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Background The diagnosis and treatment of cancer are complex and necessitate quaternary centers, which require technology and investment. To better serve the population, such centers should be distributed equitably among the states and according to demand. Even with public policy favoring an increase in the number of oncology centers in Brazil, it is necessary to verify the distribution of these centers, as they have a key role in the population’s access to cancer treatment. However, there are few studies evaluating this distribution in the literature. Objective To verify whether the distribution of the oncology network in Brazil meets the needs of each state. Method This is a descriptive study with data from official federal sources made available by the National Cancer Institute (Instituto Nacional do Câncer-INCA), Department of Informatics of the SUS, Ministry of Health, National Commission of Nuclear Energy (CNEN) and the Brazilian Institute of Geography and Statistics (IBGE). New cancer cases projected for 2020 were compared with data on the number and distribution of radiotherapy centers and highly complex oncology centers (CACON/UNACON) in each state. The Municipal Human Development Index (MHDI) was used to estimate the population’s access to health care in the states, along with gross domestic product (GDP), which was used to calculate the wealth of each state. Results In 2020, there were 386 CACON/UNACONs and 267 radiotherapy centers in Brazil, and 65.5% of the CACON/UNACONs and 66.7% of the radiotherapy centers were concentrated in five states (SP, RJ, MG, PR, RS). Of the cancer cases projected for 2020, 59.6% are concentrated in these five states. Among the states with lower GDP and lower education, there are three with a high number of anticipated cases for each CACON/UNACON (PB, SE and PI) and three with a high number of such cases for radiotherapy centers in PI, PB, RN); RR and AP do not have radiotherapy centers. Conclusion It can be concluded that the distribution of oncology centers is not equitable among the states because among the poorest states, there is a smaller number of centers for a greater number of cases.

SUMMARY OBJECTIVE: The aim of this study was to translate the techno-stress questionnaire proposed by Ragu Nathan et al into Brazilian Portuguese and to culturally adapt and validate it. For this, 4 of the 11 original questionnaires’ domains were used. METHODS: The questionnaires’ domains translated and adapted were as follows: techno-overload, techno-invasion, techno-complexity, and job satisfaction. Initially, the techno-stress questionnaire was translated into Brazilian Portuguese language according to international standards, followed by cultural adaptations. Validation for feasibility and psychometric properties of translated questionnaire was performed on 138 gynecologists and obstetricians who use message applications to communicate with patients. The physicians were divided into groups according to the weekly messaging application usage time for communication with patients: 5 h (GIII, n=23). The questionnaire was applied to all participants twice on the same day, overseen by two different interviewers, at a 15-min interval. After 15 days, it was readministered. The discriminant validity and reliability were calculated to validate the instrument. RESULTS: Techno-stress subscales showed statistically significant differences between the groups. The Cronbach’s alpha coefficient for the techno-stress questionnaire was >0.80, showing good internal consistency. No differences were observed in the test-retest comparison of the techno-stress questionnaire, and the intraclass correlation coefficient results showed excellent reproducibility (³0.75). CONCLUSION: The techno-stress questionnaire was adequately translated into Brazilian Portuguese, with good discriminant validity, good internal consistency, and adequate test-retest results.

SUMMARY OBJECTIVE: The aim of this study was to assess the use of smartphones’ messaging apps as a stressor affecting the well-being of gynecologists who use this tool to communicate with patients. METHODS: A cross-sectional study was conducted with gynecologists who use message applications to communicate with patients. Participants answered the WhatsApp Stress Scale, Oldenburg Burnout Inventory, and the techno-stress questionnaire. The population sample consisted of gynecologists and obstetricians selected by convenience. RESULTS: Physicians who spent more time using WhatsApp to communicate with patients had higher levels of stress (p=0.010), Burnout (p

To evaluate the perception of risk factors for cancer among medical students and how it varies among students in different years of their medical education. Cross-sectional study was conducted in 2019. The American Institute for Cancer Research Cancer Risk Awareness Survey questionnaire was administered to medical students at the Centro Universitario Saude ABC. Students were divided into those in their 1st to 3rd year and those in their 4th to 6th year of medical education. Qualitative variables were described by frequency and percentage, and quantitative variables were described by mean and standard deviation or median and interquartile range. The scores of the groups on the questionnaire were compared using Student’s t test. The 95% confidence interval was calculated, and p values

SUMMARY OBJECTIVE To relate anxiety and depression levels to the spirituality levels of oncology patients in the ABC region. METHODS Cross-sectional study performed at the ABC University Center oncology outpatient clinics. For the evaluation of spirituality, the Religiosity, Spirituality, and Personal Beliefs instrument of the World Health Organization (SRPB-WHO) was applied. To evaluate the levels of depression and anxiety, the Hospital Anxiety and Depression Scale (HADS) was applied. Qualitative variables were described by frequency and percentage, and quantitative variables by mean and standard deviation or median and range. Relationships were established using either the T-test or Wilcoxon-Mann-Whitney test and correlations with Pearson or Spearman tests, depending on the normality assessed by the Shapiro-Wilk test. RESULTS We included 99 patients, 68% female, with a median age of 60 years (19 to 81). A total of 24% had high or borderline levels of anxiety and 21% of depression. There was a negative correlation between levels of depression and spirituality (rho = -0.44, p

e23157 Background: Cancer-related fatigue (CRF) is a common symptom among patients with cancer. The efficacy of placebo, however, was never the main objective of any meta-analysis. Predicting the efficacy of placebo may facilitate researchers in designing future clinical trials for the treatment of CRF. Methods: We performed a systematic review searching for prospective clinical trials comparing any treatment versus placebo for the treatment of CRF. We included studies that enrolled patients with any primary site of neoplasia and any stage of cancer. We excluded all studies that assessed fatigue related to any treatment. The primary endpoint of this study is the mean effect of placebo on fatigue according to the Functional Assessment of Chronic Illness (FACIT-F) and Brief Fatigue Inventory (BFI) scales. The secondary endpoint was the proportion of patients who reported improvement in fatigue (response rate). Results: We found 520 studies, and 29 studies with 3,758 participants were included in the meta-analysis. Placebo had a mean effect of +4.88 (95%CI +2.45 to +7.29) using the FACIT-F scale, although it was statistically worse than the interventions studied (p = 0.005). Using the BFI scale, placebo had an average effect of +0.64 (95%CI +0.02 to +1.30), although it was also worse than the other interventions studied (p = 0.002). In terms of the response rate, 29% (95%CI 25%–32%) of patients taking a placebo reported a significant improvement in CRF compared to 36% of patients treated with other interventions (p = 0.030). Conclusions: Placebo treatments had a significant effect on CRF, and predicting these effects may help design future studies for CRF.

