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BACKGROUND: Obstetric and gynecological (OBGYN) surgery is becoming increasingly complex due to an aging population with increasing rates of medical comorbidities and obesity. Complications are therefore common, and impact not only the patient but can also cause distress to the OBGYN surgeon as a "second victim". OBJECTIVE: The objective of our study was to describe and quantify the range of impacts of complications on OBGYN surgeons and assess sociodemographic, clinician and practice factors associated with such impact. STUDY DESIGN: A cross-sectional survey was developed based on interviews with OBGYNs and a review of the literature. The survey assessed OBGYN's demographic, clinical and practice characteristics, estimated number of complications per year, distress, physical and mental health, sleep, relationship impact caused by complications, and explored strategies OBGYNs used to cope with complications. Univariate logistic regression analyses were used to determine the association between OBGYNs characteristics, and complication consequences. RESULTS: Overall, of 727 survey respondents, 431 (61%) were female, 384 (55%) were 50 years or older, almost half had worked as OBGYN for 15 years or more (329 (45%)), and 527 (73%) usually complete fewer than 10 surgical procedures per week. Most (568 (78%)) reported fewer than three surgical complications per year, and most (472 (66%)) thought this was similar or less than their colleagues. Complications caused most stress when they resulted in poor patient outcomes (653 (90%)), had severe patient consequences (630 (87%)) or were a result of surgeon error (627 (86%)). Complications impacted the majority of OBGYN's wellbeing and sleep. A greater proportion of those younger than 50 years old reported that their mental wellbeing (32(10%), p=0.002) and sleep (130(42%), p=0.03) were affected when a complication occurred. Females were also more likely to report that their physical health (14(3%), p=<0.001), mental health (39(9%), p=0.01) and sleep (183(43%), p=<0.001) were affected. Current trainees (11(10%)) and surgeons with less than 15 years of experience (25(9%)) were more likely to experience mental wellbeing consequences when compared to surgeons of ≥15 years experience (12(4%))(p=0.01). Females reported less willingness to interact with colleagues when complications occurred (323(75%), p=0.006) and surgeons with less than 15 years of training were less likely to report comfort in talking (221(74%), p=0.03) and interacting with others (212(74%), p=0.02). CONCLUSION: The vast majority of OBGYN experience major impact on their health and wellbeing when one of their patients develops a complication. The degree and type of impact reported is similar to those experienced by other surgical specialties. Future studies are needed that test interventions to alleviate the significant impact and follow OBGYNs longitudinally to understand how long the impact of complications lasts.
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OBJECTIVE: To test the hypothesis that mismatch repair (MMR) status (as an accurate surrogate marker for microsatellite stability) modifies the effect of surgical approach on oncological outcome for apparent early-stage endometrial cancer. METHODS: Observational data from a large prospective population study on endometrial cancer were analyzed using target trial methodology and doubly robust methods, including propensity score matching and adjusted regression analyses. Laparoscopy was compared with laparotomy, stratified by MMR status on outcomes of recurrence and site, and recurrence-free, overall, and disease-specific survival. RESULTS: After matching, there were 400 patients for analysis, with 200 in each treatment group. The mean age was 62 years and mean body mass index was 32 kg/m2. Most patients had early-stage disease (stage I n=362 (90%)) and endometrioid histology (n=363 (91%)). Adjuvant pelvic radiation was administered to 11%, adjuvant vaginal brachytherapy to 13% and adjuvant chemotherapy to 5% of patients. Five-year recurrence-free survival did not differ significantly between modes of surgery across the cohort (p=0.7) or within MMR strata (MMR-proficient p=0.9, MMR-deficient p=0.6). Similarly, there was no significant difference in overall or disease-specific survival by mode of surgery across the cohort or within MMR strata. There was no significant difference in the HR for recurrence for those treated with laparoscopy stratified by MMR status (MMR-proficient HR=0.99 (95% CI 0.28 to 3.58); MMR-deficient HR=0.83 (95% CI 0.24 to 2.87)), even when restricted to endometrioid subtype. CONCLUSION: In this study, there was no evidence of a difference in survival outcomes according to mode of surgery and MMR status.
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Neoplasias Encefálicas , Neoplasias Colorretais , Reparo de Erro de Pareamento de DNA , Neoplasias do Endométrio , Síndromes Neoplásicas Hereditárias , Feminino , Humanos , Pessoa de Meia-Idade , Estudos Prospectivos , Estadiamento de Neoplasias , Endométrio/patologia , Neoplasias do Endométrio/genética , Neoplasias do Endométrio/cirurgiaRESUMO
OBJECTIVE: To review rates of uterine preservation and gonadal function, surgical outcomes, and pregnancy outcomes in patients undergoing surgical uterine transposition. METHODS: A structured search and analysis of the published literature on uterine transposition was conducted. Information on study type, sample size, patient characteristics, clinical indications, details of the surgical technique, trans-operative and post-operative results, success rates in preserving reproductive organ function and fertility were extracted. RESULTS: A total of 18 cases were reported to date. Patients' median age was 29 (range 3-38) years. Rectal cancers accounted for 9 (50%) cases of published cases of uterine transposition, followed by 6 (33%) cervical squamous cell carcinomas, 1 (6%) vaginal squamous cell carcinoma, 1 (6%) sacral yolk sac tumor, and 1 (6%) pelvic liposarcoma. The median time for uterine transposition to the upper abdomen was 150 (range 80-360) min, and 90 (range 80-310) min for organ reimplantation in the pelvis. Cervical ischemia occurred in 5 (27.8%) cases, being the most commonly reported complication. The median follow-up time was 25 months, and three patients achieved spontaneous pregnancies resulting in successful gestations, out of five patients who were reported as having tried. One patient experienced recurrence and succumbed to the tumor during treatment. CONCLUSIONS: Uterine transposition is a feasible and safe surgical approach that offers patients undergoing pelvic radiotherapy an option to preserve gonadal and uterine function, with the potential for spontaneous pregnancy.
