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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]

Lung cancer is the leading cause of cancer mortality worldwide. The 5-year survival rate of patients is ~15%, since the majority of patients present with the disease at an advanced stage. The resulting burden from this disease entails solid efforts towards early detection and smoking cessation. In Lebanon, the triad of high incidence and mortality from lung cancer, extensive tobacco consumption and delayed diagnosis calls for urgent actions. Furthermore, lung cancer screening with a low-dose computed tomography (CT) scan allows for the early detection and reduces mortality rates, as documented in several randomized trials and meta-analyses and recommended by international relevant societies. A panel of Lebanese lung cancer experts, members of the Lebanese Society of Medical Oncology and the Lebanese Pulmonary Society, have convened and discussed all aspects and challenges related to lung cancer screening implementation in Lebanon. Accordingly, national guidelines were proposed in this joint statement, which defines the particular high-risk population that would most benefit from screening. Pillars to success involve a solid, evidence-based national program, efficient smoking cessation programs and proper referral and follow-up. In parallel, the quality and logistical basic requirements must be optimized with well-equipped centers, trained personnel and expert radiologists; in addition to promoting awareness, adherence and sustainability. Physicians need to be trained to ensure accurate risk stratification for the screening and proper referrals from different specialties. Awareness should also be raised in the general population on the safety and benefits of low-dose CT, and to encourage smoking cessation via dedicated programs. In a country where the economic situation is challenging, and where third-party payers are resistant to cover screening initiatives, support from the Lebanese Ministry of Public Health is warranted, along with a cost-effectiveness analysis to uncover the elevated cost of treating advanced stage lung cancer. [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.

Introduction. Advances in genomic techniques have been valuable in guiding decisions regarding the treatment of early breast cancer (EBC) patients. These multigene assays include Oncotype DX, Prosigna, and Endopredict. There has generally been a tendency to overtreat or undertreat patients, and having reliable prognostic factors could significantly improve rates of appropriate treatment administration. In this study, we showcase the impact of genomic tests on adjuvant treatment decisions in EBC patients. Materials and Methods. This is a retrospective study that includes EBC patients treated between December 2016 and February 2018. The physician's choice of treatment was recorded before and after obtaining the results of the genomics tests. Baseline demographics and pathological data were collected from medical records. Results. A total of 75 patients were included. Fifty patients underwent Oncotype DX genomic analysis, 11 patients underwent Prosigna analysis, and 14 patients underwent Endopredict analysis. A total of 21 physicians' plans (28%) were initially undecided and then carried out after obtaining genomic test results. 13 patients were planned to undergo endocrine therapy alone, while 8 were planned to undergo both endocrine therapy and chemotherapy. Treatment was changed in 26 patients (34.67%). The decision to deescalate therapy was taken in 19 patients (25.33%). The decision to escalate treatment was made in 7 patients (9.33%). Conclusion. Our study demonstrates the importance of genomics testing, as it assisted physicians in avoiding unnecessary adjuvant chemotherapy in 25.33% of patients, thus reducing side effects of chemotherapy and the financial burden on patients. [ABSTRACT FROM AUTHOR]

Multiple randomized studies have shown that combination of chemotherapy and immune checkpoint inhibitors (ICIs) leads to better response rates and survival as compared to chemotherapy alone in the advanced stage of NSCLC. Data suggesting a benefit to using ICIs in the neoadjuvant therapy of patients with early stage NSCLC are emerging. Eligible subjects were treatment naïve patients with stage IB, II, and resectable IIIA NSCLC. Patients received three cycles of neoadjuvant chemotherapy with four doses of avelumab every 2 weeks. Patients with squamous cell cancer received cisplatin or carboplatin on day 1 and gemcitabine on days 1 and 8 of each cycle of chemotherapy. Patients with nonsquamous histology received cisplatin or carboplatin with pemetrexed on day 1 of each cycle. Patients then proceeded to their planned surgery. Out of 15 patients accrued as part of stage 1 of the study, four had a radiologic response (1 complete response), lower than the minimum of six responses needed to continue to phase 2 of the study. The study was therefore terminated. Majority had adenocarcinoma histology and stage IIIA disease. The treatment was well tolerated with no unexpected side effects. Four patients (26.7%) had grade III/IV CTCAE toxicity. This study confirms that the preoperative administration of chemotherapy and avelumab is safe. There was no indication of increased surgical complications. The benefit of adding immunotherapy to chemotherapy did not appear to enhance the overall response rate of patients in the neoadjuvant setting in patients with resectable NSCLC because this study failed to meet its primary endpoint. [ABSTRACT FROM AUTHOR]

