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Adult patients treated for STS have al most equal gender ratio and mostly are middle aged. The majority of patients have metastatic disease and disease progression, and half of the patients died from the disease during the period of evaluation. This study obtained real-life data on the clinical management of STS in MEA countries which could be shared with the medical community.

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<18.5), 17.2% had normal weight (18.5≤BMI<25), and 30.5% were overweight (25≤BMI<30). Obesity (BMI ≥ 30) was present in 52% of these patients, while a parity of ≥3 children was present in 254 patients (59.8%) Sixty-six patients (14.7%) had tumours smaller than 2cm. 159 patients (35.4%) had node negative disease. The majority of patients had invasive duct carcinoma (87.1%) with 5 patients (1.1%) grade I, 181 (40.3%) grade II and 234 (52.1%) grade III tumours (29 (6.5%) had unknown histological grade). Thirty-four patients (7.6%) presented with stage I disease, 203 patients (45.2%) with stage II, 161 patients (35.9%) with stage III and 50 patients (11.1%) presented with stage IV disease.Out of the 387 patients with non-metastatic disease who started treatment, 217 patients (56.1%) had upfront surgery and 170 patients (43.9%) started with neoadjuvant chemotherapy. Compared to patients > 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.

been limited progress in the last two decades and outcomes remain poor with a median overall survival (OS) of w10 months. IMpower133 (NCT02763579), a global Phase 1/3, double-blind, randomized, placebo-controlled trial evaluated efficacy and safety of adding atezolizumab, a humanized monoclonal antiePD-L1 antibody, or placebo to 1L carboplatin and etoposide in ES-SCLC. Method: Patients with measurable (RECIST v1.1) ES-SCLC, ECOG performance status 0 or 1, who had not received prior systemic treatment for ES-SCLC were enrolled. PD-L1 immunohistochemical testing was not required. Patients were randomized 1:1 to receive four 21-day cycles of carboplatin (AUC 5 mg/mL/min IV, Day 1) plus etoposide (100 mg/m 2 IV, Days 1-3) with either atezolizumab (1200 mg IV, Day 1) or placebo, followed by maintenance therapy with atezolizumab or placebo until intolerable toxicity or progressive disease per RECIST v1.1. Patients meeting predefined criteria could receive treatment beyond progression. Co-primary endpoints were OS and investigator-assessed progression-free survival (PFS). Adverse events (AEs) were graded per NCI-CTCAE v4.0. Blood-based tumor mutation burden (bTMB) was assessed using prespecified cutoffs of 16 vs. <16 and 10 vs. <10 mutations/Mb. Result: In total, 201 patients were randomized to the atezolizumab group, and 202 to the placebo group. Median follow-up was 13.9 months. Median OS was 12.3 months in the atezolizumab group and 10.3 months in the placebo group (hazard ratio [HR] 0.70 [95% confidence interval (CI): 0.54, 0.91; P¼0.0069]). Median PFS was 5.2 months and 4.3 months, respectively (HR 0.77 [95% CI: 0.62, 0.96; P¼0.017]). OS and PFS benefits were consistent across key patient subgroups. Investigator-assessed confirmed objective response rates were 60.2% and 64.4% in the atezolizumab and placebo groups, respectively; median duration of response, 4.2 and 3.9 months. Exploratory analyses showed OS survival benefits in subgroups above and below prespecified bTMB cutoffs. Grade 3-4 treatment-related AEs were reported in 56.6% vs. 56.1% patients in atezolizumab vs. placebo groups, respectively; serious treatment-related AEs occurred in 22.7% and 18.9% patients, respectively. Conclusion: Addition of atezolizumab to carboplatin and etoposide provided a significant improvement in OS and PFS in 1L ES-SCLC in an all-comer patient population. No unexpected safety signals were identified. Atezolizumab plus carboplatin and etoposide may represent a new standard regimen for patients with untreated ES-SCLC.