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Carcinoma de Células Escamosas , Preservação da Fertilidade , Neoplasias Pélvicas , Neoplasias Retais , Feminino , Gravidez , Humanos , Pré-Escolar , Criança , Adolescente , Adulto Jovem , Adulto , Neoplasias Pélvicas/cirurgia , Útero , PelveRESUMO
OBJECTIVE: The purpose of this study was to establish a consensus on the surgical technique for sentinel lymph node (SLN) dissection in cervical cancer. METHODS: A 26 question survey was emailed to international expert gynecological oncology surgeons. A two-step modified Delphi method was used to establish consensus. After a first round of online survey, the questions were amended and a second round, along with semistructured interviews was performed. Consensus was defined using a 70% cut-off for agreement. RESULTS: Twenty-five of 38 (65.8%) experts responded to the first and second rounds of the online survey. Agreement ≥70% was reached for 13 (50.0%) questions in the first round and for 15 (57.7%) in the final round. Consensus agreement identified 15 recommended, three optional, and five not recommended steps. Experts agreed on the following recommended procedures: use of indocyanine green as a tracer; superficial (with or without deep) injection at 3 and 9 o'clock; injection at the margins of uninvolved mucosa avoiding vaginal fornices; grasping the cervix with forceps only in part of the cervix is free of tumor; use of a minimally invasive approach for SLN biopsy in the case of simple trachelectomy/conization; identification of the ureter, obliterated umbilical artery, and external iliac vessels before SLN excision; commencing the dissection at the level of the uterine artery and continuing laterally; and completing dissection in one hemi-pelvis before proceeding to the contralateral side. Consensus was also reached in recommending against injection at 6 and 12 o'clock, and injection directly into the tumor in cases of the tumor completely replacing the cervix; against removal of nodes through port without protective maneuvers; absence of an ultrastaging protocol; and against modifying tracer concentration at the time of re-injection after mapping failure. CONCLUSION: Recommended, optional, and not recommended steps of SLN dissection in cervical cancer have been identified based on consensus among international experts. These represent a surgical guide that may be used by surgeons in clinical trials and for quality assurance in routine practice.
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Neoplasias do Colo do Útero , Feminino , Humanos , Neoplasias do Colo do Útero/cirurgia , Neoplasias do Colo do Útero/patologia , Metástase Linfática/patologia , Consenso , Excisão de Linfonodo/métodos , Biópsia de Linfonodo Sentinela/métodos , Verde de Indocianina , Linfonodos/patologiaRESUMO
BACKGROUND: It is widely accepted total laparoscopic hysterectomy (TLH) and vaginal hysterectomy are less invasive procedures compared to total abdominal hysterectomy (TAH). However, rates of TAH remain unreasonably high. AIM: To pilot-test a model of training for practising obstetricians and gynaecologists (O&Gs) in TLH. MATERIALS AND METHODS: Training of participating O&Gs was conducted across four hospitals in Queensland, Australia, while other O&Gs were observed as contemporary controls. Type of hysterectomy, details of the surgery, including adverse events, were collected from hospital medical records. RESULTS: Eleven O&Gs completed the pre-intervention and intervention training periods, and nine completed the post-intervention follow-up. TLH rates increased from 24% prior to 75% during and 68% after intervention. Overall, the uptake rate of TLH showed a two-fold increase during the intervention period (2.08, 95% CI: 1.16-8.56, P < 0.001) and a 12% increase was retained during the follow-up period (1.12, 95% CI: 0.54-4.02, P = 0.427). Pre-intervention, across all sites, 24% of hysterectomies were performed via TAH by the participating specialist trainees, which decreased to 13% during the intervention and 14% during follow-up. The rate of adverse events decreased from 13.5% at pre-intervention, to 6.4% during and 4.2% post-intervention. By comparison, no change in surgical approach or rate of adverse events was observed in the control group. CONCLUSIONS: The implementation of a formal and structured surgical training program teaching TLH resulted in important benefits to trainees, patients and society in the four trial hospitals.
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Laparoscopia , Feminino , Humanos , Estudos de Viabilidade , Histerectomia/métodos , Histerectomia Vaginal , Laparoscopia/métodos , Projetos Piloto , Complicações Pós-Operatórias , Estudos RetrospectivosRESUMO
OBJECTIVE: The "intermediate-risk" (IR) group of early-stage cervical cancer patients is characterized by negative pelvic lymph nodes and a combination of tumor-related prognostic risk factors such as tumor size ≥2 cm, lymphovascular space invasion (LVSI), and deep stromal invasion. However, the role of adjuvant treatment in these patients remains controversial. We investigated whether adjuvant (chemo)radiation is associated with a survival benefit after radical surgery in patients with IR cervical cancer. METHODS: We analyzed data from patients with IR cervical cancer (tumor size 2-4 cm plus LVSI OR tumor size >4 cm; N0; no parametrial invasion; clear surgical margins) who underwent primary curative-intent surgery between 2007 and 2016 and were retrospectively registered in the international multicenter Surveillance in Cervical CANcer (SCCAN) study. RESULTS: Of 692 analyzed patients, 274 (39.6%) received no adjuvant treatment (AT-) and 418 (60.4%) received radiotherapy or chemoradiotherapy (AT+). The 5-year disease-free survival (83.2% and 80.3%; PDFS = 0.365) and overall survival (88.7% and 89.0%; POS = 0.281) were not significantly different between the AT- and AT+ groups, respectively. Adjuvant (chemo)radiotherapy was not associated with a survival benefit after adjusting for confounding factors by case-control propensity score matching or in subgroup analyses of patients with tumor size ≥4 cm and <4 cm. In univariable analysis, adjuvant (chemo)radiotherapy was not identified as a prognostic factor in any of the subgroups (full cohort: PDFS = 0.365; POS = 0.282). CONCLUSION: Among patients with IR early-stage cervical cancer, radical surgery alone achieved equal disease-free and overall survival rates to those achieved by combining radical surgery with adjuvant (chemo)radiotherapy.
