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Introduction Hyperthermic intraperitoneal chemotherapy (HIPEC) improved investigator-assessed recurrence-free survival and overall survival in patients with stage III ovarian cancer in the phase III OVHIPEC-1 trial. We analyzed whether an open-label design affected the results of the trial by central blinded assessment of recurrence-free survival, and tested whether HIPEC specifically targets the peritoneal surface by analyzing the site of disease recurrence. Methods OVHIPEC-1 was an open-label, multicenter, phase III trial that randomized 245 patients after three cycles of neoadjuvant chemotherapy to interval cytoreduction with or without HIPEC using cisplatin (100 mg/m2). Patients received three additional cycles of chemotherapy after surgery. Computed tomography (CT) scans and serum cancer antigen 125 (CA125) measurements were performed during chemotherapy, and during follow-up. Two expert radiologists reviewed all available CT scans. They were blinded for treatment allocation and clinical outcome. Central revision included Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurements and peritoneal cancer index scorings at baseline, during treatment, and during follow-up. Time to centrally-revised recurrence was compared between study arms using Cox proportional hazard models. Subdistribution models compared time to peritoneal recurrence between arms, accounting for competing risks. Results CT scans for central revision were available for 231 patients (94%) during neoadjuvant treatment and 212 patients (87%) during follow-up. Centrally-assessed median recurrence-free survival was 9.9 months in the surgery group and 13.2 months in the surgery+HIPEC group (HR for disease recurrence or death 0.72, 95% CI 0.55 to 0.94; p=0.015). The improved recurrence-free survival and overall survival associated with HIPEC were irrespective of response to neoadjuvant chemotherapy and baseline peritoneal cancer index. Cumulative incidence of peritoneal recurrence was lower after surgery+HIPEC, but there was no difference in extraperitoneal recurrences. Conclusion Centrally-assessed recurrence-free survival analysis confirms the benefit of adding HIPEC to interval cytoreductive surgery in patients with stage III ovarian cancer, with fewer peritoneal recurrences. These results rule out radiological bias caused by the open-label nature of the study. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to describe the pattern of recurrence and survival related to prognostic variables, including type of surgery as a clinical variable, in patients surgically treated for early cervix cancer. Methods: Records of 2124 patients who underwent a radical hysterectomy for International Federation of Gynaecology and Obstetrics stage I/IIA cervical cancer between 1982 and 2011 were reviewed. Clinical-pathologic prognostic variables, also including extent of parametrectomy, were identified and used in a multivariable Cox proportional hazard model to explore associations between disease-free survival (DFS) and prognostic variables. Results: The 5-year DFS for the total group was 86%. Large tumor diameter, nonsquamous histology, lymph node metastases, parametrial involvement, lymph vascular space invasion, deep stromal invasion, and less radical surgery were independent poor prognostic variables for survival. Disease-free survival was independently associated with the type of radical hysterectomy with pelvic lymphadenectomy in favor of more radical parametrectomy (hazard ratio, 2.0; 95% confidence interval, 1.6–2.5). This difference was not found in tumors with a diameter of at least 20 mm. Conclusions: This study confirms that variables such as large tumor diameter, nonsquamous histology, lymph vascular space invasion, deep stromal invasion, positive lymph nodes, and parametrial infiltration are poor prognostic variables in early cervix cancer treated by surgery. The extent of parametrectomy had no influence on survival in tumors of 20 mm or less. For larger tumors, a more radical hysterectomy might be associated with better DFS. Taking into account the possible bias in this study as a result of its retrospective design, ideally a prospective cohort study with clear definition of radicality is necessary to answer this important clinical question. [ABSTRACT FROM AUTHOR]

