Germline mutations in BRCA1 and BRCA2 among Brazilian women with ovarian cancer treated in the Public Health System.

BACKGROUND: Germline mutations in BRCA1 and BRCA2 genes are among the main causes of hereditary ovarian cancer. Identifying these mutations may reduce cancer risk, facilitate early detection, and enable personalized treatment. However, genetic testing is limited in the Brazilian Public Health System, and data regarding germline mutations in many regions are scarce. Therefore, the study aimed to investigate the prevalence of germline mutations in BRCA1 and BRCA2 in women with ovarian cancer treated in the Public Health System in Pernambuco, Brazil. METHODS: A cross-sectional study was conducted in the Hereditary Cancer Program from two reference oncological centers in Pernambuco. Women (n = 45) with high-grade serous ovarian cancer underwent genetic counseling and DNA sequencing for BRCA1 and BRCA2 genes. RESULTS: The prevalence of deleterious mutations in the BRCA1 and BRCA2 genes was 33%. Of the 15 germline mutations found, 13 were in BRCA1 and 2 in BRCA2; two mutations of unknown clinical significance were also found in BRCA2. Mutations c.5266dupC and c.2215 A > T were the most frequent; each was mutation observed in three patients. Additionally, the mutations c.7645dupT and c.921dupT were reported for the first time. CONCLUSION: One in three women showed a pathogenic mutation, demonstrating a significant prevalence of germline mutations in this sample. Additionally, the small sample revealed an interesting number of mutations, indicating the need to explore more regions of the country.

Proof-of-concept randomized phase II non-inferiority trial of simple versus type B2 hysterectomy in early-stage cervical cancer ≤2 cm (LESSER).

OBJECTIVE: To evaluate the non-inferiority and safety of simple hysterectomy in early stage (<2 cm) cervical cancer. METHODS: This proof-of-concept randomized phase II non-inferiority trial was performed between May 2015 and April 2018 in three oncological centers in Northeast Brazil. Patients with International Federation of Gynecology and Obstetrics (FIGO) 2009 stages IA2-IB1 cervical cancer and tumors ≤2 cm were treated with either simple or modified radical hysterectomy (Querleu-Morrow type B2). Intention-to-treat analysis was carried out. The primary endpoint was 3-year disease-free survival and secondary endpoints were overall survival, operative outcomes, adjuvant therapy, and patient's health-related quality of life (QoL). RESULTS: A total of 40 patients underwent either simple hysterectomy (n=20) or modified radical hysterectomy (n=20). All patients except three underwent open procedures (n=37/40, 92.5%). At a median follow-up of 52.1 months (IQR 43.9-60.1), 3-year disease-free survival was 95% (95% CI 68% to 99%) after simple hysterectomy and 100% (95% CI 100% to 100%) after modified radical hysterectomy (log-rank p=0.30). The corresponding 5-year overall survival rates were 90% (95% CI 64% to 97%) and 91% (95% CI 50% to 98%), respectively (log-rank p=0.46). The operative time was shorter after simple hysterectomy than after modified radical hysterectomy (150 min (IQR 137.5-180) vs 199.5 min (IQR 140-230); p=0.003), with a trend towards a longer time for vesical catheterization removal (1 day (IQR 1-1) vs 1 day (IQR 1-2); p=0.043). There was no post-operative mortality and the rates of post-operative complications were not statistically different between arms (15% and 25%; p=0.69). QoL questionnaires were received from only 17 patients (42.5%), with no major differences observed over time between the surgical arms. CONCLUSIONS: Simple hysterectomy is safe and potentially non-inferior to the radical surgery in patients with early-stage cervical cancer ≤2 cm. TRIAL REGISTRATION NUMBER: NCT02613286.

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.

A phase 2 trial of short-course Hyperthermic IntraPeritoneal Chemotherapy (HIPEC) at interval cytoreductive surgery (iCRS) for advanced ovarian cancer.

