(1) Background: Relapsed HGSOC with ascites and/or pleural effusion is a poor-prognostic population and poorly represented in clinical studies. We questioned if these patients are worth treating. In other words, if these patients received the most effective treatment, would it change the course of this disease? To our knowledge this is the first real-life study to evaluate this question in this low-survival population. (2) Methods: To tackle this question we performed a retrospective, multi-centric, real-life study, that reviewed relapsed HGSOC patients with ascites and/or pleural effusion. Our rationale was to compare the OS of two groups of patients: responders, i.e., patients who had an imagological response to treatment (complete/partial response/stable disease, RECIST criteria) versus non-responders (no response/progression upon treatment). We evaluated the predictive value of clinical variables that are available in a real-life setting (e.g., staging, chemotherapy, surgery, platinum-sensitivity). Multivariate logistic regression and survival analysis was conducted. A two-step cluster analysis SPSS tool was used for subgroup analysis. Platinum sensitivity/resistance was also analyzed, as well as multivariate and cluster analysis. (3) Results: We included 57 patients, 41.4% first line responders and 59.6% non-responders. The median OS of responders was 23 months versus 8 months in non-responders (p< 0.001). This difference was verified in platinum-sensitive (mOS 28 months vs. 8 months,p< 0.001) and platinum-resistant populations (mOS 16 months vs. 7 months,p< 0.001). Thirty-one patients reached the second line, of which only 10.3% responded to treatment. Three patients out of thirty-one who did not respond in the first line of relapse, responded in the second line. In the second line, the mOS for the responders’ group vs. non-responders was 31 months versus 13 months (p= 0.02). The two step cluster analysis tool found two different subgroups with different prognoses based on overall response rate, according to consolidation chemotherapy, neoadjuvant chemotherapy, FIGO staging and surgical treatment. Cluster analysis showed that even patients with standard clinical and treatment variables associated with poor prognosis might achieve treatment response (the opposite being also true). (4) Conclusions: Our data clearly show that relapsed HGSOC patients benefit from treatment. If given an effective treatment upfront, this can lead to a ~3 times increase in mOS for these patients. Moreover, this was irrespective of patient disease and treatment characteristics. Our results highlight the urgent need for a sensitivity test to tailor treatments and improve efficacy rates in a personalized manner.
(1) 背景：伴有腹水和/或胸腔积液的高级别浆液性卵巢癌复发患者预后较差，且在临床研究中代表性不足。我们质疑这类患者是否值得治疗。换言之，若这些患者接受最有效的治疗，能否改变疾病进程？据我们所知，这是首个针对这一低生存率人群评估该问题的真实世界研究。(2) 方法：为解决这一问题，我们开展了一项回顾性、多中心、真实世界研究，纳入了伴有腹水和/或胸腔积液的高级别浆液性卵巢癌复发患者。研究通过比较两组患者的总生存期展开：治疗应答者（即影像学评估达到完全缓解/部分缓解/疾病稳定的患者，采用RECIST标准）与非应答者（治疗无效或进展）。我们评估了真实世界环境中可获取的临床变量（如分期、化疗、手术、铂类敏感性）的预测价值，采用多因素逻辑回归与生存分析，并运用SPSS二步聚类分析工具进行亚组分析，同时对铂类敏感/耐药性进行了多因素与聚类分析。(3) 结果：研究共纳入57例患者，其中一线治疗应答者占41.4%，非应答者占59.6%。应答者的中位总生存期为23个月，非应答者为8个月（p<0.001）。该差异在铂类敏感人群（中位总生存期28个月 vs. 8个月，p<0.001）与铂类耐药人群（中位总生存期16个月 vs. 7个月，p<0.001）中均得到验证。31例患者进入二线治疗，其中仅10.3%对治疗产生应答。值得注意的是，有3例一线复发治疗无应答者在二线治疗中获得应答。二线治疗中，应答组与非应答组的中位总生存期分别为31个月与13个月（p=0.02）。二步聚类分析工具根据总体缓解率、巩固化疗、新辅助化疗、FIGO分期及手术治疗情况，识别出两个具有不同预后的亚组。聚类分析表明，即使具有标准临床与治疗不良预后特征的患者仍可能获得治疗应答（反之亦然）。(4) 结论：本研究数据明确显示高级别浆液性卵巢癌复发患者可从治疗中获益。若前期给予有效治疗，可使其中位总生存期提升约3倍，且该获益与患者疾病特征及治疗方式无关。研究结果凸显了开发敏感性检测以个性化定制治疗方案、提升疗效的迫切需求。
肿瘤(癌症)患者之家