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There has been mounting evidence on the role of healthcare providers in chronic illnesses such as cancer. The specific complexities in their roles to enable health are less heard. Gynaecological cancers have several undercurrents beyond the obvious. Semi-structured interviews were conducted with healthcare providers in Southern India (n = 35) and the data presented in this article were collected as a part of a larger study on the role of communication in the management of gynaecological cancers in India. Thematic analysis of the qualitative data provided information on the providers’ perspectives of gynaecological cancers. Patient numbers, cost, time, cultural norms, context, and institutional constraints in cancer care provision are just some of the factors impacting care provision. Healthcare providers are typically acknowledged for the criticality of their roles in the continuum of care. However, our research suggests that the psychological harm and challenges they themselves may face in providing that care are severely neglected. Through listening to healthcare provider voices, clear solutions emerge to better support the practice of those who are responsible for cancer care.

Endometrial carcinosarcoma is a rare and aggressive high-grade endometrial carcinoma with secondary sarcomatous trans-differentiation (conversion theory). The clinical presentation and diagnostic work-up roughly align with those of the more common endometrioid counterpart, although endometrial carcinosarcoma is more frequently diagnosed at an advanced stage. Endometrial carcinosarcoma is not a single entity but encompasses different histological subtypes, depending on the type of carcinomatous and sarcomatous elements. The majority of endometrial carcinosarcomas are characterized by p53 abnormalities. The proportion of POLE and microsatellite instablity-high (MSI-H) is directly related to the epithelial component, being approximately 25% and 3% in endometrioid and non-endometrioid components.The management of non-metastatic disease is based on a multimodal approach with optimal surgery followed by (concomitant or sequential) chemotherapy and radiotherapy, even for early stages. Palliative chemotherapy is recommended in the metastatic or recurrent setting, with carboplatin/paclitaxel doublet being the first-line regimen. Although the introduction of immunotherapy plus/minus a tyrosine kinase inhibitor shifted the paradigm of treatment of patients with recurrent endometrial cancer, patients with endometrial carcinosarcoma were excluded from most studies evaluating single-agent immunotherapy or the combination. However, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved the use of pembrolizumab and lenvatinib in endometrial cancer (all histotypes) after progression on chemotherapy and single-agent immunotherapy in MSI-H cancers. In the era of precision medicine, emerging knowledge on molecular endometrial carcinosarcoma is opening new promising therapeutic options for more personalized treatment. The present review outlines state-of-the-art knowledge and future directions for patients with endometrial carcinosarcoma.

Endometrial carcinosarcoma is a rare and aggressive high-grade endometrial carcinoma with secondary sarcomatous trans-differentiation (conversion theory). The clinical presentation and diagnostic work-up roughly align with those of the more common endometrioid counterpart, although endometrial carcinosarcoma is more frequently diagnosed at an advanced stage. Endometrial carcinosarcoma is not a single entity but encompasses different histological subtypes, depending on the type of carcinomatous and sarcomatous elements. The majority of endometrial carcinosarcomas are characterized by p53 abnormalities. The proportion of POLE and microsatellite instablity-high (MSI-H) is directly related to the epithelial component, being approximately 25% and 3% in endometrioid and non-endometrioid components.The management of non-metastatic disease is based on a multimodal approach with optimal surgery followed by (concomitant or sequential) chemotherapy and radiotherapy, even for early stages. Palliative chemotherapy is recommended in the metastatic or recurrent setting, with carboplatin/paclitaxel doublet being the first-line regimen. Although the introduction of immunotherapy plus/minus a tyrosine kinase inhibitor shifted the paradigm of treatment of patients with recurrent endometrial cancer, patients with endometrial carcinosarcoma were excluded from most studies evaluating single-agent immunotherapy or the combination. However, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved the use of pembrolizumab and lenvatinib in endometrial cancer (all histotypes) after progression on chemotherapy and single-agent immunotherapy in MSI-H cancers. In the era of precision medicine, emerging knowledge on molecular endometrial carcinosarcoma is opening new promising therapeutic options for more personalized treatment. The present review outlines state-of-the-art knowledge and future directions for patients with endometrial carcinosarcoma.

