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Background: In patients with breast cancer (BC) undergoing systemic chemotherapy, cancer-related fatigue (CRF) is a common problem that can negatively impact quality of life. Guarana ( Paullinia cupana) is a plant native to the Amazon basin that has been used as a stimulant since pre-Columbian times. Objective: The purpose of this study was to evaluate the effectiveness of guarana extract on fatigue, sleep quality, anxiety, depression symptoms, and menopause in a group of BC chemotherapy patients. Patients and methods: Patients with progressive fatigue after their first cycle of chemotherapy were randomized to receive either guarana 50 mg by mouth twice daily (32 patients) or placebo (43 patients) for 21 days. After a 7-day washout period, patients were crossed over to the opposite experimental arm. All patients were evaluated on days 1, 21, and 49. The primary endpoint was the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire score, and secondary endpoints were the results of the Functional Assessment of Chronic Illness Therapy-Endocrine Symptoms (FACT-ES), Brief Fatigue Inventory (BFI), Pittsburg Sleep Quality Index, Chalder Fatigue Scale, and Hospital Anxiety and Depression Scale. Results: Guarana significantly improved the FACIT-F, FACT-ES, and BFI global scores compared to placebo on days 21 and 49 ( p < 0.01). The Chalder Scale improved significantly on day 21 ( p < 0.01) but not on day 49 ( p = 0.27). Guarana did not produce any Common Terminology Criteria for Adverse Events grades 2, 3, or 4 toxicities and did not worsen sleep quality or cause anxiety or depression. Conclusions: Guarana is an effective, inexpensive, and nontoxic alternative for the short-term treatment of fatigue in BC patients receiving systemic chemotherapy. Further studies are needed to confirm these results and to evaluate their generalizability to chronic CRF and to other types of cancer. [ABSTRACT FROM AUTHOR]

Background: The benefit of palliative chemotherapy (PC) in patients with advanced solid tumors and poor performance status (ECOG-PS) has not been prospectively validated, which makes treatment decision challenging. We aimed to evaluate the overall survival, factors associated with early mortality, and adoption of additional procedures in hospitalized patients with advanced cancer and poor ECOG-PS treated with PC. Methods: We analyzed a retrospective cohort of patients with advanced cancer treated with PC during hospitalization at an academic cancer center in Brazil from 2014 to 2016. Eligibility criteria included: ECOG-PS 3–4 and start of first-line PC; or ECOG-PS ≥ 2 and start of second or subsequent lines. Primary endpoint was 30-day survival from start of PC. Kaplan-Meier method was used for survival estimates and Cox regression for factors associated with 30-day mortality. Results: Two hundred twenty-eight patients were eligible. 21.9, 66.7 and 11.4% of patients had ECOG-PS 2, 3 and 4, respectively. 49.6% had gastrointestinal tumors. Median follow-up was 49 days (range 1–507). 98.2% of patients had died, 32% during the index hospitalization. The 30-day and 60-day survival rates were 55.7 and 38.5%, respectively. 30% of patients were admitted to the intensive care unit. In a multivariable analysis, ECOG-PS 3/4 (HR 2.01; P = 0.016), hypercalcemia (HR 2.19; P = 0.005), and elevated bilirubin (HR 3.17; P < 0.001) were significantly associated with 30-day mortality. Conclusions: Patients with advanced cancer and poor ECOG-PS had short survival after treatment with inpatient PC. Inpatient PC was associated with aggressive end-of-life care. Prognostic markers such as ECOG-PS, hypercalcemia and elevated bilirubin can contribute to the decision-making process for these patients. [ABSTRACT FROM AUTHOR]

