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  1. Article ; Online: Selecting Adjuvant Treatment for Endometrial Carcinoma Using Molecular Risk Factors.

    Wortman, Bastiaan G / Nout, Remi A / Bosse, Tjalling / Creutzberg, Carien L

    Current oncology reports

    2019  Volume 21, Issue 9, Page(s) 83

    Abstract: Purpose of review: To provide an overview of common molecular risk factors in endometrial cancer (EC) with the possibility to improve adjuvant treatment selection.: Recent findings: Recent studies have discovered and confirmed four different ... ...

    Abstract Purpose of review: To provide an overview of common molecular risk factors in endometrial cancer (EC) with the possibility to improve adjuvant treatment selection.
    Recent findings: Recent studies have discovered and confirmed four different molecular subclasses in EC, with each having a distinct prognosis; POLE-ultramutated, microsatellite unstable, copy-number low, and copy-number high. Subsequent studies have shown that combining both molecular with clinicopathological risk factors can potentially improve adjuvant treatment selection for women with high-intermediate risk EC. For high risk and advanced stage EC, several molecular alterations are being explored for targeted therapy. Molecular alterations are frequently found in endometrial cancer and have currently not been implemented in the treatment guidelines for EC. Assessment of molecular alterations can distinguish patients that require less or more intensified adjuvant treatment. Trials investigating targeted therapies in EC are ongoing and have shown some promising results, however, more evidence is needed and results of randomized trials have to be awaited.
    MeSH term(s) Age Factors ; Biomarkers, Tumor/genetics ; Carcinoma, Endometrioid/genetics ; Carcinoma, Endometrioid/metabolism ; Carcinoma, Endometrioid/pathology ; Carcinoma, Endometrioid/therapy ; Chemotherapy, Adjuvant/methods ; Endometrial Neoplasms/genetics ; Endometrial Neoplasms/metabolism ; Endometrial Neoplasms/pathology ; Endometrial Neoplasms/therapy ; Female ; Humans ; Molecular Targeted Therapy/methods ; Mutation ; Prognosis ; Radiotherapy, Adjuvant/methods ; Risk Factors
    Chemical Substances Biomarkers, Tumor
    Language English
    Publishing date 2019-07-31
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2057359-5
    ISSN 1534-6269 ; 1523-3790
    ISSN (online) 1534-6269
    ISSN 1523-3790
    DOI 10.1007/s11912-019-0825-z
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 5521: Show issues Location:
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  2. Article ; Online: Molecular Classification Predicts Response to Radiotherapy in the Randomized PORTEC-1 and PORTEC-2 Trials for Early-Stage Endometrioid Endometrial Cancer.

    Horeweg, Nanda / Nout, Remi A / Jürgenliemk-Schulz, Ina M / Lutgens, Ludy C H W / Jobsen, Jan J / Haverkort, Marie A D / Mens, Jan Willem M / Slot, Annerie / Wortman, Bastiaan G / de Boer, Stephanie M / Stelloo, Ellen / Verhoeven-Adema, Karen W / Putter, Hein / Smit, Vincent T H B M / Bosse, Tjalling / Creutzberg, Carien L

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

    2023  Volume 41, Issue 27, Page(s) 4369–4380

    Abstract: Purpose: The molecular classification of endometrial cancer (EC) has proven to have prognostic value and is predictive of response to adjuvant chemotherapy. Here, we investigate its predictive value for response to external beam radiotherapy (EBRT) and ... ...

    Abstract Purpose: The molecular classification of endometrial cancer (EC) has proven to have prognostic value and is predictive of response to adjuvant chemotherapy. Here, we investigate its predictive value for response to external beam radiotherapy (EBRT) and vaginal brachytherapy (VBT) in early-stage endometrioid EC (EEC).
    Methods: Data of the randomized PORTEC-1 trial (n = 714) comparing pelvic EBRT with no adjuvant therapy in early-stage intermediate-risk EC and the PORTEC-2 trial (n = 427) comparing VBT with EBRT in early-stage high-intermediate-risk EC were used. Locoregional (including vaginal and pelvic) recurrence-free survival was compared between treatment groups across the four molecular classes using Kaplan-Meier's methodology and log-rank tests.
    Results: A total of 880 molecularly classified ECs, 484 from PORTEC-1 and 396 from PORTEC-2, were included. The majority were FIGO-2009 stage I EEC (97.2%). The median follow-up was 11.3 years. No locoregional recurrences were observed in EC with a pathogenic mutation of DNA polymerase-ε (
    Conclusion: The molecular classification of EC predicts response to radiotherapy in stage I EEC and may guide adjuvant treatment decisions. Omitting radiotherapy seems to be safe in
    MeSH term(s) Female ; Humans ; Radiation Oncology ; Endometrial Neoplasms/genetics ; Endometrial Neoplasms/radiotherapy ; Brachytherapy ; Combined Modality Therapy
    Language English
    Publishing date 2023-07-24
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 604914-x
    ISSN 1527-7755 ; 0732-183X
    ISSN (online) 1527-7755
    ISSN 0732-183X
    DOI 10.1200/JCO.23.00062
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Prognostic impact and causality of age on oncological outcomes in women with endometrial cancer: a multimethod analysis of the randomised PORTEC-1, PORTEC-2, and PORTEC-3 trials.