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Neoplasias do Colo do Útero , Feminino , Humanos , Neoplasias do Colo do Útero/patologia , Estadiamento de Neoplasias , Histerectomia , Terapia Combinada , Prognóstico , Radioterapia Adjuvante , Estudos RetrospectivosRESUMO
PURPOSE: To systematically synthesise evidence of exercise intervention efficacy for physical/psychosocial outcomes that matter to women during/following treatment for gynaecological cancer. METHODS: Five databases were searched (PubMed, EMBASE, CINAHL, PsychInfo, Scopus). Exercise-only intervention studies that included women during/ following treatment for any gynaecological cancer, with/ without control comparison, on any physical or psychosocial outcome(s), were included and qualitatively appraised using the Revised Cochrane Risk of Bias tool and a modified Newcastle-Ottawa Scale. RESULTS: Seven randomised controlled trials (RCTs), three single-arm pre-post studies, and one prospective cohort study satisfied were included (11 studies). Most studies were completed following treatment (91%), included combined (aerobic and resistance; 36%) and aerobic (36%) training, were fully/mostly (63%) unsupervised, and had a moderate-to-high risk of bias. Overall, 33 outcomes (64% objectively-measured) were assessed. Improvements were observed in aerobic capacity (VÌO2 Peak +1.6 mL/kg/min, 6-minute walk distance +20-27 m), lower- (30-second sit-to-stand +2-4 repetitions) and upper-limb strength (30-second arm curl +5 repetitions; 1RM grip strength/chest press +2.4-3.1 kg), and agility (timed up-and-go -0.6 seconds). However, changes in quality of life, anthropometry/body composition, balance and flexibility were inconsistent. There was no evidence to support worsening of outcomes. CONCLUSION: Preliminary research into the role of exercise post-gynaecological cancer suggests an improvement in exercise capacity, muscular strength, and agility which, in the absence of exercise, typically decline following gynaecological cancer. Future exercise trials involving larger and more diverse gynaecological cancer samples will improve understanding of the potential and magnitude of effect of guideline-recommended exercise on outcomes that matter to patients.
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Exercício Físico , Neoplasias , Feminino , Humanos , Neoplasias/terapia , Força Muscular , Tolerância ao Exercício , Qualidade de Vida , Terapia por ExercícioRESUMO
PURPOSE OF REVIEW: To discuss the benefits of centralization of gynaecological cancer care on patients and the healthcare system and how to overcome its barriers. RECENT FINDINGS: Evidence demonstrates that adherence to clinical practice management guidelines is more likely; the risk of adverse events is lower; survival is improved; in young women fertility preservation is higher; and cost effectiveness is higher; in systems that employ centralized care for women with gynaecological cancer. Barriers to the uptake of centralized models include knowledge, attitude as well as deficient systems and processes, including a lack of governance and leadership. Collaborative centralization refers to a model that sees both elements (centralization and treatment closer to home) utilized at the patient level that addresses some of the barriers of centralized gynaecological cancer care. SUMMARY: Evidence supports centralized gynaecological cancer care, as it results in reduced risks of adverse events, improved survival and higher fertility rates at lower cost to funders. Collaborative centralization is a process that considers both the value of centralization and collaboration amongst healthcare professionals at primary, secondary and tertiary levels of healthcare to benefit patient outcomes.
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Preservação da Fertilidade , Neoplasias dos Genitais Femininos , Feminino , Neoplasias dos Genitais Femininos/terapia , HumanosRESUMO
OBJECTIVES: Knowledge on the course of symptoms patients with ovarian cancer experience is limited. We documented the prevalence and trajectories of symptoms after first-line chemotherapy using the Measure of Ovarian Symptoms and Treatment concerns (MOST). METHODS: A total of 726 patients who received platinum-based chemotherapy for ovarian cancer were asked to complete the MOST every 3â¯months, beginning 6â¯months post-diagnosis and continuing for up to 4â¯years. We used descriptive statistics to examine temporal changes in MOST-S26 index scores for disease or treatment-related (MOST-DorT), neurotoxicity (MOST-NTx), abdominal (MOST-Abdo), and psychological (MOST-Psych) symptoms, and wellbeing (MOST-Wellbeing) and selected individual symptoms. We used group-based trajectory models to identify groups with persistently poor symptoms. RESULTS: The median MOST-Abdo, MOST-DorT and MOST-Wellbeing score were worst at chemotherapy-end but improved and stabilised by 1, 3 and 12â¯months after treatment, respectively. The median MOST-NTx score peaked at 1â¯month after treatment before improving, while the median MOST-Psych score did not change substantially over time. Long-term moderate-to-severe fatigue (32%), trouble sleeping (31%), sore hands and feet (21%), pins and needles (20%) and anxiety (18%) were common. Trajectory models revealed groups of patients with persistent symptoms had MOST-DorT scores above 30 and MOST-NTx scores above 40 at treatment-end. CONCLUSIONS: Although many patients report improvements in symptoms by 3â¯months after first-line chemotherapy for ovarian cancer, patients who scoreâ¯>â¯30/100 on MOST-S26-DorT orâ¯>â¯40/100 on MOST-S26-NTx at the end of chemotherapy are likely to have persistent symptoms. The MOST could triage this at-risk subset for early intervention.
