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  1. Article ; Online: Masticatory efficiency in complete denture and single implant-retained mandibular overdenture wearers with different occlusion schemes: A randomized clinical trial.

    Rocha, Cibele O M / Longhini, Diogo / Pereira, Rodrigo P / Lima, Amanda L O / Bonafé, Fernanda S S / Arioli Filho, João N

    The Journal of prosthetic dentistry

    2021  Volume 129, Issue 6, Page(s) 888–894

    Abstract: Statement of problem: How the masticatory function of complete denture wearers is influenced by the positioning and occlusion of posterior teeth or by the presence of a single mandibular implant is unclear.: Purpose: The purpose of this randomized ... ...

    Abstract Statement of problem: How the masticatory function of complete denture wearers is influenced by the positioning and occlusion of posterior teeth or by the presence of a single mandibular implant is unclear.
    Purpose: The purpose of this randomized crossover clinical trial was to evaluate the masticatory efficiency of wearers of bimaxillary complete dentures and of wearers of maxillary complete denture and single implant-retained mandibular overdentures, both with bilateral balanced occlusion and lingualized occlusion.
    Material and methods: Participants received 2 sets of complete dentures with interchangeable teeth in the mandibular prosthesis to allow a change in the occlusion scheme. Subsequently, 1 implant was placed in the mandibular symphysis region, and the mandibular complete dentures were converted to overdentures. The masticatory efficiency was measured by the sieve method for both occlusal schemes.
    Results: Repeated measures ANOVA showed no statistically significant difference in the masticatory efficiency with the 2 occlusal schemes for conventional complete dentures (P=.707) or overdentures (P=.407). When comparing the type of prosthesis, statistical differences were found for masticatory efficiency (P=.012), with improved mastication for the overdentures.
    Conclusions: A mandibular single implant improved the masticatory efficiency of patients with complete dentures, but the occlusal scheme did not influence this factor.
    MeSH term(s) Humans ; Denture, Overlay ; Patient Satisfaction ; Dental Implants ; Denture, Complete ; Mandible ; Mastication ; Dental Prosthesis, Implant-Supported
    Chemical Substances Dental Implants
    Language English
    Publishing date 2021-09-10
    Publishing country United States
    Document type Randomized Controlled Trial ; Journal Article
    ZDB-ID 218157-5
    ISSN 1097-6841 ; 0022-3913
    ISSN (online) 1097-6841
    ISSN 0022-3913
    DOI 10.1016/j.prosdent.2021.06.028
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  2. Article ; Online: Overall survival with first-line atezolizumab in combination with vemurafenib and cobimetinib in BRAF

    Ascierto, Paolo A / Stroyakovskiy, Daniil / Gogas, Helen / Robert, Caroline / Lewis, Karl / Protsenko, Svetlana / Pereira, Rodrigo P / Eigentler, Thomas / Rutkowski, Piotr / Demidov, Lev / Zhukova, Natalia / Schachter, Jacob / Yan, Yibing / Caro, Ivor / Hertig, Christian / Xue, Cloris / Kusters, Lieke / McArthur, Grant A / Gutzmer, Ralf

    The Lancet. Oncology

    2022  Volume 24, Issue 1, Page(s) 33–44

    Abstract: Background: Primary analysis of the phase 3 IMspire150 study showed improved investigator-assessed progression-free survival with first-line atezolizumab, vemurafenib, and cobimetinib (atezolizumab group) versus placebo, vemurafenib, and cobimetinib ( ... ...