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]

Aim: The literature lacks direct evidence comparing the different regimens evaluated in the second-line treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).Methods: We conducted a network meta-analysis (NMA) of the randomized controlled Phase III trials reporting on the second-line drug treatment options in R/M SCCHN.Results: The eligible trials included 11 regimens among which six targeted therapies, two immune checkpoint inhibitors and three chemotherapy regimens. Only nivolumab has shown statistically significant superiority over methotrexate in terms of overall survival (HR: 0.64; 95% CI: 0.43-0.96) and objective response rate (OR: 2.51; 95% CI: 1.07-5.86).Conclusion: Based on the efficacy and safety outcomes of this network meta-analysis, nivolumab seems the most favorable regimen inthe management of R/M SCCHN. [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 evaluation of chronic kidney disease (CKD) in cancer patients seems to rely mostly on the Cockcroft‐Gault (CG) formula or the creatinine levels to adjust treatment dosages which is a practice refuted by internists. Aims: We evaluate the overall agreement of the CG, modification of diet in renal disease (MDRD) and CKD–epidemiology collaboration equations (CKD‐EPI) equation with the newly devised Janowitz and Williams' (JW) equation. Methods: The renal function was estimated in 235 cancer patients according to the CG, MDRD, body surface area (BSA)‐adjusted MDRD, CKD‐EPI, BSA‐adjusted CKD‐EPI and JW formulae. Results: JW equation was more in agreement with CG and CKD‐EPI estimations than the other equations. Taking JW equation as reference, receiver operating characteristic curve analysis showed that CG eGFR had the higher area under the curve when compared with other equations. Hierarchical cluster analysis showed more proximity between CG and JW equations than the other equations. Conclusion: The newly proposed JW eGFR estimation was more in agreement with CG equation than the other equations. [ABSTRACT FROM AUTHOR]

Introduction: Breast cancer is the second leading cause of cancer-related mortality despite the staggering improvement in cancer therapeutics. So far, published data illustrate endocrine therapy as the cornerstone treatment for patients with hormone receptor-positive metastatic breast cancer. Unfortunately, most patients eventually develop resistance to this treatment.Methods: The purpose of this study is to evaluate the efficacy of mammalian target of rapamycin inhibition in reversing hormone resistance in the Lebanese breast cancer patients. Efficacy of the intervention according to the independent factors and notable side effects encountered were the primary points of the evaluation.Results: In total, fifty patients received the combination of everolimus and exemestane. The mean age of the study population was 61 ± 11 years. Sensitivity to hormonal therapy before the start of the combination treatment was estimated at 64%. Response rate was 14%, and all patients were partial responders. After regular interval evaluation, the median progression-free survival was 5.2 months since the initiation of therapy. The main toxicities associated with the combination were stomatitis (22%), myalgia (22%), skin toxicity (8%), and hyperglycemia (4%), all Grades 1 and 2.Conclusion: Everolimus has been shown to be effective in overcoming hormonal resistance in Lebanese breast cancer patients with results inferior to those reported in the BOLERO-2 population. The particular differences in molecular and pathological aspects of breast cancer in our region should stimulate the extensive research for a better understanding of the particular pattern of the disease. [ABSTRACT FROM AUTHOR]

Background: The present study reports on the efficacy and safety of adjuvant docetaxel in real-life patients with early-stage breast cancer. Methods: This is a prospective, multicenter, post-marketing study that evaluates the efficacy and safety of docetaxel-based regimens in patients with early breast cancer treated between 2007 and 2012. Results: A total of 698 female breast cancer patients receiving adjuvant docetaxel-based regimens were included in this study. Docetaxel monotherapy was administered in 4.2%, whilst most patients received polychemotherapy. Non-hematological adverse events included skin reactions in 32.7% of the subjects. Multiple adverse events were reported and most commonly included asthenia (66.5%), alopecia (43.4%), and diarrhea (24.2%). It is noteworthy that no fatal toxicities occurred. Several hematological adverse events were reported during treatment, with anemia being the most common. Conclusion: The results of this real-life experience, characterized by a relatively large sample size and long follow-up, confirm that docetaxel is effective and well tolerated in early-stage breast cancer patients. [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]

