Robotic or laparoscopic pelvic exenteration for gynecological malignancies: feasible options to open surgery.

OBJECTIVE: To acknowledge that minimally invasive pelvic exenteration is a feasible alternative to open surgery and potentially identify prediction factors for patient outcome. METHODS: The study was designed as a retrospective single team analysis of 12 consecutive cases, set between January 2008 and January 2022. RESULTS: Six anterior and 6 total pelvic exenterations were performed. A 75% of cases were treated using a robotic approach. In 4 cases, an ileal conduit was used for urinary reconstruction. Mean operative time was 360±30.7 minutes. for anterior pelvic exenterations and 440±40.7 minutes. for total pelvic exenterations and mean blood loss was 350±35 mL. An R0 resection was performed in 9 cases (75%) and peri-operative morbidity was 16.6%, with no deaths recorded. Median disease-free survival was 12 months (10-14) and overall survival (OS) was 20 months (1-127). In terms of OS, 50% of patients were still alive 24 months after surgery. Taking into consideration the follow up period,16.6% of females under 50 or above 70 years old did not reach the cut off and 4 out of 6 patients that failed to reach it were diagnosed with distant metastases or local recurrence (p=0.169). CONCLUSION: Our experience is very much consistent with literature in regard to primary site of cancer, post-operative complications, R0 resection and survival rates. On the other hand, minimally invasive approach and urinary reconstruction type were in contrast with cited publications. Minimally invasive pelvic exenteration is indeed a safe and feasible procedure, providing patients selection is appropriately performed.

Prognostic significance of heterologous component in carcinosarcoma of the gynecologic organs: a systematic review and meta-analysis.

OBJECTIVE: The aim of this study is to determine the histologic presence of heterologous component as a prognostic factor in gynecologic carcinosarcoma through a systematic review and meta-analysis. METHODS: PubMed, Web of Science, and Embase were searched for publications. Studies that evaluated survival effect of sarcomatous component based on histology in human ovarian or uterine carcinosarcoma were included. Two authors independently reviewed the references based on eligibility criteria and extracted the data including primary tumor site, survival outcome, type of survival outcome, and proportion of each sarcomatous differentiation. The quality of each eligible study was assessed with Newcastle-Ottawa scale. Meta-analysis was conducted using a random-effects model to estimate hazard ratio (HR) and 95% confidence intervals (CIs) of survival outcome for carcinosarcoma with or without heterologous component. RESULTS: Eight studies including 1,594 patients were identified. Overall proportion of carcinosarcoma with heterologous component was 43.3%. Presence of heterologous component was associated with worse overall survival (HR=1.81; 95% CI=1.15-2.85) but not with pooled recurrence-free survival and disease-free survival (HR=1.79; 95% CI=0.85-3.77). Removing multivariate analysis studies, early-stage studies, ovarian tumor study, or studies with large number of patient samples did not affect the significance between heterologous component and overall survival. CONCLUSION: Gynecologic carcinosarcoma is histologically a biphasic tumor which comprise of epithelial and mesenchymal components. Our study emphasizes pathologic evaluation of heterologous component as a prognostic factor in gynecologic carcinosarcoma when all stages were considered. TRIAL REGISTRATION: PROSPERO Identifier: CRD42022298871.

Hypotension Prediction Index guided Goal Directed therapy and the amount of Hypotension during Major Gynaecologic Oncologic Surgery: a Randomized Controlled clinical Trial.

Intraoperative hypotension (IOH) is associated with increased morbidity and mortality. Hypotension Prediction Index (HPI) is a machine learning derived algorithm that predicts IOH shortly before it occurs. We tested the hypothesis that the application of the HPI in combination with a pre-defined Goal Directed Therapy (GDT) hemodynamic protocol reduces IOH during major gynaecologic oncologic surgery. We enrolled women scheduled for major gynaecologic oncologic surgery under general anesthesia with invasive arterial pressure monitoring. Patients were randomized to a GDT protocol aimed at optimizing stroke volume index (SVI) or hemodynamic management based on HPI guidance in addition to GDT. The primary outcome was the amount of IOH, defined as the timeweighted average (TWA) mean arterial pressure (MAP) < 65 mmHg. Secondary outcome was the TWA-MAP < 65 mmHg during the first 20 min after induction of GA. After exclusion of 10 patients the final analysis included 60 patients (30 in each group). The median (25-75th IQR) TWA-MAP < 65 mmHg was 0.14 (0.04-0.66) mmHg in HPI group versus 0.77 (0.36-1.30) mmHg in Control group, P < 0.001. During the first 20 min after induction of GA, the median TWA-MAP < 65 mmHg was 0.53 (0.06-1.8) mmHg in the HPI group and 2.15 (0.65-4.2) mmHg in the Control group, P = 0.001. Compared to a GDT protocol aimed to SVI optimization, a machine learning-derived algorithm for prediction of IOH combined with a GDT hemodynamic protocol, reduced IOH and hypotension after induction of general anesthesia in patients undergoing major gynaecologic oncologic surgery.Trial registration number: NCT04547491. Date of registration: 10/09/2020.

