Sex and survival outcomes in patients with renal cell carcinoma receiving first-line immune-based combinations.

BACKGROUND: There is an ongoing debate as to whether sex could be associated with immune checkpoint inhibitor (ICI) benefit. Existing literature data reveal contradictory results, and data on first-line immune combinations are lacking. METHOD: This was a real-world, multicenter, international, observational study to determine the sex effects on the clinical outcomes in metastatic renal cell carcinoma (mRCC) patients treated with immuno-oncology combinations as first-line therapy. RESULTS: A total of 1827 mRCC patients from 71 cancer centers in 21 countries were included. The median OS was 38.7 months (95% CI 32.7-44.2) in the overall study population: 40.0 months (95% CI 32.7-51.6) in males and 38.7 months (95% CI 26.4-41.0) in females (p = 0.202). The median OS was higher in males vs. females in patients aged 18-49y (36.9 months, 95% CI 29.0-51.6, vs. 24.8 months, 95% CI 16.8-40.4, p = 0.426, with + 19% of 2y-OS rate, 72% vs. 53%, p = 0.006), in the clear cell histology subgroup (44.2 months, 95% CI 35.8-55.7, vs. 38.7 months, 95% CI 26.0-41.0, p = 0.047), and in patients with sarcomatoid differentiation (34.4 months, 95% CI 26.4-59.0, vs. 15.3 months, 95% CI 8.9-41.0, p < 0.001). Sex female was an independent negative prognostic factor in the sarcomatoid population (HR 1.72, 95% CI 1.15 - 2.57, p = 0.008). CONCLUSIONS: Although the female's innate and adaptive immunity has been observed to be more active than the male's, women in the subgroup of clear cell histology, sarcomatoid differentiation, and those under 50 years of age showed shorter OS than males.

Real-world effectiveness of pembrolizumab as first-line therapy for cisplatin-ineligible patients with advanced urothelial carcinoma: the ARON-2 study.

BACKGROUND: The advent of immune-checkpoint inhibitors has challenged previous treatment paradigms for advanced urothelial carcinoma (UC) in the post-platinum setting as well as in the first-line setting for cisplatin-ineligible patients. In this study, we investigated the effectiveness of pembrolizumab as first-line treatment for cisplatin-ineligible UC. METHODS: Data from patients aged ≥ 18 years with cisplatin-ineligible UC and receiving first-line pembrolizumab from January 1st 2017 to September 1st 2022 were collected. Cisplatin ineligibility was defined according to the Galsky criteria. Thirty-three Institutions from 18 countries were involved in the ARON-2 study. RESULTS: Our analysis included 162 patients. The median follow-up time was 18.9 months (95%CI 15.3-76.9). In the overall study population, the median OS was 15.8 months (95%CI 11.3-32.4). The median OS was significantly longer in males versus females while no statistically significant differences were observed between patients aged < 65y versus ≥ 65y and between smokers and non-smokers. According to Recist 1.1 criteria, 26 patients (16%) experienced CR, 32 (20%) PR, 39 (24%) SD and 55 (34%) PD. CONCLUSIONS: Our data confirm the role of pembrolizumab as first-line therapy for cisplatin-unfit patients. Further studies investigating the biological and immunological characteristics of UC patients are warranted in order to optimize the outcome of patients receiving immunotherapy in this setting.

Burnout in oncology: Magnitude, risk factors and screening among professionals from Middle East and North Africa (BOMENA study).

