PURPOSE:Global oncology trials face increasing scrutiny over regional enrollment imbalances, as regulatory agencies such as the US Food and Drug Administration, European Medicines Agency, and Pharmaceuticals and Medical Devices Agency demand data reflective of population diversity. This push is grounded in evidence that genetic polymorphisms (eg, UGT1A1*28, CYP2D6), human leukocyte antigen-related toxicities, and biomarker prevalence (eg, epidermal growth factor receptor mutations in approximately 15% of Western v approximately 50% of Asian patients with lung cancer) can significantly influence treatment outcomes. METHODS:We reviewed scientific literature, regulatory case studies, and methodological innovations addressing regional heterogeneity in oncology trials. Particular focus was given to statistical tools such as adaptive randomization for real-time enrollment balancing, Bayesian hierarchical models for data borrowing across regions, and Multi-Regional Clinical Trial designs for structured consistency assessments. Control arm variability because of regional differences in standard of care and drug access was also examined. RESULTS:Recent regulatory setbacks, especially involving Asia-centric trials, underscore the consequences of insufficient regional planning. Emerging statistical approaches, including adaptive and Bayesian methods, show promise in managing heterogeneity while preserving trial integrity. Persistent challenges include disparities in trial infrastructure, molecular subtype distributions, and comorbidity patterns. Broader regional inclusion and integration of real-world evidence are increasingly critical to overcoming these limitations. CONCLUSION:Regional enrollment should be viewed not as a regulatory formality, but as a scientific and ethical priority. The future of global oncology trials hinges on proactive regional planning, innovative methodology, and cross-sector collaboration. Aligning global efficiency with local relevance can enhance scientific robustness, support regulatory alignment, and expand equitable access to novel cancer therapies worldwide.

Background Prostate cancer is a substantial health concern in the Middle East and North Africa region, with many cases diagnosed at advanced stages, a high mortality to incidence ratio, and low prostate cancer awareness. This study aimed to evaluate prostate cancer screening practices in the region to inform effective early detection and management strategies.Methods A cross-sectional survey was conducted from July 1, 2023, to November 8, 2024, among physicians from 19 countries in the Middle East and North Africa region. The study used a validated questionnaire to assess prostate cancer screening practices, barriers, and educational needs.Results The survey had a response rate of 96.8% and 1163 participants. Of these participants, 34.7% routinely performed prostate cancer screenings, with 61.1% using prostate-specific antigen tests. The primary barrier was lack of patient awareness (51.2%). In addition, 65.3% of participants had no formal training. To improve screening rates, participants suggested better patient education (63.5%), increased training for health-care professionals (41.9%), and improved access to screening equipment (38.9%).Conclusion This study revealed that prostate cancer screening rates were low, with barriers including a lack of patient awareness and formal training among physicians. Addressing these issues through culturally tailored education programs may improve early detection rates and ultimately reduce the burden of prostate cancer in the Middle East and North Africa region.

Introduction:Despite extensive studies of the impact of COVID-19 on patients with cancer, there is a dearthof information from the Middle East and North Africa (MENA) region. Our study aimed to report pertinentMENA COVID-19 and Cancer Registry (MCCR) findings on patient management and outcomes.Methods:MCCR was adapted from the American Society of Clinical Oncology COVID-19 Registry to collect data specificallyfrom patients with cancer and SARS-CoV-2 infection from 12 centers in eight countries including Saudi Arabia,Jordan, Lebanon, Turkey, Egypt, Algeria, United Arab Emirates, and Morocco. The Registry included data onpatients and disease characteristics, treatment, and patient outcomes. Logistic regression was used to assessassociations with mortality.Results:Between November 29, 2020, and June 8, 2021, data were captured on2008 patients diagnosed with COVID-19 from the beginning of the pandemic. Median age was 56 years (16-98),56.4% were females, and 26% were current or ex-smokers. Breast cancer (28.5%) was the leading diagnosis and50.5% had metastatic disease. Delays of planned treatment (.14 days) occurred in 80.3% for surgery, 48.8% for adiation therapy, and 32.9% for systemic therapy. Significant reduction in the delays of all three treatmentmodalities occurred after June 1, 2020. All-cause mortality rates at 30 and 90 days were 17.1% and 23.4%,respectively. All-cause mortality rates at 30 days did not change significantly after June 1, 2020; however, 90-daymortality increased from 33.4% to 42.9% before and after that date (p 1/40.015). Multivariable regressionanalysis showed the following predictors of higher 30- and 90-day mortality: age older than 70 years, havingmetastatic disease, disease progression, and being off chemotherapy.Conclusion:Patients with cancer inthe MENA region experienced similar risks and outcome of COVID-19 as reported in other populations.Although there were fewer treatment delays after June 1, 2020, 90-day mortality increased, which maybe attributed to other risk factors such as disease progression or new patients who presented with moreadvanced disease.

