Afrăsânie Vlad-Adrian, Alexa-Stratulat Teodora, Gafton Bogdan, Froicu Eliza-Maria, Sur Daniel, Lungulescu Cristian Virgil, Gherasim-Morogai Natalia, Afrăsânie Irina, Miron Lucian, Marinca Mihai-Vasile
Department of Medical Oncology, Regional Institute of Oncology, 700483 Iasi, Romania.
Department of Oncology, Faculty of Medicine, "Grigore T. Popa" University of Medicine and Pharmacy, 700115 Iasi, Romania.
Cancers (Basel). 2023 Feb 16;15(4):1265. doi: 10.3390/cancers15041265.
We performed a retrospective study on 51 metastatic melanoma patients treated with Nivolumab in first line, at the Regional Institute of Oncology (RIO) Iasi, Romania between April 2017 and December 2019. We studied the efficacy and safety of anti-PD-1 immune checkpoint inhibitor therapy on a treatment-naive population. After a median follow-up of 36 months, the median progression free survival (PFS) was 26 months (95% CI, 15-36) and the median overall survival (OS) was 31 months (95% CI, 20.1-41.8). At 12 months after the initiation of immunotherapy, the percentage of patients alive was 70%, and at 24 months 62.5%. The most common adverse events observed were dermatological (23.5%) and grade ≥3 was identified in 4 (6.8%) patients. Multivariate analysis indicated that the presence of liver metastases (HR 4.42; 95% CI: 1.88-10.4, = 0.001) and a neutrophils/lymphocytes ratio (NLR) were associated with poor survival (HR 3.21; 95% CI: 1.04-9.87, = 0.04). Although retrospective data on a small group of patients were analyzed, we can conclude that our results in RIO are similar to those described in clinical trials and other real-world studies. Our study highlights the potential usefulness of liver metastases and NLR as novel predictive factors in clinical decision-making.
2017年4月至2019年12月期间，我们在罗马尼亚雅西地区肿瘤研究所（RIO）对51例一线接受纳武单抗治疗的转移性黑色素瘤患者进行了一项回顾性研究。我们研究了抗PD-1免疫检查点抑制剂疗法在未经治疗人群中的疗效和安全性。中位随访36个月后，中位无进展生存期（PFS）为26个月（95%CI，15 - 36），中位总生存期（OS）为31个月（95%CI，20.1 - 41.8）。免疫治疗开始后12个月时，存活患者的百分比为70%，24个月时为62.5%。观察到的最常见不良事件为皮肤方面的（23.5%），4例（6.8%）患者出现≥3级不良事件。多因素分析表明，肝转移的存在（HR 4.42；95%CI：1.88 - 10.4，P = 0.001）和中性粒细胞/淋巴细胞比值（NLR）与生存不良相关（HR 3.21；95%CI：1.04 - 9.87，P = 0.04）。尽管分析了一小群患者的回顾性数据，但我们可以得出结论，我们在RIO的结果与临床试验和其他真实世界研究中描述的结果相似。我们的研究强调了肝转移和NLR作为临床决策中新的预测因素的潜在有用性。