BACKGROUND: Burnout (BO) among oncology professionals (OP) is increasingly being recognized. Early recognition and intervention can positively affect the quality of care and patient safety. This study investigated the prevalence, work and lifestyle factors affecting BO among OPs in the Middle East and North Africa (MENA). METHODS: An online survey was conducted among MENA OPs between 10 February and 15 March 2020, using the validated Maslach Burnout Inventory of emotional exhaustion (EE), depersonalization (DP) and personal accomplishment (PA), including questions regarding demography/work-related factors and attitudes towards oncology. Data were analysed to measure BO prevalence and risk factors and explore a screening question for BO. RESULTS: Of 1054 respondents, 1017 participants (64% medical oncologists, 77% aged less than 45 years, 55% female, 74% married, 67% with children and 40% practiced a hobby) were eligible. The BO prevalence was 68% with high levels of EE and DP (35% and 57% of participants, respectively) and low PA scores (49%). BO was significantly associated with age less than 44 years, administrative work greater than 25% per day and the thought of quitting oncology (TQ). Practising a hobby, enjoying oncology communication and appreciating oncology work-life balance were associated with a reduced BO score and prevalence. North African countries reported the highest BO prevalence. Lack of BO education/support was identified among 72% of participants and TQ-predicted burnout in 77%. CONCLUSIONS: This is the largest BO study in MENA. The BO prevalence was high and several modifiable risk factors were identified, requiring urgent action. TQ is a simple and reliable screening tool for BO.

Efficacy and Safety of Laughter Yoga in Cancer Patients: A Scoping Review of Randomized Controlled Trials.

The use of laughter yoga as a complementary and alternative medicine (CAM) strategy has recently gained interest as a potential supportive intervention for cancer patients. In this review, we aimed to assess the impact of laughter yoga on the quality of life of cancer patients, with a focus on evidence from randomized controlled trials (RCTs). Our analysis indicates that laughter yoga can significantly improve the quality of life of cancer patients by improving emotional and physical functioning and reducing symptoms of depression and stress. These findings suggest that laughter yoga is a promising CAM practice for enhancing cancer patients' psychological and physical health. Future research should aim to extend these studies to more extensive and more diverse populations to validate and expand upon these findings.

Sodium-Glucose Cotransporter 2 Inhibitor (SGLT2i) Associated Diabetic Ketoacidosis in Oncology Patients: A Case Series and Literature Review.

Sodium-glucose cotransporter 2 inhibitors (SGLT2i) use is associated with an increased risk of diabetic ketoacidosis (DKA). The clinical data regarding the use of SGLT2i and its potential side effects in oncology patients is limited. We are retrospectively reporting four oncology patients with type 2 diabetes mellitus using SGLT2i who were admitted with DKA. The mean age of the patients was 61.25 years, and male to female ratio was 1:1. The duration of type 2 diabetes ranged from 10 to 20 years (mean 15.75 years) and the types of SGLT2i used were empagliflozin 25 mg and dapagliflozin 10 mg. The types of malignancy in our case series included squamous cell carcinoma of the cheek, ovarian cancer, and two patients had laryngeal carcinoma (squamous cell carcinoma). Diabetic ketoacidosis was diagnosed in three patients following chemotherapy or concurrent chemo-radiotherapy. Poor oral intake and infections were the main risk factors in our patients. Mean blood glucose level, anion gap, and bicarbonate level were 11.7 mmol/l, 32.25, and 5 mmol/l, respectively. The majority had moderate DKA based on pH (mean 7.13). The hospital course was complicated by acute kidney injury (n=4), infections (n=4) (urinary tract infections, and pneumonia), and three patients required critical care. The mean length of hospitalization was 19.2 days and no mortality was reported among our patients. SGLT2i-related DKA is an emerging complication recognized in oncology patients. Some of the risk factors for this complication are starvation, poor oral intake, and infection which are quite prevalent in oncology patients. Temporary holding of SGLT2i medication during this period might have a potential preventive role.

Oncocytic Carcinoma with Liver Metastasis: Unusual Treatment Strategies and Clinical Insights-A Case Report and Review of the Literature.

We report a distinctive case of malignant oncocytic carcinoma originating in the pancreas, an organ rarely associated with such tumours. We discuss the diagnostic journey, highlighting the tumour's resemblance to renal cell carcinoma but without renal involvement. A significant aspect of this case is the successful and sustained response to combined immunotherapy and tyrosine kinase inhibitors, demonstrating a potential therapeutic pathway for similar rare cases. This study contributes to a deeper understanding of pancreatic oncocytic tumours and their management.