Introduction: Aromatase inhibitors (AI) are widely used in adjuvant breast cancer treatment, and diffuse articular pain secondary to AI use is the most common cause of treatment discontinuation. Uncaria tomentosa (cat’s claw) has antiinflammatory activity and is used to treat arthrosis and arthritis. Patients and Methods: This prospective, single-center, double-blind, randomized, placebo-controlled phase II study analyzed 70 patients with breast cancer undergoing AI therapy with complaints of arthralgia. The patients received 100 mg of the dry extract of Uncaria tomentosa three times daily for 4 weeks. At the beginning and end of the study, patients answered the Brief Pain Inventory (BPI), Disability Arm, Shoulder, and Hand (DASH), Lequesne, SF-36 Quality of Life questionnaires, completed a visual analog scale (VAS) for pain, and underwent laboratory testing. Results: U. tomentosa was not more effective than the placebo. No evidence of grade 3 or 4 toxicity was found. In addition, no significant differences were seen in laboratory results or inflammatory markers between the two study groups. Conclusion: Dry extract of U. tomentosa was safe but ineffective in reducing AI-induced arthralgia compared with the placebo. Furthermore, the plant extract had no detectable anti-inflammatory activity.

Background: Hot flashes are common in menopausal women and significantly affect the quality of life of many patients diagnosed with breast cancer for which hormone replacement therapy is not indicated. In a previous uncontrolled study, guarana (Paullinia cupana) showed significant decreases in the amount and intensity of hot flashes in this group of women. Hypothesis/Purpose: The main objective was to reduce the intensity and frequency of hot flashes with the use of PC-18, compared with placebo in women who survived breast cancer without current evidence of disease. Study Design: The present study consists of a double-blind, randomized, placebo-controlled, uni-institutional, two-arm phase II clinical trial. Methods: The experimental group received the purified dry extract of Paullinia cupana (PC-18) at a dose of 37.5 g twice daily, while the other group received placebo, also twice daily. Results: The study included 40 patients who had completed surgical, chemotherapeutic and/or radiotherapeutic treatment for more than 3 months and who were on adjuvant hormone therapy at the time of inclusion, 20 in each arm. Both groups showed significant reductions in the number and intensity of hot flashes, with no significant difference between the arms. There was a higher intensity and frequency of hot flashes in patients receiving tamoxifen compared with those who received aromatase inhibitors. The toxicities observed were not very significant. Conclusion: This concludes that PC-18 did not demonstrate significantly greater capacity than placebo for control of hot flashes in women with a history of breast cancer and adjuvant hormone therapy.

Previous studies in patients with advanced cancer have reported that Cat’s claw dry extract (Uncaria tomentosa) and Guarana (Paullinia cupana) showed beneficial effects in patients with terminal cancer. Our objective is to investigate the combined action of these extracts in the control of symptoms in these patients. This prospective, uncontrolled pilot study evaluated the use of 100 mg of U. tomentosa dry extract three times daily combined with 50 mg of P. cupana dry extract twice daily in terminal patients with solid tumors who were ineligible for traditional therapeutic approaches. Patients had blood collected and answered questionnaires (EORTC QLQ-C30, FACIT-F, Chalder Fatigue Scale, HADS and PSQI-BR) before and after 3 and 6 weeks of treatment. Twenty-two volunteers were recruited; the mean age of the population was 68.3 years (range, 49-89 years), 86.3% were men, and half had a Karnofsky Index less than or equal to 60%. We observed improvement in fatigue, measured by the Chalder Scale (p = 0.0041), and nausea, measured by the EORTC QLQ-C30 scale (p = 0.0470), without significant weight loss (p = 0.3883) or influence on quality of life as measured by the FACIT-F questionnaire (p = 0.3375). Medications were well tolerated by most participants. No significant reduction in inflammatory parameters was observed during the treatment. The combination of U. tomentosa and P. cupana extracts is safe and has potential benefits for the control of fatigue and nausea in terminal cancer patients.

Patients with breast cancer who receive weekly paclitaxel therapy may experience deleterious effects associated with prophylactic dexamethasone use for 12 consecutive weeks. Approximately 90% of paclitaxel hypersensitivity reactions (HSRs) occur within the first 10 to 15 min of the first two infusions. We investigated the feasibility of dexamethasone withdrawal between weeks 3 and 12 (W3 and W12) in early stage breast cancer patients treated with weekly paclitaxel at the standard dose (80 mg/m2). All patients received intravenous prophylaxis of dexamethasone 20 mg, ranitidine 50 mg, and diphenhydramine 50 mg in the first 2 weeks (W1 and W2) of treatment. Provided that no serious (G3/G4) HSRs events occurred, dexamethasone was omitted between W3 and W12, while ranitidine and diphenhydramine were continued. The primary end point was the incidence of any grade HSRs during the treatment period, and the secondary end points were quality of life and weight changes. Twenty-five patients were included in the study, and 300 infusion cycles of paclitaxel were evaluated for HSRs. The overall incidence of HSRs was 0.6% (2 events), and both of these events occurred in the first week. There were no incidents of serious HSRs or anaphylaxis and no G3 or G4 toxicities. Scores from the EORTC QLQ-C30 questionnaire did not change significantly for the global health status/quality of life scale or for the symptoms scales, although changes in scores differed significantly for the functional scales. There were no clinically relevant weight changes during the treatment period. Dexamethasone withdrawal from W3 to W12 in early stage breast cancer patients treated with weekly paclitaxel is feasible. The incidence of all grades of HSRs was comparable to that reported in trials with dexamethasone for 12 consecutive weeks, and no serious events (G3/G4) occurred. Studies with larger sample sizes are needed to confirm our results which are important, especially for patients for whom corticosteroids are contraindicated.

Background Currently, molecularly targeted drugs are part of the therapeutic arsenal for the treatment of many neoplasms and are responsible for improvements in the quality of life and survival of patients. Although they act on proteins and components within biochemical pathways that are expressed to a greater extent in neoplastic cells, these drugs can also interfere with the activity of normal cells. Scope This article reviews the cutaneous side effects of main molecularly targeted cancer therapies for solid tumors. Findings The use of these drugs causes side effects, and the skin is one of the most commonly affected organs. In this literature review, we discuss the adverse cutaneous effects caused by molecularly targeted drugs. Conclusion The identification of these reactions is important to both dermatologists and oncologists so that they properly diagnose the reaction and administer adequate treatment, which would allow greater adherence to the oncological treatment and improve patients' quality of life.

