficient 1.9, p=0.01) and ED encounters increased (adjusted regression coefficient 0.10, p=0.01).

Conclusion: Patients who report cognitive concerns are significantly more likely to have higher healthcare utilization postoperatively. Attention to this preoperatively could help identify patients at higher risk and further studies should determine if additional support around surgery can mitigate this risk.

Objective: Diaphragmatic resection is frequently required to achieve optimal cytoreduction with no residual disease in patients with advanced ovarian cancer. Pleural effusion and pneumothorax are known short-term postoperative complications of diaphragmatic resection; however, few studies have reported intraoperative and long-term postoperative complications of this procedure. We investigated the intraoperative, as well as short- and long-term postoperative complications of diaphragmatic resection.

Methods: Of the patients with stage III/IV ovarian cancer, who were initially treated at our hospital between 2008 and 2020, 267 patients who underwent diaphragmatic resection were included in this study. We recorded details regarding the type of diaphragmatic resection, type of closure, and intraoperative, as well as short- and long-term postoperative complications.

Results: Of the 264 patients who underwent right-sided diaphragmatic resection, 235 underwent full-thickness resection and 29 underwent peritoneal stripping. Of the 118 patients who underwent left-sided diaphragmatic resection, 23 underwent full-thickness resection and 95 underwent peritoneal stripping. Intraoperative complications occurred in 5 patients (massive bleeding from the right hepatic vein [n=1], massive bleeding during excision of the liver adherent to the diaphragm [n=1], and lung injury [n=3]). Short-term complications included pleural effusion that necessitated drainage in 2 and pneumothorax after drain removal in 1 patient. Long-term complications included right diaphragmatic hernia in 1, left diaphragmatic hernia in 2, and pancreaticopleural fistula in 1 patient.

Conclusion: Diaphragmatic resection was associated with a low incidence of intra- and postoperative complications, which highlights the safety of this approach for management of advanced ovarian cancer.

We aimed to explore the prognostic implications of neoadjuvant chemotherapy and interval debulking surgery (NACT-IDS) compared to primary debulking surgery (PDS) in patients diagnosed with advanced ovarian cancer by meta-analysis. The search was conducted across PubMed, Web of Science, Cochrane, Wanfang Data, China National Knowledge Infrastructure, and the Chinese BioMedical Literature Database to identify pertinent studies examining the prognostic implications of NACT-IDS versus PDS in patients with advanced ovarian cancer. As of September 11, 2023, a total of 29 articles were ultimately included, encompassing 12,916 patients with advanced ovarian cancer in this meta-analysis. NACT-IDS groups exhibited a higher satisfactory tumor reduction rate (odds ratio [OR]=2.06; 95% confidence interval [CI]=1.53 to 2.76; p<0.001). NACT-IDS effectively reduced the risk of adverse cardiac events (OR=0.36; 95% CI=0.17 to 0.80; p=0.012), surgical site infections (OR=0.42; 95% CI=0.29 to 0.60; p<0.001), and embolic complications (OR=0.43; 95% CI=0.24 to 0.75; p=0.003) in patients with advanced ovarian cancer. Compared to NACT-IDS therapy for International Federation of Gynecology and Obstetrics (FIGO) III-IV ovarian cancer patients (OR=1.66; 95% CI=1.24 to 2.23; p=0.009), NACT-IDS groups exhibited a higher satisfactory tumor reduction rate for FIGO IIIC-IV (OR=2.35; 95% CI=1.50 to 3.70; p<0.001). NACT-IDS effectively enhances the satisfactory tumor reduction rate, especially for patients with stage IIIC and IV, and decreases postoperative complications among patients with advanced ovarian cancer.

Objective: Hepatic metastasectomy for gynecologic cancers remains controversial. Management of advanced endometrial cancer (EC) is complex. The purpose of this study is to analyze the efficacy of liver metastasectomy (LM) in the treatment of metastatic EC.

Methods: The National Cancer Database was used to create a retrospective cohort of adult women with EC metastatic to the liver between 2010 and 2016. Overall survival and all-cause mortality were estimated with inverse probability of treatment weighting (IPTW) curves and IPTW Cox proportional hazard regression, respectively.

Results: Among 999 EC patients with oligometastatic disease to the liver, 162 (16.2%) underwent LM, 614 (61.5%) received chemotherapy, and 129 (12.9%) had chemotherapy and LM. Those who underwent chemotherapy, 1-, 2-, and 3-year survival for chemotherapy + LM versus chemotherapy alone were 67.8 versus 56.5%, 44.9 versus 33.4%, and 35.1 versus 23.1%, respectively. In unadjusted analysis, chemotherapy + LM group had reduced mortality risk (hazard ratio [HR]=0.68; 95% confidence interval [CI]=0.54-0.86) with longer median survival time (20.1 vs. 14.6 months, p=0.011) compared to chemotherapy alone. Adjusting for demographics and treatment characteristics, a possible reduction in mortality was associated with chemotherapy + LM (HR=0.74; 95% CI=0.55-1.01) compared to chemotherapy alone.