    Wakkerman, Famke C / Wu, Jiqing / Putter, Hein / Jürgenliemk-Schulz, Ina M / Jobsen, Jan J / Lutgens, Ludy C H W / Haverkort, Marie A D / de Jong, Marianne A / Mens, Jan Willem M / Wortman, Bastiaan G / Nout, Remi A / Léon-Castillo, Alicia / Powell, Melanie E / Mileshkin, Linda R / Katsaros, Dionyssios / Alfieri, Joanne / Leary, Alexandra / Singh, Naveena / de Boer, Stephanie M /
    Nijman, Hans W / Smit, Vincent T H B M / Bosse, Tjalling / Koelzer, Viktor H / Creutzberg, Carien L / Horeweg, Nanda

    The Lancet. Oncology

    2024  

    Abstract: Background: Numerous studies have shown that older women with endometrial cancer have a higher risk of recurrence and cancer-related death. However, it remains unclear whether older age is a causal prognostic factor, or whether other risk factors become ...

    Abstract Background: Numerous studies have shown that older women with endometrial cancer have a higher risk of recurrence and cancer-related death. However, it remains unclear whether older age is a causal prognostic factor, or whether other risk factors become increasingly common with age. We aimed to address this question with a unique multimethod study design using state-of-the-art statistical and causal inference techniques on datasets of three large, randomised trials.
    Methods: In this multimethod analysis, data from 1801 women participating in the randomised PORTEC-1, PORTEC-2, and PORTEC-3 trials were used for statistical analyses and causal inference. The cohort included 714 patients with intermediate-risk endometrial cancer, 427 patients with high-intermediate risk endometrial cancer, and 660 patients with high-risk endometrial cancer. Associations of age with clinicopathological and molecular features were analysed using non-parametric tests. Multivariable competing risk analyses were performed to determine the independent prognostic value of age. To analyse age as a causal prognostic variable, a deep learning causal inference model called AutoCI was used.
    Findings: Median follow-up as estimated using the reversed Kaplan-Meier method was 12·3 years (95% CI 11·9-12·6) for PORTEC-1, 10·5 years (10·2-10·7) for PORTEC-2, and 6·1 years (5·9-6·3) for PORTEC-3. Both overall recurrence and endometrial cancer-specific death significantly increased with age. Moreover, older women had a higher frequency of deep myometrial invasion, serous tumour histology, and p53-abnormal tumours. Age was an independent risk factor for both overall recurrence (hazard ratio [HR] 1·02 per year, 95% CI 1·01-1·04; p=0·0012) and endometrial cancer-specific death (HR 1·03 per year, 1·01-1·05; p=0·0012) and was identified as a significant causal variable.
    Interpretation: This study showed that advanced age was associated with more aggressive tumour features in women with endometrial cancer, and was independently and causally related to worse oncological outcomes. Therefore, our findings suggest that older women with endometrial cancer should not be excluded from diagnostic assessments, molecular testing, and adjuvant therapy based on their age alone.
    Funding: None.
    Language English
    Publishing date 2024-04-30
    Publishing country England
    Document type Journal Article
    ZDB-ID 2049730-1
    ISSN 1474-5488 ; 1470-2045
    ISSN (online) 1474-5488
    ISSN 1470-2045
    DOI 10.1016/S1470-2045(24)00142-6
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  4. Article ; Online: Radiation Therapy Techniques and Treatment-Related Toxicity in the PORTEC-3 Trial: Comparison of 3-Dimensional Conformal Radiation Therapy Versus Intensity-Modulated Radiation Therapy.