Sociodemographic characteristics associated with indications for surgical menopause in women: a retrospective study

SUMMARY OBJECTIVE: The aim of this study was to evaluate the surgical menopause indications and sociodemographic characteristics of women. METHODS: In this retrospective study, we analyzed the sociodemographic characteristics of women with indications for surgical menopause in 2010-2020. The R Version 4.1.1 (2021-08-10) software and logistic regression analysis were used to evaluate the data. RESULTS: A total of 704 women's data were obtained in this study. Surgical menopause indications were found to stem from bleeding (46.0%), cancer (28.3%), cancer risk (18.9%), and other causes (6.8%). Surgical menopause indications originating from cancer were increased by 0.08 times (95%CI 0.01-0.68) due to smoking, 0.45 times (95%CI 0.23-0.88) due to regular drug use, and 0.36 times (95%CI 0.19-0.69) due to the presence of chronic disease (p<0.05). CONCLUSION: More than half of the women with surgical menopause indications were between 41 and 46 years of age. Additionally, 54.9% of the women had a chronic disease. Therefore, it is recommended to plan preventive health services for morbidity and mortality risks that may develop due to surgical menopause.

Efficacy of edoxaban for the treatment of gynecological cancer-associated venous thromboembolism: analysis of Japanese real-world data.

OBJECTIVE: Direct oral anticoagulants (DOACs) are increasingly being used for the treatment of cancer-associated venous thromboembolism (CAT). However, there is limited evidence of the efficacy of DOACs for the treatment of gynecological CAT. Thus, this study aimed to investigate the efficacy and safety of edoxaban for the treatment of gynecological CAT using Japanese real-world data. METHODS: We reviewed the medical records of patients with 371 gynecological cancer who received edoxaban or vitamin K antagonist (VKA) between January 2011 and December 2018. RESULTS: Altogether, 211 and 160 patients were treated with edoxaban and VKA, respectively. Fourteen patients (6.8%) in the edoxaban group and 22 (13.8%) in the VKA group showed recurrence of venous thromboembolism (VTE). Cumulative VTE recurrence was not significantly different between the 2 groups (p=0.340). Adverse events occurred in 15 (7.1%) and 11 (6.9%) patients in the edoxaban and VKA groups, respectively (p=0.697). Subgroup analysis of the edoxaban and VKA groups according to different tumor types, including ovarian, endometrial, and cervical cancer, showed equivalent outcomes in terms of VTE recurrence and adverse events. Patients without pulmonary embolism (PE) were mostly omitted from initial unfractionated heparin (UFH) therapy prior to administration of edoxaban. However, this did not increase the recurrence of VTE. CONCLUSION: This study confirmed that edoxaban is effective and safe for the treatment of gynecological CAT. This finding was consistent for different types of gynecological cancer. Additionally, initial UFH therapy prior to the administration of edoxaban may be unnecessary for patients without PE.

MASCC multidisciplinary evidence-based recommendations for the management of malignant bowel obstruction in advanced cancer.

PURPOSE: To provide evidence-based recommendations on the management of malignant bowel obstruction (MBO) for patients with advanced cancer. METHODS: The Multinational Association for Supportive Care in Cancer (MASCC) MBO study group conducted a systematic review of databases (inception to March 2021) to identify studies about patients with advanced cancer and MBO that reported on the following outcomes: symptom management, bowel obstruction resolution, prognosis, overall survival, and quality of life. The review was restricted to studies published in English, but no restrictions were placed on publication year, country, and study type. As per the MASCC Guidelines Policy, the findings were synthesized to determine the levels of evidence to support each MBO intervention and, ultimately, the graded recommendations and suggestions. RESULTS: The systematic review identified 17,656 published studies and 397 selected for the guidelines. The MASCC study group developed a total of 25 evidence-based suggestions and recommendations about the management of MBO-related nausea and vomiting, bowel movements, pain, inflammation, bowel decompression, and nutrition. Expert consensus-based guidance about advanced care planning and psychosocial support is also provided. CONCLUSION: This MASCC Guideline provides comprehensive, evidence-based recommendations about MBO management for patients with advanced cancer.

