Hospital admission and the occurrence of delirium in older adults with physical frailty: cross-sectional study.

OBJECTIVE: To analyze the relationship between hospitalization and the occurrence of delirium in older adults with physical frailty. METHOD: Cross-sectional study carried out in a public hospital in southern Brazil. Hospitalized older adults aged ≥ 60 years participated. Sociodemographic and clinical data were collected, physical frailty phenotype tests were performed and the Confusion Assessment Method was used. Descriptive analyzes were carried out and odds ratio values were estimated for the frailty and delirium variables. RESULTS: Of the 320 older adults evaluated, 21.14% presented delirium, 49% were identified as pre-frail and 36.2% as frail. Of those affected by delirium, 71.6% were classified as frail and 28.3% as pre-frail (p < 0.001). An association was observed between the occurrence of delirium and frailty (OR 1.22; 95% CI 1.07 to 1.38), age ≥ 80 years (OR 1.14; 95% CI 1.01 to 1.32), epilepsy (OR 1.38; 95% CI 1.09 to 1.76), dementia (OR 1.58; 95% CI 1.37 to 1.82), and history of stroke (OR 1.14; 95% CI 1.03 to 1.26). CONCLUSION: There was a high frequency of pre-frail and frail older adults, and the occurrence of delirium in frail was significantly higher. Special attention should be paid to frail older adults to prevent the occurrence of delirium during hospitalization.

Does sentinel node mapping impact morbidity and quality of life in endometrial cancer?

OBJECTIVES: To evaluate the prevalence of post-operative complications and quality of life (QoL) related to sentinel lymph node (SLN) biopsy vs systematic lymphadenectomy in endometrial cancer. METHODS: A prospective cohort included women with early-stage endometrial carcinoma who underwent lymph node staging, grouped as follows: SLN group (sentinel lymph node only) and SLN+LND group (sentinel lymph node biopsy with addition of systematic lymphadenectomy). The patients had at least 12 months of follow-up, and QoL was assessed by European Organization for Research and Treatment of Cervical Cancer Quality of Life Questionnaire 30 (EORTC-QLQ-C30) and EORTC-QLQ-Cx24. Lymphedema was also assessed by clinical evaluation and perimetry. RESULTS: 152 patients were included: 113 (74.3%) in the SLN group and 39 (25.7%) in the SLN+LND group. Intra-operative surgical complications occurred in 2 (1.3%) cases, and all belonged to SLN+LND group. Patients undergoing SLN+LND had higher overall complication rates than those undergoing SLN alone (33.3% vs 14.2%; p=0.011), even after adjusting for confound factors (OR=3.45, 95% CI 1.40 to 8.47; p=0.007). The SLN+LND group had longer surgical time (p=0.001) and need for admission to the intensive care unit (p=0.001). Moreover, the incidence of lymphocele was found in eight cases in the SLN+LND group (0 vs 20.5%; p<0.001). There were no differences in lymphedema rate after clinical evaluation and perimetry. However, the lymphedema score was highest when lymphedema was reported by clinical examination at 6 months (30.1 vs 7.8; p<0.001) and at 12 months (36.3 vs 6.0; p<0.001). Regarding the overall assessment of QoL, there was no difference between groups at 12 months of follow-up. CONCLUSIONS: There was a higher overall rate of complications for the group undergoing systematic lymphadenectomy, as well as higher rates of lymphocele and lymphedema according to the symptom score. No difference was found in overall QoL between SLN and SLN+LND groups.

Hospital admission and the occurrence of delirium in older adults with physical frailty: cross-sectional study / Ingreso hospitalario y aparición de delirio en adultos mayores con fragilidad física: estudio transversal / Internação hospitalar e a ocorrência de delirium em idosos na condição de fragilidade física: estudo transversal

ABSTRACT Objective To analyze the relationship between hospitalization and the occurrence of delirium in older adults with physical frailty. Method Cross-sectional study carried out in a public hospital in southern Brazil. Hospitalized older adults aged ≥ 60 years participated. Sociodemographic and clinical data were collected, physical frailty phenotype tests were performed and the Confusion Assessment Method was used. Descriptive analyzes were carried out and odds ratio values were estimated for the frailty and delirium variables. Results Of the 320 older adults evaluated, 21.14% presented delirium, 49% were identified as pre-frail and 36.2% as frail. Of those affected by delirium, 71.6% were classified as frail and 28.3% as pre-frail (p < 0.001). An association was observed between the occurrence of delirium and frailty (OR 1.22; 95% CI 1.07 to 1.38), age ≥ 80 years (OR 1.14; 95% CI 1.01 to 1.32), epilepsy (OR 1.38; 95% CI 1.09 to 1.76), dementia (OR 1.58; 95% CI 1.37 to 1.82), and history of stroke (OR 1.14; 95% CI 1.03 to 1.26). Conclusion There was a high frequency of pre-frail and frail older adults, and the occurrence of delirium in frail was significantly higher. Special attention should be paid to frail older adults to prevent the occurrence of delirium during hospitalization.

