التفاصيل البيبلوغرافية
| العنوان: |
Galunisertib plus gemcitabine vs. gemcitabine for first-line treatment of patients with unresectable pancreatic cancer |
| المؤلفون: |
Melisi, Davide, García-Carbonero, Rocío, Macarulla Mercadé, Teresa, Pezet, Denis, Deplanque, Gael, Fuchs, Martin, Trojan, Jorg, Oettle, Helmut, Kozloff, Mark, Cleverly, Ann, Smith, Claire, Estrem, Shawn T., Gueorguieva, Ivelina, Lahn, Michael M. F., Blunt, Al, Benhadji, Karim A., Tabernero, Josep, Universitat Autònoma de Barcelona |
| سنة النشر: |
2018 |
| المجموعة: |
Universitat Autònoma de Barcelona: Dipòsit Digital de Documents de la UAB |
| مصطلحات موضوعية: |
Cancer immunotherapy, Prognostic markers, Predictive markers |
| الوصف: |
Altres ajuts: This study was sponsored by Eli Lilly and Company, IN, USA. ; Galunisertib is the first-in-class, first-in-human, oral small-molecule type I transforming growth factor-beta receptor (ALK5) serine/threonine kinase inhibitor to enter clinical development. The effect of galunisertib vs. placebo in patients with unresectable pancreatic cancer was determined. This was a two-part, multinational study: phase 1b was a non-randomised, open-label, multicentre, and dose-escalation study; phase 2 was a randomised, placebo- and Bayesian-augmented controlled, double-blind study in patients with locally advanced or metastatic pancreatic adenocarcinoma considered candidates for first-line chemotherapy with gemcitabine. Patients were randomised 2:1 to galunisertib-gemcitabine (N = 104) or placebo-gemcitabine (N = 52). Gemcitabine dose was 1000 mg/m 2 QW. Primary endpoints for phases 1b and 2, respectively, were phase 2 dose and overall survival. Secondary objectives included tolerability and biomarkers. Dose-escalation suggested a 300-mg/day dose. Primary objective was met: median survival times were 8.9 and 7.1 months for galunisertib and placebo, respectively (hazard ratio [HR] = 0.79 [95% credible interval: 0.59-1.09] and posterior probability HR < 1 = 0.93). Lower baseline biomarkers macrophage inflammatory protein-1-alpha and interferon-gamma-induced protein 10 were associated with galunisertib benefit. Galunisertib-gemcitabine combination improved overall survival vs. gemcitabine in patients with unresectable pancreatic cancer, with minimal added toxicity. Future exploration of galunisertib in pancreatic cancer is ongoing in combination with durvalumab. |
| نوع الوثيقة: |
article in journal/newspaper |
| وصف الملف: |
application/pdf |
| اللغة: |
English |
| تدمد: |
15321827 |
| العلاقة: |
British Journal of Cancer; Vol. 119 (october 2018), p. 1208-1214; https://ddd.uab.cat/record/228042Test; urn:10.1038/s41416-018-0246-z; urn:oai:ddd.uab.cat:228042; urn:pmid:30318515; urn:pmcid:PMC6251034; urn:pmc-uid:6251034; urn:articleid:15321827v119p1208; urn:oai:egreta.uab.cat:publications/d6996337-ed78-4695-ba58-75d216dad8c9; urn:scopus_id:85055129225; urn:oai:pubmedcentral.nih.gov:6251034 |
| الإتاحة: |
https://ddd.uab.cat/record/228042Test |
| حقوق: |
open access ; Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original. ; https://creativecommons.org/licenses/by/4.0Test/ |
| رقم الانضمام: |
edsbas.F5A2065E |
| قاعدة البيانات: |
BASE |
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