In most cancers, lymph node status is the most critical factor impacting the evolution of the disease and the overall survival. Identifying potential nodal metastasis allows the oncologist to adjust the stage and, consequently, the patient's treatment. For this reason, a precise evaluation of the regional nodes is mandatory. In gynecological cancers, pelvic, paraaortic, and inguinal nodes are the region most frequently interested by metastasis. In the past years, comprehensive lymphadenectomy was the standard of care for endometrial, cervical, ovarian, and vulvar cancers. However, after introducing the sentinel lymph node (SNL) biopsy in breast cancers, this technique has gained much more interest in gynecology oncology. Several studies have shown that SLN allows an evaluation of the node status without the complications related to the lymphadenectomy that impacts the patient's quality of life. In this review, we discuss the role of SNL biopsy in gynecological cancers and the technique's evolution over the years. Moreover, we debate the OSNA method for SLN analysis that is recently introduced for uterine cancer.

Background Ultrasound-guided biopsy is an easy technique for obtaining tissue samples. It is commonly used for different types of tumors, such as breast and prostate cancers, in order to plan early and adequate treatment. Objective To evaluate the indications, adequacy, and safety of transvaginal ultrasound-guided biopsy in women with pelvic lesions suspected of gynecologic malignancy. Methods A retrospective study including all patients who had undergone transvaginal ultrasound-guided biopsy between April 2015 and May 2018 was carried out at the division of gynecologic oncology. Inclusion criteria were the presence at imaging of abdominal or pelvic tumors in patients considered not ideal candidates for primary gynecological surgery, or the origin and/or nature of the tumor was unclear and further management required histological verification. Patients with planned surgery were excluded from the study. Transvaginal biopsies were performed with a 18 G/25 cm core-cut biopsy needle and histology was obtained. Tru-cut biopsies were performed using an automatic bioptic gun with a 18 G/25 cm core-cut biopsy needle. Results are presented as absolute frequency (percentage) for nominal variables and as median (range) for continuous variables. Results A total of 62 women were analyzed. An adequate sample for histological analysis was obtained in all cases. Histopathological examinations showed 24 (38.7%) benign lesions (fibrosis, inflammation, uterine or ovarian myoma) and 38 (61.3%) malignant tumors, distributed as follows: 34 (89.5%) malignant gynecological lesions and 4 (10.5%) non-gynecological malignant tumors. Among the malignant lesions, there were 12/38 (31.6%) primary tumors, 24/38 (63.2%) recurrent tumors, and 2/38 (5.3%) metastases from non-genital cancer. Ten patients eventually underwent surgery. Final histology was not in agreement with the results from transvaginal ultrasound-guided biopsy in 2 of 10 patients (20%); in particular, benign disease at transvaginal

Objective: Pelvic exenteration (PE) is an extensive surgery associated with high rates of postoperative morbidity and mortality. The absence of well-defined preoperative selection criteria to identify patients eligible for PE prompted the assessment of pre-operative predictors of 30-day major surgical complications. Methods: Demographics and surgical characteristics of patients undergoing PE for gynecologic cancer in a single institution between 01/2004–12/2016 were reviewed. Postoperative complications within 30 days following surgery were graded using the Accordion grading system. Logistic regression was used to analyze potential risk factors for severe postoperative complications. Results: A total of 138 patients were included in the cohort. Forty-five patients underwent total PE, 52 anterior PE, and 41 posterior PE. Among the 137 patients with follow-up, a severe postoperative complication was experienced by 37 patients (27.0%) and 3 patients (2.2%) experienced death within 90 days. The most frequent grade 3 complications were complications of urinary reconstruction (n = 15), wound dehiscence (n = 9), and abdominal abscess requiring intervention with drain or return to the operating room (n = 6). On multivariable analysis, independent predictors of severe postoperative complications were anterior or total PE (adjusted odds ratio (aOR): 11.66, 95% CI 2.56–53.18), pre-operative hemoglobin ≤10 mg/dl (aOR 2.70, 95% CI 1.02–7.14) and presence of 3+ comorbidities (aOR: 2.76, 95% CI 1.07–7.10). Conclusions: Major complications after exenteration are common. Surgical complexity and patient selection play a considerable role in predicting complications. These data can be used to better risk stratify patients undergoing PE.