    Wortman, Bastiaan G / Post, Cathalijne C B / Powell, Melanie E / Khaw, Pearly / Fyles, Anthony / D'Amico, Romerai / Haie-Meder, Christine / Jürgenliemk-Schulz, Ina M / McCormack, Mary / Do, Viet / Katsaros, Dionyssios / Bessette, Paul / Baron, Marie Hélène / Nout, Remi A / Whitmarsh, Karen / Mileshkin, Linda / Lutgens, Ludy C H W / Kitchener, Henry C / Brooks, Susan /
    Nijman, Hans W / Astreinidou, Eleftheria / Putter, Hein / Creutzberg, Carien L / de Boer, Stephanie M

    International journal of radiation oncology, biology, physics

    2021  Volume 112, Issue 2, Page(s) 390–399

    Abstract: Purpose: Radiation therapy techniques have developed from 3-dimensional conformal radiation therapy (3DCRT) to intensity modulated radiation therapy (IMRT), with better sparing of the surrounding normal tissues. The current analysis aimed to investigate ...

    Abstract Purpose: Radiation therapy techniques have developed from 3-dimensional conformal radiation therapy (3DCRT) to intensity modulated radiation therapy (IMRT), with better sparing of the surrounding normal tissues. The current analysis aimed to investigate whether IMRT, compared to 3DCRT, resulted in fewer adverse events (AEs) and patient-reported symptoms in the randomized PORTEC-3 trial for high-risk endometrial cancer.
    Methods and materials: Data on AEs and patient-reported quality of life (QoL) of the PORTEC-3 trial were available for analysis. Physician-reported AEs were graded using Common Terminology Criteria for Adverse Events v3.0. QoL was assessed by the European Organisation for Research and Treatment of Cancer QLQC30, CX24, and OV28 questionnaires. Data were compared between 3DCRT and IMRT. A P value of ≤ .01 was considered statistically significant due to the risk of multiple testing. For QoL, combined scores 1 to 2 ("not at all" and "a little") versus 3 to 4 ("quite a bit" and "very much") were compared between the techniques.
    Results: Of 658 evaluable patients, 559 received 3DCRT and 99 IMRT. Median follow-up was 74.6 months. During treatment no significant differences were observed, with a trend for more grade ≥3 AEs, mostly hematologic and gastrointestinal, after 3DCRT (37.7% vs 26.3%, P = .03). During follow-up, 15.4% (vs 4%) had grade ≥2 diarrhea, and 26.1% (vs 13.1%) had grade ≥2 hematologic AEs after 3DCRT (vs IMRT) (both P < .01). Among 574 (87%) patients evaluable for QoL, 494 received 3DCRT and 80 IMRT. During treatment, 37.5% (vs 28.6%) reported diarrhea after 3DCRT (vs IMRT) (P = .125); 22.1% (versus 10.0%) bowel urgency (P = 0039), and 18.2% and 8.6% abdominal cramps (P = .058). Other QoL scores showed no differences.
    Conclusions: IMRT resulted in fewer grade ≥3 AEs during treatment and significantly lower rates of grade ≥2 diarrhea and hematologic AEs during follow-up. Trends toward fewer patient-reported bowel urgency and abdominal cramps were observed after IMRT compared to 3DCRT.
    MeSH term(s) Humans ; Quality of Life ; Radiotherapy Planning, Computer-Assisted/methods ; Radiotherapy, Conformal/adverse effects ; Radiotherapy, Conformal/methods ; Radiotherapy, Intensity-Modulated/adverse effects ; Radiotherapy, Intensity-Modulated/methods
    Language English
    Publishing date 2021-10-02
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 197614-x
    ISSN 1879-355X ; 0360-3016
    ISSN (online) 1879-355X
    ISSN 0360-3016
    DOI 10.1016/j.ijrobp.2021.09.042
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 1218: Show issues Location:
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  5. Article ; Online: PORTEC-4a: international randomized trial of molecular profile-based adjuvant treatment for women with high-intermediate risk endometrial cancer.

    van den Heerik, Anne Sophie V M / Horeweg, Nanda / Nout, Remi A / Lutgens, Ludy C H W / van der Steen-Banasik, Elzbieta M / Westerveld, G Henrike / van den Berg, Hetty A / Slot, Annerie / Koppe, Friederike L A / Kommoss, Stefan / Mens, Jan Willem M / Nowee, Marlies E / Bijmolt, Stefan / Cibula, David / Stam, Tanja C / Jurgenliemk-Schulz, Ina M / Snyers, An / Hamann, Moritz / Zwanenburg, Aleida G /
    Coen, Veronique L M A / Vandecasteele, Katrien / Gillham, Charles / Chargari, Cyrus / Verhoeven-Adema, Karen W / Putter, Hein / van den Hout, Wilbert B / Wortman, Bastiaan G / Nijman, Hans W / Bosse, Tjalling / Creutzberg, Carien L

    International journal of gynecological cancer : official journal of the International Gynecological Cancer Society

    2020  Volume 30, Issue 12, Page(s) 2002–2007

    Abstract: Background: Vaginal brachytherapy is currently recommended as adjuvant treatment in patients with high-intermediate risk endometrial cancer to maximize local control and has only mild side effects and no or limited impact on quality of life. However, ... ...

