Ethnic disparities in breast cancer patterns in Brazil: examining findings from population-based registries.

PURPOSE: To investigate breast cancer (BC) incidence and mortality rates among specific racial groups in Brazil. METHODS: BC incidence was evaluated from 2010 to 2015, using Brazilian Population-Based Cancer Registries, incorporating crude ratios and annual average percentage change (AAPC). Clinical and sociodemographic data from 2000 to 2019 were obtained from Hospital-Based Cancer Registries. Mortality data from 2000 to 2020 were sourced from the National Mortality Information System, comparing White women and Black women. RESULTS: Across 13 Brazilian registries, 70,896 new BC cases were reported from 2010 to 2015. The median BC incidence rate was notably higher for White women (101.3 per 100,000) compared to Black women (59.7 per 100,000). In the general population, non-significant decrease in annual BC incidence was observed (AAPC = - 1.2; p = 0.474). Black women were more likely to live in underdeveloped areas, have lower education levels, live without a partner, and have higher alcohol consumption as compared to White women. A higher proportion of Black women received advanced-stage diagnoses (60.1% versus 50.6%, p < 0.001). BC-related mortality analysis showed 271,002 recorded deaths, with significant increase in BC-specific mortality rates in both racial groups. Black women displayed an AAPC of 2.3% (p < 0.001), while White women demonstrated a moderately elevated AAPC of 0.6% (p < 0.001). CONCLUSION: This study underscores the need for targeted policies to address disparities in access to early detection and proper treatment, particularly for Black women in underprivileged regions, aiming to improve the survival rates of Brazilian women grappling with BC.

Efficacy, safety of and adherence to adjustable compression wraps in the control phase of breast cancer-related lymphedema: A randomized controlled trial.

OBJECTIVE: To evaluate efficacy, safety, and adherence to using adjustable compression wraps (ACWs) for upper limb volume control in women with breast cancer-related lymphedema. DESIGN AND SETTING: Randomized controlled trial at a reference hospital for breast cancer treatment in Brazil. PARTICIPANTS: Women in control phase of the breast cancer-related lymphedema. INTERVENTIONS: Compared use of ACWs versus compressive mesh. MAIN MEASURES: Evaluated before treatment, at 30 days, and 6 months after initiating therapy. The primary outcome was the change in excess limb volume. Secondary outcomes included adherence, incidence of adverse events, functionality, quality of life, and hand grip. Statistical analysis involved calculating the effect size (ES) with a 95% confidence interval. RESULTS: Were included 71 women with mean excess limb volume of 321.79 mL (±194.98). In the 30-day analysis (Time 1), a reduction of 37.6 mL in volume was observed only in the ACW group (p = .041, ES 0.20), with improved functionality (p = .013, ES 0.22). In the six months analysis (Time 2), the compressive mesh group increased by 2.48% in volume (p = .023, ES 0.26) and demonstrated improvement functionality (p = .036, ES 0.27). Mild adverse events and satisfactory adherence were observed. However, in the intergroup comparison, no statistically significant difference was observed for any evaluated outcome-excess volume, incidence of adverse events, adherence, hand grip, quality of life, and functionality between the groups (p > .05) at both times. CONCLUSIONS: Both compression therapies achieved satisfactory adherence, were safe, effective and equivalent for controlling limb volume in breast cancer-related lymphedema.

Effectiveness of mat pilates on fatigue in women with breast cancer submitted to adjuvant radiotherapy: randomized controlled clinical trial.

