Tailoring neo/adjuvant systemic therapy in breast cancer: "The advent of a personalized approach"-The Breast-Gynecological and Immuno-Oncology International Cancer Conference (BGICC) consensus and recommendations.

BACKGROUND: The management of early breast cancer (BC) has witnessed an uprise in the use of neoadjuvant therapy and a remarkable reshaping of the systemic therapy postneoadjuvant treatment in the last few years, with the evolution of many controversial clinical situations that require consensus. METHODS: During the 14th Breast-Gynecological and Immuno-Oncology International Cancer Conference held in Egypt in 2022, a panel of 44 BC experts from 13 countries voted on statements concerning debatable challenges in the neo/adjuvant treatment setting. The recommendations were subsequently updated based on the most recent data emerging. A modified Delphi approach was used to develop this consensus. A consensus was achieved when ≥75% of voters selected an answer. RESULTS AND CONCLUSIONS: The consensus recommendations addressed different escalation and de-escalation strategies in the setting of neoadjuvant therapy for early BC. The recommendations recapitulate the available clinical evidence and expert opinion to individualize patient management and optimize therapy outcomes. Consensus was reached in 63% of the statements (52/83), and the rationale behind each statement was clarified.

Gender inequality in genitourinary malignancies clinical trials leadership.

BACKGROUND: Over the past 2 decades, there has been a growing interest in the significance of gender roles in healthcare and several efforts and initiatives have focused on increasing female representation in the medical field. Clinical trials play a very important role in shaping medical practice; moreover, the leaders of clinical trials often represent the upper echelon of researchers in any designated field. Presently, there is no data regarding women's representation in urological oncology clinical trials leadership. Therefore, the aim of this study is to examine the extent of female representation in leading urological clinical trials. METHODOLOGY: To thoroughly examine the representation of females as principal investigators (PIs) in urological cancer clinical trials between 2000 and 2020, we conducted a comprehensive search of completed trials focused on kidney, prostate, and bladder cancer on ClinicalTrials.gov. We extracted relevant information regarding the PIs and analyzed the data using univariate analyses to identify any significant differences between male and female PIs. RESULTS: A total of 9145 cancer clinical trials were conducted over the last 2 decades, and 11.3% (n = 1033) of them were urological cancer clinical trials. We were able to obtain detailed information about the principal investigators (PI) in 79.0% (n = 816) of the clinical trials, and we found that 16.8% (n = 137) of them were led by female investigators. Upon evaluating the characteristics of the PIs, female PIs had a significantly lower median age and median total citations as compared to male PIs (55.0 vs 59.0 and 5333 vs 7902; p-value < 0.001 and 0.006, respectively). However, there was no statistically significant difference between the termination rate, publication rate, funding source, cancer type, and the subject of conducting the clinical trials between male and female PIs. CONCLUSION: Between 2000 and 2020, only 16.8% of urological cancer clinical trials were led by a female PI, perhaps reflective of a low percentage of senior female researchers in the fields of urology, oncology and radiation oncology. Universities, research institutes and funding agencies should work to improve mentorship, representation and opportunities for female investigators to encourage more involvement for female researchers in these clinical trials.

Global Equity in Clinical Trials: An ASCO Policy Statement.

ASCO is a global professional society representing more than 50,000 physicians, other health care professionals, and advocates in over 100 countries specializing in cancer treatment, diagnosis, prevention, and advocacy. ASCO strives, through research, education, and promotion of the highest quality of patient care, to create a world where cancer is prevented or cured, and every survivor is healthy. In this pursuit, health equity remains the guiding institutional principle that applies to all its activities across the cancer care continuum. This ASCO policy statement emphasizes the urgent need for global equity in clinical trials, aiming to enhance access and representation in cancer research as it not only improves cancer outcomes but also upholds principles of fairness and justice in health care.

Systemic Treatment of Patients With Metastatic Breast Cancer: ASCO Resource-Stratified Guideline Q and A.

The Systemic Treatment of Patients with Metastatic Breast Cancer: @ASCO Resource-Stratified Guideline Q and A presents takeways, rationale, and key recommendations based on #JCOGO full guideline for patients by menopausal and marker status.

