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  1. Article: Predikce odpovědi metastatického kolorektálního karcinomu na cílenou anti-EGFR léčbu.

    Fabian, Pavel / Němeček, Radim

    Ceskoslovenska patologie

    2018  Volume 54, Issue 1, Page(s) 17–21

    Abstract: The combination of modern systemic chemotherapy and anti-EGFR monoclonal antibodies improves overall survival and the quality of life for patients with metastatic colorectal cancer. By contrast, the addition of anti-EGFR therapy to the treatment regime ... ...

    Title translation Prediction of EGFR blockade responses in metastatic colorectal carcinoma.
    Abstract The combination of modern systemic chemotherapy and anti-EGFR monoclonal antibodies improves overall survival and the quality of life for patients with metastatic colorectal cancer. By contrast, the addition of anti-EGFR therapy to the treatment regime of resistant patients may lead to worse progression-free and overall survival. Therofore, identifying sensitive and resistant patients is key during initial decision-making. A number of clinical trials show that primary resistance to EGFR blockade is in most cases caused by constitutive activation of signalling pathways downstream of EGFR. Of the many biomarkers studied, only the KRAS and NRAS mutation status has reached clinical relevance in routine practice. The other markers (BRAF and PIK3CA mutations, PTEN and TP53 inactivation, EGFR and HER-2 amplification, epiregulin and amphiregulin overexpression, microRNA miR-31-3p and miR-31-5p etc.) still need to be validated. The accuracy of predictive diagnostic tools could also be increased by a combination of predictive markers on the next generation sequencing platform.
    MeSH term(s) Antibodies, Monoclonal ; Biomarkers, Tumor ; Class I Phosphatidylinositol 3-Kinases ; Colorectal Neoplasms/drug therapy ; Colorectal Neoplasms/pathology ; ErbB Receptors/drug effects ; Humans ; Mutation ; Phosphatidylinositol 3-Kinases ; Proto-Oncogene Proteins B-raf ; Proto-Oncogene Proteins p21(ras) ; Quality of Life ; Receptor, ErbB-2
    Chemical Substances Antibodies, Monoclonal ; Biomarkers, Tumor ; Phosphatidylinositol 3-Kinases (EC 2.7.1.-) ; Class I Phosphatidylinositol 3-Kinases (EC 2.7.1.137) ; EGFR protein, human (EC 2.7.10.1) ; ERBB2 protein, human (EC 2.7.10.1) ; ErbB Receptors (EC 2.7.10.1) ; Receptor, ErbB-2 (EC 2.7.10.1) ; Proto-Oncogene Proteins B-raf (EC 2.7.11.1) ; Proto-Oncogene Proteins p21(ras) (EC 3.6.5.2)
    Language Czech
    Publishing date 2018-04-09
    Publishing country Czech Republic
    Document type Journal Article
    ZDB-ID 138273-1
    ISSN 1210-7875 ; 0009-0611 ; 0371-1854
    ISSN 1210-7875 ; 0009-0611 ; 0371-1854
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  2. Article ; Online: Management of pheochromocytomas and paragangliomas: Review of current diagnosis and treatment options.

    Eid, Michal / Foukal, Jakub / Sochorová, Dana / Tuček, Štěpán / Starý, Karel / Kala, Zdeněk / Mayer, Jiří / Němeček, Radim / Trna, Jan / Kunovský, Lumír

    Cancer medicine

    2023  Volume 12, Issue 13, Page(s) 13942–13957

    Abstract: Pheochromocytomas (PCCs) are rare neuroendocrine tumors derived from the chromaffin cells of the adrenal medulla. When these tumors have an extra-adrenal location, they are called paragangliomas (PGLs) and arise from sympathetic and parasympathetic ... ...

