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Prostate cancer (PC) is the second most prevalent cancer in males, with a steadily increasing incidence in the Middle East (ME). The aim of this study was to capture real-world data on the characteristics, disease progression, and treatment patterns among PC patients in the ME. This was a retrospective, observational, multi-centre study conducted across ten hospitals/research centers in Lebanon, Kingdom of Saudi Arabia, Iraq and Kuwait. Data were abstracted from medical records of 615 male patients who were diagnosed with PC between January 2012 and the site initiation date (December 2018-May 2019) and received at least one PC treatment/intervention. The observation period ranged between 84 and 88 months. Data were collected on demographics, clinical characteristics, time to progression to the subsequent clinical state or therapy (progression from localised/ locally advanced PC to castration and to metastatic PC (metastatic castration-sensitive PC (mCSPC) or metastatic castration-resistant PC (mCRPC)), progression from mCSPC to mCRPC, and mCRPC patients' progression to first subsequent line of therapy), treatment patterns, and mortality. Most patients had localised/locally advanced PC (57.7%), followed by mCSPC (37.4%), and mCRPC (4.1%) at the time of inclusion in the study. Most patients were at tumours, nodes and metastases (TNM) stage IIIa (40.1%) or TNM stage IVb (27.8%) at study entry. Median time to metastatic disease, castration-resistance and next line therapy was 84 months (95% CI: 68--84), 41 months (95% CI: 30-56) and 7 months (95% CI: 0-41), respectively. The mortality rate was 3.6%. Disease progression was most common among patients with mCSPC (35.1%) or mCRPC (14.8%), and treatment discontinuation was most common among patients with mCRPC (36.6% treatments discontinued). The results show that most patients were at an advanced TNM stage at study entry, suggestive of a lack of awareness regarding PC. Disease progression was most common among patients with metastatic disease, reflecting the challenge of treating metastatic disease and highlighting the need for novel treatments. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Abstract Background Micropapillary bladder cancer is a rare and aggressive variant of urothelial carcinoma. A retrospective review of our experience in management of patients with muscle-invasive or metastatic micropapillary bladder cancer was performed to better define the behavior of this disease. Methods We reviewed the records of the 11 patients with micropapillary bladder cancer who were evaluated and treated at Léon Bérard Cancer Center between 1994 and 2007, accounting for 1,2% of all urothelial tumors treated in this institution. Results Mean patients age was 60 years. The majority of patients (72%) were diagnosed after 2004. After a median follow-up of 31.7 months, median overall survival was 19 months. Two patients presented with stage II, one with stage III and eight with stage IV disease All 5 patients who had node positive metastases and treated with radical surgery and adjuvant chemotherapy relapsed and had a disease free survival of 9.6 months. Conclusion Micropapillary bladder cancer is probably an underreported variant of urothelial carcinoma associated with poor prognosis. Adjuvant chemotherapy might have a questionable efficacy and the optimal treatment strategy is yet to be defined.

PURPOSE: Sunitinib offers improved efficacy for patients with metastatic renal cell carcinoma (mRCC). To provide better disease management in the Middle East, we studied its use in mRCC in real-life practice in this region. MATERIAL AND METHODS: Patients diagnosed with mRCC and started on sunitinib between 2006 and 2016 from 10 centers in Africa and the Middle East region were studied in this regional, multicenter, observational, retrospective trial to obtain routine clinical practice data on the usage patterns and outcomes of sunitinib in mRCC in real-life practice. RESULTS: A total of 289 patients were enrolled. Median age at diagnosis was 58.7 years. The patient characteristics were as follows: 73.6% of patients were males; 85.8% had clear-cell renal cell carcinoma (RCC); 97.5% had unilateral RCC; 66.3% had metastatic disease at initial diagnosis; 56.3% received previous treatment for RCC, among which 98.7% had undergone surgery; and 15.2% and 31.4% were classified in the favorable and poor-risk groups (expanded Memorial Sloan Kettering Cancer Center criteria), respectively. On treatment initiation, the mean total sunitinib dose was 48.1 mg, and 87.6% of patients were started on a sunitinib dose of 50 mg. The mean duration of sunitinib treatment was 9.6 months. Overall response rate was 20.8%, with a median duration of 8.2 months. Median time to progression was 5.7 months. Median follow-up time was 7.8 months. By months 12 and 24, 34.3% and 11.4% of patients, respectively, were still alive. Seventy-six patients (60.9%) experienced 314 adverse events. Twenty-three patients (8.0%) experienced 28 serious adverse events. Overall, 83 patients (28.7%) discontinued their sunitinib treatment. CONCLUSION: The results are indicative of the general treatment outcomes of patients with mRCC in the Middle East using sunitinib in routine clinical practice. Reported adverse events are similar to those described in the literature but at lower frequencies. [ABSTRACT FROM AUTHOR]

