Miniatura

Fitxers

LaquenteB.pdf (585.04 KB)

Tipus de document

Article

Versió

Versió publicada

Data de publicació

2017-02-14

Llicència de publicació

cc by (c) Laquente et al., 2017
Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/124332

A phase II study to evaluate LY2603618 in combination with gemcitabine in pancreatic cancer patients

Títol de la revista

Autors

Director/Tutor

ISSN de la revista

Títol del volum

Recurs relacionat

https://doi.org/10.1186/s12885-017-3131-x

Resum

Background: The aim of this study was to determine whether checkpoint kinase 1 inihibitor (CHK1), LY2603618, and gemcitabine prolong overall survival (OS) compared to gemcitabine alone in patients with unresectable pancreatic cancer. Methods: Patients with Stage II-IV locally advanced or metastatic pancreatic cancer were randomized (2: 1) to either 230 mg of LY2603618/1000 mg/m2 gemcitabine combined or 1000 mg/m2 gemcitabine alone. OS was assessed using both a Bayesian augment control model and traditional frequentist analysis for inference. Progression-free survival (PFS), overall response rate (ORR), duration of response, pharmacokinetics (PK), and safety (Common Terminology Criteria for Adverse Events [AEs] v 3.0) were also evaluated. Results: Ninety-nine patients (n = 65, LY2603618/gemcitabine; n = 34, gemcitabine) were randomized (intent-to-treat population). The median OS (months) was 7.8 (range, 0.3-18.9) with LY2603618/gemcitabine and 8.3 (range, 0.8-19.1+) with gemcitabine. Similarly, in a Bayesian analysis, the study was not positive since the posterior probability that LY2603618/gemcitabine was superior to gemcitabine in improving OS was 0.3, which did not exceed the prespecified threshold of 0.8. No significant improvements in PFS, ORR, or duration of response were observed. Drug-related treatment-emergent AEs in both arms included nausea, thrombocytopenia, fatigue, and neutropenia. The severity of AEs with LY2603618/gemcitabine was comparable to gemcitabine. The LY2603618 exposure targets (AUC((0-infinity)) >= 21,000 ng hr/mL and C-max >= 2000 ng/mL) predicted for maximum pharmacodynamic response were achieved after 230 mg of LY2603618. Conclusions: LY2603618/gemcitabine was not superior to gemcitabine for the treatment of patients with pancreatic cancer.

Matèries

Càncer de pàncrees, Quimioteràpia

Matèries (anglès)

Pancreas cancer, Chemotherapy

Citació

Col·leccions

Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

Citació

LAQUENTE, Berta, LOPEZ MARTIN, Jose, RICHARDS, Donald, ILLERHAUS, Gerald, CHANG, David z., KIM, George, STELLA, Philip, RICHEL, Dirk, SZCYLIK, Cezary, CASCINU, Stefano, FRASSINETI, G. l., CIULEANU, Tudor, HURT, Karla, HYNES, Scott, LIN, Ji, LIN, Aimee bence, HOFF, Daniel von, CALVO, Emiliano. A phase II study to evaluate LY2603618 in combination with gemcitabine in pancreatic cancer patients. _BMC Cancer_. 2017. Vol. 17, núm. 137. [consulta: 22 de gener de 2026]. [Disponible a: https://hdl.handle.net/2445/124332]

Exportar metadades

JSON - METS

Compartir registre