    Abstract Pheochromocytomas (PCCs) are rare neuroendocrine tumors derived from the chromaffin cells of the adrenal medulla. When these tumors have an extra-adrenal location, they are called paragangliomas (PGLs) and arise from sympathetic and parasympathetic ganglia, particularly of the para-aortic location. Up to 25% of PCCs/PGLs are associated with inherited genetic disorders. The majority of PCCs/PGLs exhibit indolent behavior. However, according to their affiliation to molecular clusters based on underlying genetic aberrations, their tumorigenesis, location, clinical symptomatology, and potential to metastasize are heterogenous. Thus, PCCs/PGLs are often associated with diagnostic difficulties. In recent years, extensive research revealed a broad genetic background and multiple signaling pathways leading to tumor development. Along with this, the diagnostic and therapeutic options were also expanded. In this review, we focus on the current knowledge and recent advancements in the diagnosis and treatment of PCCs/PGLs with respect to the underlying gene alterations while also discussing future perspectives in this field.
    MeSH term(s) Humans ; Pheochromocytoma/diagnosis ; Pheochromocytoma/genetics ; Pheochromocytoma/therapy ; Paraganglioma/diagnosis ; Paraganglioma/genetics ; Paraganglioma/therapy ; Carcinogenesis ; Cell Transformation, Neoplastic ; Adrenal Gland Neoplasms/diagnosis ; Adrenal Gland Neoplasms/genetics ; Adrenal Gland Neoplasms/therapy
    Language English
    Publishing date 2023-05-05
    Publishing country United States
    Document type Journal Article ; Review ; Research Support, Non-U.S. Gov't
    ZDB-ID 2659751-2
    ISSN 2045-7634 ; 2045-7634
    ISSN (online) 2045-7634
    ISSN 2045-7634
    DOI 10.1002/cam4.6010
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  3. Article ; Online: The Pharmacoeconomic Analysis of Cetuximab and Panitumumab in the 1st Line Treatment of mCRC in Real Clinical Practice in the Czech Republic.

    Sehnalová, Irena / Říhová, Barbora / Němeček, Radim / Kintrová, Kateřina / Demlová, Regina

    Klinicka onkologie : casopis Ceske a Slovenske onkologicke spolecnosti

    2019  Volume 32, Issue 4, Page(s) 288–293

    Abstract: Background: The anti-epidermal growth factor receptor (EGFR) drugs cetuximab and panitumumab are currently reimbursed when administered during the first and subsequent lines of treatment of patients in the Czech Republic with metastatic colorectal ... ...

    Title translation Farmakoekonomické hodnocení cetuximabu a panitumumabu v 1. linii léčby mCRC v reálné klinické praxi ČR.
    Abstract Background: The anti-epidermal growth factor receptor (EGFR) drugs cetuximab and panitumumab are currently reimbursed when administered during the first and subsequent lines of treatment of patients in the Czech Republic with metastatic colorectal cancer (mCRC). Because cetuximab and panitumumab do not show significant differences in efficacy, their choice may be dependent on cost. This retrospective study analyzed the costs of first-line treatment with cetuximab and panitumumab of patients with mCRC and wild type KRAS, as well as evaluated the correlations between costs and effectiveness, as determined by progression-free survival (PFS) and overall survival (OS).
    Patients and methods: This analysis included 51 patients with mCRC and confirmed wild type KRAS treated at the comprehensive cancer centre in the Czech Republic between November 2011 and April 2018. Of these 51 patients, 22 were treated with cetuximab and 29 with panitumumab. Direct medical costs (medications, clinical examinations and procedures, and hospitalization) were evaluated from the initiation of treatment with anti-EGFR drug to disease progression and death. Mean follow-up was 21 months in the cetuximab group and 19 months in the panitumumab group.
    Results: Reimbursement for anti-EGFR drugs until disease progression accounted for 71% (mean, 964,288 CZK per patient) of total costs in the cetuximab group and 77% (mean, 1,003,229 CZK per patient) of total costs in the panitumumab group, with median PFS in these two groups being 10.7 months and 8.1 months, respectively. Reimbursement of expensive center drugs from the start of anti-EGFR treatment to patient death accounted for 55% of total costs in the cetuximab group (mean, 1,752,702 CZK per patient) and 63% of total costs in the panitumumab group (mean, 1,596,919 CZK per patient), with median OS in these two groups being 20.2 months and 19.8 months, respectively. No significant between-group differences in clinical effectiveness and costs of treatment were observed (p > 0.05 each).
    Conclusion: Reimbursement for biological agents is the most expensive item in the first-line treatment of mCRC patients with wild type KRAS, both to disease progression and death. The clinical effectiveness and costs of cetuximab and panitumumab did not differ significantly. Supported by CZECRIN (identification code LM2015090); CZECRIN_4 PACIENTY (No. CZ.02.1.01/0.0/0.0/16_013/0001826). The authors declare they have no potential conflicts of interest concerning drugs, products, or services used in the study. The Editorial Board declares that the manuscript met the ICMJE recommendation for biomedical papers. Submitted: 30. 4. 2019 Accepted: 17. 6. 2019.
    MeSH term(s) Antineoplastic Agents, Immunological/economics ; Antineoplastic Agents, Immunological/therapeutic use ; Cetuximab/economics ; Cetuximab/therapeutic use ; Colorectal Neoplasms/drug therapy ; Colorectal Neoplasms/economics ; Colorectal Neoplasms/mortality ; Colorectal Neoplasms/pathology ; Cost-Benefit Analysis ; Czech Republic ; Drug Costs ; Economics, Pharmaceutical ; ErbB Receptors/antagonists & inhibitors ; Humans ; Panitumumab/economics ; Panitumumab/therapeutic use ; Retrospective Studies ; Survival Rate ; Treatment Outcome
    Chemical Substances Antineoplastic Agents, Immunological ; Panitumumab (6A901E312A) ; EGFR protein, human (EC 2.7.10.1) ; ErbB Receptors (EC 2.7.10.1) ; Cetuximab (PQX0D8J21J)
    Language English
    Publishing date 2019-08-18
    Publishing country Czech Republic
    Document type Journal Article
    ZDB-ID 1217739-8
    ISSN 1802-5307 ; 0862-495X
    ISSN (online) 1802-5307
    ISSN 0862-495X
    DOI 10.14735/amko2019288
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  4. Article ; Online: First-Line Nivolumab and Relatlimab Plus Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma: The Phase II RELATIVITY-060 Study.