Background: Taxanes are drugs used in various chemotherapeutical protocols to treat solid tumors. They have multiple systemic adverse effects, such as bone marrow suppression, alopecia, nausea, and vomiting, and may rarely cause ocular symptoms. In the past decade, a few reported cases have shown the occurrence of a cystoid macular edema with significant visual loss after the use of a taxane-based chemotherapy. The aim of this study was to compare the central macular thickness (CMT) before and after the initiation of a taxane-based therapy in visually asymptomatic patients and to elucidate the possible impact of these drugs on the vision of cancer patients. Methods: Patients with a confirmed diagnosis of a solid tumor were screened for any ophthalmic disease before inclusion and had a baseline macular spectral domain optical coherence tomography (OCT; RTVue-100; Optovue Inc., Fremont, CA, USA) before the initiation of a taxane-based chemotherapy according to different protocols, such as 4EC-4T, 3FEC/3T, or 4TC. OCT was repeated after 4 cycles (or 3 months) of treatment, and CMT was compared to baseline. Patients presenting diabetic retinopathy, age-related macular degeneration or any condition that causes macular edema confirmed by ophthalmic examination were excluded. Results: Fifty eyes of 25 patients were included; 92% of the subjects were female with a mean age of 48.52 years, 88% were diagnosed with breast cancer, 8% with esophageal cancer, and 4% with ovarian cancer. Docetaxel was the taxane administered to 92% of the patients. The received dose of docetaxel ranged between 110 and 160 mg. The other patients had paclitaxel in their protocols. No significant macular edema or drop in visual acuity were noted in any patient. Nevertheless, the mean CMT was found to be increased, particularly in the parafoveal and perifoveal areas (mean difference of +2.22 µm; p = 0.001). Conclusion: Taxane-based chemotherapy regimens seem to increase macular thickness, with a relative sparing of the fovea, in patients without significant macular edema. Further research is required to better explain the pathophysiology and possible impact of this phenomenon. [ABSTRACT FROM AUTHOR]

Evaluation of bone marrow involvement (BMI) is paramount in diffuse large B-cell lymphoma (DLBCL) for prognostic and therapeutic reasons. PET/CT scanner (PET) is now a routine examination for the staging of DLBCL with prognostic and therapeutic implications. This study evaluates the role of PET for detecting marrow involvement compared to bone marrow biopsy (BMB). This monocentric study included 54 patients diagnosed with DLBCL between 2009 and 2013 and who had FDG PET/CT in a pre-treatment setting. A correlation analysis of the detection of BMI by PET and BMB was performed. A prognostic evaluation of BMI by BMB and/or PET/CT and correlation with an overall 2-year survival were analyzed. PET was more sensitive for the detection of BMI than BMB (92.3% vs. 38.5%). It can be considered a discriminatory Pre-BMB test with a negative predictive value of 97.6%. In addition, BMI by PET had a prognostic value with strong correlation with progression-free survival (PFS) (HR = 3.81; p = 0.013) and overall survival (OS) (HR = 4.12; p = 0.03) while the BMB had not. PET shows superior performance to the BMB for the detection of marrow involvement in DLBCL. It may be considered as the first line examination of bone marrow instead of the biopsy. [ABSTRACT FROM AUTHOR]

Proper management of stage III non-small cell lung cancer (NSCLC) might result in a cure or patient long-term survival. Management should therefore be preceded by adequate and accurate diagnosis and staging, which will inform therapeutic decisions. A panel of oncologists, surgeons and pulmonologists in Lebanon convened to establish a set of recommendations to guide and unify clinical practice, in alignment with international standards of care. Whilst chest computerized tomography (CT) scanning remains a cornerstone in the discovery of a lung lesion, a positron-emission tomography (PET)/CT scan and a tumor biopsy allows for staging of the cancer and defining the resectability of the tumor(s). A multidisciplinary discussion meeting is currently widely advised for evaluating patients on a case-by-case basis, and should include at least the treating oncologist, a thoracic surgeon, a radiation oncologist and a pulmonologist, in addition to physicians from other specialties as needed. The standard of care for unresectable stage III NSCLC is concurrent chemotherapy and radiation therapy, followed by consolidation therapy with durvalumab, which should be initiated within 42 days of the last radiation dose; for resectable tumors, neoadjuvant therapy followed by surgical resection is recommended. This joint statement is based on the expertise of the physician panel, available literature and evidence governing the treatment, management and follow-up of patients with stage III NSCLC. [ABSTRACT FROM AUTHOR]