Informed consent forms for gynecologic cancer surgery: recommendations from the Korean Society of Gynecologic Oncology.

The sociomedical environment is changing. In the traditional physician-patient relationship, the physician was authoritative and the patient was obedient. The contractual relationship featured patient consent to the physician's decision. Today, the physician must explain fully the planned medical treatment, and any alternative, to the patient, who has the right to choose her treatment after considering the benefits and side-effects. The Korean Society of Gynecologic Oncology (KSGO) thus decided to standardize the surgical consent forms to meet the legal requirements of modern medicine, improve patient understanding of the surgical details, and protect medical staff from legal disputes. To determine the format and content, subcommittees for each cancer type collected and reviewed all relevant articles and the current consent forms of domestic medical institutions. After several meetings, 16 basic items to be included for each type of gynecologic cancer were selected. Also, to help patients understand the surgical details, figures were included. The revised forms were legally reviewed in terms of the appropriateness of the format and content. We also developed English versions to provide adequate information for foreign patients. We hope that these efforts will promote trust between patients and physicians, and contribute to effective treatment by laying a foundation of mutual respect.

HMGA2: A Biomarker in Gynecologic Neoplasia.

High Mobility Group A2 gene (HMGA2), an oncofetal protein, is normally expressed in fetal development and completely shuts down in almost all organs and tissue types during adulthood. It is upregulated or overexpressed again in certain mesenchymal neoplasms due to chromosomal translocations and in malignant epithelial tumors through transcription regulation. HMGA2 overexpression can either drive tumor development or promote the aggressiveness of tumor growth. Many gynecologic neoplasms, including uterine smooth muscle tumors and ovarian cancer, are associated with HMGA2 overexpression. In this article, we review recent developments in the study of HMGA2 and its expression as a potential biomarker for gynecologic neoplasms and clinic application.

Informed consent forms for gynecologic cancer surgery: recommendations from the Korean Society of Gynecologic Oncology.

The sociomedical environment is changing. In the traditional physician-patient relationship, the physician was authoritative and the patient was obedient. The contractual relationship featured patient consent to the physician's decision. Today, the physician must explain fully the planned medical treatment, and any alternative, to the patient, who has the right to choose her treatment after considering the benefits and side-effects. The Korean Society of Gynecologic Oncology thus decided to standardize the surgical consent forms to meet the legal requirements of modern medicine, improve patient understanding of the surgical details, and protect medical staff from legal disputes. To determine the format and content, subcommittees for each cancer type collected and reviewed all relevant articles and the current consent forms of domestic medical institutions. After several meetings, 16 basic items to be included for each type of gynecologic cancer were selected. Also, to help patients understand the surgical details, figures were included. The revised forms were legally reviewed in terms of the appropriateness of the format and content. We also developed English versions to provide adequate information for foreign patients. We hope that these efforts will promote trust between patients and physicians, and contribute to effective treatment by laying a foundation of mutual respect.

Symptoms, resilience, coping, and psychosocial adjustment in women with gynaecological cancer in South Korea: A cross sectional study.

PURPOSE: This cross-sectional study aimed to evaluate the relationship between symptoms, resilience, coping, and psychosocial adjustment, and to identify the influence of these variables on the psychosocial adjustment in women with gynaecological cancer in South Korea. METHODS: A correlational research design was employed based on the stress-coping theory of Lazarus and Folkman. A total of 150 women with gynaecological cancer admitted to a Korean tertiary hospital were included via convenience sampling. Data were collected using structured questionnaires between January and April 2018. Data analyses included descriptive statistics, independent t-test, χ2 test, analysis of variance, Pearson's correlation coefficient, and hierarchical multiple regression using the SPSS WIN 25.0 program. RESULTS: The study found that symptoms had the strongest association with psychosocial adjustment in women with gynaecological cancer. Psychosocial adjustment showed a statistically significant relationship with symptoms (r = 0.34, p < .001), resilience (r = -.43, p < .001), and coping (r = -.32, p < .001). A hierarchical multiple regression analysis demonstrated that symptoms (ß = 0.33, p < .001), resilience (ß = -.30, p < .001), and coping (ß = -.17, p = .032) accounted for 28.1% of the variance in psychosocial adjustment. CONCLUSIONS: It is pertinent for healthcare providers to assess and develop symptom management to provide resilience and coping strategies for gynaecological cancer women and improve their psychosocial adjustment.

