Unit of Melanoma and Innovative Therapies, IRCCS Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, Italy.
University of Siena and Center for Immuno-Oncology, University Hospital Le Scotte, Siena, Italy.
Eur J Cancer. 2023 Sep;191:113246. doi: 10.1016/j.ejca.2023.113246. Epub 2023 Jul 19.
The CheckMate 238 randomised study demonstrated the relevant benefit in terms of recurrence-free survival (RFS) of nivolumab versus ipilimumab in resected stage IIIB-C or IV melanoma patients with a tolerable safety profile.
From November 2018 to June 2019, 611 patients with stage III and IV resected melanoma were enroled to receive nivolumab as part of an Italian Expanded Access Programme (EAP). According to stages, 77% were stage III while 141 (23%) were stage IV with no evidence of disease (NED). Among stage III, 121 patients had IIIA (19.8%).
After a median follow-up of 23 months, the RFS in the Intention-to-Treat (ITT) population was 76.6% at 1 year and 59.6% at 2 years; 1- and 2-year distant metastasis-free survival were 83.7% and 71.2%, respectively. The overall survival rate in the ITT population was 93.8% at 1 year and 85.5% at 2 years. No significant differences in RFS were observed according to BRAF status. Treatment-related adverse events of grades 3-4 occurred in 11.5% of patients.
This paper reports the results of the Italian Nivolumab EAP in the adjuvant setting of stage III and IV NED melanoma patients. Our results confirm in a real-life setting the clinical activity and safety of nivolumab reported in the CheckMate238 registrative/pivotal. The enroled cohort of 611 patients highlights the relevant clinical need in this setting, also confirmed by the very short accrual time, representing one of the largest series reported as adjuvant EAP with the longest follow-up.
CheckMate 238 随机研究表明，与伊匹单抗相比，纳武利尤单抗在 IIIB-C 期或 IV 期可切除黑色素瘤患者中具有相关的无复发生存（RFS）获益，且安全性可耐受。
2018 年 11 月至 2019 年 6 月，611 例 III 和 IV 期可切除黑色素瘤患者入组接受纳武利尤单抗治疗，这是意大利扩大准入计划（EAP）的一部分。根据分期，77%为 III 期，141 例（23%）为 IV 期且无疾病证据（NED）。其中 III 期患者中，121 例为 IIIA（19.8%）。
中位随访 23 个月后，意向治疗（ITT）人群的 RFS 在 1 年时为 76.6%，在 2 年时为 59.6%；1 年和 2 年远处无转移生存率分别为 83.7%和 71.2%。ITT 人群的总生存率在 1 年时为 93.8%，在 2 年时为 85.5%。根据 BRAF 状态，RFS 无显著差异。11.5%的患者出现 3-4 级治疗相关不良事件。
本文报告了意大利纳武利尤单抗 EAP 在 III 期和 IV 期 NED 黑色素瘤患者辅助治疗中的结果。我们的结果在真实环境中证实了纳武利尤单抗在 CheckMate238 注册/关键研究中报告的临床活性和安全性。纳入的 611 例患者队列突显了这一治疗环境中的重要临床需求，入组时间非常短也证实了这一点，该队列是辅助 EAP 中报告的最大系列之一，随访时间最长。
