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

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-resis...

Descripción completa

Detalles Bibliográficos
Autores principales: Hamanishi, Junzo, Takeshima, Nobuhiro, Katsumata, Noriyuki, Ushijima, Kimio, Kimura, Tadashi, Takeuchi, Satoshi, Matsumoto, Koji, Ito, Kimihiko, Mandai, Masaki, Nakai, Hidekatsu, Sakuragi, Noriaki, Watari, Hidemichi, Takahashi, Nobutaka, Kato, Hidenori, Hasegawa, Kosei, Yonemori, Kan, Mizuno, Mika, Takehara, Kazuhiro, Niikura, Hitoshi, Sawasaki, Takashi, Nakao, Sari, Saito, Toshiaki, Enomoto, Takayuki, Nagase, Satoru, Suzuki, Nao, Matsumoto, Takashi, Kondo, Eiji, Sonoda, Kenzo, Aihara, Satomi, Aoki, Yoichi, Okamoto, Aikou, Takano, Hirokuni, Kobayashi, Hiroshi, Kato, Hisamori, Terai, Yoshito, Takazawa, Akira, Takahashi, Yusuke, Namba, Yoshinobu, Aoki, Daisuke, Fujiwara, Keiichi, Sugiyama, Toru, Konishi, Ikuo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer Health 2021
Materias:
ORIGINAL REPORTS
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8601279/
https://www.ncbi.nlm.nih.gov/pubmed/34473544
http://dx.doi.org/10.1200/JCO.21.00334
Descripción
Sumario: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/m(2) for 30 minutes [once on days 1, 8, and 15] followed by a week's rest [as one cycle], or PLD 50 mg/m(2) 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 = 316) were randomly assigned to nivolumab (n = 157) or GEM or PLD (n = 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 = .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 = .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 = .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.

Ejemplares similares