@article{0d0052b77ef0453587f234c07432623d,
title = "Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Patients With Advanced Non–Squamous Non–Small Cell Lung Cancer",
abstract = "Background: This open-label Phase III trial (NCT02264990) evaluated the PARP inhibitor, veliparib, combined with carboplatin/paclitaxel versus chemotherapy alone for first-line treatment of patients with advanced non–squamous non–small cell lung cancers (NSCLC). A 52-gene expression classifier (LP52) previously shown to identify patients more likely to respond to veliparib was evaluated as a planned correlative analysis. Materials and Methods: Adult current or former smokers with advanced non–squamous NSCLC were randomized 1:1 to veliparib (120 mg daily for 7 days/cycle) with carboplatin and paclitaxel or to investigators{\textquoteright} choice of platinum doublet chemotherapy (up to 6, 21-day cycles), with optional pemetrexed maintenance. Prospective analysis of the LP52 signature was conducted using a clinical Qiagen/HTG assay. The primary endpoint was overall survival (OS) in LP52+ patients. Results: Overall, 595 patients received veliparib + carboplatin/paclitaxel (n = 298) or chemotherapy alone (n = 297); 13% (n = 40) in each arm were LP52+. The primary endpoint was not met; median OS was 11.2 months with veliparib + carboplatin/paclitaxel versus 9.2 months with chemotherapy alone in the LP52+ subgroup (hazard ratio [HR] 0.644, 95% confidence interval [CI]: 0.396-1.048; P = .113). In the overall population, median OS was 12.1 months in both arms (HR 0.986, 95% CI: 0.827-1.176; P = .846). No new safety signals were observed. Conclusion: In patients with non–squamous NSCLC, there was no significant improvement in OS with veliparib + carboplatin/paclitaxel versus chemotherapy alone, although a trend toward improved OS in the LP52+ population suggests this subgroup may benefit from veliparib. Statistical power was limited due to the small sample size.",
keywords = "Biomarkers, Combination therapy, NSCLC, Overall survival, PARP inhibitor",
author = "Ramaswamy Govindan and Mike Lind and Amelia Insa and Khan, {Saad A.} and Dmitry Uskov and Ali Tafreshi and Salih Guclu and Jair Bar and Terufumi Kato and Lee, {Ki Hyeong} and Kazuhiko Nakagawa and Olfred Hansen and Bonne Biesma and Kundu, {Madan G.} and Martin Dunbar and Lei He and Peter Ansell and Vasudha Sehgal and Xin Huang and Jaimee Glasgow and Bach, {Bruce A.}",
note = "Publisher Copyright: {\textcopyright} 2022 The Authors",
year = "2022",
month = may,
doi = "10.1016/j.cllc.2022.01.005",
language = "אנגלית",
volume = "23",
pages = "214--225",
journal = "Clinical Lung Cancer",
issn = "1525-7304",
publisher = "Elsevier",
number = "3",
}