TY - JOUR
T1 - Nivolumab Versus Gemcitabine or Pegylated Liposomal Doxorubicin for Patients With Platinum-Resistant Ovarian Cancer
T2 - Open-Label, Randomized Trial in Japan (NINJA)
AU - Hamanishi, Junzo
AU - Takeshima, Nobuhiro
AU - Katsumata, Noriyuki
AU - Ushijima, Kimio
AU - Kimura, Tadashi
AU - Takeuchi, Satoshi
AU - Matsumoto, Koji
AU - Ito, Kimihiko
AU - Mandai, Masaki
AU - Nakai, Hidekatsu
AU - Sakuragi, Noriaki
AU - Watari, Hidemichi
AU - Takahashi, Nobutaka
AU - Kato, Hidenori
AU - Hasegawa, Kosei
AU - Yonemori, Kan
AU - Mizuno, Mika
AU - Takehara, Kazuhiro
AU - Niikura, Hitoshi
AU - Sawasaki, Takashi
AU - Nakao, Sari
AU - Saito, Toshiaki
AU - Enomoto, Takayuki
AU - Nagase, Satoru
AU - Suzuki, Nao
AU - Matsumoto, Takashi
AU - Kondo, Eiji
AU - Sonoda, Kenzo
AU - Aihara, Satomi
AU - Aoki, Yoichi
AU - Okamoto, Aikou
AU - Takano, Hirokuni
AU - Kobayashi, Hiroshi
AU - Kato, Hisamori
AU - Terai, Yoshito
AU - Takazawa, Akira
AU - Takahashi, Yusuke
AU - Namba, Yoshinobu
AU - Aoki, Daisuke
AU - Fujiwara, Keiichi
AU - Sugiyama, Toru
AU - Konishi, Ikuo
N1 - Funding Information:
Supported by Ono Pharmaceutical Co, Ltd and Bristol-Myers Squibb Company, manufacturer/licensee of nivolumab.
Publisher Copyright:
© 2021 by American Society of Clinical Oncology
PY - 2021/11/20
Y1 - 2021/11/20
N2 - 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.
AB - 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.
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U2 - 10.1200/JCO.21.00334
DO - 10.1200/JCO.21.00334
M3 - Article
C2 - 34473544
AN - SCOPUS:85121962915
SN - 0732-183X
VL - 39
SP - 3671
EP - 3681
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 33
ER -
