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  • 1
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    Online Resource
    Efficacy and safety of eribulin in HER2-negative metastatic breast cancer: the results of long-term experience in real clinical practice in Russia
    Consilium Medicum ; 2019
    In:  Journal of Modern Oncology Vol. 21, No. 1 ( 2019-03-15), p. 12-23
    Details
    In: Journal of Modern Oncology, Consilium Medicum, Vol. 21, No. 1 ( 2019-03-15), p. 12-23
    Abstract: Aim. The aim of the study is to examine the efficacy and safety of eribulin in HER2-negative metastatic breast cancer (BC) in Russian clinical practice. Materials and methods. The analysis included 459 patients with advanced BC from 44 federal and municipal medical clinics in Russia and received at least 2 courses of treatment with eribulin in accordance with the registered indications for drug. The average age of women was 56 years (between 29 and 81 years), 83% of patients had HER2-negative tumor subtype (49.9% - luminal BC and 33.1% - triple-negative BC) HER2-positive biological tumor subtype was registered in 17% of patients. Visceral metastases were diagnosed in 73% of patients and three-zone and multiple zone metastases were diagnosed in 41.6% of cases. The median number of prior lines of therapy in patients with disseminated disease was 2; anthracycline and taxane chemotherapy was applied in 94.3% of patients, and 38.1% of patients were recived CT plus capecitabine. Standard treatment regimen with eribulin was cotinuing (1.4 mg/m² as a 2-5-minute intravenous infusion administrated on days 1, 8 of a 21-day cycle) until disease progression, unacceptable toxic effects, or impossibility of the drug administration for any other reason. We estimated the efficacy and safety of treatment with eribulin in Russian patients with HER2-negative BC. Results. Objective response rate was achieved in 20.5% of cases, complete response rate was in 3.2%, partial - 17.3%, and the stable disease rate was marked in 52.7% of women, and in 19.7% of these cases was prolonged more than 6 months. The frequency of objective response was higher in luminal BC group compared with triple-negative BC: 23.5% vs 15.8%; tumor growth control 76.9% vs. 67.8%, respectively; p
    Type of Medium: Online Resource
    ISSN: 1815-1442 , 1815-1434
    URL: Article
    DOI: 10.26442/18151434.2019.1.190250
    Language: Unknown
    Publisher: Consilium Medicum
    Publication Date: 2019
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  • 2
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    Chemotherapy for patients with brain metastases from melanoma.
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 15_suppl ( 2012-05-20), p. e19012-e19012
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. e19012-e19012
    Abstract: e19012 Background: There have not been standards of chemo- and chemo-radiotherapy for treatment for patients with brain metastases. The patients (pts) with brain metastases (BM) from melanoma have poor prognoses. The main goal of this trial is to assess the efficacy of nitrosoureas (CCNU or FCNU), temozolomide (TMZ) as monotherapy, TMZ combined with whole brain irradiation (WBI), or combined chemotherapy of TMZ and cisplatin in pts with BM from melanoma. Methods: 78 pts were included in this study. 21 pts were treated with WBI (3Gy/30Gy) and concomitant TMZ therapy (75 mg/m 2 /day orally on days 1-14), 19 pts were treated with TMZ (150 mg/m 2 /day orally on days 1-5, every 4 weeks) as monotherapy, 17 pts pts were treated with nitrosoureas (CCNU or FCNU), 21 pts were treated with combined chemotherapy of TMZ (150/mg/m 2 /day orally on days 1-5, every 4 weeks) + cisplatin (20/mg/m 2 /day intravenous on days 1-5, every 4 weeks). The main aims of this study were objective response (OR) – complete response (CR) + partial response (PR) in the brain and in the extracranial sites (ES), median of survival (mOS), 1-year and 2-year survival. Results: Observations were as follows: in the TMZ + WBI treated pts, 4 OR (19,0%) in 21 pts group in the brain and 1 OR (6,7%) in 15 pts group in ES. The mOS was 6.0 months, 1-year survival was 23,8%. In the TMZ monotherapy treated pts there were 5 OR (26,3%) in 19 pts group in the brain and no OR in 13 pts group in ES. The mOS was 6 months, 1-year survival was 21,1%. In the nitrisoureas treated pts we achieved 2 OR (11,8%) in 17 pts group in the brain and 1 OR (9,1%) in 11 pts group in ES. The mOS was 5 months, 1-year survival was 17,6%. In the TMZ + cisplatin treated pts there were 7 OR (33.3%) in 21 pts group in the brain and 7 OR (35,0%) in 20 pts group in ES. The mOS was 8 months, 1-year survival was 33,3%. 2-year survival (19,0%) was achieved only in TMZ and cisplatin group. Conclusions: Previous results of our study showed promising higher efficacy of TMZ and cisplatin, especially in OR in ES (p 〈 0.05) and in 2-year survival (p 〈 0.05), in comparison with TMZ alone, nitrosoureas or TMZ with whole brain irradiation in patients with metastatic melanoma with BM. Control of extracranial lesions is important factor for patients with BM. Further investigation is to be expected.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2012.30.15_suppl.e19012