Purpose: The early phase of the COVID-19 pandemic affected cancer care globally. Evaluating the impact of the pandemic on the quality of cancer care delivery is crucial for understanding how changes in care delivery may influence outcomes. Our study compared care delivered during the early phase of the pandemic with the same period in the previous year at two institutions across continents (Princess Margaret Cancer Center [PM] in Canada and A.C. Camargo Cancer Center [AC] in Brazil)., Methods: Patients newly diagnosed with colorectal or anal cancer between February and December 2019 and the same period in 2020 were analyzed. Sociodemographic and clinical characteristics and performance of individual indicators within and between centers and between the peri-COVID-19 and control cohorts were tested using Cohen's h test to assess the standardized differences between the two groups., Results: Among 925 patients, distinct effects of the early COVID-19 pandemic on oncology services were observed. AC experienced a 50% reduction in patient consultations (98 v 197) versus a 12.5% reduction at PM (294 v 336). Similarly, AC experienced a higher proportion of stage IV disease presentations (42.9% v 29.9%; P = .015) and an increase in treatment delay (61.9% v 9.7%; P < .001) compared with prepandemic. At PM, a 10% increase in treatment interruption (32.4% v 22.3%; P < .001) and a higher rate of discontinuation of radiotherapy (9.4% v 1.1%; P < .001) were observed during the pandemic. Postsurgical readmission rates increased in both AC (20.9% v 2.6%; P < .001) and PM (10.5% v 3.6%; P < .01)., Conclusion: The early phase of the COVID-19 pandemic affected the quality of care delivery for colorectal and anal cancers at both centers. However, the magnitude of this impact was greater in Brazil.

Purpose: The utility of administering fluorouracil (5-FU) in bolus in regimens of infusional 5-FU has been questioned. We aimed to quantify the use of 5-FU bolus in infusional regimens for gastrointestinal malignancies among Brazilian oncologists., Methods: This was a cross-sectional electronic survey composed of eight multiple-choice questions sent to Brazilian oncologists during 14 days in February 2021. The survey instrument collected demographic data of participants and assessed practices in terms of 5-FU bolus use. We evaluated the association of demographic variables and 5-FU prescribing patterns with Fisher's exact test (odds ratio [OR])., Results: The survey was completed by 332 medical oncologists. Overall, 37% were experienced oncologists and 32% were gastrointestinal specialists. In the first-line metastatic and in the adjuvant settings, 40% and 67% of oncologists always prescribe 5-FU bolus in infusional regimens, respectively. Experienced oncologists more frequently omit 5-FU bolus when compared with early-career oncologists, both in the metastatic (41% v 26%; OR, 1.98; P = .005) and adjuvant settings (28% v 14%; OR, 2.32; P = .003). In addition, more GI specialists remove 5-FU bolus when compared with generalists, but only in the metastatic setting (44% v 25%; OR, 2.33; P = .001). GI specialists are more likely to consider that treatment efficacy is not affected by 5-FU bolus withdrawal than are generalists (89% v 75%; OR, 2.65; P = .003). Most respondents (67%) keep leucovorin at the same doses when omitting 5-FU