Ouyang Min, Sun Hanquan, Liu Xiaoyu, Wu Haijun, Deng Feilong, Shen Erdong, Peng Guozheng, Wu Hanbing, Zhao Yinshan, Xiong Hui, Liu Bin, He Shasha, Hu Ying, Liu Ping
Department of Gerontology, The Second Xiangya Hospital of Central South University, Changsha, China.
Department of Oncology, The Second Xiangya Hospital of Central South University, Changsha, China.
World J Surg Oncol. 2025 Jan 4;23(1):6. doi: 10.1186/s12957-024-03644-7.
This study aims to elucidate the therapeutic efficacy and safety of a taxane-based chemotherapy in combination with immune checkpoint inhibitors regimen in patients diagnosed with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
We retrospectively collected clinical data from 154 patients who received at least two cycles of PD-1 inhibitors in combination with a taxane-based chemotherapy as first-line treatment in seven hospitals in Hunan Province, between December 2018 and December 2023. These patients were subjected to long-term follow-up.
The study included 154 eligible patients, with a median follow-up period of 21.5 months. The median PFS was 8.7 months, while the median OS was 16.7 months. The 12-month PFS rate was 43.6%, and the 12-month OS rate was 60.1%. At 24 months, the PFS rate was 34.4%, and the OS rate was 36.9%. With 26 complete responses (16.9%) and 52 partial responses (33.8%), the ORR was 50.6%. Stable disease was observed in 54 patients (35.1%), resulting in a disease control rate of 85.7%, while 22 patients showed progressive disease. In the univariate analysis, the distant organ metastasis had a statistically significant impact on both PFS and OS. Subsequent radiotherapy following this protocol also showed a statistically significant effect on PFS and OS. However, radiotherapy before recurrent metastasis did not significantly affect PFS, though it did have a significant impact on OS. Other factors analyzed did not show a statistically significant effect on PFS and OS. Multivariate analysis indicated that the distant organ metastasis and subsequent radiotherapy following this protocol were independent prognostic factors for PFS in patients with R/M HNSCC, and the latter was also an independent prognostic factor for OS in these patients. Regarding safety, during treatment anemia was observed in 97 patients, leukopenia in 64, neutropenia in 33, thrombocytopenia in 28, transaminase elevation in 46, hypothyroidism in 46 patients, and one patient stopped taking the medication due to a serious adverse reaction. No treatment-related deaths occurred.
The combination of PD-1 inhibitors with a a taxane-based chemotherapy regimen as a first-line treatment for R/M HNSCC patients demonstrates good therapeutic efficacy and acceptable safety profiles.
本研究旨在阐明以紫杉烷为基础的化疗联合免疫检查点抑制剂方案治疗复发或转移性头颈部鳞状细胞癌（HNSCC）患者的疗效和安全性。
我们回顾性收集了2018年12月至2023年12月期间在湖南省七家医院接受至少两个周期PD-1抑制剂联合以紫杉烷为基础的化疗作为一线治疗的154例患者的临床资料。这些患者接受了长期随访。
该研究纳入了154例符合条件的患者，中位随访期为21.5个月。中位无进展生存期（PFS）为8.7个月，中位总生存期（OS）为16.7个月。12个月的PFS率为43.6%，12个月的OS率为60.1%。在24个月时，PFS率为34.4%，OS率为36.9%。有26例完全缓解（16.9%）和52例部分缓解（33.8%），客观缓解率（ORR）为50.6%。54例患者病情稳定（35.1%），疾病控制率为85.7%，22例患者疾病进展。在单因素分析中，远处器官转移对PFS和OS均有统计学显著影响。按照该方案进行的后续放疗对PFS和OS也有统计学显著影响。然而，复发转移前的放疗虽对OS有显著影响，但对PFS无显著影响。分析的其他因素对PFS和OS均无统计学显著影响。多因素分析表明，远处器官转移和按照该方案进行的后续放疗是复发/转移性HNSCC患者PFS的独立预后因素，后者也是这些患者OS的独立预后因素。关于安全性，治疗期间97例患者出现贫血，64例出现白细胞减少，33例出现中性粒细胞减少，28例出现血小板减少，46例出现转氨酶升高，46例出现甲状腺功能减退，1例患者因严重不良反应停药。未发生与治疗相关的死亡。
对于复发/转移性HNSCC患者，PD-1抑制剂联合以紫杉烷为基础的化疗方案作为一线治疗显示出良好的疗效和可接受的安全性。
