PDF(Pubmed)
Abstract：
Head and neck squamous cell carcinomas (HNSCC) have proven to be inherently resistant to systemic treatments as a result of histological, molecular, and etiological heterogeneity, with limited responses seen after second-line therapy and beyond. With limited treatment options after progression on systemic chemotherapy in HNSCCs, immunotherapy has a role to play with improved results. In this prospective, observational, non-randomized, open-label study, a total of 12 patients with advanced, relapsed, or metastatic HNSCC received Inj. Nivolumab weight-based dose of 3 mg per kg, intravenously every 2 weeks along with low-dose capecitabine 500 mg twice a day, was prospectively assessed. The patient\'s clinical, hematological, and staging characteristics were described and the clinical benefit rate (CBR) was calculated. A total of 12 patients received the combined metronomic chemo-immunotherapy (CMCI). The majority of patients were belonging to ECOG-PS 1(66%), with all patients being in stage IV disease. Six, four, and two patients received immunotherapy as the 5th, 3rd, and 4th line of therapy, respectively. Nivolumab and low-dose capecitabine were used in all 12 patients. CBR was seen in 66% (8/12) of patients, one patient died due to hepatitis and hepatic encephalopathy, another patient died due to pneumonia and respiratory complications, two patients had progressive disease, and two patients with stable disease discontinued treatment because of financial constraints and kept on capecitabine alone. The majority tolerated therapy well with no grade 3/4 immune-related adverse events (IRAEs). Two patients required supportive therapy with packed red cell transfusion and albumin infusions. Six-month overall survival (OS) and progression-free survival (PFS) in the study population were 83.3% and 66.6%, respectively. In conclusion, nivolumab along with metronomic chemotherapy with low-dose capecitabine was very well tolerated and exhibited anti-tumor activity with a CBR of 66%, 6-month OS of 83.3%, and 6-month PFS of 66.6%, in extensively pretreated patients with HNSCCs. Additional studies of nivolumab and metronomic chemotherapy and immuno-immuno combination therapy in these diseases are ongoing.
摘要：
头颈部鳞状细胞癌（HNSCC）已被证明对组织学的全身性治疗具有内在的抵抗力，分子，和病因异质性，二线治疗后及以后的反应有限。在HNSCC的全身化疗进展后，治疗选择有限，免疫疗法具有改善结果的作用。在这个前景中，观察,非随机化，开放标签研究，共有12名晚期患者，复发,或转移性HNSCC接受Inj。Nivolumab基于体重的剂量为3mg/kg，与低剂量卡培他滨500毫克，每天两次静脉注射，每2周一次，进行了前瞻性评估。病人的临床，血液学,描述分期特征并计算临床获益率(CBR)。共有12例患者接受了节拍化学免疫治疗（CMCI）。大多数患者属于ECOG-PS1（66％），所有患者都处于IV期疾病。六,四,两名患者在第5次接受免疫治疗，3rd,和第四行治疗，分别。所有12例患者均使用Nivolumab和低剂量卡培他滨。66%(8/12)的患者出现CBR,一名患者死于肝炎和肝性脑病,另一名病人死于肺炎和呼吸道并发症,两名患者患有进行性疾病，两名病情稳定的患者因经济困难而停止治疗,并继续单独使用卡培他滨.大多数耐受治疗良好，无3/4级免疫相关不良事件（IRAE）。两名患者需要进行填充红细胞输注和白蛋白输注的支持治疗。研究人群的6个月总生存率（OS）和无进展生存率（PFS）分别为83.3%和66.6%。分别。总之,nivolumab与低剂量卡培他滨的节拍化疗耐受性非常好，并表现出抗肿瘤活性，CBR为66％，6个月OS为83.3%，6个月PFS为66.6%，在广泛预处理的HNSCCs患者中。在这些疾病中，nivolumab和节拍化疗和免疫-免疫联合治疗的其他研究正在进行中。
