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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)
Author(s) -
Morgensztern Daniel,
Cobo Manuel,
Ponce Aix Santiago,
Postmus Pieter E.,
Lewanski Conrad R.,
Bennouna Jaafar,
Fischer Jürgen R.,
JuanVidal Oscar,
Stewart David J.,
Fasola Gianpiero,
Ardizzoni Andrea,
Bhore Rafia,
Wolfsteiner Marianne,
Talbot Denis C.,
Jin Ong Teng,
Govindan Ramaswamy
Publication year - 2018
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.31779
Subject(s) - medicine , paclitaxel , hazard ratio , clinical endpoint , lung cancer , randomized controlled trial , progression free survival , confidence interval , oncology , gastroenterology , surgery , chemotherapy
Background 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. Methods Patients were randomized to receive either nab‐paclitaxel 100 mg/m 2 on days 8 and 15 plus CC‐486 200 mg daily on days 1 to 14 or single‐agent nab‐paclitaxel 100 mg/m 2 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. Results 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. Conclusions 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.