AUTHOR=Langer Corey J. , Kim Edward S. , Anderson Eric C. , Jotte Robert M. , Modiano Manuel , Haggstrom Daniel E. , Socoteanu Matei P. , Smith David A. , Dakhil Christopher , Konduri Kartik , Berry Tymara , Ong Teng J. , Sanford Alexandra , Amiri Katayoun , Goldman Jonathan W. , Weiss Jared ,  on behalf of the ABOUND.70+ Investigators , Gajra Ajeet , Dobrescu Andrei , Halibey Bohdan E. , Langer Corey , Haggstrom Daniel , Smith David A. , Anderson Eric , Paschold Eugene H. , Cheng Haiying , Ali Haythem , Borghaei Hossein , Weiss Jared , Elias Francis Jawad , Kessler Ayla Ahmed , Wang Jen C. , Goldman Jonathan Wade , Najera Jose E. , Nimeh Nadim F. , Rosales Joseph , Konduri Kartik , Dragnev Konstantin H. , Forero Leonardo , Bui Lynne A. , Matrana Marc R. , Socoteanu Matei P. , Willis Maurice , Joshi Monika , Coleman Morton , Raj Moses Sundar , Gill Navkiranjit , Plezia Patricia M. , Modiano Manuel R. , Webb R. Timothy , Axelrod Rita , Dichmann Robert Andrew , Jotte Robert M. , Harris Ronald P. , Sonnier Scott Anthony , Patel Vijay , Dakhil Shaker R. , Mekhail Tarek , Hensing Thomas , Samaha Tony M. , Lee Vicky , McGregor Kimberly , Lawler William Eyre , Skinner William L. , DeRosa William T. 

TITLE=nab-Paclitaxel-Based Therapy in Underserved Patient Populations: The ABOUND.70+ Study in Elderly Patients With Advanced NSCLC

JOURNAL=Frontiers in Oncology

VOLUME=8

YEAR=2018

URL=https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2018.00262

DOI=10.3389/fonc.2018.00262

ISSN=2234-943X

ABSTRACT=<p>The phase 4 ABOUND.70+ trial assessed the safety and efficacy of <italic>nab</italic>-paclitaxel/carboplatin continuously or with a 1-week break between cycles in elderly patients with advanced non-small cell lung cancer (NSCLC). Patients ≥70 years with locally advanced/metastatic NSCLC were randomized 1:1 to first-line <italic>nab</italic>-paclitaxel days 1, 8, 15 plus carboplatin day 1 of a 21-day cycle (21d) or the same <italic>nab</italic>-paclitaxel/carboplatin regimen with a 1-week break between cycles (21d + break; 28d). The primary endpoint was the percentage of patients with grade ≥ 2 peripheral neuropathy (PN) or grade ≥ 3 myelosuppression. Other key endpoints included progression-free survival (PFS), overall survival (OS), and overall response rate (ORR). A total of 143 patients were randomized (71 to 21d, 72 to 21d + break). The percentage of patients with grade ≥ 2 PN or grade ≥ 3 myelosuppression was similar between the 21d and 21d + break arms (76.5 and 77.1%; <italic>P</italic> = 0.9258). Treatment exposure was lower in the 21d arm compared with the 21d + break arm. Median OS was 15.2 and 16.2 months [hazard ratio (HR) 0.72, 95% CI 0.44–1.19; <italic>P</italic> = 0.1966], median PFS was 3.6 and 7.0 months (HR 0.48, 95% CI 0.30–0.76; <italic>P</italic> &lt; 0.0019), and ORR was 23.9 and 40.3% (risk ratio 1.68, 95% CI 1.02–2.78; <italic>P</italic> = 0.0376) in the 21d and 21d + break arms, respectively. In summary, the 1-week break between treatment cycles significantly improved PFS and ORR but did not significantly reduce the percentage of grade ≥ 2 PN or grade ≥ 3 myelosuppression. Overall, the findings support the results of prior subset analyses on the safety and efficacy of first-line <italic>nab</italic>-paclitaxel/carboplatin in elderly patients with advanced NSCLC.</p>