Immunotherapy After Chemotherapy and Radiation for Clinical Stage III Lung Cancer.
Immunotherapy After Chemotherapy and Radiation for Clinical Stage III Lung Cancer.
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DOI：
10.1001/jamanetworkopen.2022.24478
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发表时间：
2022-08-01
影响因子：
13.8
通讯作者：
Boffa, Daniel J.
中科院分区：
文献类型：
--
作者：
Pichert, Matthew D.;Canavan, Maureen E.;Maduka, Richard C.;Li, Andrew X.;Ermer, Theresa;Zhan, Peter L.;Kaminski, Michael;Udelsman, Brooks, V;Blasberg, Justin D.;Park, Henry S.;Goldberg, Sarah B.;Boffa, Daniel J.
在美国，对III期不可切除的非小细胞肺癌（NSCLC）进行化疗和放疗后的免疫治疗是否与生存优势相关，特别是当护理与试验方案不同时？在这项队列研究中，免疫治疗与临床III期NSCLC患者的生存优势相关，包括在具有里程碑意义的PACIFIC试验方案之外接受治疗的患者。这些结果表明，免疫治疗对III期NSCLC的益处可能扩展到美国的普通人群，并且免疫治疗开始的时间可能具有灵活性。美国国家癌症数据库的这项队列研究比较了化疗和放疗后接受免疫治疗的不可切除III期非小细胞肺癌患者与仅接受化疗和放疗的患者的预后。2017年国际PACIFIC试验确定了放化疗后免疫治疗在不可切除的III期非小细胞肺癌（NSCLC）中的作用。然而，在美国，NSCLC患者通常与临床试验人群在年龄、健康状况、获得护理和治疗过程方面存在差异，这些都可能影响免疫治疗的疗效。确定美国普通人群中不可切除的III期非小细胞肺癌免疫治疗的结果。该队列研究分析了2015年至2017年期间被诊断为临床III期NSCLC的患者的国家癌症数据库，并随访至2018年底，这些患者接受了化疗和放疗。数据于2022年1月进行分析。多变量Cox比例风险模型中的死亡率风险和倾向匹配样本中接受化疗和放疗，接受和不接受免疫治疗的生存率共有23811例临床III期NSCLC患者，中位（IQR）年龄为66（59-72）岁，符合纳入标准（女性10454例（43.9%），亚洲564例（2.4%），黑人2930例（12.3%），白人2077例（84.3%）），包括209例（16.1%）多重合并症患者和1297例（5.4%）接受免疫治疗的患者。化疗和放疗后的免疫治疗与死亡率降低相关（危险比[HR]， 0.74; 95% CI, 0.67-0.82; P < .001）。在倾向匹配的样本中，免疫治疗与优越的3年生存率相关（52%[0个月时1297例，36个月时56例]vs 44%[0个月时2594例，36个月时173例]；P < 0.001）。833名接受免疫治疗的患者（64.2%）的治疗与PACIFIC试验方案不同，其中221名患者（17.0%）接受的放射剂量超出方案范围，731名患者（56.4%）在放射完成后6周以上开始免疫治疗。免疫治疗的生存优势持续到放疗结束后12周（HR, 0.75; 95% CI, 0.61-0.92）。在接受太平洋方案范围外放疗的患者中，免疫治疗的生存优势不显著（HR, 0.87; 95% CI, 0.69-1.01）。在这项队列研究中，III期NSCLC化疗和放疗后的免疫治疗与一般美国人群的生存优势相关，尽管三分之二的患者接受的治疗与太平洋方案不同。研究结果表明，放射后免疫治疗开始的时间可能存在灵活性；需要进一步的研究来阐明免疫治疗的临床益处。
Is immunotherapy after chemotherapy and radiation for stage III unresectable non–small cell lung cancer (NSCLC) associated with a survival advantage in the US, particularly when care differs from trial protocols? In this cohort study, immunotherapy was associated with a survival advantage among clinical stage III NSCLC patients, including patients treated outside the landmark PACIFIC trial protocol. These results suggest that immunotherapy benefits for stage III NSCLC may extend to the general population in the US and there may be flexibility in timing of immunotherapy initiation. This cohort study of US adults in the National Cancer Database compares outcomes for patients with unresectable stage III non–small cell lung cancer treated with immunotherapy after chemotherapy and radiation with those treated only with chemotherapy and radiation. The 2017 international PACIFIC trial established a role for immunotherapy after chemoradiation for unresectable stage III non–small cell lung cancer (NSCLC). However, in the US, patients with NSCLC commonly differ from clinical trial populations in terms of age, health, access to care, and treatment course, which may all factor into the efficacy of immunotherapy. To determine the outcomes of immunotherapy use in unresectable stage III NSCLC in the general US population. This cohort study analyzed the National Cancer Database for patients diagnosed with clinical stage III NSCLC between 2015 and 2017 with follow-up through the end of 2018 who were treated with chemotherapy and radiation. Data were analyzed January 2022. Mortality hazard in a multivariable Cox proportional hazards model and survival among a propensity-matched sample treated with chemotherapy and radiation, with and without immunotherapy. A total of 23 811 patients with clinical stage III NSCLC with median (IQR) age 66 (59-72) years met inclusion criteria (10 454 [43.9%] women; 564 [2.4%] Asian, 2930 [12.3%] Black, 20 077 [84.3%] White patients), including 209 (16.1%) patients with multiple comorbidities and 1297 (5.4%) immunotherapy recipients. Immunotherapy after chemotherapy and radiation was associated with reduced mortality (hazard ratio [HR], 0.74; 95% CI, 0.67-0.82; P < .001). Among a propensity-matched sample, immunotherapy was associated with superior 3-year survival (52% [1297 patients at 0 months, 56 patients at 36 months] vs 44% [2594 patients at 0 months, 173 patients at 36 months]; P < .001). The treatment of 833 patients who received immunotherapy (64.2%) differed from the PACIFIC trial protocol, including 221 patients (17.0%) who received radiation doses outside of the protocol range and 731 patients (56.4%) who started immunotherapy more than 6 weeks after radiation was completed. The survival advantage of immunotherapy persisted when initiated up to 12 weeks after radiation was completed (HR, 0.75; 95% CI, 0.61-0.92). Among patients who received radiation outside the PACIFIC protocol range, the survival advantage of immunotherapy was not significant (HR, 0.87; 95% CI, 0.69-1.01). In this cohort study, immunotherapy after chemotherapy and radiation for stage III NSCLC was associated with a survival advantage in the general US population despite two-thirds of patients treated differently than the PACIFIC protocol. The findings suggest there may be flexibility in the timing of immunotherapy initiation after radiation; further study is warranted to clarify the clinical benefits of immunotherapy.
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影响因子：
15.2
作者：
Averitt, Amelia J.;Weng, Chunhua;Perotte, Adler
通讯作者：
Perotte, Adler
影响因子：
8.4
作者：
Desilets, Antoine;Blanc-Durand, Felix;Elkrief, Arielle
通讯作者：
Elkrief, Arielle
影响因子：
5.2
作者：
Sankar K;Bryant AK;Strohbehn GW;Zhao L;Elliott D;Moghanaki D;Kelley MJ;Ramnath N;Green MD
通讯作者：
Green MD
DOI：
10.1111/j.2517-6161.1995.tb02031.x
发表时间：
1995-01-01
影响因子：
5.8
作者：
BENJAMINI, Y;HOCHBERG, Y
通讯作者：
HOCHBERG, Y
影响因子：
20.4
作者：
Faivre-Finn, Corinne;Vicente, David;Antonia, Scott J.
通讯作者：
Antonia, Scott J.