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Background: It is estimated that 50 thousand patients live with metastatic breast cancer (MBC) in Brazil. A recent Brazilian registry (LACOG 0312) on MBC demonstrated a median overall survival (OS) by breast subtype of 15 months for triple negative, 23 months for HER2 positive, and 42 months for Luminal tumors, which are very similar to developed countries except the HER2 positive group which have limited access to targeted agents in the public health system. Recently, CDK 4/6 inhibitors were approved for the treatment of HR+ HER2-negative MBC with an improvement in progression-free survival (PFS) and ribociclib and abemaciclib demonstrating benefit in OS over endocrine therapy alone, establishing the standard of care in first-line setting for this BC subtype. In Brazil, disparities exist in the incorporation of novel anticancer agents between public and private health systems limiting treatment options for patients with HR+ HER2- negative MBC in the public system, which covers most of the population. The BRAVE study aims to describe the patient journey and current patterns of care for HR+ HER2-negative MBC to identify possible gaps and how health insurance type influences treatment patterns in Brazil. Trial Design: This is an observational, retrospective cohort study. All patients diagnosed with mBC (either de novo or recurrent) in the period of January 2018 to December 2020 at participating centers will be included. Data will be collected from medical records. No interventions are proposed. Enrollment of a total of 300 patients (150 patients from public health care system and 150 patients from private health care system) is planned. ClinicalTrials.gov identifier: NCT05034393. Eligibility: Inclusion criteria: women ≥18 years old; histologically confirmed HR-positive HER2-negative invasive breast cancer; HR-positive, defined as 1% to 100% of tumor nuclei positive for ER and/or PgR as per ASCO/CAP Guideline 2020 or Allred score of ≥3; HER2-negative, defined as IHC result is 0/1+ or 2+ with ISH negative as per ASCO/CAP Guideline 2018; diagnosed with de novo or recurrent metastatic breast cancer between January 2018 and December 2020. Exclusion criteria: male BC; first-line treatment for mBC received through clinical trial. Specific Aims: Primary objective is to describe the first-line (1L) treatment of HR-positive, HER2-negative mBC in Brazil. Secondary objectives are to describe progression-free survival (PFS) in the 1L setting until month 24; describe and compare the 1L treatment of HR-positive, HER2-negative mBC and PFS until month 24 according to the health care coverage (public vs. private); describe timelines from symptoms, histopathological diagnosis, molecular test, and treatment; describe the mBC pathological characterization; describe frequency of diagnostic tests to define breast cancer molecular subtypes; describe the subsequent line of treatment and corresponding PFS; describe overall survival (OS); evaluate PFS and OS according to visceral vs. non-visceral metastatic disease, primary endocrine resistance vs. acquired endocrine resistance, de novo versus recurrent disease, public vs. private health system and pre vs postmenopausal status. Statistical Methods: No a priori sample size calculation was performed. The expected sample size of 150 patients in each group allows description of the proportion of patients using CDK 4/6 inhibitors with two-sided 90% confidence interval ranging from 53.4% to 66.6% when the expected proportion is 60% in the private health system. Present Accrual and Target Accrual: A total of 12 sites of 14 planned were activated. The first patient was enrolled on February 8, 2022. As of June 24, 2022, a total of 122 patients were enrolled, 86 from public and 36 from private health system. The target accrual of 300 patients is expected to be completed by November 2022. Results are expected to be presented by April 2023. Funding: Novartis. Acknowledgements: SAS. Citation Format: Gustavo Werutsky, Tomás Reinert, Daniela D. Rosa, Romualdo Barroso-Sousa, Heloísa Resende, Poliana A. Signorini, Juliana G. Martins Fagundes, Jose Marcio B. Figueiredo, Eduardo Cronemberger, Aline C. Vieira, Jorge Henrique Santos Leal, Luiza Nardin Weis, Ludmila Thommen, Rafaela G. Jesus, Gustavo Gössling, José Bines. Real-World Data on First-line Treatment of HR-positive, HER2-negative, Metastatic Breast Cancer in Brazil (BRAVE Study/LACOG 0221) [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT3-07-01.

Background: Breast cancer (BC) is the most frequent cancer in women in Brazil, with more than 60,000 cases estimated annually. Forty percent of patients present with stages III and IV and neoadjuvant chemotherapy (NACT) remains the mainstay of treatment for locally advanced breast cancer (LABC). Taxanes usually follow anthracyclines in breast cancer neo/adjuvant treatment, likely because of their later introduction into clinical practice. However, the potential impact of alternative sequencing remains to be studied. A single-center phase II randomized clinical trial conducted in the Brazilian National Cancer Institute showed an improvement in overall survival with taxane-first compared with anthracycline-first sequencing in HER2-negative LABC (Bines J et al, The Oncologist 2020). As a taxane-before-anthracycline sequence carries neither an incremental cost nor increased toxicity, the optimal sequencing of these agents could have significant implications for clinical practice. To confirm this finding, we are currently conducting a multicenter randomized phase III trial comparing a taxane followed by an anthracycline-based regimen with the reverse sequence in the neoadjuvant setting. Trial Design: This randomized, open-label, phase III trial will be conducted in 15 research centers in Brazil. It was approved by the local ethics committee in 2020 and is registered in Clinicatrials.gov with the identifier NCT04540692. Women with HER2-negative LABC are randomized in a 1:1 ratio to anthracycline-before-taxane (AC-T arm) or taxane-before-anthracycline (T-AC arm), stratified by hormone receptor status (positive vs. negative) and axillary lymph node status (N0 vs. N+). The anthracycline-based therapy recommended in this trial is AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2) every three weeks for four cycles, whilst the taxane-based therapy is either weekly paclitaxel 80 mg/m2 weekly for 12 weeks, paclitaxel 175 mg/m2 every three weeks, or docetaxel 75-100 mg/m2 every three weeks. The use of carboplatin concomitantly with taxane for triple-negative tumors and dose-dense regimens is allowed following institutional guidelines. Further therapies (surgery, radiotherapy, and endocrine therapy) are performed according to the physicians’ discretion. Tumor samples are collected and stored for translational studies. Eligibility: Inclusion criteria: women ≥18 years of age; histologically confirmed HER2-negative breast cancer (by ASCO/CAP guidelines); stage ≥ IIB (if TNBC) or ≥ III (if HR-positive); PS ECOG 0-2 and adequate organ function. Exclusion criteria: previous use of anti-cancer therapies; bilateral BC and pregnancy. Specific Aims: The primary objective is invasive disease-free survival (iDFS). Secondary objectives include pathological complete response (pCR) rates, overall survival (OS) and safety. Statistical Methods: Considering an unicaudal type I error of 0.05, a type II error of 0.2, and an estimated iDFS of 50% in 5 years in the control arm, a total of 227 evaluable patients should be included per arm to demonstrate a HR of 0.7 favoring the taxane-first arm. Estimating a dropout rate of 10%, 494 patients will need to be included in the study. Present Accrual and Target Accrual: A total of 9 sites of 15 planned are activated. The first patient was enrolled on January 12, 2021, and as of June 24, 2022, a total of 113 patients have been accrued. The target goal of 494 patients is expected to be achieved by 2025 and initial study results will be reported by 2026. Funding: Brazilian Health MInistry, Programa Nacional de Apoio à Atenção Oncológica (PRONON), NUP 25000.183207/2019-50. Acknowledgements: CURA Project, SAS. Citation Format: Tomás Reinert, Cristiano P. Souza, Pedro Liedke, Gustavo Werutsky, Laura Testa, Vivian Antunes, Carlos Barrios, Vivian Vasconcelos, Heloísa Resende, Geraldo Silva Queiroz, Gisah Guilgen, Yeni Nerón, Lilian Arruda Bastos, Sabina Aleixo, Daniel Cubero, Maria Cristina F. Magalhães, Ana Coradazzi, Daniela Galvão B. de Oliveira, João S. Nunes, Rafaela G. Jesus, Gustavo Gössling, José Bines. Sequencing of anthracyclines and taxanes during neoadjuvant therapy of locally advanced HER2-negative breast cancer (NEOSAMBA Study/LACOG 0419) [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT2-22-02.