PURPOSE: This clinical trial aimed to evaluate the influence of Mat Pilates and time on the change in fatigue scores in women with breast cancer undergoing adjuvant radiotherapy (RT). Additionally, assess the adherence and adverse effects of Mat Pilates sessions and the association of the level of physical activity with severe fatigue symptoms. METHODS: One hundred fifty-six patients with non-metastatic breast cancer were randomized to usual care or supervised Mat Pilates exercise. Fatigue and physical activity level were measured at baseline, end of RT, 30 days, 3 and 6 months after RT. The generalized estimating equation (GEE) with intention to treat was applied. RESULTS: A significant difference in the fatigue mean between the end of RT and the baseline was found in patients of both groups. There was no adverse effect with the practice of Mat Pilates, and it was analyzed the reduction of the symptom pain after the end of RT in women of intervention group compared to the control. There was no significant effect on fatigue between the groups. Patients with severe fatigue after 3 and 6 months of RT reported a significantly lower level of physical activity in the last periods. CONCLUSION: Fatigue levels increased at the end of RT but returned to baseline values after 6 months. A lower level of physical activity was associated with severe fatigue symptoms. Mat Pilates was safe for these women and reduced the symptom pain after treatment, but it did not successfully reduce fatigue during adjuvant RT. REGISTRATION: NCT03333993. November 7, 2017.  https://clinicaltrials.gov/ct2/show/NCT03333993?term=breast+cancer&cond=pilates&draw=2&rank=1 .

Primary diffuse large B-cell lymphoma of the head and neck in a Brazilian single-center study.

OBJECTIVES: Lymphomas represent around 10% of head and neck neoplasms, among which the diffuse large B-cell lymphoma (DLBCL) is the most common histologic subtype. In the present study, we characterized demographic parameters, anatomical sites, and survival rates of patients in a Brazilian cancer center. MATERIALS AND METHODS: Single-center retrospective epidemiological study of 243 head and neck DLBCL patients. Demographic characteristics, tumor localization, HIV status, lactate dehydrogenase (LDH) activity, and treatment modality were obtained from electronic medical records. RESULTS: The most common primary head and neck tumor location in patients with DLBCL was Waldeyer's ring. Interestingly, age above 80 years, male gender, high LDH levels, and HIV positivity were significantly associated with shorter overall survival (OS) rates and increased risk of death. We further demonstrated that treatment had a protective effect, improving OS, and reducing risk of death. Notably, we found no benefit of combination of chemotherapy and radiotherapy versus isolated treatment modalities. CONCLUSION: The study showed that primary head and neck DLBCL is more incident in middle age and elderly patients with a small male patients' majority in a Brazilian population. Moreover, we observed a 3-year OS rate of almost 60% and multivariate analysis showed that treatment was the only protective factor.

Epidemiology of tongue squamous cell carcinoma: A retrospective cohort study.

OBJECTIVE: To analyze the epidemiological profile and the specific survival of patients diagnosed with tongue squamous cell carcinoma at the National Cancer Institute (INCA). MATERIALS AND METHODS: Hospital Cancer Registry System Data and Mortality Information from 2007 to 2009 were retrieved in a retrospective cohort study of patients diagnosed with tongue squamous cell carcinoma. Specific survival was estimated using the Kaplan-Meier method. The association between independent variables and the risk of death was explored in a Cox proportional hazards regression model. RESULTS: A total of 346 patients were eligible, mostly male (77.5%), smokers (87.6%), with alcohol consumption (80.9%), with low education (65.6%), advanced staging at the time of diagnosis (71.1%), and presenting a high mortality rate (72.5%). In total, 44.5% of patients underwent a surgical approach alone or associated with another treatment modality, of which 85.1% of patients underwent neck dissection and 90.1% had free surgical margins. Specific survival was 40.6% in two years and 31.2% in five years. CONCLUSION: The 5-year specific survival was considered worse in individuals over 60 years, and who did not undergo surgical treatment or had surgery associated with another treatment, compared to patients undergoing isolated surgery.

Prognostic factors for brain metastasis in women presenting cervical cancer.