Objectives: Bevacizumab currently stands as the most prescribed anti-VEGF medication in oncology. It functions as an angiogenesis inhibitor, thereby slowing down tumor progression. However, this drug is associated with side effects both in general health and in the oral cavity. To assess the impact of Bevacizumab on mucosal healing after dental extraction in patients undergoing cancer treatment in the central region of Algeria. Materials and Methods: We conducted a cohort study that was comparative, prospective, and multicentric, carried out from June 2018 to September 2021. The sample was divided into two groups: the "With Bevacizumab" group consisted of patients on Bevacizumab with or without chemotherapy, and the second group "Without Bevacizumab" consisted of patients exclusively under conventional chemotherapy. These patients underwent dental extractions without interrupting their antineoplastic treatment. Additionally, the dental extraction protocol adhered to certain conditions, including antibiotic prophylaxis, vasoconstrictor-free anesthetic, and tight sutures. Mucosal healing was evaluated and monitored at 7, 15, and 30 days. Data analysis was performed using Python v. 3.8.16 software. Results: In total, 1250 cancer-treated patients were examined. Among them, 120 patients met the inclusion criteria, with a mean age of 52.08 ± 10.31 years, and they received an average dose of 547.9 ± 239.32 mg of Bevacizumab per cycle over an average duration of 40.08 ± 31.66 weeks. The mean total duration of treatment-free interval with Bevacizumab was estimated at 23.13 ± 7.03 days, with 12.85 ± 5.58 days before and 10.28 ± 4.68 days after dental extraction. Mucosal healing delay was only observed in the "With Bevacizumab" group (15.3% vs. 0.0%, p=0.040). Conclusions: Dental extraction is feasible during Bevacizumab treatment considering the disadvantages associated with interrupting anti-angiogenic treatment, despite the observed delay in epithelialization in our study. Clinical Relevance: Our results were able to demonstrate delayed mucosal healing (lack of epithelialization) beyond one month after tooth extraction.

There is a correlation between the rate of CEA and the tumor mass, rising rates are related to the degree of lymph local extension and the presence of distant metastases. In metastatic colorectal cancer, a constant elevation in the concentration of CEA may be associated with bad response to treatment or may persist lymph nodes remainders or subclinical metastases. A decrease in the concentration of ACE is usually indicative of a favorable prognosis and good response to treatment. this is a retrospective study of metastatic colorectal cancer patients followed from 2020 to 2022, all patients made a determination of serum CEA at the diagnosis of metastasis and a second determination in the clinical and radiological assessment after treatment by chemotherapy; the dosing was also done in consultation control for patient with complete and partial response. The primary aim of this study is to evaluate the benefit of CEA assay in evaluating the efficacy of treatment and the secondary aim is benefit in monitoring of these patients after treatment. 99 patients were treated in the department, 66 patients had synchronous metastases and 33 patients had metachronous metastases. At diagnosis, in 19 cases the rate of CEA was normal and in 80 cases the rate was high. After treatment and radiological and clinical evaluation, evaluation of ACE found rate: 16 cases of normalization with complete response, 52 cases of rating decrease with partial response and 12 cases of elevated rates with radiological progression. Patient follow-up control, rising CEA levels occurs with recurrence of the disease for all patients. In metastatic colorectal cancer, CEA assay is important to follow patients on treatment as it is high in the diagnosis; it helps to evaluate the effectiveness of treatment and monitoring of patients in the control consultation.