Oncotype DX in Breast Cancer Management: Insights and Outcomes From the United Arab Emirates.

Introduction Breast cancer remains the most significant cancer affecting women worldwide, with an increasing incidence, especially in developing regions. The introduction of genomic tests like Oncotype DX has revolutionized personalized treatment, allowing for more tailored approaches to therapy. This study focuses on the United Arab Emirates (UAE), where breast cancer is the leading cause of cancer-related deaths among women, aiming to assess the predictive accuracy of the Oncotype DX test in categorizing patients based on recurrence risk. Materials and methods A retrospective cohort study was conducted on 95 breast cancer patients diagnosed at Tawam Hospital between 2013 and 2017 who underwent Oncotype DX testing. Data on patient demographics, tumor characteristics, treatment details, and Oncotype DX scores were collected. Survival analysis was performed using the Kaplan-Meier method, with the chi-square goodness of fit test assessing the model's adequacy. Results The cohort's age range was 27-71 years, with a mean age of 50, indicating a significant concentration of cases in the early post-menopausal period. The Oncotype DX analysis classified 55 patients (57.9%) as low risk, 29 (30.5%) as medium risk, and 11 (11.6%) as high risk of recurrence. The majority, 73 patients (76.8%), did not receive chemotherapy, highlighting the test's impact on treatment decisions. The survival analysis revealed no statistically significant difference in recurrence rates across the Oncotype DX risk categories (p = 0.268231). Conclusion The Oncotype DX test provides a valuable genomic approach to categorizing breast cancer patients by recurrence risk in the UAE. While the test influences treatment decisions, particularly the use of chemotherapy, this study did not find a significant correlation between Oncotype DX risk categories and actual recurrence events. These findings underscore the need for further research to optimize the use of genomic testing in the UAE's diverse patient population and enhance personalized treatment strategies in breast cancer management.

Exploring Oral Cavity Cancer in the United Arab Emirates (UAE).

Background This study delves into the demographics and clinical characteristics of oral cavity tumors in the context of the United Arab Emirates. It further investigates the efficacy of four different treatment modalities in impacting patient survival rates. It aims to understand if any treatments significantly improve survival compared to others. Methodology To assess the survival outcomes across the different treatment groups, the study employed the log-rank test, a non-parametric statistical test widely used in survival analysis. The sample consisted of patients from the electronic medical records assigned to one of the following four treatment groups: radiotherapy only (RT), radiotherapy with surgery and chemotherapy (RT+S+C), radiotherapy with surgery (RT+S), and, finally, radiotherapy with chemotherapy including immunotherapy (RT+C). Data collection involved tracking survival times from the initiation of treatment until the last follow-up period or the occurrence of an event (e.g., death). The statistical analysis was conducted using the chi-squared statistic to determine the distribution of survival times across the groups, providing a quantitative measure of the difference between the observed and expected survival. The Kaplan-Meier curve was plotted for the cohort divided into four groups. Results The log-rank test yielded a p-value of 0.321019, suggesting no statistically significant difference in survival among the treatment groups at the 5% significance level. The chi-squared statistic was 3.498018, within the 95% acceptance region, further corroborating the null hypothesis of no significant survival difference across the groups. Despite this, an observed medium effect size of 0.59 indicates a moderate difference in survival between the groups. Conclusions The findings illustrate that while there is no statistically significant difference in survival rates among the four treatment groups, the medium effect size observed suggests a moderate difference in survival. This emphasizes the need to consider the statistical significance and effect size in clinical research, as they provide different insights into treatment efficacy.

Management of Metastatic Urothelial Carcinoma in Emerging Markets (EM): An Expert Opinion.

