- Lung Cancer Treatments and Mutations
- Cancer Immunotherapy and Biomarkers
- Lung Cancer Research Studies
- Advanced Breast Cancer Therapies
- Pancreatic and Hepatic Oncology Research
- Breast Cancer Treatment Studies
- Cancer Treatment and Pharmacology
- Cancer survivorship and care
- Peptidase Inhibition and Analysis
- COVID-19 and healthcare impacts
- Hepatocellular Carcinoma Treatment and Prognosis
- Cancer Genomics and Diagnostics
- Gastric Cancer Management and Outcomes
- Lung Cancer Diagnosis and Treatment
- Immunotherapy and Immune Responses
- Cancer therapeutics and mechanisms
- Metastasis and carcinoma case studies
- Neuroendocrine Tumor Research Advances
- HER2/EGFR in Cancer Research
- Inflammatory Biomarkers in Disease Prognosis
- Biosimilars and Bioanalytical Methods
- Cholangiocarcinoma and Gallbladder Cancer Studies
- Esophageal Cancer Research and Treatment
- Radiomics and Machine Learning in Medical Imaging
- Cancer Mechanisms and Therapy
Tbilisi State Medical University
2022-2023
Institute of Clinical Research
2021
Athens Medical Center
2021
Cabozantinib has shown clinical activity in combination with checkpoint inhibitors solid tumours. The COSMIC-312 trial assessed cabozantinib plus atezolizumab versus sorafenib as first-line systemic treatment for advanced hepatocellular carcinoma.
Importance Programmed cell death ligand 1 inhibitors combined with chemotherapy has changed the approach to first-line treatment in patients extensive-stage small lung cancer (SCLC). It remained unknown whether adding a programmed (PD-1) inhibitor provided similar or better benefits SCLC, which would add evidence on efficacy of checkpoint SCLC. Objective To evaluate and adverse event profile PD-1 serplulimab plus compared placebo as Design, Setting, Participants This international,...
Abstract First-line cemiplimab (anti-programmed cell death-1 (PD-1)) monotherapy has previously shown significant improvement in overall survival (OS) and progression-free (PFS) versus chemotherapy patients with advanced non-small lung cancer (aNSCLC) PD-ligand 1 (PD-L1) expression ≥50%. EMPOWER-Lung 3 ( NCT03409614 ), a double-blind, placebo-controlled, phase study, examined plus platinum-doublet as first-line treatment for aNSCLC, irrespective of PD-L1 or histology. In this 466 stage...
Abstract Background Camizestrant (C), a next-generation oral selective estrogen receptor (ER) antagonist and degrader (ngSERD) has shown promising clinical activity in ER+ breast cancer (BC) the Phase 1 SERENA-1 study1,2 with dose-dependent safety profile. The 2 randomized SERENA-2 study (NCT04214288) initially assessed three doses of C vs fulvestrant (F) post-menopausal women HER2˗ BC disease recurrence or progression after ≤1 endocrine therapy (ET) advanced setting. Methods evaluated...
EMPOWER-Lung 3 part 2 (NCT03409614), a double-blind, placebo-controlled phase study, investigated cemiplimab (antiprogrammed cell death protein 1) plus chemotherapy versus placebo in patients with advanced NSCLC without EGFR, ALK, or ROS1 aberrations, either squamous nonsquamous histology, irrespective of programmed death-ligand 1 levels. At primary analysis, after 16.4 months follow-up, improved median overall survival (OS) alone (21.9 13.0 mo, hazard ratio [HR] = 0.71, 95% confidence...
Balstilimab (antiprogrammed death-1) and zalifrelimab (anticytotoxic T-lymphocyte-associated antigen-4) are two new checkpoint inhibitors emerging as promising investigational agents for the treatment of advanced cervical cancer. This phase II trial (ClinicalTrials.gov identifier: NCT03495882) evaluated combination balstilimab plus in patients with recurrent and/or metastatic cancer who relapsed after prior platinum-based therapy.
8505 Background: Monoclonal antibodies against programmed death-ligand 1 (PD-L1) have been approved for the first-line treatment of extensive-stage small-cell lung cancer (ES-SCLC) in combination with chemotherapy. However, whether a death (PD-1) inhibitor provides similar survival benefit this patient population remains unclear. In study, efficacy and safety serplulimab, novel humanized monoclonal anti-PD-1 antibody, were assessed chemotherapy previously untreated ES-SCLC patients. Methods:...
1066 Background: Camizestrant, a next-generation oral selective estrogen receptor antagonist and degrader (ngSERD), was compared at two dose levels to fulvestrant 500 mg (F) in post-menopausal women with advanced ER+, HER2˗ breast cancer disease recurrence or progression after ≤1 endocrine therapy the setting Phase 2 randomized SERENA-2 study (NCT04214288). Camizestrant demonstrated statistically significant clinically meaningful benefit vs F progression-free survival (PFS) overall...
