Complex physical therapy employing self-adjusting garment (ReadyWrap®) in breast cancer-related lymphedema cases in Brazilian women: a protocol for a randomized controlled trial.

BACKGROUND: Lymphedema is a common complication following breast cancer treatment. The aim of this study is to evaluate the effectiveness of a self-adjusting compression garment (ReadyWrap®) in reducing (phase 1) and maintaining (phase 2) upper limb volume in women presenting breast cancer-related lymphedema. METHODS: This study will comprise a randomized, controlled, single-blind clinical trial concerning women with breast cancer-related lymphedema undergoing treatment at a public cancer treatment reference hospital in the city of Rio de Janeiro, Brazil. The intervention will be carried out by adapting self-dressing versus the standard treatment of compressive bandaging (phase 1) and compressive mesh (phase 2). Both groups will be assessed at the beginning and end of intensive treatment and followed up for up to 12 months to evaluate immediate and late outcomes. Assessments will be carried out by physical upper limb examination (inspection, palpation, volume, dynamometry, and thermography) and questionnaires application to assess patient's quality of life pertaining to the health, functionality, and symptoms of the affected upper limb, as well adverse effects and adherence to treatment. Data will be analyzed descriptively and analytically through univariate and multiple linear regressions. P values < 0.05 will be considered statistically significant. DISCUSSION: This study will evaluate the effectiveness of a self-adjustable garment (ReadyWrap®) in the treatment of lymphedema secondary to breast cancer in Brazilian women compared to the gold standard treatment for limb volume reduction (phase 1) and maintenance (phase 2) phases comprising, respectively, a compressive bandaging and a compressive mesh. The outcome results will provide data based on both quantitative responses and self-reported participant outcomes. The study will also assess the cost-effectiveness of the ReadyWrap® treatment versus standard care. Finally, we expect to reaffirm one more product/therapy as a treatment for this extremely complex and impactful condition following the data analysis. TRIAL REGISTRATION: NCT04934098 [Clinical trials phase 1]. Registered on June 22, 2021. NCT04881604 [Clinical trials phase 2]. Registered on May 11, 2021.

Shoulder amplitude movement does not influence postoperative wound complications after breast cancer surgery: a randomized clinical trial.

PURPOSE: The goal of this study is to evaluate the influence of shoulder exercises with restricted amplitude movement (RAM) or free amplitude movement (FAM) performed from the first postoperative day (1st POD) on the incidence of surgical wound complications (SWC) in breast cancer. METHODS: This study comprises a randomized clinical trial with an intention-to-treat analysis including 465 women aged 18 to 79, who underwent curative surgery for breast cancer. Participants were submitted to perform free amplitude movement (FAM) or restricted amplitude movement (RAM) shoulder exercises, until the 30th postoperative day. The outcome measures were the SWC: seroma, dehiscence, necrosis, infection, hematoma and bruise. RESULTS: 461 participants completed the follow-up. Thirty days after surgery, 63.8% of the women presented some surgical wound complication, with necrosis (39.3%) and seroma (30.8%) as the most frequent. No statistically significant differences in SWC according to postoperative amplitude shoulder exercise (FAM vs RAM), even after a stratified analysis by type of surgery (segmentectomy vs mastectomy) or axillary approach (axillary lymphadenectomy versus sentinel lymph node biopsy) were observed. CONCLUSION: FAM exercises do not increase the incidence of postoperative wound complications compared to RAM exercises. TRIAL REGISTRATION: NCT03796845.

Impact of Number of Positive Lymph Nodes and Lymph Node Ratio on Survival of Women with Node-Positive Breast Cancer.