The most prevalent subtype of breast cancer (BC) is luminal hormonal-positive breast cancer. The neoadjuvant chemotherapy regimens have side effects, emphasizing the need to identify new startegies. Analyze the complete pathologic response (pCR) rate and overall response in a low-risk hormone-positive subset of patients receiving neoadjuvant hormone treatment (NAHT) with or without Palbociclib (a CDK4/CDK6 inhibitor) to boost NAHT effectiveness. Based on the upfront 21-gene Oncotype DX or low-risk Breast Recurrence Score assay (RS™), the SAFIA trial is designed as a prospective multicenter international, double-blind neoadjuvant phase-III trial that selects operable with luminal BC patients that are HER2-negative for the induction hormonal therapy with Fulvestrant 500 mg ± Goserelin (F/G) followed by randomization of responding patients to palbociclib versus placebo. The pCR rate served as the study’s main outcome, while the secondary endpoint was a clinical benefit. Of the 354 patients enrolled, 253 initially responded and were randomized to either F/G fulvestrant with palbociclib or placebo. Two hundred twenty-nine were eligible for the evaluation of the pathologic response. No statistically significant changes were observed in the pCR rates for the patients treated with the F/G therapy with placebo or palbociclib (7

There is a correlation between the rate of CEA and the tumor mass, rising rates are related to the degree of lymph local extension and the presence of distant metastases In metastatic colorectal cancer, a constant elevation in the concentration of CEA may be associated with bad response to treatment or may persist lymph nodes remainders or subclinical metastases. A decrease in the concentration of CEA is usually indicative of a favorable prognosis and good response to treatment. This is a retrospective study of metastatic colorectal cancer patients follow from 2020 to 2022, all patients made a determination of serum CEA at the diagnosis of metastasis and a second determination in the clinical and radiological assessment after treatment by chemotherapy; the Dosing was also done in consultation control for patient with complete and partial response. The primary aim of this study is to evaluate the benefit of CEA assay in evaluating the efficacy of treatment and the secondary aim is benefit in monitoring of these patients after treatment. 99 patients were treated in the department, 66 patients had synchronous metastases and 33 patients had metachronous metastases. At diagnosis, in 19 cases the rate of CEA was normal and in 80 cases the rate was high. After treatment and radiological and clinical evaluation, evaluation of CEA found rate: 16 cases of normalization with complete response, 52 cases of Rating Decrease with partial response and 12 cases of elevated rates with radiological progression. Patient follow-up control, rising CEA levels occurs with recurrence of the disease for all patients. In metastatic colorectal cancer, CEA assay is important to follow patients on treatment as it is high in the diagnosis; it helps to evaluate the effectiveness of treatment and monitoring of patients in the control consultation.

BACKGROUND:Rat sarcoma virus mutational status guides first-line treatment in metastatic colorectal cancer. This study was a multi center, multi-country ambispective, observational study in the Middle East and North Africa assessing regional rat sarcoma virus testing practices in newly diagnosed patients.METHODS:The retrospective arm (2011-2014) included adults with metastatic colorectal cancer who had initiated first-line therapy with ≥1 post-baseline visit and survival data. The prospective arm (2014-2019) enrolled newly diagnosed patients with histologically proven metastatic colorectal cancer with ≥1 measurable lesion per Response Evaluation Criteria in Solid Tumors, and tissue availability for biomarker analysis. Data look-back and follow-up were 2 years; the rate of RAS mutation was evaluated.RESULTS:RAS testing was ordered for patients in retrospective (326/417) and prospective (407/500) studies. In the former, testing was typically prescribed after first-line treatment initiation, significantly more in patients with stage IV disease (P < .005), resulting in the addition of targeted therapy (41.8% anti-epidermal growth factor receptor, 30.2% anti-vascular endothelial growth factor) in wild-type metastatic colorectal cancer, and significantly impacted the treatment of left-sided tumors (P = .037). In the latter, 58.4% were RAS wild-type; 41.6% were RAS mutant. Non-prescription of RAS testing was attributed to test unavailability, financial, or medical rea sons; predictors of testing prescription were older age, primary tumor in ascending colon, and high tumor grade. RAS status knowledge resulted in the addition of anti-vascular endothelial growth factor (20.4%) or anti-epidermal growth factor receptor therapy (21.2%).CONCLUSION:Before 2014, RAS testing in patients with colorectal cancer in the Middle East and North Africa was often performed after first-line treatment. Testing is more routine in newly diagnosed patients, potentially shifting early treatment patterns.