Fatigue is frequent among oncologic patients. Unpurified Paullinia cupana dry extract showed encouraging results for chemotherapy-induced fatigue in our previous studies. We report two randomized, double-blind studies with a standardized dry purified Paullinia cupana extract named PC-18. For both studies, we recruited early breast cancer patients who had an increase in their fatigue scores after their first cycle of adjuvant chemotherapy. In the first study, we compared an oral dose of 37.5 mg of PC-18 twice daily with placebo. In the second study, we examined PC-18 at either 7.5 or 12.5 mg orally twice daily versus placebo. In both studies, PC-18 was not superior to placebo as assessed by both Chalder and Brief Fatigue Inventory (BFI) fatigue questionnaires, probably reflecting unexpectedly good placebo antifatigue activity. Since all capsules employed in both studies contained about 100 mg of magnesium silicate as an excipient, we retrospectively evaluated frozen serum samples from the second study and found a significant increase in magnesium levels after patients received placebo. By multivariate analysis, higher prerandomization magnesium levels and higher BFI scores together with the use of a 12.5 mg dose of PC-18 all correlated significantly with higher posttreatment BFI scores. We observed no significant toxicities in any of the trials. We conclude that the absence of differences between PC-18 and placebo may be due to the unexpectedly high antifatigue activity of the placebo in these studies. Further studies evaluating the role of magnesium supplementation for chemotherapy-induced fatigue are needed.

Oncology is an essential field of medicine; however, its teaching is occasionally underemphasized and uncoordinated during medical school. An alternative method of providing additional oncological information to medical students is through extracurricular activities, such as congresses and medical student associations. The aim of this paper is to describe a Medical Student Oncology Congress entirely designed and organized by medical students. Three medical students from oncology study and research groups identified the gap in oncology training at universities and decided to organize a congress for students. They selected representatives from 26 universities in Brazil for onsite registration and created a website for online registration and promotion of the congress. To determine the topics of the lectures, they searched the medical literature for the most commonly occurring cancers in adults and children. Extrapolating the academic content of oncology, they organized lectures by non-governmental organizations (NGOs), talks on career guidance and research in this field as well as a role-playing workshop to train future doctors on how to deliver news to patients. There were a total of 609 attendees, with 590 students from 26 different universities in Brazil. Approximately 82% were medical students, and among the participants there were also 15 medical educators. A total of 80.75% of the participants were extremely satisfied with the congress, and 99.17% would recommend it to a colleague. Most of the overall cost of the congress, 96%, was covered by registration fees. There was a 6% positive net balance, which was donated to the NGOs participating in the congress. This successful experience proves that it is possible to have a congress fully designed, organized and managed by students. It demonstrates how students can be active participants in their own education, as opposed to a classic approach through which only professors are responsible for instruction.

SUMMARY INTRODUCTION: Drug interaction is an important cause of global morbidity. It is of particular importance in cancer patients since they are often in use of polypharmacy, related to interactions between the drugs and the chemotherapeutics used. OBJECTIVE: To evaluate the drug interaction between chemotherapy and other drugs in cancer patients. METHODS: a cross-sectional study carried out in the outpatient oncology department of a public tertiary hospital. Two hundred thirty-five patients were included, and the drugs they were using were identified. Using the MedScape and Epocrates database, we evaluated the interactions between medications and chemotherapy by defining their frequency and dividing their severity from interaction into mild, close monitoring necessity and severe. RESULTS: 161 patients had some drug interaction. We identified 9 types of mild interactions, 23 types of interactions with close monitoring necessity, and 2 types of serious interactions. The most frequent interactions were between fluorouracil and leucovorin (32 cases) and cyclophosphamide and doxorubicin (19 cases). Serious interactions were between aspirin and pemetrexed; and leucovorin and Bactrim. CONCLUSION: In the present study, drug interactions were frequent, including serious interactions with a potential increase in morbidity and mortality. Thus, it is necessary for oncologists to draw up a therapeutic plan considering potential interactions between prescribed chemotherapy and current medications in use by patients. RESUMO INTRODUÇÃO: Interação medicamentosa é uma importante causa de morbidade mundial. Apresenta especial importância em pacientes oncológicos, pois esses frequentemente estão em uso de polifarmácia, podendo haver interações entre os medicamentos e os quimioterápicos utilizados. OBJETIVO: Avaliar a interação medicamentosa entre a quimioterapia e outros medicamentos em pacientes oncológicos. MÉTODOS: Estudo transversal realizado em serviço ambulatorial de oncologia de um hospital público terciário. Foram incluídos 235 pacientes, identificando-se quais medicamentos eram utilizados por eles. Por meio do auxílio do banco de dados do MedScape e Epocrates, avaliaram-se as interações entre as medicações e os quimioterápicos, definindo sua frequência e dividindo sua gravidade da interação em leve, monitorização próxima e grave. RESULTADOS: Do total estudado, 161 pacientes apresentavam alguma interação medicamentosa, sendo nove tipos de interações leves, 23 tipos de interações com necessidade de monitorização próxima e dois tipos de interações graves. As interações mais frequentes foram entre fluoracil e leucovorin (32 casos) e ciclofosfamida e doxorrubicina (19 casos). As interações sérias foram entre aspirina e pemetrexed; e leucovorim e bactrim. CONCLUSÃO: No presente trabalho, interações medicamentosas foram frequentes, incluindo interações graves com potencial aumento de morbimortalidade. Assim, faz-se necessário que oncologistas tracem um plano terapêutico levando em consideração as possíveis interações medicamentosas entre a quimioterapia prescrita e demais medicações em uso pelos pacientes.