    Hegewisch-Becker, Susanna / Mendez, Guillermo / Chao, Joseph / Nemecek, Radim / Feeney, Kynan / Van Cutsem, Eric / Al-Batran, Salah-Eddin / Mansoor, Wasat / Maisey, Nicholas / Pazo Cid, Roberto / Burge, Matthew / Perez-Callejo, David / Hipkin, R William / Mukherjee, Sourav / Lei, Ming / Tang, Hao / Suryawanshi, Satyendra / Kelly, Ronan J / Tebbutt, Niall C

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology

    2024  , Page(s) JCO2301636

    Abstract: Purpose: Open-label phase II study (RELATIVITY-060) to investigate the efficacy and safety of first-line nivolumab, a PD-1-blocking antibody, plus relatlimab, a lymphocyte-activation gene 3 (LAG-3)-blocking antibody, plus chemotherapy in patients with ... ...

    Abstract Purpose: Open-label phase II study (RELATIVITY-060) to investigate the efficacy and safety of first-line nivolumab, a PD-1-blocking antibody, plus relatlimab, a lymphocyte-activation gene 3 (LAG-3)-blocking antibody, plus chemotherapy in patients with previously untreated advanced gastric cancer (GC) or gastroesophageal junction cancer (GEJC).
    Methods: Patients with unresectable, locally advanced or metastatic GC/GEJC were randomly assigned 1:1 to nivolumab + relatlimab (fixed-dose combination) + chemotherapy or nivolumab + chemotherapy. The primary end point was objective response rate (ORR; per RECIST v1.1 by blinded independent central review [BICR]) in patients whose tumors had LAG-3 expression ≥1%.
    Results: Of 274 patients, 138 were randomly assigned to nivolumab + relatlimab + chemotherapy and 136 to nivolumab + chemotherapy. Median follow-up was 11.9 months. In patients with LAG-3 expression ≥1%, BICR-assessed ORR (95% CI) was 48% (38 to 59) in the nivolumab + relatlimab + chemotherapy arm and 61% (51 to 71) in the nivolumab + chemotherapy arm; median progression-free survival (95% CI) by BICR was 7.0 months (5.8 to 8.4) versus 8.3 months (6.9 to 12.1; hazard ratio [HR], 1.41 [95% CI, 0.97 to 2.05]), and median overall survival (95% CI) was 13.5 months (11.9 to 19.1) versus 16.0 months (10.9 to not estimable; HR, 1.04 [95% CI, 0.70 to 1.54]), respectively. Grade 3 or 4 treatment-related adverse events (TRAEs) occurred in 69% and 61% of all treated patients, and 42% and 36% of patients discontinued because of any-grade TRAEs in the nivolumab + relatlimab + chemotherapy and nivolumab + chemotherapy arms, respectively.
    Conclusion: RELATIVITY-060 did not meet its primary end point of improved ORR in patients with LAG-3 expression ≥1% when relatlimab was added to nivolumab + chemotherapy compared with nivolumab + chemotherapy. Further studies are needed to address whether adding anti-LAG-3 to anti-PD-1 plus chemotherapy can benefit specific GC/GEJC patient subgroups.
    Language English
    Publishing date 2024-05-09
    Publishing country United States
    Document type Journal Article
    ZDB-ID 604914-x
    ISSN 1527-7755 ; 0732-183X
    ISSN (online) 1527-7755
    ISSN 0732-183X
    DOI 10.1200/JCO.23.01636
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    Zs.MO 650: Show issues

