한빛사논문
- 조회1,344
Hee Jin Cho 1,13, Kum-Hee Yun 2,13, Su-Jin Shin 3,13, Young Han Lee 4, Seung Hyun Kim 5, Wooyeol Baek 6, Yoon Dae Han 7, Sang Kyum Kim 8, Hyang Joo Ryu 8, Joohee Lee 4, Iksung Cho 9, Heounjeong Go 10, Jiwon Ko 10,11, Inkyung Jung 12, Min Kyung Jeon 2, Sun Young Rha 2 & Hyo Song Kim 2,*
1Department of Biomedical Convergence Science and Technology, CMRI, Kyungpook National University, Daegu, Republic of Korea.
2Division of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.
3Department of Pathology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
4Department of Radiology, Yonsei University College of Medicine, Seoul, Republic of Korea.
5Department of Orthopaedic Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea.
6Department of Plastic Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea.
7Department of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea.
8Department of Pathology, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
9Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea. 10Department of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
11Asan Institute for Life Sciences, Asan Medical Center, Seoul, Republic of Korea.
12Division of Biostatistics, Department of Biomedical Systems Informatics, Yonsei University College of Medicine, Seoul, Republic of Korea.
13These authors contributed equally: Hee Jin Cho, Kum-Hee Yun, Su-Jin Shin.
*Corresponding author: correspondence to Hyo Song Kim
Abstract
We aimed to determine the activity of the anti-VEGF receptor tyrosine-kinase inhibitor, pazopanib, combined with the anti-PD-L1 inhibitor, durvalumab, in metastatic and/or recurrent soft tissue sarcoma (STS). In this single-arm phase 2 trial (NCT03798106), treatment consisted of pazopanib 800 mg orally once a day and durvalumab 1500 mg once every 3 weeks. Primary outcome was overall response rate (ORR) and secondary outcomes included progression-free survival (PFS), overall survival, disease control rate, immune-related response criteria, and safety. The ORR was 30.4% and the trial met the pre-specified endpoint. The median PFS was 7.7 months (95% confidence interval: 5.7–10.4). The common treatment-related adverse events of grades 3–4 included neutropenia (9 [19.1%]), elevated aspartate aminotransferase (7 [14.9%]), alanine aminotransferase (5 [10.6%]), and thrombocytopenia (4 [8.5%]). In a prespecified transcriptomic analysis, the B lineage signature was a significant key determinant of overall response (P = 0.014). In situ analysis also showed that tumours with high CD20+ B cell infiltration and vessel density had a longer PFS (P = 6.5 × 10−4) than those with low B cell infiltration and vessel density, as well as better response (50% vs 12%, P = 0.019). CD20+ B cell infiltration was identified as the only independent predictor of PFS via multivariate analysis. Durvalumab combined with pazopanib demonstrated promising efficacy in an unselected STS cohort, with a manageable toxicity profile.
논문정보
- Research article
- 2024년 01월 (BRIC 등록일 2024-01-24)
- 국내 연구진
- 의약학 > 종양의학
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