Background: Tumor boards (TB) are synonymous with quality of care but have been occasionally misunderstood and underutilized. This survey aimed to evaluate health professionals' perceptions of TBs in Brazil. Materials & methods: The survey was sent electronically. Results: Of 206 respondents, 67.8% attended TBs at least once and 82.4% dedicated at least 1 h weekly to them; 64.2% preferred a more “educational” model over case discussions only; 63.1% had institutional leadership capable of promoting multidisciplinarity; 21.1% and 32.7% of the physicians and nonphysicians, respectively, felt intimidated to express their opinions; 91.6% believed that TBs improve cancer outcomes. Postpandemic, 52.7% preferred a hybrid (virtual/face-to-face) model. Conclusion: This study provides a glimpse of the reality of TBs in Brazil, with potential implications for clinical practice.

Supplementary Figure S1-S6 and Supplementary Tables S1-S8

BACKGROUND ETs that target ER activity and/or estrogen synthesis are the mainstay of ER+ BC treatment. Despite best management, up to 20% of pts with ER+/HER2- eBC develop resistance (in some cases due to the acquisition of tumor mutations in ESR1 that can drive estrogen-independent transcription and proliferation) and still have high recurrence rates on standard ETs. New treatment alternatives for ER+/HER2- eBC are needed to reduce risk of recurrence and improve survival, tolerability, quality of life, and adherence. Giredestrant is a highly potent, nonsteroidal oral selective ER antagonist and degrader (SERD). It achieves robust ER occupancy and is active against tumors that retain ER-sensitivity or have ESR1 mutation(s). Giredestrant has been demonstrated to be more potent in vitro and achieves higher ER occupancy in vivo than fulvestrant, the only currently approved SERD. Early phase clinical studies have demonstrated that single-agent giredestrant (30 mg daily) has promising clinical and pharmacodynamic activity, and is well-tolerated in the ER+/HER2- eBC and metastatic BC settings. TRIAL DESIGN This is a phase III, global, randomized, open-label, multicenter study evaluating the efficacy and safety of adjuvant giredestrant vs physician’s choice of adjuvant ET in pts with medium- and high-risk stage I-III histologically confirmed ER+/HER2- eBC. Pts are randomized 1:1 to oral 30 mg daily giredestrant or physician’s choice of standard ET (tamoxifen, anastrozole, letrozole, or exemestane, given according to prescribing information). Stratification factors are risk (medium vs high, based on anatomic [tumor size, nodal status] and biologic features [grade, Ki67, gene signatures if available]); geographic region (US/Canada/Western Europe vs Asia-Pacific vs rest of the world); prior chemotherapy (no vs yes); and menopausal status (pre-/perimenopausal vs postmenopausal). Beginning on Day 1 of Cycle 1, pts will be treated with giredestrant or physician’s choice of standard ET for at least 5 years. Continuing physician’s choice of standard ET after 5 years is at discretion of the investigator and per local standard of care. ELIGIBILITY Female/male pts with medium-/high-risk stage I-III ER+/HER2- eBC; prior curative surgery; completion of (neo)adjuvant chemotherapy (if administered) and/or surgery Citation Format: Aditya Bardia, Peter Schmid, Nadia Harbeck, Mothaffar F Rimawi, Sara A Hurvitz, Sherene Loi, Shigehira Saji, Kyung Hae Jung, Gustavo Werutsky, Daniil Stroyakovskii, Vanesa López-Valverde, David Tesarowski, Chenglin Ye, Michael Davis, Tanja Badovinac Crnjevic, Pablo Diego Perez-Moreno, Charles E Geyer, Jr. Lidera breast cancer: A phase III adjuvant study of giredestrant (GDC-9545) vs physician’s choice of endocrine therapy (ET) in patients (pts) with estrogen receptor-positive, HER2-negative early breast cancer (ER+/HER2- EBC) [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr OT2-11-09.

Background: Quality of life (QOL) in breast cancer patients (pts) can be greatly impacted by initial treatment and ongoing therapy, particularly if side effects and symptoms are not well tolerated. The PALLAS trial investigated whether the addition of 2 years of palbociclib (palbo) to adjuvant endocrine therapy (ET) improved invasive disease-free survival (iDFS) over adjuvant ET alone. We report on the main patient-reported outcome (PRO) quality of life (QOL) and symptom severity results of this trial by treatment arm. Methods: PALLAS is an ongoing multicenter, open label phase 3 trial that enrolled hormone receptor positive, HER2-negative, stage II-III breast cancer patients at 406 cancer centers across 21 countries. Patients were randomly assigned (1:1) to either 2 years of palbo (125mg/day, 3 weeks on 1 week off) plus ongoing provider or patient-choice adjuvant ET (palbo+ET) versus ongoing ET alone. The primary study endpoint was iDFS. Treatment with palbo in all pts stopped at the time of the second interim analysis (5/2020) due to futility; all pts then moved to follow up. The PRO analyses were triggered for completion after awareness of the pre-specified 469 iDFS cases in November 2020. Eight PRO endpoints were measured serially (i.e., day 1 of each monthly cycle for the first 3 months, then every 3 months for the first 2 years, and once at year 3). The endpoints were the EORTC QLQ-C30 global health status/QOL score, the Brief Fatigue Inventory score, the modified Brief Pain Inventory severity and pain interference scores, the EORTC QLQ-BR23 alopecia score, and the Breast Cancer Prevention Trial hot flash symptoms, vaginal problems, and musculoskeletal pain scores. Linear mixed models compared the average difference between arms across time points during the initial 2-year treatment period adjusting for cycle 1 day 1 (C1D1) PRO scores, demographic and clinical variables. The average differences between arms (palbo+ET vs ET alone) and the two-sided (1-[0.05/8]) x 100% confidence intervals, adjusted for multiple comparisons, were calculated. Analysis of covariance compared the average between-arm differences by endpoint at 3 years. Results: The PRO intention to collect population included 4688 (81%) of the overall trial pts, and was clinically and demographically representative of the remaining 1073 pts. Each analysis population, with measures at C1D1 and at least 1 post-C1D1 assessment for each PRO endpoint, comprised ≥ 89% of the 4688 pts and the proportions were similar between arms. After adjustment for baseline covariates, on average, no clinically important differences between arms were observed for any of the eight endpoints over the 2 year treatment period (Table 1). All effect sizes were below the pre-specified 0.2 threshold. These PRO results were similar at the 3 year time point. Conclusions: No clinically significant differences in either patient-reported QOL or symptom severity were found, on average, between participants in the two PALLAS treatment arms while either taking palbo+ET or ET alone, or after study-wide termination of palbo. In general, the addition of palbociclib in the adjuvant breast cancer setting did not contribute to increased symptom burden within this survivorship population. Further analyses will examine the relationship between PROs and treatment discontinuation by arm and study time point. Support: AFT, Pfizer, https://acknowledgments.alliancefound.org Table 1.Results of the Patient-Reported QOL and Symptom Severity Analyses Between the Two Treatment Arms During the First 2 Years of PALLASPRO Endpoint *Palbo + ET Adjusted average score (95% CI)ET alone Adjusted average score (95% CI)Average Difference + (Palbo + ET vs ET alone)[99.38% CI] Clinically ++ Important DifferenceEORTC QLQ-C30 Global Health Status/QOL71.7 (71.2, 72.2)74.0 (73.5, 74.5)-2.3 (-3.3, -1.4)**NoBrief Fatigue Inventory Score2.3 (2.2, 2.3)2.1 (2.0, 2.1)0.2 (0.1, 0.3)NoModified Brief Pain Inventory - Severity Score2.3 (2.2, 2.3)2.4 (2.4, 2.5)-0.2 (-0.3, -0.1)NoModified Brief Pain Inventory - Interference Score1.7 (1.6, 1.7)1.7 (1.6, 1.7)0.0 (-0.1, 0.1)NoEORTC QLQ-BR23 Alopecia1.4 (1.4, 1.4)1.3 (1.3, 1.3)0.1 (0.1, 0.1)NoBreast Cancer Prevention Trial - Hot Flash Symptoms1.2 (1.2, 1.3)1.2 (1.2, 1.3)0.0 (-0.1, 0.1)NoBreast Cancer Prevention Trial - Vaginal Problems0.8 (0.8, 0.8)0.8 (0.7, 0.8)0.0 (0.0, 0.1)NoBreast Cancer Prevention Trial - Musculoskeletal Pain1.2 (1.2, 1.2)1.3 (1.3, 1.3)-0.1 (-0.2, 0.0)No* For the EORTC QLQ-C30 Global Health Status/QOL subscale, higher scores indicate better QOL. For all other PRO endpoints, higher scores indicate worse symptom levels. ** The lower bound of the one-sided CI (adjusted for multiple comparisons) was -3.3. Because the lower limit is greater than the pre-specified non-inferiority margin of -3.44, non-inferiority of palbo+ET relative to ET-alone was concluded. The non-inferiority margin corresponds to a 0.2 SD in the EORTC QLQ-C30 global health/QOL score. +The average difference was adjusted for the following baseline covariates: Cycle 1 day 1 score, region (if applicable), age category, first adjuvant ET, race, ethnicity, N-stage, T-stage, histological grade, PgR, prior chemotherapy, ECOG Performance Status. ++Based on each instrument’s published clinically relevant cut-offs, if available. After calculating Cohen’s d treatment effect sizes, (i.e. by dividing the average difference by the ET-alone arm standard deviation from cycle 1 day 1), all effect sizes were below the pre-specified 0.2 threshold, and would not be considered clinically important. Citation Format: Michelle Joy Naughton, David Zahrieh, Michael Gnant, Nicholas Zdenkowski, Julie Lemieux, Jun J Mao, Vesna Bjelic-Radisic, Eileen Shinn, Marija Balic, Christoph Thomssen, Jane Neisel, Manuel Ruiz-Echarri, Sibylle Loibl, Claudine Isaacs, David Cameron, Fernando Manuel Henao Carrasco, Matthew Goetz, Viktor Wette, Gustavo Werutsky, Hope Rugo, Marcus Vetter, Ling-Ming Tseng, Kathy Miller, Florian Fitzal, Juan Miguel Gil Gil, Haeseong Park, Barbro Linderholm, Emilio Bajetta, Zoneddy Dayao, Aleix Prat, Karin Ehrhardt, Otto Metzger, Amal Arahmani, Ernest Law, Ann Partridge, Lisa Carey, Alex Zoroufy, Amylou Dueck, Dominik Hlauschek, Angela DeMichele, Erica Mayer. Quality of life and symptom severity in the PALLAS randomized trial of palbociclib with adjuvant endocrine therapy in early breast cancer (AFT-05) [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P4-10-01.