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  5. Article: Stereotactic Body Radiotherapy (SBRT) of Pancreatic Cancer-A Critical Review and Practical Consideration.

    Burkoň, Petr / Trna, Jan / Slávik, Marek / Němeček, Radim / Kazda, Tomáš / Pospíšil, Petr / Dastych, Milan / Eid, Michal / Novotný, Ivo / Procházka, Tomáš / Vrzal, Miroslav

    Biomedicines

    2022  Volume 10, Issue 10

    Abstract: Pancreatic cancer is the third leading cause of cancer death in the developed world and is predicted to become the second by 2030. A cure may be achieved only with surgical resection of an early diagnosed disease. Surgery for more advanced disease is ... ...

    Abstract Pancreatic cancer is the third leading cause of cancer death in the developed world and is predicted to become the second by 2030. A cure may be achieved only with surgical resection of an early diagnosed disease. Surgery for more advanced disease is challenging and can be contraindicated for many reasons. Neoadjuvant therapy may improve the probability of achieving R0 resection. It consists of systemic treatment followed by radiation therapy applied concurrently or sequentially with cytostatics. A novel approach to irradiation, stereotactic body radiotherapy (SBRT), has the potential to improve treatment results. SBRT can deliver higher doses of radiation to the tumor in only a few treatment fractions. It has attracted significant interest for pancreatic cancer patients, as it is completed quickly, requires less time away from full-dose chemotherapy, and is well-tolerated than conventional radiotherapy. In this review, we aim to provide the reader with a basic overview of current evidence for SBRT indications in the treatment of pancreatic tumors. In the second part of the review, we focus on practical information with respect to SBRT treatment plan preparation the performance of such therapy. Finally, we discuss future directions related to the use of magnetic resonance linear accelerators.
    Language English
    Publishing date 2022-10-04
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2720867-9
    ISSN 2227-9059
    ISSN 2227-9059
    DOI 10.3390/biomedicines10102480
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  6. Article ; Online: Deficient mismatch repair as a prognostic marker in stage II colon cancer patients.

    Gkekas, Ioannis / Novotny, Jan / Fabian, Pavel / Nemecek, Radim / Palmqvist, Richard / Strigård, Karin / Pecen, Ladislav / Svoboda, Tomas / Gurlich, Robert / Gunnarsson, Ulf

    European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology

    2019  Volume 45, Issue 10, Page(s) 1854–1861

    Abstract: Background: A number of reports have evaluated the relationship between deficient DNA mismatch repair (dMMR) and colorectal cancer prognosis. Unfortunately, the exact prognostic role of dMMR has not been clearly established due to contradictory results. ...

