Department of Radiation Oncology, Sichuan Cancer Hospital and Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.
Chengdu Medical College, Chengdu, China.
Radiat Oncol. 2023 Jul 4;18(1):109. doi: 10.1186/s13014-023-02310-8.
Programmed cell death-1 (PD-1) inhibitor was proven to be useful for the recurrent/metastatic head and neck squamous carcinoma (R/M HNSCC) patients. Though both PD-1 inhibitor alone and combination with chemotherapy showed some benefit for PFS and OS, the survival outcome was still not satisfactory. Some studies showed the possible benefit for PD-1 inhibitors combination with radiation for head and neck squamous carcinoma, however there was few studies concerned about synergy of concurrent PD-1 inhibitor combination with chemoradiotherapy for R/M HNSCC. So, we aimed to explore the potential effect and toxicity of the concurrent PD-1 inhibitor and chemoradiotherapy for R/M HNSCC.
We consecutively enrolled the R/M HNSCC patients treated with concurrent PD-1 inhibitor and chemoradiotherapy from August 2018 to April 2022 in Sichuan Cancer hospital. All the patients received the combination of PD-1 inhibitor and chemotherapy, and followed with synergy of concurrent PD-1 inhibitor and chemoradiotherapy, then maintenance PD-1 inhibitor. ORR and DCR was calculated by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST-1.1), and Common terminology criteria for adverse events (CTCAE-4.0) was used to evaluate the toxicity.The Kaplan-Meier method was used to analyze OS and PFS.
40 R/M HNSCC patients were enrolled in our stuty. The median follow up time was 14 months. 22 patients had recurrent disease only, 16 patients had metastatic disease only, and 2 patients had both recurrence and metastasis disease. For the recurrent lesions, 23 patients received a median radiation dose of 64 Gy (range 50-70 Gy). 18 patients received a median dose of 45 Gy (range 30-66 Gy) for metastatic lesions. The median courses of PD-1 inhibitors and chemotherapy were 8 and 5 respectively. After the treatment, the ORR and DCR were 70.0% and 100%. The median OS was 19 months (range 6.3-31.7 months), with 1 and 2-years OS rates of 72.8% and 33.3%. The median PFS was 9 months (range 3.1-14.9 months), with 6 and 12 months PFS rates of 75.5% and 41.4% respectively. The PFS had no statistical significance in PD-L1 negative and positive group (7 vs 12 months, p = 0.059). The most common grade 3 or 4 adverse events(AE) were leucopenia (25.0%), neutropenia (17.5%), anemia (10.0%), thrombocytopenia (5.0%), hyponatremia (2.5%), and pneumonia(2.5%). No grade 5 AE was observed.
The synergy of concurrent PD-1 inhibitor treatment with chemoradiotherapy shows promise as a treatment strategy and an acceptable toxicity for the R/M HNSCC patients.
程序性细胞死亡受体-1（PD-1）抑制剂已被证明对复发性/转移性头颈部鳞状细胞癌（R/M HNSCC）患者有效。尽管 PD-1 抑制剂单独使用以及与化疗联合使用在 PFS 和 OS 方面均显示出一定的益处，但生存结果仍不尽如人意。一些研究表明 PD-1 抑制剂联合放疗对头颈部鳞状细胞癌可能有益，但是很少有研究关注 R/M HNSCC 中同步 PD-1 抑制剂联合放化疗的协同作用。因此，我们旨在探讨同步 PD-1 抑制剂和放化疗对 R/M HNSCC 的潜在作用和毒性。
我们连续纳入了 2018 年 8 月至 2022 年 4 月在四川省肿瘤医院接受同步 PD-1 抑制剂和放化疗治疗的 R/M HNSCC 患者。所有患者均接受 PD-1 抑制剂联合化疗治疗，随后进行同步 PD-1 抑制剂和放化疗联合治疗，然后维持 PD-1 抑制剂治疗。采用免疫相关实体瘤反应评价标准（irRECIST-1.1）计算客观缓解率（ORR）和疾病控制率（DCR），采用不良事件通用术语标准（CTCAE-4.0）评价毒性。采用 Kaplan-Meier 法分析 OS 和 PFS。
本研究共纳入 40 例 R/M HNSCC 患者。中位随访时间为 14 个月。22 例患者仅有复发性疾病，16 例患者仅有转移性疾病，2 例患者同时存在复发和转移疾病。对于复发性病变，23 例患者接受了 64 Gy（范围 50-70 Gy）的中位放疗剂量。18 例转移性病变患者接受了 45 Gy（范围 30-66 Gy）的中位剂量。PD-1 抑制剂和化疗的中位疗程分别为 8 个和 5 个。治疗后，ORR 和 DCR 分别为 70.0%和 100%。中位 OS 为 19 个月（范围 6.3-31.7 个月），1 年和 2 年 OS 率分别为 72.8%和 33.3%。中位 PFS 为 9 个月（范围 3.1-14.9 个月），6 个月和 12 个月 PFS 率分别为 75.5%和 41.4%。PD-L1 阴性和阳性组的 PFS 无统计学意义（7 个月比 12 个月，p=0.059）。最常见的 3 级或 4 级不良事件（AE）为白细胞减少症（25.0%）、中性粒细胞减少症（17.5%）、贫血（10.0%）、血小板减少症（5.0%）、低钠血症（2.5%）和肺炎（2.5%）。未观察到 5 级 AE。
同步 PD-1 抑制剂治疗联合放化疗作为一种治疗策略具有良好的协同作用，对 R/M HNSCC 患者具有可接受的毒性。
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