Wang Qing, Kuang Lei, Liu Boyang, Chen Qi, Li Yanyu, Zhou Jiayun, Zhang Jingbo, Yang Xinhui, Wan Guiping, Wischhusen Jörg, Salcedo-Hernández Rosa A, Ladbury Colton, Yin Zeyuan, Zhang Bei
Department of Obstetrics and Gynecology, Xuzhou Central Hospital, Xuzhou Clinical School of Xuzhou Medical University, Xuzhou, China.
Nanjing University of Chinese Medicine, Nanjing, China.
Transl Cancer Res. 2025 May 30;14(5):3161-3174. doi: 10.21037/tcr-2025-641. Epub 2025 May 27.
Current clinical research on platinum-resistant recurrent ovarian cancer (PRROC) is primarily based on prospective clinical trials, while real-world evidence remains extremely scarce. The continuous accumulation of real-world evidence can effectively address the limitations of clinical trials, and real-world evidence is increasingly gaining recognition in guiding clinical practice. This study sought to describe the clinical outcomes and characteristics of patients diagnosed with PRROC in a real-world setting. Comparing clinical outcomes [e.g., progression-free survival (PFS) and overall survival (OS)] of PRROC patients provides researchers with valuable insights into the current treatment status, effectiveness, and contributory factors of PRROC.
Patients with histologically confirmed diagnosis of OC from six tertiary referral centers in China from January 2018 to December 2023 were recruited at diagnosis of PRROC. All study patients were followed up to December 1, 2023. We evaluated the characteristics, treatment patterns, and outcomes of these patients. In addition, the background characteristics of the patients were identified, and independent prognostic factors for OS were investigated.
In this cohort of 504 patients diagnosed with PRROC, 277 patients (54.96%) received a single-agent non-platinum chemotherapy, and 227 patients (45.04%) received a platinum-containing regimen. Compared to the single-agent non-platinum chemotherapy group, the platinum-based combination chemotherapy group had significantly longer PFS [5.6 vs. 4.0 months, hazard ratio (HR): 0.431, 95% confidence interval (CI): 0.356-0.521, P<0.0001] and OS (15.9 13.0 months; HR: 0.766, 95% CI: 0.638-0.919, P=0.005). The poly (adenosine diphosphate-ribose) polymerase inhibitor (PARPi) monotherapy group tended to have not statistically significant improvement PFS (4.5 4.0 months; HR: 0.788, 95% CI: 0.573-1.085, P=0.15) and OS (13.1 13.0 months; HR: 1.101, 95% CI: 0.767-1.580, P=0.56) compared to the single-agent non-platinum chemotherapy group. Adding antiangiogenic therapy to platinum-based combination chemotherapy and single-agent non-platinum chemotherapy resulted in improved treatment efficiencies. Independent prognostic factors for OS were the progression-free interval (PFI), histological type, and clinical trial participation. In the subgroup of patients who received platinum-based combination chemotherapy, the patients with a PFI >3-6 months who were re-treated with platinum-based chemotherapy had longer OS than those with a PFI >0-3 months (16.47 12.83 months, HR: 1.522, 95% CI: 1.155-2.006, P=0.003).
In this real-world cohort, we found that patients diagnosed with PRROC, particularly those with a PFI of >3-6 months, experienced substantial benefits from the re-administration of platinum agents. Thus, platinum rechallenge therapy could represent a promising treatment approach for PRROC. Biomarkers of platinum sensitivity are needed in clinical practice to identify potential responders who should be offered re-treatment with platinum.
目前关于铂耐药复发性卵巢癌(PRROC)的临床研究主要基于前瞻性临床试验,而真实世界证据仍然极为匮乏。真实世界证据的不断积累能够有效解决临床试验的局限性,并且在指导临床实践方面越来越受到认可。本研究旨在描述在真实世界中被诊断为PRROC的患者的临床结局和特征。比较PRROC患者的临床结局[如无进展生存期(PFS)和总生存期(OS)]可为研究人员提供有关PRROC当前治疗状况、有效性及影响因素的宝贵见解。
招募2018年1月至2023年12月在中国六个三级转诊中心组织学确诊为卵巢癌且诊断为PRROC的患者。所有研究患者随访至2023年12月1日。我们评估了这些患者的特征、治疗模式和结局。此外,确定了患者的背景特征,并调查了OS的独立预后因素。
在这一队列的504例诊断为PRROC的患者中,277例患者(54.96%)接受了单药非铂类化疗,227例患者(45.04%)接受了含铂方案。与单药非铂类化疗组相比,铂类联合化疗组的PFS显著更长[5.6个月对4.0个月,风险比(HR):0.431,95%置信区间(CI):0.356 - 0.521,P<0.0001],OS也更长(15.9个月对13.0个月;HR:0.766,95%CI:0.638 - 0.919,P = 0.005)。聚(二磷酸腺苷 - 核糖)聚合酶抑制剂(PARPi)单药治疗组与单药非铂类化疗组相比,PFS(4.5个月对4.0个月;HR:0.788,95%CI:0.573 - 1.085,P = 0.15)和OS(13.1个月对13.0个月;HR:1.101,95%CI:0.767 - 1.580,P = 0.56)有改善趋势,但无统计学意义。在铂类联合化疗和单药非铂类化疗中添加抗血管生成治疗可提高治疗效率。OS的独立预后因素为无进展间期(PFI)、组织学类型和参与临床试验。在接受铂类联合化疗的亚组患者中,PFI>3 - 6个月且再次接受铂类化疗的患者的OS长于PFI>0 - 3个月的患者(16.47个月对12.83个月,HR:1.522,95%CI:1.155 - 2.006,P = 0.003)。
在这个真实世界队列中,我们发现被诊断为PRROC的患者,尤其是PFI>3 - 6个月的患者,再次使用铂类药物可获得显著益处。因此,铂类再挑战疗法可能是PRROC一种有前景的治疗方法。临床实践中需要铂敏感性生物标志物来识别可能从铂类再治疗中获益的潜在患者。