    Abstract Background: Primary analysis of the phase 3 IMspire150 study showed improved investigator-assessed progression-free survival with first-line atezolizumab, vemurafenib, and cobimetinib (atezolizumab group) versus placebo, vemurafenib, and cobimetinib (control group) in patients with BRAF
    Methods: The multicentre, double-blind, placebo-controlled, randomised, phase 3 IMspire150 study was done at 108 academic and community hospitals in 20 countries. Patients aged 18 years or older with previously untreated unresectable stage IIIc or stage IV melanoma and an Eastern Cooperative Oncology Group performance status of 0 or 1 were eligible for inclusion. Patients were randomly assigned (1:1) to receive either atezolizumab (840 mg intravenously on day 1 and 15) or placebo plus vemurafenib (960 mg or 720 mg twice daily orally) and cobimetinib (60 mg once daily orally; 21 days on and 7 days off) in 28-day cycles. Atezolizumab and placebo were added to treatment regimens from cycle two onwards. Randomisation was done centrally (Durham, NC, USA) based on a permuted block randomisation scheme (block size of 4) using an interactive web-based response system and was stratified by geographical region and baseline lactate dehydrogenase concentration. Overall survival was analysed in the intention-to-treat population and safety was analysed in all patients who received at least one dose of study drug according to actual treatment received. The primary endpoint was investigator-assessed progression-free survival, which was previously reported. Here, we report the second, prespecified, interim overall survival analysis, which was planned after about 270 overall survival events had occurred. The trial is ongoing, but is no longer enrolling patients, and it is registered with ClinicalTrials.gov, NCT02908672.
    Findings: Between Jan 13, 2017, and April 26, 2018, 514 patients (median age 54 years [IQR 43-63]; 299 [58%] men and 215 [42%] women) were enrolled in the trial and randomly assigned to the atezolizumab group (256 [50%] patients) or the control group (258 [50%] patients). At the data cutoff (Sept 8, 2021), 273 patients had died (126 in the atezolizumab group and 147 in the control group). Median follow-up was 29·1 months (IQR 10·1-45·4) for the atezolizumab group versus 22·8 months (10·6-44·1) for the control group. Median overall survival was 39·0 months (95% CI 29·9-not estimable) in the atezolizumab group versus 25·8 months (22·0-34·6) in the control group (HR 0·84 [95% CI 0·66-1·06]; p=0·14). The most common adverse events of any grade in the atezolizumab group were blood creatine phosphokinase increased (123 [53%] of 231 patients), diarrhoea (116 [50%]), and pyrexia (115 [50%]). The most common adverse events of any grade in the control group were diarrhoea (157 [56%] of 280 patients), blood creatine phosphokinase increased (135 [48%]), and rash (119 [43%]). The most common grade 3-4 adverse events were increased lipase (54 [23%] of 231 patients in the atezolizumab group vs 62 [22%] of 280 patients in the control group), increased blood creatine phosphokinase (51 [22%] vs 50 [18%]), and increased alanine aminotransferase (32 [14%] vs 26 [9%]). Serious adverse events were reported in 112 (48%) patients in the atezolizumab group and 117 (42%) patients in the control group. Grade 5 adverse events were reported in eight (3%) patients in the atezolizumab group versus six (2%) patients in the control group. Two grade 5 adverse events (hepatitis fulminant and hepatic failure) in the atezolizumab group were considered to be associated with the triplet combination, and one event in the control group (pulmonary haemorrhage) was considered to be associated with cobimetinib.
    Interpretation: Additional follow-up of the IMspire150 trial showed that overall survival was not significantly improved with atezolizumab, vemurafenib, and cobimetinib compared with placebo, vemurafenib, and cobimetinib in patients with BRAF
    Funding: F Hoffmann-La Roche.
    MeSH term(s) Male ; Humans ; Female ; Middle Aged ; Vemurafenib/adverse effects ; Proto-Oncogene Proteins B-raf/genetics ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Melanoma/drug therapy ; Melanoma/genetics ; Mutation ; Double-Blind Method
    Chemical Substances Vemurafenib (207SMY3FQT) ; atezolizumab (52CMI0WC3Y) ; cobimetinib (ER29L26N1X) ; Proto-Oncogene Proteins B-raf (EC 2.7.11.1) ; BRAF protein, human (EC 2.7.11.1)
    Language English
    Publishing date 2022-11-29
    Publishing country England
    Document type Randomized Controlled Trial ; Multicenter Study ; Clinical Trial, Phase III ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2049730-1
    ISSN 1474-5488 ; 1470-2045
    ISSN (online) 1474-5488
    ISSN 1470-2045
    DOI 10.1016/S1470-2045(22)00687-8
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  3. Article ; Online: Atezolizumab, vemurafenib, and cobimetinib as first-line treatment for unresectable advanced BRAF

