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Front Oncol. 2018 Jul 24;8:262. doi: 10.3389/fonc.2018.00262. eCollection 2018.

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

Author information

1
Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, United States.
2
Levine Cancer Institute, Carolinas Healthcare System, Charlotte, NC, United States.
3
Knight Cancer Institute, Oregon Health & Science University, Portland, OR, United States.
4
Rocky Mountain Cancer Centers, Denver, CO, United States.
5
Arizona Clinical Research Center, Tucson, AZ, United States.
6
Texas Oncology, Longview, TX, United States.
7
Compass Oncology, Vancouver, WA, United States.
8
Cancer Center of Kansas, Wichita, KS, United States.
9
Baylor Charles A. Sammons Cancer Center, Texas Oncology PA, Dallas, TX, United States.
10
Celgene Corporation, Summit, NJ, United States.
11
David Geffen School of Medicine at UCLA, Los Angeles, CA, United States.
12
Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, United States.

Abstract

The phase 4 ABOUND.70+ trial assessed the safety and efficacy of nab-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 nab-paclitaxel days 1, 8, 15 plus carboplatin day 1 of a 21-day cycle (21d) or the same nab-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%; P = 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; P = 0.1966], median PFS was 3.6 and 7.0 months (HR 0.48, 95% CI 0.30-0.76; P < 0.0019), and ORR was 23.9 and 40.3% (risk ratio 1.68, 95% CI 1.02-2.78; P = 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 nab-paclitaxel/carboplatin in elderly patients with advanced NSCLC.

KEYWORDS:

advanced non-small cell lung cancer; carboplatin; elderly; nab-paclitaxel; phase 4; randomized trial

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