OBJECTIVE: to report the final analysis of a phase 2 trial assessing the efficacy and safety of short-course hyperthermic intraperitoneal chemotherapy (HIPEC) for patients with advanced epithelial ovarian cancer (EOC). METHODS: this was an open-label, multicenter, single-arm trial of HIPEC in patients with advanced EOC who underwent interval cytoreductive surgery (iCRS) after neoadjuvant chemotherapy (NACT). HIPEC was performed as a concentration-based regimen of platinum-based chemotherapy for 30 minutes. Primary endpoint was the rate of disease progression occurring at nine months following iCRS plus HIPEC (PD9). Secondary endpoints were postoperative complications, time to start adjuvant chemotherapy, length of hospital and ICU stay, quality of life (QoL) over treatment, and ultimately 2-year progression-free survival (PFS) and overall survival (OS). Analysis was by intention-to-treat with final database lock for survival outcomes on February 23, 2021. RESULTS: fifteen patients with stage III EOC were enrolled between February 2015 and July 2019, in four centers. The intention to treat PD9 was 6.7%. With a median follow-up of 33 months (IQR, 24.3-46.5), the median PFS was 18.1 months and corresponding 2-year rates of PFS and OS was 33.3% and 93.3%, respectively. Three patients (20%) experienced graded III complications. Median length of hospital and ICU stay was 5 (IQR, 4-6.5) and 1 (IQR, 1-1) days, respectively. Time to restart systemic chemotherapy was 39 (IQR, 35-49.3) days and no significant difference over time in QoL was observed. CONCLUSIONS: we demonstrate preliminary efficacy and safety of short-course HIPEC in patient with advanced EOC.

A phase 2 trial of short-course Hyperthermic IntraPeritoneal Chemotherapy (HIPEC) at interval cytoreductive surgery (iCRS) for advanced ovarian cancer / Quimioterapia Intraperitoneal Hipertérmica (HIPEC) de curta duração ao tempo da cirurgia citorredutora de intervalo (iCRS) para câncer de ovário avançado: ensaio clínico de fase 2

ABSTRACT Objective: to report the final analysis of a phase 2 trial assessing the efficacy and safety of short-course hyperthermic intraperitoneal chemotherapy (HIPEC) for patients with advanced epithelial ovarian cancer (EOC). Methods: this was an open-label, multicenter, single-arm trial of HIPEC in patients with advanced EOC who underwent interval cytoreductive surgery (iCRS) after neoadjuvant chemotherapy (NACT). HIPEC was performed as a concentration-based regimen of platinum-based chemotherapy for 30 minutes. Primary endpoint was the rate of disease progression occurring at nine months following iCRS plus HIPEC (PD9). Secondary endpoints were postoperative complications, time to start adjuvant chemotherapy, length of hospital and ICU stay, quality of life (QoL) over treatment, and ultimately 2-year progression-free survival (PFS) and overall survival (OS). Analysis was by intention-to-treat with final database lock for survival outcomes on February 23, 2021. Results: fifteen patients with stage III EOC were enrolled between February 2015 and July 2019, in four centers. The intention to treat PD9 was 6.7%. With a median follow-up of 33 months (IQR, 24.3-46.5), the median PFS was 18.1 months and corresponding 2-year rates of PFS and OS was 33.3% and 93.3%, respectively. Three patients (20%) experienced graded III complications. Median length of hospital and ICU stay was 5 (IQR, 4-6.5) and 1 (IQR, 1-1) days, respectively. Time to restart systemic chemotherapy was 39 (IQR, 35-49.3) days and no significant difference over time in QoL was observed. Conclusions: we demonstrate preliminary efficacy and safety of short-course HIPEC in patient with advanced EOC.

