| Autor: |
Nobukazu Fujimoto, MD, PhD, Morihito Okada, MD, PhD, Takashi Kijima, MD, PhD, Keisuke Aoe, MD, PhD, Terufumi Kato, MD, Kazuhiko Nakagawa, MD, PhD, Yuichiro Takeda, MD, PhD, Toyoaki Hida, MD, PhD, Kuninobu Kanai, MD, PhD, Jun Hirano, MPharm, Yuichiro Ohe, MD, PhD |
| Jazyk: |
angličtina |
| Rok vydání: |
2021 |
| Předmět: |
|
| Zdroj: |
JTO Clinical and Research Reports, Vol 2, Iss 3, Pp 100135- (2021) |
| Druh dokumentu: |
article |
| ISSN: |
2666-3643 |
| DOI: |
10.1016/j.jtocrr.2020.100135 |
| Popis: |
Introduction: We examined the long-term efficacy and safety of nivolumab, a human monoclonal antibody that inhibits interactions between the programmed cell death protein-1 receptor and its ligands (programmed death-ligand 1 and programmed death-ligand 2), in Japanese patients with malignant pleural mesothelioma (MPM). Methods: Japanese patients with previously treated MPM (one or two regimens) were enrolled in a single-arm, phase 2 study and received nivolumab intravenously 240 mg every 2 weeks until progressive disease or unacceptable toxicity. The primary end point was the centrally assessed objective response rate. Other end points included overall survival (OS), progression-free survival (PFS), treatment-related adverse events, and patient-reported outcomes (Lung Cancer Symptom Scale for mesothelioma and EuroQOL visual analog scale). Patient enrollment started on June 16, 2016. Here, we report 3-year follow-up data (cutoff date: November 12, 2019). Results: Thirty-four patients were enrolled. The centrally assessed objective response rate was previously reported (29.4%). The 2- and 3-year OS rates were 35.3% and 23.5%, respectively, and the corresponding PFS rates were 17.0% and 12.7%. Median OS and PFS were 17.3 and 5.9 months, respectively. Eight patients were alive at 3 years of follow-up. Nivolumab was well tolerated and no new safety signals were found. The patient-reported outcomes were maintained without marked deteriorations during the study. Conclusions: Our results reveal clinically relevant long-term efficacy and safety of nivolumab for the treatment of MPM. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
|