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
    detail.hit.zdb_id: 2005181-5
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  • 3
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    Online Resource
    Pharmacogenomic assessment of cisplatin-based chemotherapy outcomes in ovarian cancer
    Future Medicine Ltd ; 2014
    In:  Pharmacogenomics Vol. 15, No. 3 ( 2014-02), p. 329-337
    Details
    In: Pharmacogenomics, Future Medicine Ltd, Vol. 15, No. 3 ( 2014-02), p. 329-337
    Abstract: Aim: Cisplatin and its analogs are potent antitumor agents. However, their use is restricted by significant variability in tumor response and toxicity. There is a great need to identify genetic markers to predict the most important adverse events and patient outcomes. Materials & methods: We have evaluated the association between polymorphisms in 106 genes involved mainly in xenobiotic metabolism, DNA repair, the cell cycle and apoptosis, and outcomes in 104 ovarian cancer patients receiving cisplatin–cyclophosphamide chemotherapy. Arrayed primer extension technology was used to genotype 228 SNPs. Results: Ten SNPs in nine genes were found to be associated with one or more of the assessed clinical end points. SNPs in TPMT and NQO1 were significantly associated with progression-free survival. Polymorphisms in ERCC5, RAD52, MUTYH and LIG3 correlated with the occurrence of severe neutropenia. SNPs in NAT2 and EPHX1 were associated with anemia and nephrotoxicity, respectively. A SNP in ADH1C was correlated with complete tumor response. Conclusion: The results obtained suggest that SNPs in different genes involved in drug metabolism can be important in identifying patients at risk for nonresponse to or toxicity from cisplatin-based treatment. Original submitted 2 August 2013; Revision submitted 25 November 2013
    Type of Medium: Online Resource
    ISSN: 1462-2416 , 1744-8042
    URL: Article
    DOI: 10.2217/pgs.13.237
    Language: English
    Publisher: Future Medicine Ltd
    Publication Date: 2014
    SSG: 15,3
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  • 4
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    Online Resource
    The potential of using eribulin in patients with breast cancer, associated with brain metastasis: the scientific background and the Russian clinical experience
    Consilium Medicum ; 2019
    In:  Journal of Modern Oncology Vol. 21, No. 2 ( 2019-06-15), p. 17-24
    Details
    In: Journal of Modern Oncology, Consilium Medicum, Vol. 21, No. 2 ( 2019-06-15), p. 17-24
    Abstract: Aim. Eribulin is an active cytostatic, associated with a wide range of mechanisms of antitumor effects, but eribulin efficiency and safety in patients with breast cancer (BC), associated with cerebral metastases are still poorly understood. Materials and methods. We analyzed the combined Russian experience of eribulin application in BC patients associated with brain metastases; the analysis included 459 Russian women with advanced BC who had received at least 2 course of eribulin during the period from 2014 to 2018; 35 of 459 patients had brain metastases (40.0% - luminal HER2-negative subtype, 31.4% - triple negative subtype and 28.6%h - HER2-positive BC). The median age was 52 years (39 - 80 years of age). In most cases, the patient had two or more metastatic brain lesions (68.6%; the median was - 3); brain radiotherapy was used in 62.8% of patients before eribulin treatment and in 5.8% of patients was held stereotactic radiation therapy during eribulin chemotherapy. We analyzed the efficiency of eribulin application (the therapy continued until disease progression, the development of unacceptable toxicity, or impossibility to apply the drug for any other reason). Results. The results showed that clinical efficacy (objective response rate + stabilization of disease lasting for more than 6 months) was 48.6%: partial response - in 20% of patients and stabilization of disease - 62.9%; tumor growth control was in 82.9%. Median PFS in all group of patients with brain metastases was 4.1 months and was similar to median PFS in patients who received radiotherapy before eribulin treatment or without eribulin - 4.1 vs 3.47 months; p=0.798. Conclusions. The application of eribulin in BC patients with brain metastasis are absolutely justified, the drug demonstrates the efficiency in a retrospective analysis in a Russian population. The determination of the optimal algorithm for the treatment of patients with metastatic BC associated with brain metastasis requires a multidisciplinary approach and further research.