Factors associated with late-stage presentation of cervical cancer in Ghana.

Objective: To explore factors associated with late clinical presentation among Ghanaian women with cervical cancer. Design: This is a cross-sectional survey using a paper questionnaire. Setting: Komfo Anokye Teaching Hospital (KATH) in Kumasi, Ghana. Participants: Participants were women presenting for cervical cancer care at KATH. Inclusion criteria were histologically diagnosed cervical cancer and age ≥18 years. The exclusion criteria was age <18. All women presenting from August 2018-August 2019 were recruited. Main outcome measures: The primary outcome was the proportion of participants presenting with late-stage cervical cancer, defined as stage II or higher. Results: Of 351 total participants, 33.6% were unemployed, 35.3% had no formal education, and 96.6% had an average monthly income of less than five hundred Ghana cedis ($86 USD). Time from symptoms to seeing a doctor ranged from fewer than two weeks (16.0%) to more than twelve months (8.6%). Participants' most common barrier in seeking healthcare was financial constraints (50.0%). Most participants presented at late-stage cervical cancer (95.2%, n=334), with only 4.8% (n=17) presenting at stage I. Of participants presenting with late-stage cervical cancer, the vast majority had never had a Papanicolaou (Pap) smear (99.1%) nor a recent gynecologic exam (99.3%). After adjusting for age, parity, and distance to a healthcare facility, a late-stage presentation was associated with lower income and living in a rural area. Conclusions: In Ghana, 95% of women with cervical cancer seek care at a late clinical stage, defined as stage II or greater, when the cancer is inoperable. Funding: None declared.

Hymenialdisine is Cytotoxic Against Cisplatin-Sensitive but Not Against Cisplatin-Resistant Cell Lines.

OBJECTIVES: New compounds are needed to overcome the resistance to commonly used cytotoxic chemotherapy for epithelial ovarian cancer. Marine sponges are a rich source of diverse chemical compounds and hymenialdisine has been found to have antiproliferative effects. This study aimed to investigate the cytotoxic effect of hymenialdisine in cisplatin-sensitive and cisplatin resistant ovarian cancer cell lines. METHODS: This study took place at Sultan Qaboos University, Muscat, Oman between August and November, 2019. The anti-cancer effects of hymenialdisine or cisplatin were assessed using treating cells with different concentrations of hymenialdisine and cisplatin. Cell viability was determined using the AlamarBlue® Assay. RESULTS: The half-maximal inhibitory concentration (IC50) of cisplatin was estimated at 31.4 µM for A2780S and 76.9 µM for A2780CP, whereas the IC50 of hymenialdisine was evaluated at 146.8 µM for A2780S cells. Despite the higher concentrations of hymenialdisine (up to 300 µM), IC50 could not be determined for the A2780CP cell line. CONCLUSION: When compared to cisplatin, hymenialdisine was less toxic against both A2780S and A2780CP ovarian cancer cell lines.

A serial multiple mediator model of sense of coherence, coping strategies, depression, and quality of life among gynecologic cancer patients undergoing chemotherapy.

PURPOSE: This study evaluated whether coping strategies (positive reframing, planning, and active coping) and depression mediate the relationship between sense of coherence (SOC) and quality of life (QoL) using a serial multiple mediator model in patients with gynecologic cancer who are undergoing chemotherapy. METHODS: A sample of 148 participants, with a mean age of 52.17 years (range 20-75) and diagnosed with gynecological cancer (e.g., cervix, ovary and endometrium) was surveyed in a cross-sectional study. Data were collected using a structured self-reporting questionnaire. A serial multiple mediator model was analyzed to explain sequential causality among two mediators (coping strategy and depression) and to investigate the direct and indirect effects of the mediator model in SPSSWIN 26.0 and PROCESS macro program. RESULTS: The conceptual serial mediation model of SOC, positive reframing, depression, and QoL revealed a significant positive total effect (coefficient c = 13.099, SE = 1.647, p < 0.001). The path through single mediation of positive reframing (Effect = 0.925) and depression (Effect = 5.942) and that through both mediators (Effect = 1.161) were statistically significant. The total indirect effect was also statistically significant (Effect = 8.028). Moreover, the conceptual serial mediation model on SOC, planning, depression, and QoL revealed a significant positive total effect (coefficient c = 13.099, SE = 1.647, p < 0.001). The path through both mediation of planning and depression (Effect = 1.162) and the total indirect effect were statistically significant (Effect = 8.172). CONCLUSIONS: Helping patients with gynecologic cancer undergoing chemotherapy to strengthen SOC may improve QoL by equipping them with efficient positive reframing or planning strategies to reduce depression.

