Increased rates of immunosuppressive treatment and hospitalization after checkpoint inhibitor therapy in cancer patients with autoimmune disease.
Increased rates of immunosuppressive treatment and hospitalization after checkpoint inhibitor therapy in cancer patients with autoimmune disease.
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DOI：
10.1136/jitc-2020-001627
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发表时间：
2020-12
影响因子：
10.9
通讯作者：
Cheng SK
中科院分区：
文献类型：
--
作者：
Bender DA;Heilbroner SP;Wang TJC;Shu CA;Hyde B;Spina C;Cheng SK
免疫检查点抑制剂（ICI）是治疗恶性肿瘤的重要新治疗选择。关于ICI治疗既存自身免疫性疾病（AID）患者的相对安全性的现有数据有限。在这项利用肿瘤学医疗索赔数据库的回顾性研究中，我们确定了有和没有AID的患者在接受ICI（pembrolizumab，nivolumab和ipilimumab）治疗后180天内接受免疫抑制剂治疗和住院治疗的比率。患者被诊断为恶性黑色素瘤或肺癌。评价的免疫抑制剂包括口服泼尼松和静脉注射甲泼尼龙。124名患有AID的癌症患者和1896名没有AID的癌症患者符合口服泼尼松分析的入选标准，而284名患有AID的患者和3230名没有AID的患者符合所有其他分析的入选标准。在PD-1抑制剂治疗后，AID组在ICI治疗的180天内口服泼尼松和静脉注射甲泼尼龙的治疗率相对于对照组显著增加（口服泼尼松：AID组16.7% vs非AID组8.3%，p=0.0048;静脉注射甲泼尼龙：AID中8.4%的患者接受了治疗，非AID中3.7%的患者接受了治疗，p=0.0012）。PD-1抑制剂治疗后，患有AID的黑色素瘤患者的住院率相对于未患有AID的黑色素瘤患者显著增加（AID患者为24.1%，非AID患者为5.8%，p<0.0001）。与未患AID的患者相比，患有AID的癌症患者在接受ICI治疗后的住院率和免疫抑制剂治疗率更高。这表明AID患者在接受检查点抑制剂治疗时可能会增加毒性风险。需要进一步的前瞻性临床试验来确定安全性。
Immune checkpoint inhibitors (ICIs) are important new therapeutic options for the treatment of malignancy. Existing data on the relative safety of ICI treatment in patients with pre-existing autoimmune disease (AID) are limited. In this retrospective study utilizing an oncology medical claims database, we determined the rates of treatment with immunosuppressive agents and hospitalization within 180 days of treatment with ICIs (pembrolizumab, nivolumab, and ipilimumab) in patients both with and without AID. Patients had diagnoses of either malignant melanoma or lung cancer. Immunosuppressive agents evaluated included oral prednisone and intravenous methylprednisolone. 124 cancer patients with AID and 1896 cancer patients without AID met inclusion criteria for oral prednisone analysis, while 284 patients with AID and 3230 patients without AID met inclusion criteria for all other analyzes. Following treatment with PD-1 inhibitors, rates of treatment with both oral prednisone and intravenous methylprednisolone within 180 days of ICI treatment were significantly increased in the AID group relative to the control group (oral prednisone: 16.7% treatment in AID vs 8.3% in non-AID, p=0.0048; intravenous methylprednisolone: 8.4% treatment in AID vs 3.7% in non-AID, p=0.0012). Rates of hospitalization were significantly increased in melanoma patients with AID relative to melanoma patients without AID following treatment with PD-1 inhibitors (24.1% in AID vs 5.8% in non-AID, p<0.0001). Cancer patients with AID have higher rates of hospitalization and treatment with immunosuppressive agents following treatment with ICI therapy compared with patients with no AID. This suggests that patients with AID may have increased toxicity risk while being treated with checkpoint inhibitor therapy. Further prospective clinical trials are needed to determine safety.
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