Galina Statsenko

Budgetary Health Care Institution of the Omsk Region "Clinical Oncology Center"

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Mustafa Özgüroğlu

Istanbul University-Cerrahpaşa

124

Niels Reinmuth

Asklepios Fachkliniken München-Gauting

124

Artem Poltoratskiy

Institute of Oncology NN Petrov

122

Maximilian J. Hochmair

Karl Landsteiner Society

121

Dmytro Trukhin

Odessa National Medical University

120

Luís Paz-Ares

Hospital Universitario 12 De Octubre

120

Katsuyuki Hotta

Okayama University Hospital

120

Libor Havel

Charles University

120

Jonathan W. Goldman

University of California, Los Angeles

120

Jun Ho Ji

The University of Texas Southwestern Medical Center

119

Cooperative Institutions

Ministry of Health of the Russian Federation

Russian Cancer Research Center NN Blokhin

Russian Academy of Sciences

Dana-Farber Cancer Institute

AstraZeneca (United States)

AstraZeneca (United Kingdom)

Peking University

Cancer Research Center

State Healthcare Institution "Regional Clinical Oncological Dispensary"

AstraZeneca (Brazil)

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Supplementary Figure S1 from Durvalumab ± Tremelimumab + Platinum-Etoposide in Extensive-Stage Small Cell Lung Cancer (CASPIAN): Outcomes by PD-L1 Expression and Tissue Tumor Mutational Burden

Luís Paz-Ares Marina Chiara Garassino Yuanbin Chen Niels Reinmuth Katsuyuki Hotta

Sample flow for biomarker analysis.

Durvalumab

Tremelimumab

10.1158/1078-0432.27095587.v1

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Citations (0)

Supplementary Figure S8 from Durvalumab ± Tremelimumab + Platinum-Etoposide in Extensive-Stage Small Cell Lung Cancer (CASPIAN): Outcomes by PD-L1 Expression and Tissue Tumor Mutational Burden

Luís Paz-Ares Marina Chiara Garassino Yuanbin Chen Niels Reinmuth Katsuyuki Hotta

Prevalence of PD-L1 expression on TC and IC in the PD-L1 BEP. *Includes patients whose tumors had <1% PD-L1 expression on TCs or ICs, but not absolute zero.

Durvalumab

Tremelimumab

10.1158/1078-0432.27095557

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Supplementary Figure S4 from Durvalumab ± Tremelimumab + Platinum-Etoposide in Extensive-Stage Small Cell Lung Cancer (CASPIAN): Outcomes by PD-L1 Expression and Tissue Tumor Mutational Burden

Luís Paz-Ares Marina Chiara Garassino Yuanbin Chen Niels Reinmuth Katsuyuki Hotta

Subgroup analysis of confirmed ORR by PD-L1 TC and IC expression for (A) durvalumab plus tremelimumab plus EP versus EP and (B) durvalumab plus EP versus EP. In each panel, the shaded band shows the confidence interval for the ITT population; circle sizes are proportional to the number of responses. Groups are not plotted when there are ≤5 responses across both arms.

Durvalumab

Tremelimumab

10.1158/1078-0432.27095569

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Supplementary Table S5 from Durvalumab ± Tremelimumab + Platinum-Etoposide in Extensive-Stage Small Cell Lung Cancer (CASPIAN): Outcomes by PD-L1 Expression and Tissue Tumor Mutational Burden

Luís Paz-Ares Marina Chiara Garassino Yuanbin Chen Niels Reinmuth Katsuyuki Hotta

Summary of adverse events of any cause by PD-L1 subgroup (PD-L1 safety population).

Durvalumab

Tremelimumab

10.1158/1078-0432.27095536

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Non-interventional study OVATAR final report: Diagnostic and treatment approaches in Russian ovarian cancer population—BRCAm group analysis.

Journal of Clinical Oncology (2019)

Alexandra Tyulyandina Т. В. Кекеева Vera Gorbunova Л. А. Коломиец Galina Statsenko

e13111 Background: First large Russian ovarian cancer observational study was conducted in 2014-2018. Methods: A total of 500 patients in 29 sites in Russia with newly diagnosed ovarian, peritoneal and fallopian tube cancer was enrolled (NCT02122588). The primary objective was to describe treatment approaches in the first line treatment. 141 patients (pts) with BRCA1/2 mutations (BRCA1/2mt) detected by NGS in blood and tissue were observed prospectively during at least 2 years. Results: Rate of BRCA1/2 mutations in Russian population is high – 28.4% (141 from 496 available for any testing). 77.6% (388/500) underwent biomarkers blood testing prior to treatment. CA-125 was positive in 99.7% (387/388), 15.2% (59/388) of pts had positive CA19-9, CA72-4 - in 2.3% (9/388). Positive CEA was presented in 15.2% (59/388). This marker was detected more frequently in BRCA2mt pts subgroup (28.0% (7/25)) than in BRCA1mt pts: 9.0% (8/90) (p = 0.05). 26.6% (133/500) of all study population had an oncology family history; 44.0% (62/141) BRCA1/2mt pts had relatives with oncological diseases and 19.7% (70/355) in BRCA wild type pts (p = 0.0001). 98.6% (139/141) of BRCA1/2mt pts received first line therapy. Objective response rate was registered in 79.8% (111/139) pts. Progression after platinum based regimens was observed in 53.6% (59/110) BRCA1mt pts and 44.8% (13/29) BRCA2mt pts. 35.6 % (21/59) of BRCA1mt pts had platinum-refractory and platinum-resistant relapses, while 15.4% in BRCA2mt subgroup (2/13) (p = 0.64). Platinum-sensitive relapses were in 64.4% (38/59) BRCA1mt pts and 84.6% BRCA2mt (11/13) (p = 0,64). Median PFS in BRCA1/2mt pts was 25.5 months. Among BRCA1/2mt pts underwent cytoreduction median PFS in subgroup without visible residual tumor was 36.4 months and in subgroup with residual tumor < 1 cm 15.3 months. Conclusions: In this large-scale prospective non-interventional study diagnostics and treatment approaches in Russian ovarian cancer pts were evaluated and high frequency of BRCA1/2mt was observed. Pts with BRCA1/2mt had better prognosis and most of them had platinum-sensitive relapses after first line chemotherapy that allowed platinum-based regimen rechallenge.