Background: Ipat is a potent oral AKT inhibitor that has been studied in multiple clinical trials, primarily in breast and prostate cancers. Combining fulv and AKT inhibition demonstrated efficacy in pts with HR+ aBC regardless of PI3K/AKT pathway alterations [Jones, Lancet Oncol 2020]. IPATunity150 (NCT04060862) was designed as a phase III trial with an open-label phase Ib portion adding ipat to palbo plus fulv in biomarker-unselected HR+ HER2-negative aBC. The biological rationale was to prevent or delay resistance to CDK4/6 inhibition plus endocrine therapy (ET). AKT1 alterations and PTEN loss have been implicated in resistance to CDK4/6 inhibitors [Wander, Cancer Discov 2020; Costa, Cancer Discov 2020]. We report results from the open-label phase Ib portion. Patients and Methods: The primary objective was to assess safety and pharmacokinetics (PK) of ipat in combination with palbo and fulv; several efficacy parameters were also analyzed. Pts with measurable disease who had not previously received a CDK4/6 inhibitor and had experienced relapse during adjuvant ET were treated with ipat at a dose of 300 mg/d, d1-21 q28d, plus standard-of-care doses of palbo (125 mg/d, d1-21 q28d) plus fulv (500 mg q28d with a loading dose in cycle 1). The selected ipat dose was lower than the 400 mg typically used in other studies because of the anticipated drug-drug interaction (DDI) when combining ipat (a sensitive CYP3A4 substrate and mild-to-moderate CYP3A inhibitor) with palbo (a weak time-dependent CYP3A4 inhibitor and CYP3A substrate). Results: Of the 20 pts treated, 20% were Asian, 65% had primary endocrine resistance (relapse ≤2 years after starting adjuvant ET), 80% had received prior (neo)adjuvant chemotherapy, and 60% had liver and/or lung metastases. At the data cutoff (19 Mar 2021; median follow-up 6.1 months), median treatment duration was 5.1, 5.9, and 5.3 months for ipat, palbo, and fulv, respectively. Treatment was ongoing in 13 pts. Grade 3/4 adverse events (AEs) occurred in 80% of pts (no grade 5). The most common AEs were diarrhea (80% any grade, 10% grade 3, no grade 4) and neutropenia (75% any grade, 45% grade 3, 20% grade 4). Other notable grade ≥3 AEs were grade 3 liver function test elevations in 10%. There were no cases of febrile neutropenia and only 1 case of pneumonitis (grade 1). AEs led to at least one dose reduction of ipat in 6 pts (30%; diarrhea n=3 [with vomiting in 1 pt], neutropenia n=3 [with fatigue in 1 pt]) and of palbo in 9 pts (45%; all for neutropenia). One pt (5%) discontinued ipat and palbo permanently due to ongoing neutropenia after protocol-defined dose reductions. As expected, a DDI led to increased ipat exposure (AUC0-24,ss ~60% and Cmax ~40%) when ipat and palbo were combined. Based on population PK analysis, palbo AUC0-24,ss was ~30% higher than reported from the PALOMA 1 and 2 trials, which was expected and consistent with previously reported physiologically based PK modeling of palbo exposure when administered with moderate CYP3A inhibitors [Yu, J Clin Pharmacol 2017]. All 20 pts had at least one post-baseline tumor assessment. Best overall response rate was 45% (95% CI: 23-68%), including confirmed responses in 7 pts (35%; 5% complete response, 30% partial response) at the clinical cutoff date. Median duration of response was 9.6 months (95% CI: 7.1-not estimable). An additional 10 pts (50%) had stable disease. Progression-free survival results were immature (events in 7 pts). There was no obvious association between efficacy and mutations in PIK3CA/AKT1 as tested in ctDNA. Conclusion: The triplet combination of ipat, fulv, and palbo had an acceptable safety profile generally consistent with that of the individual study drugs; ipat exposure was increased through a predicted DDI. Updated results will be presented. Citation Format: Mafalda Oliveira, Aditya Bardia, Sung-Bae Kim, Naoki Niikura, Cristina Hernando, Gustavo Werutsky, Yoland Antill, Pedro Liedke, Catherine Oakman, Eriko Tokunaga, Seth Wander, Vanessa Krause, Toshinari Yamashita, Frauke Schimmoller, Jacob Rotmensch, Heidi Savage, Rucha Sane, Nicholas Turner. Ipatasertib (ipat) in combination with palbociclib (palbo) and fulvestrant (fulv) in patients (pts) with hormone receptor-positive (HR+) HER2-negative advanced breast cancer (aBC) [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P5-16-11.

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.

The increasing burden of cancer represents a substantial problem for Latin America and the Caribbean. Two Lancet Oncology Commissions in 2013 and 2015 highlighted potential interventions that could advance cancer care in the region by overcoming existing challenges. Areas requiring improvement included insufficient investment in cancer control, non-universal health coverage, fragmented health systems, inequitable concentration of cancer services, inadequate registries, delays in diagnosis or treatment initiation, and insufficient palliative services. Progress has been made in key areas but remains uneven across the region. An unforeseen challenge, the COVID-19 pandemic, strained all resources, and its negative effect on cancer control is expected to continue for years. In this Series paper, we summarise progress in several aspects of cancer control since 2015, and identify persistent barriers requiring commitment of additional resources to reduce the cancer burden in Latin America and the Caribbean.

Purpose The safety and effectiveness of moderately hypofractionated post-operative radiation therapy for breast cancer were demonstrated by several trials. This study aimed to evaluate the current patterns of practice and to assess possible aspects that affect the decision-making process regarding the use of fractionation in breast cancer patients in Latin America and the Caribbean (LAC). Methods Radiation oncologists from LAC were invited to contribute to this this study. A 38-question survey was used to evaluate their opinions. Results A total of 173 radiation oncologists from 13 countries answered the questionnaire. The majority of respondents (84.9%) preferred moderately hypofractionated post-operative radiation therapy as their first choice in cases of whole breast irradiation. For whole breast plus regional nodal irradiation, post-mastectomy (chest wall and regional nodal irradiation) without reconstruction, and post-mastectomy (chest wall and regional node irradiation) with reconstruction hypofractionated post-operative radiation therapy was preferred by 72.2% 71.1%, and 53.7% of respondents, respectively. Breast cancer stage, and flap-based breast reconstruction were the factors associated with absolute contraindications for the use of hypofractionated schedules. Conclusion Even though moderately hypofractionated post-operative radiation therapy for breast cancer is considered a new standard to the vast majority of the patients, its unrestricted application in clinical practice across LAC still faces reluctance.