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Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Carcinoma Epitelial do Ovário/tratamento farmacológico , Comprometimento Cognitivo Relacionado à Quimioterapia/fisiopatologia , Fadiga/fisiopatologia , Neoplasias Císticas, Mucinosas e Serosas/tratamento farmacológico , Neoplasias Ovarianas/tratamento farmacológico , Doenças do Sistema Nervoso Periférico/fisiopatologia , Distúrbios do Início e da Manutenção do Sono/fisiopatologia , Idoso , Ansiedade/psicologia , Carboplatina/administração & dosagem , Carcinoma Epitelial do Ovário/patologia , Quimioterapia Adjuvante , Comprometimento Cognitivo Relacionado à Quimioterapia/etiologia , Comprometimento Cognitivo Relacionado à Quimioterapia/psicologia , Procedimentos Cirúrgicos de Citorredução , Fadiga/induzido quimicamente , Fadiga/psicologia , Feminino , Humanos , Efeitos Adversos de Longa Duração , Estudos Longitudinais , Pessoa de Meia-Idade , Terapia Neoadjuvante , Neoplasias Císticas, Mucinosas e Serosas/patologia , Neoplasias Ovarianas/patologia , Paclitaxel/administração & dosagem , Medidas de Resultados Relatados pelo Paciente , Doenças do Sistema Nervoso Periférico/induzido quimicamente , Doenças do Sistema Nervoso Periférico/psicologia , Distúrbios do Início e da Manutenção do Sono/induzido quimicamente , Distúrbios do Início e da Manutenção do Sono/psicologiaRESUMO
OBJECTIVE: Women with ovarian cancer who have a pathogenic germline variant in BRCA1 or BRCA2 (BRCA) have been shown to have better 5-year survival after diagnosis than women who are BRCA-wildtype (non-carriers). Modifiable lifestyle factors, including smoking, physical activity and body mass index (BMI) have previously been associated with ovarian cancer survival; however, it is unknown whether these associations differ by germline BRCA status. METHODS: We investigated measures of lifestyle prior to diagnosis in two cohorts of Australian women with invasive epithelial ovarian cancer, using Cox proportional hazards regression to calculate adjusted hazard ratios (HRs) and 95% confidence intervals (CIs). RESULTS: In the combined studies (n = 1923), there was little association between physical activity, BMI or alcohol intake and survival, and no difference by BRCA status. However, the association between current smoking status before diagnosis and poorer survival was stronger for BRCA variant carriers (HR 1.98; 95% CI 1.20-3.27) than non-carriers (HR 1.18; 95% CI 0.96-1.46; p-interaction 0.02). We saw a similar differential association with smoking when we pooled results from two additional cohorts from the USA and UK (n = 2120). Combining the results from all four studies gave a pooled-HR of 1.94 (95% CI 1.28-2.94) for current smoking among BRCA variant carriers compared to 1.08 (0.90-1.29) for non-carriers. CONCLUSIONS: Our results suggest that the adverse effect of smoking on survival may be stronger for women with a BRCA variant than those without. Thus, while smoking cessation may improve outcomes for all women with ovarian cancer, it might provide a greater benefit for BRCA variant carriers.
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Genes BRCA2 , Neoplasias Ovarianas , Austrália/epidemiologia , Proteína BRCA1/genética , Proteína BRCA2/genética , Carcinoma Epitelial do Ovário/genética , Feminino , Genes BRCA1 , Células Germinativas , Mutação em Linhagem Germinativa , Humanos , Estilo de Vida , Neoplasias Ovarianas/genética , Fumar/efeitos adversos , Fumar/epidemiologiaRESUMO
BACKGROUND: Up to 26% of patients with early-stage cervical cancer experience relapse after primary surgery. However, little is known about which factors influence prognosis following disease recurrence. Therefore, our aims were to determine post-recurrence disease-specific survival (PR-DSS) and to identify respective prognostic factors for PR-DSS. METHODS: Data from 528 patients with early-stage cervical cancer who relapsed after primary surgery performed between 2007 and 2016 were obtained from the SCANN study (Surveillance in Cervical CANcer). Factors related to the primary disease and recurrence were combined in a multivariable Cox proportional hazards model to predict PR-DSS. RESULTS: The 5-year PR-DSS was 39.1% (95% confidence interval [CI] 22.7%-44.5%), median disease-free interval between primary surgery and recurrence (DFI1) was 1.5 years, and median survival after recurrence was 2.5 years. Six significant variables were identified in the multivariable analysis and were used to construct the prognostic model. Two were related to primary treatment (largest tumour size and lymphovascular space invasion) and four to recurrence (DFI1, age at recurrence, presence of symptoms, and recurrence type). The C-statistic after 10-fold cross-validation of prognostic model reached 0.701 (95% CI 0.675-0.727). Three risk-groups with significantly differing prognoses were identified, with 5-year PR-DSS rates of 81.8%, 44.6%, and 12.7%. CONCLUSIONS: We developed the robust model of PR-DSS to stratify patients with relapsed cervical cancer according to risk profiles using six routinely recorded prognostic markers. The model can be utilised in clinical practice to aid decision-making on the strategy of recurrence management, and to better inform the patients.