    Type of Medium: Online Resource
    ISSN: 1815-1442 , 1815-1434
    URL: Article
    DOI: 10.26442/18151434.2019.2.190395
    Language: Unknown
    Publisher: Consilium Medicum
    Publication Date: 2019
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  • 5
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    Randomized phase II study of carboplatin and paclitaxel with either linifanib or placebo for advanced nonsquamous NSCLC.
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 15_suppl ( 2012-05-20), p. 7512-7512
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. 7512-7512
    Abstract: 7512 Background: Linifanib is a potent and selective inhibitor of VEGF and PDGF receptors with modest single-agent activity in NSCLC. We evaluated the combination of linifanib with carboplatin (C) and paclitaxel (P) for first-line therapy of advanced non-squamous NSCLC. Methods: Patients (pts) with stage IIIB/IV, non-squamous NSCLC, stratified by ECOG PS and gender, were randomized to receive up to six 3-wk cycles of C (AUC 6 mg/ml/min) and P (200 mg/m 2 ) with daily placebo (Arm A), linifanib 7.5 mg (Arm B), or linifanib 12.5 mg (Arm C). The primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival (OS), 12 m survival rate, and objective response rate (ORR). Safety was assessed by NCI-CTCAE v3.0. Results: 138 pts were randomized at 37 sites in 6 countries. Baseline characteristics were: median age, 61 y; men, 57%; smoker, 84%. Efficacy results are shown in the table. Thrombocytopenia was the only Grade 3/4 AE significantly higher on linifanib (Arm B: 16.7%; Arm C: 29.8%) vs. placebo (2.1%). Other adverse events (AEs) related to the dose of linifanib were diarrhea, thrombocytopenia, hypertension, weight loss, palmar-plantar erythrodysaesthesia syndrome, and hypothyroidism. Analysis of samples for predictive biomarkers including serum VEGF and placental growth factor are underway. Conclusions: The addition of linifanib to chemotherapy was tolerable at the doses tested and resulted in a significant improvement in PFS, with a modest survival improvement for Arm C in first-line therapy of advanced non-squamous NSCLC. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2012.30.15_suppl.7512
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
    detail.hit.zdb_id: 2005181-5
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  • 6
    Online Resource
    Online Resource
    Chemotherapy of ovarian cancer patients with metastases in the brain.
