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Purpose: This study aimed to identify, evaluate, and rank suitable safety innovations developed during the COVID-19 pandemic in Latin American and Caribbean (LAC) radiation oncology centers., Methods: We conducted a multimodal participatory engagement collaboration with the Latin-American and Caribbean Society of Medical Oncology. The study consisted of four phases. Innovations were collected from a panel of radiotherapy experts representing a diverse group of 11 countries from LAC (Phase I). Next, a medical scientific team compared the innovations against international standards regarding their potential impact on risk of infection, clinical operation, and continuity of quality cancer care (Phase II). Their findings were supplied to the country representatives who rated the innovations for acceptability in their cancer centers (Phase III), resulting in a final report of the panel's recommendations (Phase IV)., Results: A total of 81 innovations were reported by the country representatives and merged by the medical scientific team into 24 innovations that combined similar innovations. The 24 innovations were grouped into six categories including practices aimed at (1) reducing clinic crowding (n = 3), (2) increasing screening and vaccinations for COVID-19 disease (n = 5), (3) implementing social distancing (n = 6), (4) strengthening personal infection equipment and disinfection (n = 6), (5) avoiding delaying or shortening treatment protocols (n = 2), and (6) mixed procedures (n = 2). The medical scientific team found nearly all innovations were supported by international recommendations and rated as safe, efficient, and acceptable., Conclusion: By using the lessons learned from the Community-Led Action Research in Oncology: Pandemic-Appropriate Radiotherapy Innovations Evaluated study, a manual of scalable practices in radiation oncology clinics may be developed to guide actions during future large-scale public health crises in low- and middle-income countries of LAC.

Choosing Wisely is an initiative by the American Board of Internal Medicine (ABIM) and ABIM Foundation to deter unnecessary medical treatments and procedures. Faced with the burden of modern technologies and treatments, it is crucial to identify practices lacking value in daily care. The Latin American and Caribbean Society (SLACOM), comprising cancer control experts, deems it vital to tailor this initiative for enhancing cancer care in the region. Through a modified DELPHI methodology involving two rounds of electronic questionnaires and a hybrid meeting to discuss key points of contention, ten essential recommendations were identified and prioritised to avoid harmful oncology procedures in our region. These consensus-based recommendations, contextualised for Latin America, have been compiled and shared to benefit patients. The Scientific Committee, consisting of prominent oncologists and health experts, collaborates remotely to drive this project forward., Competing Interests: The authors declare that they have no conflicts of interest., (© the authors; licensee ecancermedicalscience.)

The ecancer 'Choosing Wisely' conference was held for the first time in Latin America in Santa Cruz, Bolivia. The event had more than 150 registered attendees in addition to 22 speakers from different countries and different specialities in the field of oncology, who presented topics on prevention, oncological surgery, clinical oncology and palliative care, in order to demonstrate the current evidence of how to approach a patient in daily clinical practice based on the human resources, materials and drugs available, trying to offer the maximum benefit to the patient based on current scientific evidence. In addition to addressing issues of vital importance in breast cancer, during the 2 days of the event, updated information generated in recent years was presented, the results of which will change clinical practice. All the experts were in favour of developing strategies and methods that help us to properly select treatments to optimise resources and reduce the economic toxicity of the most modern and current treatments. This conference was an event of vital importance because it was the first face-to-face event for ecancer and the physicians after difficult years due to COVID-19., Competing Interests: The author is not aware of any affiliations, memberships, funding or financial holdings that might be perceived as affecting the objectivity of this review., (© the authors; licensee ecancermedicalscience.)