Urothelial carcinoma (UC) is the 10th most common cancer globally with an almost 4 times higher prevalence in men. The main risk factors for development of urothelial carcinoma are advanced age, smoking, arsenic contamination, exposure to carcinogens. Metastatic urothelial carcinoma (mUC) has overall poor prognosis with a 5-year overall survival rate of only < 5%. The standard of care comprises of platinum-based chemotherapy, but the responses are often not sustained. A working group was established with an objective to discuss the most recent clinical data on the genitourinary tumors of interest and comprised of experts across Latin America, Emerging Asia (except China, Japan, and South Korea), Africa, and the Middle East (known as Emerging Markets or EM). There is an evident disparity in terms of uneven mortality and incidence rate distribution among various regions. There is a lack and/or insufficient data on epidemiology, treatment, and outcomes in the EM. The lack of registries impacts the healthcare decisions and the lower incidence from the region might not be reflective of the true disease burden. The treatment outcomes of mUC can be improved by understanding the current disease burden and treatment approach of mUC and identifying the gaps and challenges associated with management. Hence, a literature review was developed to summarize the current disease burden and treatment approach of mUC across EM. The review also highlights the unmet needs for mUC management in EM and suggests a way forward to improve the current situation in order to better serve the patients.

Systemic Immune-Inflammation Index in Patients Treated With First-Line Immune Combinations for Metastatic Renal Cell Carcinoma: Insights From the ARON-1 Study.

BACKGROUND: Systemic treatment with immune combinations is the gold standard for metastatic renal cell carcinoma (mRCC) worldwide. The systemic immune-inflammation index (SII) is a prognostic marker for several types of malignant neoplasms, including mRCC, in the era of tyrosine kinase inhibitor (TKI) treatment. Data regarding the prognostic value of the SII in patients with mRCC treated with immunotherapy are scarce and controversial.  METHODS: We retrospectively collected the data of patients with mRCC from 56 centers in 18 countries. SII (Platelet × Neutrophil/Lymphocyte count) was calculated prior to the first systemic treatment and cut-off was defined by a survival receiver operating characteristic (ROC) analysis. The primary objective of our retrospective study was to assess the outcomes of patients treated with first-line immunotherapy.  RESULTS: Data from 1034 mRCC patients was collected and included in this analysis. The SII cut-off value was 1265. After a follow-up of 26.7 months, and the overall survival (OS) and progression-free survival (PFS) were 39.8 and 15.7 months, respectively. According to SII (low vs. high), patients with low-SII had longer OS (55.7 vs. 22.2 months, P < .001), better PFS (20.8 vs. 8.5 months, P < .001), and higher overall response rate (52 vs. 37%, P = .033). CONCLUSION: A high SII is associated with poor oncological outcomes in patients with mRCC. SII could be an easily accessible prognostic indicator for use in clinical practice.

Impact of COVID-19 on Management and Outcomes of Oncology Patients: Results of MENA COVID-19 and Cancer Registry (MCCR).

Introduction: Despite extensive studies of the impact of COVID-19 on patients with cancer, there is a dearth of information from the Middle East and North Africa (MENA) region. Our study aimed to report pertinent MENA 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 specifically from 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. Logistic regression was used to assess associations with mortality. Results: Between November 29, 2020, and June 8, 2021, data were captured on 2008 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 and 50.5% had metastatic disease. Delays of planned treatment (>14 days) occurred in 80.3% for surgery, 48.8% for radiation therapy, and 32.9% for systemic therapy. Significant reduction in the delays of all three treatment modalities 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-day mortality increased from 33.4% to 42.9% before and after that date (p = 0.015). Multivariable regression analysis showed the following predictors of higher 30- and 90-day mortality: age older than 70 years, having metastatic disease, disease progression, and being off chemotherapy. Conclusion: Patients with cancer in the 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 may be attributed to other risk factors such as disease progression or new patients who presented with more advanced disease.

Real-world Outcome of Patients with Advanced Renal Cell Carcinoma and Intermediate- or Poor-risk International Metastatic Renal Cell Carcinoma Database Consortium Criteria Treated by Immune-oncology Combinations: Differential Effectiveness by Risk Group?