RESUMO Objetivo: apresentar a análise final de ensaio clínico de fase 2 que avaliou a eficácia e a segurança da quimioterapia intraperitoneal hipertérmica (HIPEC) de curta duração em pacientes com câncer epitelial de ovário avançado (EOC). Métodos: estudo aberto, multicêntrico, de braço único avaliando a HIPEC em pacientes com EOC avançado submetidos a cirurgia citorredutora de intervalo (iCRS) após quimioterapia neoadjuvante (NACT). A HIPEC foi realizada como regime baseado na concentração de cisplatina, perfundida por 30 minutos. O desfecho primário foi a taxa de progressão da doença 9 meses após a iCRS com HIPEC (PD9). Os desfechos secundários foram complicações pós-operatórias, tempo para iniciar a quimioterapia adjuvante, tempo de internação e permanência em UTI, qualidade de vida (QoL) ao longo do tratamento e, finalmente, sobrevida cumulativa livre de progressão (PSF) e global (OS) em 2 anos. As análises foram em intenção de tratar (ITT) com fechamento dos dados para análise da sobrevida em 23 de fevereiro de 2021. Resultados: quinze pacientes com EOC em estágio III foram incluídos no estudo entre fevereiro de 2015 e julho de 2019 em quatro centros recrutadores. A PD9 por ITT foi de 6,7%. Com acompanhamento mediano de 33 meses (IQR, 24,3-46,5), a PFS mediana foi de 18,1 meses e as taxas correspondentes de PFS e OS em 2 anos foram 33,3% e 93,3%, respectivamente. Três pacientes (20%) apresentaram complicações grau III. O tempo mediano de internamento hospitalar e em UTI foi de 5 (IQR, 4-6,5) e 1 (IQR, 1-1) dias, respectivamente. O tempo para reinício da quimioterapia sistêmica foi de 39 dias (IQR, 35-49,3) e não foi observada diferença significativa na QoL ao longo do tratamento. Conclusões: demonstrou-se eficácia e segurança preliminares da HIPEC de curta duração em pacientes com EOC avançado.

Quality of life in a phase 2 trial of short-course hyperthermic intraperitoneal chemotherapy (HIPEC) at interval debulking surgery for high tumor burden ovarian cancer.

INTRODUCTION: to evaluate the effect of short-course (i.e.: 30 minutes) HIPEC on health-related quality of life (HRQoL) in our feasibility study; NCT02249013. METHODS: a prespecified secondary end-point of our open-label, multicenter, single-arm, phase 2 trial on safety and efficacy was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30, version 3.0). Patients were required to complete the HRQoL questionnaire at baseline, after HIPEC, and after the end of the treatment. Changes of HRQoL over time were assessed by median scores for each domain and analyzed by Friedman`s test at a significant two-sided level of 0.05. RESULTS: fifteen patients with high tumor burden EOC were recruited from our public health system between February 2015 and July 2019. A baseline EORTC QLQ-C30 questionnaire and at least one follow-up questionnaire was received from all of the patients. No significant difference over time in the QLQC30 summary scores was observed (p>0.05). The transitory impairment on patients HRQoL immediately after the short-course HIPEC trended to return to baseline at the end of the multimodal treatment. CONCLUSIONS: we found no significant impairment of short-course HIPEC on patients HRQoL into the context of our comprehensive treatment protocol.

Brazilian Society of Surgical Oncology guidelines for surgical treatment of endometrial cancer in regions with limited resources.

BACKGROUND: Approximately 70% of cancer-related deaths occur in low- and middle-income countries. In addition to social and racial inequalities, treatment options in these countries are usually limited because of the lack of trained staff and equipment, limited patient access to health services, and a small number of clinical guidelines. OBJECTIVES: The Brazilian Society of Surgical Oncology developed this guideline to address these barriers and guide physicians treating patients with endometrial cancer (EC) in regions with limited resources and few specialized centers. METHODS: The guideline was prepared from 10 January to 25 October 20192019 by a multidisciplinary team of 56 experts to discuss the main obstacles faced by EC patients in Brazil. Thirteen questions considered critical to the surgical treatment of these patients were defined. The questions were assigned to 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 for presentations in meetings, classified the level of evidence, and voted on the recommendations. RESULTS: For all questions including staging, fertility spearing treatment, genetic testing, sentinel lymph node use, surgical treatment, and other clinical relevant questions, major agreement was achieved by the participants, always using accessible alternatives. CONCLUSIONS: It is possible to provide adequate treatment for most EC patients in resource-limited areas, but the first option should be referral to specialized centers with more resources.