PURPOSEHepatocellular carcinoma (HCC), the fourth most common cancer in Africa, has a dismal overall survival of only 3 months like in sub-Saharan Africa. This is affected by the low gross domestic product and human development index, absence of coherent guidelines, and other factors.METHODSAn open forum for HCC-experienced health care workers from Africa and the rest of the world was held in October 2021. Participants completed a survey to help assess the real-life access to screening, diagnoses, and treatment in the North and Southern Africa (NS), East and West Africa (EW), Central Africa (C), and the rest of the world.RESULTSOf 461 participants from all relevant subspecialties, 372 were from Africa. Most African participants provided hepatitis B vaccination and treatment for hepatitis B and C. More than half of the participants use serum alpha-fetoprotein and ultrasound for surveillance. Only 20% reported using image-guided diagnostic liver biopsy. The Barcelona Clinic Liver Cancer is the most used staging system (52%). Liver transplant is available for only 28% of NS and 3% EW. C reported a significantly lower availability of resection. Availability of local therapy ranged from 94% in NS to 62% in C. Sorafenib is the most commonly used systemic therapy (66%). Only 12.9% reported access to other medications including immune checkpoint inhibitors. Besides 42% access to regorafenib in NS, second-line treatments were not provided.CONCLUSIONSimilarities and differences in the care for patients with HCC in Africa are reported. This reconfirms the major gaps in access and availability especially in C and marginally less so in EW. This is a call for concerted multidisciplinary efforts to achieve and sustain a reduction in incidence and mortality from HCC in Africa.

Despite extensive studies of the impact of COVID-19 on patients with cancer, there is a dearth of information from the MENA region. Our study aims to report pertinent MCCR findings on patient management and outcomes. MCCR was adapted from ASCO COVID-19 Registry to collect data on patients with cancer and SARS-CoV-2 infection from 12 centers in eight countries including: Saudi Arabia, Jordan, Lebanon, Turkey, Egypt, Algeria, United Arab Emirates, and Morocco. The Registry included data on patients and disease characteristics, treatment, and patient outcomes. Between November 29, 2020 and December 7, 2021, data on 1345 patients were captured. Median age was 57 years (18-98), 56.1% females, and 27.1% were current or ex-smokers. Out of the 1144 patients (85.1%) with solid tumors, delays of planned treatment > 14 days occurred in 81.4% for surgery, 51.7% for radiation therapy and 34.6% for drug therapy. No delays in surgery and radiation therapy occurred after June 1, 2020, and the delays of drug therapy were reduced from 20.8% to 5.2% (P < 0.0001). All-cause mortality at 30 and 90 days were 15.9% and 22.1%, respectively. All-cause mortality rates at 30 and 90 days were reduced after June 1st, 2020, from 17.3% to 3.7%, and from 24.2% to 3.7%, respectively (P < 0.0001). Univariate analysis showed multiple prognotic factors such as age > 70 years, male gender, lung cancer vs other solid tumors, diagnosis of COVID-19 before June 2020, ever smokers, among others. The Multivariate Logistic Regression analysis results shown in Table.Table: 500PMultivariate logistic regression analysis of 30- and 90-days all-cause mortality (N=1345 patients)30 Days All-Cause Mortality90 Days All-Cause MortalityOR95% CIP-valueOR95% CIP-valueDiagnosed after June 1, 2020 vs. before June 1, 2020*0.2510.095-0.6630.0050.1250.047-0.328<0.0001On chemotherapy at diagnosis yes vs. no*0.6450.398-1.0450.0750.6420.411-1.0000.050Stable Disease vs. Progressing disease*0.2440.132-0.451<0.00010.1850.108-0.319<0.0001Metastatic vs. Locoregional disease*2.4081.222-4.7480.0113.3131.783-6.156<0.0001Comorbidities vs. no comorbidity*1.7321.067-2.8130.0261.7991.150-2.8140.010Obesity vs. none*0.7160.444-1.1550.1710.5910.381-0.9150.018∗ Reference group. Open table in a new tab ∗ Reference group. Patients with cancer in MENA region experienced similar risks and outcome of COVID-19 reported in other populations. The reduction in mortality rate after June 2020 reflects a better approach to managing these patients resulting in improved outcome.