In Brazil, patients with gastric cancer have not been systematically followed-up and evaluated, thus data regarding patterns of care and outcomes are scarce or missing. The objective of this study was to evaluate patterns of care of advanced gastric cancer in standard practice in Brazil. This was an observational, multicenter, retrospective study, which included patients with metastatic and/or unresectable gastric cancer (MGC) who underwent at least one line of treatment. We analyzed data on 155 patients diagnosed with MGC, most are men (57.4%), with mean age of 61.9 years at diagnosis, with 99 (63.9%) from the public healthcare system and 56 (36.1%) from the private setting. Platinum- and/or fluoropyrimidine-containing regimens prevailed as first-line therapy, while irinotecan was the most used regimen in the second and in the third lines. More than 40% of patients underwent only one line of systemic therapy, of which around 40% either died during the treatment or went on to best supportive care (BSC) only. The remaining patients received further treatment lines. A fifth of the patients in the study died within two months after discontinuation of the first-line treatment. Adverse events, use of concomitant medications, support procedures, outpatient visits, and hospitalizations were reported for most patients, especially in the first and second lines of treatment and during exclusive BSC. Survival during or after the first-line chemotherapy remains poor among patients with MGC. Adverse events and health resource use were common in the first and second lines of treatment and in exclusive BSC. These results suggest that there is space for improvement in the treatment of MGC in Brazil.

Chemotherapy-induced fatigue (CIF) is a frequent symptom that impairs patient functioning and quality of life. We aimed to evaluate whether systemic chemotherapy can induce a specific gene expression profile in peripheral blood mononuclear cells (PBMNC) of patients with locoregional breast cancer (LRBC) who develop CIF. PBMNC were collected from 3 patients who developed CIF before and after their initial cycle of chemotherapy, and RNA-seq was performed in an Ion Torrent™ System. A total of 12.345 transcripts were sequenced, of which 26 were selected out of 71 that had significantly different expression before and after chemotherapy. The RNA-seq results were validated by RT-qPCR in a different group of 28 patients with LRBC who developed CIF after their first cycle of chemotherapy and in six patients who also received chemotherapy but did not develop CIF (controls). We assessed CIF according the BFI and Chalder Questionnaires. We observed a significant increase in expression of DUSP18 and RHOBTB1 and decreased expression of NCAN and RAET1G in patients who developed CIF after chemotherapy. Control patients only exhibited a significant decrease in NCAN expression. CIF induces specific changes in gene expression in the PBMNC of LRBC patients. Some of these changes, such as downregulation of NCAN expression, may reflect direct effects of chemotherapy since they are also observed in the controls. Furthermore, CIF may involve downregulation of skeletal muscle genes (RHOBT1, DUSP18) and immune systems (RAETG1), whereas NCAN downregulation may underlie the adverse cognitive effects of chemotherapy.

SUMMARY INTRODUCTION Structural disparities between different Brazilian regions in public health system cause patients to migrate in search of better conditions to treat their diseases. Besides patient’s discomfort, there is a concentration of care in large centres, causing overload to current capacity. OBJECTIVE To evaluate migratory flow and associated factors in a reference service in oncology. METHODS Cross-sectional study conducted at a referral oncology service in Great ABC region of São Paulo. Patients were interviewed, and clinical and demographic data collected. RESULTS Between March-July 2016, 217 patients were included. Analysis showed a divergence between the postal code registered in the medical record and that recorded during the interview in approximately 10% of cases. Of these, 42.9% were residents of other states. Search for treatment motivated most patients to seek service outside their city. CONCLUSION Results reflect the informal search for medical care outside the home area. Besides the direct impact on patients’ quality of life, migratory flow has an economic-social impact because these patients place a burden and impose costs on services of cities where they do not perform their responsibilities as citizens. Confirmation of the existence of a significant migratory flow demonstrates the need to discuss restructuring public health policies. RESUMO INTRODUÇÃO As disparidades estruturais entre diferentes regiões brasileiras no sistema de saúde pública fazem com que os pacientes migrem em busca de melhores condições para tratar suas doenças. Além do desconforto do paciente, há uma concentração de cuidados em grandes centros, causando sobrecarga da capacidade atual. OBJETIVO Avaliar o fluxo migratório e fatores associados em um serviço de referência em oncologia. MÉTODOS Estudo transversal realizado em um serviço de oncologia de referência na região do Grande ABC, em São Paulo. Os pacientes foram entrevistados e dados clínicos e demográficos coletados. RESULTADOS Entre março e julho de 2016 foram incluídos 217 pacientes. A análise mostrou uma divergência entre o código de endereçamento postal registrado no prontuário médico e o registrado durante a entrevista em aproximadamente 10% dos casos. Desses, 42,9% eram residentes de outros estados. A busca de tratamento motivou a maioria dos pacientes a buscar serviços fora de sua cidade. CONCLUSÃO Os resultados refletem a busca informal de cuidados médicos fora da área de residência. Além do impacto direto na qualidade de vida dos pacientes, o fluxo migratório tem um impacto econômico-social porque esses pacientes colocam um fardo e impõem custos aos serviços das cidades onde não executam suas responsabilidades como cidadãos. A confirmação da existência de um fluxo migratório significativo demonstra a necessidade de discutir a reestruturação das políticas de saúde pública.

Hand-foot syndrome (HFS) is common and frequently occurs in the first cycle of treatment in approximately 40% to 50% of patients who receive capecitabine. Turmeric (Curcuma longa) is a plant used in Ayurvedic medicine with clinical activity in various inflammatory conditions. Our objective was to evaluate whether turmeric was active for the prevention of capecitabine-induced HFS. We included patients older than 18 years of age without previous exposure to capecitabine who were scheduled to receive this medication. Before starting treatment, after three weeks and at the end of six weeks, we evaluated dermatologic toxicity, conducted quality-of-life questionnaires (EORTC-QLQC30 and DLQI) and collected serum inflammatory biomarkers (inerleukin-6 (IL-6), tumor necrosis factor-a (TNF-a), C-reactive protein (CRP), and albumin). We administered turmeric at a dose of 4 g/day (2 pills 12 hours apart) starting at the beginning of capecitabine treatment and lasting six weeks. We included 40 patients whose mean age was 62 years. Most were female (80%), 52% had breast cancer, and 47.5% had GI tumors. After the first cycle of capecitabine treatment, we observed that 11 of 40 patients developed HFS (27.5%; 95% CI [15, 42]), whereas four patients developed HFS equal or superior to grade 2 (10%; 95% CI [3.3, 23]). We did not find any correlations between the inflammatory markers tested and HFS. We show that turmeric combined with capecitabine seems to produce a lower rate of HFS, especially grade 2 or higher. These findings need to be reproduced in larger controlled studies.