Quality of life in a phase 2 trial of short-course hyperthermic intraperitoneal chemotherapy (HIPEC) at interval debulking surgery for high tumor burden ovarian cancer / Avaliação da qualidade de vida em ensaio clínico de fase 2 envolvendo quimioterapia intraperitoneal hipertérmica (HIPEC) de curta duração no momento da citorredução de intervalo em pacientes com câncer de ovário de grande volume tumoral

ABSTRACT Introduction: to evaluate the effect of short-course (i.e.: 30 minutes) HIPEC on health-related quality of life (HRQoL) in our feasibility study; NCT02249013. Methods: a prespecified secondary end-point of our open-label, multicenter, single-arm, phase 2 trial on safety and efficacy was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30, version 3.0). Patients were required to complete the HRQoL questionnaire at baseline, after HIPEC, and after the end of the treatment. Changes of HRQoL over time were assessed by median scores for each domain and analyzed by Friedman`s test at a significant two-sided level of 0.05. Results: fifteen patients with high tumor burden EOC were recruited from our public health system between February 2015 and July 2019. A baseline EORTC QLQ-C30 questionnaire and at least one follow-up questionnaire was received from all of the patients. No significant difference over time in the QLQC30 summary scores was observed (p>0.05). The transitory impairment on patients HRQoL immediately after the short-course HIPEC trended to return to baseline at the end of the multimodal treatment. Conclusions: we found no significant impairment of short-course HIPEC on patients HRQoL into the context of our comprehensive treatment protocol.

RESUMO Objetivo: avaliar o impacto da quimioterapia intraperitoneal hipertérmica (HIPEC) de curta duração (i.e.: 30 minutos) na qualidade de vida (QoL) relacionada à saúde (HRQoL) no contexto de ensaio clínico terapêutico piloto; NCT02249013. Métodos: avaliou-se o desfecho secundário predeterminado de HRQoL em ensaio clínico de fase 2 de segurança e eficácia, aberto, multicêntrico, de braço único, utilizando-se o questionário European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30, versão 3.0). As pacientes foram solicitadas a responder o questionário de HRQoL antes do tratamento, após a HIPEC, e ao fim do tratamento interdisciplinar. As variações da HRQoL ao longo do tempo foram avaliadas pelas medianas dos escores de cada domínio e analisadas pelo teste de Friedman, considerando-se nível de significância estatística bicaudal de 5%. Resultados: quinze pacientes com câncer de ovário de grande volume tumoral foram recrutadas do sistema de saúde pública (i.e.: SUS) entre fevereiro de 2015 e julho 2019. Um questionário basal e pelo menos um questionário de acompanhamento foram coletados de todas as pacientes. Não se observou diferença significativa ao longo do tempo na HRQoL em nenhum dos domínios ou sintomas estudados (p> 0,05). O comprometimento transitório da HRQoL imediatamente após a HIPEC de curta duração tendeu a retornar à linha de base ao final do tratamento multimodal. Conclusões: não se observou impacto significativo da HIPEC de curta duração sobre a HRQoL no contexto deste protocolo de tratamento interdisciplinar.

Ensaio clínico fase II de não inferioridade, randomizado e controlado, para avaliação da histerectomia extrafascial no tratamento do câncer de colo uterino em estágio Ia2-Ib1 ≤ 2cm / LESs surgical radicality for early stage cervical cancer (LESSER)