Background: Only drafts of regulatory guidelines for the registration of biosimilars are available in Lebanon. We analyzed the results of a regional survey conducted in Lebanon to understand the impact of different parameters on the acceptance and future prescription of biosimilars. We also reviewed the current situation of biosimilars around the world. The study surveyed healthcare professionals from the Arab countries, Iran, Belgium and Italy. Data about the participants' specialty, country of residence, their knowledge about biosimilars, biosimilars' prescription, price influence and the manufacturer's credibility were collected. Results: 117 questionnaires were completed and returned: 46 (39.3%) respondents were oncologists. 72 (61.5%) respondents were Lebanese, and the others from Egypt, Syria, Algeria, Iraq, Sudan, Jordan, Iran, Belgium and Italy. 77 (65.8%) respondents had knowledge about biosimilars, of whom 48 (62.3%) considered biosimilars as biologics that demonstrate bioequivalence with the original biodrug and have all preclinical and clinical trials equal to those already performed with the original biodrug. 74 (63.2%) out of 117 respondents agreed that biosimilars in the Arab and Middle Eastern market are already marketed. Among the 48 participants who prescribe biosimilars, the main prescription driver was the drug's approval by the FDA and EMA (68.8%). 71 (60.7%) respondents considered that the main advantage of biosimilars is their lower price and 41 (35%) out of the 117 respondents declared that they should know in which country the drug has been tested/created before using it in their own country. 35% of the respondents thought that the cost of a treatment should not come before its effectiveness or safety/tolerance, given that the biosimilar will be less expensive than the reference drug. Conclusions: Biosimilars' acceptance and use is increasing worldwide. Only few physicians are aware of biosimilars presence in the market and do prescribe them in Lebanon and the Arab region. This could be mainly explained by lack of confidence in efficacy, safety, manufacturing process and price of these products, and lack of clear legislation. Thus, WHO is finalizing a new guideline for similar biotherapeutic agents. This could be a starting point for the Lebanese government to support the authorization of biosimilars. [ABSTRACT FROM AUTHOR]

Objective There is a lack of data on the quality of information that cancer patients receive from their oncologists in Lebanon and Middle Eastern countries. In view of the social and psychological characteristics of our society, we assess the reliability and validity of the questionnaire elaborated by the European Organization for Research and Treatment of Cancer (EORTC) for the measurement of the quality of information provided to cancer patients. Methods The questionnaire was translated into Arabic according to the EORTC recommendations. We conducted this study on Lebanese patients above 18 years of age receiving chemotherapy for a malignant tumor at Hotel Dieu de France University Hospital. Convergent and discriminate validity was assessed by correlating each item respectively with its own scale and any other scale. The internal consistency of the Arabic version of the EORTC INFO 25 was assessed by calculating Cronbach alpha coefficient. Results We enrolled 30 patients (18 women and 12 men; mean age 55±16 years). The internal consistency of the EORTC QLQ-INFO25 was found valid in the Lebanese population. The internal consistency estimate of the full questionnaire showed a reliability of 0.715. The EORTC QLQ-INFO 25 was also assessed for reliability, convergent and discriminant validity of multi item scales and was validated for a Cronbach alpha value > 0.7: information about the disease ɑ=0.890; information about the medical tests ɑ=0.940; information about treatment ɑ=0.868; information about other services ɑ=0.786. Conclusion The validation of the EORTC questionnaire in the Lebanese population would allow us to use it in further studies especially with the introduction of palliative care in our medical system. [ABSTRACT FROM AUTHOR]