PURPOSE: Although rare, brain metastases (BM) from cervical cancer (CC) are highly lethal. Adequate patient selection for specific treatments can improve survival rates in patients afflicted by this condition. This study aimed to describe the characteristics of CC patients who developed BM and overall survival-associated factors. Brain metastasis impact on the overall survival was assessed as a secondary objective. METHODS: This assessment comprises a retrospective cohort study on 3394 women presenting CC diagnosed between January 2010 and December 2017 at a single referral center. Incident BM cases were included. Descriptive statistics were calculated. Kaplan-Meier curves were used for the survival analysis and a Cox proportional hazards regression model was applied to explore the risk of death according to the analyzed independent variables. RESULTS: A total of 48 incident BM cases were identified. The median time between CC diagnosis and BM development was 1.5 years. Headaches (29.2%), dizziness/altered balance (29.2%), vertigo (29.2%) and motor disturbances (25.0%) were the most common signs and symptoms at presentation. Median overall survival after BM diagnosis was of 1.6 months (95% CI 0.9-2.3) while in the group of women without BM it was 5.5 years (95% CI 4.9-6.1). Concerning the Cox multivariate analysis, presenting one extracerebral metastases site (HR 2.8; 95% CI 1.3-6.2; p = 0.009) and receiving supportive treatment (HR 13.7; 95% CI 3.1-60.5; p 0.001) were independently associated with the risk of death. CONCLUSION: The median survival of women with BM following CC was poor. Women without extracerebral metastases and undergoing multimodal treatment displayed better overall survival rates.

Incidence and risk factors associated with the development of metastatic spinal cord compression due to bone metastasis in women with cervical cancer.

PURPOSE: The aim of this study was to determine the incidence and factors associated with the development of metastatic spinal cord compression (MSCC) after cervical cancer (CC). METHODS: This retrospective cohort of 3551 women with CC who underwent treatment at the Brazilian National Cancer Institute were included in the study. Clinical and sociodemographic variables were obtained from the Hospital Cancer Registry and from hospital records. A descriptive study of the population was carried out, using means and standard deviations or frequencies and percentages. The Kaplan-Meier curve was used to identify annual incidence rates. Associations between the independent variables and the outcome (MSCC) were evaluated by a univariate analysis, applying crude and adjusted odds ratios (aOR) assuming 95% confidence intervals. RESULTS: The MSCC incidence was of 1.5% (n = 51), associated to advanced staging (aOR = 2.65, 95% CI: 1.45-4.85, p = 0.001) and initial treatment with concomitant chemotherapy and radiotherapy (aOR = 4.40, 95% CI: 1.74-11.13, p = 0.002). CONCLUSIONS: Our findings revealed the incidence and factors associated with MSCC, indicating a subset of patients who may be potential targets for the prevention and early treatment of this condition, indicating unprecedented and relevant data for the Brazilian epidemiological scenario due to the high CC incidence rates.

Clinical Experience with Compression Taping to Treat Seroma After Breast Cancer Surgery: A Medical Device Clinical Study.

OBJECTIVE: To evaluate the safety of compressive taping in patients with seroma secondary to breast cancer surgery. METHODS: This study was a nonrandomized clinical study of medical devices applied to women indicated for seroma aspiration puncture after breast cancer surgery in a public reference hospital in Brazil. The intervention consisted of applying compressive taping over the seroma fluctuation area and maintained for 5 days. Evaluated outcomes comprised dermal changes caused by taping, subjective symptoms reported during the intervention period, and percent change in the punctured volume before and after the intervention. RESULTS: A total of 35 women (mean age, 56.7 ± 12.2 years) were included. Most presented with an advanced disease stage (≥IIB; 62.9%). Although a 28.6% incidence of dermal changes caused by taping was observed, an average reduction in the aspirated volume of -28.2 mL was identified (95% confidence interval, -48.3 to -8.0; P = .008). Treatment adherence was high (91.4%), and most patients reported satisfaction with the treatment (85.7%). CONCLUSIONS: The use of compressive taping on seroma areas can be considered safe, is well accepted by patients, and might be used as a noninvasive treatment option for seroma developing after breast cancer surgery.

Higher severity and risk of in-hospital mortality for COVID-19 patients with cancer during the year 2020 in Brazil: A countrywide analysis of secondary data.

