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Clinical research is the cornerstone of improvements in cancer care. However, it has been conducted predominantly in high-income countries with few clinical trials available in Brazil and other low-and-middle-income countries (LMIC). Of note, less than one-third of registered clinical trials addressing some of the most commonly diagnosed cancers (breast, lung and cervical) recruited patients from LMIC in the last years. The Institute Project CURA promoted the fourth CURA meeting, discussing barriers to cancer clinical research and proposing potential solutions. A meeting was held in São Paulo, Brazil, in June 2023 with representatives from different sectors: Brazilian Health Regulatory Agency (Anvisa), National Commission of Ethics in Research (CONEP), non-governmental organisations, such as the Latin American Cooperative Oncology Group, the Brazilian Society of Clinical Oncology (SBOC), Contract Research Organisations, pharmaceutical companies and investigators. A total of 16 experts pointed out achievements as shortening the time of regulatory processes involving Anvisa and CONEP, development of staff training programs, maintenance of the National Program of Oncological Attention (PRONON), and the foundation of qualified centres in North and Northeast Brazilian regions. Participants also highlighted the need to be more competitive in the field, which requires optimising ongoing policies and implementing new strategies as decentralisation of clinical research centres, public awareness campaigns, community-centered approaches, collaborations and partnerships, expansion of physicians-directed policies, exploring the role of the steering committee. Active and consistent reporting of the initiatives might help to propagate ongoing advances, increasing Brazilian participation in clinical cancer research. Engagement of all players is crucial to maintain continuous progress with further improvements in critical points including regulatory timelines and increments in qualified human resources which aligned with new educational initiatives focused on physicians and the general population will expand access to cancer clinical trials in Brazil., Competing Interests: Heloisa Resende has received research funding from Novartis and Roche, all outside the scope of this manuscript. Gustavo Werutsky has received research funding from AstraZeneca/MedImmune, Bristol-Myers Squibb Brazil, Pfizer, Roche and Roche/Genentech, all outside the scope of this manuscript. Has consulting or advisory role at Merck. Carlos H Barrios has received research funding from AB Science, Abbvie, Abraxis BioScience, Amgen, Asana Biosciences, Astellas Pharma, AstraZeneca, Biomarin, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Clinica Atlantis, Covance, Daiichi Sankyo, Exelixis, GlaxoSmith-Kline, Halozyme, ImClone Systems, INC Research, inVentiv Health, Janssen, LEO Pharma, Lilly, Medivation, Merck, Merck KGaA, Merrimack, Millennium, Mylan, Novartis, Pfizer, PharmaMar, Polyphor, Roche/Genentech, Sanofi, Shanghai Henlius Biotech and Taiho Pharmaceutical, all outside the scope of this manuscript. Has consulting or advisory role at AstraZeneca, Boehringer Ingelheim, Eisai, GlaxoSmithKline, Libbs, Lilly, MSD Oncology, Novartis, Pfizer, Roche/Genentech and United Medical. Has stock and other ownership interests in MedSIR and Tummi. All other authors have no conflicts of interest to disclose., (© the authors; licensee ecancermedicalscience.)

Background: Epidemiological and clinical cancer research is essential to understanding tumour behaviour and developing new therapies in oncology. However, several countries including Brazil as well as many other regions of the world have limited participation in cancer research. Despite 625,000 new cancer cases recorded in Brazil in 2022, only 2.2% of ongoing cancer clinical trials are available in the country. We conducted an online survey to describe physician engagement with research and to identify the main barriers precluding participation in and conduct of clinical cancer research in the country., Methods: An anonymous online survey of 23 objective questions was sent by e-mail to Brazilian members of the Latin American Cooperative Oncology Group and the Brazilian Society of Clinical Oncology. The first 13 questions addressed demographic information, medical training and previous research participation. In the second part, the main barriers to engagement and participation in clinical trials in Brazil were addressed. Continuous variables were measured by median and range. Analyses were performed using SAS statistical software (version 9.4; SAS Institute, Inc. Cary, NC)., Results: 109 physicians answered the survey. Most participants were oncologists ( N = 98, 89.9%), living in capital cities ( N = 84, 77.1%), were from the Southeast region of Brazil ( N = 63, 57.8%) and worked at institutions providing exclusively private healthcare ( N = 59, 54.1%). Of the 109 respondents, 83 (76.1%) reported working in research centres (as investigators or sub-investigators). Surprisingly, 31.2% of physicians recognised they invite less than 1% of their patients to participate in clinical trials, even though 98 (89.9%) considered the participation of patients in clinical trials extremely relevant. The main barriers compromising the conduct of research in the country were the low number of available trials (48.2%) and the lack of qualified human resources to staff research sites (22.9%). Other reported barriers were the lengthy regulatory approval process (42.2%), followed by a lack of awareness of clinical research by patients resulting in low recruitment rates (24.1%). Of the 26 (23.8%) respondents not working with research, 25 (96.1%) reported interest in being involved, 31.8% have tried participating in research and 62.4% reported limited knowledge of trial procedures., Conclusion: These results suggest a clear need to further engage physicians in clinical research activities in Brazil. Patient education strategies should improve the low recruitment rates and secondarily increase the number of proposed trials in the country., Competing Interests: Heloisa Resende has received research funding from Novartis and Roche, all outside the scope of this manuscript. Taiane Francieli Rebelatto has no relationships to disclose. Gustavo Werutsky has received research funding from AstraZeneca/MedImmune, Bristol-Myers Squibb Brazil, GlaxoSmithKline, Lilly, Novartis, Pfizer, Roche and Roche/Genentech, all outside the scope of this manuscript. Has consulting or advisory role at Merck. Gustavo Gössling has received research funding from AstraZeneca/Merck and Janssen Oncology, all outside the scope of this manuscript. Vinícius Aguiar has no relationships to disclose. Guilherme Lopes has no relationships to disclose. Biazi Assis has no relationships to disclose. Lilian Arruda has no relationships to disclose. Carlos H Barrios has received research funding from AB Science, Abbvie, Abraxis BioScience, Amgen, Asana Biosciences, Astellas Pharma, AstraZeneca, Biomarin, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Clinica Atlantis, Covance, Daiichi Sankyo, Exelixis, GlaxoSmithKline, Halozyme, ImClone Systems, INC Research, inVentiv Health, Janssen, LEO Pharma, Lilly, Medivation, Merck, Merck KGaA, Merrimack, Millennium, Mylan, Novartis, Pfizer, PharmaMar, Polyphor, Roche/Genentech, Sanofi, Shanghai Henlius Biotech and Taiho Pharmaceutical, all outside the scope of this manuscript. Has consulting or advisory role at AstraZeneca, Boehringer Ingelheim, Eisai, GlaxoSmithKline, Libbs, Lilly, MSD Oncology, Novartis, Pfizer, Roche/Genentech and United Medical. Has stock and other ownership interests in MedSIR and Tummi., (© the authors; licensee ecancermedicalscience.)

99m Tc-EDDA/HYNIC-TOC is an easily available and cheaper radionuclide that could be used for somatostatin-receptor-based imaging of neuroendocrine tumours (NETs). We aimed to evaluate the diagnostic performance of 99m Tc-EDDA/HYNIC-TOC compared to 111 In-DTPA-octreotide in patients (pts) with NETs. We performed a prospective diagnostic study including pts with biopsy-confirmed NET and at least one visible lesion at conventional imaging. Two independent nuclear medicine physicians evaluated pts who underwent 99m Tc and 111 In scans and images. The primary outcome was comparative diagnostic accuracy of 99m Tc and 111 In. Secondary outcomes include safety. Nine pts were included and performed 14 paired scans. Overall, 126 lesions were identified. 99m Tc demonstrated superior sensitivity both when all images were analysed (93.7, 95% CI 88.1% - 96.8% versus 74.8%, 95% CI 66.6 - 81.6%, p < 0.001) and when liver-specific images were analysed (97.8%, 95% CI 92.7% - 99.5% versus 85.1%, 95% CI 76.6% - 91.0%, p < 0.001). 99m Tc was also associated with a lower negative likelihood ratio (LR) (0.002, 95% CI 0.009 - 0.1 versus 0.19, 95% CI 0.12 - 0.42, p = 0.009) when evaluating hepatic lesions. Adverse events happened in 3 pts after 111 In and in 2 pts after 99m Tc, all grade 1. The 99m Tc demonstrated a higher sensitivity overall and a better negative LR in liver-specific images compared to 111 In in pts with NETs. Our findings suggest that 99m Tc is an alternative to 111 In and is especially useful in ruling out liver metastases. NCT02691078., Competing Interests: Dr Moriguchi-Jeckel and Dr Werutsky report grants from Financiadora de Estudos e Projetos (FINEP) for the conduct of the study. Drs R. Madke, Viana, Nabinger, and Fernandes report employment relationships with the RPH Group. Dr. Werutsky reports personal fees from AstraZeneca, Bayer, Beigene, Daiichi Sankyo, Genentech/Roche, GSK, Lilly, MSD, Novartis, Pfizer, Sanofi, and Seattle Genetics outside the submitted work. The other authors declare that they have no conflict of interest., (© the authors; licensee ecancermedicalscience.)