Introdução: O tratamento cirúrgico do câncer do colo do uterino consiste numa ressecção radical com necessidade de parametrectomia, acrescentando assim morbidade ao tratamento, talvez, não necessária em pacientes com doença inicial. Objetivo: Avaliar a não-inferioridade da histerectomia extrafascial em comparação à histerectomia radical modificada, ambas com linfadenectomia pélvica bilateral, em termos de eficácia e segurança para tratamento dos tumores de colo uterino em estádio IA2 ­ IB1 ≤ 2cm. Casuística e métodos: Quarenta e duas mulheres portadoras de câncer do colo uterino em estadios clínicos IA2 a IB1 com tumores ≤ 2cm, candidatas a tratamento cirúrgico eletivo com intenção curativo foram randomizadas 1:1 para realização de histerectomia extrafacial ou histerectomia radical modificada no período entre maio de 2015 a abril de 2018, 40 foram avaliadas. Características clínicas e patológicas foram coletadas de forma prospectiva. Os dados de qualidade de vida foram coletados com o uso do questionário EORTC QLQ-30. Resultados: Ambos os grupos apresentaram, tanto as características clínicas (Idade, Peformance Status, ASA, Estadiamento clínico e tamanho da lesão no exame físico no pré-operatório), quanto as características tumorais no anatomo patológicas (subtipo, Grau de diferenciação, tamanho maior que 2 cm, invasão angiolifática, número de linfonodos dissecados, presença de linfonodo metastático e invasão estromal) similares. O tempo cirúrgico mediano foi maior (199,5 minutos) no grupo de histerectomia radical modificada, com uma diferença de 49,5 minutos (p=0,003), assim como o tempo de sondagem vesical no pós-operatório também foi maior em pacientes submetidas a histerectomia radical modificada (p=0,043). Não houve mortalidade pós-operatória (nos primeiros 30 dias) e a taxa de complicações pós-operatórias foi similar, com 15% e 20% (p=1,000), assim como o a necessidade de adjuvânica com 30% e 20% (p=0,480), para os braços de histerectomia extrafascial e radical modificada, respectivamente. Houve similariedade nas escalas de funcionalidade física ou sintomas entre ambos os braços do estudo antes e 6 meses após o procedimento cirúrgico, exceto a função emocional que melhorou no grupo de histerectomia radical modificada após 6 meses, quando comparado com o mesmo grupo de pacientes antes da cirurgia. O seguimento mediano foi de 16,2 meses e a sobrevida livre de doença em 2 anos (análise interina) foi de 95% e 100% nos braços histerectomia fascial e radical modificada, respectivamente (p=0,405). Uma paciente faleceu após 25 meses de seguimento, no grupo da histerectomia extrafascial, devido a progressão de doença regional. Conclusão: A histerectomia extrafascial apresentou uma baixa morbidade e mostrou-se segura no tratamento das pacientes com câncer de colo uterino inicial e não parece ser inferior à histerectomia radical modificada nesse contexto, e a parametrectomia talvez seja desnessária nesse subgrupo populacional. As análises dos dados do desfecho primário, após um maior seguimento, são esperadas antes da realização da conclusão final

Introduction: Surgical treatment of cervical cancer consists of a radical resection requiring parametrectomy, thus adding morbidity to the treatment, perhaps not necessary in patients with initial disease. Objective: To evaluate non-inferiority of simple hysterectomy in comparison to radical modified hysterectomy, both inclunding bilateral pelvic lynphadenectomy, in terms of efficacy and safety for treatment of uterine cervical tumors in stage IA2 - IB1 ≤ 2cm. Methods: Forty-two women with uterine cervical cancer in clinical stages IA2 to IB1 with tumors ≤ 2 cm, candidates for elective surgical treatment with curative intent were randomized 1: 1 to perform simple hysterectomy or modified radical hysterectomy in the period from May 2015 to April 2018, 40 were evaluated. Clinical and pathological characteristics were collected prospectively. Health-related quality of life was assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Results: Clinical characteristics (age, Peformance Status, ASA, clinical staging and lesion size in the preoperative physical examination), as well as tumor characteristics in anatomical pathology (subtype, degree of differentiation, size greater than 2 cm, angiolipathic invasion, dissected node's number, nodal metastasis and stromal invasion) were well balanced between the treatment groups. The median surgical time was greater (195 minutes) in the modified radical hysterectomy group, with a difference of 49,5 minutes (p = 0.003), such as, postoperative bladder catheterization days was also higher in patients submitted to modified radical hysterectomy (p = 0.043). There was no postoperative mortality (in the first 30 days) among all patients and the rate of postoperative complications was similar, with 15% and 20% (p = 1,000), as well as the need for adjuvante treatment with 30% and 20% (p = 0.480) for the arms of simple and modified radical hysterectomy, respectively. Global health or quality of life and physical functioning scores were similar between groups, before and 6 months after the surgeries, except for the emotional function, that improved in the group of modified radical hysterectomy after 6 months when compared with the same group of patients prior to surgery. The median follow-up was 16.2 months and the 2-year disease free survival (interim analysis) was 95% and 100% in the simple hysterectomy's and modified radical's arms, respectively (p = 0.405). Only one patient died after 25 months of follow-up in the simple hysterectomy group due to regional disease progression. Conclusion: Simple hysterectomy presented low morbidity and it was safe in the treatment of patients with early stage cervical cancer and does not appear to be inferior to modified radical hysterectomy in this context, and parametrectomy may be not necessary in this population subgroup. We wait the final analysis of the primary endpoint

Phase II trial of neoadjuvant chemotherapy followed by chemoradiation in locally advanced cervical cancer.