BACKGROUND: Coronavirus disease 2019 (COVID-19) and cancer are serious public health problems worldwide. However, little is known about the risk factors of in-hospital mortality among COVID-19 patients with and without cancer in Brazil. The objective of this study was to evaluate the risk factors of in-hospital mortality among COVID-19 patients with and without cancer and to compare mortality according to gender and topography during the year 2020 in Brazil. METHODS: This was a secondary data study of hospitalized adult patients with a diagnosis of COVID-19 by real-time polymerase chain reaction testing in Brazil. The data were collected from the Influenza Epidemiological Surveillance Information System. RESULTS: This study analyzed data from 322,817 patients. The prevalence of cancer in patients with COVID-19 was 2.3%. COVID-19 patients with neurological diseases and cancer had the most lethal comorbidities in both sexes. COVID-19 patients with cancer were more likely to be older (median age, 67 vs 62 years; P < .001), to have a longer hospital stay (13.1 vs 11.5 days; P < .001), to be admitted to the intensive care unit (45.3% vs 39.6%; P < .001), to receive more invasive mechanical ventilation (27.1% vs 21.9%), and to have a higher risk of death (adjusted odds ratio [aOR], 1.94; 95% confidence interval [CI], 1.83-2.06; P < .001) than those without cancer. Patients with hematological neoplasia (aOR, 2.85; 95% CI, 2.41-3.38; P < .001) had a higher risk of mortality than those with solid tumors (aOR, 1.83; 95% CI, 1.72-1.95; P < .001) in both sexes. CONCLUSIONS: Brazilian COVID-19 patients with cancer have higher disease severity and a higher risk of mortality than those without cancer.

Comparison of the performance of four staging systems in determining the prognosis of breast cancer among women undergoing neoadjuvant chemotherapy.

PURPOSE: Different tumor-related factors have been proposed to assess the risk of disease progression and death in women undergoing neoadjuvant breast cancer chemotherapy. Recently, besides the classical pre-treatment clinical stage (CS) and post-treatment pathologic stage (PS), estrogen receptor status and histologic grade (CPS + EG score) and HER2 results (Neo-Bioscore) have also been added to this suite of staging systems, generating new scores. The present study aims to compare the performance of these four staging systems, namely CS, PS, CPS + EG and Neo-Bioscore, in the prognosis of breast cancer in women undergoing neoadjuvant chemotherapy. METHODS: This study comprises a retrospective cohort study of female breast cancer patients diagnosed at the Brazilian National Cancer Institute, Brazil from January 2013 to December 2015. A descriptive analysis of patient characteristics was conducted, and Kaplan-Meier curves, a Cox proportional hazard analysis and Receiver Operating Characteristic (ROC) curves were developed according to the assessed staging system scores. RESULTS: A total of 803 patients were eligible for this study. Most were under 65 years old (88.0%), presented advanced tumors (clinical stage ≥ IIB 77.1%), with positive estrogen receptor (71.2%) and negative HER2 (75.7%) results. During the follow-up, 172 patients (21.4%) evolved to death. A statistical difference (p < 0.001) was observed between 5 year disease-free survival and 5 year overall survival rates according to the PS, CPS + EG and Neo-Bioscore staging systems. CONCLUSION: The PS, CPS + EG and Neo-Bioscore staging systems were proven to be equivalent to predict the prognosis of patients undergoing neoadjuvant chemotherapy.

Predictors of overall survival in non-small-cell lung cancer patients with metastatic spinal cord compression treated with short-course radiotherapy.

Metastatic spinal cord compression (MSCC) is a condition that impacts directly on the patient's prognosis. OBJECTIVE: The study purpose was to identify predictors of overall survival in non-small-cell lung cancer (NSCLC) patients with MSCC. METHODS: A cohort study involving NSCLC patients enrolled between 2008 and 2017 was performed. Sixty-four patients treated with short-course radiotherapy were included. Clinical and socio-demographic data were extracted from medical records. Data were analysed using survival analysis and Cox proportional hazard regression analysis. RESULTS: The median survival time was 2.5 months (95% CI: 1.6-3.5). Patients >60 years had shorter survival than younger patients (HR 1.85; 95% CI 1.06-3.24; p = 0.02), and patients with performance status (PS) >2 had shorter survival than those with PS≤2 (HR 1.93; 95% CI 1.12-3.33; p = 0.01). CONCLUSION: This study found worse PS and higher age are independent predictors of overall survival in NSCLC patients with MSCC treated with short-course radiotherapy after adjusting the potential confounding factors (PS, age and target therapy).