e18797 Background: Patients with cancer are vulnerable population that suffered during the COVID-19 pandemic from SARS-CoV-2 infection and from the pandemic’s impact on healthcare systems. We are presenting the findings of MENA Registry for COVID-19 and Cancer (MRCC) regarding the SARS-CoV-2 infection presentation, diagnosis, treatment, complications, and outcomes. Methods: MRCC was adapted from ASCO COVID-19 Registry and included patients with SARS-CoV-2 infection and underlying cancer diagnosis including a newly diagnosed cancer in the work-up phase or patients with active cancer receiving cancer therapy or supportive care, or within first year of adjuvant chemotherapy or after one year of curative therapy and receiving hormonal therapy. Registry included data on patients from 12 centers in eight countries in the MENA region, namely: Saudi Arabia, Jordan, Lebanon, Turkey, Egypt, Algeria, United Arab Emirates, and Morocco. The data included patient and disease characteristics, COVID-19 presentation, management, and outcomes. The follow up is differential as data get captured at different points of disease trajectory for each patient which may not reflect the final outcome. Results: Data on 1345 patients were captured in the study by December 7, 2021. Median age was 57.1 years (18-98), whereas 56.1% were females. The median follow-up was 98.5 days (0-554). The most common COVID-19 symptoms was fever (50.3%) and 26.8% of patients were asymptomatic. Out of the 959 patients with complete data on hospitalization, 554 (57.8%) were hospitalized and 126 of them (22.7%) were admitted to intensive care unit (ICU). The majority of hospitalized patients (60%) had respiratory complications and 13.9% had sepsis and 8.5% suffered acute renal injury. As shown in Table, more than quarter of the patients died with 47% of death from COVID-19 or related complication and 60.6% died at home. More than half of the patients were fully recovered from infection. Conclusions: Although more than half of the patients recovered form COVID-19 and more are expected to recover with a longer follow up, the death toll and complications remain high in this patient population. Future analysis of the impact of vaccination and better disease management as well as the impact of newer variants would provide a useful insight on managing this vulnerable population.[Table: see text]