Background: Usefulness of intraoperative goal-directed hemodynamic management (GDHM) for patients without comorbidities is debated. After clinical implementation of a pulse contour analysis-guided GDHM protocol, which foresees early vasopressor use for recruiting unstressed volume, we conducted a matched-controlled analysis to explore its impact on the amount of fluids intraoperatively administered to patients without comorbidities who underwent extended abdominal surgery for ovarian cancer. Methods: After 1:1 matching accounting for body mass index, oncologic disease severity and intraoperative blood losses, 22 patients treated according to this GDHM protocol were compared to a control group of 22 patients who had been managed according to the clinical decision of attending physicians, taken without advanced monitoring. Results are displayed as median[interquartile range]. Results: All analyzed patients underwent radical hysterectomy, bilateral adnexectomy, bowel resection, peritonectomy and extended pelvic/periaortic lymphadenectomy; median length of surgery was 517[480–605] min in patients receiving GDHM and 507[480–600] min in control group. Intraoperatively, patients undergoing GDHM received less fluids (crystalloids 2950[2700–3300] vs. 5150[4700–6000] mL, p < 0.001; colloids 100[50–200] vs. 750[500–1000] mL, p < 0.001) and showed a trend to more frequent vasopressor administration (32 vs 9%, p = 0.13). Greater intraoperative diuresis (540[480–620] mL vs. 450[400–500] mL, p = 0.007), lower blood lactates at surgery end (1.5[1.1–2] vs. 4.1[3.3–5] mmol/L, p < 0.001), shorter time to bowel function recovery (1 [1, 2] vs. 4 [3–5] days, p < 0.001) and hospital discharge (7 [6–8] vs 12 [9–16] days, p < 0.0001) were detected in patients receiving GDHM. Conclusions: In high-tumor load gynaecological patients without comorbidities who receive radical and prolonged surgery, intraoperative use of this novel GDHM protocol helped limit fluids administration w

ACKGROUND/AIM: To report on morbidity and oncological outcomes in a consecutive series of gynecological malignancies involving the vascular district. PATIENTS AND METHODS: We retrospectively evaluated a consecutive series between 1/2015 and 1/2017 with suspicious gynecological malignancies involving the vascular district. Peri-operative data and survival rates were computed. RESULTS: Eight-hundred-four women with gynecological malignancies were admitted for major oncologic surgery during the study period, and among them, 50 cases (6.2%) showed vascular involvement. Twenty-seven and 23 patients were submitted to minor and major vascular procedures, respectively. R0 resection was achieved in 44 patients. There were no perioperative mortalities. Major postoperative complications occurred in 6 patients (12.0%). The 2-year disease free survival (DFS) was 67% if R0 resection was achieved. In patients with positive pathological margins (n=2), the 2-year DFS was 33%. CONCLUSION: Vascular procedures can be safely performed with a proper pre-operative planning and may not be an impediment to major gynecological oncological surgery.

OBJECTIVE: The study aimed to characterize cancer-related concerns among women with a new diagnosis of gynecological cancer from a developmental life stage perspective. The study compared the degree of cancer-related concern between young women (45 years or younger), middle age women (46-64 years), and older women (65 years or older). MATERIALS/METHODS: Data from women (N = 243) with a condition diagnosed as primary gynecological cancer who were participating in a randomized control trial were analyzed. Women completed a measure that assessed the degree of concern in 12 cancer-related domains (physical functioning, cancer treatment, emotional functioning, sexual functioning, disease progression/death, own well-being, partner well-being, relationship with spouse/partner, body image, relationship with others, employment, and finances). Multivariate comparisons were made between the 3 age groups on the cancer-related concerns. RESULTS: There were age group differences in overall cancer-related concern and specific cancer-related domains. Young women reported the greatest cancer-related concern (P < 0.001). They reported greater concern over emotional functioning (P < 0.001) and sexual functioning (P < 0.001) compared to the middle- and older-age groups. Older women reported less concern over the impact of cancer on finances (P = 007). There were no differences between age groups in concern over physical impairment, cancer treatment, disease progression/death, own well-being, partner well-being, relationship with spouse/partner, body image, and relationship with others. CONCLUSIONS: Age may play an important role in the impact of a gynecological cancer diagnosis in domains of functioning, specifically emotional functioning, sexual functioning, and finances. Other cancer-related areas may represent more universal degree of impact. Professionals may benefit from considering the impact of cancer from a developmental life stage perspective.