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 Non-Steroidal Anti-Inflammatory Drugs on Recurrence and Survival after Melanoma Surgery: A Cohort Study.

The aim of the study was to investigate if there was an association between intraoperative NSAID use and recurrence or survival. A cohort of patients who underwent sentinel lymph node biopsy for the treatment of cutaneous melanoma was retrospectively recruited. After applying inclusion and exclusion criteria, 516 were included (NSAIDs = 307). The 10-year melanoma-specific survival was 63.2%. Log-rank test showed no statistically significant differences in time to treatment failure, melanoma-specific survival, disease-free survival, and overall survival between the study groups. The current study did not support the use of intraoperative NSAIDs in preventing death or recurrence in patients with melanoma.

Incidence, prevalence, and factors associated with lymphedema after treatment for cervical cancer: a systematic review.

BACKGROUND: Lower limb lymphedema is a frequent and debilitating complication after cervical cancer treatment. OBJECTIVE: To evaluate the incidence and prevalence of lymphedema after treatment for cervical cancer and evaluate the factors associated with this outcome. METHODS: The study was performed according to the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) guidelines and was registered in the International Prospective Register of Systematic Reviews (PROSPERO). Eligible studies were identified through the databases Medline (via PubMed), LILACS, Scopus, and Web of Science. For the search, descriptors, keywords, and synonyms were used for cervical cancer, lymphedema, and outcomes of interest (incidence, prevalence, frequency, occurrence, morbidity, risk factors, and prognosis). Observational studies were included that were published in English, Portuguese, or Spanish, between January 1, 2013 and December 31, 2019, with frequency data and associated factors for lymphedema after cervical cancer treatment. Studies that evaluated the presence of lymphedema less than 6 months after surgery or radiotherapy and those in which frequency data were not stratified by tumor topography, were excluded. RESULTS: Twenty-three studies were included. The incidence of lymphedema varied between 0% and 69%. Different designs and methods were employed for lymphedema assessment. The main factors associated with lymphedema included extension of lymphadenectomy, number of lymph nodes removed, removal of circumflex iliac lymph nodes, and adjuvant radiotherapy. Other factors associated with lymphedema included cellulitis, lymphocyst formation, increased age, invasive lymph node staging, higher body mass index, and insufficient physical activity. CONCLUSIONS: The frequency of lymphedema after treatment for cervical cancer is variable. The different designs and methodology to measure this complication make it difficult to draw definitive conclusions about its prevalence. The method used for lymphedema assessment is not standardized.

Alcohol consumption does not increase the risk of surgical wound complications in breast cancer patients.

Alcohol consumption, despite influencing several organic processes, has been scarcely studied regarding the risk of developing surgical wound complications after surgical breast cancer treatment. The aim of this study was to analyse the association between alcohol consumption and the development of surgical wound complications in women undergoing surgical treatment for breast cancer. A prospective cohort study was conducted, comprising 486 women between 40 and 69 years old, interviewed during the preoperative period and followed up for 30 days. The occurrence of seroma, necrosis, surgical site infection (SSI), dehiscence, ecchymosis, and hematoma were considered as outcomes. Alcohol consumption during the 30 days prior to surgery was reported by 20.8% of the patients, with 8.4% being occasional consumers and 12.4% regular consumers. Binge drinking was reported by 10.2% of the women. The presence of surgical wound complications was observed in 65.2%. The most frequent complications were seroma (54.3%), necrosis (17.7%), and SSI (7.8%). No statistically significant association between alcohol consumption and the development of cicatricial complications was observed.

Survival and risk factors for mortality in pediatric patients with acute myeloid leukemia in a single reference center in low-middle-income country.

