ONCOmmunity

Randomized Phase III Trial Comparing Weekly Docetaxel Plus Cisplatin Versus Docetaxel Monotherapy Every 3 Weeks in Elderly Patients With Advanced Non-Small-Cell Lung Cancer: The Intergroup Trial JCOG0803/WJOG4307L.

By: Tetsuya Abe, Koji Takeda, Yuichiro Ohe, Shinzoh Kudoh, Yukito Ichinose, Hiroaki Okamoto, Nobuyuki Yamamoto, Hiroshige Yoshioka, Koichi Minato, Toshiyuki Sawa, Yasuo Iwamoto, Hideo Saka, Junki Mizusawa, Taro Shibata, Shinichiro Nakamura, Masahiko Ando, Akira Yokoyama, Kazuhiko Nakagawa, Nagahiro Saijo, Tomohide Tamura

Tetsuya Abe and Akira Yokoyama, Niigata Cancer Center Hospital, Niigata; Koji Takeda, Osaka City General Hospital; Shinzoh Kudoh, Osaka City University; Shinichiro Nakamura, West Japan Oncology Group Data Center; Kazuhiko Nakagawa, Kinki University, Osaka; Yuichiro Ohe, National Cancer Center Hospital East, Chiba; Yukito Ichinose, National Kyushu Cancer Center, Fukuoka; Hiroaki Okamoto, Yokohama Municipal Citizens Hospital, Kanagawa; Nobuyuki Yamamoto, Wakayama Medical University School of Medicine, Wakayama; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Koichi Minato, Gunma Cancer Center, Gunma; Toshiyuki Sawa, Gifu Municipal Hospital, Gifu; Yasuo Iwamoto, Hiroshima City Hospital, Hiroshima; Hideo Saka, Nagoya Medical Center; Masahiko Ando, Nagoya University Hospital, Aichi; Junki Mizusawa and Taro Shibata, Japan Clincal Oncology Group Data Center, National Cancer Center; Nagahiro Saijo, Japanese Society of Medical Oncology; and Tomohide Tamura, National Cancer Center Hospital, Tokyo, Japan. t-abe@niigata-cc.jp.
2015-1-14; doi: 10.1200/JCO.2014.55.8627

Abstract

Purpose

This phase III trial aimed to confirm the superiority of weekly docetaxel and cisplatin over docetaxel monotherapy in elderly patients with advanced non-small-cell lung cancer (NSCLC).

Patients

Chemotherapy-naïve patients with stage III, stage IV, or recurrent NSCLC age ≥ 70 years with a performance status of 0 or 1 who were considered unsuitable for bolus cisplatin administration were randomly assigned to receive docetaxel 60 mg/m(2) on day 1, every 3 weeks, or docetaxel 20 mg/m(2) plus cisplatin 25 mg/m(2) on days 1, 8, and 15, every 4 weeks. The primary end point was overall survival (OS).

Results

In the first interim analysis, OS of the doublet arm was inferior to that of the monotherapy arm (hazard ratio [HR], 1.56; 95% CI, 0.98 to 2.49), and the predictive probability that the doublet arm would be statistically superior to the monotherapy arm on final analysis was 0.996%, which led to early study termination. In total, 276 patients with a median age of 76 years (range, 70 to 87 years) were enrolled. At the updated analysis, the median survival time was 14.8 months for the monotherapy arm and 13.3 months for the doublet arm (HR, 1.18; 95% CI, 0.83 to 1.69). The rates of grade ≥ 3 neutropenia and febrile neutropenia were higher in the monotherapy arm, and those of anorexia and hyponatremia were higher in the doublet arm.

Conclusion

This study failed to demonstrate any survival advantage of weekly docetaxel plus cisplatin over docetaxel monotherapy as first-line chemotherapy for advanced NSCLC in elderly patients.