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Adenocarcinoma/mortalidade , Carcinoma Adenoescamoso/mortalidade , Carcinoma Neuroendócrino/mortalidade , Carcinoma de Células Escamosas/mortalidade , Recidiva Local de Neoplasia/mortalidade , Neoplasias do Colo do Útero/mortalidade , Adenocarcinoma/patologia , Adenocarcinoma/fisiopatologia , Adenocarcinoma/terapia , Adulto , Doenças Assintomáticas , Carcinoma Adenoescamoso/patologia , Carcinoma Adenoescamoso/fisiopatologia , Carcinoma Adenoescamoso/terapia , Carcinoma Neuroendócrino/patologia , Carcinoma Neuroendócrino/fisiopatologia , Carcinoma Neuroendócrino/terapia , Carcinoma de Células Escamosas/patologia , Carcinoma de Células Escamosas/fisiopatologia , Carcinoma de Células Escamosas/terapia , Quimioterapia Adjuvante , Feminino , Humanos , Histerectomia , Linfonodos/patologia , Pessoa de Meia-Idade , Análise Multivariada , Recidiva Local de Neoplasia/patologia , Recidiva Local de Neoplasia/fisiopatologia , Recidiva Local de Neoplasia/terapia , Estadiamento de Neoplasias , Prognóstico , Modelos de Riscos Proporcionais , Radioterapia Adjuvante , Taxa de Sobrevida , Traquelectomia , Carga Tumoral , Neoplasias do Colo do Útero/patologia , Neoplasias do Colo do Útero/fisiopatologia , Neoplasias do Colo do Útero/terapiaRESUMO
OBJECTIVE: To determine the role of vaginal vault cytology as a surveillance tool for the detection of recurrence in patients with early stage cervical cancer treated with hysterectomy without adjuvant therapy. METHODS: A retrospective cohort study was conducted of all women with cervical cancer treated with a hysterectomy from January 2000 to July 2016 at the Royal Brisbane & Women's Hospital, Australia. Women included were diagnosed with the equivalent of International Federation of Gynecology and Obstetrics (FIGO) 2018 stage 1A1 to 1B3 squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, received either simple or radical hysterectomy with or without pelvic lymph node dissection, and did not receive adjuvant therapy. Age, stage, histology, surgical procedure, and details of individual surveillance regimens including examination findings and indications and results for all vault cytology tests performed in the first 5 years following surgical management were collected. RESULTS: A total of 155 women met the inclusion criteria. Most cases were FIGO 2018 stage 1B1 (61.9%) and squamous cell carcinoma (64.5%). Included women underwent a median of 80 months of surveillance (range 25-200, IQR 64-108). In the first 5 years of surveillance, there were a total of 1001 vault cytology smears performed, with a median of 6 smears (IQR 5-9) per woman. A total of 19 smears were abnormal (1.9%). Of the cohort of 155 women, 19 (12.3%) had an abnormality detected; 1 (0.65%) had a high-grade intraepithelial abnormality and 2 (1.3%) had recurrences detected on cytology; however, a lesion was also seen and biopsied in all three women. A total of 16 of 1001 smears (1.6%) had low-grade abnormalities detected, all of which resolved with clinical observation only. All were alive and well at last review. There were in total 6 (3.9%) recurrences, 2 (33%) of which had abnormal cytology as above, and all of which had a lesion to biopsy and/or abnormal medical imaging. CONCLUSIONS: The routine use of vaginal vault cytology in surveillance following hysterectomy for early stage cervical cancer did not appear to alter the detection of recurrent malignancy.
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Carcinoma de Células Escamosas , Neoplasias do Colo do Útero , Carcinoma de Células Escamosas/diagnóstico , Carcinoma de Células Escamosas/epidemiologia , Carcinoma de Células Escamosas/cirurgia , Pré-Escolar , Feminino , Humanos , Histerectomia , Recidiva Local de Neoplasia/diagnóstico , Recidiva Local de Neoplasia/cirurgia , Estudos Retrospectivos , Neoplasias do Colo do Útero/diagnóstico , Neoplasias do Colo do Útero/patologia , Neoplasias do Colo do Útero/cirurgia , Esfregaço VaginalRESUMO
BACKGROUND: Physical symptoms, anxiety, depression, fear of recurrence, sexual dysfunction, and social withdrawal are common in women after treatment for ovarian cancer. Most patients would like and need help dealing with these symptoms. The traditional model of follow-up care is unstructured and largely focused on diagnosing recurrent disease, and most oncologists lack skills to identify and manage psychosocial issues. No high quality prospective clinical trials have been conducted to determine the optimal follow-up regimen or the cost effectiveness of ovarian cancer surveillance strategies. PRIMARY OBJECTIVES: To assess emotional wellbeing, acceptability, safety, and cost effectiveness of nurse led follow-up via telehealth for women with ovarian cancer following completion of primary treatment. STUDY HYPOTHESIS: We hypothesize that compared with routine clinic based follow-up, nurse led follow-up via telehealth, including serum CA125 monitoring and completion of a patient reported outcome instrument, the Measure of Ovarian Symptoms and Treatment concerns-Surveillance (MOST-S26), will improve emotional wellbeing in women with ovarian cancer; be feasible, safe, acceptable, and not delay the time to diagnosis of recurrent disease; will result in greater patient satisfaction; will identify more patients with psychological distress, lead to better care, and improved psychological outcomes; and be cost-effective. TRIAL DESIGN: Phase II multicenter randomized trial comparing 3 monthly nurse led telehealth consultations that include serum CA125 monitoring and completion of the MOST-S26, with routine clinic based follow-up. The allocation ratio will be 1:1. MAJOR INCLUSION/EXCLUSION CRITERIA: Eligible patients will be women with high grade epithelial ovarian cancer who have normalized serum CA125 (to <35 kU/L) at completion of first line chemotherapy. PRIMARY ENDPOINTS: Emotional wellbeing at 12 months. SAMPLE SIZE: 150 patients. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: July 2023. Results expected in 2025, 24 months after the last participant is enrolled. TRIAL REGISTRATION: ACTRN12620000332921.