Despite advances in therapy and care for children with acute myeloid leukemia (AML), survival rates for children in low- and middle-income countries (LMICs) remain poor. We studied risk factors for mortality and survival in children with AML in a LMIC to develop strategies to improve survival for AML children in these countries. This retrospective cohort (2000-2014) analyzed newly diagnosed AML patients (age < 19 years) at a reference center in Brazil. Demographic and clinical variables were reviewed by AML subtype: acute promyelocytic leukemia (APL), AML with Down syndrome (AML-DS), and other AML subtypes. Cumulative hazard risk for early death (ED) until 6 weeks of treatment and risk factors for mortality were determined by the multivariate Cox hazard models. Survival was assessed for each AML subtypes. A total of 220 patients were diagnosed: APL 50 (22.7%), AML-DS 16 (7.3%), and other AML subtypes 154 (70.0%). The cumulative hazard function values for ED for all patients with AML were 12.5% (95% CI 8.5-18.4%); for each AML patients subtypes: APL, 21.7% (95% CI 11.7-40.5%); AML-DS, 6.2% (95% CI 0.9-44.4%); and other AML subtypes, 10.2% (95% CI 6.2-17.0%). White blood cell count (cutoff 10 × 109/L for APL and 100 × 109/L for other AML subtypes) and Afro-descendance were significant risk factors for mortality in APL and other AML subtypes, respectively. Overall survival for patients with APL, AML-DS, and other AML subtypes was 66.8%, 62.5%, and 38.0%, respectively. APL patients had the highest incidence of ED and those with other subtypes had increased relapse risk. We also observed high rates of death in complete remission mainly due to infection. Better risk classification and identification of risk factors for infection may improve the survival of these patients.

Level of human development is associated with cervical cancer stage at diagnosis.

The objective was to describe the cervical cancer cases in Brazil by the age-group and stage at diagnosis, and to associate them with the human development index (HDI), where the women live. This was a retrospective study that used data from the Brazilian hospital-based cancer registry from 2005 to 2014. The data were accessed by 5-year age/groups and the federal units. The association between the proportion of cases at Stage I and HDI was estimated in an adjusted linear regression analysis. Among the staged cases, the proportions of cases diagnosed at FIGO Stage I, II, III and IV were 21.2%, 30.7%, 39.9% and 8.2%, respectively. The cases were diagnosed mostly in women aged 45-49 years. There was a significant increase in the proportion of Stage I cases with an increasing HDI (coefficient, 0.46; 95% confidence interval, 0.17-0.76). In conclusion, most of the cases were diagnosed at late stages. The stage at the diagnosis was associated with the human development level. Impact Statement What is already known on this subject? The stage at diagnosis varies according to the level of organisation of the cancer control programme. It is expected that in well-developed programmes there will be a shift to an early stage diagnosis. What the results of this study add? The stage at a diagnosis was associated with the human development level where the women live in Brazil, where most cases were diagnosed at the late stages. What the implications are of these findings for clinical practice and/or further research? This analysis can help with better planning strategies for cancer control. Regional strategies would improve the efficiency of cancer care interventions in countries with large socioeconomic disparities.

Acute promyelocytic leukaemia is highly frequent among acute myeloid leukaemias in Brazil: a hospital-based cancer registry study from 2001 to 2012.

The WHO classification that defines subtypes of acute myeloid leukaemias (AMLs) is relatively unexplored at the population-based level. This study aimed to examine the frequency of acute promyelocytic leukaemia (APL or AML-M3) in Brazil. Data were extracted from 239 cancer centres (2001-2012) and categorized according to the International Classification of Diseases for Oncology (CID-O 3.0) and WHO classification (n = 9116). CID-O3 code 9866 identified 614 APL patients. AML not otherwise specified (NOS) was frequent, and the APL group represented the main subtype specified. The mean age of APL was lower than that of other AMLs (31.5, standard deviation (SD) 18.6 versus 40.9, SD 24.6; p < 0.001); there was a high frequency of APL in the 13-21-year-old (11.8 %) and ≤12.9-year-old (6.4 %) age groups. Time taken to begin treatment (as ≤14 days versus >14 days) and induction death rate were lower in APL than in other AML subtypes (p < 0.001). This report provides additional evidence on the distribution of APL among cases of AML in Brazil.

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.