BACKGROUND: Renal c carcinoma (RCC) is one of the most common urinary cancers worldwide, with a predicted increase in incidence in the coming years. Immunotherapy, as a single agent, in doublets, or in combination with anti-vascular endothelial growth factor receptor tyrosine kinase inhibitors (TKIs), has rapidly become a cornerstone of the RCC therapeutic scenario, but no head-to-head comparisons have been made. In this setting, real-world evidence emerges as a cornerstone to guide clinical decisions. OBJECTIVE: The objective of this retrospective study was to assess the outcome of patients treated with first-line immune combinations or immune oncology (IO)-TKIs for advanced RCC. DESIGN, SETTING, AND PARTICIPANTS: Data from 930 patients, 654 intermediate risk and 276 poor risk, were collected retrospectively from 58 centers in 20 countries. Special data such as sarcomatoid differentiation, body mass index, prior nephrectomy, and metastatic localization, in addition to biochemical data such as hemoglobin, platelets, calcium, lactate dehydrogenase, neutrophils, and radiological response by investigator's criteria, were collected. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Overall survival (OS) and progression-free survival (PFS) were estimated using the Kaplan-Meier method. The median follow-up was calculated by the inverse Kaplan-Meier method. RESULTS AND LIMITATIONS: The median follow-up time was 18.7 mo. In the 654 intermediate-risk patients, the median OS and PFS were significantly longer in patients with the intermediate than in those with the poor International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) criteria (38.9 vs 17.3 mo, 95% confidence interval [CI] p < 0.001, and 17.3 vs 11.6 mo, 95% CI p < 0.001, respectively). In the intermediate-risk subgroup, the OS was 55.7 mo (95% CI 31.4-55.7) and 40.2 mo (95% CI 29.6-51.6) in patients treated with IO + TKI and IO + IO combinations, respectively (p = 0.047). PFS was 30.7 mo (95% CI 16.5-55.7) and 13.2 mo (95% CI 29.6-51.6) in intermediate-risk patients treated with IO + TKI and IO + IO combinations, respectively (p < 0.001). In the poor-risk subgroup, the median OS and PFS did not show a statistically significant difference between IO + IO and IO + TKI. Our study presents several limitations, mainly due to its retrospective nature. CONCLUSIONS: Our results showed differences between the IO + TKI and IO + IO combinations in intermediate-risk patients. A clear association with longer PFS and OS in favor of patients who received the IO + TKI combinations compared with the IO-IO combination was observed. Instead, in the poor-risk group, we observed no significant difference in PFS or OS between patients who received different combinations. PATIENT SUMMARY: Renal cancer is one of the most frequent genitourinary tumors. Treatment is currently based on immunotherapy combinations or immunotherapy with tyrosine kinase inhibitors, but there are no comparisons between these.In this study, we have analyzed the clinical course of 930 patients from 58 centers in 20 countries around the world. We aimed to analyze the differences between the two main treatment strategies, combination of two immunotherapies versus immunotherapy + antiangiogenic therapy, and found in real-life data that intermediate-risk patients (approximately 60% of patients with metastatic renal cancer) seem to benefit more from the combination of immunotherapy + antiangiogenic therapy than from double immunotherapy. No such differences were found in poor-risk patients. This may have important implications in daily practice decision-making for these patients.

Efficacy of temsirolimus in metastatic chromophobe renal cell carcinoma.

BACKGROUND: Renal cell carcinoma (RCC) is a histopathologically and molecularly heterogeneous disease with the chromophobe subtype (chRCC) accounting for approximately 5% of all cases. The median overall survival of advanced RCC has improved significantly since the advent of tyrosine kinase inhibitors and mammalian target of rapamycin (mTOR) inhibitors. However, high-quality evidence for the use of new generation tyrosine kinase inhibitors in patients with advanced chRCC is lacking. Few published case reports have highlighted the use of temsirolimus in chRCC. CASE PRESENTATION: Here, we report the case of a 36-year-old Caucasian woman with metastatic chRCC with predominantly skeletal metastases who was refractory to sunitinib who demonstrated a durable clinical response to temsirolimus lasting 20 months. We review the available evidence pertaining to the use of new generation molecularly targeted agents, in particular mTOR inhibitors in chRCC and discuss their emerging role in the management of this disease which would aid the oncologists faced with the challenge of treating this rare type of RCC. CONCLUSION: Conducting randomised clinical trials in this rarer sub-group of patients would be challenging and our case report and the evidence reviewed would guide the physicians to make informed decision regarding the management of these patients.

