Concomitant Drugs Prognostic Score in Patients With Metastatic Renal Cell Carcinoma Receiving Ipilimumab and Nivolumab in the Compassionate Use Program in Italy: Brief Communication.

IF 3.2 4区 医学 Q3 IMMUNOLOGY
Journal of Immunotherapy Pub Date : 2023-01-01 Epub Date: 2022-11-04 DOI:10.1097/CJI.0000000000000446
Sebastiano Buti, Umberto Basso, Diana Giannarelli, Ugo De Giorgi, Marco Maruzzo, Roberto Iacovelli, Luca Galli, Camillo Porta, Francesco Carrozza, Giuseppe Procopio, Giuseppe Fonarini, Giovanni Lo Re, Matteo Santoni, Roberto Sabbatini, Antonio Cusmai, Paolo Andrea Zucali, Carlo Aschele, Editta Baldini, Elena Zafarana, Adolfo Favaretto, Silvana Leo, Alketa Hamzaj, Rosanna Mirabelli, Franco Nole', Silvia Zai, Claudio Chini, Cristina Masini, Sonia Fatigoni, Andrea Rocchi, Emiliano Tamburini, Alessio Cortellini, Melissa Bersanelli
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引用次数: 0

Abstract

A concomitant drug-based score was developed by our group and externally validated for prognostic and predictive purposes in patients with advanced cancer treated with immune checkpoint inhibitors (ICIs). The model considers the use of three classes of drugs within a month before initiating ICI, assigning score 1 for each between proton pump inhibitor and antibiotic administration until a month before immunotherapy initiation and score 2 in case of corticosteroid intake. In the present analysis, the drug score was validated in a prospective population of 305 patients with metastatic renal cell carcinoma treated with ipilimumab plus nivolumab in the first-line setting. The value of the model in predicting overall survival and progression-free survival was statistically significant and clinically meaningful, with an overall survival rate at 12 months of 73% vs. 44% (P<0.0001), and median progression-free survival of 11.6 (95% CI: 9.1-14.1) months versus 4.8 (95% CI: 2.7-7.0) months (P=0.002), respectively, for patients belonging to the favorable group (score 0-1) versus the unfavorable (score 2-4). Further development will be represented by the gut microbiome analysis according to the drug-based model classification and to the outcome of patients to ICI therapy to demonstrate the link between drug exposure and immune sensitivity.

Abstract Image

在意大利的同情使用计划中接受Ipilimumab和Nivolumab治疗的转移性肾癌患者的伴随药物预后评分:简短交流。
我们的研究小组开发了一种基于药物的伴随评分,并对接受免疫检查点抑制剂(ICIs)治疗的晚期癌症患者的预后和预测目的进行了外部验证。该模型考虑了在开始ICI前一个月内使用三类药物,在质子泵抑制剂和抗生素给药之间各得1分,直到免疫治疗开始前一个月中,在皮质类固醇摄入的情况下得2分。在本分析中,药物评分在305名转移性肾细胞癌患者的前瞻性人群中进行了验证,这些患者在一线环境中接受了易普利木单抗联合尼沃单抗的治疗。该模型在预测总生存率和无进展生存率方面的价值具有统计学意义和临床意义,12个月时的总生存率为73%对44%(P
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来源期刊
Journal of Immunotherapy
Journal of Immunotherapy 医学-免疫学
CiteScore
6.90
自引率
0.00%
发文量
79
审稿时长
6-12 weeks
期刊介绍: Journal of Immunotherapy features rapid publication of articles on immunomodulators, lymphokines, antibodies, cells, and cell products in cancer biology and therapy. Laboratory and preclinical studies, as well as investigative clinical reports, are presented. The journal emphasizes basic mechanisms and methods for the rapid transfer of technology from the laboratory to the clinic. JIT contains full-length articles, review articles, and short communications.
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