bolus, and only 16% always recommend dihydropyrimidine dehydrogenase testing., Conclusion: Our survey indicates that experience in oncology practice and percentage of time dedicated to treat GI cancers influence the prescription of 5-FU bolus in Brazil, with more frequent omission of it among experienced gastrointestinal specialists, particularly in the metastatic setting., Competing Interests: Anelisa K. CoutinhoConsulting or Advisory Role: Amgen, Bayer, Roche/Genentech, Merck Serono, MSD Oncology, Sanofi/Aventis, Servier, United MedicalSpeakers' Bureau: Amgen, Bayer, Lilly, Roche/Genentech, Merck Serono, MSD Oncology, Roche Molecular Diagnostics, Sanofi/Aventis, Novartis, Servier, United Medical, Johnson & Johnson/Janssen, AstraZenecaResearch Funding: Bristol Myers Squibb, Servier Rui Fernando WeschenfelderHonoraria: Bayer, Lilly, MSD, Ipsen, NovartisConsulting or Advisory Role: Bayer, Lilly, MSD, Novartis, Ipsen Duilio RochaConsulting or Advisory Role: NovartisSpeakers' Bureau: Novartis, Ipsen, Bayer, Merck Serono, United Medical, Servier Aline Chaves AndradeSpeakers' Bureau: Bayer Gustavo dos Santos FernandesHonoraria: Roche, MSD Oncology, BayerResearch Funding: Roche, Memorial Sloan-Kettering Cancer Center, BMS BrazilTravel, Accommodations, Expenses: Roche Paulo Marcelo HoffLeadership: Oncologia D'OrStock and Other Ownership Interests: OncoStar Oncology ClinicsHonoraria: Bayer Health, United MedicalConsulting or Advisory Role: United Health Group, Bayer, Lilly, ExelixisResearch Funding: Bayer, MSD Oncology, Novartis, Exelixis, Roche/Genentech, AstraZeneca/MedImmune, Lilly Rodrigo DienstmannEmployment: OncoclínicasConsulting or Advisory Role: Roche, Boehringer IngelheimSpeakers' Bureau: Roche, Ipsen, Sanofi, MSD Oncology, Servier, Amgen, LibbsResearch Funding: Merck Matheus Costa e SilvaEmployment: Grupo Oncoclínicas, Rede D'Or São Luiz Rachel P. RiechelmannHonoraria: Novartis, Amgen, MSD Oncology, Servier, Roche/GenentechConsulting or Advisory Role: Bayer, Roche/Genentech, Ipsen, Astellas PharmaResearch Funding: Bayer, Roche/Foundation Medicine, AmgenNo other potential conflicts of interest were reported.

Purpose: COVID-19 has affected cancer care worldwide. Clinical trials are an important alternative for the treatment of oncologic patients, especially in Latin America, where trials can be the only opportunity for some of them to access novel and, sometimes, standard treatments., Methods: This was a cross-sectional study, in which a 22-question survey regarding the impact of the COVID-19 pandemic on oncology clinical trials was sent to 350 representatives of research programs in selected Latin American institutions, members of the Latin American Cooperative Oncology Group., Results: There were 90 research centers participating in the survey, with 70 of them from Brazil. The majority were partly private or fully private (n = 77; 85.6%) and had confirmed COVID-19 cases at the institution (n = 57; 63.3%). Accruals were suspended at least for some studies in 80% (n = 72) of the responses, mostly because of sponsors' decision. Clinical trials' routine was affected by medical visits cancelation, reduction of patients' attendance, reduction of other specialties' availability, and/or alterations on follow-up processes. Formal COVID-19 mitigation policies were adopted in 96.7% of the centers, including remote monitoring and remote site initiation visits, telemedicine visits, reduction of research team workdays or home office, special consent procedures, shipment of oral drugs directly to patients' home, and increase in