Introduction: Cancer is the second leading cause of death in the world, and it is expected to be the main cause by the year 2030. Current trends of higher incidence and the introduction of new treatments lead to the challenge of treating more people with increasing costs per capita. In Brazil, current and future challenges are even more significant because of the limited resources destined for healthcare., Methods: We propose a methodology to compare cost-effectiveness performance with a regression of cancer lethality against the resources available for different nations, using the gross domestic product and the mortality-to-incidence ratio. Our objective is to evaluate and compare outcomes observed in Brazil., Results: According to our methodology, Brazil is performing well in breast and prostate cancer (observed lethality 9% and 15% lower than expected, respectively). It performs close to expected in colon (0.8% higher) and cervix (2% higher). However, lung cancer had a higher lethality than expected (6.5% higher). We also found that breast, prostate and cervical cancers are the primary sites more related to income. Lung cancer had the weakest relationship with resources., Conclusion: Brazil has different cost-effectiveness results in the management of cancer depending on the primary site. Also, national income has a significant and heterogeneous effect on the lethality of different tumour types. This economic analysis is important for low- to middle-income countries seeking to evaluate cancer outcomes in limited-resource settings., Competing Interests: Rodrigo Pellegrini: NoneTomás Reinert: Speaker honoraria: Novartis, AstraZeneca, Pfizer, Libbs, Lilly, Pierre FabreConsulting or advisory role: AstraZeneca, Lilly, NovartisResearch funding: AstraZenecaCarlos Henrique Barrios: Stock and other ownership interests: Biomarker, MedSIR, TummiSpeaker honoraria: Novartis, Roche/Genentech, Pfizer, GlaxoSmithKline, Sanofi, Boehringer Ingelheim, EisaiConsulting or advisory role: Boehringer Ingelheim, Roche/Genentech, Novartis, GlaxoSmithKline, Eisai, Pfizer, AstraZeneca, Libbs, MSD Oncology, United MedicalResearch funding: Pfizer, Novartis, Amgen, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Roche/Genentech, Lilly, Sanofi, Taiho Pharmaceutical, Mylan, Merrimack, Merck, AbbVie, Astellas Pharma, Biomarin, Bristol-Myers Squibb, Daiichi Sankyo, Abraxis BioScience, AB Science, Asana Biosciences, Medivation, Exelixis, ImClone Systems, LEO Pharma, Millennium, Janssen, Atlantis Clinica, INC Research, Halozyme, Covance, Celgene, inVentiv HealthTravel, accommodations, expenses: Roche/Genentech, Novartis, Pfizer, BMS Brazil, AstraZeneca, MSD Oncology, (© the authors; licensee ecancermedicalscience.)

The 17th edition of the St Gallen International Breast Cancer Conference was held in March 2021 in an entirely virtual mode. More than 3,300 participants took part in this important bi-annual critical review of the 'state of the art' in the multidisciplinary care of early-stage breast cancer (BC). Seventy-four experts from all continents discussed and commented on the previously elaborated consensus questions as well as numerous interrogations on early-BC diagnosis and treatment asked by the audience. The theme of this year's Conference was 'Customising local and systemic therapies'. This paper summarises the results of the 2021 international panel votes as a quick news update. We discuss the most important issues on genetics, pathology, surgery, radiotherapy and systemic therapies presented and debated throughout the conference. We selected the topics based on applicability into the personalised care of BC patients and focused on questions that have a clear impact on our current clinical practice., Competing Interests: Tomás Reinert Speaker honoraria: Novartis, AstraZeneca, Pfizer, Libbs, Lilly, RocheConsulting or advisory role: AstraZeneca, Lilly, NovartisResearch funding: AstraZeneca, LibbsAlessandra Borba Anton de Souza: none Guilherme Parisotto Sartori: none Fernando Mariano Obst: none Carlos Henrique Barrios Stock and other ownership interests: Biomarker, MedSIR, TummiSpeaker honoraria: Novartis, Roche/Genentech, Pfizer, GlaxoSmithKline, Sanofi, Boehringer Ingelheim, EisaiConsulting or advisory role: Boehringer Ingelheim, Roche/Genentech, Novartis, GlaxoSmithKline, Eisai, Pfizer, AstraZeneca, Libbs, MSD Oncology, United MedicalResearch funding: Pfizer, Novartis, Amgen, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Roche/Genentech, Lilly, Sanofi, Taiho Pharmaceutical, Mylan, Merrimack, Merck, AbbVie, Astellas Pharma, Biomarin, Bristol-Myers Squibb, Daiichi Sankyo, Abraxis BioScience, AB Science, Asana Biosciences, Medivation, Exelixis, ImClone Systems, LEO Pharma, Millennium, Janssen, Atlantis Clinica, INC Research, Halozyme, Covance, Celgene, inVentiv HealthTravel, accommodations, expenses: Roche/Genentech, Novartis, Pfizer, BMS Brazil, AstraZeneca, MSD Oncology, (© the authors; licensee ecancermedicalscience.)