    American Society of Clinical Oncology (ASCO) ; 2014
    In:  Journal of Clinical Oncology Vol. 32, No. 15_suppl ( 2014-05-20), p. e13027-e13027
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 32, No. 15_suppl ( 2014-05-20), p. e13027-e13027
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2014.32.15_suppl.e13027
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2014
    detail.hit.zdb_id: 2005181-5
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  • 7
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    Online Resource
    Low titre autoantibodies against recoverin in sera of patients with small cell lung cancer but without a loss of vision
    Elsevier BV ; 2001
    In:  Lung Cancer Vol. 34, No. 1 ( 2001-10), p. 99-104
    Details
    In: Lung Cancer, Elsevier BV, Vol. 34, No. 1 ( 2001-10), p. 99-104
    Type of Medium: Online Resource
    ISSN: 0169-5002
    URL: Article
    DOI: 10.1016/S0169-5002(01)00212-4
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2001
    detail.hit.zdb_id: 2025812-4
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  • 8
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    Online Resource
    Randomized Phase II Study of Carboplatin and Paclitaxel With Either Linifanib or Placebo for Advanced Nonsquamous Non–Small-Cell Lung Cancer
    American Society of Clinical Oncology (ASCO) ; 2015
    In:  Journal of Clinical Oncology Vol. 33, No. 5 ( 2015-02-10), p. 433-441
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 33, No. 5 ( 2015-02-10), p. 433-441
    Abstract: Linifanib, a potent, selective inhibitor of vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF) receptors, has single-agent activity in non–small-cell lung cancer (NSCLC). We evaluated linifanib with carboplatin and paclitaxel as first-line therapy of advanced nonsquamous NSCLC. Patients and Methods Patients with stage IIIB/IV nonsquamous NSCLC were randomly assigned to 3-week cycles of carboplatin (area under the curve 6) and paclitaxel (200 mg/m 2 ) with daily placebo (arm A), linifanib 7.5 mg (arm B), or linifanib 12.5 mg (arm C). The primary end point was progression-free survival (PFS); secondary efficacy end points included overall survival (OS) and objective response rate. Results One hundred thirty-eight patients were randomly assigned (median age, 61 years; 57% men; 84% smokers). Median PFS times were 5.4 months (95% CI, 4.2 to 5.7 months) in arm A (n = 47), 8.3 months (95% CI, 4.2 to 10.8 months) in arm B (n = 44), and 7.3 months (95% CI, 4.6 to 10.8 months) in arm C (n = 47). Hazard ratios (HRs) for PFS were 0.51 for arm B versus A (P = .022) and 0.64 for arm C versus A (P = .118). Median OS times were 11.3, 11.4, and 13.0 months in arms A, B, and C, respectively. HRs for OS were 1.08 for arm B versus A (P = .779) and 0.88 for arm C versus A (P = .650). Both linifanib doses were associated with increased toxicity, including a higher incidence of adverse events known to be associated with VEGF/PDGF inhibition. Baseline plasma carcinoembryonic antigen/cytokeratin 19 fragments biomarker signature was associated with PFS improvement and a trend toward OS improvement with linifanib 12.5 mg. Conclusion Addition of linifanib to chemotherapy significantly improved PFS (arm B), with a modest trend for survival benefit (arm C) and increased toxicity reflective of known VEGF/PDGF inhibitory effects.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2014.55.7173
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2015
    detail.hit.zdb_id: 2005181-5
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  • 9
    Online Resource
    Online Resource
    Platinum-based combinations as first-line chemotherapy in advanced, persistent, or recurrent cervical cancer.
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 15_suppl ( 2012-05-20), p. e15543-e15543
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. e15543-e15543
    Abstract: e15543 Background: Platinum compounds are the most active agents in cervical carcinoma. The aim of this study was to evaluate the activity and toxicity of platinum-based chemotherapy as first line treatment in patients with advanced/recurrent cervical cancer. Methods: Since 2005 to 2011years 68 pts were include in the pilot study. Patients with histological proven primary carcinoma, measurable tumors, age ≥ 18, PS of 0-1, adequate bone marrow, renal and hepatic functions were eligible for this trial. Prior chemotherapy was allowed only in the context of radiosensitization. Treatment consisted of 2 modes: PC - paclitaxel 175 mg/m2 3-h I.v. + cisplatin 75 mg/m2 or carboplatin AUC-6 ( 6 pts)- d1x 21d; IC – irinotecan 65 ìg/m2 + cisplatin 40 mg/m2 on d 1 and 8 x 21 d. Responses were assessed using RESIST. Results: 68 pts were identified. There were no differences between the groups in terms prior radiation or radiochemotherapy. Group PC: 28 pts were included. Efficacy and toxicity was available for 27. Two pts continue treatment. Median age 43,5 years (range 28-69). The ORR was 55.5% (CR - 5(18.5%) and PR -10(37.0%)). 