Since December 2019, the world has been mired in an infectious pandemic that has displaced other health priorities for 21st century populations. Concerned about this situation, Latin American experts on cancer decided to evaluate the impact of the pandemic on cancer control in the region. The analysis was based on information obtained from public sources and scientific publications and included the characteristics of the health care and cancer control prior to the pandemic, the COVID-19 pandemic and measures implemented by the governments of the region, and the regional impact of the pandemic on cancer control together with the costs of cancer care and possible impact of the pandemic on cancer expense. We compared 2019 and 2020 data corresponding to the period March 16-June 30 and found a significant reduction in the number of first-time visits to oncology services (variable depending on the country between -28% and -38%) and a corresponding reduction in pathology (between -6% and -50%), cancer surgery (between -28% and -70%), and chemotherapy (between -2% and -54%). Furthermore, a significant reduction in cancer screening tests was found (PAP smear test studies: between -46% and -100%, mammography: between -32% and -100%, and fecal occult blood test: -73%). If this situation becomes a trend, the health and economic impact will be compounded in the postpandemic period, with an overload of demand on health services to ensure diagnostic tests and consequent treatments. On the basis of this information, a set of prevention and mitigation measures to be immediately implemented and also actions to progressively strengthen health systems are proposed., Competing Interests: Eduardo CazapResearch Funding: Novartis Suyapa BejaranoResearch Funding: MSD Oncology, KinexTravel, Accommodations, Expenses: Pfizer, Asofarma Hugo CastroSpeakers' Bureau: Roche, PfizerResearch Funding: MerckTravel, Accommodations, Expenses: Roche Francisco Gutierrez-DelgadoTravel, Accommodations, Expenses: Pfizer, Boehringer Ingelheim, Lilly, AstraZeneca, ExelixisNo other potential conflicts of interest were reported.

Globally, biosimilars are expected to have a key role in improving patient access to biological therapies and addressing concerns regarding the escalating cost of health care. Indeed, in Europe, increased use of biologics and reduced drug prices have been observed after the introduction of biosimilars. Recently, several monoclonal antibody biosimilars of anticancer therapies have been approved, and numerous others are in various stages of clinical development. Biosimilars are authorized via a regulatory pathway separate from that used for generic drugs; they are also regulated separately from novel biologics. Biosimilar approval pathways in many major regulatory regions worldwide are, to a broad degree, scientifically aligned. However, owing to regional differences in health care priorities, policies, and resources, some important regulatory inconsistencies are evident. Acceptance of biosimilars by health care systems, health care professionals, and patients will be a key factor in the uptake of these therapies, and such regulatory variations could contribute to confusion and diminished confidence regarding the quality, efficacy, and reliability of these agents. Furthermore, the need for manufacturers to account for regulatory inconsistencies introduces inefficiencies and delays into biosimilar development programs. These issues should be addressed if biosimilars are to attain their maximal global potential. This review summarizes the evolution of the global biosimilar landscape and provides examples of inconsistencies between regulatory requirements in different regions. In addition, we review ongoing efforts to improve regulatory alignment and highlight the importance of education as a crucial factor in generating trust in, and acceptance of, biosimilars on a worldwide scale., Implications for Practice: Biosimilars of monoclonal antibody anticancer therapies are beginning to emerge, and more are likely to become available for clinical use in the near future. The extent to which biosimilars can contribute to cancer care will depend on their level of acceptance by health care systems, health care professionals, and patients. A better understanding of the regulatory basis for the approval of biosimilars may enhance confidence and trust in these agents. In order to have informed discussions about treatment choices with their patients, oncologists should familiarize themselves with the biosimilar paradigm., Competing Interests: Disclosures of potential conflicts of interest may be found at the end of this article., (© AlphaMed Press 2018.)

Competing Interests: The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or jco.ascopubs.org/site/ifc. Eduardo CazapHonoraria: Bayer Healthcare, Bristol-Myers Squibb, Fresenius Kabi, Roche Consulting or Advisory Role: Bayer Healthcare Speakers' Bureau: Bayer Healthcare Research Funding: Daiichi Sankyo (Inst)Mauricio Magalhães CostaNo relationship to discloseAbelardo Meneses GarcíaNo relationship to discloseRaúl Murillo MorenoNo relationship to discloseEva M. Ruiz de Castilla YabarEmployment: Alexion Pharmaceuticals (I) Stock or Other Ownership: Alexion Pharmaceuticals (I) Honoraria: Novartis Consulting or Advisory Role: Novartis, Pfizer Speakers' Bureau: Novartis Expert Testimony: Merck Travel, Accommodations, Expenses: Pfizer, Janssen Pharmaceuticals, Novartis, Bayer, AbbViePablo Sitic VargasTravel, Accommodations, Expenses: Bayer Schering PharmaIgnacio ZervinoNo relationship to disclose