Peu de publications ont été réalisées sur l’expression des immunecheckpoints (PD1-et PD-L1) par les cellules lymphoïdes tumorales des lymphomes B diffus à grandes cellules (LBDGC) NOS EBV+ et EBV-. Caractérisation et comparaison du profil d’expression de PD1, PD-L1 par les cellules lymphoïdes tumorales des LBDGC NOS EBV+ et EBV−. Nous avons comparé 78 patients LBDGC EBV− NOS dont 67 de phénotype ABC et 11 GCB avec 13 patients LBDGC EBV+ ABC suivis et traités par R-CHOP sur une période de 44 mois. Nous avons estimé le pourcentage d’expression par les cellules lymphoïdes tumorales de PD-L1 (CAL10) avec un cut off de 30 %, et PD-1(NAT 105) avec un cut off de 5 %. Dans notre série, il a été observé une différence significative entre les deux groupes sur l’expression de PD-L1 par les cellules lymphomateuses p < 0,0001. Cette expression a été retrouvée dans 100 % des LBDGC EBV+ et dans 24,4 % des LBDGC EBV−. Le PD-1 n’a pas montré de différence significative entre les deux groupes p = 0,261. Il a été exprimé par 15,4 % des LBDGC EBV+ et 6,4 % des LBDGC EBV. L’expression de PD-L1 a été corrélée à une mauvaise réponse au traitement et une survie inférieure p = 0,006. Nous avons également noté une différence significative entre les deux groupes sur la réponse au traitement R-CHOP ( p = 0,01) et sur le taux de survie entre les LBDGC EBV+ et EBV-, Log Rank (Mantel-Cox) p = 0,0001. La fréquence d’expression de PD-L1 dans les LBDGC est de l’ordre de 20 % à 30 %, mais dépend du seuil de positivité retenu et du compartiment cellulaire analysé, tumoral ou environnemental. Nos résultats sont concordants avec les données de la littérature avec un seuil de positivité à 30 %. Elles sont également concordantes sur la fréquence plus élevée de cellules tumorales PD-L1+ dans les LBDGC de phénotype ABC ainsi que l’association forte entre l’expression de PD-L1 et la présence d’EBV. De rares observations ont cependant décrit dans un faible pourcentage de cas, l’expression de PD-1 à la surface des cellules lymphomateuses et la possible co-expression de PD-1 et de PD-L1 par les mêmes cellules tumorales. Les résultats restent controversés. Notre étude démontre que l’expression de PD-L1 par les cellules lymphoïdes tumorales est un facteur prédictif de la réponse thérapeutique et la survie ; en plus du statut EBV dans les LBDGC.

596 Background: Luminal, human epidermal growth factor receptor 2 (HER2)-negative breast cancer (BC) encompasses the most common subtype of breast malignancies. Neoadjuvant strategies of operable BC are primarily based upon chemotherapy (CT), while neoadjuvant hormone therapy (NAHT) has not been well studied in the Middle East and North Africa (MENA) region. However, these tumors might respond poorly to neoadjuvant CT with significant side effects, emphasizing the need to identify patients who could be candidates for NAHT. Methods: The SAFIA trial is a prospective multicentre, international, double-blind, neoadjuvant phase-III trial using upfront 21-gene Oncotype DX Breast Recurrence Score assay (RS) <31) to select operable Luminal HER2-negative patients for induction hormonal therapy with Fulvestrant 500 mg +/– Goserelin (F/G) before randomizing responding patients to F/G + Palbociclib (Cyclin-Dependent Kinase 4/6 inhibitor / CDK 4/6) versus F/G + Placebo. The primary endpoint of this study was the complete pathologic response (pCR) rate. Results: A total of 354 patients were enrolled, leading to 277 patients treated with induction F/G. Of these, 253 responding patients were randomized to F/G fulvestrant with palbociclib or Placebo. Two hundred and thirty patients were evaluable for pathologic response. No statistically significant differences were identified in terms of pCR rates between F/G with palbociclib or placebo: 2% versus 7%, respectively. According to the radiologic responses post- induction F/G, the hormone sensitivity rate was 89.8%, while the clinical benefit of 8–9 months of neoadjuvant F/G was 96%. Safety in the MENA population was acceptable with a grade 3-4 neutropenia rate of 25% in the F/G plus palbociclib arm. The feasibility of performing the 21-gene breast recurrence score assay on core biopsy specimens was optimal in 96.4% of cases. Conclusions: The addition of palbociclib to neoadjuvant F/G did not show any additional benefit in terms of pathologic response, including pCR in neoadjuvant therapy of Luminal HER2-negative BC responding to induction F/G. The use of an upfront 21-gene assay appeared feasible on biopsy specimens, and the identification of tumors with RS<31 allowed to select endocrine sensitive patients, leading ultimately to a 96% clinical benefit with 8–9 months of F/G neoadjuvant therapy. Clinical trial information: NCT03447132. [Table: see text]

Colorectal cancer (CRC) is ranked as the third most prevalent and the second deadliest cancer worldwide. In the Middle East and North Africa (MENA) region, the number of CRC cases increased over the past decades and will nearly double by 2030. The lack of clear MENA guidelines for the management of patients with CRC represents a step backwards in the fight against this burden. Therefore a panel of 24 MENA experts in the field of gastrointestinal oncology developed, using a Delphi process, the first consensus recommendations for the management of patients with advanced CRC. Forty-seven different statements were formulated in the areas of epidemiology, screening, biomarkers and treatment. These recommendations will guide, standardize and unify the management of this cancer in the MENA region.

