Nab-paclitaxel (abraxane)-based chemotherapy to treat elderly patients with advanced non-small-cell lung cancer: a single center, randomized and open-label clinical trial.
BACKGROUND
The purpose of this study is to evaluate the clinical efficacy and safety of abraxane-based chemotherapy with/without nedaplatin in elderly patients with non-small-cell lung cancer (NSCLC).


METHODS
From October 2009 to January 2013, 48 elderly patients (≥65 years) with NSCLC were investigated in this clinical trial. The patients were randomized and equally allocated into arms A and AP: (A) abraxane (130 mg/m(2), days 1, 8); (B) abraxane + nedaplatin (20 mg/m(2) days 1-3, q3w). The parameters of objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and side effects were evaluated between two arms.


RESULTS
Over 80% of the patients completed four cycles of chemotherapy. The total ORR was 21.3%, DCR was 55.3%, PFS 4.5 months and OS 12.6 months. No significant difference was found between arms A and AP in terms of ORR (16.7% vs. 26.1%, P=0.665) or DCR (55.3% vs. 56.5%, P=0.871). The median PFS in arm A was 3.3 months [25-75% confidence interval (CI): 3.1-7.2] and 5.5 months (25-75% CI: 3.2-7.0) in arm AP with no statistical significance (P=0.640). The median OS in arm A was 12.6 months (25-75% CI: 5.7-26.2) and 15.1 months (25-75% CI: 6.4-35.3) in arm AP with no statistical significance (P=0.770). The side effects were mainly grade 1-2. The incidence of grade 3-4 toxicities was 29.1% in arm A and 62.5% in arm AP with a statistical significance (P=0.020).


CONCLUSIONS
Compared with combined therapy, abraxane alone chemotherapy was beneficial for elderly NSCLC patients with better tolerability and less adverse events, whereas did not significantly differ in terms of ORR, DCR, PFS or OS.
Department of Oncology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510407, China.
Hanrui
H
Chen
Department of Oncology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510407, China.
Xuewu
X
Huang
Department of Oncology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510407, China.
Shutang
S
Wang
Department of Oncology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510407, China.
Xinting
X
Zheng
Department of Oncology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510407, China.
Jietao
J
Lin
Department of Oncology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510407, China.
Peng
P
Li
Department of Oncology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510407, China.
Lizhu
L
Lin
Nab-paclitaxel; advanced non-small-cell lung cancer (NSCLC); efficacy; elderly; pretreated