BACKGROUND Endocrine therapies (ETs) that target estrogen receptor (ER) activity and/or estrogen synthesis are the mainstay of ER+ breast cancer (BC) treatment. Despite best management, ≤20% of patients (pts) with ER+/HER2– early BC (eBC) develop resistance (in some cases due to acquisition of tumor mutations in ESR1 that can drive estrogen-independent transcription and proliferation) and still have high recurrence rates on standard ETs. New treatment alternatives for ER+/HER2– eBC are needed to reduce risk of recurrence and improve survival, tolerability, quality of life, and adherence. Giredestrant, a highly potent, nonsteroidal oral selective ER antagonist and degrader (SERD), achieves robust ER occupancy and is active against tumors that retain ER-sensitivity or have ESR1 mutation(s). It has been demonstrated to be more potent in vitro and achieves higher ER occupancy in vivo than fulvestrant, the only currently approved SERD. Early-phase clinical studies have demonstrated that single-agent giredestrant (30 mg daily) has promising clinical and pharmacodynamic activity and is well tolerated in the ER+/HER2– eBC and metastatic BC settings. TRIAL DESIGN This is a phase III, global, randomized, open-label, multicenter study evaluating efficacy and safety of adjuvant giredestrant vs physician’s choice of adjuvant ET (PCET) in pts with medium- and high-risk stage I–III histologically confirmed ER+/HER2– eBC. Pts are randomized 1:1 to oral 30 mg daily giredestrant or PCET (tamoxifen, anastrozole, letrozole, or exemestane, given according to prescribing information). Stratification factors are risk (medium vs high, based on anatomic [tumor size, nodal status] and biologic features [grade, Ki67, gene signatures if available]); geographic region (US/Canada/Western Europe vs Asia-Pacific vs rest of the world); prior chemotherapy (no vs yes); and menopausal status (pre-/perimenopausal vs postmenopausal). Beginning on Day 1 of Cycle 1, pts will be treated with giredestrant or PCET for ≥5 years. Continuing PCET after 5 years is at discretion of the investigator and per local standard of care. ELIGIBILITY Female/male pts with medium-/high-risk stage I–III ER+/HER2– eBC; prior curative surgery; completion of (neo)adjuvant chemotherapy (if administered) and/or surgery < 12 months prior to enrollment; no prior ET (≤4 weeks of [neo]adjuvant ET is allowed). For men and pre-/perimenopausal women, a luteinizing hormone-releasing hormone agonist will be given per local prescribing information (mandatory for pts in the giredestrant arm). AIMS Primary endpoint: Invasive disease-free survival (IDFS). Secondary endpoints: Overall survival; IDFS (STEEP definition, including second non-primary BC); disease-free survival; distant recurrence-free survival; locoregional recurrence-free interval; safety; pharmacokinetics; pt-reported outcomes. In addition, this study aims to improve health equity in research and expand clinical trial access. The study will also use/develop digital healthcare solutions, which will enable better understanding of pts’ needs and their adherence to ET. STATISTICAL METHODS The primary endpoint analysis will use a stratified log-rank test at an overall 0.05 significance level (two-sided). An interim analysis and a futility analysis are planned, and an independent data monitoring committee will be in place. ACCRUAL 1018/4100 pts have been recruited globally. CONTACT INFORMATION For more information or to refer a patient, email global.rochegenentechtrials@roche.com or call 1-888-662-6728 (USA only). Clinicaltrials.gov number NCT04961996. AB, PS and CG contributed equally. This abstract was originally presented at SABCS 2021 (OT2-11-09). a>Disclosure(s): Peter Schmid, MD, PhD: Astellas Pharma: Contracted Research (Ongoing); AstraZeneca: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing), Honoraria (Ongoing); Bayer: Consulting Fees (e.g., advisory boards) (Ongoing), Honoraria (Ongoing); Boehringer Ingelheim: Consulting Fees (e.g., advisory boards) (Ongoing), Honoraria (Ongoing); Celgene: Consulting Fees (e.g., advisory boards) (Ongoing); Eisai: Consulting Fees (e.g., advisory boards) (Ongoing); F. Hoffmann-La Roche Ltd.: Third-party writing assistance for this abstract, furnished by Sunaina Indermun, BPharm, PhD, of Health Interactions, was provided by Roche (Ongoing); Genentech: Contracted Research (Ongoing); Medivation Inc.: Contracted Research (Ongoing); Merck: Consulting Fees (e.g., advisory boards) (Ongoing), Honoraria (Ongoing); Novartis: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing), Honoraria (Ongoing); OncoGenex: Contracted Research (Ongoing); Pfizer: Consulting Fees (e.g., advisory boards) (Ongoing), Honoraria (Ongoing); Puma Biotechnology: Consulting Fees (e.g., advisory boards) (Ongoing), Honoraria (Ongoing); Roche: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing), Honoraria (Ongoing) Charles E. Geyer Jr, MD, FACP: Abbvie: Contracted Research (Terminated, July 1, 2022), Writing assistance (Terminated, July 1, 2022); AstraZeneca: Contracted Research (Ongoing), Writing assistance (Ongoing); Daiichi/Sankyo: Contracted Research (Ongoing); Exact Sciences: Consulting Fees (e.g., advisory boards) (Ongoing); F. Hoffman-La Roche Ltd: Contracted Research (Ongoing), Third-party writing assistance for this abstract, furnished by Sunaina Indermun, BPharm, PhD, of Health Interactions, was provided by Roche) (Ongoing); Genentech: Contracted Research (Ongoing), Writing assistance (Ongoing) Nadia Harbeck, MD, PhD: Amgen: Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); AstraZeneca: Consulting Fees (e.g., advisory boards) (Ongoing), Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); Daiichi Sankyo: Consulting Fees (e.g., advisory boards) (Ongoing), Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); Eli Lilly: Consulting Fees (e.g., advisory boards) (Ongoing), Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); Exact Sciences: Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); MSD: Consulting Fees (e.g., advisory boards) (Ongoing), Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); Novartis: Consulting Fees (e.g., advisory boards) (Ongoing), Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); Pfizer: Consulting Fees (e.g., advisory boards) (Ongoing), Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); Pierre Fabre: Consulting Fees (e.g., advisory boards) (Ongoing), Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); Roche: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing), Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing), Third-party writing assistance for this abstract, furnished by Sunaina Indermun, BPharm, PhD, of Health Interactions, was provided by Roche (Ongoing); Sandoz: Consulting Fees (e.g., advisory boards) (Ongoing); Seagen: Consulting Fees (e.g., advisory boards) (Ongoing), Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); WSG: Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds) (Ongoing) Mothaffar Rimawi, MD: Daiichi Sankyo: Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); F. Hoffmann-La Roche Ltd.: Contracted Research (Ongoing), Third-party writing assistance for this abstract, furnished by Sunaina Indermun, BPharm, PhD, of Health Interactions, was provided by Roche (Ongoing); Genentech: Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); Macrogenics: Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); Pfizer: Contracted Research (Ongoing); Seattle Genetics: Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing) Sara Hurvitz, MD, FACP: Ambrx: Contracted Research (Ongoing); Amgen: Contracted Research (Ongoing); Arvinas: Contracted Research (Ongoing); Astra Zeneca: Contracted Research (Ongoing); Bayer: Contracted Research (Ongoing); Cytomx: Contracted Research (Ongoing); Daiichi-Sankyo: Contracted Research (Ongoing); Dignitana: Contracted Research (Ongoing); Eli Lilly: Contracted Research (Ongoing); Genentech/Roche: Contracted Research (Ongoing); Gilead: Contracted Research (Ongoing); GSK: Contracted Research (Ongoing); Ideal Implant: Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds) (Ongoing); Immunomedics: Contracted Research (Ongoing); Macrogenics: Contracted Research (Ongoing); Novartis: Contracted Research (Ongoing); OBI Pharma: Contracted Research (Ongoing); Orinove: Contracted Research (Ongoing); Pfizer: Contracted Research (Ongoing); Phoenix Molecular Designs, Ltd.: Contracted Research (Ongoing); Pieris: Contracted Research (Ongoing); PUMA: Contracted Research (Ongoing); Radius: Contracted Research (Ongoing); Sanofi: Contracted Research (Ongoing); Seattle Genetics/Seagen: Contracted Research (Ongoing); Zymeworks: Contracted Research (Ongoing) Miguel Martín, MD, PhD: AstraZeneca: Consulting Fees (e.g., advisory boards) (Ongoing), Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); Daiichi Sankyo: Consulting Fees (e.g., advisory boards) (Ongoing), Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); F. Hoffmann-La Roche: Third-party writing assistance