OBJECTIVE: Cervical cancer is a global public health challenge. Since 1999, platin based chemoradiation (CRT) is the standard treatment for those patients with locally advanced disease. However, this population still has a dismal prognosis and, alternatives approaches such as adjuvant chemotherapy are controversial, especially because of increased toxicity. Neoadjuvant chemotherapy (NACT) could be an option for more intensive treatment with manageable toxicity. METHODS: A phase II, prospective, non-randomized trial was conducted at a reference center in Recife, Brazil. Locally advanced cervical cancer patients (Ib2-IVa) were treated with neoadjuvant cisplatin 35mg/m2 and gemcitabine 1000mg/m2 D1 and D8, for 2cycles. Then, they received CRT (50.4Gy) with weekly cisplatin 40mg/m2 followed by brachytherapy. Response rate (RR) and toxicity were the primary endpoints. Progression-free survival (PFS) and overall survival (OS) were secondary endpoints. RESULTS: Between Sep/2013 and Oct/2015, 50 patients were initiated on NACT and CRT. RR was 81% at the end of treatment. Hematological and gastrointestinal toxicity were most common. Grade 3/4 toxicity was 20% during NACT and 44% during CRT. Late adverse events were present in 20% of patients. PFS at 1 and 3-years were 73.4% (IC 58.7-83.6) and 53.9% (IC 36.9-68.3), respectively; and, OS at 1 and 3-years were 93.9% (IC 82.4-98.0) and 71.3% (IC 53.3-83.3), respectively. CONCLUSION: In our hands NACT in locally advanced cervical cancer patients did not show a meaningful improvement in ORR. Nevertheless, we believe it should be further explored in prospective trials.

Surgical treatment of clinically early-stage endometrial carcinoma without systematic lymphadenectomy / Tratamento cirúrgico do câncer de endométrio em estágio clínico precoce sem linfadenectomia radical.

Objective: the main aim of this study was to describe the authors’ experience with the surgical treatment of endometrial cancer without systematic lymphadenectomy. Methods: a retrospective cohort study was carried out on a subset of patients suffering of clinically early-stage endometrial carcinoma who underwent hysterectomy and salpingo-oophorectomy without systematic (radical) lymph nodes dissection at our centers from June, 2002, to November, 2011. Descriptive statistics were explored as medians (interquartile range) or frequencies (percentages), as appropriated, and the Kaplan–Meier method was applied for survival estimation. Results: eighty-three patients who underwent surgical treatment with no lymph node dissection (n = 20; 24.1%) or with only a sampling procedure (n=63; 75.98%) were selected for analysis. Among these patients, 27 (32.53%) underwent surgery alone and 56 (67.46%) received some adjuvant treatment. Postoperative complications occurred in five patients (6.02%). Over a median follow-up of 27.4 months (Q25 = 13.7 – Q75 = 46.5), 15 (18.07%) patients suffered from relapses and 11 deaths occurred as result of disease recurrence. Cumulative 1, 2 and 3-year disease- free survivals were 97.32, 91.18 and 78.02%, respectively. Conclusion: on a case-by-case basis, the surgical treatment of clinically early-stage endometrial carcinoma without systematic lymphadenectomy did not seem to decrease survival outcomes and presented low rates of surgical morbidity in our experience, but was also related to a high rate use of adjuvant therapy. .

