Background: When monotherapy with PD-1 inhibitors in metastatic melanoma fails, there are currently no standard second-line choices. In case of the unavailability of clinical trials, ipilimumab represents a possible alternative treatment. Methods: We collected data of 44 patients who received ipilimumab after the failure of PD-1 inhibitors from July 2017 to May 2023 at our Institute. Overall survival (OS), progression-free survival (PFS), and post-progression survival (PPS) based on BRAF or NRAS mutation status, sex, and the presence of brain metastases were estimated using the Kaplan–Meier method. Cox regression was used to evaluate independence in multivariate analysis. The objective response rate (ORR) was estimated based on RECIST 1.1. Results: Among the 44 patients enrolled in this study, 28 BRAF-wildtype, 9 BRAF-mutated, and 7 NRAS-mutated patients were identified. OS analysis showed a significant difference between wildtype and BRAF- or NRAS-mutated patients: 23.2 months vs 5.3 and 4.59, respectively,p= 0.017. The presence of brain metastases and BRAF or NRAS mutation were independent factors for mortality in multivariate analysis. Conclusions: In case of failure to enroll patients in innovative clinical trials, second-line ipilimumab still represents an effective therapy in patients with metastatic wildtype melanoma and in the absence of brain metastases.
背景：当转移性黑色素瘤患者对PD-1抑制剂单药治疗失败时，目前尚无标准的二线治疗方案。在无法参与临床试验的情况下，伊匹木单抗可作为一种潜在替代疗法。方法：我们收集了2017年7月至2023年5月期间在本机构接受PD-1抑制剂治疗失败后使用伊匹木单抗的44例患者数据。基于BRAF或NRAS突变状态、性别及是否存在脑转移，采用Kaplan-Meier法评估总生存期（OS）、无进展生存期（PFS）及进展后生存期（PPS）。多变量分析采用Cox回归评估独立性。客观缓解率（ORR）依据RECIST 1.1标准进行评估。结果：本研究纳入的44例患者中，包括28例BRAF野生型、9例BRAF突变型和7例NRAS突变型患者。OS分析显示野生型与BRAF或NRAS突变型患者存在显著差异：分别为23.2个月 vs 5.3个月和4.59个月（p=0.017）。多变量分析表明，脑转移的存在以及BRAF或NRAS突变是影响死亡率的独立因素。结论：在无法纳入创新性临床试验的情况下，对于无脑转移的转移性野生型黑色素瘤患者，二线伊匹木单抗治疗仍是一种有效的治疗选择。
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