8 pts (29.6%) SD and 4 (14.8%) PD. The median TTP was 7 months. Overall, 148 cycles were administered with a median of 5 (range 2-8) cycles. Major toxicities were as follows: GIII and GIV neutropenia in 22.2% and 11.1% pts; GIII anemia - in 2 pts; GI-II neuropathy in 45.9% pts. G III nausea/vomiting were in 3 pts (11.1%). Group IC: 40 pts were included, 38 were available for efficacy. Median age 49,8 years (range 25-67). The ORR was 47.3% (5 CR(13.2%) and 13 PR (34.2%)). 13 (34.2%) pts had SD and 7 (18.4%) - PD. The median TTP was 6 months. All 40 pts receved 254 cycles ( median 6.3 (range 1-11) cycles. GIII and IV neutropenia were in 40% and 10% pts; GIII anemia in 20% pts. G I-II neuropathy and G I-II diarrhea in 15% pts and 30%pts. G IV of diarrhea observed in 1 pt. GIII-IV nausea and vomiting were in 20% and 15%pts. There were no statistical differences in clinical outcome (OR(p= 0,69) and TTP(p=0,65)) between these 2 platinum-based regimes. Conclusions: Our data indicate that both regimes had high efficacy and well tolerated as first line treatment in patients with advanced/recurrent cervical cancer. The randomized study is necessary.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2012.30.15_suppl.e15543
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
    detail.hit.zdb_id: 2005181-5
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  • 10
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    Online Resource
    Clinical outcome according to tumor HER2 status and EGFR expression in advanced gastric cancer patients from the EXPAND study.
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 15_suppl ( 2013-05-20), p. 4021-4021
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. 4021-4021
    Abstract: 4021 Background: In the EXPAND study adding cetuximab to first-line capecitabine and cisplatin chemotherapy (CT) failed to improve clinical outcome in patients (pts) with advanced gastric or gastroesophageal junction cancer. This analysis assessed treatment outcome according to tumor HER2 status (a pre-defined subgroup) and EGFR expression in EXPAND study pts. Methods: Tumor HER2 status was determined primarily by immunohistochemistry (IHC), HER2 +ve tumors were IHC 3+ or IHC 2+ and fluorescence in situ hybridization (FISH) +ve. EGFR expression was assessed by IHC. A continuous scoring system (scale of 0–300) was used to determine the level of EGFR expression. Biomarker status was correlated with clinical outcome. Results: In both treatment arms, pts with HER2 +ve tumors (n=144) vs HER2 -ve tumors (n=535) had a longer median overall survival (OS): 13.3 (95% CI 10.9–15.5) vs 9.2 (95% CI 8.1–10.5) months in the CT + cetuximab arm and 14.0 (95% CI 11.3–17.1) vs 9.7 (95% CI 8.6–11.0) months in the CT arm, and a better overall response rate, 51.4 (95% CI 39.3–63.3) vs 27.0 (95% CI 21.9–32.6) % and 37.5 (95% CI 26.4–49.7) vs 26.4 (95% CI 21.1–32.3) % respectively. In stepwise multivariable models, pts with HER2 -ve vs HER2 +ve tumors showed an increased risk of death (adjusted hazards ratio 1.552, 95% CI 1.244–1.936) and reduced odds of response (adjusted odds ratio 0.477, 95% CI 0.316–0.720). EGFR tumor expression was evaluable in 774 pts from the intent to treat population (n=904). The EGFR IHC score was low (median 0, range 0–300). No discriminating threshold for the IHC score was identified. However in pt subgroups defined by a series of cut-off points from an IHC score of 10 upwards (rising incrementally by 10), there was a tendency for improved OS, progression-free survival, and tumor response when adding cetuximab to CT in pts with high tumor EGFR IHC scores. Conclusions: In this analysis of EXPAND study pts, those with HER2 +ve tumors were associated with better outcome irrespective of the treatment arm compared with pts with HER2 -ve tumors. Tumor EGFR expression was generally low. Adding cetuximab to CT failed to improve outcome overall, but may benefit a small proportion of pts with high EGFR tumor expression. Clinical trial information: 2007-004219-75.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2013.31.15_suppl.4021
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
    detail.hit.zdb_id: 2005181-5
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