OBJECTIVE: This study aimed to evaluate the association of axillary lymph node ratio (LNR) and number of positive lymph nodes (pN) with the risk of breast cancer recurrence and death. MATERIALS AND METHODS: A retrospective cohort study of node-positive stage II and III breast cancer patients diagnosed and treated between 2008 and 2009 at the Brazilian National Cancer Institute (INCA), Brazil. Overall and disease-free survival curves for number of positive lymph nodes (pN) and lymph node ratio (LNR) risk groups were constructed using the Kaplan-Meier method and compared by the log-rank test. Multivariate analysis was performed using stepwise forward Cox regression models. RESULTS: In total, 628 women with node-positive breast cancer were included. Most patients (69.5%) had advanced clinical stage tumors (≥IIB). The median follow-up was 58 months (range: 3-92 months). The adjusted recurrence hazard of pN2 and pN3 patients was 2.47 (95% Confidence Interval [CI] 1.72-3.56) and 2.42 (1.62-3.60), respectively, compared to pN1 patients (p<0.001), while the hazard of intermediate (0.21-0.65) and high-risk (>0.65) LNR was 2.11 (1.49-3.00) and 3.19 (2.12-4.80), respectively, compared to low-risk LNR (≤0.20) patients (p<0.001). On the other hand, the hazard of death of pN2 and pN3 patients was 2.17 (1.42-3.30) and 2.41 (1.53-3.78), respectively (p<0.001), and the hazard of intermediate (0.21-0.65) and high-risk (>0.65) LNR patients was 1.70 (1.13-2.56) and 2.74 (1.75-4.28), respectively (p≤0.001). CONCLUSION: Higher pN and LNR were associated with shorter disease-free survival and overall survival times.

Advanced Clinical Stage at Diagnosis of Breast Cancer Is Associated with Poorer Health-Related Quality of Life: A Cross-Sectional Study.

OBJECTIVE: To describe the clinical stage in women diagnosed with breast cancer and the association between clinical stage and Health-related quality of life (HRQoL). MATERIALS AND METHODS: This was a cross-sectional study involving women diagnosed with breast cancer. HRQoL was assessed with European Organization for Research and Treatment of Cancer 30-Item Quality of Life Questionnaire and the Quality of Life Questionnaire Breast Cancer 23. The principal exposure was clinical stage (

Health-related Quality of Life in Women with Cervical Cancer.

OBJECTIVE: To analyze the factors associated with health-related quality of life (HRQoL) in women with cervical cancer (CC) in a single center in Rio de Janeiro, state of Rio de Janeiro, Brazil. METHODS: A cross-sectional study in women with a diagnosis of CC followed-up in the gynecology outpatient clinic of the Hospital do Câncer II (HCII, in the Portuguese acronym) of the Instituto Nacional de Câncer (INCA, in the Portuguese acronym). The data were collected from March to August 2015. Women with palliative care, communication/cognition difficulty, undergoing simultaneous treatment for other types of cancer, or undergoing chemotherapy and/or radiation therapy were excluded. For the evaluation of the HRQoL, a specific questionnaire for women with CC was used (Functional Assessment of Cancer Therapy - Cervix Cancer [FACT-Cx]). The total score of the questionnaire ranges from 0 to 168, with higher scores indicating a better HRQoL. RESULTS: A total of 115 women were included in the present study, with a mean age of 52.64 years old (standard deviation [SD] = 12.13). The domains of emotional (16.61; SD = 4.55) and functional well-being (17.63; SD = 6.15) were those which presented the worst scores. The factors that had an association with better HRQoL in women with CC were having a current occupation, a longer time since the treatment and diagnosis, and women who had undergone hysterectomy. CONCLUSION: Considering the domains of HRQoL of the women treated for cervical cancer, a better score was observed in the domains of physical and social/family well-being. For most domains, better scores were found between those with a current occupation, with a longer time after the diagnosis and treatment, and among those who had undergone a hysterectomy.