AbstractThis publication presents an overview of the major topics and issues to be considered when planning and implementing treatment as it applies to cancer care in Algeria, and access to prevention, screening, palliative, and treatment services. Situational analysis related to cancer shows that Algeria has significant advantages in terms of infrastructure, equipment, human resources, and even financial resources. Given the recent implementation of the national cancer plan, this analysis provides valuable initial insight into the demographic and clinical characteristics of patients with cancer. The data provides a comprehensive picture of the fight against cancer with a focus on oncology. Better efforts should be made in the field of prevention, detection, and treatment for patients regardless of their age, health, or resources.Future investment in the field of cancer should strengthen the impact of the national capacities; the performance should be more than ever on the agenda of the national health authorities to achieve two goals, such as reducing cancer related mortality and reducing cancer incidence.The main objective is to stress the importance of being as close as possible to healthcare professionals and help them treat their patients better through training, not just new products, or technologies, but to think about sustainable strategies that look towards the future lying in precision and individualized healthcare.

PURPOSE:Cancer is a leading cause of increased morbidity and mortality worldwide. This work aims to study the Arab world males' cancers (AMCs) and the similarities and disparities with the world males' cancers (WMCs) from different burden points of view. MATERIALS AND METHODS:A descriptive review of the 2020 Global Cancer Observatory revealed AMCs compared with the 2020 WMCs and the 2018 AMCs. Data on the top 27 AMCs were compared among the region's countries and the world groups. RESULTS:In 2020, a total estimate of 217,203 new AMCs, 2.2% of WMCs, with an average age-standardized rate of 133.5/100,000 population, compared with 222/100,000 population of WMCs, was observed. Death estimates were 148,395, 2.7% of WMCs, with an average age-standardized rate of 95/100,000 population, compared with 120.8/100,000 population of WMCs. The five-year prevalence was observed in 442,014, 1.8% of WMCs. The average AMC mortality to incidence ratio (MIR) was 0.68, compared with 0.55 in WMCs and 0.54 in Arab females. Lung cancer was the top in incidence and mortality, whereas penile cancer was the lowest. The range of MIRs among the 27 cancer types was 0.19-0.96. CONCLUSION:The descriptive review of the 2020 males' cancers in the Arab world revealed a relatively high MIR, compared with males' cancers worldwide and the females' cancers in the Arab world. This requires further evaluation to discern the underlying causes and address them systematically. More cancer control actions are warranted.

PURPOSELuminal, human epidermal growth factor receptor 2–negative breast cancer represents the most common subtype of breast malignancies. Neoadjuvant strategies of operable breast cancer are mostly based on chemotherapy, whereas it is not completely understood which patients might benefit from neoadjuvant hormone therapy (NAHT).MATERIALS AND METHODSThe SAFIA trial is a prospective multicenter, international, double-blind, neoadjuvant phase III trial, using upfront 21-gene Oncotype DX Breast Recurrence Score assay (recurrence score [RS] < 31) to select operable luminal human epidermal growth factor receptor 2–negative patients, for induction hormonal therapy HT (fulvestrant 500 mg with or without goserelin) before randomly assigning responding patients to fulvestrant 500 mg (with or without goserelin) plus either palbociclib (cyclin-dependent kinase 4/6 inhibitor) or placebo. The objectives of this interim analysis were to assess the feasibility of upfront RS determination on core biopsies in the Middle-East and North Africa region and evaluate the efficacy of induction NAHT in patients with an RS < 31.RESULTSAt the time of this interim analysis, 258 patients with relative risk were accrued, including 202 patients (RS < 31% to 78.3%) treated with induction NAHT and 182 patients evaluable so far for response. The feasibility of performing the Oncotype DX assays on core biopsy specimens was optimal in 96.4% of cases. Overall, 93.4% of patients showed hormone sensitivity and no difference in NAHT efficacy was noticed between RS 0-10, 11-25, and 26-30. Interestingly, patients with high RS (26-30) showed a trend toward a higher major response rate (P = .05).CONCLUSIONThe upfront 21-gene assay performed on biopsies is feasible in our population and has allowed us to select patients with high hormone sensitivity (RS < 31). This approach could be an alternative to upfront surgery without significant risk of progression, particularly during pandemic times.