for this abstract, furnished by Eleanor Porteous, MSc, of Health Interactions, was provided by Roche (Ongoing); Genentech/Roche: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing), Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing), Third-party writing assistance for this abstract, furnished by Sunaina Indermun, BPharm, PhD, of Health Interactions, was provided by Roche (Ongoing); Gilead: Consulting Fees (e.g., advisory boards) (Ongoing), Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); Lilly/ImClone: Consulting Fees (e.g., advisory boards) (Ongoing), Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing), Honoraria (Ongoing); Novartis: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing), Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing), Honoraria (Ongoing); Pfizer: Consulting Fees (e.g., advisory boards) (Ongoing), Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing), Honoraria (Ongoing); Pierre Fabre: Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing), Honoraria (Ongoing); Seagen: Consulting Fees (e.g., advisory boards) (Ongoing), Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing), Honoraria (Ongoing) Sherene Loi, MBBS (Hons), PhD, FRACP, FAHMS, GAICD: Aduro Biotech, Inc.: Consulting Fees (e.g., advisory boards) (Ongoing); Akamara Therapeutics: Uncompensated scientific advisory board member (Ongoing); AstraZeneca: Consulting Fees (e.g., advisory boards) (Ongoing), Uncompensated consultant (Ongoing); BMS: Uncompensated consultant (Ongoing); Breast Cancer Research Foundation, New York: Supported by the Breast Cancer Research Foundation, New York (Ongoing); G1 Therapeutics: Consulting Fees (e.g., advisory boards) (Ongoing); GlaxoSmithKline: Consulting Fees (e.g., advisory boards) (Ongoing); Merck: Uncompensated consultant (Ongoing); National Breast Cancer Foundation of Australia Endowed Chair: Supported by the National Breast Cancer Foundation of Australia Endowed Chair (Ongoing); Novartis: Consulting Fees (e.g., advisory boards) (Ongoing), Uncompensated consultant (Ongoing); Roche-Genentech: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing), Third-party writing assistance for this abstract, furnished by Sunaina Indermun, BPharm, PhD, of Health Interactions, was provided by Roche (Ongoing), Uncompensated consultant (Ongoing); Seattle Genetics: Uncompensated consultant (Ongoing); Silverback Therapeutics: Consulting Fees (e.g., advisory boards) (Ongoing) Shigehira Saji, MD, PhD: Astra Zeneca: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing), Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); Bayer: Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); Boerhringer-ingelheim: Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); Breast International Group: Executive board member (Ongoing); Chugai: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing), Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); Daiichi Sankyo: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing), Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); Eisai: Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); Eli Lilly: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing), Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); F. Hoffmann-La Roche Ltd.: Contracted Research (Ongoing), Third-party writing assistance for this abstract, furnished by Sunaina Indermun, BPharm, PhD, of Health Interactions, was provided by Roche (Ongoing); Japan Breast Cancer Research Group: Executive board member (Ongoing); Japanese Breast Cancer Society: Executive board member (Ongoing); Japanese Society of Medical Oncology: Executive board member (Ongoing); Kyowa Kirin: Consulting Fees (e.g., advisory boards) (Ongoing), Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); MSD: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing), Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); Nihonkayaku: Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); Novartis: Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); Ono: Consulting Fees (e.g., advisory boards) (Ongoing), Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); Pfizer: Consulting Fees (e.g., advisory boards) (Ongoing), Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); Taiho: Contracted Research (Ongoing), Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); Takeda: Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing) Kyung Hae Jung, MD, MS, PhD: AstraZeneca: Consulting Fees (e.g., advisory boards) (Ongoing); Celgene: Consulting Fees (e.g., advisory boards) (Ongoing); Daiichi-Sankyo: Consulting Fees (e.g., advisory boards) (Ongoing); Eisai: Consulting Fees (e.g., advisory boards) (Ongoing); Everest Medicine: Consulting Fees (e.g., advisory boards) (Ongoing); Merck: Consulting Fees (e.g., advisory boards) (Ongoing); MSD: Consulting Fees (e.g., advisory boards) (Ongoing); Novartis: Consulting Fees (e.g., advisory boards) (Ongoing); Pfizer: Consulting Fees (e.g., advisory boards) (Ongoing); Roche: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing), Third-party writing assistance for this abstract, furnished by Sunaina Indermun, BPharm, PhD, of Health Interactions, was provided by Roche (Ongoing); Takeda: Consulting Fees (e.g., advisory boards) (Ongoing) Gustavo Werutsky, MD, PhD: AstraZeneca: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing), Honoraria (Ongoing); Bayer: Contracted Research (Ongoing); Beigene: Contracted Research (Ongoing); Daiichi Sankyo: Consulting Fees (e.g., advisory boards) (Ongoing); Genentech/Roche: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing), Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers’ bureaus) (Ongoing); GSK: Contracted Research (Ongoing); Lilly: Contracted Research (Ongoing), Honoraria (Ongoing); MSD: Honoraria (Ongoing); Novartis: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing), Honoraria (Ongoing); Pfizer: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing), Honoraria (Ongoing); Sanofi: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing); Seattle Genetics: Contracted Research (Ongoing) Daniil L. Stroyakovsky, MD: Roche: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing), Third-party writing assistance for this abstract, furnished by Sunaina Indermun, BPharm, PhD, of Health Interactions, was provided by Roche (Ongoing) Vanesa López-Valverde, PharmD, PhD: F. Hoffmann-La Roche Ltd.: Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds) (Ongoing), Salary (Ongoing), Third-party writing assistance for this abstract, furnished by Sunaina Indermun, BPharm, PhD, of Health Interactions, was provided by Roche (Ongoing) Michael Davis, PsyD: F. Hoffmann-La Roche Ltd.: Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds) (Ongoing), Third-party writing assistance for this abstract, furnished by Sunaina Indermun, BPharm, PhD, of Health Interactions, was provided by Roche (Ongoing); Genentech, Inc.: Salary (Ongoing) Tanja Badovinac Crnjevic, MD, PhD: F. Hoffmann-La Roche Ltd.: Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds) (Ongoing), Salary (Ongoing), Third-party writing assistance for this abstract, furnished by Sunaina Indermun, BPharm, PhD, of Health Interactions, was provided by Roche (Ongoing) Pablo D. Perez-Moreno, MD: F. Hoffmann-La Roche Ltd.: Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds) (Ongoing), Third-party writing assistance for this abstract, furnished by Sunaina Indermun, BPharm, PhD, of Health Interactions, was provided by Roche (Ongoing); Genentech, Inc.: Salary (Ongoing) Aditya Bardia, MD, MPH: AstraZeneca: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing); BioTheranostics: Consulting Fees (e.g., advisory boards) (Ongoing); Daiichi Sankyo: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing); Eli Lilly: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing); Foundation Medicine: Consulting Fees (e.g., advisory boards) (Ongoing); Genentech/Roche: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing); Immunomedics/Gilead: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing); Merck: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing); Novartis: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing); Pfizer: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing); Phillips: Consulting Fees (e.g., advisory boards) (Ongoing); Radius Health: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing); Sanofi: Consulting Fees (e.g., advisory boards) (Ongoing), Contracted Research (Ongoing) Citation Format: Peter Schmid, Charles E. Geyer Jr, Nadia Harbeck, Mothaffar Rimawi, Sara Hurvitz, Miguel Martín, Sherene Loi, Shigehira Saji, Kyung Hae Jung, Gustavo Werutsky, Daniil L. Stroyakovsky, Vanesa López-Valverde, Michael Davis, Tanja Badovinac Crnjevic, Pablo D. Perez-Moreno, Aditya Bardia. lidERA Breast Cancer: A phase III adjuvant study of giredestrant (GDC-9545) vs physician’s choice of endocrine therapy in patients with estrogen receptor+, HER2– early breast cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT2-03-02.

