조진현 (인하대학교 의과대학, 인하대학교병원) | 한빛사논문 > 한빛사

한빛사논문

조회1,227

조진현Jinhyun Cho

인하대학교 의과대학, 인하대학교병원

J. Clin. Oncol., Published online before print June 15, 2018 | https://doi.org/10.1200/JCO.2017.77.3184 Pembrolizumab for Patients With Refractory or Relapsed Thymic Epithelial Tumor: An Open-Label Phase II Trial

Jinhyun Cho¹, Hae Su Kim², Bo Mi Ku³, Yoon-La Choi³, Razvan Cristescu⁴, Joungho Han³, Jong-Mu Sun³, Se-Hoon Lee³, Jin Seok Ahn³, Keunchil Park³, and Myung-Ju Ahn^3,*

¹Inha University Hospital, Inha University School of Medicine, Incheon;
²Veterans Health Service Medical Center;
³Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea;
and ⁴Razvan Cristescu, Merck Research Laboratories, Boston, MA.

^*Corresponding author: Myung-Ju Ahn, MD, PhD, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Korea;

Abstract

Purpose

Limited treatment options exist for patients with thymic epithelial tumor (TET) whose disease progresses after platinum-based chemotherapy. We conducted a phase II study of pembrolizumab in patients with TET to evaluate its efficacy and safety.

Methods

Patients with histologically confirmed TET whose disease progressed after at least one line of platinum-based chemotherapy were eligible for the study. Patients were excluded if they had an active autoimmune disease requiring systemic treatment within the past year or documented history of clinically severe autoimmune disease. Patients received 200 mg of pembrolizumab intravenously every 3 weeks until tumor progression or unacceptable toxicity. The primary objective of response rate was assessed every 9 weeks by investigators.

Results

Of 33 patients enrolled, 26 had thymic carcinoma and seven had thymoma. Of seven thymoma, two (28.6%; 95% CI, 8.2% to 64.1%) had partial response, and five (71.6%) had stable disease. Of 26 thymic carcinoma, five (19.2%; 95% CI, 8.5% to 37.9%) had partial response and 14 (53.8%) had stable disease. The median progression-free survival was 6.1 months for both groups. The most common adverse events of any grade included dyspnea (11; 33.3%), chest wall pain (10; 30.3%), anorexia (seven; 21.2%), and fatigue (seven; 21.2%). Five (71.4%) of seven patients with thymoma and four (15.4%) of 26 patients with thymic carcinoma reported grade ≥ 3 immune-related adverse events, including hepatitis (four; 12.1%), myocarditis (three; 9.1%), myasthenia gravis (two; 6.1%), thyroiditis (one; 3.0%), antineutrophil cytoplasmic antibody?associated rapidly progressive glomerulonephritis (one; 3.0%), colitis (one; 3.0%), and subacute myoclonus (one; 3.0%).

Conclusions

Pembrolizumab showed encouraging antitumor activity in patients with advanced TET. Given the high incidence of autoimmunity, additional studies are needed to identify those who can benefit from pembrolizumab without immune-related adverse events.

논문정보

형식Research article
게재일2018년 06월 (BRIC 등록일 2018-07-04)
연구진국내(교신)+국외 연구진
분야 의약학 > 종양의학

댓글 작성 로그인

CV 열람하기

연락처 보기