RESUMEN Objetivo Analizar la relación entre la hospitalización y la aparición de delirio en adultos mayores con fragilidad física. Método Estudio transversal realizado en un hospital público del sur de Brasil. Participaron adultos mayores hospitalizados con edad ≥ 60 años. Se recogieron datos sociodemográficos y clínicos, se realizaron pruebas de fenotipo de fragilidad física y se utilizó el Confusion Assessment Method. Se realizaron análisis descriptivos y se estimaron los odds ratio para las variables fragilidad y delirio. Resultados De los 320 adultos mayores evaluados, el 21,14% presentó delirio, el 49% fueron identificados como prefrágiles y el 36,2% como frágiles. De los adultos mayores afectados por delirio, el 71,6% fueron clasificados como frágiles y el 28,3% como prefrágiles (p < 0,001). Se observó asociación entre la aparición de delirio y fragilidad (OR 1,22; IC 95% 1,07 a 1,38), edad ≥ 80 años (OR 1,14; IC 95% 1,01 a 1,32), epilepsia (OR 1,38; IC 95% 1,09 a 1,76), demencia (OR 1,58; IC del 95%: 1,37 a 1,82) y antecedentes de accidente cerebrovascular (OR 1,14; IC del 95%: 1,03 a 1,26). Conclusión Hubo una alta frecuencia de adultos mayores prefrágiles y frágiles y la aparición de delirio en los frágiles fue significativamente mayor. Se debe prestar especial atención a los adultos mayores frágiles para prevenir la aparición de delirio durante la hospitalización.

RESUMO Objetivo Analisar a relação entre hospitalização e ocorrência de delirium em idosos na condição de fragilidade física. Método Estudo transversal desenvolvido em hospital público no Sul do Brasil. Participaram idosos hospitalizados, idade ≥ 60 anos. Foram coletados dados sociodemográficos e clínicos, e feitos testes do fenótipo da fragilidade física, bem como o Confusion Assessment Method. Realizaram-se análises descritivas e estimaram-se as odds ratio para as variáveis fragilidade e delirium. Resultados Dos 320 idosos avaliados, 21,14% apresentaram delirium, 49% foram identificados como pré-frágeis e 36,2% frágeis. Dos idosos acometidos por delirium, 71,6% foram classificados como frágeis e 28,3% pré-frágeis (p< 0,001). Observou-se associação entre ocorrência de delirium e fragilidade (OR 1,22; IC 95% 1,07 a 1,38), idade ≥ 80 anos (OR 1,14; IC 95% 1,01 a 1,32), epilepsia (OR 1,38; IC 95% 1,09 a 1,76), demência (OR 1,58; IC 95% 1,37 a 1,82), e história de acidente vascular encefálico (OR 1,14; IC 95% 1,03 a 1,26). Conclusão Observou-se alta frequência de idosos pré-frágeis e frágeis e ocorrência de delirium expressivamente maior nos frágeis. Atenção especial deve ser empregada a idosos frágeis para prevenir a ocorrência de delirium durante a hospitalização.

Cancer risk-reducing surgery: Brazilian society of surgical oncology guideline part 1 (gynecology and breast).

BACKGROUND: Risk-reducing operations are an important part of the management of hereditary predisposition to cancer. In selected cases, they can considerably reduce the morbidity and mortality associated with cancer in this population. OBJECTIVES: The Brazilian Society of Surgical Oncology (BSSO) developed this guideline to establish national benchmarks for cancer risk-reducing operations. METHODS: The guideline was prepared from May to December 2021 by a multidisciplinary team of experts to discuss the surgical management of cancer predisposition syndromes. Fourteen questions were defined and assigned to expert groups that reviewed the literature and drafted preliminary recommendations. Following a review by the coordinators and a second review by all participants, the groups made final adjustments, classified the level of evidence, and voted on the recommendations. RESULTS: For all questions including risk-reduction bilateral salpingo-oophorectomy, hysterectomy, and mastectomy, major agreement was achieved by the participants, always using accessible alternatives. CONCLUSION: This and its accompanying article represent the first guideline in cancer risk reduction surgery developed by the BSSO, and it should serve as an important reference for the management of families with cancer predisposition.

Brazilian Society of Surgical Oncology consensus on fertility-sparing surgery for cervical cancer.

