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Introduction: Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors are indicated in the first-line treatment of hormonal receptor positive and HER-2 negative (HR+/HER2- negative) metastatic breast cancer (MBC). Although phase III randomized controlled trials (RCTs) proved their clinical efficacy, they can increase healthcare expenditure. To date, there are no observational studies to validate the clinical findings of the existed RCTs. In addition, only a few pharmacoeconomic evaluations were published regarding the two common CDK4/6 inhibiting agents, palbociclib and ribociclib to evaluate their financial burden. Objectives: To evaluate the clinical efficacy of palbociclib and ribociclib in the local settings in Qatar. Moreover, to conduct a thorough pharmacoeconomic analysis for the two medications and compare them in terms of their cost-effectiveness and cost-utility. Methodology: A retrospective observational study on HR+/HER-2 negative stage IV breast cancer patients receiving palbociclib or ribociclib in Qatar was conducted, followed by a comparative pharmacoeconomic analysis. The primary outcomes were progression-free survival (PFS) and overall-survival (OS). Safety profiles of both medications were also evaluated. Clinical data of all MBC in Qatar were collected from the National Center for Cancer Care and Research (NCCCR) from January 2017 to December 2019 using Cerner ® system. To evaluate the long-term costs-effectiveness, a 10-year within-cycle corrected Markov’s model was developed. The Markov’s model consisted of three main health states: progression-free (PFS), progressed disease (PD), and death. Incremental cost-effectiveness ratio (ICER) and incremental cost-utility ratio (ICUR) were generated and compared to a three gross-domestic-product (3 GDP) per capita. Model costs were obtained from the department of accounting and finance in the NCCCR, transition probabilities were calculated from individual patient data obtained in the clinical phase, and utilities were summarized from the published literature. Deterministic and probabilistic sensitivity analyses were carried out. Modeling was conducted via TreeAge Pro ® software. Results: There was no statistically significant difference between palbociclib and ribociclib in PFS; median PFS time was 17.85 versus 13.55 months respectively; p> 0.05. Similarly, there was no statistically significant difference in OS (29.82 versus 31.72 months; p>0.05). For the pharmacoeconomic analysis, ribociclib dominated palbociclib in yielding an ICER of - 83,090.88 QAR per life-year gained, and ICUR of -31,868.06 QAR per quality-adjusted life-year gained. The results remained robust in all cases of the deterministic sensitivity analyses suggesting ribociclib is more cost-effective than palbociclib. Taking all combined uncertainties into account, the overall confidence in the base-case conclusion was around 60%. Conclusions: Both treatment strategies have similar efficacy and safety profiles. Nonetheless, ribociclib is a more cost-effective option than palbociclib based on the base-case results and based on the addressed uncertainties related to the model inputs. Citation Format: Nour Hisham Al-Ziftawi, Shereen Elazzazy, Mohammed Fasihul Alam, Asrul Akmal Shafie, Anas Hamad, Salha Bujassoum, Mohamed Izham Ibrahim. Clinical and pharmacoeconomic analyses of CDK4/6 inhibitors use in stage IV breast cancer females in the state of Qatar: A comparative retrospective observational study with cost effectiveness and cost utility analyses [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P3-16-03.

Background:Globally, triple-negative breast cancer (TNBC) is responsible for approximately 15% of all invasive Breast cancer and has been typically associated with poor prognosis. Some retrospective studies have suggested a relatively higher incidence of TNBC in the Middle East and North African Arab countries. Nevertheless, there is complete lack of prospective data, on TNBC in the region, including clinico-pathologic characteristics, treatment patterns and disease outcomes. The TRIPOLI study aims to bridge this information gap.Methods:TRIPOLI is an ongoing prospective multinational, disease registry, designed to recruit 700 newly diagnosed TNBC patients, from 15 institutions within 9 Arab countries: Egypt, Jordon, Morocco, Kingdom of Saudi Arabia, Lebanon, Oman, Kuwait, Qatar and Iraq. This interim analysis includes the patients’ characteristics and treatment approaches of the first 449 cases included in the study from December 2017 to September 2019.Results:All the 449 TNBC patients were females, with a median age of 49 years (range 23.8 - 93.6 years). Premenopausal status was reported in 54.7%, while a positive family history of BC was stated in 25.2% of these cases. 0.2% of patients were below normal (BMI 40 years, patients ≤ 40 years were less likely to be obese (39.4% versus 60.6%; p=0.002), more likely to have grade III tumours (62.3% versus 53.5%; p=0.116), more likely to have T3 or T4 tumours (41.4% versus 32.7%; p=0.038).Conclusion:In this interim analysis, Arab women with TNBC had high parity (≥ 3) and high BMI, compared to existing literature based on western population. High tumor grade, younger age and advanced stages at presentation are in line with similar world-wide reports. Younger women in the Arab region (≤40 years) presented with poor prognostic features, which will be further elucidated in subsequent reports. Citation Format: Hamdy A. Azim, Alaa Kandil, Heba El Zawahry, Hikmat Abdel-Razeq, Hesham Elghazaly, Suad Al Kharusi, Manal M. Abdelwahab, Salah Fayaz, Ahmed Saadeddin, Huda A. Alabdulkarim, Rasha Aboelhassan, Hassan Errihani, Tahseen Al Rubai, Salha Bujassoum Al Bader, Nashwa Mohamed Abdel Aziz, Nagi El Saghir, Giulia Attinà, Ahmed Yosry, Mohamed El Leithy, Loay Kassem, Marwan Ghosn. Triple negative breast cancer prospective registry in middle East and Africa (TRIPOLI) study: Interim analysis of the patients’ characteristics [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS7-65.