Objectives: To obtain routine clinical practice data on cabazitaxel usage patterns for patients with metastatic castration‐resistant prostate cancer (mCRPC) and to describe physician‐assessed cabazitaxel effectiveness, health‐related quality of life (HRQoL) and safety. Patients and Methods: CAPRISTANA was an international, observational cohort study examining cabazitaxel use for the treatment of patients with mCRPC. Effectiveness was assessed by overall survival (OS), progression‐free survival (PFS), time to treatment failure (TTF) and disease control rate. HRQoL was assessed using the Functional Assessment of Cancer Therapy‐Prostate questionnaire (FACT‐P) and the three‐level European Quality of Life questionnaire (EQ‐5D‐3L). Safety was assessed by adverse event (AE) reporting. Results: A total of 189 patients were treated across 54 centres between April 2012 and June 2016. At baseline, 58.7% had ≥1 comorbidity, 93.7% had an Eastern Cooperative Oncology Group performance status ≤1, and 60.1% had a Gleason score at diagnosis of ≥8. Patients received a median of 6 cabazitaxel cycles; 84.7% received cabazitaxel as second‐line therapy. The median OS, PFS and TTF were 13.2, 5.6 and 4.4 months, respectively. Cabazitaxel led to disease control in 52.9% of patients. HRQoL was maintained (40.3%) or improved (32.2%) in 72.5% of patients based on total FACT‐P scores. Interestingly, 53.6% of patients reported pain improvement and a further 21.2% maintained pain control based on FACT‐P prostate cancer‐specific pain scores. The most common treatment‐related grade ≥3 AEs were neutropenia (7.9%) and anaemia (2.1%). Conclusion: Patients in CAPRISTANA treated with cabazitaxel had similar disease outcomes and safety profiles compared with large phase III clinical trials. Most patients had maintained or improved HRQoL scores; >70% of patients had maintained or improved pain control. [ABSTRACT FROM AUTHOR]

Background: Colorectal cancer (CRC) is a highly prevalent major health problem constituting 10% of all diagnosed cancers and 9% of all cancer deaths. Systemic chemotherapy for colorectal cancer is recommended as a post-operative adjuvant therapy for patients with early stages of the disease and as 1st line metastatic chemotherapy for those with advanced stage. The traditional regimen in the past decades included 5FU/ LV. However, addition of Oxaliplatin to the 5-FU/LV regimen improved the clinical outcome in early and advanced stages of colorectal cancer. This study was conducted to assess the therapeutic management of Oxaliplatin/ 5-FU based regimen in both adjuvant and first line metastatic therapy in non-selected patients from Jordan and Lebanon with early and advanced stages of colorectal cancers. Methods: This was a multi-center, prospective, observational study that included patients with any stage of colorectal cancer whose physicians decided to treat with Oxaliplatin/ 5-FU based regimens as adjuvant or first line metastatic chemotherapy. All statistical tests were two-sided with a 5% significance level. Data was analyzed using SPSS (version 17). Adverse events were coded using MedDRA (version 18.0). Results: 563 patients were included in the trial and 513 were eligible for analysis. The demographics of the patients and the charac- teristics of the tumors were comparable between the adjuvant and metastatic chemotherapy groups. The median age of the patients was 61.9 years, 57.3% were male and only 2.8% had an ECOG ≥2. 98.4% of the tumors were adenocarcinoma and around 70% were moderately differentiated. 55% of the patients were treated with Oxaliplatin/ oral 5-FU regimen and 45% with Oxaliplatin/ 5-FU; no significant difference was found between the adjuvant and metastatic chemotherapy groups regarding the used regimens. The median number of treatment cycles administered by patients in the adjuvant chemotherapy group (9 cycles) was significantly higher (p=0.02) than that of the metastatic chemotherapy group (8 cycles), without affecting the median treatment duration that was around 5 months in both groups. The median dose intensities of Oxaliplatin and 5-FU in the adjuvant chemotherapy group were significantly higher than those in the metastatic group (p= 0.004 and p=0.001 respectively). 77.9% and 13.4% of patients receiving adjuvant chemotherapy presented respectively an adverse event or a serious adverse event in the adjuvant setting, while 74.7% and 29.6% in the metastatic setting. The incidence rate of serious adverse events was significantly higher among the metastatic group compared to the adjuvant group (x% vs. y%, p<0.001). The most frequently reported non-serious events were peripheral sensory neuropathy (50.3%), nausea (23.1%), diarrhea (20.6%), anemia (17.1%), vomiting (15.8%), thrombo- cytopenia (13.3%) and neutropenia (9.6%). The most frequently reported serious events (other than disease relapse/ recurrence/ pro- gression) were diarrhea (2.0%), vomiting (1.4%) abdominal pain (1.2%) and anemia (0.9%). Eight deaths were considered to be probably related to the chemotherapy treatment. Conclusions This trial revealed that oxaliplatin is administered at lower dose-intenstity and in fewer cycles in our studied population in Lebanon and Jordan. The incidence of peripheral neuropathy and other adverse events are lower in our population compared to those report- ed in the literature. Further prospective trials with long-term follow-up seem necessary to evaluate the impact of this clinical practice on the outcomes of the adjuvant and metastatic colorectal cancers. [ABSTRACT FROM AUTHOR]

Background: The epidemiology of gastric cancer in the Middle East has never been described. Therefore, the characteristics of gastric cancer in the Lebanese population will be reported in this study.Patients and Methods: A retrospective study that included all patients diagnosed with gastric cancer at Hotel Dieu de France University Hospital in Beirut, Lebanon between 2010 and 2016 was conducted. All eligible patients were reviewed for demographic and epidemiologic analysis.Results: The study included 123 patients diagnosed with gastric cancer. The median age at diagnosis was 59 years (range 15–72 years), and the median ECOG performance status was 2 (range 1–4). Most patients were metastatic at diagnosis (52.8%), and diffuse pathology type was predominant (39%). HER2 was positive in 16.2% and correlated with the occurrence of hepatic metastasis (p = 0.048). The HER2 status did not differ significantly between the histological subtypes, the site of the tumor, the stage of the gastric cancer at diagnosis, and the recurrence of cancer (p > 0.05).Conclusion: Gastric cancer in the Lebanese population is characterized by aggressive features such as advanced stage at diagnosis, high prevalence of diffuse type histology, and HER2 positivity. [ABSTRACT FROM AUTHOR]