Hiroko Tsukada1, Akira Yokoyama2, Koichi Goto3, Tetsu Shinkai4, Masao Harada5, Masahiko Ando6, Taro Shibata7, Yuichiro Ohe8, Tomohide Tamura8, Nagahiro Saijo. 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 assigneddocetaxel 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].
RCT Entities:
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].
Authors: Takehito Shukuya; Keita Mori; Joseph M Amann; Erin M Bertino; Gregory A Otterson; Peter G Shields; Satoshi Morita; David P Carbone Journal: J Thorac Oncol Date: 2016-08-03 Impact factor: 15.609