MB02 (bevacizumab biosimilar) showed similar structural, functional, and pharmacokinetic properties to reference bevacizumab (Avastin®; EU-bevacizumab). To confirm clinical similarity between EU-bevacizumab, a comparability study was undertaken in the first-line treatment of stage IIIB/IV non-squamous non-small cell lung cancer (NSCLC). This multinational, double-blind, randomized, phase III (STELLA) compared or EU-bevacizumab (15 mg/kg) administered with chemotherapy (paclitaxel 200 mg/m2...
TPS8663 Background: Fianlimab (anti–lymphocyte activation gene 3 [LAG-3]) and cemiplimab (anti–programmed cell death-1 [PD-1]) are high-affinity, fully human, IgG4 monoclonal antibodies. In patients (pts) with advanced non-small lung cancer (aNSCLC) programmed death-ligand 1 (PD-L1) expression ≥50% no actionable mutations, first-line monotherapy showed significantly prolonged overall survival (OS) progression-free (PFS) versus chemotherapy, a safety profile consistent previous reports for...
Abstract Background EMPOWER‐Lung 3, a randomized 2:1 phase 3 trial, showed clinically meaningful and statistically significant overall survival improvement with cemiplimab plus platinum‐doublet chemotherapy versus placebo for first‐line treatment of advanced non–small cell lung cancer. This study evaluated patient‐reported outcomes (PROs). Methods PROs were assessed at day 1 (baseline), the start each cycle (every weeks) first six doses, then every three cycles, using European Organisation...
e23172 Background: Ovarian function suppression (OFS) is recommended for premenopausal patients with hormone (HR) positive early breast cancer at higher risk of recurrence. This achieved the use luteinizing hormone–releasing agonist (LHRH) or oophorectomy. Sexual health an important aspect women cancer, although unfortunately this issue often not addressed. The aim study was to explore sexual issues in HR-positive LHRH vs. Oophorectomy. Methods: A prospective observational conducted during...
TPS8660 Background: Non-small cell lung cancer (NSCLC) is the most common type of cancer. Anti–programmed death-1 (PD-1) therapies have improved outcomes in patients with NSCLC; however, do not respond or only for a limited time. The combination cemiplimab (anti–PD-1) and chemotherapy has been studied first-line treatment advanced NSCLC (aNSCLC), regardless programmed death-ligand 1 (PD-L1) status. While standard care continues to evolve NSCLC, one approach potentially improve checkpoint...
8100 Background: ASTRUM-005 is a randomized, double-blind, phase 3 trial comparing efficacy and safety of serplulimab (a novel anti-PD-1 antibody) plus chemotherapy (chemo) vs. placebo chemo as first-line therapy for extensive-stage small-cell lung cancer (ES-SCLC). Interim analysis presented at 2022 ASCO Annual Meeting showed significantly prolonged overall survival (OS) in the arm. Continuing improvements were seen all endpoints an updated reported ESMO Asia Congress 2022. Here we present...
TPS9602 Background: Fianlimab (anti-lymphocyte activation gene 3 [LAG-3]) and cemiplimab (anti- programmed cell death-1 [PD-1]) are both high-affinity, fully human, IgG4 monoclonal antibodies (Abs). Concurrent blockade of anti-LAG-3 anti-PD-1 has shown enhanced efficacy (increase in progression free survival [PFS]) advanced melanoma (Mel). We previously presented data from a phase 1 study showing 63.8% objective response rate (ORR) across two separate cohorts PD-(L)1 naïve metastatic Mel...
In EMPOWER-Lung 3 (NCT03409614) Part 1, patients with aNSCLC and PD-L1 <50% were randomized to treatment arms: CHEMO, CEMI+CHEMO or CEMI+IPI+CHEMO. Clinical outcomes for CEMI+IPI+CHEMO vs CHEMO (including OS [HR: 0.615 (95% CI, 0.441–0.857)]) previously reported; safety profile was generally consistent the known CEMI, IPI. PROs evaluated reported here. assessed at day 1 (baseline), start of each cycle (every weeks) first 6 doses, then every cycles, using EORTC QLQ-C30 QLQ-LC13...
EMPOWER-Lung 3 part 2 (NCT03409614), a double-blind, placebo-controlled phase study, assessed cemiplimab (anti-programmed cell death protein 1) plus chemotherapy versus alone in patients with advanced non-small lung cancer (NSCLC) without EGFR, ALK, or ROS1 aberrations, regardless of histology PD-L1 expression levels. We report results from subgroup analysis ≥ 1 %.
e13512 Background: The efficacy of curative-intent chemoradiation in treating cervical cancer is intricately tied to patient adherence treatment protocols, often influenced by quality life. In many areas the world, centers are located far from where patients live. We sought evaluate impact distance hospital and life on radiation adherence, especially for Country Georgia. Methods: A prospective study conducted at Todua Clinic, Tbilisi, Georgia, May 2023 - January 2024, involved locally...
Esophageal carcinoma is the seventh most common cancer and sixth lethal worldwide. There are two main histological types of esophageal carcinoma: adenocarcinoma (AC) squamous cell (SCC). Both more in males than females. Menopause an independent risk factor for while usage hormonal therapy (estrogen plus progesterone) associated with a lower SCC postmenopausal women. Gender differences have impact on incidence, however, it unclear if gender has prognostic value survival. The present case...