OBJETIVO: Analisar os fatores associados à qualidade de vida em mulheres com câncer de colo do útero tratadas em um hospital de referência no Rio de Janeiro, RJ, Brasil. MéTODOS: Estudo transversal em mulheres com diagnóstico de câncer do colo do útero em seguimento ambulatorial no Hospital de Câncer II (HCII) do Instituto Nacional de Câncer (INCA). Os dados foram coletados no período de março a agosto de 2015. Foram excluídas as mulheres em cuidados paliativos, com dificuldade de comunicação/cognição, que estavam em tratamento simultâneo para outros tipos de câncer, ou em quimioterapia e/ou radioterapia. Para a avaliação da qualidade de vida relacionada à saúde, foi utilizado um questionário específico para mulheres com câncer de colo do útero (Avaliação Funcional da Terapia do Câncer ­ Câncer Cervical (FACT-Cx, na sigla em inglês). O escore total do questionário varia de 0 a 168, com escores mais altos indicando melhor qualidade de vida relacionada à saúde. RESULTADOS: Foram incluídas 115 mulheres com uma média de idade de 52,64 anos (desvio padrão [DP] = 12,13). Os domínios de questões emocionais (16,61; DP = 4,55) e de bem-estar funcional (17,63; DP = 6,15) foram os que apresentaram os piores escores. Os fatores que tiveram associação com melhor qualidade de vida relacionada à saúde em mulheres com câncer de colo do útero foram ocupação atual, maior tempo após o tratamento e diagnóstico, e mulheres que haviam sido submetidas a histerectomia. CONCLUSãO: Considerando os domínios da qualidade de vida relacionada à saúde de mulheres tratadas para câncer do colo do útero, foi observado melhor escore nos domínios de bem-estar físico e social. Para a maioria dos domínios, os melhores escores foram observados entre aquelas com ocupação atual, com mais tempo após o diagnóstico e tratamento, além daquelas que se submeteram a histerectomia.

Effectiveness of four inflammatory markers in predicting prognosis in 2374 women with breast cancer.

OBJECTIVE: To analyze the association between four biomarkers and overall survival in patients with breast cancer (BC). METHODOLOGY: This cohort study had a sample of 2374 women over the age of 18, diagnosed and treated in a single reference center for BC in Brazil, during the year 2008-2009. The following pretreatment indices were analyzed: neutrophil-lymphocyte ratio (NLR), a derived neutrophil-lymphocyte ratio (dNLR), absolute neutrophil count (ANC) and platelet-lymphocyte ratio (PLR). A descriptive analysis was performed using median (range) and absolute and relative frequency as categorical variables. Exploratory survival evaluation was performed using the Kaplan-Meier method and the log-rank test for comparison between survival curves, with a statistical significance level of 5%. The variables with p<0.20 were selected for inclusion in a multivariate Cox regression model, considering as statistically significant p<0.05. RESULTS: After adjusting for clinical variables, the biomarkers associated with worse overall survival were NLR >5 (HR=1.66 95%CI 1.08-2.55; p=0.021) and PLR >300 (HR=1.82 95%CI 1.10-2.99; p=0.019). When stratified by molecular subtype, the independent markers related to death were PLR >300 for triple negative (HR 3.27 95%CI 1.38-7.76; p=0.007); NLR >5 (HR 2.47 95%CI 1.16-5.28; p=0.019), ANC >7500 (HR 1.84 95%CI 1.17-2.90; p=0.008) and dNLR >3 (HR 2.45 95%CI 1.29-4.66; p=0.006) for luminal. CONCLUSION: NLR and PLR are independent markers of prognosis in BC. Further studies are needed in patients with overexpression of HER 2.

Men and women show similar survival rates after breast cancer.

PURPOSE: To compare the disease-free survival (DFS) and overall survival (OS) rates of men and women undergoing treatment for breast cancer. METHODS: A retrospective cohort study of patients with breast cancer diagnosed and treated at the Cancer Hospital III of the National Cancer Institute of Brazil, Rio de Janeiro, Brazil, between 1999 and 2013. Male breast cancer cases were matched for age, year of diagnosis, and clinical staging to three female cases (1:3). Patient characteristics were abstracted from hospital records and medical charts. Cases were analyzed using descriptive statistics, and comparisons between the genders were performed using Kaplan-Meier curves and Cox regression analysis with 95% confidence intervals. RESULTS: The study population comprised 98 men and 294 women. There were significant differences (p < 0.05) between the genders for marital status, alcohol consumption, smoking, presence of hypertension and other comorbidities, histological type of tumor, expression of estrogen receptors, progesterone receptors, human epidermal growth factor receptor-type 2, type of breast surgery, neoadjuvant chemotherapy, adjuvant radiotherapy, and use of palliative bisphosphonate therapy. Five- and 10-year DFS rates were, respectively, 80.0 and 51.4% for men and 71.4 and 63.5% for women (p = 0.245), and 5- and 10-year OS rates were, respectively, 65.0 and 47.5% for men and 56.5 and 41.4% for women (p = 0.221). CONCLUSION: There was no significant difference in prognosis (DFS and OS rates) between the genders, but significant differences in sociodemographic and clinical characteristics were detected between male and female breast cancer cases.