Unilateral Axillary Lymphadenopathy in Cancer Patients Post-COVID-19 Vaccination: Review and Case Series.

Novel coronavirus-19 (COVID-19) variants continue to spread worldwide with the development of highly transmissible strains. Several guidelines addressing management of cancer patients during the COVID-19 pandemic have been published, primarily based upon expert opinion. The COVID-19 pandemic has affected all aspects of breast cancer care including screening, diagnosis, treatment, and long-term follow-up. Recent reports indicate that mRNA COVID-19 vaccines can provoke lymphadenopathy in both cancer patients and healthy individuals. Unilateral axillary lymphadenopathy (UAL) post-COVID-19 vaccination is a challenging presentation for cancer patients because of the potential for misinterpretation as malignancy. The World Health Organization's target to vaccinate 70% of the world's population by mid-2023 is likely to increase the incidence of post-COVID-19 vaccination UAL. In this article, we review the published evidence regarding UAL post-COVID-19 vaccination and present diverse cases of breast cancer patients where false-positive UAL post-COVID-19 vaccination proved to be a therapeutic challenge. The United Arab Emirates (UAE) vaccination program is well ahead of other countries in the world, having accomplished the target of 100% vaccination of the population with at least one dose. Therefore, an increasing number of recently vaccinated patients are likely to present with UAL, detected by surveillance imaging, post-vaccination. We have therefore made recommendations regarding the management of cancer patients with UAL post-COVID-19 vaccination in order to avoid misdiagnosis and unnecessary imaging or invasive biopsy procedures.

Bone targeting agents, but not radiation therapy, improves survival in patients with bone metastases from advanced urothelial carcinoma receiving pembrolizumab: results from the ARON-2 study.

The ARON-2 study (NCT05290038) aimed to assess the real-world efficacy of pembrolizumab in patients recurred or progressed after platinum-based chemotherapy. This retrospective analysis reports the outcomes of urothelial carcinoma (UC) patients with bone metastases (BM). Medical records of patients with documented metastatic UC treated by pembrolizumab as second-line therapy were reviewed from60 institutions in 20 countries. Patients were assessed for Overall Response Rate (ORR), Progression-Free Survival (PFS), and Overall Survival (OS). Univariate and multivariate analyses were used to explore the association of variables of interest with OS and PFS. 881 patients were included; of them, 263 (30%) presented BM. Median follow-up time was 22.7 months. Patients with BM showed both shorter median OS (5.9 months vs 13.1 months, p < 0.001) and PFS (3.5 months, vs 7.3 months, p < 0.001) compared to patients without BM. Patients who received bone targeted agents (BTAs) showed a significantly longer median OS (8.5 months vs 4.6 months, p = 0.003) and PFS (6.1 months vs 3.2 months, p = 0.003), while no survival benefits were observed among patients who received radiation therapy for BM during pembrolizumab treatment compared to those who did not. In multivariate analysis, performance status, concomitant liver metastases, and the lack of use of BTAs were significantly associated with worse OS and PFS. Bone involvement in UC patients treated with pembrolizumab predicts inferior survival. Poor performance status and liver metastases may further worsen outcomes, while the use of BTAs is associated with improved outcomes.

Geographical differences in the management of metastatic de novo renal cell carcinoma in the era of immune-combinations.