Objetivo: descrever a experiência dos autores com o tratamento cirúrgico do câncer de endométrio em estádio precoce sem linfadenectomia radical. Métodos: realizou-se estudo de coorte retrospectivo envolvendo um subgrupo de pacientes com câncer de endométrio em estágio clínico precoce tratadas com histerectomia e salpingo-ooforectomia sem linfadenectomia radical, em dois centros pernambucanos, de junho de 2002 a novembro de 2011. As variáveis foram descritas como mediana (intervalo interquartílico) ou frequências (percentuais), utilizando- se o método de Kaplan-Meier para a estimativa das taxas de sobrevivência. Resultados: oitenta e três pacientes submetidas a tratamento cirúrgico sem dissecção linfonodal (n = 20, 24,1%) ou com dissecção apenas por amostragem (n = 63; 75,98%) foram selecionadas para análise. Entre essas pacientes, 27 (32,53%) foram tratadas somente com cirurgia e 56 (67,46%) receberam tratamento adjuvante. Cinco pacientes apresentaram complicações pós-operatórias (6,02%). Durante o acompanhamento mediano de 27,4 meses (Q25 = 13,7 - Q75 = 46,5), 15 (18,07%) pacientes apresentaram recorrência, dentre as quais 11 faleceram em decorrência da recidiva neoplásica. Observou-se sobrevivência cumulativa proporcional livre de doença em um, dois e três anos de 97,32, 91,18 e 78,02%, respectivamente. Conclusão: em um contexto de indicação caso-a-caso, o tratamento cirúrgico do câncer de endométrio em estádio precoce sem linfadenectomia radical parece não ter prejudicado a sobrevivência e apresentou baixas taxas de morbidade cirúrgica em nossa experiência, mas também foi acompanhado de elevada utilização de terapia adjuvante. .

Surgical treatment of clinically early-stage endometrial carcinoma without systematic lymphadenectomy.

OBJECTIVE: the main aim of this study was to describe the authors' experience with the surgical treatment of endometrial cancer without systematic lymphadenectomy. METHODS: a retrospective cohort study was carried out on a subset of patients suffering of clinically early-stage endometrial carcinoma who underwent hysterectomy and salpingo-oophorectomy without systematic (radical) lymph nodes dissection at our centers from June, 2002, to November, 2011. Descriptive statistics were explored as medians (interquartile range) or frequencies (percentages), as appropriated, and the Kaplan-Meier method was applied for survival estimation. RESULTS: eighty-three patients who underwent surgical treatment with no lymph node dissection (n = 20; 24.1%) or with only a sampling procedure (n=63; 75.98%) were selected for analysis. Among these patients, 27 (32.53%) underwent surgery alone and 56 (67.46%) received some adjuvant treatment. Postoperative complications occurred in five patients (6.02%). Over a median follow-up of 27.4 months (Q25 = 13.7 - Q75 = 46.5), 15 (18.07%) patients suffered from relapses and 11 deaths occurred as result of disease recurrence. Cumulative 1, 2 and 3-year disease- free survivals were 97.32, 91.18 and 78.02%, respectively. CONCLUSION: on a case-by-case basis, the surgical treatment of clinically early-stage endometrial carcinoma without systematic lymphadenectomy did not seem to decrease survival outcomes and presented low rates of surgical morbidity in our experience, but was also related to a high rate use of adjuvant therapy.

Qual a importância do número de linfonodos pélvicos dissecados para o estadiamento locorregional do câncer de colo uterino? / How important is the number of pelvic lymph node retrieved to locorregional staging of cervix cancer?