Alcohol consumption and the risk of cancer in Brazil: A study involving 203,506 cancer patients.

This study aims to analyze the association between alcohol consumption and the risk of developing the most common types of cancer in the Brazilian population. It is a case-control study in which the most common types of cancer were considered as cases and non-melanoma skin cancers as controls. Data were routinely obtained by hospital-based cancer registrars. Individuals between 18 and 100 years old, diagnosed between January 1, 2000 and December 31, 2009, with information regarding alcohol consumption, were included. The odds ratio (OR) for each type of cancer was calculated, adjusting for confounding variables. The etiologic fraction (EF) was calculated in cases with statistically significant results. The study included 203,506 individuals (110,550 women and 92,956 men), with an average age of 59 years. A statistically significant association was found between alcohol consumption and increased risk of cancers of the respiratory and digestive systems, prostate, and female breast. The association between alcohol consumption and cancers of the urinary tract, male genital organs, and other neoplasias was not statistically significant. Consumption of alcoholic beverages increased the risk of developing cancer of the nasal cavity, pyriform sinus, oral cavity, oropharynx, nasopharynx, larynx, hypopharynx, lung, esophagus, stomach, liver, pancreas, breast, prostate, colon and rectum, and anus and anal canal.

Quality of Life and Volume Reduction in Women with Secondary Lymphoedema Related to Breast Cancer.

Purpose. To assess the quality of life (QOL) as a predictor of volume reduction in women undergoing complex physical therapy (CPT) for lymphoedema following breast cancer. Methods. Clinical trial in 57 women undergoing CPT. Results. At baseline, in measuring quality of life for the EORTC QLQ-C30 questionnaire subscale of functionality, the worst scores for emotional function (55 points) and better social function (89 points) were observed. The symptom scales showed the worst pain averaged (66 points). The overall quality of life showed a low score (40 points). In the BR 23 module, low scores were observed in the field of future perspective (47 points). After treatment of lymphoedema, absolute reduction of excess volume between the upper limbs of 282 mL was observed, representing a reduction of 15%. No association was observed between the domains of quality of life and response to treatment of lymphoedema. Conclusion. This study included 57 women with advanced and chronic lymphoedema in early treatment with CPT and low scores for quality of life. The lymphoedema therapeutic response was not influenced by the QOL at the beginning of treatment.

[Determinants of late stage diagnosis of cervical cancer in Brazil]. / Determinantes do diagnóstico em estadio avançado do câncer do colo do útero no Brasil.

PURPOSE: To assess the determinants of late stage in women with cervical cancer in Brazil. METHODS: A cross-sectional study of secondary basis. Women with invasive cervical cancer enrolled in the Cancer Hospital Registry between January 2000 and December 2009 were included. Late clinical stage (≥IIB) was the outcome considered. The following variables were studied: age at diagnosis, race or ethnicity, years of education, marital status, alcohol consumption, smoking status, place of residence, year of diagnosis, initial treatment received, and status after the first treatment. Odds ratio (OR) with 95% confidence intervals (95%CI) and a logistic regression model were used. P values<0.05 were considered statistically significant. RESULTS: 37,638 cases were included, with a mean age of 52.4±14.1 years. Late clinical stages were observed in 70.6% of cases and were associated with the presence of squamous cell carcinoma (OR=1.8; 95%CI 1.7-2.0), age ≥50 years (OR=1.5; 95%CI 1.4-1.6), living with a partner (OR=1.3; 95%CI 1.2-1.4), black skin color (OR=1.2; 95%CI 1.1-1.4), and low educational level (OR=1.2; 95%CI 1.1-1.3). CONCLUSION: In Brazil, the diagnosis of cervical cancer is a delayed event. Although the main factor associated with late stage of cervical cancer identified in this study is a biological factors (histological type) and, consequently, not eligible for intervention, it was confirmed that socioeconomic disparities in the country are associated with late stage disease.

Comparison of adenocarcinoma (ACA) and squamous cell carcinoma (SCC) of the uterine cervix in a sub-optimally screened cohort: a population-based epidemiologic study of 51,842 women in Brazil.