BACKGROUND: The upfront treatment of metastatic renal cell carcinoma (mRCC) has been revolutionized by the introduction of immune-based combinations. The role of cytoreductive nephrectomy (CN) in these patients is still debated. The ARON-1 study (NCT05287464) was designed to globally analyze real-world data of mRCC patients receiving first-line immuno-oncology combinations. This sub-analysis is focused on the role of upfront or delayed partial or radical CN in three geographical areas (Western Europe, Eastern Europe, America/Asia). METHODS: We conducted a multicenter retrospective observational study in mRCC patients treated with first-line immune combinations from 55 centers in 19 countries. From 1152 patients in the ARON-1 dataset, we selected 651 patients with de novo mRCC. 255 patients (39%) had undergone CN, partial in 14% and radical in 86% of cases; 396 patients (61%) received first-line immune-combinations without previous nephrectomy. RESULTS: Median overall survival (OS) from the diagnosis of de novo mRCC was 41.6 months and not reached (NR) in the CN subgroup and 24.0 months in the no CN subgroup, respectively (P<0.001). Median OS from the start of first-line therapy was NR in patients who underwent CN and 22.4 months in the no CN subgroup (P<0.001). Patients who underwent CN reported longer OS compared to no CN in all the three geographical areas. CONCLUSIONS: No significant differences in terms of patients' outcome seem to clearly emerge, even if the rate CN and the choice of the type of first-line immune-based combination varies across the different Cancer Centers participating in the ARON-1 project.

Global Real-World Outcomes of Patients Receiving Immuno-Oncology Combinations for Advanced Renal Cell Carcinoma: The ARON-1 Study.

BACKGROUND: Immuno-oncology combinations have achieved survival benefits in patients with metastatic renal cell carcinoma (mRCC). OBJECTIVE: The ARON-1 study (NCT05287464) was designed to globally collect real-world data on the use of immuno-combinations as first-line therapy for mRCC patients. PATIENTS AND METHODS: Patients aged ≥ 18 years with a cytologically and/or histologically confirmed diagnosis of mRCC treated with first-line immuno-combination therapies were retrospectively included from 47 International Institutions from 16 countries. Patients were assessed for overall survival (OS), progression-free survival (PFS), and overall clinical benefit (OCB). RESULTS: A total of 729 patients were included; tumor histology was clear-cell RCC in 86% of cases; 313 patients received dual immuno-oncology (IO + IO) therapy while 416 were treated with IO-tyrosine kinase inhibitor (IO + TKI) combinations. In the overall study population, the median OS and PFS were 36.5 and 15.0 months, respectively. The median OS was longer with IO+TKI compared with IO+IO therapy in the 616 patients with intermediate/poor International mRCC Database Consortium (IMDC) risk criteria (55.7 vs 29.7 months; p = 0.045). OCB was 84% for IO+TKI and 72% for IO + IO combination (p < 0.001). CONCLUSIONS: Our study may suggest that immuno-oncology combinations are effective as first-line therapy in the mRCC real-world context, showing outcome differences between IO + IO and IO + TKI combinations in mRCC subpopulations. CLINICAL TRIAL REGISTRATION: NCT05287464.

Clinico-Pathological Features Influencing the Prognostic Role of Body Mass Index in Patients With Advanced Renal Cell Carcinoma Treated by Immuno-Oncology Combinations (ARON-1).

BACKGROUND: Obesity has been associated with improved response to immunotherapy in cancer patients. We investigated the role of body mass index (BMI) in patients from the ARON-1 study (NCT05287464) treated by dual immuno-oncology agents (IO+IO) or a combination of immuno-oncology drug and a tyrosine kinase inhibitors (TKI) as first-line therapy for metastatic renal cell carcinoma (mRCC). PATIENTS AND METHODS: Medical records of patients with documented mRCC treated by immuno-oncology combinations were reviewed at 47 institutions from 16 countries. Patients were assessed for overall survival (OS), progression-free survival (OS), and overall clinical benefit (OCB), defined as the sum of the rate of partial/complete responses and stable disease. Univariate and multivariate analyses were used to explore the association of variables of interest with survival. RESULTS: A total of 675 patients were included; BMI was >25 kg/m2 in 345 patients (51%) and was associated with improved OS (55.7 vs. 28.4 months, P < .001). The OCB of patients with BMI >25 kg/m2 versus those with BMI ≤25 kg/m2 was significantly higher only in patients with nonclear cell histology (81% vs. 65%, P = .011), and patients with liver metastases (76% vs. 58%, P = .007), Neutrophil to lymphocyte ratio >4 (77% vs 62%, P = .022) or treated by nivolumab plus ipilimumab (77% vs. 64%, P = .044). In the BMI ≤25 kg/m2 subgroup, significant differences were found between patients with NLR >4 versus ≤4 (62% vs. 82%, P = .002) and patients treated by IO+IO versus IO+TKIs combinations (64% vs. 83%, P = .002). CONCLUSION: Our study suggests that the prognostic significance and the association of BMI with treatment outcome varies across clinico-pathological mRCC subgroups.