Paullinia cupana (guaraná) is an Amazonian plant that has been previously shown to be effective in treating chemotherapy-related fatigue (CRF) in patients with breast cancer. We aimed to evaluate the efficacy of a purified dry extract of P. cupana (PC-18) in patients with various solid tumors treated with chemotherapy.We included 40 patients with solid tumors who showed increases in their Brief Fatigue Inventory (BFI) questionnaire scores after 1 week of systemic chemotherapy. PC-18 was administered at 37.5 mg by mouth two times per day (PO bid), starting after 1 week of chemotherapy, for 3 weeks (induction phase). Patients who had an improvement in or stabilization of their BFI scores were randomized to receive either PC-18 at the same dose or placebo for the following 3 weeks (maintenance phase).After PC-18 treatment, the BFI fatigue scores improved or stabilized in 36 out of the 40 patients (mean BFI score difference = 2.503; 95% confidence interval: 1.716-3.375, p = .0002). Three weeks after randomization (16 patients on PC-18 and 17 on placebo), we observed no significant differences in the BFI, Functional Assessment of Chronic Illness Therapy, Hospital Anxiety and Depression Scale, and Pittsburgh Sleep Quality Index scores between patients randomized to PC-18 versus placebo.We conclude that the PC-18 extract may be effective for the treatment of CRF in patients with a variety of solid tumors. A conditioning effect, which was observed in patients who had a beneficial effect of PC-18 on CRF, may explain the better than expected fatigue scores of the placebo-treated patients.

Chemotherapy-induced nausea and vomiting (CINV) is a distressing side effect that affects many patients undergoing emetogenic chemotherapy, despite the use of antiemetic medications. The purpose of this trial was to evaluate the efficacy and safety of gabapentin for the prevention of CINV during the first cycle of treatment in patients receiving moderately or highly emetogenic chemotherapy. Eighty chemotherapy-naive patients, scheduled to receive moderately and highly emetogenic chemotherapy, were enrolled in this randomised, double-blind, placebo-controlled clinical trial. All patients received intravenous ondansetron 8 mg, dexamethasone 10 mg and ranitidine 50 mg before chemotherapy on day 1 and oral dexamethasone 4 mg twice a day on days 2 and 3. Patients were randomly assigned to take gabapentin 300 mg or placebo on the following schedule: 5 and 4 days before chemotherapy once daily, 3 and 2 days before chemotherapy twice daily, 1 day before to 5 days after chemotherapy thrice daily. The primary endpoint was complete overall protection from both vomiting and nausea over the course of the entire study (day 1 through day 5), and complete protection during the delayed period (24–120 h after chemotherapy). The proportion of patients achieving complete response improved from 40% to 62.5%, (p = 0.04) when comparing the control group and the gabapentin group, respectively. In the subset of patients who achieved complete control in the acute phase, the percentage of patients who achieved delayed complete control was higher in the gabapentin group (89.3 × 60.7%, p = 0.01). Adverse events did not significantly differ between study arms. Gabapentin is a low-cost strategy to improve complete control of CINV, specially delayed CINV control.

e22168Background: Chemotherapy-Induced-Fatigue (CIF) is a frequent symptom that impairs patient functioning during chemotherapy for neoplastic disease. We aimed at evaluating if CIF can induce a sp...

This study aims to evaluate the efficacy of methadone as substitute for morphine and to investigate if the addition of acetaminophen could reduce the time to attain an equianalgesic dose of methadone and/or to improve the level of pain control in oncologic patients.Fifty patients on stable doses of morphine for 1 week were switched to methadone using a "stop-start" strategy and randomized in a double-blind fashion to receive either acetaminophen (750 mg PO every 6 hours) or placebo for a 7-day period. We collected data regarding level of pain, side effects, and quality of life.Substitution of morphine for methadone resulted in a significant reduction in constipation (p0.001) and xerostomia (p = 0.03). There was also an improvement in the numeric pain scale (p = 0.03) as well as a significant improvement in the functional level and symptomatology according to the QLQ-C30 questionnaire. Addition of acetaminophen did not improve pain control or reduce the time of stabilization of analgesia once methadone was introduced. At the end of the study, most patients (70.8%, p = 0.001) preferred methadone to morphine.Early switching from morphine to methadone was a safe and efficient strategy for the reduction of side effects and improvement of analgesia, allowing for a comfortable dosing regimen. In this scenario, the association with acetaminophen did not improve pain control or reduce the time to achieve an equianalgesic dose of methadone.

Burnout syndrome is a common occurrence among oncologists. Doctors enrolled in residency programs in clinical oncology are exposed to similar risk factors; however, few data are available in this population. This study assessed the occurrence of burnout and associated factors among first-year residents at Brazilian institutions. The present prospective, multicenter, cohort study was conducted with doctors enrolled in residency programs in clinical oncology at Brazilian institutions affiliated with the public health system. The participants answered a sociodemographic questionnaire, the Maslach Burnout Inventory (MBI), Lipp's Stress Inventory, and the Beck Depression Inventory (BDI), upon admission to the program and 6 and 12 months later. Of 37 eligible residency programs in 2009, 11 (30.6 %) agreed to participate in the study. Fifty-four residents, representing 100 % of new admissions to the participating institutions, were included. Most of the participants met the criteria for severe burnout upon admission to the residency programs (emotional exhaustion in 49.0 % and depersonalization in 64.7 %). The scores on MBI domains emotional exhaustion and depersonalization increased significantly (p

234 Background: Fatigue is one side effect of cancer and its treatment, and remains as the most prevalent symptom for those who survived. To date, the search for novel approaches regarding Cancer-Related Fatigue persists. As such, Paullinia cupana – a medicinal plant – has shown promising results for the treatment of chemotherapy-induced fatigue. Methods: We conducted a phase II randomized double-blind clinical trial, in which we compared a standardized dry purified Paullinia cupana extract (PC-18) - in doses of 7.5 mg and 12.5 mg given orally twice a day - to placebo for the treatment of fatigue in women with early breast cancer scheduled to receive their first cycle of adjuvant systemic chemotherapy. Only patients that experienced increase in the score of either BFI, HAD or Chalder fatigue scales following the first cycle of chemotherapy were included. For possible associations between qualitative variables, Chi-square test was used. Poisson regression was used to test for the relationship between the drug used and the outcome regarding the difference assessed in scores aforementioned. The significance level was 5%. The program used was Stata 12.0. This study has been approved by our Institutional Review Board (number: 34327214.1.1001.0082) and participants have all signed informed consent forms. Results: PC-18 on 7.5 mg has not been statistically significant with any improvements on assessed scores when compared to placebo (IRR 0.99 [CI] 0.81 – 1.23, p = 0.958 for BFI; IRR 1.04 [CI] 0.56 – 1.95, p = 0,898 for HAD; IRR 0.95 [CI] 0.75 – 1.19, p = 0.645 for Chalder), while greater dosage (12.5mg) has shown the following outcomes regarding the scores (IRR 0.49 [CI] 0.30 – 0.81, p = 0.005 for BFI; IRR 0.89 [CI] 0.45 – 1.76, p = 0,735 for HAD; IRR 0.99 [CI] 0.80 – 1.23, p = 0.914 for Chalder) in the same comparison. Conclusions: Disregarding preliminary data on previous studies, PC-18 has not shown to be better than placebo. Clinical trial information: 34327214.1.1001.0082.