Introduction: Management regarding completing hysterectomy in case of intraoperative finding of positive lymph nodes in early-stage cervical cancer differs between institutions. The aim of this study was to compare survival and toxicity after completed hysterectomy followed by adjuvant (chemo-)radiotherapy versus abandoned hysterectomy and primary treatment with chemoradiotherapy (CRT). Methods: A retrospective multicenter cohort study was performed. All patients were scheduled for radical hysterectomy with pelvic lymphadenectomy (RHL). In the RHL group, hysterectomywas completed followed by adjuvant (chemo-)radiotherapy. In the second group, hysterectomy was abandoned, and CRTwas conducted. Primary outcomes were disease-free survival (DFS) and overall survival. Amultivariable analysis on DFS was performed. Toxicity was scored according to theNationalCancer Institute CTCAE (Common TerminologyCriteria for Adverse Events) v4.03. Results: A total of 121 patients were included (RHL, n = 89; CRT, n = 32). There was no difference in overall survival (84% vs 77%). Five-year DFS was in favor of completing RHL (81% vs 67%). Multivariable analysis showed that, corrected for lymph node variables, treatment regimen was not associated with DFS. After RHL, pelvic recurrence rate was significantly lower compared with CRT (2% vs 16%). CTCAE grade 3Y4 toxicity rates were higher in the CRT compared with the RHL group (59% vs 30%), mainly because of differences in chemotherapy-related hematologic toxicity. Conclusions: In patients with clinically N0 early-stage cervical cancer with intraoperative detection of positive nodes, completing RHL followed by adjuvant (chemo-)radiotherapy may result in a better pelvic control compared with abandoning hysterectomy and treatment with chemoradiotherapy. However, if corrected for lymph node variables, treatment (RHL or CRT) was not associated with DFS. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to develop clinically relevant and evidence-based guidelines as part of European Society of Gynaecological Oncology's mission to improve the quality of care for women with gynecologic cancers across Europe. Methods: The European Society of Gynaecological Oncology Council nominated an international development group made of practicing clinicians who provide care to patients with vulvar cancer and have demonstrated leadership and interest in the management of patients with vulvar cancer (18 experts across Europe). To ensure that the statements are evidence based, the current literature identified from a systematic search has been reviewed and critically appraised. In the absence of any clear scientific evidence, judgment was based on the professional experience and consensus of the development group (expert agreement). The guidelines are thus based on the best available evidence and expert agreement. Prior to publication, the guidelines were reviewed by 181 international reviewers including patient representatives independent from the development group. Results: The guidelines cover diagnosis and referral, preoperative investigations, surgical management (local treatment, groin treatment including sentinel lymph node procedure, reconstructive surgery), radiation therapy, chemoradiation, systemic treatment, treatment of recurrent disease (vulvar recurrence, groin recurrence, distant metastases), and follow-up. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to compare urinary and bowel symptoms and quality of life (QoL) among women treated with a Wertheim–Meigs (WM, type III) or Wertheim–Okabayashi (WO, type IV) radical hysterectomy with pelvic lymphadenectomy for early-stage cervical cancer. Methods: In this cross-sectional observational study, patients treated with a WO or a (nerve sparing) WM radical hysterectomy (with or without adjuvant radiotherapy) between January 2000 and December 2010 in the Center for Gynaecological Oncology Amsterdam or Leiden University Medical Center were included. To assess QoL, urinary and bowel symptoms we used the EORTC QLQ-C30, EORTC QLQ-CX24, and Leiden Questionnaire. We performed a multivariate analysis to identify factors associated with urinary symptoms. Results: Two hundred sixty-eight women were included (152 WO and 116 WM). Quality of life was not significantly different in patients treated by WO or WM. Urinary symptoms were more often reported by patients in the WO group compared to the WM group: "feeling of urine retention" (53% vs 32%), "feeling less/no urge to void" (59% vs 14%), and "timed voiding" (49% vs 10%). With regard to bowel symptoms, there was no difference between both. Multivariate analysis showed that surgical technique was an independent factor for differences in urinary symptoms. Conclusions: Patients undergoing more radical surgery for early-stage cervical cancer report significantly more urinary dysfunction, whereas bowel function and health-related QoL are not decreased. [ABSTRACT FROM AUTHOR]

The objective of the study is to determine the risk factors for groin recurrence (GR) in patients with primary vulvar squamous cell carcinoma (SCC) after inguinofemoral lymphadenectomy (IFL) without lymph node metastases and/or adjuvant chemoradiotherapy.The study is a multicenter retrospective review of clinical and histopathological data of patients with lymph node-negative vulvar SCC who underwent an IFL. Patients with and without GRs were compared to identify risk factors.In 134 patients, 252 groins were eligible for the analyses—16 patients underwent ipsilateral IFL and 118 patients underwent bilateral IFL. Groin recurrences occurred in 4 (1.6%) of the 252 dissected groins. Besides, 1 patient who underwent ipsilateral IFL had a recurrence in the nonoperated contralateral groin; this groin was left out of analysis. The median number of dissected nodes per groin was 9.8 (range, 1-38) in all patients and 6.5 (range, 5-8) in patients with GR. Multivariate analyses showed that GR was related to poor differentiation (P = 0.04), and node count less than 9 (P = 0.04), no association with age, tumor localization, tumor diameter, focality, invasion depth, or stage was found. Nineteen patients with both low node count and poor differentiation had 19% GRs. Survival analyses showed less favorable survival in patients with poor differentiation.The overall risk of developing GR after negative IFL in patients with vulvar SCC is low (1.6% per groin) but significantly higher in patients with tumors with a poor differentiation and lymph node count less than 9 at IFL. A large well-designed prospective study is needed to evaluate closer surveillance in patients at risk. [ABSTRACT FROM AUTHOR]