OBJECTIVE: Several controversies remain on conservative management of cervical cancer. Our aim was to develop a consensus recommendation on important and novel topics of fertility-sparing treatment of cervical cancer. METHODS: The consensus was sponsored by the Brazilian Society of Surgical Oncology (BSSO) from March 2020 to September 2020 and included a multidisciplinary team of 55 specialists. A total of 21 questions were addressed and they were assigned to specialists' groups that reviewed the literature and drafted preliminary recommendations. Further, the coordinators evaluated the recommendations that were classified by the level of evidence, and finally, they were voted by all participants. RESULTS: The questions included controversial topics on tumor assessment, surgical treatment, and surveillance in conservative management of cervical cancer. The two topics with lower agreement rates were the role of minimally invasive approach in radical trachelectomy and parametrial preservation. Additionally, only three recommendations had <90% of agreement (fertility preservation in Stage Ib2, anti-stenosis device, and uterine transposition). CONCLUSIONS: As very few clinical trials have been developed in surgery for cervical cancer, most recommendations were supported by low levels of evidence. We addressed important and novel topics in conservative management of cervical cancer and our study may contribute to literature.

Sentinel lymph node mapping versus sentinel lymph node mapping with systematic lymphadenectomy in endometrial cancer: an open-label, non-inferiority, randomized trial (ALICE trial).

BACKGROUND: Growing evidence suggest that sentinel lymph node (SLN) biopsy in endometrial cancer accurately detects lymph node metastasis. However, prospective randomized trials addressing the oncological outcomes of SLN biopsy in endometrial cancer without lymphadenectomy are lacking. PRIMARY OBJECTIVES: The present study aims to confirm that SLN biopsy without systematic node dissection does not negatively impact oncological outcomes. STUDY HYPOTHESIS: We hypothesized that there is no survival benefit in adding systematic lymphadenectomy to sentinel node mapping for endometrial cancer staging. Additionally, we aim to evaluate morbidity and impact in quality of life (QoL) after forgoing systematic lymphadenectomy. TRIAL DESIGN: This is a collaborative, multicenter, open-label, non-inferiority, randomized trial. After total hysterectomy, bilateral salpingo-oophorectomy and SLN biopsy, patients will be randomized (1:1) into: (a) no further lymph node dissection or (b) systematic pelvic and para-aortic lymphadenectomy. MAJOR INCLUSION AND EXCLUSION CRITERIA: Inclusion criteria are patients with high-grade histologies (endometrioid G3, serous, clear cell, and carcinosarcoma), endometrioid G1 or G2 with imaging concerning for myometrial invasion of ≥50% or cervical invasion, clinically suitable to undergo systematic lymphadenectomy. PRIMARY ENDPOINTS: The primary objective is to compare 3-year disease-free survival and the secondary objectives are 5-year overall survival, morbidity, incidence of lower limb lymphedema, and QoL after SLN mapping ± systematic lymphadenectomy in high-intermediate and high-risk endometrial cancer. SAMPLE SIZE: 178 participants will be randomized in this study with an estimated date for completing accrual of December 2024 and presenting results in 2027. TRIAL REGISTRATION NUMBER: NCT03366051.

Open Versus Minimally Invasive Radical Hysterectomy in Cervical Cancer: The CIRCOL Group Study.

PURPOSE: To analyze the survival outcomes of patients in a Brazilian cohort who underwent minimally invasive surgery (MIS) compared with open surgery for early stage cervical cancer. METHODS: A multicenter database was constructed, registering 1280 cervical cancer patients who had undergone radical hysterectomy from 2000 to 2019. For the final analysis, we included cases with a tumor ≤ 4 cm (stages Ia2 to Ib2, FIGO 2018) that underwent surgery from January 2007 to December 2017. Propensity score matching was also performed. RESULTS: A total of 776 cases were ultimately analyzed, 526 of which were included in the propensity score matching analysis (open, n = 263; MIS, n = 263). There were 52 recurrences (9.9%), 28 (10.6%) with MIS and 24 (9.1%) with open surgery (p = 0.55); and 34 deaths were recorded, 13 (4.9%) and 21 (8.0%), respectively (p = 0.15). We noted a 3-year disease-free survival (DFS) rate of 88.2% and 90.3% for those who received MIS and open surgery, respectively (HR 1.32; 95% CI: 0.76-2.29; p = 0.31) and a 5-year overall survival (OS) rate of 91.8% and 91.1%, respectively (HR 0.80; 95% CI: 0.40-1.61; p = 0.53). There was no difference in 3-year DFS rates between open surgery and MIS for tumors ≤ 2 cm (95.7% vs. 90.8%; p = 0.16) or > 2 cm (83.9% vs. 85.4%; p = 0.77). Also, the 5-year OS between open surgery and MIS did not differ for tumors ≤ 2 cm (93.1% vs. 93.6%; p = 0.82) or > 2 cm (88.9% vs. 89.8%; p = 0.35). CONCLUSIONS: Survival outcomes were similar between minimally invasive and open radical hysterectomy in this large retrospective multicenter cohort.