Advances in medical oncology has led cancer patients to live longer. Moreover, the field of molecular oncology is rapidly evolving, new therapies emerge, and drugs are approved quickly. This has led nephrologists to encounter new and partially unrecognized treatments of the targeted therapy agents with kidney adverse effects. These agents fall mainly into 2 categories affecting the vascular endothelial growth factor and endothelial growth factor pathways. This review covers the incidence of kidney disease induced by these agents, pathophysiologic mechanisms, and clinical presentation, and is the first to recommend an adequate management for each pathophysiology. [ABSTRACT FROM AUTHOR]

Objectives. To determine the incidence, characteristics, and survival outcomes of triple-negative breast cancer patients in a medical oncology practice in Lebanon. Methods. The pathology reports of all breast cancer cases diagnosed or treated in 1997-2008 were reviewed. Results. One hundred seventy breast cancer cases (9.3%) of the 1,834 cases that were identified in this practice over a 10-year span had a triple-negative phenotype, with a median age at diagnosis of 52 years. The pathology distribution of those cases was as follows: invasive ductal carcinoma, 85%; medullary carcinoma, 5%; invasive lobular carcinoma, 5%; 95 cases (63%) were grade III. At diagnosis, 17% presented with stage I, 47% had stage II, 24% had stage III, and 12% had stage IV disease, whereas 11% had an inflammatory component. After a median follow- up of 17 months, 43 patients (25.3%) had relapsed and the most common sites of relapse were the brain (19%), lungs (19%), and bones (12%). The risk for recurrence peaked at 1.5 years and became almost nil after 3 years. Twenty patients received induction chemotherapy, among whom six (42.9%) had a complete response and six (42.9%) had a partial response to treatment. None of the patients progressed on neoadjuvant chemotherapy. The 5-year disease- free survival rate was 75% for stage I, 58% for stage II, and 40% for stage III patients, whereas the 5-year overall survival rate was 88% for stage I, 72% for stage II, and 63% for stage III patients. Adjuvant therapy was administered to 96% of patients, using a taxane-based regimen in 38% of cases. The median survival time for stage IV patients was 19 months, with a first line taxane-based regimen used in 50% of cases. Conclusions. The incidence of triple-negative breast cancer in Lebanon is similar to that described in the literature. In order to determine targets for future therapeutic options, it is essential to understand the biology of this particular breast cancer subtype. [ABSTRACT FROM AUTHOR]

We report a case of metastatic castration-resistant prostate cancer, who received prior treatment with docetaxel and was then given cabazitaxel as salvage therapy. The patient was monitored by prostate-specific antigen doubling time and prostate-specific antigen absolute value. The prostate-specific antigen doubling time was found to be a good response predictor in the patient. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Introduction: Autophagy is an intracellular process that plays a key role in the cellular homeostasis. Recently, it has been described as a potential therapeutic target in oncology, whether by activating or inhibiting its different cascades. Autophagy inhibitors interact with different molecular processes of the hallmarks of cancer., Areas Covered: Multiple proteins of the autophagy cascade could be aimed by specific inhibitors in many tumors, notably bladder cancer. In fact, bladder cancer has been increasing in prevalence over the last decade, and resistance to conventional treatment has been extensively reported in the literature. Autophagy inhibitors in bladder cancer have been described in preclinical studies to increase the sensitivity of the tumor to chemotherapy and radiotherapy. This paper is a review of the literature, which selected randomized trials, cohort studies, and case-control studies documenting the relationship between autophagy inhibitors and bladder cancer treatment., Expert Opinion: Autophagy is a promising pathway for cancer cell targeting that opens the horizons for a potential new therapeutic area in particular the multidisciplinary management of bladder cancer.