    Abstract Background: A number of reports have evaluated the relationship between deficient DNA mismatch repair (dMMR) and colorectal cancer prognosis. Unfortunately, the exact prognostic role of dMMR has not been clearly established due to contradictory results. This study aims to determine the prognostic impact of dMRR in stage II colon cancer patients only. The appropriate identification of high-risk stage II colon cancers is of paramount importance in the selection of patients who may benefit from adjuvant treatment after surgery.
    Methods: Four hundred and fifty-two patients with curative resection of stage II colon cancer were included. Hospital records were used as data source, providing clinical, surgical, pathology, oncology and follow-up information for statistical analysis focusing on overall survival (OS) and time to progression (TTP). Mismatch repair status was determined by immunohistochemistry. Patient survival was followed-up for a mean of 77·35 months.
    Results: dMMR was detected in 93 of 452 patients (20·6%). No impact on overall survival (Log-Rank, p = 0·583, 95% CI 0·76-1·67). However, the hazard ratio 0·50 for TTP was highly significant (Log-Rank, p = 0·012, 95% CI 0·28-0·87) in patients with dMMR compared with those with mismatch repair proficient tumours (pMMR).
    Conclusions: Patients with dMMR tumours have a lower risk for recurrence compared to those with pMMR tumours, but this finding did not correlate to better overall survival.
    MeSH term(s) Adenocarcinoma/diagnosis ; Adenocarcinoma/genetics ; Adenocarcinoma/metabolism ; Adult ; Aged ; Aged, 80 and over ; Colonic Neoplasms/diagnosis ; Colonic Neoplasms/genetics ; Colonic Neoplasms/therapy ; Combined Modality Therapy ; DNA Mismatch Repair ; DNA, Neoplasm/genetics ; Female ; Follow-Up Studies ; Humans ; Immunohistochemistry ; Male ; Middle Aged ; Neoplasm Staging ; Prognosis ; Retrospective Studies
    Chemical Substances DNA, Neoplasm
    Language English
    Publishing date 2019-05-28
    Publishing country England
    Document type Journal Article ; Multicenter Study
    ZDB-ID 632519-1
    ISSN 1532-2157 ; 0748-7983
    ISSN (online) 1532-2157
    ISSN 0748-7983
    DOI 10.1016/j.ejso.2019.05.023
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    Zs.A 1149: Show issues Location:
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  7. Article ; Online: MicroRNAs targeting EGFR signalling pathway in colorectal cancer.

    Mlcochova, Jitka / Faltejskova, Petra / Nemecek, Radim / Svoboda, Marek / Slaby, Ondrej

    Journal of cancer research and clinical oncology

    2013  Volume 139, Issue 10, Page(s) 1615–1624

    Abstract: MicroRNAs (miRNAs) are short, 18-25-nucleotide long, non-coding single-stranded RNAs, which are capable to regulate gene expression on post-transcriptional level through binding to their target protein-encoding mRNAs. miRNAs regulate individual ... ...

    Abstract MicroRNAs (miRNAs) are short, 18-25-nucleotide long, non-coding single-stranded RNAs, which are capable to regulate gene expression on post-transcriptional level through binding to their target protein-encoding mRNAs. miRNAs regulate individual components of multiple oncogenic pathways. One of them is epidermal growth factor receptor (EGFR) signalling pathway that regulates cell proliferation, differentiation, migration, angiogenesis and apoptosis. All these processes are deregulated in colorectal cancer (CRC). Moreover, EGFR has been validated as the therapeutic target in CRC, and monoclonal antibodies cetuximab and panitumumab are used in the therapy of patients with metastatic CRC. Because of the extensive involvement of miRNAs in the regulation of EGFR signalling, it seems they could also serve as promising predictive biomarkers to anti-EGFR therapy. In this review, we summarize current knowledge about miRNAs targeting EGFR signalling pathway, their functioning in CRC pathogenesis and potential usage as biomarkers.
    MeSH term(s) Biomarkers, Tumor/genetics ; Colorectal Neoplasms/genetics ; Colorectal Neoplasms/metabolism ; ErbB Receptors/genetics ; ErbB Receptors/metabolism ; Gene Expression Regulation, Neoplastic ; Humans ; MicroRNAs/genetics ; Protein Kinases/genetics ; Protein Kinases/metabolism ; RNA Interference ; Signal Transduction
    Chemical Substances Biomarkers, Tumor ; MicroRNAs ; Protein Kinases (EC 2.7.-) ; EGFR protein, human (EC 2.7.10.1) ; ErbB Receptors (EC 2.7.10.1)
    Language English
    Publishing date 2013-07-02
    Publishing country Germany
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Review
    ZDB-ID 134792-5
    ISSN 1432-1335 ; 0171-5216 ; 0084-5353 ; 0943-9382
    ISSN (online) 1432-1335
    ISSN 0171-5216 ; 0084-5353 ; 0943-9382
    DOI 10.1007/s00432-013-1470-9
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  8. Article: Onkologie v obrazech: Generalizovaný Kaposiho sarkom.