Patients with irresectable granulosa cell tumors (GCTs) often receive chemotherapy. The effectiveness of this approach, however, is uncertain. The aim of our study was to assess the response rate to chemotherapy for residual and recurrent inoperable GCT.All consecutive chemotherapy-naive patients in 3 referral hospitals who were treated with chemotherapy for residual or recurrent GCT between 1968 and 2011 were included. Main outcome was the response according to Response Evaluation Criteria in Solid Tumor criteria. A literature search in MEDLINE through PubMed was performed, from inception to August 19, 2013.Twenty-seven patients with a GCT who received chemotherapy were identified. Eighteen patients were not evaluable because they had either no measurable disease, or no imaging was performed before and after chemotherapy. One of the 9 evaluable patients (11%) had a complete response, and 1 patient (11%) had a partial response, resulting in a response rate of 22% (95% confidence interval, 0%-49%). Seven patients (78%) had stable disease (range, 2-50 months), and none had progressive disease. Fifteen studies that assessed response rates to chemotherapy on measurable disease in a total of 224 patients showed a response rate of 50% (95% confidence interval, 44%-57%). Strict criteria of response, however, were not uniformly applied in the majority of these published series.In the present study, we present only a moderate beneficial effect of chemotherapy in patients with irresectable GCT with measurable disease. Comparison with previous studies is hampered by a lack of standardized response evaluation in the majority of studies. Given the toxicity of platinum-based chemotherapy, administering this treatment should be a well-considered decision. [ABSTRACT FROM AUTHOR]

This study aimed to compare the negative predictive value (NPV) of clinical examination with or without anesthesia and magnetic resonance imaging (MRI) in identifying patients with cervical carcinoma without parametrial infiltration.This retrospective cohort study was conducted at the Academic Medical Center in Amsterdam. The medical files of 203 patients diagnosed with cervical cancer stages IB1-IIA, who underwent surgical treatment between January 1, 2003, and January 31, 2011, were reviewed. We compared clinical International Federation of Gynecology and Obstetrics staging and MRI during the staging procedure. The results were compared with the parametrial status by surgical-pathological investigation, which was considered to be the reference standard.Based on the surgical-pathological findings, 16.7% of the patients treated surgically had parametrial infiltration. For parametrial infiltration, examination under anesthesia (EUA) had an NPV of 65.3% and MRI of 76.9%, respectively. We found no significant difference between these NPVs.Examination under anesthesia and MRI are equal in identifying cervical cancer patients without parametrial infiltration with a tendency for MRI to perform better than EUA. When outpatient clinical staging is considered inconclusive, pretreatment staging may be limited to MRI. In these cases, EUA seems to have no additional value. [ABSTRACT FROM AUTHOR]

The frequency of lymph node metastases in stage IA2 cervical cancer is reported to range from 0% to 9.7%. Treatment recommendations vary likewise from a cone biopsy to a Wertheim radical hysterectomy and pelvic lymph node dissection. The objective of this study was to get insight into the true frequency of lymph node metastases and/or parametrial involvement in stage IA2 cervical cancer.The hospital records of 48 patients with stage IA2 cervical carcinoma who registered from 1994 to 2006 were reviewed, and a literature search was performed.Of 48 registered patients, 14 were confirmed to have stage IA2. No lymph node metastases or parametrial invasion and recurrences were found. The collated literature data showed a risk of lymph node metastases of 4.8% (range, 0%-9.7%). The presence of adenocarcinoma and the absence of lymph vascular space invasion resulted in a low risk on lymph node metastases (0.3% and 1.3%, respectively). Parametrial involvement has not been reported.The risk of the selected patients with stage IA2 cervical cancer on lymph node metastases is low. In patients with stage IA2 squamous cell cancer with lymph vascular space invasion, a standard pelvic lymph node dissection should be recommended. Parametrectomy should be included if the nodes are positive. In the other patients, the treatment can be individualized and does not have to include lymph node dissection or parametrectomy. [ABSTRACT FROM AUTHOR]