Factors impacting the time to ovarian cancer diagnosis based on classic symptom presentation in the United States.

BACKGROUND: Patients with ovarian cancer often present with late-stage disease and nonspecific symptoms, but little is known about factors affecting the time to diagnosis (TTD) in the United States. METHODS: A retrospective, population-based study of the Surveillance, Epidemiology, and End Results-Medicare database was conducted. It included women 66 years old or older with stage II to IV epithelial ovarian cancer with at least 1 code for abdominal/pelvic pain, bloating, difficulty eating, or urinary symptoms within 1 year of the cancer diagnosis. TTD was defined from the first claim with a prespecified symptom to the ovarian cancer diagnosis. Kruskal-Wallis tests were used to assess for differences in TTD by group medians. Univariate and generalized linear models with a log-link function evaluated TTD by covariables. RESULTS: For the 13,872 women analyzed, the mean and median times to diagnosis were 2.9 and 1.1 months, respectively. The median TTD differed significantly by first symptom (P < .001), number of symptoms (P < .001), and first physician specialty seen (P < .001). In a multivariable analysis, TTD differed significantly according to race/ethnicity (P < .001), geographic region (P = .001), urban-rural location (P = .031), emergency room presentation (P < .001), and number of specialties seen (P < .001). A shorter TTD was associated with a diagnosis in 2006-2010 (relative risk [RR], 0.92; 95% confidence interval [CI], 0.87-0.98) or 2011-2015 (RR, 0.87; 95% CI, 0.81-0.93) in comparison with 1992-1999. CONCLUSIONS: The time from a symptomatic presentation to care to a diagnosis of ovarian cancer is influenced by clinical and demographic variables. This study's findings reinforce the importance of educating all physicians on ovarian cancer symptoms to aid in diagnosis. LAY SUMMARY: Ovarian cancer is often diagnosed once disease has spread because the classic symptoms of ovarian cancer-abdominal or pelvic pain, bloating, difficulty eating, and urinary issues-can be mistaken for other problems. This study examined the time between when women with classic ovarian cancer symptoms went to a physician and when they received a cancer diagnosis in a large database population. The authors found that the time to diagnosis differed according to the type and number of symptoms and what type of physician a woman saw as well as factors such as race, geographic location, and year of diagnosis.

Effect of Elastic Abdominal Binder on Pain and Functional Recovery Following Gynecologic Cancer Surgery: A Randomized Controlled Trial.

Background and Objectives: Clinicians have been using elastic abdominal binder for stabilizing incision site after major abdominal surgery. However, the benefits of that practice have never been formally assessed. The aim of this study was to examine the effects of the use of elastic abdominal binder on postoperative pain and recovery of gynecologic cancer patients. Materials and Methods: One-hundred and nine women diagnosed with cervical, endometrial, or ovarian cancer, who underwent open abdominal surgery were assigned randomly into two groups: intervention (56 patients) and control (53 patients). The women in the intervention group applied abdominal binder from postoperative day 1. For the control group, the women did not wear the binder or similar devices. The primary outcomes were pain and functional recovery. Subgroup analysis on participants age ≥ 50 was also performed. Results: For the entire study cohort, the baseline, postoperative day 1, and postoperative day 2 pain scores in the intervention group were significantly lower than the control group. However, there was no significant difference between the groups for postoperative day 3 pain score and for the change in pain scores from the baseline value. Of note, the age ≥ 50 subgroup represented a more balanced cohort with comparable baseline pain scores between the study groups. For this population, the pain scores for postoperative day 1-3 were significantly lower in the intervention group. The intervention group had a longer six-minute walking distance on postoperative day 3 with a trend toward a smaller difference in the day 3 distance from the baseline. Conclusions: The potential benefits of abdominal binder use in reducing postoperative pain and improving functional recovery after open gynecologic cancer surgery could be demonstrated only in those age ≥ 50.