Mesenchymal-epithelial transition exon 14 (METex14) skipping mutations occur in about 3%-4% of patients with non-small cell lung cancer (NSCLC). This is an aggressive subtype associated with poor prognosis. METex14 skipping is a potentially targetable mutation. Targeted therapy is a promising treatment modality for patients with advanced/metastatic METex14-mutant NSCLC. Performing systematic molecular testing to detect the driver mutation is essential for initiating targeted therapy. However, there is a lack of guidelines on molecular testing for assessing the eligibility of patients for targeted therapy. Therefore, a multidisciplinary panel consisting of experts from the Middle East, Africa, and Russia convened via a virtual advisory board meeting to provide their insights on various molecular testing techniques for the diagnosis of METex14 skipping mutation, management of patients with targeted therapies, and developing consensus recommendations for improving the processes. The expert panel emphasized performing molecular testing and liquid biopsy before treatment initiation and tissue re-biopsy for patients with failed molecular testing. Liquid biopsy was recommended as complementary to tissue biopsy for disease monitoring and prognosis. Selective MET inhibitors were recommended as the first and subsequent lines of therapy. These consensus recommendations will facilitate the management of METex14 skipping NSCLC in routine practice and warrant optimum outcomes for these patients., Competing Interests: The authors have declared financial relationships, which are detailed in the next section., (Copyright © 2023, Mahrous et al.)

Background: Lung cancer is the number one cause of mortality among all types of cancer worldwide. Its treatment landscape has shifted from the classic chemotherapy alone to newer regimens based on the discovery of new immunotherapy and targeted therapy drugs. However, chemotherapy is still an option for treatment of advanced non-small cell lung cancer (NSCLC) after progression on immunotherapy alone or in combination with first-line chemotherapy., Methods: This is a retrospective study based on chart review of patients diagnosed with advanced NSCLC cases who received Docetaxel as second or third line after being treated by immunotherapy and/or chemotherapy in previous lines. The data was collected from the medical records of physicians' clinics in three different hospital centers in Lebanon over the period of 5 years from July 2015 until December 2020. February 2021 was data analysis cut off time. The main aim was to assess the role of Docetaxel post-chemoimmunotherapy for patients with diagnosed NSCLC., Results: A total of 21 patients were included in this study. The majority of our patients were males (81%). As for histologic type, most patients had non-squamous lung cancer (67%) as compared to 33% who had squamous lung cancer. Overall, our study reported a 24% response rate to Docetaxel including stable disease and partial response and a median progression free survival (PFS) of 3 months. The mean time interval elapsed from diagnosis to the initiation of Docetaxel was 11.5 months., Conclusion: New therapeutic options should be validated for the treatment of NSCLC in the second and subsequent lines of therapy considering the poor prognosis of this disease. The chemotherapy in second and third line may keep an important role in the treatment after progression on newer agents, but it needs more evidence in prospective studies including a larger number of patients.

Background: This commentary explores and discusses the challenges oncologists face in diagnosing and managing breast cancer patients with BRCA gene mutations in Lebanon and the Middle East., Methods: Key opinion leaders shared their recommendations to achieve better patient outcomes and satisfaction based on evidence-based medicine and their clinical experience in BRCA management., Results: Challenges associated with BRCA management can be divided into four main levels: physicians, patients, test, and treatment factors. More genetic counselors are to be identified given their important role in the management of individuals with BRCA gene mutations., Conclusion: Genetic counseling, continuing education, infrastructure, testing, expertise, and financial support are needed to fulfill the unmet needs in the management of BRCA mutation carriers.

Introduction: Oncotype DX is approved in multiple countries but its cost-effectiveness is a matter of considerable health debate. Lebanon is high-middle income country according to the World Bank classification however it is facing a mounting financial and health care burden from cancer. Therefore, we conducted a costeffectiveness analysis of Oncotype DX based Lebanese on real-life data., Methods: We updated a Canadian cost-effectiveness model of Oncotype DX by incorporating Lebanese data. The patient population was a real-life cohort of 82 women diagnosed with hormone receptor - positive and HER2 - negative early breast cancer., Results: Overall, providing Oncotype DX to only intermediate Adjuvant! Online risk patients costs an additional $83 CAD (93,883 LBP) per additional QALY. From this point, extending provision to also cover high Adjuvant! Online risk patients costs an additional $736 CAD (831,578 LBP) per additional QALY. From this point, extending provision further to also cover low Adjuvant! Online risk patients (such that Oncotype DX is provided to all patients) costs an additional $14,562 CAD (16.46m LBP) per additional QALY. Given that most women in our population-based sample were classified as intermediate Adjuvant! Online risk patients, our study focused on this subset in the second analysis. Providing Oncotype DX to intermediate Adjuvant! Online risk patients has a relatively small additional cost compared to not providing Oncotype DX, and results in a relatively large QALY gain. The incremental cost per QALY is $2,022 CAD (2.29m LBP), implying that Oncotype DX is cost-effective for intermediate Adjuvant! Online risk patients if the willingness-to-pay for a QALY is greater than 2.29m LBP., Conclusion: As one of the few economic evaluations to date conducted using Lebanese data, this evaluation provides information to decision makers regarding the cost-effectiveness of providing Oncotype DX to Lebanese patients.

