Pembrolizumab Plus Amrubicin in Patients With Relapsed SCLC: Multi-Institutional, Single-Arm Phase 2 Study
- Hiroaki Akamatsu, MD, PhD
- Shunsuke Teraoka, MD
- Hidetoshi Hayashi, MD, PhD
- Daichi Fujimoto, MD
- Atsushi Hayata, MD, PhD
- Koji Haratani, MD, PhD
- Yuichi Ozawa, MD, PhD
- Takeshi Yoshida, MD, PhD
- Tsutomu Iwasa, MD, PhD
- Toshio Shimokawa, MD
- Keisuke Tomii, MD, PhD
- Kazuhiko Nakagawa, MD, PhD
- Nobuyuki Yamamoto, MD, PhD
DOIAbstract
Introduction: In patients with relapsed SCLC, amrubicin (AMR) is the current standard treatment in Japan. Nevertheless, its efficacy is not satisfactory and prognosis is poor. Preclinical study suggested that anthracycline agent might induce immunogenic cell death and work synergistically with immune checkpoint inhibitors. Methods: Patients with relapsed SCLC who relapsed after completion of platinum-containing regimen were registered. Patients were treated with pembrolizumab (200 mg, flat dose on d 1, every 3 wk for 2 y) plus AMR (40 mg/m2 on d 1–3, every 3 wk until progression). Primary end point was overall response rate (ORR). Secondary end points consisted of progression-free survival (PFS), overall survival, and safety. On the basis o...
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