The increasing tendency to a tailored treatment in gynecologic oncology has required the extension of the intervention to other non-gynecological structures, as the urinary district. Moreover the role of the urological surgery in gynecologic oncology is still not completely explored. The objective of the study is to evaluate the occurrence of urological procedures in gynecologic oncology surgery.

The European Network for Gynaecological Oncological Trial groups (ENGOT) is a research network of the European Society of Gynaecological Oncology and was founded in Berlin in October 2007. Earlier, we reported on the ENGOT minimal requirements for trials between academic groups and pharmaceutical companies. In this paper, we summarize the roadmap for performing trials in the ENGOT framework. In this roadmap, we define how an ENGOT trial should be set up and discuss the following items: What are the conditions to classify a study as an ENGOT trial? What is an ENGOT protocol? How are an ENGOT protocol, informed consent (ICF), and case report form (CRF) produced? How is the center selection and feasibility performed in ENGOT trials? How are regulatory and operational tasks handled? How should a confidentiality agreement between the industry and the whole ENGOT network be negotiated? How are contracts made between the industry and ENGOT and between ENGOT groups? How are funding, insurance, and communication flow arranged in ENGOT trials? What are the requirements for conducting substudies and what are the tasks for the leading group in an ENGOT trial? A template of a confidentiality agreement, a checklist of ENGOT criteria for new study proposals, and guidelines for authorship are also provided. Copyright © 2013 by IGCS and ESGO.

BACKGROUND: Recent insights provide support for the treatment of cancer during pregnancy, a coincidence that poses both mother and fetus at risk. Our aim was to critically review studies on the physiologic variations during pregnancy, the most common tumor markers used in diagnosis and follow-up of gynecological cancers. METHODS: We conducted a systematic review of six tumor markers during normal pregnancy: carbohydrate antigen (CA) 15-3 (breast cancer); squamous cell carcinoma antigen (cervical cancer); and CA 125, anti-Müllerian hormone, inhibin B and lactate dehydrogenase (ovarian cancer). RESULTS: For CA 15-3, 3.3% to 20.0% of all measurements were above the cut-off (maximum 56 U/mL in the third trimester). Squamous cell carcinoma antigen values were above cut-off in 3.1% and 10.5% of the measurements (maximum 4.3 µg/L in the third trimester). Up to 35% of CA 125 levels were above cut-off: levels were highest in the first trimester, with a maximum value up to 550 U/mL. Inhibin B, anti-Müllerian hormone and lactate dehydrogenase levels were not elevated in maternal serum during normal pregnancy. CONCLUSION: During normal pregnancy, tumor markers including CA 15.3, squamous cell carcinoma antigen and CA 125 can be elevated; inhibin B, anti-Müllerian hormone and lactate dehydrogenase levels remain below normal cut-off values. Knowledge of physiological variations during pregnancy can be clinically important when managing gynecological cancers in pregnant patients.

Background Persistent infections with high-risk types of human papillomavirus (HPV) are associated with the development of cervical neoplasia. Compared to cytology HPV testing is more sensitive in detecting high-grade cervical cancer precursors, but with lower specificity. HPV based primary screening for cervical cancer is currently discussed in Germany. Decisions should be based on a systematic evaluation of the long-term effectiveness and cost-effectiveness of HPV based primary screening. Research questions What is the long-term clinical effectiveness (reduction in lifetime risk of cervical cancer and death due to cervical cancer, life years gained) of HPV testing and what is the cost-effectiveness in Euro per life year gained (LYG) of including HPV testing in primary cervical cancer screening in the German health care context? How can the screening program be improved with respect to test combination, age at start and end of screening and screening interval and which recommendations should be made for the German health care context? Methods A previously published and validated decision-analytic model for the German health care context was extended and adapted to the natural history of HPV infection and cervical cancer in order to evaluate different screening strategies that differ by screening interval, and tests, including cytology alone, HPV testing alone or in combination with cytology, and HPV testing with cytology triage for HPV-positive women. German clinical, epidemiological and economic data were used. In the absence of individual data, screening adherence was modelled independently from screening history. Test accuracy data were retrieved from international meta-analyses. Predicted outcomes included reduction in lifetime-risk for cervical cancer cases and deaths, life expectancy, lifetime costs, and discounted incremental cost-effectiveness ratios (ICER). The perspective of the third party payer and 3% annual discount rate were a dopt