    Gutzmer, Ralf / Stroyakovskiy, Daniil / Gogas, Helen / Robert, Caroline / Lewis, Karl / Protsenko, Svetlana / Pereira, Rodrigo P / Eigentler, Thomas / Rutkowski, Piotr / Demidov, Lev / Manikhas, Georgy Moiseevich / Yan, Yibing / Huang, Kuan-Chieh / Uyei, Anne / McNally, Virginia / McArthur, Grant A / Ascierto, Paolo A

    Lancet (London, England)

    2020  Volume 395, Issue 10240, Page(s) 1835–1844

    Abstract: Background: IMspire150 aimed to evaluate first-line combination treatment with BRAF plus MEK inhibitors and immune checkpoint therapy in BRAF: Methods: IMspire150 was a randomised, double-blind, placebo-controlled phase 3 study done at 112 institutes ...

    Abstract Background: IMspire150 aimed to evaluate first-line combination treatment with BRAF plus MEK inhibitors and immune checkpoint therapy in BRAF
    Methods: IMspire150 was a randomised, double-blind, placebo-controlled phase 3 study done at 112 institutes in 20 countries. Patients with unresectable stage IIIc-IV, BRAF
    Findings: Between Jan 13, 2017, and April 26, 2018, 777 patients were screened and 514 were enrolled and randomly assigned to the atezolizumab group (n=256) or control group (n=258). At a median follow-up of 18·9 months (IQR 10·4-23·8), progression-free survival as assessed by the study investigator was significantly prolonged with atezolizumab versus control (15·1 vs 10·6 months; hazard ratio [HR] 0·78; 95% CI 0·63-0·97; p=0·025). Common treatment-related adverse events (>30%) in the atezolizumab and control groups were blood creatinine phosphokinase increased (51·3% vs 44·8%), diarrhoea (42·2% vs 46·6%), rash (40·9%, both groups), arthralgia (39·1% vs 28·1%), pyrexia (38·7% vs 26·0%), alanine aminotransferase increased (33·9% vs 22·8%), and lipase increased (32·2% vs 27·4%); 13% of patients in the atezolizumab group and 16% in the control group stopped all treatment because of adverse events.
    Interpretation: The addition of atezolizumab to targeted therapy with vemurafenib and cobimetinib was safe and tolerable and significantly increased progression-free survival in patients with BRAF
    Funding: F Hoffmann-La Roche and Genentech.
    MeSH term(s) Adult ; Aged ; Antibodies, Monoclonal, Humanized/adverse effects ; Antibodies, Monoclonal, Humanized/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Azetidines/adverse effects ; Azetidines/therapeutic use ; Double-Blind Method ; Drug Administration Schedule ; Female ; Humans ; Kaplan-Meier Estimate ; Male ; Melanoma/drug therapy ; Melanoma/genetics ; Melanoma/pathology ; Middle Aged ; Mutation ; Neoplasm Metastasis ; Neoplasm Staging ; Piperidines/adverse effects ; Piperidines/therapeutic use ; Progression-Free Survival ; Proto-Oncogene Proteins B-raf/genetics ; Vemurafenib/adverse effects ; Vemurafenib/therapeutic use
    Chemical Substances Antibodies, Monoclonal, Humanized ; Azetidines ; Piperidines ; Vemurafenib (207SMY3FQT) ; atezolizumab (52CMI0WC3Y) ; BRAF protein, human (EC 2.7.11.1) ; Proto-Oncogene Proteins B-raf (EC 2.7.11.1) ; cobimetinib (ER29L26N1X)
    Language English
    Publishing date 2020-06-13
    Publishing country England
    Document type Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 3306-6
    ISSN 1474-547X ; 0023-7507 ; 0140-6736
    ISSN (online) 1474-547X
    ISSN 0023-7507 ; 0140-6736
    DOI 10.1016/S0140-6736(20)30934-X
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  4. Article: Superoxide dismutase activity in adriamycin-induced cardiotoxicity in humans: a potential novel tool for risk stratification.