outpatient diagnostic studies. Importantly, some of these changes were suggested to be part of future oncology clinical trials' routine, particularly the ones regarding remote methods, such as telemedicine., Conclusion: To our knowledge, this was the first survey to evaluate the impact of COVID-19 on Latin American oncology clinical trials. The results are consistent with surveys from other world regions. These findings may endorse improvements in clinical trials' processes and management in the postpandemic period., Competing Interests: Aline B. Lara GongoraHonoraria: MSD Oncology, Amgen Denis L. JardimHonoraria: Janssen-Cilag, Roche/Genentech, Astellas Pharma, MSD Oncology, BMS Brazil, Pfizer, Libbs, MerckConsulting or Advisory Role: Janssen-Cilag, Pfizer, MSDTravel, Accommodations, Expenses: MSD, BMS Brazil, Janssen-Cilag Angelica Nogueira-RodriguesHonoraria: Roche, MSD, AstraZenecaConsulting or Advisory Role: Roche, AstraZeneca, MSD, Eisai Carlos H. BarriosStock and Other Ownership Interests: Biomarker, MedSIR, TummiHonoraria: Novartis, Roche/Genentech, Pfizer, GlaxoSmithKline, Sanofi, Boehringer Ingelheim, Eisai, MSD, Lilly, Bayer, AstraZeneca, Zodiac PharmaConsulting or Advisory Role: Boehringer Ingelheim, Roche/Genentech, Novartis, GlaxoSmithKline, Eisai, Pfizer, AstraZeneca, Libbs, MSD Oncology, United Medical, LillyResearch Funding: Pfizer, Novartis, Amgen, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Roche/Genentech, Lilly, Sanofi, Taiho Pharmaceutical, Mylan, Merrimack, Merck, AbbVie, Astellas Pharma, Biomarin, Bristol Myers Squibb, Daiichi Sankyo, Abraxis BioScience, AB Science, Asana Biosciences, Medivation, Exelixis, ImClone Systems, LEO Pharma, Millennium, Janssen, Clinica Atlantis, INC Research, Halozyme, Covance, Celgene, inVentiv Health, Merck KGaA, Shanghai Henlius Biotech, Polyphor, PharmaMarTravel, Accommodations, Expenses: Roche/Genentech, Novartis, Pfizer, BMS Brazil, AstraZeneca, MSD Oncology, Lilly Fernando MalufHonoraria: Janssen Oncology, Astellas Pharma, Bayer Schering Pharma, Merck Sharp & Dohme, Roche/Genentech, BMS Brazil, Ipsen, Sanofi/Aventis, Merck Serono, AstraZenecaConsulting or Advisory Role: Janssen Oncology, Astellas Pharma, Bayer Schering Pharma, Merck Sharp & Dohme, Roche/Genentech, BMS Brazil, Ipsen, Merck Serono, AstraZenecaResearch Funding: Janssen-Cilag, Merck Sharp & DohmeTravel, Accommodations, Expenses: Merck Sharp & Dohme, Bayer Schering Pharma Rachel RiechelmannHonoraria: Novartis, Amgen, MSD Oncology, Servier, Roche/GenentechConsulting or Advisory Role: Bayer, Roche/Genentech, Ipsen, Astellas PharmaResearch Funding: Bayer, Roche/Foundation Medicine, Amgen Henry GomesConsulting or Advisory Role: AstraZenecaSpeakers' Bureau: Roche, Novartis, AstraZeneca, Bristol Myers Squibb, LillyResearch Funding: MSD Oncology William N. WilliamHonoraria: Roche/Genentech, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Merck, Lilly, PfizerConsulting or Advisory Role: AstraZeneca, Merck, Pfizer, Bristol Myers Squibb, Bayer, RocheSpeakers' Bureau: Boehringer IngelheimResearch Funding: OSI Pharmaceuticals, Boehringer Ingelheim, Merck, Lilly, Bristol Myers SquibbTravel, Accommodations, Expenses: AstraZeneca, Merck, Bristol Myers Squibb, Roche/Genentech Camilla A. F. YamadaSpeakers' Bureau: Janssen OncologyTravel, Accommodations, Expenses: Bayer, Janssen Gilberto de Castro JuniorHonoraria: AstraZeneca, Pfizer, Merck Sharp & Dohme, Bristol Myers Squibb, Novartis, RocheConsulting or Advisory Role: Boehringer Ingelheim, Pfizer, Bayer, Roche, Merck Sharp & Dohme, Bristol Myers