14 research outputs found

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

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    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 = 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

    Effects of Various Numbers of Runs on the Success of Hamstring Injury Prevention Program in Sprinters

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    Studies have not adequately addressed the influence of fatigue, which is considered a major risk factor for hamstring injuries. Therefore, this study aimed to clarify how a muscle fatigue condition affects the success of hamstring injury prevention programs in sprinters. The study subjects were 613 collegiate male sprinters. They employed submaximal/maximal running for a large number of runs and supramaximal running for a small number of runs in daily training. The hamstring injury prevention program had become the most effective strategy in the past 24 seasons of track and field for preventing hamstring injuries. The number of sprinters who experienced hamstring injuries in three periods over the 24 seasons was recorded. The incidents of hamstring injuries during supramaximal running per athlete-seasons were 137.9, 60.6, and 6.7 for Periods I, II, and III, respectively, showing a significant decline (p < 0.01). Furthermore, the incidents of hamstring injuries during submaximal and maximal running per season showed no significant change. The results of this study indicate that by inducing muscle fatigue, a small number of runs makes hamstring injury prevention programs effective
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