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Neoplasias Ovarianas , Telemedicina , Carcinoma Epitelial do Ovário , Feminino , Seguimentos , Humanos , Papel do Profissional de Enfermagem , Neoplasias Ovarianas/tratamento farmacológico , Medidas de Resultados Relatados pelo Paciente , Estudos ProspectivosRESUMO
BACKGROUND: There are limited data from retrospective studies regarding whether survival outcomes after laparoscopic or robot-assisted radical hysterectomy (minimally invasive surgery) are equivalent to those after open abdominal radical hysterectomy (open surgery) among women with early-stage cervical cancer. METHODS: In this trial involving patients with stage IA1 (lymphovascular invasion), IA2, or IB1 cervical cancer and a histologic subtype of squamous-cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, we randomly assigned patients to undergo minimally invasive surgery or open surgery. The primary outcome was the rate of disease-free survival at 4.5 years, with noninferiority claimed if the lower boundary of the two-sided 95% confidence interval of the between-group difference (minimally invasive surgery minus open surgery) was greater than -7.2 percentage points (i.e., closer to zero). RESULTS: A total of 319 patients were assigned to minimally invasive surgery and 312 to open surgery. Of the patients who were assigned to and underwent minimally invasive surgery, 84.4% underwent laparoscopy and 15.6% robot-assisted surgery. Overall, the mean age of the patients was 46.0 years. Most patients (91.9%) had stage IB1 disease. The two groups were similar with respect to histologic subtypes, the rate of lymphovascular invasion, rates of parametrial and lymph-node involvement, tumor size, tumor grade, and the rate of use of adjuvant therapy. The rate of disease-free survival at 4.5 years was 86.0% with minimally invasive surgery and 96.5% with open surgery, a difference of -10.6 percentage points (95% confidence interval [CI], -16.4 to -4.7). Minimally invasive surgery was associated with a lower rate of disease-free survival than open surgery (3-year rate, 91.2% vs. 97.1%; hazard ratio for disease recurrence or death from cervical cancer, 3.74; 95% CI, 1.63 to 8.58), a difference that remained after adjustment for age, body-mass index, stage of disease, lymphovascular invasion, and lymph-node involvement; minimally invasive surgery was also associated with a lower rate of overall survival (3-year rate, 93.8% vs. 99.0%; hazard ratio for death from any cause, 6.00; 95% CI, 1.77 to 20.30). CONCLUSIONS: In this trial, minimally invasive radical hysterectomy was associated with lower rates of disease-free survival and overall survival than open abdominal radical hysterectomy among women with early-stage cervical cancer. (Funded by the University of Texas M.D. Anderson Cancer Center and Medtronic; LACC ClinicalTrials.gov number, NCT00614211 .).
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Histerectomia/métodos , Procedimentos Cirúrgicos Minimamente Invasivos , Neoplasias do Colo do Útero/cirurgia , Adenocarcinoma/mortalidade , Adenocarcinoma/cirurgia , Adulto , Carcinoma Adenoescamoso/mortalidade , Carcinoma Adenoescamoso/cirurgia , Carcinoma de Células Escamosas/mortalidade , Carcinoma de Células Escamosas/cirurgia , Intervalo Livre de Doença , Feminino , Humanos , Pessoa de Meia-Idade , Recidiva Local de Neoplasia , Estadiamento de Neoplasias , Estudos Prospectivos , Taxa de Sobrevida , Neoplasias do Colo do Útero/mortalidade , Neoplasias do Colo do Útero/patologiaRESUMO
PURPOSE: Intrauterine levonorgestrel (LNG-IUD) is used to treat patients with endometrial adenocarcinoma (EAC) and endometrial hyperplasia with atypia (EHA) but limited evidence is available on its effectiveness. The study determined the extent to which LNG-IUD with or without metformin (M) or weight loss (WL) achieves a pathological complete response (pCR) in patients with EAC or EHA. PATIENTS AND METHODS: This phase II randomized controlled clinical trial enrolled patients with histologically confirmed, clinically stage 1 FIGO grade 1 EAC or EHA; a body mass index > 30 kg/m2; a depth of myometrial invasion of less than 50% on MRI; a serum CA125 ≤ 30 U/mL. All patients received LNG-IUD and were randomized to observation (OBS), M (500 mg orally twice daily), or WL (pooled analysis). The primary outcome measure was the proportion of patients developing a pCR (defined as absence of any evidence of EAC or EHA) after 6 months. RESULTS: From December 2012 to October 2019, 165 patients were enrolled and 154 completed the 6-months follow up. Women had a mean age of 53 years, and a mean BMI of 48 kg/m2. Ninety-six patients were diagnosed with EAC (58%) and 69 patients with EHA (42%). Thirty-five participants were randomized to OBS, 36 to WL and 47 to M (10 patients were withdrawn). After 6 months the rate of pCR was 61% (95% CI 42% to 77%) for OBS, 67% (95% CI 48% to 82%) for WL and 57% (95% CI 41% to 72%) for M. Across the three treatment groups, the pCR was 82% and 43% for EHA and EAC, respectively. CONCLUSION: Complete response rates at 6 months were encouraging for patients with EAC and EHA across the three groups. TRIAL REGISTRATION: U.S. National Library of Medicine, NCT01686126.