OBJETIVO: Avaliar a importância do número de linfonodos pélvicos dissecados para o estadiamento locorregional de pacientes portadoras de câncer do colo uterino com estadiamento FIGO IA2 a IB2, submetidas a tratamento cirúrgico radical. MÉTODOS: Estudo de corte transversal incluindo pacientes submetidas à histerectomia radical tipo II de Piver e linfadenectomia pélvica, em dois centros pernambucanos, entre janeiro de 2001 e dezembro de 2008. Utilizou-se análise da área sob curva ROC como medida-resumo do desempenho do número de linfonodos dissecados para a predição do acometimento metastático linfonodal pélvico. Adicionalmente, também se avaliou a relação entre essas variáveis, usando a regressão logística e o teste exato de Fisher. RESULTADOS: A avaliação anatomopatológica incluiu 662 linfonodos dissecados (mediana=9, q25=6 - q75=13) de 69 pacientes. A avaliação da área sob curvas ROC revelou AUC=0,642 para a predição do estadiamento linfonodal pélvico pelo número de linfonodos dissecados. AUCs de 0,605 e 0,526 foram observadas quando se classificaram as pacientes, utilizando-se 10 e 15 linfonodos como pontos de corte, respectivamente. Por regressão logística, evidenciou-se odds-ratio de 0,912 (IC95%=0,805-1,032; p=0,125). A dissecção de ≥10 ou ≥15 linfonodos não se associou ao achado anatomopatológico de comprometimento metastático dos linfonodos pelo teste de Fisher (p=0,224 e p=0,699, respectivamente). CONCLUSÃO: O número de linfonodos dissecados não se correlacionou com comprometimento metastático linfonodal pélvico nessa casuística, o que sugere que a dissecção de um maior número de linfonodos não incremente o estadiamento locorregional do câncer de colo uterino.

OBJECTIVE: To explore how important is the number of pelvic lymph nodes dissected for the nodal staging in FIGO IA2-IB2 cervical cancer, submitted to radical surgical treatment. METHODS: A cross-sectional study was carried out on patients who underwent Piver class II radical hysterectomy and pelvic lymphadenectomy, in two centers in the state of Pernambuco, from January, 2001 to December, 2008. The analysis of the area under the ROC curve was adopted as a summary-measure of discriminatory power of the number of nodes dissected in predicting the pelvic nodal status. Additionally, we also confirm our findings using logistic regression and the Fisher's exact test. RESULTS: The postoperative pathological study included 662 pelvic lymph nodes dissected (median per-patient=9, q25=6 - q75=13) from 69 patients. The ROC curve analysis revealed AUC=0.642, for the discriminatory value of the number of nodes dissected in predicting the pelvic nodal status. Similar findings were found after categorization using 10 and 15 lymph nodes as cut-offs (AUC=0.605 and 0.526, respectively). Logistic regression revealed odds ratio of 0.912 (95%CI=0.805-1.032; p=0.125) for the predictive value of the number of nodes dissected, and a number of nodes ≥10 or ≥15 lymph nodes was not significantly associated with the nodal status by the Fischer's exact test (p=0.224 and p=0.699, respectively). CONCLUSION: The number of pelvic lymph nodes dissected did not correlate with pelvic lymph node metastatic involvement. This study suggests that dissection of a greater number of lymph nodes does not increase locoregional nodal staging in cervical cancer.

How important is the number of pelvic lymph node retrieved to locorregional staging of cervix cancer?

OBJECTIVE: To explore how important is the number of pelvic lymph nodes dissected for the nodal staging in FIGO IA2-IB2 cervical cancer, submitted to radical surgical treatment. METHODS: A cross-sectional study was carried out on patients who underwent Piver class II radical hysterectomy and pelvic lymphadenectomy, in two centers in the state of Pernambuco, from January, 2001 to December, 2008. The analysis of the area under the ROC curve was adopted as a summary-measure of discriminatory power of the number of nodes dissected in predicting the pelvic nodal status. Additionally, we also confirm our findings using logistic regression and the Fisher's exact test. RESULTS: The postoperative pathological study included 662 pelvic lymph nodes dissected (median per-patient=9, q25=6 - q75=13) from 69 patients. The ROC curve analysis revealed AUC=0.642, for the discriminatory value of the number of nodes dissected in predicting the pelvic nodal status. Similar findings were found after categorization using 10 and 15 lymph nodes as cut-offs (AUC=0.605 and 0.526, respectively). Logistic regression revealed odds ratio of 0.912 (95%CI=0.805-1.032; p=0.125) for the predictive value of the number of nodes dissected, and a number of nodes ≥10 or ≥15 lymph nodes was not significantly associated with the nodal status by the Fischer's exact test (p=0.224 and p=0.699, respectively). CONCLUSION: The number of pelvic lymph nodes dissected did not correlate with pelvic lymph node metastatic involvement. This study suggests that dissection of a greater number of lymph nodes does not increase locoregional nodal staging in cervical cancer.