Fallopian tube

Fallopian tube cancer

10.1200/jco.2019.37.15_suppl.e13111

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Supplementary Table S5 from Durvalumab ± Tremelimumab + Platinum-Etoposide in Extensive-Stage Small Cell Lung Cancer (CASPIAN): Outcomes by PD-L1 Expression and Tissue Tumor Mutational Burden

Luís Paz-Ares Marina Chiara Garassino Yuanbin Chen Niels Reinmuth Katsuyuki Hotta

Summary of adverse events of any cause by PD-L1 subgroup (PD-L1 safety population).

Durvalumab

Tremelimumab

10.1158/1078-0432.25232285

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Citations (0)

Supplementary Figure S5 from Durvalumab ± Tremelimumab + Platinum-Etoposide in Extensive-Stage Small Cell Lung Cancer (CASPIAN): Outcomes by PD-L1 Expression and Tissue Tumor Mutational Burden

Luís Paz-Ares Marina Chiara Garassino Yuanbin Chen Niels Reinmuth Katsuyuki Hotta

Kaplan-Meier analysis of OS in the ITT population and the tTMB BEP.

Durvalumab

Tremelimumab

10.1158/1078-0432.25232315

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Supplementary Figure S9 from Durvalumab ± Tremelimumab + Platinum-Etoposide in Extensive-Stage Small Cell Lung Cancer (CASPIAN): Outcomes by PD-L1 Expression and Tissue Tumor Mutational Burden

Luís Paz-Ares Marina Chiara Garassino Yuanbin Chen Niels Reinmuth Katsuyuki Hotta

Distribution of tTMB scores by treatment arm in the tTMB BEP.

Durvalumab

Tremelimumab

10.1158/1078-0432.25232303

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Alofanib in subsequent therapy for advanced gastric cancer: Final results from the phase Ib clinical trial.

Journal of Clinical Oncology (2022)

Ilya Tsimafeyeu Liubov Yu Vladimirova Anastasia Mochalova Н. С. Бесова Galina Statsenko

e16077 Background: Alofanib (RPT835) is a first-in-class allosteric inhibitor that induces conformational changes in the extracellular domain of FGFR2. Here, we present the final results of the phase Ib clinical study (RPT835GC1B) of alofanib. Methods: Patients with metastatic gastric adenocarcinoma resistant to standard therapy with measurable disease were eligible. The dose finding part used a 3+3 design, starting with a dose level of 50 mg/m2, intravenously, 5 days on, 2 days off. Five dose levels were foreseen. Primary endpoint was maximum tolerated dose (MTD). Secondary endpoints included toxicity, PK, objective response rate (ORR), overall survival (OS), and progression-free survival (PFS). Results: 21 patients were enrolled. 4 (19.1%), 14 (66.7%), 9 (43%), 3 (14.3%), and 12 (57%) patients had ECOG PS 2, ≥2 metastatic sites, liver metastases, bone metastases, and 3-6 lines previous therapy, respectively. The MTD has not been reached and dose of 350 mg/m2 has been declared as recommended phase II dose. With median follow-up of 13.0 months 15 (71.4%) patients had any grade treatment related adverse events (TRAE). Grade 3-4 TRAE occurred in 6 (28.6%) patients. Two (9.5%) patients discontinued treatment due to grade 3 diarrhea and grade 4 reactions immediately after injections. There were no treatment-related deaths in the study. One partial response (5.26%) with a duration of 18.53 months was identified. Disease control rate (DCR) was 68.4% and median duration of stable disease was 4.91 months. Median PFS was 3.63 (95% CI 1.58–5.68) months. Median OS was 7.0 (3.82–10.18) months. 6-month OS rate was 57.1%. OS was almost 2 times better in patients with DCR (median 10.05 vs. 5.9 months) and without bone metastases (8.6 vs. 3.1). Only one patient (4.8%) had FGFR2 amplification (time to death was 7 months). PK parameters linearly changed depending on the dose level, but no correlation with efficacy was found. Table summarizes rate of TRAE and DCR in dose cohorts. Conclusions: Alofanib was feasible and showed early signals of efficacy in heavily-pretreated patients with metastatic gastric cancer. A phase 2 randomized trial is planned. Clinical trial information: NCT04071184. [Table: see text]

Clinical endpoint

10.1200/jco.2022.40.16_suppl.e16077

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Citations (1)

LBA86 Durvalumab (D) ± tremelimumab (T) + platinum-etoposide (EP) in 1L ES-SCLC: Characterization of long-term clinical benefit and tumour mutational burden (TMB) in CASPIAN

Annals of Oncology (2020)

Jonathan W. Goldman Marina Chiara Garassino Yuanbin Chen Niels Reinmuth Katsuyuki Hotta

Durvalumab

Subgroup analysis

10.1016/j.annonc.2020.08.2328

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Citations (27)