医学
临床终点
内科学
揭穿
人口
卵巢癌
肿瘤科
外科
化疗
临床研究阶段
不利影响
癌症
临床试验
环境卫生
作者
Bing Xia,Wen Jiang,J. Paul Chen,Yun-Fei Chen,Shan Wu,Wenbin Shen,Yaping Tian,Yun-Fei Chen,Xiaohong Chen,Weiqing Wu,Yuguang Ma,Jing Wang,Wei‐Xiang Qi,Zhonghua Wang,Xiangcheng Li,Xingxing Huang,Lin H,Bin Hong,Hebing Zhou
标识
DOI:10.1016/j.annonc.2023.09.1941
摘要
Optimal tumor reduction surgery is crucial for for advanced ovarian cancer (OC) prognosis. Neoadjuvant chemotherapy can increase surgery chances for OC, but the benefit to patients (pts) is limited. PARP inhibitors combined with anti-angiogenic drugs have significant benefits in the first-line maintenance and recurrence treatment of OC. This study aims to evaluate the efficacy and safety of Pamiparib combined with Surufatinib neoadjuvant therapy (NAT) for advanced unresectable OC in the entire population. This is a single-center, single-arm, phase II study following Simon's two-stage design. 20 pts with newly diagnosed unresectable (Fagotti score ≥ 8 or upper abdominal CT score ≥ 3) FIGO III-IV OC were recruited. Enrolled pts will receive NAT with Pamiparib (40 mg bid q3w for 3 cycles) combined with Surufatinib (250mg bid q3w for 2 cycles), followed by interval debulking surgery (IDS) and4 cycles of platinum-containing chemotherapy. The primary endpoint is complete resection rate (R0), and secondary endpoints include objective response rate (ORR), pathologic complete response(pCR) rate, progression-free survival, overall survival, and safety. As of Aug 30, 2023, of the 20 enrolled pts, 16 had completed genetic testing, and 14 were homologous recombination deficiency (HRD) positive, with 9 cases of BRCA1/2 mutations. By Aug 30, 2023, 17 pts completed NAT and IDS with an ORR of 100%. 15 pts achieved R0 surgery (88.24%), and 2 pts achieved R1. All 20 pts were evaluable by GCIG CA125 criteria, and CA125 response was all observed (100%). Grade 3 or 4 treatment-related adverse events that occurred are neutropenia, thrombocytopenia, anemia, and hepatic dysfunction. Pamiparib combined with Surufatinib as a new neoadjuvant "chemotherapy-free" regimen showed extremely high R0 and ORR rates with manageable toxicity profiles. Currently, the experiment is still ongoing and further analysis and reporting of more data will be conducted.
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