Impact of the COVID-19 Pandemic on Cancer Researchers in 2020: A Qualitative Study of Events to Inform Mitigation Strategies.

Introduction: The COVID-19 pandemic has had an unprecedented impact on global health systems and economies. With ongoing and future challenges posed to the field due to the pandemic, re-examining research priorities has emerged as a concern. As part of a wider project aiming to examine research priorities, here we aimed to qualitatively examine the documented impacts of the COVID-19 pandemic on cancer researchers. Materials and Methods: We conducted a literature review with the aim of identifying non-peer-reviewed journalistic sources and institutional blog posts which qualitatively documented the effects of the COVID-19 pandemic on cancer researchers. We searched on 12th January 2021 using the LexisNexis database and Google, using terms and filters to identify English-language media reports and blogs, containing references to both COVID-19 and cancer research. The targeted search returned 751 results, of which 215 articles met the inclusion criteria. These 215 articles were subjected to a conventional qualitative content analysis, to document the impacts of the pandemic on the field of cancer research. Results: Our analysis yielded a high plurality of qualitatively documented impacts, from which seven categories of direct impacts emerged: (1) COVID measures halting cancer research activity entirely; (2) COVID measures limiting cancer research activity; (3) forced adaptation of research protocols; (4) impacts on cancer diagnosis, cases, and services; (5) availability of resources for cancer research; (6) disruption to the private sector; and (7) disruption to supply chains. Three categories of consequences from these impacts also emerged: (1) potential changes to future research practice; (2) delays to the progression of the field; and (3) potential new areas of research interest. Discussion: The COVID-19 pandemic had extensive practical and economic effects on the field of cancer research in 2020 that were highly plural in nature. Appraisal of cancer research strategies in a post-COVID world should acknowledge the potential for substantial limitations (such as on financial resources, limited access to patients for research, decreased patient access to cancer care, staffing issues, administrative delays, or supply chain issues), exacerbated cancer disparities, advances in digital health, and new areas of research related to the intersection of cancer and COVID-19.

Uterine transposition for gynecological cancers.

OBJECTIVE: Uterine transposition has emerged as an alternative for fertility preservation in women with pelvic malignancies that require radiotherapy. The goal of this study was to evaluate the short-term outcomes of patients undergoing uterine transposition after trachelectomy for cervical cancer or before chemoradiation for vaginal cancer. METHODS: We retrospectively evaluated patients with early stage cervical cancer after radical trachelectomy or with vaginal cancer with indication for pelvic radiation who had uterine transposition performed as fertility sparing strategy. RESULTS: Four patients with cervical cancer and one patient with vaginal cancer were included. Median age was 32 years (range 28-38). All patients had squamous cell carcinomas. All patients with cervical cancer had radical trachelectomies with sentinel lymph node dissection (SLN). Two of these patients also had pelvic lymphadenectomies. Indications for adjuvant radiotherapy was due to Sedlis criteria in two patients and to lymph node metastasis in the other two patients. The patient with stage IIB vaginal cancer was recommended primary chemoradiation. All patients underwent uterine transposition before radiotherapy. The median uterine transposition surgical time was 90 min (range 80-205) and no early complications (30 days) occurred. Average time from uterine transposition to start of radiotherapy was 16 days (10-28). After radiation, the uterus along with the ovaries and tubes were repositioned and the residual cervix sutured to the vagina. One patient declined uterine reimplantation after radiation and underwent a hysterectomy. After a median follow-up of 25 months (range 1-30), all patients were without evidence of disease. All patients with preserved uterus have normal menses after treatment. One patient has attempted to conceive with IVF techniques without success. CONCLUSIONS: Uterine transposition may be an option in selected patients with cervical and vaginal cancers who want to preserve fertility. However, further studies that address its oncological safety and obstetrical outcomes are encouraged.

Surgical versus clinical staging prior to primary chemoradiation in patients with cervical cancer FIGO stages IIB-IVA: oncologic results of a prospective randomized international multicenter (Uterus-11) intergroup study.