Squibb, AstraZeneca, Yuhan, Merck SeronoSpeakers' Bureau: AstraZeneca, Bayer, Novartis, Roche, Merck Serono, Bristol Myers Squibb, Merck Sharp & Dohme, Boehringer Ingelheim, PfizerTravel, Accommodations, Expenses: Merck Sharp & Dohme, Novartis, Pfizer, Roche, AstraZeneca, Boehringer Ingelheim, Bayer, Bristol Myers Squibb Daniela D. RosaConsulting or Advisory Role: Roche, Novartis, AstraZeneca, Lilly, GlaxoSmithKline, Sanofi, Libbs, Pfizer, Amgen, Zodiac PharmaSpeakers' Bureau: Novartis, Lilly, PfizerTravel, Accommodations, Expenses: Roche Andreia C. de MeloHonoraria: MSD Oncology, Novartis, BMS BrazilSpeakers' Bureau: BMS Brazil, MSD OncologyResearch Funding: Roche, MSD Oncology, BMS Brazil, Novartis, Clovis Oncology, AstraZenecaTravel, Accommodations, Expenses: MSD Oncology Denisse BretelConsulting or Advisory Role: Merck Oscar ArrietaHonoraria: AstraZeneca, Merck Sharp & Dohme, RocheConsulting or Advisory Role: Boehringer Ingelheim, Bristol Myers Squibb, Lilly, PfizerResearch Funding: AstraZeneca, Roche, Merck Sharp & Dohme Andrés F. CardonaHonoraria: Bristol Myers Squibb, Roche, Boehringer Ingelheim, AbbVie, Merck Sharp & Dohme, CelldexConsulting or Advisory Role: Roche, Merck Sharp & Dohme, Novartis, AstraZeneca, Bristol Myers Squibb, Foundation Medicine, Boehringer Ingelheim, Foundation for Clinical and Applied Cancer Research (FICMAC)Speakers' Bureau: Merck Sharp & Dohme, Roche, Bristol Myers Squibb, Novartis, Foundation for Clinical and Applied Cancer Research (FICMAC), Foundation MedicineTravel, Accommodations, Expenses: Merck Sharp & Dohme, Bristol Myers Squibb, Roche, Boehringer Ingelheim, Foundation Medicine Diogo A. BastosHonoraria: MSD, Roche, Bristol Myers Squibb, Janssen-Cilag, Astellas Pharma, AstraZeneca, BayerConsulting or Advisory Role: Roche, Bayer, Janssen-Cilag, MSD OncologyResearch Funding: Janssen-Cilag, Pfizer, Astellas PharmaTravel, Accommodations, Expenses: Janssen-Cilag, BayerNo other potential conflicts of interest were reported.

Little is known about the features and outcomes of Brazilian patients with pancreatic cancer. We sought to describe the socio-economic characteristics, patterns of health care access, and survival of patients diagnosed with malignant pancreatic tumors from 2000 to 2014 in São Paulo, Brazil. We included patients with malignant exocrine and non-classified pancreatic tumors according to the International Classifications of Disease (ICD)-O-2 and -O-3, diagnosed from 2000 to 2014, who were registered in the FOSP database. Prognostic factors for overall survival (OS) in the subgroup of patients with ductal or non-specified (adeno)carcinoma were evaluated using Cox proportional hazard model. The study population consists of 6855 patients. Median time from the first visit to diagnosis and treatment were 13 (Interquartile range [IQR] 4-30) and 24 (IQR 8-55) days, respectively. Both intervals were longer for patients treated in the public setting. Median OS was 4.9 months (95% confidence interval [95% CI] 4.7-5.2). Increasing age, male gender, lower educational level, treatment in the public setting, absence of treatment, advanced stage, and treatment from 2000 to 2004 were associated with inferior OS. From 2000-2004 to 2010-2014, no improvement in OS was seen for patients treated in the public setting. Survival of patients with malignant pancreatic tumors remains dismal. Socioeconomical variables, especially health care funding, are major determinants of survival. Further work is necessary to decrease inequalities in access to medical care for patients with pancreatic cancer in Brazil.