Cat's claw (Uncaria tomentosa) is a native Amazon plant that exhibits anti-inflammatory and antitumor properties. We wanted to assess its activity for symptom management of terminal cancer patients.This prospective phase II study assessed the effects of a 100-mg dose of a dry extract of U. tomentosa three times per day in patients with advanced solid tumors who had no further therapeutic options and a life expectancy of at least 2 months. The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) and Functional Assessment of Chronic Illness Therapy - Fatigue questionnaires were used to assess the participants' quality of life, the Hospital Anxiety and Depression Scale questionnaire was used to assess anxiety and depression, and the Pittsburgh Sleep Quality Index was used to assess sleep quality. In addition, several biochemical and inflammatory parameters were analyzed.Fifty-one volunteers were recruited. Their median age was 64 (range, 33-85) years, and 47% of patients were female. More than 65% of patients had scores on the Karnofsky Performance Scale of 80% or less. Treatment improved the patients' overall quality of life (p=0.0411) and social functioning (p=0.0341), as assessed by the EORTC QLQ C-30, and reduced fatigue (p=0.0496) according to the Chalder Fatigue Questionnaire. None of the biochemical or inflammatory parameters assessed (interleukin-1 and -6, C-reactive protein, tumor necrosis factor-α, erythrocyte sedimentation rate, and α-1-acid glycoprotein) changed significantly. No tumor response was detected according to the Response Evaluation Criteria In Solid Tumors; however, the disease stabilized for more than 8 months in four participants. The medication was well tolerated by most patients.Use of cat's claw might be beneficial in patients with advanced cancer by improving their quality of life and reducing fatigue. The mechanism of action does not seem to be related to the anti-inflammatory properties of this plant.

Objective: The objective of this study was to evaluate the safety of using tegafur–uracil (UFT) in colorectal cancer patients with partial dihydropyrimidine dehydrogenase (DPD) deficiency. Patients and Methods: The study included five colorectal cancer patients who presented with acute toxicity (grades 3 and 4) after being given the first cycle of chemotherapy using 5-fluorouracil. The DPD deficiency was confirmed by gene sequencing. After a full recovery from all side effects, we changed the regimen to UFT (300 mg/m2/day) associated with leucovorin (90 mg/day) for 21 days, with an empirical dose reduction of at least 10% in the first cycle. Results: We prospectively analysed 22 UFT cycles in 5 patients. We did not observe any episodes of grade 3 or 4 toxicity. The predominant toxicities were of grades 1 and 2 (nausea, vomiting and diarrhoea). Conclusion: Here, we demonstrate a complete absence of severe toxicity in all patients and cycles analysed. We believe that UFT is a safe alternative for the treatment of patients with partial DPD deficiency.

Imatinib therapy has undoubtedly contributed to the treatment of metastatic gastrointestinal stromal (GIST) tumors that were previously untreatable. However, disease progression during treatment with tyrosine kinase inhibitors remains an issue in clinical practice not fully explained by KIT and PDGFRA mutation status. We investigated the role of three important signaling molecules (insulin-like growth factor 1 receptor [IGF1R], protein kinase C-? [PKC?], and Raf kinase inhibitor protein [RKIP]) that have been implicated in GIST pathogenesis as potential biomarkers for prediction of response to imatinib treatment. We retrospectively reviewed 76 patients with metastatic GIST submitted to imatinib treatment between 2002 and 2007, and analyzed 63 of them. Insulin-like growth factor 1, total PKC?, phosphorylated PKC?, and RKIP immunohistochemical expression were correlated with objective response to imatinib treatment and progression-free and overall survival. Median follow-up was 31.2 mo (95% confidence interval, 26.3-36.1 mo). There was a statistically significant association between IGF1R expression and type of response to imatinib treatment (P = 0.05)-that is, higher IGF1R expression was related to lower objective response. However, IGF1R higher expression did not affect progression-free and overall survival. Insulin-like growth factor 1, but not PKC? and RKIP, emerges as a potential biomarker for prediction of response to imatinib treatment in metastatic GISTs. Validation studies are warranted., This work was supported by an unrestricted grant from Novartis Brazil. Financial support was also provided by Fundacao do Cancer and Instituto Nacional de Cancer (INCA), Rio de Janeiro-Brazil.

9557 Background: Cat’s claw (Uncaria tomentosa) is a native amazonic plant that exhibits anti-inflammatory and antitumor properties. Methods: This prospective phase II study assessed the effects of...

e20524 Background: Fatigue and Depression are common in patients undergoing Breast Cancer (BC) treatment. Catuama is a registered phytotherapic that contains 4 brazilian herbs per capsule: Trichilia catigua (87.5mg), Ptychopetalum olacoides (87.5mg), Paullinia cupana (125 mg) and Zingiber officinale (10mg). Objectives: Since one of its constituents is Guarana (Paulinia cupana) which we already reported to have anti-fatigue effects, we decided to test Catuama potential anti-fatigue effects in BC women undergoing adjuvant 4 weeks of Radiation Therapy (RxT). Methods: This is a double blinded, randomized, placebo-controlled, Phase II cross-over trial. Patients with histologically proven BC with the indication of adjuvant RxT, non-pregnant nor breastfeeding, older than 18 years of age, with ECOG PS 0 or 1, without a history of cardiac, renal, hepatic or psychiatric decompensation, received Catuama 1 capsule twice daily versus a matching placebo for the first 2 weeks of RxT treatment, followed by a week of wash out, followed by an additional two weeks of treatment with crossover of experimental arms. Patients were evaluated on days 1, 15 and 36 with the Brief Fatigue Inventory (BFI), Hospital Anxiety and Depression Scale (HADS), Quality of Life FACIT-F, FACIT-ES questionnaires, and Chalder Fatigue scale. Results: We enrolled 90 patients with a median age of 53 years (26 – 80). We saw no statistically significant differences of FACIT ES, FACIT F, HADS, Chalder or BFI scores treated with Catuama or Placebo when we considered all included patients. When we selected only patients with a BFI score above 30, Catuama significantly decreased BFI scores as compared to baseline (p

