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Jpn J Clin Oncol. 2015 Jan;45(1):88-95. doi: 10.1093/jjco/hyu176. Epub 2014 Nov 6.

Randomized controlled trial comparing docetaxel-cisplatin combination with weekly docetaxel alone in elderly patients with advanced non-small-cell lung cancer: Japan Clinical Oncology Group (JCOG) 0207†.

Author information

1
Niigata Cancer Center Hospital, Niigata kawagishi-clinic@ca.wakwak.com.
2
Niigata Cancer Center Hospital, Niigata.
3
National Cancer Center Hospital East, Kashiwa.
4
National Hospital Organization Shikoku Cancer Center, Matsuyama.
5
National Hospital Organization Hokkaido Cancer Center, Sapporo.
6
Kyoto University, Kyoto.
7
JCOG Data Center, National Cancer Center, Tokyo.
8
National Cancer Center Hospital, Tokyo, Japan.

Abstract

OBJECTIVE:

Prospective trials specifically designed for elderly patients with advanced non-small-cell lung cancer demonstrating the benefit of platinum-based therapies are still lacking. This trial was designed to clarify whether the addition of cisplatin to monotherapy could improve survival for elderly patients.

METHODS:

Elderly patients (age ≥70 years, ECOG performance Status 0-1) with advanced non-small-cell lung cancer were randomized to receive docetaxel 20 mg/m(2) plus cisplatin 25 mg/m(2) on Day 1, 8 and 15 (docetaxel plus cisplatin) or docetaxel 25 mg/m(2) on the same schedule (docetaxel). Both regimens were repeated every 4 weeks until disease progression.

RESULTS:

One hundred and twenty-six patients were enrolled. Sixty-three were randomly assigned docetaxel plus cisplatin and 63 docetaxel monotherapy. Median age was 76 years (range 70-88). The second planned interim analysis was performed on 112 assessable patients (docetaxel/docetaxel plus cisplatin: 56/56). Although the formal criterion for stopping the trial was not met, the Data and Safety Monitoring Committee recommended study termination on ethical grounds based on the interaction (two-sided P = 0.077, hazard ratios for ≤74/≥75: 0.23/0.72) between age and subgroup and treatment arm, which suggested that docetaxel may not represent an adequate control arm regimen for the age subgroup of 70-74 years.

CONCLUSIONS:

The interpretation of study results is limited due to early stopping. Further study is needed to confirm survival benefit of platinum-based chemotherapy for elderly non-small-cell lung cancer [UMIN-CTR (www.umin.ac.jp/ctr/) ID: C000000146].

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00190476.

KEYWORDS:

cisplatin; docetaxel; elderly; interim analysis; non-small-cell lung cancer

PMID:
25378648
DOI:
10.1093/jjco/hyu176
[Indexed for MEDLINE]

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