The incidence of cancer in Latin America and the Caribbean (LAC) is increasing yearly and is expected to reach 2.4 million new cases by 2040, with a more pronounced effect in Central America and South America. In addition, cancer is already the most frequent cause of premature death for most countries in LAC, and the second cause of death independent of country socioeconomic status, clearly demonstrating that the cancer burden in LAC should be addressed now rather than considered as an issue to be dealt with in the future. LAC countries performed in a mid-range zone in terms of income and mortality-to-incidence ratio compared to other countries globally. The LAC continent has, in general, a median income per capita and a median availability of radiotherapy (RDT) machines per capita. Patients that have private health coverage are more likely to receive preventive care such as pap smears and mammography in many countries of the LAC. The human development index was negatively related to mortality from oral cancer in the LAC countries with medium and low Human Development Index (HDI). Cancer treatment adverse events can negatively affect survivors' workability compromising their return to work after diagnosis. In conclusion, the cancer burden can be a major public health issue with a considerable socioeconomic impact in LAC countries. It is demonstrated in several studies that unequal access to optimal care is frequent in LAC and that health insurance type may impact patients' diagnosis and outcome.

Background The aim of this study was to carry out a descriptive analysis of the somatic genetic profile and co‐occurring mutations of non‐small cell lung cancer (NSCLC) samples from patients tested with comprehensive genomic profiling (CGP). Methods This was a retrospective cross‐sectional study of patients diagnosed with NSCLC from 2013 to 2018 in Brazil and whose samples were submitted to CGP (FoundationOne or FoundationACT) using either tumor or circulating tumor DNA (ctDNA) from plasma. Results We recovered 513 CGP results from patients, 457 (89.1%) of which were from tumors and 56 (10.9%) from plasma. The median age of patients was 64 years old, of which 51.6% were males. TP53 mutations were identified in 53.6% of tumor samples, KRAS mutations in 24.2%, EGFR activating mutations were detected in 22.5%, STK11 mutations in 11.6%, PIK3CA mutations in 8.8%, ALK rearrangements in 5.4%, BRAF mutations in 5.2%, and ERBB2 alterations in 4.9%. The most commonly comutated gene was TP53. TP53 p.R337H was observed in 4.3% of samples and was associated with somatic mutations in EGFR and ERBB2 (P, This is the first report of the prevalence of driver mutations in Brazilian NSCLC patients using comprehensive genomic profiling.

BACKGROUND Healthy lifestyle has been shown to have a positive impact on quality of life, risk of recurrence, and overall survival in breast cancer (BC). Physicians play an important role in encouraging their patients to lifestyle modification. Nonetheless, little is known whether physician lifestyle can impact on healthy habits recommendations to BC patients. We aimed to evaluate how physician’s lifestyle influences the prescription of healthy habits to BC patients. METHODSLACOG 1218 was an observational, cross-sectional study. An online questionnaire composed of 14 objective questions to evaluate physician lifestyle and prescription of healthy habits to BC patients was developed and circulated by e-mail to breast surgeons, clinical and radiation oncologists who were members of the Brazilian Society of Clinical Oncology (SBOC) and Latin American Cooperative Oncology Group (LACOG) and dedicated to the treatment of BC patients. The primary objective of the study was to evaluate the correlation between the physician lifestyle and the prescription of healthy habits to BC patients. A multivariate Poisson regression analysis was used to assess which factors of physician lifestyle could influence prescription of healthy habits.RESULTSA total of 267 physicians answered the questionnaire from October to November 2018. Of these, 142 (53.2%) were clinical oncologists, 116 (43.5%) were breast surgeons, and 9 (3.4%) were radiation oncologists. Female were 58.4%, 51.8% were older than 50 years and the majority 71.5% worked in private health insurance practice. In terms of physician lifestyle, 228 (85.4%) had healthy eating habits, 236 (88.4%) practiced physical activity and 93 (34.9%) were self-reported with overweight or obese. A total of 143 (46.1%) did not drink alcohol or drunk less than once a month and did not consume more than 5 doses and only 8 (3%) of them were current smoker. Overall, 84.3% of the physicians advised their BC patients on the importance of lifestyle modification. Physicians who did not exercise regularly have a higher chance of not advising for health lifestyle (HR 2.48; 95% CI 1.28 to 4.82, p=0.0265) as opposite to physicians older than 50 years (RR 0.37; CI 95% 0.15 - 0.92; p=0.0118).Obesity treatment and management was performed by 121 (45.3%) of physicians. Being a breast surgeon (RR 1.29; 95% CI 1.02 to 1.63, p=0.0025) or radiation oncologists (RR 1.82; 95% CI 1.43 to 2.31, p=0.0025) were the only factors associated with not performing obesity treatment and management. About 53.4% of physicians referred overweight or obese patients to a dietician and/or endocrinologist. Male gender (RR 1.35; CI 95% 1.03-1.76; p=0.0296), breast surgeons (RR 1.99; CI 95% 1.50-2.64; p=0.0001) and clinical practice in public health system (RR 1.53; CI 95% 1.20-1.96; p=0.0012) were factors associated with not referring patients to dietician and/or endocrinologist as opposed to physicians older than 50 years (RR 0.46; CI 95% 0.28-0.75; p=0.0005).CONCLUSIONIn general physicians treating BC patients have a healthy lifestyle. Physicians who practice physical activity regularly or older than 50 years had more chance to advise lifestyle modification. Only half of BC patients’ physicians treat obesity or refer these patients to specialist which in this case may impact BC patient’s outcome. Citation Format: Renata Cangussú, Eldsamira Mascarenhas, Taiane F Rebelatto, Paulo R Nunes, Rafaela G de Jesus, Facundo Zaffaroni, Gustavo Werutsky. Influence of physician’s lifestyle on the prescription of healthy habits to breast cancer patients (LACOG 1218) [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS7-91.

INTRODUCTIONPatients diagnosed with breast cancer (BC) in Brazil are on average 54 years old and the majority (70%) have stage II-III. Age and clinical stage have a negative impact on patient personal life and labor productivity. The socioeconomic status is a fundamental part of the population’s health, which includes marital and employment status. Our aim was to analyze the socioeconomic impact of BC diagnosis which is poorly studied in low or middle-income countries. METHODSThis is a cross-sectional study including patients from AMAZONA III cohort study. Eligible patients were female aged > 18 years with diagnosis of any stage invasive BC from 2016 to 2018 in 24 participating hospitals in Brazil. The present analysis evaluated the marital and employment status at baseline and at 1-year follow-up after BC diagnosis. Patients with missing data were excluded and women older than 60 years, retirement age in Brazil, were not included in this analysis. A multivariate Poisson regression analysis with robust variance was adjusted to assess which patients’ characteristics associated with job loss and relationship status. The characteristics evaluated were age (⇐ 50 vs. > 50 years), educational level (Illiterate to completed first degree or completed second degree vs. higher), personal income (no income – 2 minimum wages vs. 2 to 5 minimum wages vs. more than 5 minimum wages), clinical-stage (I-III vs. IV), molecular subtype (luminal, HER2 positive vs. triple negative), surgery type (breast conserving surgery vs. any type of mastectomy), and systemic treatment (chemotherapy vs. hormonal therapy vs. none). The significance level was set at 5%. All analyses were conducted using SAS version 9.4 (SAS Institute, Cary, NC). RESULTSFrom a total of 1257 patients with evaluable employment status, 655 patients (52.1%) had working activity at the time of BC diagnosis. After 1 year of follow-up, there was an absolute decrease of 5.3% in patients’ employment (52.1% to 46.8%; p= 0.0075). Loss of employment was higher in older patient > 50 years (8.7%), lower educational level (9.9%), those earning 2-5 minimum wages (11.2%), stage I-III (7%), triple negative (6.9%), mastectomy (9.9%) and treatment with hormone therapy (11%). Patients with higher educational level (RR 0.61, 95% CI 0.36-0.94, p=0.0265) were at lower risk of employment loss whereas patients with personal income of more than 2 minimum wages (RR 1.83, 95% CI 1.08-3.10, p=0.0236) and mastectomy (RR 2.16, 95% CI 1.47-3.17, p=0.0015) were at higher risk of being unemployed loss after 1 year of diagnosis. Other factors such as age, clinical stage, BC subtype and treatment were not independently associated with unemployment. A total of 1947 patients had marital status information at baseline. Of those, 1182 (60.7%) were married or in common-law marriage at BC diagnosis. After 1 year of follow-up, 52 (2.7%) of these women loss their relationship (60.7% vs. 58%; p=0.08). Loss of relationships was higher (5.2%) in younger patients (≤ 50 years), lower educational level (4.9%), no income or up to 2 minimum wages (5.4%), stage IV (7.7%), HER2 positive (5.5%), mastectomy (5.4%) and treatment with hormone therapy (5.5%). None of the variables evaluated such as age, educational level, personal income, clinical-stage, molecular subtype, surgery type and systemic treatment, were significantly associated with change of marital status for patients previously married or in common-law marriage. CONCLUSION The socioeconomic impact of BC diagnosis was minimal at 1-year follow-up in Brazil. Nonetheless personal income and surgery type were associated with higher chance of unemployment whereas no specific variables were related to marital status change. Government social policies specifically for work return remains critical for BC patients in short-term after BC diagnosis. Citation Format: Gustavo Werutsky, Daniela Dornelles Rosa, Carlos Barrios, Eduardo Cronemberger, Geraldo Queiroz, Jose Bines, Mahira Lopes Rosa, Rafaela Gomes, Ana P Heck, Laura Freitas, Arthur F da Silva, Matheus Rodrigues, Andre P Fay, Sergio Simon. The socioeconomic impact of breast cancer in Brazil: An analysis of AMAZONA III cohort study [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS7-89.