Systemic Treatment of Patients With Metastatic Breast Cancer: ASCO Resource-Stratified Guideline.

PURPOSE: To guide clinicians and policymakers in three global resource-constrained settings on treating patients with metastatic breast cancer (MBC) when Maximal setting-guideline recommended treatment is unavailable. METHODS: A multidisciplinary, multinational panel reviewed existing ASCO guidelines and conducted modified ADAPTE and formal consensus processes. RESULTS: Four published resource-agnostic guidelines were adapted for resource-constrained settings; informing two rounds of formal consensus; recommendations received ≥75% agreement. RECOMMENDATIONS: Clinicians should recommend treatment according to menopausal status, pathological and biomarker features when quality results are available. In first-line, for hormone receptor (HR)-positive MBC, when a non-steroidal aromatase inhibitor and CDK 4/6 inhibitor combination is unavailable, use hormonal therapy alone. For life-threatening disease, use single-agent chemotherapy or surgery for local control. For premenopausal patients, use ovarian suppression or ablation plus hormone therapy in Basic settings. For human epidermal growth factor receptor 2 (HER2)-positive MBC, if trastuzumab, pertuzumab, and chemotherapy are unavailable, use trastuzumab and chemotherapy; if unavailable, use chemotherapy. For HER2-positive, HR-positive MBC, use standard first-line therapy, or endocrine therapy if contraindications. For triple-negative MBC with unknown PD-L1 status, or if PD-L1-positive and immunotherapy unavailable, use single-agent chemotherapy. For germline BRCA1/2 mutation-positive MBC, if poly(ADP-ribose) polymerase inhibitor is unavailable, use hormonal therapy (HR-positive MBC) and chemotherapy (HR-negative MBC). In second-line, for HR-positive MBC, Enhanced setting recommendations depend on prior treatment; for Limited, use tamoxifen or chemotherapy. For HER2-positive MBC, if trastuzumab deruxtecan is unavailable, use trastuzumab emtansine; if unavailable, capecitabine and lapatinib; if unavailable, trastuzumab and/or chemotherapy (hormonal therapy alone for HR-positive MBC).Additional information is available at www.asco.org/resource-stratified-guidelines. It is ASCO's view that healthcare providers and system decision-makers should be guided by the recommendations for the highest stratum of resources available. The guideline is intended to complement but not replace local guidelines.

Germline Testing Around the Globe: Challenges in Different Practice Settings.

Cancer is an increasing global public health burden. Lately, more emphasis has emerged on the importance of heredity in cancer, mostly driven by the introduction of germline genetic variants-directed therapeutics. It is true that 40% of cancer risk is attributed to modifiable environmental and lifestyle factors; still, 16% of cancers could be heritable, accounting for 2.9 of the 18.1 million cases diagnosed worldwide. At least two third of those will be diagnosed in countries with limited resources-low- and middle-income countries, especially where high rates of consanguine marriage and early age at diagnosis are already prevalent. Both are hallmarks of hereditary cancer. This creates a new opportunity for prevention, early detection, and recently therapeutic intervention. However, this opportunity is challenged by many obstacles along the path to addressing germline testing in patients with cancer in the clinic worldwide. Global collaboration and expertise exchange are important to bridge the knowledge gap and facilitate practical implementation. Adapting existing guidelines and prioritization according to local resources are essential to address the unique needs and overcome the unique barriers of each society.

Durable effect of imatinib and metronomic chemotherapy with capecitabine in pancreatic carcinoma.