The Japan National Committee for the Union for International Cancer Control (UICC) and UICC-Asia Regional Office (ARO) organized a Roundtable Discussion as part of the official program of the UICC World Cancer Congress 2014 in Melbourne, Australia. The theme for the Roundtable Discussion was - Looking Toward the Realization of Universal Health Care (UHC) for Cancer in Asia - and it was held on December 5, 2014. The meeting was held based on the recognition that although each country may take a different path towards the realization of UHC, one point that is common to all is that cancer is projected to be the most difficult disease to address under the goals of UHC and that there is, therefore, an urgent and pressing need to come to a common understanding and awareness with regard to UHC concepts that are a priority component of a post-MDG development agenda. The presenters and participants addressed the issue of UHC for cancer in Asia from their various perspectives in academia and international organizations. Discussions covered the challenges to UHC in Asia, collaborative approaches by international organizations, the need for uniform and relevant data, ways to create an Asia Cancer Barometer that could be applied to all countries in Asia. The session concluded with the recognition that research on UHC in Asia should continue to be used as a tool for cancer cooperation in Asia and that the achievement of UHC would require research and input not only from the medical community, but from a broad sector of society in a multidisciplinary approach. Discussions on this issue will continue towards the Asia-Pacific Cancer Conference in Indonesia in August 2015.

Background: Breast cancer (BC) is the leading cause of malignancy-related deaths among women aged ≤ 45 years. There are unexplored and uncertain issues for BC in this particular group in Latin America. The aim of this study is to evaluate BC incidence and mortality among young women and related clinicopathological and survivorship aspects in this region., Materials and Methods: Data were obtained from Globocan 2008 and the International Agency for Research on Cancer's Cancer Incidence in Five Continents series plus databases. We requested collaboration from the 12 different national cancer institutes in Latin America through SLACOM, the Latin American and Caribbean Society of Medical Oncology, and conducted a systematic literature review to obtain local data regarding the prevalence of BC among young women and their characteristics, outcomes, and survivorship-related issues., Results: BC incidence and mortality proportions for Latin American women aged <44 years were higher when compared with those of developed countries (20% vs. 12% and 14% vs. 7%, respectively). We found only a few Latin American series addressing this topic, and prevalence varied between 8% and 14%. Stage II and III disease, high histological grade, and triple-negative and HER2 BC were features frequently observed among young Latin American BC patients., Conclusion: The rising incidence and mortality of BC in young Latin American women is a call to action in the region. It is necessary to monitor the epidemiological and clinical data through reliable cancer registries and to consider the implementation of protocols for education of patients and health professionals. This unmet, growing burden must be considered as a top priority of the national programs in the fight against BC, and models of specialized units should be implemented for this particular group of patients to provide better care for this emergent challenge.

This review presents an overview of breast cancer care, burden, and outcomes in Latin America, as well as the challenges and opportunities for improvement. Information was gleaned through a review of the literature, public databases, and conference presentations, in addition to a survey of clinical experts and patient organizations from the region. Breast cancer annual incidence (114,900 cases) and mortality (37,000 deaths) are the highest of all women's cancers in Latin America, and they are increasing. Twice as many breast cancer deaths are expected by 2030. In Peru, Mexico, Colombia, and Brazil, diagnosis and death at younger ages deprives society of numerous productive years, as does high disease occurrence in Argentina and Uruguay. Approximately 30%-40% of diagnoses are metastatic disease. High mortality-to-incidence ratios (MIRs) in Latin America indicate poor survival, partly because of the late stage at diagnosis and poorer access to treatment. Between 2002 and 2008, MIRs decreased in all countries, albeit unevenly. Costa Rica's change in MIR outpaced incidence growth, indicating impressive progress in breast cancer survival. The situation is similar, although to a lesser extent, in Colombia and Ecuador. The marginal drops of MIRs in Brazil and Mexico mainly reflect incidence growth rather than progress in outcomes. Panama's MIR is still high. Epidemiological data are scattered and of varying quality in Latin America. However, one could ascertain that the burden of breast cancer in the region is considerable and growing due to demographic changes, particularly the aging population, and socioeconomic development. Early diagnosis and population-wide access to evidence-based treatment remain unresolved problems, despite progress achieved by some countries.

