| 論文種別 | 原著(症例報告除く) |
| 言語種別 | 英語 |
| 査読の有無 | その他(不明) |
| 表題 | Turtle Study: A Phase 2 Study of Durvalumab Plus Carboplatin and Etoposide in Elderly Patients With Extensive-Stage SCLC (LOGiK 2003). |
| 掲載誌名 | 正式名：JTO clinical and research reports 略 称：JTO Clin Res Rep ISSNコード：26663643/26663643 |
| 掲載区分 | 国外 |
| 巻・号・頁 | 6(7),pp.100836 |
| 著者・共著者 | Hidenobu Ishii, Koichi Azuma, Yuta Yamanaka, Hiroshige Yoshioka, Yukihiro Toi, Naoki Shingu, Katsuhiko Naoki, Masaki Okamoto, Yuko Tsuchiya-Kawano, Taishi Harada, Hiroyuki Inoue, Hiroshi Ishii, Kazunori Tobino, Chiho Nakashima, Yoshifusa Koreeda, Yasushi Hisamatsu, Shinsuke Tsumura, Takashi Inagaki, Keiko Mizuno, Takayuki Shimose, Isamu Okamoto |
| 発行年月 | 2025/04 |
| 概要 | INTRODUCTION:The combination of immune checkpoint inhibitors with chemotherapy is the standard treatment for extensive-stage (ES) SCLC. However, its safety for elderly patients is not fully validated. We evaluated the safety and efficacy of durvalumab plus carboplatin and etoposide in elderly patients with ES-SCLC.METHODS:In this prospective, single-arm, multicenter, phase 2 clinical trial, patients with ES-SCLC aged above or equal to 75 years received chemotherapy with up to four cycles of durvalumab 1500 mg on day 1, carboplatin at a dose equivalent to an area under the curve of 5 on day 1, and etoposide 80 mg/m2 on days 1 to 3 every 3 weeks as induction therapy. Maintenance therapy with durvalumab 1500 mg was administered every 4 weeks until disease progression or unacceptable toxicity. The primary end point was safety, and key secondary end points were objective response rate, progression-free survival, overall survival, quality of life, and Geriatric Assessment.RESULTS:Between August 2021 and February 2023, 40 patients were enrolled at 17 institutions and 38 were assessable for safety and efficacy. Grade 3 or higher adverse events occurred in 36 patients (94.6%). The most common adverse events were hematologic, including grade 3 or higher neutropenia (76.3%) and febrile neutropenia (15.8%). The objective response rate, median progression-free survival, and median overall survival were 89.5%, 5.4 months, and 16.1 months, respectively. No decrease in quality of life or functional assessment scores was observed after treatment.CONCLUSION:Durvalumab plus carboplatin and etoposide was tolerable and expected to be effective in elderly patients with ES-SCLC. |
| DOI | 10.1016/j.jtocrr.2025.100836 |
| PMID | 40534995 |