Combination immunotherapy using ipilimumab/nivolumab is the golden standard treatment for patients with melanoma and asymptomatic brain metastases (MBM). However, it remains uncertain if real-world patients have the same treatment effects compared to patients enrolled in clinical trials. The aim of this study was to compare clinical benefits between real-world patients and patients enrolled in clinical trials when administering ipilimumab/nivolumab in treatment-naive patients with asymptomatic MBM. Using data from the Danish Metastatic Melanoma Database (DAMMED), 79 patients with clinical parameters similar to the inclusion criteria from two phase II trials, the ABC and the CheckMate-204 trials, were included in the analyses. Thirteen patients (16.5%) achieved complete response (CR) and an overall response rate (ORR) of 46.9%. We found an overall 6-month Progression-Free Survival (PFS) rate of 53.5% and a median PFS of 6.5 months. Median overall survival (mOS) was not reached during the 5-year follow-up. These results were comparable to the phase II trials. In conclusion, clinical benefits from phase II studies were comparable to Danish real-world data regarding OS, PFS, and CR. Confirming that combination immunotherapy can be recommended as first-line treatment for patients with asymptomatic, treatment-naive melanoma brain metastases.
伊匹单抗/纳武单抗联合免疫疗法是治疗黑色素瘤伴无症状脑转移（MBM）患者的金标准方案。然而，真实世界患者是否与临床试验入组患者具有相同的治疗效果仍不明确。本研究旨在比较真实世界患者与临床试验患者在初治无症状MBM中应用伊匹单抗/纳武单抗治疗的临床获益差异。通过丹麦转移性黑色素瘤数据库（DAMMED）纳入79例临床参数符合两项II期试验（ABC试验和CheckMate-204试验）入组标准的患者进行分析。结果显示13例患者（16.5%）达到完全缓解（CR），总缓解率（ORR）为46.9%。6个月无进展生存（PFS）率为53.5%，中位PFS为6.5个月。在5年随访期间中位总生存期（mOS）尚未达到。这些结果与II期临床试验数据具有可比性。综上所述，II期研究中的临床获益与丹麦真实世界数据在总生存期、无进展生存期和完全缓解率方面表现相当，证实联合免疫疗法可作为初治无症状黑色素瘤脑转移患者的一线治疗方案。
肿瘤(癌症)患者之家