To prospectively assess the diagnostic performance of simple ultrasound rules to predict benignity/malignancy in an adnexal mass and to test the performance of the risk of malignancy index, two logistic regression models, and subjective assessment of ultrasonic findings by an experienced ultrasound examiner in adnexal masses for which the simple rules yield an inconclusive result. Prospective temporal and external validation of simple ultrasound rules to distinguish benign from malignant adnexal masses. The rules comprised five ultrasonic features (including shape, size, solidity, and results of colour Doppler examination) to predict a malignant tumour (M features) and five to predict a benign tumour (B features). If one or more M features were present in the absence of a B feature, the mass was classified as malignant. If one or more B features were present in the absence of an M feature, it was classified as benign. If both M features and B features were present, or if none of the features was present, the simple rules were inconclusive. 19 ultrasound centres in eight countries. 1938 women with an adnexal mass examined with ultrasound by the principal investigator at each centre with a standardised research protocol. Reference standard Histological classification of the excised adnexal mass as benign or malignant. Diagnostic sensitivity and specificity. Of the 1938 patients with an adnexal mass, 1396 (72%) had benign tumours, 373 (19.2%) had primary invasive tumours, 111 (5.7%) had borderline malignant tumours, and 58 (3%) had metastatic tumours in the ovary. The simple rules yielded a conclusive result in 1501 (77%) masses, for which they resulted in a sensitivity of 92% (95% confidence interval 89% to 94%) and a specificity of 96% (94% to 97%). The corresponding sensitivity and specificity of subjective assessment were 91% (88% to 94%) and 96% (94% to 97%). In the 357 masses for which the simple rules yielded an inconclusive result and with available results of

Objective: To review the current status of large phase academic clinical trials for women with ovarian cancer, address cross-cutting issues, and identify promising areas for future collaboration.Methods: In May 2009, the Gynecologic Cancer Intergroup, which represents 19 Cooperative Groups conducting trials for women with gynecologic cancer, and the US National Cancer Institute convened a Clinical Trials Planning Meeting.Results: The topics covered included the impact of new developments in cancer biology upon molecular targets and novel agents, pharmacogenomics, advances in imaging, the potential benefit of diet and exercise to reduce the risk of recurrence, academic partnership with industry, statistical considerations for phases 2 and 3 trials, trial end points, and symptom benefit and health-related quality-of-life issues. The clinical trials discussed spanned the spectrum of ovarian cancer from initial diagnosis, staging, and cytoreductive surgery to consolidation chemotherapy, and treatment of recurrent disease.Conclusions: Ongoing and effective collaboration with industry, government, and patients aims to ensure that the most important scientific questions can be answered rapidly. We encourage women with ovarian cancer and their oncologists to consider participation in the academic clinical trials conducted by the member groups of the Gynecologic Cancer Intergroup.

The purpose of this study was to assess the diagnostic accuracy of transvaginal sonographic examination of small adnexal masses by simple descriptive sonographic scoring.

Ifosfamide and doxorubicin are the most active agents in the treatment of sarcomas and are characterized by a marked dose-response relationship. The objective of this study was to determine the maximum tolerated dose (MTD) of both agents in combination under granulocyte-macrophage colony-stimulating factor (GM-CSF) cover.

Objective: To address the incidence of deep wound dehiscence and incisional hernia formation with two types of mass closure after vertical midline laparotomy performed in patients with gynecologic cancer. Methods: Continuous and interrupted mass closures were compared randomly in 632 patients. Both methods were performed with absorbable material. Of the 614 subjects who could be evaluated, 308 underwent a continuous, non-locking closure with looped polyglyconate suture, and 306 were closed with interrupted polyglycolic acid according to the Smead-Jones technique. Results: Three (1%) subjects with the continuous closure and five (1.6%) with the interrupted closure had an abdominal wound infection (P = .50). One patient whose incision was closed with continuous suturing had a deep wound dehiscence (without evisceration). The follow-up period was 6 months to 3 years. No patient had evidence of chronic sinus drainage. Thirty-two (10.4%) of the patients who had the continuous closure and 45 (14.7%) of those who were closed with the interrupted method had evidence of incisional hernia (P = .14). No hernia developed in any patient with a wound infection. Four (1.3%) hernias after the continuous closure and eight (2.6%) after the interrupted closure required surgical repair because of patient discomfort (P = .38). Conclusion: The interrupted closure was not superior to the continuous closure for short- and long-term wound security. The continuous method was preferable because it was more cost-efficient and faster. (C) 1997 by The American College of Obstetricians and Gynecologists