OBJECTIVE: Revised staging of patients with locally advanced cervical cancer is based on clinical examination, imaging, and potential surgical findings. A known limitation of imaging techniques is an appreciable rate of understaging. In contrast, surgical staging may provide more accurate information on lymph node involvement. The aim of this prospective study was to evaluate the impact of pre-treatment surgical staging, including removal of bulky lymph nodes, on disease-free survival in patients with locally advanced cervical cancer. METHODS: Uterus-11 was a prospective international multicenter study including patients with locally advanced cervical cancer who were randomized 1:1 to surgical staging (experimental arm) or clinical staging (control arm) followed by primary platinum-based chemoradiation. Patients with histologically proven squamous cell carcinoma, adenocarcinoma, or adenosquamous cancer International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IIB-IVA underwent gynecologic examination and pre-treatment imaging including abdominal computed tomography (CT) and/or abdominal magnetic resonance imaging (MRI). Patients had chest imaging (any of the following: X-ray, CT, or PET-CT). The primary endpoint was disease-free survival and the secondary endpoint was overall survival. An ad hoc analysis was performed after trial completion for cancer-specific survival. Randomization was conducted from February 2009 to August 2013. RESULTS: A total of 255 patients (surgical arm, n=130; clinical arm, n=125) with locally advanced cervical cancer were randomized. Of these, 240 patients were eligible for analysis. The two groups were comparable with respect to patient characteristics. The surgical approach was transperitoneal laparoscopy in most patients (96.6%). Laparoscopic staging led to upstaging in 39 of 120 (33%) patients. After a median follow-up of 90 months (range 1-123) in both arms, there was no difference in disease-free survival between the groups (p=0.084). For patients with FIGO stage IIB, surgical staging is superior to clinical staging with respect to disease-free survival (HR 0.51, 95% CI 0.30 to 0.86, p=0.011). In the post-hoc analysis, surgical staging was associated with better cancer-specific survival (HR 0.61, 95% CI 0.40 to 0.93, p=0.020). CONCLUSION: Our study did not show a difference in disease-free survival between surgical and clinical staging in patients with locally advanced cervical cancer. There was a significant benefit in disease-free survival for patients with FIGO stage IIB and, in a post-hoc analysis, a cancer-specific survival benefit in favor of laparoscopic staging. The high risk of distant metastases in both arms emphasizes the need for further evaluation.

International radical trachelectomy assessment: IRTA study.

BACKGROUND: Radical trachelectomy is considered a viable option for fertility preservation in patients with low-risk, early-stage cervical cancer. Standard approaches include laparotomy or minimally invasive surgery when performing radical trachelectomy. PRIMARY OBJECTIVE: To compare disease-free survival between patients with FIGO (2009) stage IA2 or IB1 (≤2cm) cervical cancer who underwent open versus minimally invasive (laparoscopic or robotic) radical trachelectomy. STUDY HYPOTHESIS: We hypothesize that minimally invasive radical trachelectomy has similar oncologic outcomes to those of the open approach. STUDY DESIGN: This is a collaborative, multi-institutional, international, retrospective study. Patients who underwent a radical trachelectomy and lymphadenectomy between January 1, 2005 and December 31, 2017 will be included. Institutional review board approval will be required. Each institution will be provided access to a study-specific REDCap (Research Electronic Data Capture) database maintained by MD Anderson Cancer Center and will be responsible for entering patient data. INCLUSION CRITERIA: Patients with squamous, adenocarcinoma, or adenosquamous cervical cancer FIGO (2009) stages IA2 and IB1 (≤2 cm) will be included. Surgery performed by the open approach or minimally invasive approach (laparoscopy or robotics). Tumor size ≤2 cm, by physical examination, ultrasound, MRI, CT, or positron emission tomography (at least one should confirm a tumor size ≤2 cm). Centers must contribute at least 15 cases of radical trachelectomy (open, minimally invasive, or both). EXCLUSION CRITERIA: Prior neoadjuvant chemotherapy or radiotherapy to the pelvis for cervical cancer at any time, prior lymphadenectomy, or pelvic retroperitoneal surgery, pregnant patients, aborted trachelectomy (intra-operative conversion to radical hysterectomy), or vaginal approach. PRIMARY ENDPOINT: The primary endpoint is disease-free survival measured as the time from surgery until recurrence or death due to disease. To evaluate the primary objective, we will compare disease-free survival among patients with FIGO (2009) stage IA2 or IB1 (≤2cm) cervical cancer who underwent open versus minimally invasive radical trachelectomy. SAMPLE SIZE: An estimated 535 patients will be included; 256 open and 279 minimally invasive radical trachelectomy. Previous studies have shown that recurrence rates in the open group range from 3.8% to 7.6%. Assuming that the 4.5-year disease-free survival rate for patients who underwent open surgery is 95.0%, we have 80% power to detect a 0.44 HR using α level 0.10. This corresponds to an 89.0% disease-free survival rate at 4.5 years in the minimally invasive group.

Translation and cultural adaptation of the Functional Assessment of Chronic Illness Therapy - Cervical Dysplasia (FACIT-CD) to evaluate quality of life in women with cervical intraepithelial neoplasia.