TPS272 Background: Treatment of metastatic castration-resistant prostate cancer (mCRPC) has been steadily evolving during the last decade, but access remains a significant issue in low- and middle-income countries (LMICs). As novel therapies emerge and translate into clinical practice, the gap in treatment patterns between patients who do or do not have access to these therapies is expected to increase. The resulting disparities in outcomes are likely to be more noticeable in countries with pronounced inequality, such as Brazil. In Brazil, while a minority of patients have private insurance and have access to nearly all available treatment options, approximately 75% of patients depend on the public health system, which is unable to afford most of the recent treatment innovations for mCRPC, such as novel hormonal agents (NHA) or PARP inhibitors. LACOG 1818 was developed to investigate and compare outcomes of patients with mCRPC treated at private and public hospitals in Brazil. Methods: LACOG 1818 (NCT04962919) is a retrospective multicentric study investigating disparities in cancer treatment and survival among public and private institutions in Brazil. Patients with mCRPC diagnosed within January 2014 and December 2017 will be included and their data will be abstracted from medical records. Primary endpoint is cause-specific survival, comparing patients from private and public institutions. We estimate that 299 events are needed to detect a hazard ratio of 0.75 indicating a lower risk of prostate cancer-related death for patients treated at private institutions with a power of 80% and a bicaudate significance level of 10%. Considering a follow up of 24 months and a median cause-specific survival of 20 months in patients from public institutions, 590 patients are planned to be included. Secondary endpoints include describing comorbidities, sociodemographic and clinicopathological characteristics of patients with mCRPC; comparing overall survival of patients with mCRPC treated at public and private institutions; comparing treatments patterns of patients with mCRPC treated at public and private institutions; and describing skeleton-related complications, bone-directed treatments, and admission rates. From January 2020 to August 2022, 244 of planned 590 patients have been enrolled in 7 Brazilian centers. Additional 12 centers are still planned to open before 2023. Results are expected in the first semester of 2023. Clinical trial information: NCT04962919 .

TPS14 Background: Penile squamous cell carcinoma (PSCC) is an uncommon malignancy which accounts for 2,300 new cases and 400 deaths annually worldwide. However, in low-income countries from South America, Asia and Africa, incidence corresponds to 10-20% of all malignancies in men. Approximately 4% of PSCC patients present with metastatic disease at diagnosis. Also, even if diagnosed in early stages (localized disease), around 30% of patients will recur. No improvements have been achieved over the last three decades in platinum-based chemotherapy, which remains the standard-of-care; objective response rate (ORR), median progression-free survival (PFS) and overall survival (OS) are currently at 20-30%, 3-4 months and 7-15 months, respectively. HPV16 is the most important known risk factor for PSCC. Favorable results have been achieved with Pembrolizumab in other HPV-associated cancers, such as cervical and oropharyngeal cancer. HERCULES (LACOG 0218) aims to evaluate the efficacy of pembrolizumab combined with platinum-based chemotherapy as first-line treatment in advanced PSCC. Methods: HERCULES is a phase 2, single-arm, multicentric trial evaluating patients with histologically proven PSCC and metastatic disease (de novo or recurrent); or recurrent locally advanced disease not amenable to curative-intent therapy; or TanyN3M0 or T4NanyM0 (stage IV – AJCC 8th ed) not amenable to curative-intent therapy. Additional inclusion criteria were ECOG PS 0–1; measurable disease by RECIST 1.1; no prior systemic therapy for recurrent or metastatic disease (however, patients progressing after 12 months of neo/adjuvant chemotherapy completion are allowed). The primary endpoint is ORR up to week 24. Secondary endpoints are OS, PFS, clinical benefit rate, immune related response criteria, quality of life, safety, and predictive biomarkers of response/survival. Eligible subjects receive 5-FU 1000mg/m²/day IV D1-D4, cisplatin 70mg/m² or carboplatin AUC 5 IV D1 plus pembrolizumab 200mg IV D1 at each 3-week (Q3W) dosing cycle for 6 cycles, followed by Pembrolizumab 200mg IV Q3W maintenance. Patients without disease progression are allowed to continue pembrolizumab monotherapy until completing 34 cycles, disease progression or unacceptable toxicity, whichever comes first. Tumor evaluations are performed every 6 weeks until week 24. Sample size was calculated as 33 patients to detect an increase in ORR from 20% to 40% up to week 24 with 78.5% power and considering 10% drop-out. From Aug 2020 to Jul 2022, 33 patients were enrolled in 11 Brazilian research sites. Results are expected in 2023. NCT04224740. Clinical trial information: NCT04224740 .

Introduction We analyzed the prevalence of non–small-cell lung cancer (NSCLC) with a programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) of ≥ 50% and compared the results with the existing data from clinical trials and databases from other countries. Materials and Methods The Latin American Cooperative Oncology Group and Grupo Brasileiro de Oncologia Toracica performed a retrospective, cross-sectional study from August 2017 to April 2018. PD-L1 expression was collected from pathology reports from 5 laboratories in Brazil. All tests were sponsored by the pharmaceutical industry on request from the treating medical oncologist. PD-L1 expression was assessed by immunohistochemistry. The variables were summarized as absolute and relative frequencies or the median and interquartile range. Pearson's χ2 test was used to compare the TPS categories stratified by sex, age, and histologic type. All analyses were performed with SAS, version 9.4, and were deemed statistically significant at P Results A total of 1512 patients were included in the present study. Their median age was 66 years. Most patients were men (56.02%), and the most common histologic type was adenocarcinoma (58.04%); 109 tumors (11.31%) had EGFR mutations and 34 (3.64%) had ALK gene rearrangements. Overall, 56.54% had a PD-L1 TPS Conclusion The prevalence of high PD-L1 expression among the Brazilian NSCLC samples was lower than previously described in other countries, which could affect the number of patients who might be candidates for immunotherapy alone.

