التفاصيل البيبلوغرافية
العنوان:
Data from Randomized, Placebo-Controlled, Phase II Study of Veliparib in Combination with Carboplatin and Paclitaxel for Advanced/Metastatic Non–Small Cell Lung Cancer
المؤلفون:
Vera Gorbunova , Vincent Giranda , Mark McKee , Peter Ansell , Hao Xiong , Juliann Dziubinski , Caroline Nickner , Jiang Qian , Qin Qin , Ulrich Keiholz , Ebenezer Kio , Fabrice Barlesi , Sergey Orlov , Laszlo Urban , Erzsebet Juhasz , C. Michael Jones , Martin Reck , Julien Mazieres , Normand Blais , Suresh S. Ramalingam
بيانات النشر:
American Association for Cancer Research (AACR), 2023.
سنة النشر:
2023
الوصف:
Purpose: PARP plays an important role in DNA repair. Veliparib, a PARP inhibitor, enhances the efficacy of platinum compounds and has been safely combined with carboplatin and paclitaxel. The primary endpoint of this phase II trial determined whether addition of veliparib to carboplatin and paclitaxel improved progression-free survival (PFS) in previously untreated patients with advanced/metastatic non–small cell lung cancer.Experimental Design: Patients were randomized 2:1 to carboplatin and paclitaxel with either veliparib or placebo. Veliparib (120 mg) or placebo was given on days 1 to 7 of each 3-week cycle, with carboplatin (AUC = 6 mg/mL/min) and paclitaxel (200 mg/m2) administered on day 3, for a maximum of 6 cycles.Results: Overall, 158 were included (median age, 63 years; male 68%, squamous histology 48%). Median PFS was 5.8 months in the veliparib group versus 4.2 months in the placebo group [HR, 0.72; 95% confidence interval (CI), 0.45–1.15; P = 0.17)]. Median overall survival (OS) was 11.7 and 9.1 months in the veliparib and placebo groups, respectively (HR, 0.80; 95% CI, 0.54–1.18; P = 0.27). In patients with squamous histology, median PFS (HR, 0.54; 95% CI, 0.26–1.12; P = 0.098) and OS (HR, 0.73; 95% CI, 0.43–1.24; P = 0.24) favored veliparib treatment. Objective response rate was similar between groups (veliparib: 32.4%; placebo: 32.1%), but duration of response favored veliparib treatment (HR, 0.47; 95% CI, 0.16–1.42; P = 0.18). Grade III/IV neutropenia, thrombocytopenia, and anemia were comparable between groups.Conclusions: Veliparib combination with carboplatin and paclitaxel was well-tolerated and demonstrated a favorable trend in PFS and OS versus chemotherapy alone. Patients with squamous histology had the best outcomes with veliparib combination. Clin Cancer Res; 23(8); 1937–44. ©2016 AACR.
URL الوصول:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::45e7ce0aeb342f5774b9143be1c1edd9 https://doi.org/10.1158/1078-0432.c.6526571.v1
حقوق:
OPEN
رقم الأكسشن:
edsair.doi.dedup.....45e7ce0aeb342f5774b9143be1c1edd9
قاعدة البيانات:
OpenAIRE