e20601 Background: Chemoterapy induced fatigue (CRF) is a common complain and few studies assessed so far the role of inflammatory biomarkers as predictors of CRF. OBJECTIVE: The primary objective of our study is to evaluate potential biomarkers of CRF in breast cancer (BC) patients receiving adjuvant Chemotherapy (CHT). Methods: Thirty-seven localized BC patients (clinical stages I-III) consecutively treated at the oncology service of Faculdade de Medicina da Fundação ABC were enrolled in this study. All patients received doxorubicin and cyclophosphamide based chemotherapy. Before the beginning of chemotherapy and before the second cycle, all patients answered the BFI (Brief Fatigue Inventory) questionnaire. The following inflammatory markers were collected: C-reactive protein (CRP), tumor necrosis Factor alpha (TNF-α) and interleukin 6 (IL-6). We correlated these inflammatory markers with BFI scores of each patient before and after cycle 1 and cycle 2 of chemotherapy. Results: The mean values of the inflammatory markers were: CRP 4.58 mg/dL (IC 95% 3.17-5.90), TNF-α 11 mg/dL ( IC 95% 8.84-13.79) and IL-6 3.74 (IC 95% 1.93-5.54). We observed a positive correlation between the BFI scores and TNF-α (p=0.0201). Conclusions: TNF-α may represent a potential CRF biomarker. Future studies may elucidate the potential usefulness of TNF-α for monitoring the anti-fatigue effects of new drugs for the treatment of CRF.

e19537 Background: The palliative care NCCN recommendations are classified according to the level of scientific evidence in four groups: category I, high level of evidence with uniform consensus; category IIA, lower level of evidence with uniform consensus; category IIB, lower level of evidence without a uniform consensus but with no major disagreement; and category III, any level of evidence but with major disagreement. Palliative care guidelines have not yet been judged as to the relative content of each of the aforementioned types of recommendations. Methods: We analyzed the distribution of categories of evidence cited in the 10 supportive care NCCN guidelines, version 2.2011. Results: Of the 2,537 recommendations found in the 10 guidelines, the proportion of category I, IIA and IIB recommendations were 2.9%, 95.7%, 1.4%, respectively. There wasn’t any category III recommendation (table 1). The fields with a higher rate of category I recommendations were fatigue (14.3%) and chemotherapy induced nausea and vomiting (12.7%). No category I recommendations were found on Senior Adult Oncology, Cancer and Chemotherapy induced Anemia and Adult Cancer Pain. Conclusions: : Palliative care NCCN recommendations are largely based on lower level of evidence, but with uniform expert opinion. This data show the urgent need to expand palliative care research in oncology. [Table: see text]

e16568 Background: The Quality Oncology Practice Initiative (QOPI) is a voluntary program developed by ASCO to aid oncology practices in quality self-assessment and continuous improvement of patient records. It consists of a cyclical, semiannual measurement of the adequacy of several care processes pertaining to some important aspects of patient care. Few academic cancer centers have been QOPI participants in the United States and there aren’t reports to our knowledge of any Latin American Cancer Center adopting this strategy. Methods: This study shows the pilot initiative to implement the QOPI at the ABC School of Medicine, Discipline of Oncology, a large public academic cancer center of Santo André, São Paulo, Brazil. Results: From January 2008 to December 2010, we consecutive selected 37 patients with gastric cancer, 40 with breast cancer, 33 with lung cancer and 40 colorectal cancer. The table below shows the first round of the core QOPI. Conclusions: There are several opportunities for improvement such as assessing and recording of pain and analgesic use, documentation patient consent and of the intent of chemotherapy and providing patients with their chemotherapy summaries. Our current electronic record will be modified to reflect the aforementioned needs in order to improve our results in the following rounds of QOPI program. [Table: see text]

5588 Background: Head and neck squamous cell carcinoma (HNSCC) patients (pts) are at elevated risk of developing a second primary tumor (SPT). Here we aimed to study the frequency of SPTs and those characteristics related to an increased probability of SPT occurrence. Methods: It is a cross-sectional study in pts diagnosed with SCC primary located in oral cavity, oropharynx, hypopharynx or larynx, treated in two Brazilian institutions, with an index tumor diagnosed from Jan/2000 to Jan/2009. All pts were followed according the current recommendations, including clinical visits, imaging and endoscopic procedures. A SPT was defined following the Warren and Gates criteria (Am J Cancer 51:1358,1932), and they were classified as synchronous or metachronous if detected less or more than six months after the diagnosis of the index tumor, respectively. Results: 38 out of 318 HNSCC pts (12%) were diagnosed with 41 SPTs in their follow-up, being 12 synchronous (29%) and 29 metachronous (71%), all classified as SCC. Regarding the index tumor, it was primary located in oral cavity (114 pts, 36%), oropharynx (87 pts, 27%), larynx (83 pts, 26%) and hypopharynx (34 pts, 11%), and staged as I-II (30%) or III-IV (67%). The SPTs were located more frequently in oral cavity (27%), lungs (27%), oropharynx (15%) and esophagus (12%) and staged as I-II (44%) or III-IV (42%). Among the 29 metachronous SPTs, 12 (41%) were diagnosed in the first two years of follow-up, 11 (38%) between two and five years, and 6 (21%) after five years. Considering all the studied HNSCC pts and index tumor characteristics, including primary site, persistence of tabacco and alcohol habits, and treatment, none was identified as related to an increased probability of developing a SPT. In the median follow-up of 40 mo., the median overall survival was not reached in all 318 HNSCC pts. No difference in overall survival was observed between those pts diagnosed or not with a SPT (HR 0.35, p=0.555). Conclusions: We found a 12% incidence of SPTs in these HNSCC pts. At diagnosis, SPTs were located more frequently in oral cavity and lungs, in advanced stages, and may occur even after five years after the index tumor. More efficient primary and secondary preventive strategies of SPTs must be developed.