Background: The standard treatment for localized squamous-cell carcinoma of the anal canal is definitive chemoradiotherapy. A meta-analysis of published studies conducted by our group showed significantly lower rates of disease-free survival (DFS) and overall survival at 3 years among HIV-positive patients. We aimed to compare detailed treatment outcomes between the groups of HIV-positive and -negative patients., Patients and Methods: We performed a retrospective multicenter study of a comparative cohort of consecutive patients with histologic diagnosis of localized squamous-cell carcinoma of the anal canal who received definitive chemoradiotherapy. Patients' characteristics and outcomes were compared according to HIV status. The primary end points were time to complete response (CR) and DFS time., Results: From June 2001 to September 2018, a total of 185 patients were included; 43 (30.2%) were HIV positive and 142 (69.8%) were HIV negative. The overall CR rates were 67.4% and 91.5% for HIV-positive and -negative patients, respectively (P < .001). The median follow-up was 47.8 months and the median time to experience CR was 7.8 months (95% confidence interval [CI], 5.7-10.5) for HIV-positive versus 4.89 months (95% CI, 4.54-5.25) for HIV-negative (P < .001) patients. The median DFS times were 79.7 months (95% CI, 56.8-102.6) and 127.9 months (95% CI, 112.6-143.2) for HIV-positive and -negative patients, respectively (P = .02). There was a trend toward greater grade 3/4 toxicity in the HIV-positive group., Conclusion: HIV-positive patients take longer to experience CR and present worse DFS. These findings have clinical implications because waiting longer to define CR among these patients may prevent unnecessary anorectal amputations., (Copyright © 2020 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Postoperative complications after gastric cancer resection vary in different series and they might have a significant impact in long-term outcomes. Our aim was to build a prediction rule on gastric cancer patients' overall and major morbidity risks., Methods: This retrospective study included 1223 patients from a single center who were resected between 1992 and 2016. Overall and major morbidity predictors were identified through multiple logistic regression. Models' performances were assessed through discrimination, calibration, and cross-validation, and nomograms were constructed., Results: The mean age was 61.3-year old and the male gender was more frequent (60%). The most common comorbidities were hypertension (HTN), diabetes, and chronic obstructive pulmonary disease (COPD). A D2-distal gastrectomy was the most frequent procedure and 87% of all lesions were located in the middle or distal third. Age, COPD, coronary heart disease, chronic liver disease, pancreatic resection, and operative time were independent predictors of overall and major morbidity. The extent of resection and splenectomy was associated with overall events and HTN with major ones. Both models were very effective in predicting events among patients at higher risk., Conclusions: The overall and major morbidity models and nomograms included clinical- and surgical-related data that were very effective in predicting events, especially for high-risk patients., (© 2019 Wiley Periodicals, Inc.)

Background: The Consent Form (CF) is an important document that informs patients about benefits and risks of a study, it assures patients the right to accept or reject participation in a procedure related to their health. Some authors believe that Consent Forms are complex and difficult to read for most people., Objective: Correlate the difficulty of understanding CF, through the Flesch Index (FI) and Flesch-Kincaid Index (FKI), used in our oncology outpatient clinic, with the profile of our patient's education. We also wanted to verify readability and presence of the information which must be part of these CF according to item IV.1 from Resolution 196/96 of the Brazilian Health Council., Results: We obtained 10 CFs, according to FI and FKI the mean was 38.5 and 18.16 respectively, indicating that, at least, 18 years of study are needed for the comprehension. This result is incompatible with the Brazilian population where more than 50% have less than 8 years of study. According to the quality of the CF, they were well elaborated, and had most of the necessary contents. When the authors correlated FKI and quality of CF, they concluded that the quality of CF does not correlate with readability (p= 0.884, Pearson correlation coefficients 0.053)., Conclusion: Despite the good content quality of most of the analyzed CF, their level of reading difficulty is not compatible with the literacy skills of a major part of the Brazilian population.

Background: To evaluate the prognostic value of the ratio between positive and total dissected lymph nodes in patients with colon cancer who underwent primary tumor surgical resection., Methods: Retrospective chart review of consecutive patients with colon cancer treated at hospitals affiliated to the ABC Foundation School of Medicine, Santo André. Demographic data were collected as well as information on colon cancer, treatment and clinical outcomes., Results: One hundred and six patients were included. Mean age was 62.82+/-11.6 years and most were men (53.8%). Median number of lymph nodes dissected per patient was 11.5 (3-45 lymph nodes) and 58.5% had more than 10 dissected lymph nodes. The median follow-up was 25.05+/-15.21 months (2-64 months). In univariate analysis for overall survival, lymph node ratio (p=0.044), tumor stage (p=0.001) and tumor recurrence (p=0.058) were considered significant. In multivariate analysis only tumor stage was significantly associated with overall survival (p=0.001)., Conclusion: In this limited retrospective series, the ratio between positive and dissected lymph nodes was not independently associated with overall survival among patients with colon cancer, when considered together with the pathological stage. Larger and prospective studies are warranted to define the impact of such ratio on the overall survival of colon cancer patients.