Substantial differences in population-based cancer control outcomes exist within and between nations. Optimal outcomes derive from 'what we know', 'what we apply in practice', and 'how complete and compliant is the population uptake of public health and clinical practice change'. This continuum of research (scientific discovery) to practice (application and uptake) to policy impacts the speed and completeness of practice change and is greatly influenced by the ability, opportunity and readiness of countries to implement evidence informed practices and policies through innovative change. Session 4 of the 4th International Cancer Control Congress focused on knowledge exchange through three plenary presentations and five interactive workshop discussions: 1) the role of epidemiological data as a basis for policy formulation; 2) existing global frameworks for cancer control; 3) knowledge exchange as it relates to public health practice and policy; 4) knowledge exchange in relation to primary, community, and specialist cancer care; and 5) the role of public engagement and advocacy in influencing cancer control policy. Common themes emerging from workshop discussions included the recognition of the importance of knowledge exchange processes, constituents and forums as key aspects of preparedness, awareness and readiness to implement public health and clinical practice change. The importance of cultural and contextual differences between nations was identified as a challenge requiring development of tools for generating relevant population/societal data (e.g., projection methodologies applied to population demographics, outcomes and resources, both societal, human and fiscal) and capacity building for facilitating knowledge transfer and exchange between the constituencies engaged in population-based public health practice and clinically based primary care and disease specialty practice exchange (researchers, health practitioners, health administrators, politicians, patients and families, and the private and public sectors). Understanding patient and public engagement advocacy and its role in influencing health and public policy investment priorities emerged as a critical and fundamental aspect of successful implementation of evidence-informed cancer control change.

Survival following a diagnosis of cancer is contingent upon an interplay of factors, some non-modifiable (e.g., age, sex, genetics) and some modifiable (e.g., volitional choices) but the majority determined by circumstance (personal, social, health system context and capacity, and health policy). Accordingly, mortality and survival rates vary considerably as a function of geography, opportunity, wealth and development. Quality of life is impacted similarly, such that aspects of care related to coordination and integration of care across primary, community and specialist environments; symptom control, palliative and end-of-life care for those who will die of cancer; and survivorship challenges for those who will survive cancer, differs greatly across low, middle and high-income resource settings. Session 3 of the 4th International Cancer Control Congress (ICCC-4) focused on cancer care and treatment through three plenary presentations and five interactive workshop discussions: 1) establishing, implementing, operating and sustaining the capacity for quality cancer care; 2) the role of primary, community, and specialist care in cancer care and treatment; 3) the economics of affordable and sustainable cancer care; 4) issues around symptom control, support, and palliative/end-of-life care; and 5) issues around survivorship. A number of recommendations were proposed relating to capacity-building (standards and guidelines, protocols, new technologies and training and deployment) for safe, appropriate evidence-informed care; mapping and analysis of variations in primary, community and specialist care across countries with identification of models for effective, integrated clinical practice; the importance of considering the introduction, or expansion, of evidence-supported clinical practices from the perspectives of health economic impact, the value for health resources expended, and sustainability; capacity-building for palliative, end-of-life care and symptom control and integration of these services into national cancer control plans; the need for public education to reduce the fear and stigma associated with cancer so that patients are better able to make informed decisions regarding follow-up care and treatment; and the need to recognize the challenges and needs of survivors, their increasing number, the necessity to integrate survivorship into cancer control plans and the economic and societal value of functional survival after cancer. Discussions highlighted that coordinated care and treatment for cancer patients is both a ' systems'challenge and solution, requiring the consideration of patient and family circumstances, societal values and priorities, the functioning of the health system (access, capacity, resources, etc.) and the importance assigned to health and illness management within public policy.

In middle resource countries (MRCs), cancer control programs are becoming a priority as the pattern of disease shifts from infectious diseases to non-communicable diseases such as breast cancer, the most common cancer among women in MRCs. The Middle Resource Scenarios Working Group of the BHGI 2010 Global Summit met to identify common issues and obstacles to breast cancer detection, diagnosis and treatment in MRCs. They concluded that breast cancer early detection programs continue to be important, should include clinical breast examination (CBE) with or without mammography, and should be coupled with active awareness programs. Mammographic screening is usually opportunistic and early detection programs are often hampered by logistical and financial problems, as well as socio-cultural barriers, despite improved public educational efforts. Although multidisciplinary services for treatment are available, geographical and economic limitations to these services can lead to an inequity in health care access. Without adequate health insurance coverage, limited personal finances can be a significant barrier to care for many patients. Despite the improved availability of services (surgery, pathology, radiology and radiotherapy), quality assurance programs remain a challenge. Better access to anticancer drugs is needed to improve outcomes, as are rehabilitation programs for survivors. Focused and sustained government health care financing in MRCs is needed to improve early detection and treatment of breast cancer., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

