Frontiers in Oncology (Jul 2018)

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

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

DOI
https://doi.org/10.3389/fonc.2018.00262
Journal volume & issue
Vol. 8

Abstract

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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.

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