流感疫苗接种对接受免疫检查点抑制剂的晚期癌症患者生存的影响（INVIDIa-2）：多中心、前瞻性、观察性研究的最终结果
Impact of influenza vaccination on survival of patients with advanced cancer receiving immune checkpoint inhibitors (INVIDIa-2): final results of the multicentre, prospective, observational study.
作者信息
Bersanelli Melissa, Verzoni Elena, Cortellini Alessio, Giusti Raffaele, Calvetti Lorenzo, Ermacora Paola, Di Napoli Marilena, Catino Annamaria, Guadalupi Valentina, Guaitoli Giorgia, Scotti Vieri, Mazzoni Francesca, Veccia Antonello, Guglielmini Pamela Francesca, Perrone Fabiana, Maruzzo Marco, Rossi Ernesto, Casadei Chiara, Montesarchio Vincenzo, Grossi Francesco, Rizzo Mimma, Travagliato Liboria Maria Grazia, Mencoboni Manlio, Zustovich Fable, Fratino Lucia, Accettura Caterina, Cinieri Saverio, Camerini Andrea, Sorarù Mariella, Zucali Paolo Andrea, Ricciardi Serena, Russo Antonio, Negrini Giorgia, Banzi Maria Chiara, Lacidogna Gaetano, Fornarini Giuseppe, Laera Letizia, Mucciarini Claudia, Santoni Matteo, Mosillo Claudia, Bonetti Andrea, Longo Lucia, Sartori Donata, Baldini Editta, Guida Michele, Iannopollo Mauro, Bordonaro Roberto, Morelli Maria Francesca, Tagliaferri Pierosandro, Spada Massimiliano, Ceribelli Anna, Silva Rosa Rita, Nolè Franco, Beretta Giordano, Giovanis Petros, Santini Daniele, Luzi Fedeli Stefano, Nanni Oriana, Maiello Evaristo, Labianca Roberto, Pinto Carmine, Clemente Alberto, Tognetto Michele, De Giorgi Ugo, Pignata Sandro, Di Maio Massimo, Buti Sebastiano, Giannarelli Diana
机构信息
Medical Oncology Unit, University Hospital of Parma, Parma, Italy.
SS.Oncologia Genitourinaria, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.
出版信息
EClinicalMedicine. 2023 Jun 29;61:102044. doi: 10.1016/j.eclinm.2023.102044. eCollection 2023 Jul.
BACKGROUND
The prospective multicentre observational INVIDIa-2 study investigated the clinical effectiveness of influenza vaccination in patients with advanced cancer receiving immune checkpoint inhibitors (ICI). In this secondary analysis of the original trial, we aimed to assess the outcomes of patients to immunotherapy based on vaccine administration.
METHODS
The original study enrolled patients with advanced solid tumours receiving ICI at 82 Italian Oncology Units from Oct 1, 2019, to Jan 31, 2020. The trial's primary endpoint was the time-adjusted incidence of influenza-like illness (ILI) until April 30, 2020, the results of which were reported previously. Secondary endpoints (data cut-off Jan 31, 2022) included the outcomes of patients to immunotherapy based on vaccine administration, for which the final results are reported herein. A propensity score matching by age, sex, performance status, primary tumour site, comorbidities, and smoking habits was planned for the present analysis. Only patients with available data for these variables were included. The outcomes of interest were overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease-control rate (DCR).
FINDINGS
The original study population consisted of 1188 evaluable patients. After a propensity score matching, 1004 patients were considered (502 vaccinated and 502 unvaccinated), and 986 of them were evaluable for overall survival (OS). At the median follow-up of 20 months, the influenza vaccination demonstrated a favourable impact on the outcome receiving ICI in terms of median OS [27.0 months (CI 19.5-34.6) in vaccinated vs. 20.9 months (16.6-25.2) in unvaccinated, p = 0.003], median progression-free survival [12.5 months (CI 10.4-14.6) vs. 9.6 months (CI 7.9-11.4), p = 0.049], and disease-control rate (74.7% vs. 66.5%, p = 0.005). The multivariable analyses confirmed the favourable impact of influenza vaccination in terms of OS (HR 0.75, 95% C.I. 0.62-0.92; p = 0.005) and DCR (OR 1.47, 95% C.I. 1.11-1.96; p = 0.007).
INTERPRETATION
The INVIDIa-2 study results suggest a favourable immunological impact of influenza vaccination on the outcome of cancer patients receiving ICI immunotherapy, further encouraging the vaccine recommendation in this population and supporting translational investigations about the possible synergy between antiviral and antitumour immunity.
FUNDING
The Federation of Italian Cooperative Oncology Groups (FICOG), Roche S.p.A., and Seqirus.
背景
前瞻性多中心观察性INVIDIa - 2研究调查了流感疫苗接种对接受免疫检查点抑制剂（ICI）的晚期癌症患者的临床有效性。在这项对原始试验的二次分析中，我们旨在评估基于疫苗接种情况的患者接受免疫治疗的结果。
方法
原始研究于2019年10月1日至2020年1月31日在意大利82个肿瘤治疗单位纳入了接受ICI的晚期实体瘤患者。试验的主要终点是至2020年4月30日的流感样疾病（ILI）的时间调整发病率，其结果已在之前报道。次要终点（数据截止于2022年1月31日）包括基于疫苗接种情况的患者接受免疫治疗的结果，本文报告其最终结果。本分析计划按年龄、性别、体能状态、原发肿瘤部位、合并症和吸烟习惯进行倾向评分匹配。仅纳入这些变量有可用数据的患者。感兴趣的结果包括总生存期（OS）、无进展生存期（PFS）、客观缓解率（ORR）和疾病控制率（DCR）。
结果
原始研究人群包括1188例可评估患者。经过倾向评分匹配后，纳入1004例患者（502例接种疫苗和502例未接种疫苗），其中986例可评估总生存期（OS）。在中位随访20个月时，流感疫苗接种在中位总生存期方面对接受ICI治疗的结果显示出有利影响[接种疫苗者为27.0个月（CI 19.5 - 34.6），未接种疫苗者为20.9个月（16.6 - 25.2），p = 0.003]，中位无进展生存期[12.5个月（CI 10.4 - 14.6）对9.6个月（CI 7.9 - 11.4），p = 0.049]，以及疾病控制率（74.7%对66.5%，p = 0.005）。多变量分析证实了流感疫苗接种在总生存期（HR 0.75，95% C.I. 0.62 - 0.92；p = 0.005）和疾病控制率（OR 1.47，95% C.I. 1.11 - 1.96；p = 0.007）方面的有利影响。
解读
INVIDIa - 2研究结果表明流感疫苗接种对接受ICI免疫治疗的癌症患者的结果具有有利的免疫影响，进一步鼓励在该人群中推荐接种疫苗，并支持关于抗病毒和抗肿瘤免疫之间可能协同作用的转化研究。
资助
意大利肿瘤协作组联合会（FICOG）、罗氏股份公司和赛诺菲。
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