OBJECTIVE: To translate and perform the cultural adaptation of the tool Functional Assessment of Chronic Illness Therapy - Cervical Dysplasia (FACIT-CD) to the Portuguese language. METHODS: A descriptive cross-sectional study, with translation and cultural adaptation of the assessment tool performed according to international guidelines and the Functional Assessment of Chronic Illness Therapy (FACIT) protocol group. It involved eight experts, six from Brazil, one from Portugal and one from the United States. After translation and back-translation of the tool, the semantic analysis process was carried out. We randomly included 20 women aged between 18 and 70 years with altered cervical cytology exam, seen at the Department of Prevention and Gynecologic Oncology - Hospital de Câncer de Barretos. RESULTS: The sample consisted of women with low education level. In the first pre-test, ten women participated and half of them considered the questions CD1, CD2 and CD3 as difficult, because they did not understand the meaning of the term "pelvic area". The question CD5, "I worry about spreading the infection", was also considered difficult to understand by five women. After the reconsideration of the expert committee and FACIT group, the second pre-test was performed. At this stage, we concluded that the previously raised understanding problems had been solved. CONCLUSION: The translated version of FACIT-CD in universal Portuguese language is equivalent to the original version in English and was easily understood by patients with cervical intraepithelial neoplasia. OBJETIVO: Traduzir e adaptar o instrumento Functional Assessment of Chronic Illness Therapy - Cervical Dysplasia (FACIT-CD), para a língua portuguesa. MÉTODOS: Estudo descritivo, transversal, com metodologia de tradução e adaptação cultural de instrumento de avaliação, realizado por meio de diretrizes internacionais e seguindo o protocolo do grupo Functional Assessment of Chronic Illness Therapy (FACIT). Envolveu oito especialistas, sendo seis nativos do Brasil, um de Portugal e um dos Estados Unidos. Ao término do processo de tradução e retrotradução, deu-se início ao processo de análise semântica. Foram incluídas aleatoriamente 20 mulheres entre 18 e 70 anos com exame de citologia cervical alterado, atendidas no Departamento de Prevenção e Ginecologia Oncológica do Hospital de Câncer de Barretos. RESULTADOS: A amostra foi composta por mulheres com baixa escolaridade. No primeiro pré-teste participaram dez mulheres, sendo que a metade considerou as questões CD1, CD2 e CD3 difíceis por não compreenderem o significado do termo "região pélvica". A questão CD5, "Estou preocupada em disseminar a infecção", também foi considerada de difícil entendimento por cinco mulheres. Após as reconsiderações do comitê de especialistas e do grupo FACIT, foi realizado o segundo pré-teste. Nesta fase, pode-se concluir que os problemas de entendimento anteriores foram resolvidos. CONCLUSÃO: A versão traduzida do FACIT-CD é equivalente à versão original em inglês e em língua portuguesa universal, sendo facilmente compreendida pelas pacientes com neoplasia intraepitelial cervical.

Translation and cultural adaptation of the Functional Assessment of Chronic Illness Therapy - Cervical Dysplasia (FACIT-CD) to evaluate quality of life in women with cervical intraepithelial neoplasia / Tradução e adaptação cultural do Functional Assessment of Chronic Illness Therapy - Cervical Dysplasia (FACIT-CD) para avaliar qualidade de vida em mulheres com neoplasia intraepitelial cervical

ABSTRACT Objective To translate and perform the cultural adaptation of the tool Functional Assessment of Chronic Illness Therapy - Cervical Dysplasia (FACIT-CD) to the Portuguese language. Methods A descriptive cross-sectional study, with translation and cultural adaptation of the assessment tool performed according to international guidelines and the Functional Assessment of Chronic Illness Therapy (FACIT) protocol group. It involved eight experts, six from Brazil, one from Portugal and one from the United States. After translation and back-translation of the tool, the semantic analysis process was carried out. We randomly included 20 women aged between 18 and 70 years with altered cervical cytology exam, seen at the Department of Prevention and Gynecologic Oncology - Hospital de Câncer de Barretos. Results The sample consisted of women with low education level. In the first pre-test, ten women participated and half of them considered the questions CD1, CD2 and CD3 as difficult, because they did not understand the meaning of the term "pelvic area". The question CD5, "I worry about spreading the infection", was also considered difficult to understand by five women. After the reconsideration of the expert committee and FACIT group, the second pre-test was performed. At this stage, we concluded that the previously raised understanding problems had been solved. Conclusion The translated version of FACIT-CD in universal Portuguese language is equivalent to the original version in English and was easily understood by patients with cervical intraepithelial neoplasia.