e19552 Background: Paulinia cupana (guaraná) is an amazonic plant with stimulant proprieties which was shown previously to be effective for chemotherapy related fatigue in patients with breast cancer in a randomized double blind placebo controlled trial conducted by our group (J Altern Complement Med. 2011;17(6):505-12). Purpose: Extend our study to patients with different tumor types receiving various regimens of chemotherapy, treated with a purified dry extract of Paulinia cupana (PC-18). Methods: We included patients with solid tumors older than 18 years of age who were scheduled to receive systemic chemotherapy. We excluded patients with fibromyalgia and uncontrolled hypothyroidism, depression, anemia, hypertension or cardiac disease. We evaluated basal fatigue with the BFI questionnaire before chemotherapy, and included only patients who had an increase in their BFI score after one week. PC-18 was given at 50 mg PO bid, starting after one week of chemotherapy. We employed the FACIT-F, BFI, Chalder, HADS and PSQI questionnaires to evaluate fatigue, anxiety, depression and sleep quality at one week and after 4 weeks of chemotherapy. Results: 36 patients with a mean age of 54 years, 61 % female, 28% with breast, 22% colorectal, 8.3% lung , 8.3% head/neck, 5.6% ovarian and 27% of other carcinomas were included. Fatigue scores improved significantly when we compared scores of the BFI (mean difference = 19.39; 95%CI 12.4 – 26.37, p < 0.0001), FACIT-F (mean difference = -11.51; 95%CI -19.25 - -3.76, p = 0.0049) and Chalder (mean difference = 4.571; 95% CI 1.86 – 7.28, p = 0.0018) questionnaires. HADS subscales scores of anxiety (p = 0.025) and depression (p = 0.0095) also improved significantly after 3 weeks of PC-18 therapy. PSQI scores did not change significantly (p = 0.26) after 3 weeks of PC-18 treatment. Conclusions: We conclude that Paulinia cupana (Guaraná) PC-18 extract is active for treatment of chemotherapy related fatigue in patients with a variety of solid tumors and also improves their anxiety and depression scores without worsening the quality of their sleep.

For cancer patients undergoing radiation therapy (RT) or systemic chemotherapy (CHT), cancer-related fatigue (CRF) is a common problem that can negatively impact their 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. PURPOSE: To evaluate the effectiveness of guarana extract on fatigue in BC patients undergoing either CHT or RT. A total of 137 cancer patients (85% with Breast Cancer) undergoing either CHT (101) or RT (36) were randomized to receive either a placebo or guarana. In all 3 studies, the guarana was given as an unmanipulated dry extract at a dose of 75 mg PO QD in the first two studies or 50 mg PO BID in the third study. Patients were crossed over to the other experimental arm, and we evaluated fatigue with the Chalder Scale in all three studies. Guarana significantly improved the The Chalder Scale Global Scores (- 0.85; 95% CI:-1.31 to -0.40; p = 0.0002); Physical Fatigue Scores (-0.44; 95% CI: - 0.74 to - 0.13; p = 0.005) and Mental Fatigue Scores (-0.93; 95% CI: - 1.14 to - 0.72; p

CONTEXT AND OBJECTIVE Oxaliplatin is one of the chemotherapy regimens most used for treating colorectal cancer. One of the main limitations to its use is induction of peripheral neuropathy. Previous studies have shown that vitamin E can reduce the incidence of peripheral neuropathy by 50%. This study aimed to assess the effectiveness of vitamin E for prevention of oxaliplatin-induced peripheral neuropathy. DESIGN AND SETTING Prospective, phase II, randomized pilot study developed at a university hospital in the Greater ABC region. METHODS Patients were randomized five days before starting oxaliplatin treatment, to receive either vitamin E or placebo until the end of the chemotherapy regimen. The outcome was evaluated using the Common Terminology Criteria for Adverse Events (CTCAE), version 3, and specific gradation scales for oxaliplatin-induced peripheral neuropathy. Patients with colorectal and gastric cancer who had been scheduled to receive oxaliplatin-based chemotherapy were included. Both groups received calcium and magnesium supplementation before and after oxaliplatin infusions. RESULTS Eighteen patients were randomized to the vitamin E group and 16 to the placebo group. Cumulative incidence of 83% with peripheral neuropathy grades 1/2 was observed in the vitamin E group, versus 68% in the placebo group (P = 0.45). A trend towards more diarrhea was observed among patients who received vitamin E (55.6% vs. 18.8%; P = 0.06). There were no other significant differences in toxicity between the groups. CONCLUSIONS No significant decrease in the incidence of acute oxaliplatin-induced peripheral neuropathy was demonstrated through vitamin E use. CLINICAL TRIAL REGISTRATION NCT01523574.

BackgroundFatigue is common in cancer patients receiving adjuvant chemotherapy. To further understand the mechanism of fatigue and search for potential biomarkers, we conducted this prospective study. Methods We enrolled breast cancer (BC) patients before their first adjuvant Adriamycin‐based chemotherapy cycle. Patients responded to the brief fatigue inventory (BFI) and Chalder fatigue questionnaires and had their blood drawn for both plasma evaluation and evaluation of the peripheral mononuclear cell fraction (PMNCF) mRNA expression of various biomarkers. We evaluated FSH, LH, estradiol, DHEA, DHEAS, IL6, IL2, ILIRA, IL1β, CRP, Cortisol in the plasma and IL2, IL10, IL6, TGF‐β, KLRC1, TNF, BTP, SNCA, SOD1, BLNK, PTGS2 and INF γ expression in the PMNCF. Results11 patients did not exhibit an increase in their BFI scores and served as controls, whereas 32 patients exhibited an increase in their BFI scores compared with the baseline scores. From the biomarkers we evaluated in the PMNCF, the only one significantly associated with fatigue was TGF‐β (p = 0.0343), while there was a trend towards significance with KLRC1 (p = 0.0627). We observed no evidence of significant associations of any plasma biomarkers with the development of fatigue. However when we analyzed patients with more severe fatigue, plasma IL1‐RA levels correlated directly with higher fatigue scores (p = 0.0136). ConclusionsWe conclude that fatigue induced by chemotherapy in BC patients is associated with changes in IL1‐ra plasma levels and in TGF‐β lymphocyte expression. Its mechanism may be different than that observed in long‐term BC survivors or that induced by radiation therapy. Trial registrationNCT02041364 [ClinicalTrials.gov]