Effectiveness and safety of nivolumab in patients with head and neck cancer in Japanese real-world clinical practice: a
- PDF / 933,290 Bytes
- 12 Pages / 595.276 x 790.866 pts Page_size
- 110 Downloads / 190 Views
ORIGINAL ARTICLE
Effectiveness and safety of nivolumab in patients with head and neck cancer in Japanese real‑world clinical practice: a multicenter retrospective clinical study Nobuhiro Hanai1 · Yasushi Shimizu2 · Shin Kariya3 · Ryuji Yasumatsu4 · Tomoya Yokota5 · Takashi Fujii6 · Kiyoaki Tsukahara7 · Masafumi Yoshida8 · Kenji Hanyu9 · Tsutomu Ueda10 · Hitoshi Hirakawa11 · Shunji Takahashi12 · Takeharu Ono13 · Daisuke Sano14 · Moriyasu Yamauchi15 · Akihito Watanabe16 · Koichi Omori17 · Tomoko Yamazaki18 · Nobuya Monden19 · Naomi Kudo20 · Makoto Arai21 · Daiju Sakurai22 · Takahiro Asakage23 · Issei Doi24 · Takayuki Yamada25 · Akihiro Homma26 Received: 25 June 2020 / Accepted: 29 October 2020 © Japan Society of Clinical Oncology 2020
Abstract Background To fill the data gap between clinical trials and real-world settings, this study assessed the overall effectiveness and safety of nivolumab in patients with head and neck cancer (HNC) during Japanese real-world clinical practice. Methods This was a multicenter, retrospective study in Japanese patients with recurrent or metastatic HNC who received nivolumab for the first time between July and December 2017. Data on the clinical use, effectiveness, and safety of nivolumab were extracted from patient medical records. Results Overall, 256 patients were enrolled in this study. The median duration of nivolumab treatment was 72.5 days, with patients receiving a median of 6.0 (range 1–27) doses. Median overall survival (OS) was 9.5 (95% confidence interval [CI] 8.2–12.0) months and the estimated 12-month OS rate was 43.2%. The objective response rate (ORR) was 15.7% overall and 21.1%, 7.1%, and 13.6% in patients with primary nasopharynx, maxillary sinus, and salivary gland tumors, respectively, who had been excluded from CheckMate 141. Grade ≥ 3 immune-related adverse events occurred in 5.9% of patients. No new safety signals were identified compared with adverse events noted in CheckMate 141. Conclusions The effectiveness and safety of nivolumab in real-world clinical practice are consistent with data from the CheckMate 141 clinical trial. Therapeutic response was also observed in the groups of patients excluded from CheckMate 141. Trial registration number UMIN-CTR (UMIN000032600), Clinicaltrials.gov (NCT03569436) Keywords Nivolumab · Real-world clinical practice · Recurrent or metastatic head and neck cancer · Multicenter retrospective study
Introduction Nivolumab is a fully human immunoglobulin G4 monoclonal antibody targeted against programmed cell death protein-1 (PD-1). Nivolumab was approved in March 2017 for the treatment of recurrent or distant metastatic head and Electronic supplementary material The online version of this article (https://doi.org/10.1007/s10147-020-01829-0) contains supplementary material, which is available to authorized users. * Akihiro Homma ak‑[email protected] Extended author information available on the last page of the article
neck cancer (HNC) in Japan. This approval was based on the survival benefits and the manageab
Data Loading...