Background: Pancreatic ductal carcinoma (PDC) is a challenging diagnosis with a particularly poor prognosis, even after curative surgery (median survival: <30 months). The prognosis of borderline resectable pancreatic cancer (BR-PDC) is even worse. We describe a patient with BR-PDC who achieved stable disease with metronomic chemotherapy after refusing surgery. Case presentation: A 75-year-old woman was presented with jaundice and epigastric pain. Imaging confirmed a mass in the pancreatic head encasing the superior mesenteric vein, with obstruction of the pancreatic and bile ducts. After stenting to relieve the obstruction, Fine needle aspiration (FNA) confirmed the diagnosis of PDC. The patient refused surgery and radiation therapy but agreed for chemotherapy. After the second cycle of mFOLFIRINOX - complicated by febrile neutropenia - she refused further IV therapy. Genomic profiling revealed KIT amplification. Therefore, she was started on imatinib with dramatic improvement both clinically and biochemically reflected in carbohydrate antigen 19-9 drop. However, that response was short-lived at 3 months. Therefore, capecitabine was added at a low dose of 1 g bid on an alternate weekly basis. The patient did well and she is currently alive with a stable disease as of 2 years after diagnosis. Conclusion: Metronomic chemotherapy, especially capecitabine added to the targeted therapy, imatinib, is a potentially useful treatment for PDC where no other options are available, especially those harbouring no mutation in the dominant four genes. Indeed, the absence of mutation with KIT amplification could be a potential marker for improved outcomes with targeted and metronomic therapy, which deserves further evaluation in a clinical trial setting.

Breast Cancer Priorities in Limited-Resource Environments: The Price-Efficacy Dilemma in Cancer Care.

Breast cancer has become one of the leading causes of morbidity and mortality in low- and middle-income countries, where 62% of the world's total new cases are diagnosed. Therefore, the productivity loss because of premature death resulting from female breast cancer is also on the rise. The major challenge in low- and middle-income countries is to reduce the proportion of women presenting with advanced-stage disease, a challenge unlikely to be overcome by adoption of expensive national mammography screening programs. Awareness and education campaigns should focus not only on patients and societies but also on policy makers to address and optimize breast cancer care. Adaptation of existing guidelines and prioritization according to local resources are essential to address the unique needs and overcome the unique barriers of each society to facilitate practical implementation and improve outcomes. Emphasis on the principle of a cancer groundshot in addressing value in cancer care is vital to improving access to therapies that are proven to work rather than chasing after new drugs or innovations of doubtful or marginal clinical benefit. Until we have drug-pricing interventions that take into account the local income of each society, we must acknowledge the fact that the delivery of cancer care will never be the same all around the world.

Cancer Burden Among Arab-World Females in 2020: Working Toward Improving Outcomes.

PURPOSE: Cancer is the leading cause of morbidity and mortality worldwide. This work presents the Arab-world females' cancers (AFCs) statistics in 2020, compared with the 2018 AFCs statistics, the Arab-world male cancers statistics, and the world females' cancers (WFCs) statistics in 2020. This can help set the stage for a better policy for cancer control programs and improve outcomes. MATERIALS AND METHODS: A descriptive review of the 2020 Global Cancer Observatory concerning AFCs was performed. Data on various cancers were compiled and compared among the countries in the region and WFCs. RESULTS: A total estimate of 244,317 new cases and 132,249 deaths is reported in AFCs; representing 2.65% and 2.99% of WFCs, respectively, with an average crude incidence/mortality ratio of 116.2 (/100,000 population)/62.9 (/100,000 population) and an age-standardized incidence/mortality ratio of 137.7(/100,000 population)/77.2(/100,000 population) compared with 238.8(/100,000 population)/114.6(/100,000 population) and 186(/100,000 population)/84.2(/100,000 population) of WFCs, respectively. Five-year prevalent cases were 585,295; 2.28% of WFCs. In comparison to males, females accounted for 47.8% of the whole population, 52.9% in incidence, 46.9% in mortality, and 56.9% in the prevalence of patients with cancer. Mortality-to-incidence ratio (MIR) was 0.54 (range 0.39-0.62 in Arab countries, compared with 0.48 globally), and it ranged from 0.14 to 0.97 in the 30 AFC types. Breast cancer was the most common cancer in incidence and mortality, with an MIR of 0.39. CONCLUSION: The 2020 descriptive analysis of the females' cancers in the Arab world revealed a relatively high MIR compared with females' cancers worldwide; a lower MIR compared with the males; and comparable MIR to 2018 one. We call for more in-depth studies to determine the causes of these differences that might translate into actionable interventions and better outcomes.

Predictors of poor precautionary practices towards COVID-19 among cancer patients.