Treatment-related leukemia after taxane and platinum therapy in gynecological cancer patients (Gynecologic Oncology Trial and Investigation Consortium 011).

AIM: To clarify incidence and clinical features of treatment-related leukemia (TRL) due to taxane/platinum therapy in gynecological cancer patients. METHODS: We conducted a retrospective study of gynecological cancer patients who were diagnosed at facilities participating in the Gynecologic Oncology Trial and Investigation Consortium and started only taxane/platinum therapy as chemotherapy between 2002 and 2006. RESULTS: The site of the primary lesion was the ovary in 124, endometrium in 37, and uterine cervix in 4. The regimen of chemotherapy was paclitaxel (T) + carboplatin (C) therapy in 134 and others in 31 patients. The cumulative incidence was 2.4% (4/165), and the incidence was 2.9/1,000 person-years. All four cases were acute myeloid leukemia. The average total doses of T and C in patients without TRL were 1,693 (SD 1,050) and 4,170 (SD 2,423) mg. For TRL patients, the total T and C doses were, respectively, 1,555 and 3,540 mg, 1,620 and 4,200 mg, 2,130 and 4,700 mg, 3,220 mg and 8,310 mg. The fourth patient received additional 2,415 mg of docetaxel and 2,155 mg of nedaplatin. The intervals from the primary chemotherapy to the onset of TRL were 27, 34, 67, and 114 months. Three patients had no evidence of ovarian cancer. Three patients died of TRL at 4 days, 5 months, and 11 months, one patient remained in remission at 25 months after diagnosis of TRL. CONCLUSION: Patients receiving taxane/platinum therapy should undergo long-term follow-up with attention to the development of TRL, even if the gynecologic malignant cancer is in remission.

Efficacy of palonosetron plus dexamethasone in preventing chemotherapy-induced nausea and emesis in patients receiving carboplatin-based chemotherapy for gynecologic cancers: a phase II study by the West Japan Gynecologic Oncology Group (WJGOG 131).

OBJECTIVE: Palonosetron is effective for the management of acute and delayed chemotherapy-induced nausea and vomiting (CINV). While emetogenic carboplatin-based chemotherapy is widely used to treat gynecologic cancers, few studies have evaluated the antiemetic effectiveness of palonosetron in this setting. METHODS: A multicenter, single-arm, open-label phase II trial was conducted to evaluate the safety and effectiveness of palonosetron in controlling CINV in patients with gynecologic cancer. Chemotherapy-naïve patients received intravenous palonosetron (0.75 mg/body) and dexamethasone before the infusion of carboplatin-based chemotherapy on day 1. Dexamethasone was administered (orally or intravenously) on days 2-3. The incidence and severity of CINV were evaluated using the patient-completed Multinational Association of Supportive Care in Cancer Antiemesis Tool and treatment diaries. The primary endpoint was the proportion of patients experiencing complete control (CC) of vomiting, with "no rescue antiemetic medication" and "no clinically significant nausea" or "only mild nausea" in the delayed phase (24-120 hours post-chemotherapy). Secondary endpoints were the proportion of patients with a complete response (CR: "no vomiting" and "no rescue antiemetic medication") in the acute (0-24 hours), delayed (24-120 hours), and overall (0-120 hours) phases, and CC in the acute and overall phases. RESULTS: Efficacy was assessable in 77 of 80 patients recruited. In the acute and delayed phases, the CR rates the primary endpoint, were 71.4% and 59.7% and the CC rates, the secondary endpoint, were 97.4% and 96.1%, respectively. CONCLUSION: While palonosetron effectively controls acute CINV, additional antiemetic management is warranted in the delayed phase after carboplatin-based chemotherapy in gynecologic cancer patients (Trial registry at UMIN Clinical Trials Registry, UMIN000012806).

Reliability and Validity of the Korean Memorial Symptom Assessment Scale-Short Form in Gynecological Cancer Patients.

