在复发性铂耐药卵巢癌随机临床试验中，化疗药物识别引导治疗提高客观缓解率。

ChemoID-guided therapy improves objective response rate in recurrent platinum-resistant ovarian cancer randomized clinical trial.

作者信息

Herzog Thomas J, Krivak Thomas C, Bush Stephen, Diaz John P, Lentz Scott, Nair Navya, Zgheib Nadim Bou, Gunderson-Jackson Camille, Barve Abhijit, Denning Krista L, Lirette Seth T, Howard Candace M, Valluri Jagan, Claudio Pier Paolo

机构信息

Department of Obstetrics and Gynecology, University of Cincinnati Cancer Center, Cincinnati, USA.

Division of Gynecologic Oncology, Allegheny Health Network Cancer Institute, Pittsburgh, USA.

出版信息

NPJ Precis Oncol. 2025 Mar 25;9(1):86. doi: 10.1038/s41698-025-00874-0.

Patients with recurrent platinum-resistant ovarian cancer (PROC) have poor clinical outcomes, owing mainly to the presence of therapy-resistant cancer stem cells (CSCs). The NCT03949283 randomized clinical trial enrolled patients with recurrent PROC to receive ChemoID-guided chemotherapy or the best physician-choice regimen selected from the same list of thirteen mono or combination chemotherapies. The primary outcome was objective response rate (ORR) assessed on CT scans using the RECIST 1.1 criteria at 6 months follow-up. Subjects treated with the ChemoID assay had an ORR of 55% (CI 39% - 73%), compared to 5% (CI 0% - 11%) for those treated with physician's choice chemotherapy (p <0.0001). Secondary endpoints of duration of response (DOR) and progression-free survival (PFS) of subjects treated with chemotherapies guided by the ChemoID assay versus physician's choice chemotherapy were a median of 8 months vs. 5.5 months (p <0.0001), and 11.0 months (CI 8.0- NA) vs 3.0 months (CI 2.0- 3.5) with 27% of hazard ratio (CI95, 0.15-0.49; p <0.001), respectively.

复发性铂耐药卵巢癌（PROC）患者的临床预后较差，主要原因是存在对治疗耐药的癌症干细胞（CSC）。NCT03949283随机临床试验招募了复发性PROC患者，使其接受化学识别引导的化疗或从相同的13种单一或联合化疗药物列表中选择的最佳医生选择方案。主要结局是在6个月随访时根据RECIST 1.1标准通过CT扫描评估的客观缓解率（ORR）。接受化学识别检测的受试者的ORR为55%（CI 39% - 73%），而接受医生选择化疗的受试者的ORR为5%（CI 0% - 11%）（p <0.0001）。化学识别检测引导的化疗与医生选择化疗治疗的受试者的反应持续时间（DOR）和无进展生存期（PFS）的次要终点分别为中位数8个月对5.5个月（p <0.0001），以及11.0个月（CI 8.0 - NA）对3.0个月（CI 2.0 - 3.5），风险比为27%（CI95，0.15 - 0.49；p <0.001）。