Objective: Our study goal was to evaluate the behavioral response and practices of cancer patients to the coronavirus disease 2019 (COVID-19) pandemic in the Middle East and north Africa. Methods: A cross-sectional study was conducted using a validated anonymous 45-question survey administered via SurveyMonkey® to cancer patients in 13 centers in Algeria, Egypt, Jordan, Kuwait, Morocco and Saudi Arabia. Results: During the study period (from 21 April to 30 May 2020), 3642 patients participated in the study. The majority of patients (84.81%) were worried about contracting the infection. The reported strict adherence to precautions included avoiding the following actions: hand-shaking (77.40%), hugging and kissing (82.89%), social gathering (90.09%), meeting friends (84.68%) and visiting markets (75.65%). In a multivariate analysis, patients with poor precautionary practices were about twice as likely to cancel their medical appointment or a treatment session. Conclusion: Improving cancer patients' knowledge of and adherence to precautionary measures is needed not just to reduce the risk of acquiring infection but also to minimize the interruption of their medical care.

Lay abstract COVID-19 poses a higher risk for patients with cancer than other patients; therefore, it is prudent that they adhere to precautionary measures to protect themselves from the infection. We conducted a study to evaluate the behaviors and practices of these patients in response to the COVID-19 pandemic in the Middle, East and North Africa. We developed a survey of 45 questions that was distributed in 13 centers in Algeria, Egypt, Jordan, Kuwait, Morocco and Saudi Arabia between 21 April and 30 May 2020. About 85% of the 3642 patients who participated in the study were worried about contracting the infection. A substantial percentage of them (10­30%) were not adhering to various precautions and social distancing rules. On the other hand, 16% of them canceled medical appointments and 12% canceled treatment sessions. Our study showed the need for better adherence of patients with cancer to the infection precautions and most importantly, the need to have a better compliance with their treatment plans, such as keeping their scheduled appointments, to avoid harms from treatment delays.

Breast-Gynaecological & Immuno-Oncology International Cancer Conference (BGICC) Consensus and Recommendations for the Management of Triple-Negative Breast Cancer.

Background: The management of patients with triple-negative breast cancer (TNBC) is challenging with several controversies and unmet needs. During the 12th Breast-Gynaecological & Immuno-oncology International Cancer Conference (BGICC) Egypt, 2020, a panel of 35 breast cancer experts from 13 countries voted on consensus guidelines for the clinical management of TNBC. The consensus was subsequently updated based on the most recent data evolved lately. Methods: A consensus conference approach adapted from the American Society of Clinical Oncology (ASCO) was utilized. The panellists voted anonymously on each question, and a consensus was achieved when ≥75% of voters selected an answer. The final consensus was later circulated to the panellists for critical revision of important intellectual content. Results and conclusion: These recommendations represent the available clinical evidence and expert opinion when evidence is scarce. The percentage of the consensus votes, levels of evidence and grades of recommendation are presented for each statement. The consensus covered all the aspects of TNBC management starting from defining TNBC to the management of metastatic disease and highlighted the rapidly evolving landscape in this field. Consensus was reached in 70% of the statements (35/50). In addition, areas of warranted research were identified to guide future prospective clinical trials.

Impact of the COVID-19 Pandemic on Oncologists: Results of an International Study.

PURPOSE: As frontline workers facing the COVID-19 pandemic, healthcare providers should be well-prepared to fight the disease and prevent harm to their patients and themselves. Our study aimed to evaluate the knowledge, attitude, and practice of oncologists in response to the COVID-19 pandemic and its impact on them. METHODS: A cross-sectional study was conducted using a validated questionnaire disseminated to oncologists by SurveyMonkey. The tool had 42 questions that captured participants' knowledge, attitude, and practice; their experiences; and the pandemic's impact on various aspects of their lives. Participants from Middle East and North African countries, Brazil, and the Philippines completed the electronic survey between April 24 and May 15, 2020. RESULTS: Of the 1,010 physicians who participated in the study, 54.75% were male and 64.95% were medical or clinical oncologists. The level of knowledge regarding the prevention and transmission of the virus was good in 52% of participants. The majority (92%) were worried about contracting the virus either extremely (30%) or mildly (62%), and 84.85% were worried about transmitting the virus to their families. Approximately 76.93% reported they would take the COVID 19 vaccine once available, with oncologists practicing in Brazil having the highest odds ratio of intention to receive the COVID-19 vaccine (odds ratio, 11.8, 95% CI, 5.96 to 23.38, P < .001). Participants reported a negative impact of the pandemic on relations with coworkers (15.84%), relations with family (27.84%), their emotional and mental well-being (48.51%), research productivity (34.26%), and financial income (52.28%). CONCLUSION: The COVID-19 pandemic has adverse effects on various personal and professional aspects of oncologists' lives. Interventions should be implemented to mitigate the negative impact and prepare oncologists to manage future crises with more efficiency and resilience.