CONTEXT: Symptoms of patients with cancer need to be evaluated with a standard instrument. The Memorial Symptom Assessment Scale-Short Form (MSAS-SF) is a symptom assessment tool that has been validated in many languages. OBJECTIVES: The aim of the present study was to validate the Korean-version Memorial Symptom Assessment Scale-Short Form (MSAS-SF) in patients with gynecologic cancer. METHODS: We translated the MSAS-SF into Korean, and 175 gynecologic cancer inpatients completed the MSAS-SF, Functional Assessment Cancer Therapy-General (FACT-G), and gathered demographic and clinical data and Karnofsky Performance Status (KPS). Reliability was assessed for internal consistency with Cronbach's alpha coefficient. Pearson's correlation coefficient was calculated between the MSAS-SF and FACT-G subscales for convergent validity. T-test analysis was used to compare differences in MSAS-SF subscales by cancer stage and KPS for discriminant validity. RESULTS: The Cronbach's alpha coefficients for the MSAS-SF subscales ranged from 0.80 to 0.91. The Korean-version MSAS-SF subscales showed convergent validity with FACT-G subscales. The correlation coefficients were -0.640 (P < 0.001) and -0.628 (P < 0.001) for global distress index and total MSAS score with FACT-G total score. The scores of MSAS-SF subscales showed appropriate differences by cancer stage and KPS. CONCLUSION: The Korean-version MSAS-SF is a valid tool for the reliable assessment of patients with gynecologic cancer in Korea.

Efficacy of palonosetron plus dexamethasone in preventing chemotherapy-induced nausea and emesis in patients receiving carboplatin-based chemotherapy for gynecologic cancers: a phase II study by the West Japan Gynecologic Oncology Group (WJGOG 131) / 부인종양

OBJECTIVE: Palonosetron is effective for the management of acute and delayed chemotherapy-induced nausea and vomiting (CINV). While emetogenic carboplatin-based chemotherapy is widely used to treat gynecologic cancers, few studies have evaluated the antiemetic effectiveness of palonosetron in this setting. METHODS: A multicenter, single-arm, open-label phase II trial was conducted to evaluate the safety and effectiveness of palonosetron in controlling CINV in patients with gynecologic cancer. Chemotherapy-naïve patients received intravenous palonosetron (0.75 mg/body) and dexamethasone before the infusion of carboplatin-based chemotherapy on day 1. Dexamethasone was administered (orally or intravenously) on days 2–3. The incidence and severity of CINV were evaluated using the patient-completed Multinational Association of Supportive Care in Cancer Antiemesis Tool and treatment diaries. The primary endpoint was the proportion of patients experiencing complete control (CC) of vomiting, with “no rescue antiemetic medication” and “no clinically significant nausea” or “only mild nausea” in the delayed phase (24–120 hours post-chemotherapy). Secondary endpoints were the proportion of patients with a complete response (CR: “no vomiting” and “no rescue antiemetic medication”) in the acute (0–24 hours), delayed (24–120 hours), and overall (0–120 hours) phases, and CC in the acute and overall phases. RESULTS: Efficacy was assessable in 77 of 80 patients recruited. In the acute and delayed phases, the CR rates the primary endpoint, were 71.4% and 59.7% and the CC rates, the secondary endpoint, were 97.4% and 96.1%, respectively. CONCLUSION: While palonosetron effectively controls acute CINV, additional antiemetic management is warranted in the delayed phase after carboplatin-based chemotherapy in gynecologic cancer patients (Trial registry at UMIN Clinical Trials Registry, UMIN000012806).

Development of Lower Extremity Lymphedema Nursing Practice Protocol for Patients Following Gynecologic Cancer Treatment

PURPOSE: This study aimed to develop and evaluate the lower extremity lymphedema nursing practice protocol for patients following gynecologic cancer treatment. METHODS: Thirteen web-sites were searched for eligible clinical practice guidelines (CPGs) and eleven databases were searched to identify evidence to develop a lower extremity lymphedema nursing practice protocol for patients following gynecologic cancer treatment. RESULTS: Based on the inclusion and exclusion criteria, eight CPGs and ninety-six studies, two guidelines and eight studies were identified as evidence. The protocol development group consisted of ten experts who have at least five years' experience in the related area. A lower extremity lymphedema nursing practice protocol for patients following gynecologic cancer treatment was developed including forty-three recommendations in five domains. Significant differences were found in nurses' pre and post knowledge and confidence on lower extremity lymphedema prevention and management. CONCLUSION: Nurses and other professionals could utilize this evidence based lower extremity lymphedema nursing practice protocol and apply it to patients undergoing gynecologic cancer treatment.