Conclusion: This study of LM for EC suggests LM in addition to chemotherapy may be associated with improved outcomes for patients with EC.

Objective: Serous tubal intraepithelial carcinoma (STIC), a potential precursor of high-grade serous carcinoma, is associated with subsequent carcinomas development. This study aimed to identify cases of STIC and serous tubal intraepithelial lesions (STIL) and examine clinical outcomes and patterns of care in BRCA1/2 mutations carriers undergoing risk-reducing salpingo-oophorectomy (RRSO), as well as patients with incidental STIC/STIL after benign gynecologic surgery.

Methods: This retrospective study was conducted at six institutions to examine patients with isolated STIC/STIL. Demographic, adjuvant treatment, and follow-up data were collected from the date of implementation of Sectioning and Extensively Examining the Fimbriated end protocol, which varied from 2006 to 2015, until December 2022.

Results: We analyzed the data of 1,119 women who underwent RRSO and were carriers of BRCA1/2 mutations. The detection rate of isolated STIC/STIL was 1.70%. No patient with STIC/STIL received adjuvant chemotherapy or staging operations. The institutions used different surveillance intervals and methods, with the most common being a 3-6 month interval (11 of 19 patients) and gynecological sonography (17 of 19 patients). All patients remained with no evidence of disease (NED) throughout the follow-up period (2-121 months). Additionally, we analyzed data from five women with incidental STIC/STIL diagnosed after benign gynecological surgery; one woman underwent staging surgery. During the follow-up period (3-46 months), all patients remained in NED.

Conclusion: While patient monitoring after STIC/STIL detection may be considered due to the minimal risk of carcinoma, excessive concern may not be necessary. Furthermore, adjuvant chemotherapy should be considered only with caution.

Sentinel lymph node biopsy (SLNB) has improved detection of low-volume node metastasis (LVNM) in endometrial cancer (EC), but its prognostic significance and the need for adjuvant therapy (AT) remain unclear. A comprehensive search was performed until August 31, 2024 in multiple databases and sources. From 21 studies, 65,228 apparent early-stage EC patients were identified: 370 with macrometastases (MAC), 526 with micrometastases (MM), 2,138 with isolated tumor cells (ITCs), and 62,194 with negative nodes. Findings indicated: 1) The MM group had a lower risk of recurrence or progression (R/P) than the MAC group (risk ratio [RR]=0.49; 95% confidence interval [CI]=0.31-0.78; p=0.002), higher risk than the negative nodes group (RR=2.07; 95% CI=1.59-2.68; p<0.001), and similar risk to the ITC group (RR=0.67; 95% CI=0.44-1.02; p=0.060). 2) The MM group had higher 3-year progression-free survival (PFS) (RR=1.36; 95% CI=1.21-1.52; p<0.001) and overall survival (OS) (RR=1.22; 95% CI=1.09-1.37; p<0.001) than the MAC group, similar to the ITC and negative nodes groups. 3) The ITC group had a lower R/P risk and higher 3-year PFS/OS than the MAC group, similar to the negative nodes group. 4) AT reduced the R/P risk in the MM group (RR=0.41; 95% CI=0.22-0.76; p=0.005) and increased 3-year OS in the ITC group (RR=1.06; 95% CI=1.04-1.08; p<0.001). Early-stage EC with LVNM had better prognostic outcomes than MAC, and AT may improve outcomes of LVNM patients. More evidence from prospective randomized controlled trials is needed to confirm these findings due to the inherent biases of retrospective studies. Trial Registration PROSPERO Identifier: CRD42022364536.