Management of metastatic castration-resistant prostate cancer in Middle East African countries: Challenges and strategic recommendations.

Despite the reliance on Western guidelines for managing prostate cancer (PC), there are wide variations and gaps in treatment among developing countries such as the Middle East African (MEA) region. A multidisciplinary team of experts from the MEA region engaged in a comprehensive discussion to identify the real-world challenges in diagnostics and treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC) and provided insights on the urgent unmet needs. We present a consensus document on the region-specific barriers, key priority areas and strategic recommendations by experts for optimizing management of mCRPC in the MEA. Limited access to genetic testing and economic constraints were highlighted as major concerns in the MEA. As the therapeutic landscape continues to expand, treatment selection for mCRPC needs to be increasingly personalized. Enhanced genetic testing and judicious utilization of newer therapies like olaparib, articulated by reimbursement support, should be made accessible for the underserved populations in the MEA. Increasing awareness on testing through educational activities catalyzed by digital technologies can play a central role in overcoming barriers to patient care in the MEA region. The involvement of multidisciplinary teams can bridge the treatment gaps, facilitating holistic and optimal management of mCRPC. Region-specific guidelines can help health-care workers navigate challenges and deliver personalized management through collaborative efforts - thus curb health-care variations and drive consistency. Development of region-specific scalable guidelines for genetic testing and treatment of mCRPC, factoring in the trade-off for access, availability, and affordability, is crucial.

Prevalence and Risk Factors of Burnout Among Female Oncologists From the Middle East and North Africa.

Background: Burnout (BO) is a recognized challenge among the oncology workforce. It affects both genders with a higher frequency among women. This study examined the factors contributing to the development of burnout among female oncologists from the Middle East and North Africa (MENA). Methods: An online cross-sectional survey was distributed to oncology professionals from different countries in the MENA region. The validated Maslach Burnout Inventory (MBI) of emotional exhaustion (EE), Depersonalization (DE), and Personal Achievement (PA) plus questions about demography/work-related factors and attitudes toward oncology were included. Data were analyzed to measure BO prevalence and related factors. Results: Between 10 February and 15 March 2020, 545 responses were submitted by female oncologists. The responses pre-dated the COVID-19 pandemic emergence in the region. BO prevalence was 71% among female professionals. Women aged <44 years represented 85% of the cohort. Sixty-two percent were married, 52% with children and one-third practiced a hobby. Two-thirds worked in medical oncology, worked for <10 years and 35% worked in academia. The majority (73%) spent >25% on administrative work daily. Nearly half of the respondents (49%) expressed a recurring thought of quitting oncology and 70% had no burnout support or education. Inability to deliver optimal care was reported as distressing for career development in 82%. Factors significantly influencing the BO risk were identified. Marital status, having children, academia and years in practice did not impact the risk of BO among female oncologists from MENA. Conclusion: Female oncologists from the Middle East and North Africa (MENA) were found to have a high prevalence of BO. In this cohort, the majority of women oncology workers were young and in their early to mid-career stages. Burnout was linked to being younger, practicing in North African nations, having a heavy administrative load, and having persistent thoughts of quitting. Practicing a hobby and engaging in oncology communication, on the other hand, reduced the chance of BO. Burnout support and education, specifically for oncology women, is required.