Breast cancer (BC) is the most common type of cancer among women in Brazil. Evidence shows that delayed treatment onset is associated with increased mortality. This study aimed to evaluate median days between diagnosis and treatment and factors associated with delayed start of treatment ( 60 days after diagnosis): stage, treatment received, subtype, epidemiological characteristics, and type of healthcare coverage.This analysis included 1709 stage I-III BC patients from AMAZONA III, a prospective, observational study, diagnosed from January 2016 to March 2018 in 22 centers in Brazil.The median number of days from diagnosis to beginning of first oncologic treatment was 46 days (IQR 28-75) overall, 43 days (IQR 25-75) for stage I disease, 49 days (IQR 28-81) for stage II, and 44 days (IQR 30-68) for stage III, (p = 0.1180). According to first treatment received, diagnosis-to-treatment interval was 43 days (IQR 29-65) for neoadjuvant chemotherapy and 48 days (IQR 26-81) for surgery. Diagnosis-to-treatment interval was higher in women treated in the public system versus the private system (56 vs. 34 days, p 0.0001). Patients in the public system had an increased odds of delayed treatment initiation (OR 4.74 95% CI 3.09-7.26, p .0001). The longer interval from diagnosis to treatment in the public system was independent of clinical stage, type of treatment (systemic vs surgery first), subtype and region of the country.By characterizing the delays in care delivery, our study will aid stakeholders to better design interventions and allocate resource to improve timely treatment for breast cancer in Brazil.gov Identifier: NCT02663973, registered on January, 26th, 2016.

INTRODUCTION: The evaluation of an individual with risk of hereditary breast cancer is based on the patient's family history and the characteristics of the neoplasia. BRCA1 and BRCA 2 are the most common genes associated with hereditary predisposition for breast or ovarian cancer. The evaluation of an individual with risk of hereditary breast cancer is key to identify patients with indication to BRCA test. Recent studies in US suggests that 31 to 34% of patients with breast cancer should be referred for genetic evaluation. In Brazil, the proportion of BC patients with indication to genetic evaluation is unknown. OBJECTIVE: To describe the prevalence of breast cancer patients enrolled in the AMAZONA III study with indication for genetic evaluation considering the criteria for hereditary breast and ovarian cancer syndrome (HBOC). METHOD: We evaluated the database of the AMAZONA III observational, prospective cohort study which included 2950 patients newly diagnosed with BC in the period of 2016-18 within 23 Brazilian sites. The criteria used to select patients who should be referred for genetic testing were extracted from the National Comprehensive Cancer Network (NCCN) guideline 2018. The characteristics of interest were summarized through descriptive statistics. RESULTS: A total of 1094 (37%) BC patients had at least one criteria for HBOC syndrome test. The most common criteria for testing was age equal or inferior 45 years (27%), BC diagnosis under 50 years and family history of breast cancer (13.5%). From the 2950 enrolled patients, 651 (22%) had the information about whether an evaluation of BRCA test was performed. Of them only 45 (6.9%) performed BRCA test, one patient from public health system and the others from private health system and from those tested 18 (40%) had an identified pathogenic mutation. CONCLUSION: A high proportion of patients diagnosed with BC in Brazil have a criteria for HBOC syndrome testing. Nonetheless a few patients have access to genetic counseling and BRCA test, especially in the public health system. Therefore its critical to implement health policies to facilitate the access to specialized care in hereditary cancer. Frequency of each criteria regarding all 2950 patientsTotal - n (%)Missing - n (%) Citation Format: Alessandra BorbaAnton de Souza, Daniela Rosa, Antonio LuiZ Frasson, Felipe Pereira Zerwes, Nathalia Cunha Rossato, Patricia Asthon-Prolla, Sergio Simon, Jose Bines, Carlos Barrios, Alessandra Morelle, Carlos AlbertoSampaio Filho, Max Mano, Rafaela Gomes, Gustavo Werutsky. Prevalence of patients with indication of genetic evaluation for hereditary breast and ovarian syndrome in the Brazilian cohort study - AMAZONA III [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-09-11.

PURPOSE Physicians rarely receive formal training in leadership skills. Çitaku and colleagues have identified a set of leadership competencies (LCs) providing validity evidence in North American (NA) and European Union (EU) medical education institutions. We aim to apply this same survey to a sample of Latin American (LA) medical leaders from the oncology community and related areas, compare the results with those of the previous survey, and perform subgroup analyses within the LA cohort. METHODS The survey was sent to nearly 8,000 physicians of participating professional organizations. In addition to the 63 questions, we also collected data on the type of institution, country, specialty, sex, age, years of experience in oncology, and leadership position. RESULTS The 217 LA respondents placed the highest value on task management competencies (91.37% reported these as important or very important v 87.0% of NA/EU respondents; P < .0001), followed by self-management (87.45% of LA respondents v 87.55% of NA/EU respondents; P = not significant [NS]), social responsibility (86.83% of LA respondents v 87.48% of NA/EU respondents; P = NS), innovation (86.69% of LA respondents v 85.31% of NA/EU respondents; P = NS), and leading others (83.31% of LA respondents v 84.71% of NA/EU respondents; P = NS). Social responsibility, which was first in importance in the NA/EU survey, was only third in the LA survey. Subgroup analyses showed significant variations in the ratings of specific LCs within the LA population. CONCLUSION LCs valued by LA leaders somewhat differ from those valued by their NA and EU counterparts, implying that cultural aspects might influence the perception of desired LCs. We also detected variations in the responses within the LA population. Our data indicate that current physician leadership training programs should be tailored to suit specific needs and cultural aspects of each region. Further validity studies of this instrument with other samples and cultures are warranted.

BACKGROUND Healthy lifestyle is capable of positively modifying the survival of breast cancer(BC) patients. We aimed to evaluate how physician’s lifestyle influences on the prescription of healthy habits to BC patients.METHODS An online questionnaire to evaluate physician lifestyle and prescription of healthy habits to BC patients was developed and circulated by e-mail to physicians dedicated to treat BC patients. A multivariate Poisson regression analysis assessed which factors of physician lifestyle could influence on prescription of healthy habits.RESULTSA total of 267 physicians answered the questionnaire from October to November 2018. In terms of physician lifestyle, 228(85.4%) had healthy eating habits and 236(88.4%) practiced physical activity. Overall, 84.3% of the physicians advised their BC patients on the importance of lifestyle modification. Physicians who did not exercise regularly have a higher chance of not advising for health lifestyle (RR 2.48; p=0.0265) as opposite to physicians ≥50 years-old (RR 0.37; p=0.0118). Obesity treatment and management was performed by 45.3% of physicians. Being a breast surgeon (RR 1.29; p=0.0025) or radiation oncologists (RR 1.82; p=0.0025) were associated with not performing obesity treatment and management. About 53.4% of physicians referred overweight or obese patients to a dietitian and/or endocrinologist. Male gender (RR 1.35; p=0.0296), breast surgeons (RR 1.99; p=0.0001) and clinical practice in public health system (RR 1.53; p=0.0012) were associated with not referring as opposed to physicians ≥50 years-old (RR 0.46; p=0.0005).CONCLUSIONIn general physicians treating BC patients have a healthy lifestyle. Only half of BC patients’ physicians treat obesity or refer these patients to specialist which in this case may impact BC patient’s outcome.

ObjectivesCervical cancer is the fourth most common cancer in women worldwide. Epidemiological and quality of life (QoL) data in patients with cervical cancer from low- and middle-income countries are scarce. We aimed to describe sociodemographic and clinicopathological characteristics and quality of life of patients with cervical cancer at diagnosis in Brazil.MethodsEVITA is a prospective cohort study of newly diagnosed patients with cervical cancer from May 2016 to December 2017, stages I–IVB, from 16 Brazilian sites representing the five Brazilian regions. At baseline, medical evaluation was performed and European Organization for Research and Treatment of Cancer (EORTC) QLQ-CX24/C30 questionnaires were administered.ResultsA total of 631 patients were included. Mean±SD age was 49.3±13.9 years; skin color was non-white in 65.3%, and 68.0% had ≤8 years of formal education. In total, 85.1% of patients had a Pap smear. The main reasons reported by patients for not having a Pap smear were: lack of interest (46.9%), shame or embarrassment (19.7%), lack of knowledge (19.7%), and difficulty with access (9.1%). Most patients were diagnosed with locally advanced or metastatic disease (FIGO clinical stage II–IV in 81.8%– stage II in 35.2%, stage III in 36.1%, and stage IV in 10.5%). Patients with clinical stage III–IV had worse physical functioning and role functioning.ConclusionsCervical cancer in Brazil is usually diagnosed at an advanced stage. Most patients have low formal education and are unemployed. Lack of interest was identified as a main reason for not having a screening test, and limited access was reported as a reason by