BACKGROUND:The coronavirus disease 2019 (COVID-19) pandemic presents serious challenges to cancer care because of the associated risks from the infection itself and the disruption of care delivery. Therefore, many professional societies have published recommendations to help manage patients with cancer during the current pandemic. The objective of our study is to assess the national responses of Middle East North Africa (MENA) countries in terms of publishing relevant guidelines and analyse various components of these guidelines.METHODS:A survey based on the preliminary review of the literature regarding cancer care adaptations has been developed and then completed by a group of oncologists from the following Arab countries affected by the pandemic: Algeria, Egypt, Iraq, Jordan, Kuwait, Lebanon, Morocco, Oman, Saudi Arabia, Syria, Tunisia, United Arab Emirates and Yemen. The survey inquired about COVID-19 cases, national recommendations regarding general measures of COVID-19 prevention and patient care in oncology as well as their implementation about cancer care adaptations during the pandemic.RESULTS:Analysis of the COVID-19 pandemic-related guidelines revealed at least 30 specific recommendations that we categorised into seven essential components. All included countries had national guidelines except one country. Estimated full compliances with all specific category recommendations ranged from 30% to 69% and partial compliance ranged from 23% to 61%.CONCLUSION:There is a very good response and preparedness in the Arab Middle East and North Africa region surveyed. However, there are inconsistencies in the various components of the guidelines across the region, which reflects the evolving status of the pandemic in each country as well as the lack of clear evidence-based guidelines for many of the issues in question. There is a need for a clear framework on essential components that should be included in these guidelines to assure providing the best guidance to the oncology community.

PURPOSEProgrammed death-ligand 1 (PD-L1) is a marker for checkpoint inhibitor use in the management of solid tumors, especially in non–small-cell lung cancer (NSCLC). Our study was aimed at determining the patterns of PD-L1 expression and cluster of differentiation 8 (CD8) immunostains in patients with NSCLC in the Arab population.METHODSArchival tumor tissue from patients with a confirmed diagnosis of NSCLC were obtained and stained for PD-L1 with antibody 22C3, using immunohistochemistry staining and giving the tumor proportion score (TPS) as a percentage from 0%-100% of stained tumor cells. Tumors were categorized into negative expressers (TPS < 1%), low positive (TPS, 1%-49%), and high positive (TPS, 50%-100%). Correlation of expression with clinical and pathologic features, including CD8-positive (CD8+) lymphocyte density, was also analyzed.RESULTSTwo hundred patients with NSCLC were included in the study from 6 centers in Saudi Arabia and Algeria. Median age was 65 years (28-93 years), and the majority were men (75%) with stage 4 NSCLC (64%). The TPS was high in 37 patients (18%), low in 60 patients (30%), and negative in 103 patients (52%). In a univariate analysis, the following were significant predictors of any PD-L1 expression (> 1%): male sex, being Saudi national patients, high expression of CD8+, and presence of tumor-infiltrating lymphocytes. In the multivariate analysis, only high expression of CD8+ cells (≥ 2+) was significant, with an odds ratio of 4.4 (95% CI, 1.5 to 12.9; P = .003)CONCLUSIONPD-L1 expression in our population is similar to the published literature and correlated with the density of CD8+ cells. Validation of the predictive value of this marker in our population and identifying easier and reliable methods to test for it are warranted.