Implementation of breast cancer continuum of care in low- and middle-income countries during the COVID-19 pandemic.

Breast cancer is the most common malignancy among women worldwide. The current COVID-19 pandemic represents an unprecedented challenge leading to care disruption, which is more severe in low- and middle-income countries (LMIC) due to existing economic obstacles. This review presents the global perspective and preparedness plans for breast cancer continuum of care amid the COVID-19 outbreak and discusses challenges faced by LMIC in implementing these strategies. Prioritization and triage of breast cancer patients in a multidisciplinary team setting are of paramount importance. Deescalation of systemic and radiation therapy can be utilized safely in selected clinical scenarios. The presence of a framework and resource-adapted recommendations exploiting available evidence-based data with judicious personalized use of current resources is essential for breast cancer care in LMIC during the COVID-19 pandemic.

Resource-Stratified Guideline-Based Cancer Care Should Be a Priority: Historical Context and Examples of Success.

Low- and middle-income countries (LMICs) are shouldering most of the burden of the rapidly increasing cancer incidence and mortality worldwide, and this situation is projected to worsen in coming decades. Studies estimate that more than one million deaths could be prevented annually if all patients received high-quality care, but most LMICs lack the resources and infrastructure to adopt U.S. or European clinical oncology practice guidelines. Several organizations have developed resource-stratified guidelines (RSGs) to provide graduated and/or region-specific strategies for cancer diagnosis and treatment. The birth of these efforts traces to 2002, when the World Health Organization (WHO) called for tailoring cancer treatments to the level of available resources by country; the Breast Health Global Initiative (BHGI) formalized the first stratified guidelines for breast cancer shortly thereafter. Since then, multiple organizations including ASCO and the National Comprehensive Cancer Network (NCCN) have created guidelines customized for various cancer subtypes and regions. These RSGs offer roadmaps for policy makers, clinicians, and health care administrators in LMICs to design projects in implementation science that can gradually and strategically raise the quality of cancer care in their nation or region. Although the same resource limitations that complicate cancer care in these areas also pose barriers to data gathering and research, some countries have met the challenge and are improving cancer care using RSGs as a metric for success.

Female oncologists in the Middle East and North Africa: progress towards gender equality.

BACKGROUND: Female doctors are increasingly choosing oncology as a career while they are still under-represented in leadership positions globally. The European Society of Medical Oncology has recently surveyed its members regarding gender equality in the work place. Limited data are available from the Middle East. The aim of our study was to survey female oncologists practicing in the Middle East to identify common challenges and suggest areas for improvement. METHODS: A cross-sectional survey was distributed among female participants attending the annual Lebanese Society of Medical Oncology meeting in March 2018, and in the Pan-Arab annual meeting in April 2018. The questionnaire used included questions assessing sociodemographic characteristics, involvement in leadership and academic positions and the impact of career on family life. RESULTS: Overall, 88 questionnaires were collected from women practicing all over the Middle East. 59% reported that a male doctor was responsible for the work team; however, 57% covered a managerial or leadership role within their job. 64% of the female oncologists believed that their gender had at least moderate, significant and even major impact on their career. Participants reported that their careers have a considerable impact on their relationship with friends and social networking (49%) and their family and marriage (44%). 58% report having problems with finding balance between work and family, and 50% find barriers to attend international meetings. Several ways to improve were suggested, 56% voted for offering development and leadership training specifically women, 45% suggested implementing a flexible work schedule. CONCLUSION: In what is considered a male dominant environment, gender equality according to female oncologists working in the Middle East, is very comparable to the world data provided. Several strategies have been identified to continue progress in this domain with the aim to improve academic leadership opportunities and work-life balance for all.