Purpose: A CDK4/6 inhibitor (CDK4/6i) combined with endocrine therapy is the standard of care for patients with hormone receptor-positive (HR+) and HER2-negative (HER2-) metastatic breast cancer (MBC). However, the incorporation of these agents into clinical practice remains challenging. This study aims to estimate the impact of the lack of access to ribociclib on mortality of premenopausal patients with MBC in Brazil., Methods: Based on published epidemiological studies and national cancer registries, we estimated the number of premenopausal patients with potential indication of ribociclib as first-line treatment for MBC. Efficacy estimates were based on results from the Monaleesa-7 trial. Our analysis is made under the unrealistic assumption that all premenopausal MBC patients would be candidates for the treatment. To estimate the number of yearly premature deaths that could be prevented, we considered the largest absolute effect on mortality when sequentially applying the observed hazard ratio., Results: We estimated an annual incidence of 4,294 premenopausal HR+, HER2- MBC patients in Brazil. Considering these patients, at 12, 24 and 60 months, the number of surviving subjects would be 3,504, 2,859 and 1,553 for endocrine therapy (ET) alone; and 3,717, 3,217 and 2,086 for ET plus ribociclib. The largest difference between both groups was observed at the end of the sixth year when the use of ribociclib would prevent 538 premature deaths (survival of 1,805 versus 1,267 patients by the 72nd month)., Conclusion: We estimate that lack of access to CDK4/6i for patients with HR+, HER2-, MBC will cause the premature death of a significant number of premenopausal women with MBC. The unavailability of effective therapies has measurable consequences. Progress in this area demands a concerted effort to prevent further loss of lives., Competing Interests: Tomás Reinert: Speaker honoraria: Novartis, AstraZeneca, Pfizer, Libbs, Lilly, Pierre FabreConsulting or advisory role: AstraZeneca, Lilly, NovartisResearch funding: AstraZenecaRodrigo Pellegrino: noneCarlos Henrique Barrios: Stock and other ownership interests: Biomarker, MedSIR, TummiSpeaker honoraria: Novartis, Roche/Genentech, Pfizer, GlaxoSmithKline, Sanofi, Boehringer Ingelheim, EisaiConsulting or advisory role: Boehringer Ingelheim, Roche/Genentech, Novartis, GlaxoSmithKline, Eisai, Pfizer, AstraZeneca, Libbs, MSD Oncology, United MedicalResearch funding: Pfizer, Novartis, Amgen, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Roche/Genentech, Lilly, Sanofi, Taiho Pharmaceutical, Mylan, Merrimack, Merck, AbbVie, Astellas Pharma, Biomarin, Bristol-Myers Squibb, Daiichi Sankyo, Abraxis BioScience, AB Science, Asana Biosciences, Medivation, Exelixis, ImClone Systems, LEO Pharma, Millennium, Janssen, Atlantis Clinica, INC Research, Halozyme, Covance, Celgene, inVentiv HealthTravel, accommodations, expenses: Roche/Genentech, Novartis, Pfizer, BMS Brazil, AstraZeneca, MSD Oncology, (© the authors; licensee ecancermedicalscience.)

Provision of high-level healthcare is a challenge for all low- to middle-income countries (LMICs) since healthcare systems are heterogeneous, face many challenges such as inadequate funding, inequitable distribution of resources and services and usually are not adequately equipped to deal with a huge problem such as breast cancer. The development of anti-HER2 therapies can be considered one of the most important examples of the translation of molecular biology knowledge into clinical benefits for cancer patients. While a variety of novel therapeutic strategies are emerging, current treatment regimens remain focussed on targeted therapy with monoclonal antibodies, mainly trastuzumab, the first agent developed in this field. While these results have revolutionised the outcome of HER2+ patients in clinical trials and in high-income countries where they are widely available, results have not impacted the natural history of this aggressive disease in most of the world. Unfortunately, the availability of these drugs is far from universal in many LMICs, and in Latin America, in particular, patients with HER2+ breast cancer are treated exclusively with standard chemotherapy, a more toxic and less efficient therapy. While the complexity of the situation and the multiple factors that have an impact in this scenario are recognised, we need to map the future and develop feasible strategies to address possible solutions to the problem of drug access. A clear and unbiased diagnosis of the situation is a good starting point. Defining healthcare priorities and a clear strategy for the allocation of resources is difficult but mandatory. In this article, we will discuss current and future challenges regarding access (and lack of access) to high-cost cancer drugs in Latin America, with a focus on anti-HER2 therapies.