    Svoboda, Marek / Grell, Peter / Nemecek, Radim / Sachlova, Milana / Slampa, Pavel

    Klinicka onkologie : casopis Ceske a Slovenske onkologicke spolecnosti

    2012  Volume 25, Issue 5, Page(s) 394

    Title translation Oncology in images: generalized Kaposi sarcoma.
    MeSH term(s) Aged ; Humans ; Male ; Sarcoma, Kaposi/diagnosis ; Sarcoma, Kaposi/pathology ; Skin Neoplasms/diagnosis ; Skin Neoplasms/pathology
    Language Czech
    Publishing date 2012
    Publishing country Czech Republic
    Document type Case Reports ; Journal Article
    ZDB-ID 1217739-8
    ISSN 0862-495X
    ISSN 0862-495X
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  9. Article: Mutational analysis of primary and metastatic colorectal cancer samples underlying the resistance to cetuximab-based therapy.

    Nemecek, Radim / Berkovcova, Jitka / Radova, Lenka / Kazda, Tomas / Mlcochova, Jitka / Vychytilova-Faltejskova, Petra / Slaby, Ondrej / Svoboda, Marek

    OncoTargets and therapy

    2016  Volume 9, Page(s) 4695–4703

    Abstract: Purpose: Although several molecular markers predicting resistance to cetuximab- or panitumumab-based therapy of metastatic colorectal cancer were described, mutations in RAS proto-oncogenes remain the only predictors being used in daily clinical ... ...

    Abstract Purpose: Although several molecular markers predicting resistance to cetuximab- or panitumumab-based therapy of metastatic colorectal cancer were described, mutations in RAS proto-oncogenes remain the only predictors being used in daily clinical practice. However, 35%-45% of wild-type RAS patients still do not respond to this anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody-based therapy, and therefore the definition of other predictors forms an important clinical need. The aim of the present retrospective single-institutional study was to evaluate potential genes responsible for resistance to anti-EGFR therapy in relation to mutational analysis of primary versus metastatic lesions.
    Patients and methods: Twenty-four paired primary and corresponding metastatic tissue samples from eight nonresponding and four responding metastatic colorectal cancer patients treated with cetuximab-based therapy were sequenced using a next-generation sequencing panel of 26 genes involved in EGFR signaling pathway and colorectal carcinogenesis.
    Results: Mutational status of primary tumors and metastatic lesions was highly concordant in TP53, APC, CTNNB1, KRAS, PIK3CA, PTEN, and FBXW7 genes. Metastatic samples harbor significantly more mutations than primary tumors. Potentially negative predictive value of FBXW7 mutations in relationship to anti-EGFR treatment outcomes was confirmed. Finally, new occurrences of activating KRAS mutations were identified in a group of patients initially determined as wild-type RAS by routinely used qPCR-based RAS mutational tests. All newly detected activating KRAS mutations most likely led to cetuximab treatment failure.
    Conclusion: The results of the present study suggest a need of careful consideration of previously published results of anti-EGFR-targeted therapy with regard to potentially inaccurate diagnostic tools used in the past. Based on our findings, we recommend more extensive use of next-generation sequencing testing in daily clinical practice, as it brings a significant added value in terms of validity of the diagnostic procedure.
    Language English
    Publishing date 2016-07-28
    Publishing country New Zealand
    Document type Journal Article
    ZDB-ID 2495130-4
    ISSN 1178-6930
    ISSN 1178-6930
    DOI 10.2147/OTT.S102891
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  10. Article ; Online: MABp1 as a novel antibody treatment for advanced colorectal cancer: a randomised, double-blind, placebo-controlled, phase 3 study.