Metastatic Perivascular Epithelioid Cell Tumor Of The Kidney: A Case Report With Emphasis On Response To The Tyrosine-Kinase Inhibitor Sunitinib.

Several case reports have provided most of the information available on perivascular epithelioid cell tumors, but with no consensus regarding diagnosis or treatment paradigms. Sunitinb is a VEGFR multitargeted tyrosine-kinase inhibitor that is regarded as a first-line treatment of clear cell-type metastatic renal-cell carcinoma after cytoreductive surgery. Our case was a 29-year-old male who presented with a metastatic left renal tumor and underwent left partial nephrectomy followed by adjuvant tyrosine kinase-inhibitor treatment. We report this case to present the peculiarity of this rare pathological variant, its clinical and diagnostic features, and challenges regarding treatment options, since the response of this rare tumor to adjuvant tyrosine kinase-inhibitor therapy has not been well described.

ASCO Resource-Stratified Guidelines: Methods and Opportunities.

The objectives of this article are to describe the ASCO Resource-Stratified Guidelines and to provide background within the context of ASCO Guidelines and efforts to address the global cancer burden.

Global Health Initiatives of the International Oncology Community.

Cancer has become one of the leading causes of morbidity and mortality in low- and middle-income countries (LMICs), where 60% of the world's total new cases are diagnosed. The challenge for effective control of cancer is multifaceted. It mandates integration of effective cancer prevention, encouraging early detection, and utilization of resource-adapted therapeutic and supportive interventions. In the resource-constrained setting, it becomes challenging to deliver each service optimally, and efficient allocation of resources is the best way to improve the outcome. This concept was translated into action through development of resource-stratified guidelines, pioneered by the Breast Health Global Initiative (BHGI), and later adopted by most oncology societies in an attempt to help physicians deliver the best possible care in a limited-resource setting. Improving outcome entails collaboration between key stakeholders, including the pharmaceutical industry, local and national health authorities, the World Health Organization (WHO), and other nonprofit, patient-oriented organizations. Therefore, we started to observe global health initiatives-led by ASCO, the Union for International Cancer Control (UICC), and the WHO-to address these challenges at the international level. This article discusses some of these initiatives.

Access to Cancer Therapeutics in Low- and Middle-Income Countries.

Cancer is rapidly becoming a major health care problem, especially in developing countries, where 60% of the world's total new cases are diagnosed. The success of new antineoplastic medicines and modern radiation devices to cure a good proportion of patients with cancer and to alleviate the suffering of many more has been achieved at a dramatic cost. Therefore, it has become mandatory for health care authorities and pharmaceutical companies to cooperate to use and develop resources in an efficient manner to improve health care delivery to patients with cancer worldwide. Regulatory harmonization is an important key to overcome delays in the approval process, whether for antineoplastic and pain control medicines or for essential medical devices. More emphasis on the significant role of opiates in pain control among patients with cancer is needed to overcome the ingrained belief in their potential for addiction. The World Health Organization (WHO) serves an important role in guiding priorities for health care and efficiently allocating resources by providing essential medicine lists (EMLs) and device lists. However, the financial challenge for access to health care is multi-tiered and requires collaboration between key stakeholders including pharmaceutical industry, local national health authorities, WHO, and other nonprofit, patient-oriented organizations.

Erythropoietin-induced acute erythroid leukemia-like picture: a potential pitfall.

A 31-year-old male patient presented with fever and pancytopenia. He was diagnosed as a case of chronic anemia since early childhood. The etiology of the anemia was not known. The patient was transfusion dependent, and he had been maintained on erythropoietin for three years prior to admission. A bone marrow examination revealed prominent proliferation of immature and dysplastic erythroid precursors. Acute erythroid leukemia of the pure erythroid subtype was suspected. However, because of the history of erythropoietin therapy a definite diagnosis was not made. On follow-up one month later, the marrow changes had reversed to normal.