The efficacy and tolerability of granisetron in the management of acute and delayed emesis was compared with that of a multiple antiemetic drug combination regimen, including metoclopramide, dexamethasone, lorazepam and orphenadrine. The trial was a randomized, cross-over study involving 111 patients with gynecological cancers undergoing chemotherapy with cisplatin. Granisetron was significantly more effective than the combination regimen during the first 24 h after chemotherapy; complete response, rates were 67 and 48%, respectively (p = 0.002). There was a significant reduction in the effectiveness of the combination during the second treatment cycle, compared with the first. In contrast, the efficacy of granisetron did not differ between the two cycles. The response rate during the 6 days after chemotherapy was 40.8% in both groups. At the end of the study, 55% of patients preferred granisetron and 23% preferred the combination (p < 0.001). Granisetron was well tolerated. The principal adverse event was headache, which was reported in 7% of patients. The results of this study confirm that granisetron is effective in the treatment of cisplatin-induced nausea and vomiting during the 24 h after chemotherapy.

Transvaginal sonographically guided puncture may be used for diagnostic and therapeutic purpose in general gynecology and in oncology. To define the complication rate of this technique, 500 consecutive procedures were reviewed; 289 procedures were on cystic masses, 146 on solid tumors, 34 on mixed tumors, and 31 on other lesions. No life-threatening complications occurred. Early mild and self-limited complications developed in eight procedures (1.6%). Short-term complications occurred in four cases (0.8%; two infections, one pelvic pain, one hemorrhage); two of these required surgery. Transvaginal sonographically guided puncture is safe and does not entail a higher risk of infection than transabdominal punctures.

Infections often complicate the medical or surgical treatment of hospitalized cancer patients. In these cases, a broad-spectrum antibiotic treatment is necessary before the microbiological results are available. The aim of the present study is to verify the efficacy of pefloxacin as empirical antibiotic therapy in controlling infectious complications induced by surgery, chemotherapy or radiotherapy in female patients with gynecological cancer. To this purpose, 58 hospitalized patients with gynecologic malignancy and severe infectious complications were treated with intravenous pefloxacin at the dosage regimen of 400 mg every 12 hours. In all, 49 (or 91%) of the 54 evaluable patients were cured. The mean duration of successful treatment was 5.9 +/- 2.1 days (ranging 4-13 days). No side effects or clinical laboratory abnormalities requiring reduction or discontinuation of therapy were observed. We conclude that pefloxacin may be considered a first choice, broad-spectrum, single antibiotic for use in the empirical therapy of infections in gynecological cancer patients.

PURPOSE: To ascertain the complication rate associated with ultrasound (US)-guided puncture of gynecologic lesions. MATERIALS AND METHODS: Between 1986 and 1992, 878 transabdominal and 122 transvaginal US-guided punctures of gynecologic lesions were performed in 893 patients. Most of the procedures were performed in adnexal cysts (n = 838); the rest, in solid tumors (n = 66), mixed tumors (n = 56), or lymphoceles, abscesses, or fluid collections (n = 40). No anesthesia or antibiotic prophylaxis was routinely used. RESULTS: No life-threatening complication was recorded. Early complications (defined as complications that occurred within 24 hours after puncture) were recorded in 31 patients and consisted mainly of transient vagal symptoms or pain. Short-term complications (within 5 days after puncture) were recorded in 10 patients, six of whom required surgery. CONCLUSION: US-guided puncture of gynecologic lesions is safe in selected patients. Complication rates depend on the type of lesion and are very high in dermoid cysts, which should not be punctured, and extremely low in serous cysts, solid tumors, and mixed tumors

The authors analyse the results obtained in a study of 28 cancer patients managed with total parenteral nutrition (TPN) for a period variant from 5 to 19 days. The results fully justify the usefulness of the TPN in cancer patients before the treatment against the cancer.