Nivolumab Versus Gemcitabine or Pegylated Liposomal Doxorubicin for Patients With Platinum-Resistant Ovarian Cancer: Open-Label, Randomized Trial in Japan (NINJA)

Junzo Hamanishi, Nobuhiro Takeshima, Noriyuki Katsumata, Kimio Ushijima, Tadashi Kimura, Satoshi Takeuchi, Koji Matsumoto, Kimihiko Ito, Masaki Mandai, Hidekatsu Nakai, Noriaki Sakuragi, Hidemichi Watari, Nobutaka Takahashi, Hidenori Kato, Kosei Hasegawa, Kan Yonemori, Mika Mizuno, Kazuhiro Takehara, Hitoshi Niikura, Takashi SawasakiSari Nakao, Toshiaki Saito, Takayuki Enomoto, Satoru Nagase, Nao Suzuki, Takashi Matsumoto, Eiji Kondo, Kenzo Sonoda, Satomi Aihara, Yoichi Aoki, Aikou Okamoto, Hirokuni Takano, Hiroshi Kobayashi, Hisamori Kato, Yoshito Terai, Akira Takazawa, Yusuke Takahashi, Yoshinobu Namba, Daisuke Aoki, Keiichi Fujiwara, Toru Sugiyama, Ikuo Konishi

研究成果: Article査読

15 被引用数 (Scopus)

抄録

PURPOSE This phase III, multicenter, randomized, open-label study investigated the efficacy and safety of nivolumab versus chemotherapy (gemcitabine [GEM] or pegylated liposomal doxorubicin [PLD]) in patients with platinum-resistant ovarian cancer. MATERIALS AND METHODS Eligible patients had platinum-resistant epithelial ovarian cancer, received # 1 regimen after diagnosis of resistance, and had an Eastern Cooperative Oncology Group performance score of # 1. Patients were randomly assigned 1:1 to nivolumab (240 mg once every 2 weeks [as one cycle]) or chemotherapy (GEM 1000 mg/m2 for 30 minutes [once on days 1, 8, and 15] followed by a week’s rest [as one cycle], or PLD 50 mg/m2 once every 4 weeks [as one cycle]). The primary outcome was overall survival (OS). Secondary outcomes included progression-free survival (PFS), overall response rate, duration of response, and safety. RESULTS Patients (n 5 316) were randomly assigned to nivolumab (n 5 157) or GEM or PLD (n 5 159) between October 2015 and December 2017. Median OS was 10.1 (95% CI, 8.3 to 14.1) and 12.1 (95% CI, 9.3 to 15.3) months with nivolumab and GEM or PLD, respectively (hazard ratio, 1.0; 95% CI, 0.8 to 1.3; P 5 .808). Median PFS was 2.0 (95% CI, 1.9 to 2.2) and 3.8 (95% CI, 3.6 to 4.2) months with nivolumab and GEM or PLD, respectively (hazard ratio, 1.5; 95% CI, 1.2 to 1.9; P 5 .002). There was no statistical difference in overall response rate between groups (7.6% v 13.2%; odds ratio, 0.6; 95% CI, 0.2 to 1.3; P 5 .191). Median duration of response was numerically longer with nivolumab than GEM or PLD (18.7 v 7.4 months). Fewer treatment-related adverse events were observed with nivolumab versus GEM or PLD (61.5% v 98.1%), with no additional or new safety risks. CONCLUSION Although well-tolerated, nivolumab did not improve OS and showed worse PFS compared with GEM or PLD in patients with platinum-resistant ovarian cancer.

本文言語English
ページ(範囲)3671-3681
ページ数11
ジャーナルJournal of Clinical Oncology
39
33
DOI
出版ステータスPublished - 2021 11月 20

ASJC Scopus subject areas

  • 腫瘍学
  • 癌研究

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