한빛사논문
Junsik Park1,2, Jung Bok Lee3, Myong Cheol Lim4, Byoung-Gie Kim5, Jae-Weon Kim6, Sunghoon Kim1, Chel Hun Choi5, Hee Seung Kim6, Sang Yoon Park4 and Jung-Yun Lee1 On behalf of the KGOG investigators
1Department of Obstetrics and Gynecology, Yonsei University College of Medicine, Seoul, Republic of Korea
2Severance Biomedical Science Institute, Yonsei University College of Medicine, Seoul, Republic of Korea
3Department of Clinical Epidemiology & Biostatistics, University of Ulsan College of Medicine, Seoul, Republic of Korea
4Gynecologic Cancer Branch & Center for Uterine Cancer, National Cancer Center, Goyang, Republic of Korea
5Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
6Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Republic of Korea
Correspondence to Dr Jung-Yun Lee
Abstract
Background: This study assessed the antitumor activity and safety of durvalumab plus tremelimumab combined with neoadjuvant chemotherapy (NAC) in patients newly diagnosed with advanced ovarian cancer. Here, we report the primary endpoint of the original cohort of the KGOG 3046/TRU-D study.
Methods: In this investigator-initiated single-arm, phase II trial, patients with stage IIIC-IVB ovarian cancer were administered three cycles of durvalumab (1500 mg) and tremelimumab (75 mg) with NAC, followed by interval debulking surgery (IDS). After surgery, three cycles of durvalumab (1120 mg) and adjuvant chemotherapy followed by durvalumab maintenance (1120 mg [total 12 cycles]) were administered. The primary endpoint of the study was 12-month progression-free survival (PFS) rate.
Results: Twenty-three patients were enrolled. The median patient age was 60 years (range 44-77 years), and most patients presented with high-grade serous carcinoma (87.0%) and stage IV disease (87.0%). At the time of data cut-off on January 17, 2023, the median follow-up duration was 29.2 months (range 12.0-42.2). The 12-month, 24-month, and 30 month PFS rates were 63.6%, 45.0%, and 40.0%, respectively. All patients underwent IDS, with an R0 resection rate of 73.9%, and 17.4% achieved pathological complete response. Skin rashes were the most common treatment-related adverse events (TRAEs, 69.6%). However, all TRAEs completely resolved after steroid use.
Conclusion: This study showed promising activity with a durable clinical response, supporting the potential of NAC with dual immune checkpoint blockade in advanced-stage ovarian cancer.
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