Rutkowski Tomasz Wojciech, Kurczyk Agata, Drosik-Rutowicz Katarzyna, Kiprian Dorota, Dębicka Izabella, Sierko Ewa, Konopka-Filippow Monika, Kaźmierska Joanna, Łukasiewicz-Grella Monika, Cząstkiewicz-Trawińska Diana, Mrochem-Domin Izolda, Ryniewicz-Zander Iwona, Borysiewicz Zuzanna, Chmielowska Ewa, Jasiówka Marek, Źrebiec-Figura Monika, Karpińska Agnieszka, Pacholczak-Madej Renata, Leś Dominika, Pietruszka Agnieszka, Łasinska Izabela, Składowski Krzysztof
Radiation and Clinical Oncology Department and Department of Biostatistics and Bioinformatics, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice, Poland.
Radiotherapy Department, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.
Int J Cancer. 2025 Mar 1;156(5):1074-1084. doi: 10.1002/ijc.35248. Epub 2024 Nov 5.
Patients with head and neck squamous cell carcinoma (HNSCC) who have progressed following primary treatment (PT) have a poor prognosis. In this group, nivolumab has been demonstrated to significantly improve outcomes. This study presents the efficacy of nivolumab in Polish patients with recurrent and/or metastatic (R/M) HNSCC using real-world data. The analyzed group consisted of 324 adult patients with R/M HNSCC following platinum-based therapy. Patients were divided into 3 groups based on the time from completion of PT to nivolumab initiation (tPT-N): within 6 months (refractory), between 6 and 24 months (sensitive, tPT-N ≤24), and beyond 24 months (sensitive, tPT-N >24). Survival analysis and the Cox proportional hazards model were performed to evaluate how various risk factors affect patient outcomes. The 1-year and 2-year overall survival (OS) was 19.1%, 6.1%, 30.7%, 9.4%, and 45.7%, 29.1% in refractory, sensitive tPT-N ≤24, sensitive tPT-N >24 patients, respectively and was higher for both sensitivity groups vs. refractory (p = .004) and for sensitive tPT-N >24 versus refractory and sensitive tPT-N ≤24 (p <.001). Patients with nasopharyngeal cancer had OS significantly higher than patients with other primary tumor localization. The multivariate Cox analysis showed a significant favorable effect of tPT-N >24 (HR = 0.53, p = .001) and nasopharyngeal cancer on OS (HR = 0.20, p = .008). Conversely, female sex was identified as an unfavorable factor for OS (HR = 1.48, p = .020). In our study, we established that the benefit of nivolumab increases with the increasing tPT-N. The probability of death is significantly lower in male patients and patients with nasopharyngeal cancer regardless of tPT-N.
接受过初始治疗（PT）后病情进展的头颈部鳞状细胞癌（HNSCC）患者预后较差。在这组患者中，已证实纳武单抗可显著改善预后。本研究利用真实世界数据展示了纳武单抗在波兰复发性和/或转移性（R/M）HNSCC患者中的疗效。分析的队列由324例接受铂类治疗后出现R/M HNSCC的成年患者组成。根据从PT结束到开始使用纳武单抗的时间（tPT-N），将患者分为3组：6个月内（难治性）、6至24个月之间（敏感，tPT-N≤24）、24个月后（敏感，tPT-N>24）。进行生存分析和Cox比例风险模型分析，以评估各种风险因素如何影响患者预后。难治性、敏感tPT-N≤24以及敏感tPT-N>24的患者1年和2年总生存率（OS）分别为19.1%、6.1%、30.7%、9.4%以及45.7%、29.1%，两个敏感组的总生存率均高于难治性组（p = 0.004），敏感tPT-N>24组高于难治性组和敏感tPT-N≤24组（p <0.001）。鼻咽癌患者的总生存率显著高于其他原发肿瘤部位的患者。多因素Cox分析显示，tPT-N>24（HR = 0.53，p = 0.001）和鼻咽癌对总生存率有显著的有利影响（HR = 0.20，p = 0.008）。相反，女性被确定为总生存率的不利因素（HR = 1.48，p = 0.020）。在我们的研究中，我们确定纳武单抗的获益随着tPT-N的增加而增加。无论tPT-N如何，男性患者和鼻咽癌患者的死亡概率显著更低。