RESUMO Objetivo Traduzir e adaptar o instrumento Functional Assessment of Chronic Illness Therapy - Cervical Dysplasia (FACIT-CD), para a língua portuguesa. Métodos Estudo descritivo, transversal, com metodologia de tradução e adaptação cultural de instrumento de avaliação, realizado por meio de diretrizes internacionais e seguindo o protocolo do grupo Functional Assessment of Chronic Illness Therapy (FACIT). Envolveu oito especialistas, sendo seis nativos do Brasil, um de Portugal e um dos Estados Unidos. Ao término do processo de tradução e retrotradução, deu-se início ao processo de análise semântica. Foram incluídas aleatoriamente 20 mulheres entre 18 e 70 anos com exame de citologia cervical alterado, atendidas no Departamento de Prevenção e Ginecologia Oncológica do Hospital de Câncer de Barretos. Resultados A amostra foi composta por mulheres com baixa escolaridade. No primeiro pré-teste participaram dez mulheres, sendo que a metade considerou as questões CD1, CD2 e CD3 difíceis por não compreenderem o significado do termo "região pélvica". A questão CD5, "Estou preocupada em disseminar a infecção", também foi considerada de difícil entendimento por cinco mulheres. Após as reconsiderações do comitê de especialistas e do grupo FACIT, foi realizado o segundo pré-teste. Nesta fase, pode-se concluir que os problemas de entendimento anteriores foram resolvidos. Conclusão A versão traduzida do FACIT-CD é equivalente à versão original em inglês e em língua portuguesa universal, sendo facilmente compreendida pelas pacientes com neoplasia intraepitelial cervical.

Variations in gynecologic oncology training in low (LIC) and middle income (MIC) countries (LMICs): Common efforts and challenges.

Gynecologic cancer, cervical cancer in particular, is disproportionately represented in the developing world where mortality is also high. Screening programs, increased availability of chemotherapy, and an awareness of HIV-related cancers have in part accelerated a need for physicians who can treat these cancers, yet the infrastructure for such training is often lacking. In this paper, we address the variations in gynecology oncology training in LMICs as well as the ubiquitous challenges, in an effort to guide future agendas.

Incidence of Histologically Proven Pelvic and Para-Aortic Lymph Node Metastases and Rate of Upstaging in Patients with Locally Advanced Cervical Cancer: Results of a Prospective Randomized Trial.

BACKGROUND: Surgical staging is associated with a significant rate of upstaging compared to clinical/radiological staging in patients with locally advanced cervical cancer. OBJECTIVE: To analyze the stage-specific percentage of pelvic and para-aortic lymph node metastases and the upstaging ratio in a prospective randomized trial (Uterus-11). METHODS: FIGO stage IIB-IVA cervical cancer patients were randomized to surgical staging (arm A) or to clinical staging and primary chemoradiation (arm B). Arm B patients underwent CT-guided biopsy of suspicious para-aortic lymph nodes. Confirmed para-aortic metastasis patients received extended-field radiation therapy. RESULTS: A total of 234 patients were enrolled, including 120 (arm A) and 114 (arm B) treated per protocol. The groups were well balanced. Pelvic and para-aortic lymph node metastases were identified after surgical staging in 51 and 24% of patients, respectively (p < 0.001). Pelvic and para-aortic lymph node metastases were confirmed in 45 and 20% of IIB patients and in 71 and 37% of IIIB patients, respectively. Upstaging occurred in 39/120 (33%) in arm A and in 9/114 (8%) in arm B (p < 0.001). CONCLUSION: The histological results in both groups led to a considerable rate of upstaging. Oncological data from the Uterus-11 study may reveal whether modified therapy translates into a survival benefit.

Pre-treatment MRI minimum apparent diffusion coefficient value is a potential prognostic imaging biomarker in cervical cancer patients treated with definitive chemoradiation.