    Hickish, Tamas / Andre, Thierry / Wyrwicz, Lucjan / Saunders, Mark / Sarosiek, Tomasz / Kocsis, Judit / Nemecek, Radim / Rogowski, Wojciech / Lesniewski-Kmak, Krzysztof / Petruzelka, Lubos / Apte, Ron N / Mohanty, Prasant / Stecher, Michael / Simard, John / de Gramont, Aimery

    The Lancet. Oncology

    2017  Volume 18, Issue 2, Page(s) 192–201

    Abstract: Background: MABp1, an antibody that targets interleukin 1α, has been associated with antitumour activity and relief of debilitating symptoms in patients with advanced colorectal cancer. We sought to establish the effect of MABp1 with a new primary ... ...

    Abstract Background: MABp1, an antibody that targets interleukin 1α, has been associated with antitumour activity and relief of debilitating symptoms in patients with advanced colorectal cancer. We sought to establish the effect of MABp1 with a new primary endpoint in patients with advanced colorectal cancer.
    Methods: Eligible patients for the double-blind phase of this ongoing, placebo-controlled, randomised, phase 3 trial, had metastatic or unresectable disease, Eastern Cooperative Oncology Group performance status score 1 or 2, systemic inflammation, weight loss, and other disease-related morbidities associated with poor prognosis, and were refractory to oxaliplatin and irinotecan. Patients were randomly assigned 2:1 to receive either MABp1 or placebo. Randomisation codes were obtained from a centrally held list via an interactive web response system. Patients received an intravenous infusion of 7·5 mg/kg MABp1 or placebo given every 2 weeks for 8 weeks. The primary endpoint was assessed in patients who received at least one dose of MABp1 or placebo (modified intention-to-treat population), and was a composite of stable or increased lean body mass and stability or improvement in two of three symptoms (pain, fatigue, or anorexia) at week 8 compared with baseline measurements. This study is registered with ClinicalTrials.gov, number NCT02138422.
    Findings: Patients were enrolled between May 20, 2014, and Sept 2, 2015. The double-blind phase of the study was completed on Nov 3, 2015. Of 333 patients randomly assigned treatment, 207 received at least one dose of MABp1 and 102 at least one dose of placebo. 68 (33%) and 19 (19%) patients, respectively, achieved the primary endpoint (relative risk 1·76, 95% CI 1·12-2·77, p=0·0045). The most common grade 3-4 adverse events in the MABp1 group compared with in the placebo group were anaemia (eight [4%] of 207 vs five [5%] of 102 patients), increased concentration of alkaline phosphatase (nine [4%] vs two [2%]), fatigue (six [3%] vs seven [7%]), and increased concentration of aspartate aminotransferase (six [3%] vs two [2%]). After 8 weeks, 17 (8%) patients in the MABp1 group and 11 (11%) in the placebo group had died, but no death was judged to be related to treatment. The incidence of serious adverse events was not significantly different in the MABp1 group and placebo groups (47 [23%] vs 33 [32%], p=0·07).
    Interpretation: The primary endpoint was a useful means of measuring clinical performance in patients. MABp1 might represent a new standard in the management of advanced colorectal cancer.
    Funding: XBiotech.
    MeSH term(s) Adenocarcinoma/drug therapy ; Adenocarcinoma/immunology ; Adenocarcinoma/secondary ; Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal/therapeutic use ; Colorectal Neoplasms/drug therapy ; Colorectal Neoplasms/immunology ; Colorectal Neoplasms/pathology ; Double-Blind Method ; Female ; Follow-Up Studies ; Humans ; Lymphatic Metastasis ; Male ; Middle Aged ; Neoplasm Staging ; Prognosis ; Survival Rate
    Chemical Substances Antibodies, Monoclonal ; MABp1 monoclonal antibody
    Language English
    Publishing date 2017-01-14
    Publishing country England
    Document type Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
    ZDB-ID 2049730-1
    ISSN 1474-5488 ; 1470-2045
    ISSN (online) 1474-5488
    ISSN 1470-2045
    DOI 10.1016/S1470-2045(17)30006-2
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