Background:Triple-negative breast cancer (TNBC) has a higher rate of early relapse and mortality compared to other types of breast cancer (BC). CCL5 and its signaling pathway have been linked to TNBC. Methods:We characterized variants in CCL5and that of six other CCL5 signaling genes (CCND1, ZMIZ1, CASP8, NOTCH2, MAP3K21 and HS6ST3) among 1,082 unrelated Arab subjects, including 196 TNBC, accessed their association with BC-specific overall survival (OVS) and progression-free survival (PFS), and correlated CCL5 expression with CCL5genotypes. Results: CCND1 rs614367-TTgenotype was highly associated with the TNBC risk (OR = 5.14; P = 0.004) and the rs614367-Tallele was associated with decreased PFS in TNBC. A decreased risk of lymph node metastasis was associated with the MAP3K21rs1294255-C allele, particularly in rs1294255-GC (OR = 0.47; P = 0.001). CCL5variants (rs2107538and rs2280789) were linked to CCL5 serum and mRNA levels. In the TCGA TNBC/Basal-like cohort the MAP3K21rs1294255-G allele was associated with a decreased OVS. High expression of CCL5in breast tumors was significantly associated with an increased OVS in all BC patients, but particularly in TNBC/Basal-like patients. Conclusion:Genetic variation in CCL5 signaling genes may predict not only TNBC risk but also disease aggression. Citation Format: Salha Bujassoum Al-Bader, Jingxuan Shan, David Bedognetti, Lotfi Chouchane. Genetic variants of CCL5 signaling pathway genes in susceptibility and prognosis of triple negative breast cancers in Arab population [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-09-10.

Background Qatar has one of the highest age-adjusted breast cancer incidences in the Arab world. Although this is much lower than the incidence in the West. Breast cancer incidence in Qatar was 45 per 100,000 in 2003-2007.These higher incidence rates in Qatar are mainly due to the growing population. The prevalent age group, for Qatari and non-Qatari patients, was 40-50 years old. This suggests that the age-specific incidence of breast cancer in Qatari women is unlike the pattern usually seen in Western nations where median age at diagnosis is 61 years, moreover the diagnosis is often at advanced stages of breast cancer. These factors led to establishment the first hospital based (BCSP) in Qatar. It uses a distributed model of mammography service. The program launched 2008, accepts eligible asymptomatic women at ages 40 - 69 years. Methods A retrospective study was done during the period from April 2008 –December 2013. Our aim is to describe our experience of (BCSP) in Qatar and to monitor performance indicators. Our (BCSP) includes an office call and recall as well as triple assessment. We also discuss positive cases in multi-disciplinary meeting. Results Total number of screened women was 4264 with an increasing participation, year by year. Out of these, Qatari patient’s accounts for 1145, and non Qatari for 3119. The age group of cases was (43-51). Total breast biopsies were 82, of which 45 were positive of breast carcinomas, (37) invasive ductal carcinoma, (8) noninvasive ductal carcinoma. The Invasive cancer detection rate was 8.2 %. The positive predictive value (PPV) was 46%. Sensitivity value has improved from 51% in 2008 to 70% in 2012 as well as specificity value that has increased from 77% in 2008 to 83% in 2012. Conclusion Public acceptance of (BCSP) in Qatar gradually increased and detection rates are higher than western countries. We’re detecting biologically aggressive tumors at younger age groups. We’ve a unique population and we need to utilize our data and evidence based medicine to guide policy makers and women to make the correct decision towards (BCSP). Citation Format: Salha Bujassoum, Reena Alassam, Hekmat Bugrein, Mufid Elmistiri. Qatar experience of Standard risk breast cancer screening program (BCSP) [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P3-02-05.