The efficacy and safety of first-line metastatic melanoma treatment with ipilimumab + nivolumab versus nivolumab in a real-world setting.

IF 11 1区医学 Q1 DERMATOLOGY British Journal of Dermatology Pub Date : 2024-11-28 DOI:10.1093/bjd/ljae470

Billard Karine, Laurent Mortier, Olivier Dereure, Sophie Dalac, Henri Montaudié, Delphine Legoupil, Caroline Dutriaux, Julie De Quatrebarbes, Eve Maubec, Marie-Thérèse Leccia, Florence Granel-Brocard, Florence Brunet-Possenti, Jean-Philippe Arnault, Caroline Gaudy-Marqueste, Cecile Pages, Philippe Saiag, Jean-Matthieu L'orphelin, Ouidad Zehou, Thierry Lesimple, Clara Allayous, Raphael Porcher, Bastien Oriano, Stephane Dalle, Céleste Lebbé

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Abstract

Background: The Checkmate 067 randomized controlled trial, published in 2015, demonstrated improved progression-free survival and numerically, although not statistically, superior overall survival for ipilimumab + nivolumab. The objective of this study was to compare the efficacy and safety of nivolumab to ipilimumab + nivolumab as first-line treatment for metastatic melanoma in a real-world setting.

Methods: Patients were prospectively included in the French Melbase cohort from 2013 to 2022. Eligible patients were those in first-line treatment for stage-IIIc or -IV melanoma, undergoing immunotherapy with nivolumab or ipilimumab + nivolumab. The primary endpoint was overall survival at 36 months. The secondary endpoints included progression-free survival at 36 months, best radiological response, and safety analyses. We conducted a propensity score using the IPTW method to overcome the various confounding factors and also a subgroup analysis (brain metastasis, LDH levels, and BRAF mutation status).

Results: A total of 406 patients were treated with nivolumab, and 416 with ipilimumab + nivolumab. Overall survival at 36 months was higher in the ipilimumab + nivolumab group (57.1%, ([95%CI 50.7-64.2]) than in the nivolumab group (46.6% [95%CI 41.6-52.1]), HR 1.4[1.1;1.8]. Progression-free survival at 36 months was significantly improved in the ipilimumab + nivolumab group (42.3%) compared to the nivolumab group (21.9%), with a HR 1.6[1.4;1.9]. The objective response rate was similar for the two groups (44%). The overall incidence of side effects was comparable (82 vs. 84%), and severe toxicity (grade ≥ 3) was more frequent, though not significantly so, in the ipilimumab + nivolumab arm (29% vs. 41%).

Conclusions: Our results are consistent with those from the Checkmate 067 study, except for the objective response rate and the incidence of toxicities, which proved to be lower in our analysis.

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在真实世界环境中使用伊匹单抗+尼妥珠单抗与尼妥珠单抗进行一线转移性黑色素瘤治疗的疗效和安全性。

背景：2015年发表的Checkmate 067随机对照试验显示，伊匹单抗+尼夫单抗的无进展生存期得到改善，总生存期在数字上（尽管没有统计学意义）更优。本研究的目的是在真实世界环境中比较尼妥珠单抗与伊匹单抗+尼妥珠单抗作为转移性黑色素瘤一线治疗的疗效和安全性：2013年至2022年期间，法国Melbase队列对患者进行了前瞻性纳入。符合条件的患者为接受尼妥珠单抗或伊匹单抗+尼妥珠单抗免疫疗法的IIIc期或IV期黑色素瘤一线治疗患者。主要终点是36个月的总生存期。次要终点包括36个月的无进展生存期、最佳放射学反应和安全性分析。我们采用IPTW方法进行了倾向评分，以克服各种混杂因素，同时还进行了亚组分析（脑转移、LDH水平和BRAF突变状态）：共有406名患者接受了尼夫单抗治疗，416名患者接受了伊匹单抗+尼夫单抗治疗。伊匹单抗+尼夫单抗组的36个月总生存率（57.1%，[95%CI 50.7-64.2]）高于尼夫单抗组（46.6% [95%CI 41.6-52.1]），HR为1.4[1.1;1.8]。伊匹单抗+尼夫单抗组的36个月无进展生存率（42.3%）明显高于尼夫单抗组（21.9%），HR为1.6[1.4;1.9]。两组的客观反应率相似（44%）。副作用的总体发生率相当（82%对84%），严重毒性（≥3级）在ipilimumab+nivolumab组更为常见，但并不显著（29%对41%）：我们的结果与Checkmate 067研究的结果一致，但客观反应率和毒性发生率除外，在我们的分析中，客观反应率和毒性发生率较低。

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来源期刊

British Journal of Dermatology 医学-皮肤病学

CiteScore

16.30

自引率

3.90%

发文量

1062

审稿时长

2-4 weeks

期刊介绍： The British Journal of Dermatology (BJD) is committed to publishing the highest quality dermatological research. Through its publications, the journal seeks to advance the understanding, management, and treatment of skin diseases, ultimately aiming to improve patient outcomes.