BACKGROUND: Diffusion Weighted (DW) Magnetic Resonance Imaging (MRI) has been studed in several cancers including cervical cancer. This study was designed to investigate the association of DW-MRI parameters with baseline clinical features and clinical outcomes (local regional control (LRC), disease free survival (DFS) and disease specific survival (DSS)) in cervical cancer patients treated with definitive chemoradiation. METHODS: This was a retrospective study approved by an institutional review board that included 66 women with cervical cancer treated with definitive chemoradiation who underwent pre-treatment MRI at our institution between 2012 and 2013. A region of interest (ROI) was manually drawn by one of three radiologists with experience in pelvic imaging on a single axial CT slice encompassing the widest diameter of the cervical tumor while excluding areas of necrosis. The following apparent diffusion coefficient (ADC) values (×10(-3) mm(2)/s) were extracted for each ROI: Minimum - ADCmin, Maximum - ADCmax, Mean - ADCmean, and Standard Deviation of the ADC - ADCdev. Receiver operating characteristic (ROC) curves were built to choose the most accurate cut off value for each ADC value. Correlation between imaging metrics and baseline clinical features were evaluated using the Mann Whitney test. Confirmatory multi-variate Cox modeling was used to test associations with LRC (adjusted by gross tumor volume - GTV), DFS and DSS (both adjusted by FIGO stage). Kaplan Meyer curves were built for DFS and DSS. A p-value < 0.05 was considered significant. Women median age was 52 years (range 23-90). 67 % had FIGO stage I-II disease while 33 % had FIGO stage III-IV disease. Eighty-two percent had squamous cell cancer. Eighty-eight percent received concurrent cisplatin chemotherapy with radiation. Median EQD2 of external beam and brachytherapy was 82.2 Gy (range 74-84). RESULTS: Women with disease staged III-IV (FIGO) had significantly higher mean ADCmax values compared with those with stage I-II (1.806 (0.4) vs 1.485 (0.4), p = 0.01). Patients with imaging defined positive nodes also had significantly higher mean (±SD) ADCmax values compared with lymph node negative patients (1.995 (0.3) vs 1.551 (0.5), p = 0.03). With a median follow-up of 32 months (range 5-43) 11 patients (17 %) have developed recurrent disease and 8 (12 %) have died because of cervical cancer. ROC curves based on DSS showed optimal cutoffs for ADCmin (0.488 × 10(-3)), ADCmean (0.827 × 10(-3)), ADCmax (1.838 × 10(-3)) and ADCdev (0.148 × 10(-3)). ADCmin higher than the cutoff was significantly associated with worse DFS (HR = 3.632-95 % CI: 1.094-12.054; p = 0.035) and DSS (HR = 4.401-95 % CI: 1.048-18.483; p = 0.043). CONCLUSION: Pre-treatment ADCmax measured in the primary tumor may be associated with FIGO stage and lymph node status. Pre-treatment ADCmin may be a prognostic factor associated with disease-free survival and disease-specific survival in cervical cancer patients treated with definitive chemoradiation. Prospective validation of these findings is currently ongoing.

Laparoscopic Vaginal-Assisted Nerve-Sparing Radical Trachelectomy.

STUDY OBJECTIVE: To demonstrate a laparoscopic vaginal-assisted nerve-sparing radical trachelectomy. DESIGN: An edited educational video, including a step-by-step description of the procedure. SETTING: Radical trachelectomy is the main surgical indication for selected cases of initial cervical cancer with a fertility-sparing approach. Although transvaginal access is the most traditional route, this technique has not gained widespread acceptance because of the complexity of the ureteral dissection and the limited amount of resected parametrial tissue. This video describes a laparoscopic technique including an adequate parametrial resection with autonomic preservation (C1 level) and a standard laparoscopic ureteric dissection under direct visualization. All parametrial dissections were performed by laparoscopy using a nerve-sparing technique. The uterine vessels were well dissected and transected at their origin. The colpotomy was performed by laparoscopy with a 1-cm vaginal margin using a monopolar energy hook. To achieve an adequate endocervical margin and to avoid thermal injury to the endocervix, the cervical section was performed transvaginally with a cold knife. The specimen was then retrieved, and a segment of the remaining cervix was removed for frozen section analysis. If the margin was free of tumor, the cervical-vaginal anastomosis was performed transvaginally. An endocervical device was placed to avoid postoperative cervical stenosis. INTERVENTIONS: Laparoscopic vaginal-assisted nerve-sparing radical trachelectomy. CONCLUSION: This video demonstrates a reproducible laparoscopic technique for radical trachelectomy with a nerve-sparing technique. The vaginal route was used at the moment of sectioning the cervix/isthmus to permit adequate margin evaluation.

Laparoscopy in uterine cervical cancer. Current state and literature review.

Cervical cancer remains the most frequent gynecological tumor in Brazil and other developing countries. Minimally invasive techniques, especially laparoscopy, have been increasingly employed in such tumors. This article aims to describe the main applications of laparoscopy in the treatment and staging of cervical cancer. In the early stages, it is possible to provide a fertility-preserving surgery in the form of radical trachelectomy and, in a study protocol, the function-preserving surgery, avoiding parametrectomy and the associated morbidity. A fully laparoscopic radical hysterectomy is fairly standard in the literature and has the tendency to become the standard of care in early cases, for patients who want to bear no more children. In advanced stages, minimally invasive surgery can offer ovarian transposition, with intent to prevent actinic castration, without upsetting the time for the start of radiotherapy and chemotherapy. Staging laparoscopic surgery, including pelvic and para-aortic lymphadenectomy, has been the subject of studies, since it has the potential to modify the extension of radiotherapy depending on the extent of lymph node spread.