BACKGROUND: Most cancers of the uterine cervix are SCC, but the relative and absolute incidence of ACA has risen in recent years, and ACA now accounts for approximately 20% of invasive cervical cancers in the screened populations worldwide. OBJECTIVE: To compare the epidemiological, clinical characteristics, and treatment outcomes of ACA with those of SCC of the cervix in a sub-optimally screened population. METHODS: Data from cervical cancer patients with SCC and ACA treated from 2000 through 2009 were obtained from the Brazilian Hospital Cancer Register databases. The summary odds ratios and chi-square tests were estimated. RESULTS: A total of 51,842 patients including 45,540 (87.8%) cases of SCC and 6302 (12.2%) of ACA were analyzed. Compared with the ACA patients, the SCC patients were younger and more frequently black and had a higher degree of illiteracy and alcohol and tobacco consumers. The tumor stage at the time of diagnosis was also significantly different between the two groups. However, initial therapeutic response and death rate after the first course of treatment were similar in both groups. CONCLUSIONS: Differences between ACA and SCC were observed for all demographic and clinical variables analyzed but not for responses to treatment and death at the end of the first course of treatment. Irrespective of the histological subtype, the quality of screening and treatment must be improved in developing countries, since initial therapeutic response of ACA and SCC is similar.

Quality of life as a predictor of overall survival after breast cancer treatment.

PURPOSE: To describe quality of life (QoL) in a cohort of surviving women 4 years after breast cancer treatment and to analyze its role as a predictor of mortality within 2 years. METHODS: This is a prospective cohort study of 544 women who have undergone surgical treatment, from 2001 to 2002 and who answered a questionnaire about QoL in 2006. After, we conducted a survival study to evaluate the association between QoL and mortality within 2 years with the same population. We conducted factor analysis between the variables of the scales of function and symptoms. Survival analysis was conducted by Kaplan-Meier, and differences in survival curves were assessed with the log-rank test, assuming significant statistical level of 5 %. The Cox proportional hazards regression model was used to explore the relationship between QoL variables (functional scales) and prognostic value for survival. RESULTS: The mean age of the women was 59.1 years (SD 11.66). The mean of overall QoL score was 75.16 (SD 20.93). Using factor analysis, we identified three conditions that made up the construct of QoL in this group of patients: social, psycho-emotional, and physical. Social condition was the most important factor. After assessment of QoL, the mean survival was 23 months (SD 3.90). Women who reported worse future perspective had higher chance of death compared with women better prospect of future (HR = 3.46; 95 % CI 1.36-8.79; p value = 0.009). CONCLUSION: Future perspectives were predictors of mortality, which reinforce the relevance of social support and psychological aspects for these women.

Arm symptoms and overall survival in Brazilian patients with advanced breast cancer.

INTRODUCTION: Advanced breast cancer is a very frequent serious public health problem. OBJECTIVE: This study aimed to analyze the prevalence of arm symptoms and overall survival in affected patients. METHODOLOGY: A retrospective cohort study was accomplished in 196 women presenting with advanced breast cancer. A descriptive analysis was carried out by and overall survival probabilities were calculated according to Kaplan-Meier method and Cox regression. RESULTS: These included 196 woman had a medium age of 55.9 years, the majority being obese (71.3%) and having a IIIB clinical staging (52.3%). The most prevalent arm symptoms were pain (54.6%), paresthesia in upper limb (8.5%), lymphedema (> 200 ml) (6.6%), shoulder restriction (4.7%) and axillary web syndrome (0.6%). The median follow-up was 18.7 months (SD 7,33), 4.0% of the patients had metastasis and 31.6% were dead. The mean free disease survival was 20.4 months (95% CI 18.4-22.4), and the mean survival time was 26.3 months (95% CI 24.7-28.0). After adjusted the association with arm symptom and overall survival for clinical stage and presence of distant metastasis, the shoulder restriction was a predict variable, were represents the risk 2.59 for worse survival in compared with woman with no shoulder restriction (CI 95% 1.06-5.98). CONCLUSION: The population studied at this study presented high prevalence of complications earlier than neo adjuvant treatment. After controlling for effects of tumor variables, the shoulder restriction was statistically associated with poor overall survival after 2 years.