    Rohde, Luis E / Belló-Klein, Adriane / Pereira, Rodrigo P / Mazzotti, Nicolle G / Geib, Guilherme / Weber, Cristiane / Silva, Luis F / Clausell, Nadine

    Journal of cardiac failure

    2005  Volume 11, Issue 3, Page(s) 220–226

    Abstract: Background: Oxidative stress has been implicated in Adriamycin cardiotoxicity experimentally. We evaluated whether changes in systemic markers of antioxidant reserve occur and are associated with left ventricular (LV) dysfunction during Adriamycin use ... ...

    Abstract Background: Oxidative stress has been implicated in Adriamycin cardiotoxicity experimentally. We evaluated whether changes in systemic markers of antioxidant reserve occur and are associated with left ventricular (LV) dysfunction during Adriamycin use in humans.
    Methods and results: We prospectively evaluated oncology patients eligible for Adriamycin chemotherapy. Blood samples for enzymatic (erythrocyte superoxide dismutase activity [SOD-U SOD/mg protein]) and nonenzymatic antioxidants (total radical trapping antioxidant potential [TRAP-U of Trolox/microL plasma]) were collected at baseline (B), intermediate (I), and final (F) cycles. LV ejection fraction (LVEF) was assessed by radionuclide ventriculography. Fifty-one patients (49 +/- 12 years, 90% female) underwent 5.9 +/- 0.9 chemotherapy cycles and received 301 +/- 52 mg/m 2 of Adriamycin. LVEF decreased from 61 +/- 6% (B) to 56 +/- 7% (F) ( P < .001), but only 6 (12%) patients developed significant LV systolic dysfunction (LVEF < 50%). SOD activity increased significantly during treatment (4.5 +/- 1.8 [B], 6.0 +/- 2.1 [I], 5.6 +/- 2.2 [F]; P < .01), whereas TRAP values were unchanged. Baseline SOD activity from patients who developed LV systolic dysfunction was significantly higher than from those who maintained normal LVEF (5.9 +/- 1.8 versus 4.3 +/- 1.7; P < .05). In multivariate analysis, baseline SOD levels remained independently associated with LV dysfunction ( P = .05).
    Conclusion: Erythrocyte SOD activity increases after Adriamycin treatment and high baseline levels predicts Adriamycin-induced cardiotoxicity in humans.
    MeSH term(s) Antibiotics, Antineoplastic/therapeutic use ; Antioxidants/analysis ; Antioxidants/pharmacology ; Biomarkers/blood ; Chromans/pharmacology ; Doxorubicin/therapeutic use ; Erythrocytes/enzymology ; Female ; Humans ; Male ; Middle Aged ; Multivariate Analysis ; Neoplasms/drug therapy ; Predictive Value of Tests ; Prospective Studies ; ROC Curve ; Radionuclide Ventriculography ; Stroke Volume/drug effects ; Superoxide Dismutase/blood ; Ventricular Dysfunction, Left/chemically induced ; Ventricular Dysfunction, Left/diagnostic imaging ; Vitamin E/analogs & derivatives ; Vitamin E/pharmacology
    Chemical Substances Antibiotics, Antineoplastic ; Antioxidants ; Biomarkers ; Chromans ; Vitamin E (1406-18-4) ; Doxorubicin (80168379AG) ; Superoxide Dismutase (EC 1.15.1.1) ; 6-hydroxy-2,5,7,8-tetramethylchroman-2-carboxylic acid (S18UL9710X)
    Language English
    Publishing date 2005-03-29
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1281194-4
    ISSN 1532-8414 ; 1071-9164
    ISSN (online) 1532-8414
    ISSN 1071-9164
    DOI 10.1016/j.cardfail.2004.08.161
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