RT Journal Article
T1 ABOUND.2L+: A randomized phase 2 study of nanoparticle albumin-bound paclitaxel with or without CC-486 as second-line treatment for advanced nonsquamous non-small cell lung cancer (NSCLC).
A1 Morgensztern, Daniel
A1 Cobo, Manuel
A1 Ponce-Aix, Santiago
A1 Postmus, Pieter E
A1 Lewanski, Conrad R
A1 Bennouna, Jaafar
A1 Fischer, Jürgen R
A1 Juan-Vidal, Oscar
A1 Stewart, David J
A1 Fasola, Gianpiero
A1 Ardizzoni, Andrea
A1 Bhore, Rafia
A1 Wolfsteiner, Marianne
A1 Talbot, Denis C
A1 Jin-Ong, Teng
A1 Govindan, Ramaswamy
K1 5-azacytidine
K1 CC-486 (oral 5-azacitidine)
K1 Advanced
K1 Nanoparticle albumin-bound paclitaxel (nab-paclitaxel)
K1 Non-small cell lung cancer (NSCLC)
K1 Nonsquamous
K1 Safety
K1 Second-line
K1 Survival
AB This randomized phase 2 trial compared the efficacy and safety of second-line nanoparticle albumin-bound paclitaxel (nab-paclitaxel) with or without the addition of CC-486 (an oral formulation of 5-azacytidine) in patients with advanced-stage, nonsquamous non-small cell lung cancer. Patients were randomized to receive either nab-paclitaxel 100 mg/m2 on days 8 and 15 plus CC-486 200 mg daily on days 1 to 14 or single-agent nab-paclitaxel 100 mg/m2 on days 1 and 8, with both regimens administered every 21 days until tumor progression or unacceptable toxicity. The primary endpoint was progression-free survival. Secondary endpoints included the overall response rate, the disease control rate, and overall survival. Between January 2015 and August 2016, 161 patients were randomized (81 to the combination arm and 80 to the single-agent nab-paclitaxel arm). There was no benefit from the addition of CC-486 to nab-paclitaxel. The median progression-free survival was 3.2 months for the combination and 4.2 months for single-agent nab-paclitaxel (hazard ratio, 1.3; 95% confidence interval, 0.9-1.9). The median overall survival was 8.1 months in the combination arm and 17 months in the single-agent nab-paclitaxel arms (hazard ratio, 1.7; 95% confidence interval, 1.08-2.57). Grade 3 or greater treatment-related, emergent adverse events were reported by 40.5% of patients in the combination arm and by 31.6% of those in the single-agent nab-paclitaxel arm. Single-agent nab-paclitaxel was associated with promising outcomes and a tolerable safety profile as second-line treatment for patients with advanced-stage, nonsquamous non-small cell lung cancer. There was no benefit from the addition of CC-486 to nab-paclitaxel.
PB John Wiley & Sons
YR 2018
FD 2018-11-01
LK http://hdl.handle.net/10668/13148
UL http://hdl.handle.net/10668/13148
LA en
NO Morgensztern D, Cobo M, Ponce Aix S, Postmus PE, Lewanski CR, Bennouna J, et al. ABOUND.2L+: A randomized phase 2 study of nanoparticle albumin-bound paclitaxel with or without CC-486 as second-line treatment for advanced nonsquamous non-small cell lung cancer (NSCLC). Cancer. 2018 Dec 15;124(24):4667-4675
DS RISalud
RD Apr 8, 2025