Assuntos
Neoplasias do Endométrio/tratamento farmacológico , Dispositivos Intrauterinos Medicados , Levanogestrel/administração & dosagem , Neoplasias do Endométrio/patologia , Neoplasias do Endométrio/terapia , Feminino , Humanos , Metformina/administração & dosagem , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Redução de Peso , Programas de Redução de Peso/métodosRESUMO
OBJECTIVE: Physical activity following cancer diagnosis is associated with improved outcomes, including potential survival benefits, yet physical activity levels among common cancer types tend to decrease following diagnosis and remain low. Physical activity levels following diagnosis of less common cancers, such as ovarian cancer, are less known. The objectives of this study were to describe physical activity levels and to explore characteristics associated with physical activity levels in women with ovarian cancer from pre-diagnosis to 2 years post-diagnosis. METHODS: As part of a prospective longitudinal study, physical activity levels of women with ovarian cancer were assessed at multiple time points between pre-diagnosis and 2 years post-diagnosis. Physical activity levels and change in physical activity were described using metabolic equivalent task hours and minutes per week, and categorically (sedentary, insufficiently, or sufficiently active). Generalized Estimating Equations were used to explore whether participant characteristics were related to physical activity levels. RESULTS: A total of 110 women with ovarian cancer with a median age of 62 years (range 33-88) at diagnosis were included. 53-57% of the women were sufficiently active post-diagnosis, although average physical activity levels for the cohort were below recommended levels throughout the 2-year follow-up period (120-142.5min/week). A decrease or no change in post-diagnosis physical activity was reported by 44-60% of women compared with pre-diagnosis physical activity levels. Women diagnosed with stage IV disease, those earning a lower income, those receiving chemotherapy, and those currently smoking or working were more likely to report lower physical activity levels and had increased odds of being insufficiently active or sedentary. CONCLUSIONS: Interventions providing patients with appropriate physical activity advice and support for behavior change could potentially improve physical activity levels and health outcomes.
Assuntos
Sobreviventes de Câncer/estatística & dados numéricos , Exercício Físico/fisiologia , Neoplasias Ovarianas/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Estudos Longitudinais , Pessoa de Meia-Idade , Estudos ProspectivosRESUMO
OBJECTIVE: To compare long-term quality of life in women treated for early-stage endometrial cancer with population norms, and to compare quality of life outcomes of patients who had total laparoscopic or total abdominal hysterectomy. METHODS: Once the last enrolled patient had completed 4.5 years of follow-up after surgery, participants in the Laparoscopic Approach to Cancer of the Endometrium (LACE) clinical trial were asked to complete a self-administered questionnaire. Two instruments-EuroQol 5 Dimension 3-level (EQ-5D-3L) and the Functional Assessment of Cancer Treatment-General Population (FACT-GP)-were used to determine quality of life. The mean computed EQ-5D-3L index scores for LACE participants at different age categories were compared with Australian normative scores; and the FACT-GP scores were compared between patients treated with surgical treatments. RESULTS: Of 760 women originally enrolled in the LACE trial, 259 (50.2%) of 516 women consented to provide long-term follow-up data at a median of 9 years (range 6-12) after surgery. On the EQ-5D-3L, long-term endometrial cancer survivors reported higher prevalence of anxiety/depression than normative levels across all age groups (55-64 years, 30% vs 14.9%; 65-74 years, 30.1% vs 15.8%; ≥75 years, 25.9% vs 10.7%). For women ≥75 years of age, the prevalence of impairment in mobility (57.6% vs 43.3%) and usual activities (58.8% vs 37.9%) was also higher than for population norms. For the FACT-GP, the physical (effect size: -0.28, p<0.028) and functional (effect size: -0.30, p<0.015) well-being sub-scale favored the total laparoscopic hysterectomy compared with total abdominal hysterectomy recipients. CONCLUSION: Compared with population-based norms, long-term endometrial cancer survivors reported higher prevalence of anxiety/depression across all age groups, and deficits in mobility and usual activities for women aged ≥75 years. Physical and functional well-being were better among women who were treated with total laparoscopic hysterectomy than among those receiving total abdominal hysterectomy.