Purpose: The use of total parenteral nutrition (TPN) in terminally ill cancer patients is considered an aggressive approach with very limited benefits. We examined the practice of TPN in our end of life cancer patients and we investigated the patient and tumor characteristics that justify this practice. To our knowledge, this is the first study describing TPN administration of Middle Eastern patients with advanced cancer., Methods: We conducted this retrospective observational study at Hotel-Dieu de France University Hospital, Lebanon. Eligible cases included all cancer patients that died at our institution between the 1st of January and the 31st of December 2014. The patients and tumors characteristics were analyzed for their potential role as determinant of TPN administration. The patients' hospitalization and causes of death were evaluated for the analysis of TPN benefits., Results: Among the 129 patients enrolled, 39% had received TPN among which TPN administration correlated negatively to hyperlipidemia (OR= 0.33; 95% CI [0.12-0.87]) and to the presence of at least three cardiovascular risk factors (OR= 0.28; 95% CI [0.10 - 0.80]). However, it correlated positively to gastrointestinal tumors (OR= 3.9; 95% CI [1.3- 11.7]) and to imaging studies during the last month of life (OR= 3.4; 95% CI [1.3 - 9.0]). The TPN administration did not correlate to hospitalization during the last two weeks of life., Conclusion: The adoption of an optimal palliative care approach in Middle Eastern cancer patients at the end of life remains challenging. Oncologists seem to consider cardiovascular risk factors as a probable surrogate to predict complications of TPN.

Molecular profiling and functional assessment of signalling pathways of advanced solid tumours are becoming increasingly available. However, their clinical utility in guiding patients' treatment remains unknown. Here, we assessed whether molecular profiling helps physicians in therapeutic decision making by analysing the molecular profiles of 1057 advanced cancer patient samples after failing at least one standard of care treatment using a combination of next-generation sequencing (NGS), immunohistochemistry (IHC) and other specific tests. The resulting information was interpreted and personalized treatments for each patient were suggested. Our data showed that NGS alone provided the oncologist with useful information in 10-50% of cases (depending on cancer type), whereas the addition of IHC/other tests increased extensively the usefulness of the information provided. Using internet surveys, we investigated how therapy recommendations influenced treatment choice of the oncologist. For patients who were still alive after the provision of the molecular information (76.8%), 60.4% of their oncologists followed report recommendations. Most treatment decisions (93.4%) were made based on the combination of NGS and IHC/other tests, and an approved drug- rather than clinical trial enrolment- was the main treatment choice. Most common reasons given by physicians to explain the non-adherence to recommendations were drug availability and cost, which remain barriers to personalised precision medicine. Finally, we observed that 27% of patients treated with the suggested therapies had an overall survival > 12 months. Our study demonstrates that the combination of NGS and IHC/other tests provides the most useful information in aiding treatment decisions by oncologists in routine clinical practice., Competing Interests: CONFLICTS OF INTEREST HS, AF, GG and J-FL are employees of OncoDNA. GG and J-FL report ownership of OncoDNA shares etc.

Ampullary carcinoma (AC) is a rare gastrointestinal tumor without clear treatment recommendations. The management of this tumor is usually extrapolated from the treatment of pancreatic, biliary duct and intestinal cancers. Few papers have studied the AC as an independent entity and yet succombs to several limitations. These studies were retrospective single institutional experiences with limited sample sizes recruited over a long period of time. Unlike metastatic ACs where chemotherapy is the only recommended option, localized AC once excised may be approached by either chemotherapy alone or concomitant chemoradiation therapy. In this review, we report the overall survival and recurrence factors of more than 1000 patients from all the studies treating exclusively ACs. We also review the medical treatment of this tumor and conclude to the necessity of multi-institutional randomized controlled studies for AC exclusively., Competing Interests: Conflict-of-interest statement: To the best of our knowledge, no conflict of interest exists.