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    Wyświetlanie 1-8 z 8
    Tytuł:
    Polatuzumab vedotin in previously untreated diffuse large B-cell lymphoma
    Autorzy:
    Gau, Jyh-Pyng
    Bergua-Burgues, Juan M.
    Herbaux, Charles
    Munhoz, Eduardo
    Chauchet, Adrien
    Greil, Richard
    Hirata, Jamie
    Sehn, Laurie H.
    Abrisqueta, Pau
    Salles, Gilles
    Sharman, Jeff P.
    Cheung, Matthew C.
    Trneny, Marek
    Friedberg, Jonathan W.
    Tilly, Herve
    Mykhalska, Larysa
    Hapgood, Greg
    Jurczak, Wojciech
    Shin, Ho-Jin
    Pinto, Antonio
    Matasar, Matthew
    Yan, Mark
    Burke, John M.
    Jiang, Yanwen
    Song, Yuqin
    Oberic, Lucie
    Morschhauser, Franck
    Flowers, Christopher R.
    Lee, Calvin
    Izutsu, Koji
    Mehta-Shah, Neha
    Rai, Shinya
    Opis:
    Background: Diffuse large B-cell lymphoma (DLBCL) is typically treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). However, only 60% of patients are cured with R-CHOP. Polatuzumab vedotin is an antibody–drug conjugate targeting CD79b, which is ubiquitously expressed on the surface of malignant B cells. Methods: We conducted a double-blind, placebo-controlled, international phase 3 trial to evaluate a modified regimen of R-CHOP (pola-R-CHP), in which vincristine was replaced with polatuzumab vedotin, as compared with standard R-CHOP, in patients with previously untreated intermediate-risk or high-risk DLBCL. Patients 18 to 80 years of age were randomly assigned in a 1:1 ratio to receive six cycles of either pola-R-CHP or R-CHOP, plus two cycles of rituximab alone. The primary end point was investigator-assessed progression-free survival. Secondary end points included overall survival and safety. Results: Overall, 879 patients underwent randomization: 440 were assigned to the pola-R-CHP group and 439 to the R-CHOP group. After a median follow-up of 28.2 months, the percentage of patients surviving without progression was significantly higher in the pola-R-CHP group than in the R-CHOP group (76.7% [95% confidence interval (CI), 72.7 to 80.8] vs. 70.2% [95% CI, 65.8 to 74.6] at 2 years; stratified hazard ratio for progression, relapse, or death, 0.73 by Cox regression; 95% CI, 0.57 to 0.95; P=0.02). Overall survival at 2 years did not differ significantly between the groups (88.7% [95% CI, 85.7 to 91.6] in the pola-R-CHP group and 88.6% [95% CI, 85.6 to 91.6] in the R-CHOP group; hazard ratio for death, 0.94; 95% CI, 0.65 to 1.37; P=0.75). The safety profile was similar in the two groups. Conclusions: Among patients with previously untreated intermediate-risk or high-risk DLBCL, the risk of disease progression, relapse, or death was lower among those who received pola-R-CHP than among those who received R-CHOP. (Funded by F. Hoffmann–La Roche/Genentech; POLARIX ClinicalTrials.gov number, NCT03274492. opens in new tab.)
    Dostawca treści:
    Repozytorium Uniwersytetu Jagiellońskiego
    Artykuł
    Tytuł:
    Umbralisib, a Dual PI3Kδ/CK1ε Inhibitor in Patients With Relapsed or Refractory Indolent Lymphoma
    Autorzy:
    Cheah, Chan Y.
    Chavez, Julio C.
    Sharman, Jeff P.
    Miskin, Hari P.
    Hodson, Daniel J.
    Leslie, Lori A.
    Babu, Sunil
    Cheson, Bruce D.
    Oconnor, Owen A.
    Weiss, Michael S.
    Law, Jennie Y.
    Samaniego, Felipe
    Jurczak, Wojciech
    Grosicki, Sebastian
    Derenzini, Enrico
    Reeves, James A.
    Knopinśka-Posłuszny, Wanda
    Phillips, Tycel
    Lech-Maranda, Ewa
    Ghosh, Nilanjan
    Burke, John M.
    Fonseca, Gustavo
    Zinzani, Pier Luigi
    Shao, Spencer H.
    Pagel, John M.
    Fowler, Nathan H.
    Caimi, Paolo F.
    Sportelli, Peter
    Opis:
    Purpose: Phosphatidylinositol-3-kinase (PI3K) inhibitors have shown activity in relapsed or refractory (R/R) indolent non-Hodgkin lymphoma (iNHL). PI3K inhibitors have been hampered by poor long-term tolerability and toxicity, which interfere with continuous use. Umbralisib, a dual inhibitor of PI3Kδ/casein kinase-1ε, exhibits improved selectivity for PI3Kδ compared with other PI3K inhibitors. This phase IIb trial was designed to evaluate the efficacy and safety of umbralisib in patients with R/R iNHL. Patients and Methods; In this multicohort, open-label, phase IIb study, 208 patients with R/R marginal zone, follicular, or small lymphocytic lymphoma (MZL, FL, or SLL) unresponsive to prior treatments (≥ 1 MZL; ≥ 2 FL/SLL), including ≥ 1 anti-CD20–based therapy, were administered umbralisib 800 mg orally once daily until disease progression, unacceptable toxicity, or study withdrawal. Primary end point is overall response rate; secondary end points include time to response, duration of response, progression-free survival, and safety. Results; The median follow-up is 27.7 months (efficacy) and 21.4 months (safety). The overall response rate was 47.1%, and tumor reduction occurred in 86.4% of patients. The median time to response was 2.7-4.6 months. The median duration of response was not reached for MZL, 11.1 months for FL, and 18.3 months for SLL. Median progression-free survival was not reached for MZL, 10.6 months for FL, and 20.9 months for SLL. At least one grade ≥ 3 treatment-emergent adverse event (TEAE) was reported in 53.4% of patients. TEAEs led to umbralisib discontinuation in 32 patients (15.4%). A total of 31 patients (14.9%) discontinued because of a treatment-related adverse event. Grade ≥ 3 TEAEs reported in ≥ 10% of patients: neutropenia (11.5%) and diarrhea (10.1%). Increased ALT/AST (grade ≥ 3) occurred in 6.7%/7.2% of patients. Conclusion; Umbralisib achieved meaningful clinical activity in heavily pretreated patients with iNHL. The safety profile was manageable, with a relatively low incidence of immune-mediated toxicities and adverse event–related discontinuations.
    Dostawca treści:
    Repozytorium Uniwersytetu Jagiellońskiego
    Artykuł
      Wyświetlanie 1-8 z 8

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