To evaluate the role of carboplatin-based chemotherapy in patients diagnosed with malignant gonadal germ cell tumors (GCTs), we conducted a systematic review and meta-analysis. We searched PubMed, MEDLINE, Embase, Cochrane library, and Web of Science. Randomized controlled trials or cohort studies on gonadal GCTs between January 1, 1970 and April 26, 2023 were enrolled. The treatment failure rate and mortality rate were the primary outcomes. Subgroup analysis based on the primary tumor site and dose of carboplatin was also conducted. In total, 8 studies with 1,409 patients were included. Compared to cisplatin-based chemotherapy, carboplatin-based chemotherapy had an increased treatment failure rate (odds ratio [OR]=2.23; 95% confidence interval [CI]=1.61-3.08; p<0.001), but similar overall survival outcomes (OR=1.68; 95% CI=0.61-4.61; p=0.315). Subgroup analysis revealed that carboplatin-based chemotherapy did not increase the risk of treatment failure and death in ovarian GCT, while a higher risk of treatment failure and a similar risk of death were observed in testicular GCT. Patients treated with high-dose carboplatin calculated 400 or 600 mg/m² (area under the curve=7.9) obtained similar failure-free survival to the cisplatin group (OR=0.84; 95% CI=0.40-1.73; p=0.629). Compared to the cisplatin group, milder nausea and vomiting, nephrotoxicity, ototoxicity, and more severe myelosuppression were observed in the carboplatin group. In conclusion, carboplatin-based chemotherapy achieves a comparable overall survival outcome to cisplatin-based chemotherapy in gonadal GCT patients, suggesting that carboplatin is a candidate substitute for cisplatin. The efficacy of carboplatin is dose-dependent. High-dose carboplatin can obtain better therapeutic effects with more tolerable toxicities than cisplatin.

Background: Patients with cervical cancer treatment experience an impairment of sexual function and quality of life. This issue is usually underreported and undertreated, and evidence-based interventions are lacking. Prevention of sexual dysfunction is a crucial pillar in improving the quality of life of these patients. The primary objective of this trial is to evaluate the impact of a multimodal intervention, encompassing prevention of vaginal dysfunction and patient education, on sexual function and quality of life in cervical cancer survivors utilizing patient-reported outcome measurements.

Methods: Multi-institutional, randomized clinical trial where patients will be randomized 1:2 at diagnosis of initial or locally advanced cervical cancer to control arm or intervention arm. After treatment, control arm patients will undergo standard follow-up by their referring physician. The multimodal intervention for patients in the intervention group includes application of vaginal estrogens plus hyaluronic-acid cream along with use of vaginal vibrator, systematic evaluation of the need of systemic hormone replacement therapy and treatment if needed, and access to online content about sexuality, nutrition, sports and lifestyle habits. Through 4 appointments (at diagnosis, 1, 6, and 12 months after treatment), sexual health, vaginal trophism and self-perceived quality of life of patients in both arms will be assessed with validated questionnaires as female sexual function index (FSFI), European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30, and Cx-24, Cervantes Scale, vaginal health index and vaginal thickness assessed by ultrasound. The major inclusion criteria will be patients aged ≥18 years with the International Federation of Gynecology and Obstetrics stage I-III cervical cancer treated with surgery and/or radiotherapy. The primary endpoint will be FSFI score 12 months after treatment, which will be compared between groups. Uni- and multivariate analysis will be performed to identify factors influencing sexual function recovery after treatment. The sample size will be of 120 eligible patients, who will be randomized to detect an improvement of 5.2 points in FSFI score. Complete accrual is estimated in March 2026. To date, the present study has no external funding.

Trial registration: ClinicalTrials.gov Identifier: NCT06031493.

Objective: This study aimed to assess the prognostic significance of para-aortic lymphadenectomy (PALX) and para-aortic lymph node metastasis in endometrial cancer (EC) patients at risk of post-operative recurrence.

Methods: Japanese Gynecologic Oncology Group (JGOG) 2043 was a randomized controlled trial assessing the efficacy of adjuvant chemotherapy in EC patients at risk for post-operative recurrence. A retrospective analysis included patients who underwent pelvic lymphadenectomy (PLX) alone or both PLX and PALX in JGOG2043. Data on positive lymph nodes and other clinicopathological risk factors were collected.

Results: PLX and PALX were performed on 402 patients, while PLX alone was conducted on 250 patients. Evaluating the effect of PALX on survival was challenging through a comparison of the outcomes of the 2 cohorts since PALX was predominantly administered to higher-risk patients. Patients with 2 or more metastases in para-aortic nodes exhibited significantly poorer overall survival than those with no or 1 metastasis, respectively (p<0.001, p=0.031). Multivariate analysis revealed that 2 or more metastases in para-aortic nodes is independent risk factors for disease-free survival (hazard ratio [HR]=1.72; 95% confidence interval [CI]=1.10-2.72; p=0.019) and are marginally significant for overall survival (HR=1.58; 95% CI=0.92-2.72; p=0.096) compared to no or a single metastasis.

Conclusion: The clinical relevance of PALX was challenging to evaluate in the JGOG2043 cohort; however, the presence of 2 or more para-aortic node metastases was identified as an independent unfavorable prognostic factor in EC patients at risk of recurrence.