局部晚期头颈部鳞状细胞癌的诱导化疗联合免疫治疗。
Induction chemotherapy combined with immunotherapy in locally advanced head and neck squamous cell carcinoma.
机构信息
Department of Stomatology, Oral Medicine Center of The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, People's Republic of China.
Department of Head Neck and Thyroid, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, Henan, People's Republic of China.
出版信息
BMC Cancer. 2021 May 27;21(1):622. doi: 10.1186/s12885-021-08373-8.
BACKGROUND
This study aimed to explore the efficacy and safety of sintilimab combined with induction chemotherapy (IC) in locally advanced head and neck squamous cell carcinoma (HNSCC) patients.
METHODS
A total of 163 patients were prospectively enrolled; 98 patients received IC only, and 65 patients received IC with sintilimab. Following neoadjuvant therapy, patients either underwent surgery (31.9%) or chemoradiotherapy (68.1%). Objective response rate (ORR), progression free survival (PFS), overall survival (OS), and toxicities between the two groups were compared.
RESULTS
The ORR in the IC group was significantly lower than that in the IC with sintilimab group (68.4% vs 84.6%, P = 0.019). Grade 3 or higher acute toxicity occurred in 15 (15.3%) and 12 (18.5%) patients in the IC and IC with sintilimab groups, respectively. However, this difference was not significant (P = 0.596). After follow-up with a median time of 28.0 months, the IC group had a 2-year PFS rate of 27% (95%CI: 18-36%), whereas the IC with sintilimab group had a 2-year PFS rate of 44% (95%CI: 32-56%), and this difference was significant (P = 0.041). The 2-year OS rates in the IC and IC with sintilimab groups were 61% (95%CI: 52-70%) and 70% (95%CI: 60-80%), respectively, the difference was not significant (P = 0.681).
CONCLUSIONS
Addition of sintilimab to IC could provide longer PFS time than traditional chemotherapy regimen, without increasing the toxicity events.
背景
本研究旨在探讨信迪利单抗联合诱导化疗（IC）治疗局部晚期头颈部鳞状细胞癌（HNSCC）患者的疗效和安全性。
方法
共前瞻性纳入 163 例患者；98 例患者仅接受 IC 治疗，65 例患者接受 IC 联合信迪利单抗治疗。新辅助治疗后，患者行手术（31.9%）或放化疗（68.1%）。比较两组患者的客观缓解率（ORR）、无进展生存期（PFS）、总生存期（OS）和毒性反应。
结果
IC 组的 ORR 明显低于 IC 联合信迪利单抗组（68.4% vs 84.6%，P=0.019）。IC 组和 IC 联合信迪利单抗组分别有 15 例（15.3%）和 12 例（18.5%）患者发生 3 级或更高级别的急性毒性反应，但差异无统计学意义（P=0.596）。中位随访时间为 28.0 个月后，IC 组 2 年 PFS 率为 27%（95%CI：18-36%），IC 联合信迪利单抗组为 44%（95%CI：32-56%），差异有统计学意义（P=0.041）。IC 组和 IC 联合信迪利单抗组的 2 年 OS 率分别为 61%（95%CI：52-70%）和 70%（95%CI：60-80%），差异无统计学意义（P=0.681）。
结论
与传统化疗方案相比，IC 联合信迪利单抗可提供更长的 PFS 时间，且不会增加毒性反应事件。
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