Assuntos
Neoplasias do Endométrio/terapia , Idoso , Feminino , Humanos , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Qualidade de Vida , Resultado do TratamentoRESUMO
BACKGROUND: Sentinel node biopsy is a surgical technique to explore lymph nodes for surgical staging of endometrial cancer, which has replaced full retroperitoneal lymph node dissection. However, the effectiveness of sentinel node biopsy, its value to patients, and potential harms compared with no-node dissection have never been shown in a randomized trial. PRIMARY OBJECTIVES: Stage 1 will test recovery from surgery. Stage 2 will compare disease-free survival at 4.5 years between patients randomized to sentinel node biopsy versus no retroperitoneal node dissection. STUDY HYPOTHESIS: The primary hypothesis for stage 1 is that treatment with sentinel node biopsy will not cause detriment to patient outcomes (lymphedema, morbidity, loss of quality of life) and will not increase treatment-related morbidity or health services costs compared with patients treated without a retroperitoneal node dissection at 12 months after surgery. The primary hypothesis for stage 2 is that disease-free survival at 4.5 years after surgery in patients without retroperitoneal node dissection is not inferior to those receiving sentinel node biopsy. TRIAL DESIGN: This phase III, open-label, two-arm, multistage, randomized non-inferiority trial (ENDO-3) will determine the value of sentinel node biopsy for surgical management of endometrial cancer. Patients with endometrial cancer are randomized to receive: (1) laparoscopic/robotic hysterectomy, bilateral salpingo-oophorectomy with sentinel node biopsy or (2) laparoscopic/robotic hysterectomy, bilateral salpingo-oophorectomy without retroperitoneal node dissection. In stage 1, 444 patients will be enrolled to demonstrate feasibility and quality of life. If this is demonstrated, we will enroll another 316 patients in stage 2. MAJOR INCLUSION AND EXCLUSION CRITERIA: Inclusion criteria include women aged 18 years or older with histologically confirmed endometrial cancer; clinical stage 1, who meet the criteria for laparoscopic or robotic total hysterectomy and bilateral salpingo-oophorectomy. Patients with uterine mesenchymal tumors are excluded. PRIMARY ENDPOINTS: The endpoint for stage 1 is surgical recovery, with the proportion of patients returning to usual daily activities at 3 months post-surgery as measured with the EQ-5D. Stage 2 is disease-free survival at 4.5 years. SAMPLE SIZE: 760 participants (both stages). ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Stage 1 commenced in January 2021 and is planned to be completed in December 2024 when 444 participants have completed 12 months' follow-up. Stage 2 will enroll a further 316 participants for a total of 760 patients. TRIAL REGISTRATION: NCT04073706.
Assuntos
Carcinoma Endometrioide/cirurgia , Neoplasias do Endométrio/cirurgia , Excisão de Linfonodo/métodos , Biópsia de Linfonodo Sentinela/métodos , Adulto , Ensaios Clínicos Fase III como Assunto , Intervalo Livre de Doença , Feminino , Humanos , Histerectomia/métodos , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Procedimentos Cirúrgicos Robóticos/métodosRESUMO
INTRODUCTION: There has been a constant increase in the number of published surgical videos with preference for open-access sources, but the proportion of videos undergoing peer-review prior to publication has markedly decreased, raising questions over quality of the educational content presented. The aim of this study was the development and validation of a standard framework for the appraisal of surgical videos submitted for presentation and publication, the LAParoscopic surgery Video Educational GuidelineS (LAP-VEGaS) video assessment tool. METHODS: An international committee identified items for inclusion in the LAP-VEGaS video assessment tool and finalised the marking score utilising Delphi methodology. The tool was finally validated by anonymous evaluation of selected videos by a group of validators not involved in the tool development. RESULTS: 9 items were included in the LAP-VEGaS video assessment tool, with every item scoring from 0 (item not presented in the video) to 2 (item extensively presented in the video), with a total marking score ranging from 0 to 18. The LAP-VEGaS video assessment tool resulted highly accurate in identifying and selecting videos for acceptance for conference presentation and publication, with high level of internal consistency and generalisability. CONCLUSIONS: We propose that peer review in adherence to the LAP-VEGaS video assessment tool could enhance the overall quality of published video outputs.
Assuntos
Lista de Checagem , Avaliação Educacional , Guias como Assunto , Laparoscopia/normas , Gravação em Vídeo/normas , Humanos , Reprodutibilidade dos Testes , Inquéritos e QuestionáriosRESUMO
INTRODUCTION: Sentinel lymph node dissection is widely used in the staging of endometrial cancer. Variation in surgical techniques potentially impacts diagnostic accuracy and oncologic outcomes, and poses barriers to the comparison of outcomes across institutions or clinical trial sites. Standardization of surgical technique and surgical quality assessment tools are critical to the conduct of clinical trials. By identifying mandatory and prohibited steps of sentinel lymph node (SLN) dissection in endometrial cancer, the purpose of this study was to develop and validate a competency assessment tool for use in surgical quality assurance. METHODS: A Delphi methodology was applied, included 35 expert gynecological oncology surgeons from 16 countries. Interviews identified key steps and tasks which were rated mandatory, optional, or prohibited using questionnaires. Using the surgical steps for which consensus was achieved, a competency assessment tool was developed and subjected to assessments of validity and reliability. RESULTS: Seventy percent consensus agreement standardized the specific mandatory, optional, and prohibited steps of SLN dissection for endometrial cancer and informed the development of a competency assessment tool. Consensus agreement identified 21 mandatory and three prohibited steps to complete a SLN dissection. The competency assessment tool was used to rate surgical quality in three preselected videos, demonstrating clear separation in the rating of the skill level displayed with mean skills summary scores differing significantly between the three videos (F score=89.4; P<0.001). Internal consistency of the items was high (Cronbach α=0.88). CONCLUSION: Specific mandatory and prohibited steps of SLN dissection in endometrial cancer have been identified and validated based on consensus among a large number of international experts. A competency assessment tool is now available and can be used for surgeon selection in clinical trials and for ongoing, prospective quality assurance in routine clinical care.