    Abstract Background: Vaginal brachytherapy is currently recommended as adjuvant treatment in patients with high-intermediate risk endometrial cancer to maximize local control and has only mild side effects and no or limited impact on quality of life. However, there is still considerable overtreatment and also some undertreatment, which may be reduced by tailoring adjuvant treatment to the patients' risk of recurrence based on molecular tumor characteristics.
    Primary objectives: To compare the rates of vaginal recurrence in women with high-intermediate risk endometrial cancer, treated after surgery with molecular-integrated risk profile-based recommendations for either observation, vaginal brachytherapy or external pelvic beam radiotherapy or with standard adjuvant vaginal brachytherapy STUDY HYPOTHESIS: Adjuvant treatment based on a molecular-integrated risk profile provides similar local control and recurrence-free survival as current standard adjuvant brachytherapy in patients with high-intermediate risk endometrial cancer, while sparing many patients the morbidity of adjuvant treatment and reducing healthcare costs.
    Trial design: A multicenter, international phase III randomized trial (2:1) of molecular-integrated risk profile-based adjuvant treatment (experimental arm) or adjuvant vaginal brachytherapy (standard arm).
    Major inclusion/exclusion criteria: Women aged 18 years and over with a histological diagnosis of high-intermediate risk endometrioid endometrial cancer after total abdominal or laparoscopic hysterectomy and bilateral salpingo-oophorectomy. High-intermediate risk factors are defined as: (i) International Federation of Gynecology and Obstetrics stage IA (with invasion) and grade 3; (ii) stage IB grade 1 or 2 with age ≥60 and/or lymph-vascular space invasion; (iii) stage IB, grade 3 without lymph-vascular space invasion; or (iv) stage II (microscopic and grade 1).
    Endpoints: The primary endpoint is vaginal recurrence. Secondary endpoints are recurrence-free and overall survival; pelvic and distant recurrence; 5-year vaginal control (including treatment for relapse); adverse events and patient-reported symptoms and quality of life; and endometrial cancer-related healthcare costs.
    Sample size: 500 eligible and evaluable patients.
    Estimated dates for completing accrual and presenting results: Estimated date for completing accrual will be late 2021. Estimated date for presentation of (first) results is expected in 2023.
    Trial registration: The trial is registered at clinicaltrials.gov (NCT03469674) and ISRCTN (11659025).
    MeSH term(s) Brachytherapy ; Carcinoma, Endometrioid/genetics ; Carcinoma, Endometrioid/radiotherapy ; Carcinoma, Endometrioid/therapy ; Clinical Trials, Phase III as Topic ; DNA-Binding Proteins/genetics ; DNA-Binding Proteins/metabolism ; Endometrial Neoplasms/genetics ; Endometrial Neoplasms/radiotherapy ; Endometrial Neoplasms/therapy ; Female ; Humans ; Mismatch Repair Endonuclease PMS2/genetics ; Mismatch Repair Endonuclease PMS2/metabolism ; Multicenter Studies as Topic ; MutL Protein Homolog 1/genetics ; MutL Protein Homolog 1/metabolism ; MutS Homolog 2 Protein/genetics ; MutS Homolog 2 Protein/metabolism ; Radiotherapy, Adjuvant ; Randomized Controlled Trials as Topic
    Chemical Substances DNA-Binding Proteins ; G-T mismatch-binding protein ; MLH1 protein, human ; PMS2 protein, human (EC 3.6.1.-) ; MSH2 protein, human (EC 3.6.1.3) ; Mismatch Repair Endonuclease PMS2 (EC 3.6.1.3) ; MutL Protein Homolog 1 (EC 3.6.1.3) ; MutS Homolog 2 Protein (EC 3.6.1.3)
    Language English
    Publishing date 2020-10-12
    Publishing country England
    Document type Clinical Trial Protocol ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1070385-8
    ISSN 1525-1438 ; 1048-891X
    ISSN (online) 1525-1438
    ISSN 1048-891X
    DOI 10.1136/ijgc-2020-001929
    Database MEDical Literature Analysis and Retrieval System OnLINE

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