International collaborations like the Breast Health Global Initiative (BHGI) can help low and middle income countries (LMCs) to establish or improve breast cancer control programs by providing evidence-based, resource-stratified guidelines for the management and control of breast cancer. The Problem Solving Working Group of the BHGI 2010 Global Summit met to develop a consensus statement on problem-solving strategies addressing breast cancer in LMCs. To better assess breast cancer burden in poorly studied populations, countries require accurate statistics regarding breast cancer incidence and mortality. To better identify health care system strengths and weaknesses, countries require reasonable indicators of true health system quality and capacity. Using qualitative and quantitative research methods, countries should formulate cancer control strategies to identify both system inefficiencies and patient barriers. Patient navigation programs linked to public advocacy efforts feed and strengthen functional early detection and treatment programs. Cost-effectiveness research and implementation science are tools that can guide and expand successful pilot programs., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

The Breast Health Global Initiative (BHGI) brought together international breast cancer experts to discuss breast cancer in low resource countries (LRCs) and identify common concerns reviewed in this consensus statement. There continues to be a lack of public and health care professionals' awareness of the importance of early detection of breast cancer. Mastectomy continues to be the most common treatment for breast cancer; and a lack of surgeons and anesthesia services was identified as a contributing factor in delayed surgical therapy in LRCs. Where available, radiation therapy is still more likely to be used for palliation rather than for curative treatment. Tumor receptor status is often suboptimally performed due to lack of advanced pathology services and variable quality control of tissue handling and processing. Regional pathology services can be a cost-effective approach and can serve as reference, training and research centers. Limited availability of medical oncologists in LRCs often results in non-specialist providing chemotherapeutic services, which requires additional supervision and training. Palliative care is an emerging field in LRCs that requires investment in training and infrastructure development. A commitment and investment in the development of breast cancer care services by LRC governments and health authorities remains a critical need in LRCs., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

The Breast Health Global Initiative (BHGI) applied an evidence-based consensus review process to develop guidelines for breast cancer early detection, diagnosis, and treatment in low- and middle-income countries (LMCs) including those in Latin America. Breast cancer outcomes correlate with the degree to which 1) cancers are detected early, 2) cancers can be diagnosed correctly, and 3) proper multimodality treatment can be provided in a timely fashion. Cancer prevention through health behavior modification may influence breast cancer incidence in LMCs. Diagnosing breast cancer at earlier stages will reduce breast cancer mortality. Programs to promote breast self-awareness and clinical breast examination and resource-adapted mammographic screening are important early detection steps. Screening mammography has been shown to reduce breast cancer mortality, but is cost prohibitive in some settings. Breast imaging, initially with ultrasound and, at higher resource levels with diagnostic mammography, improves preoperative diagnostic assessment and permits image-guided needle sampling. Multimodality therapy includes surgery, radiation, and systemic therapies.

Tobacco use is declining in most industrialized countries but that does not mean the tobacco problem is going away. Unless aggressive steps are taken to change consumption trends, current tobacco-related cancer deaths will increase dramatically in the next few decades.

The activity and mild toxicity profile of single-agent gemcitabine therapy in untreated (chemonaive) patients with non-small-cell lung cancer (NSCLC) is well documented. This phase II trial was conducted to determine the objective tumour response rate and toxicity profile of single-agent gemcitabine in pretreated patients with NSCLC. Patients with histological evidence of advanced NCSLC stage IIIB or IV; at least one prior chemotherapy regimen including a platinum or taxane analogue; an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; clinically measurable disease; adequate bone marrow reserve; and adequate renal function; received 1000 mg m(-2) gemcitabine administered over 30 min on days 1, 8 and 15 of a 28-day cycle defined as 3 weekly treatments followed by 1 week of rest. Twenty-nine patients were evaluated for efficacy and 32 for toxicity. One patient achieved a complete response and five patients had a partial response resulting in a total response rate of 20.6% (95% confidence interval (CI) 6-34). Median response duration was 7 months (range 4-11 months). Twelve (41%) patients reached stable disease after two cycles of therapy and 11 (38%) patients had disease progression. Median progression-free survival time was 3 months and median overall survival time was 5.5 months. Toxicity was generally mild (grades 0-2). Severe (grade 3 or 4) haematological toxicities included grade 3 anaemia in one patient and grade 3 thrombocytopenia in two patients. Severe non-haematological toxicities included one patient each with grade 3 liver transaminase elevations, nausea/vomiting and diarrhoea. This study confirms the activity and safety of single-agent gemcitabine in pretreated patients with advanced NSCLC who are refractory or sensitive to first-line therapy.