Efficacy and survival of nivolumab treatment for recurrent/unresectable esophageal squamous-cell carcinoma: real-world clinical data from a large multi-institutional cohort

期刊论文
出版模式：

开放获取
发表日期：

2024年5月8日

查看全文

Tomoki Makino,
Shigeto Nakai,
Kota Momose,
Kotaro Yamashita,
Koji Tanaka,
Hiroshi Miyata,
Sachiko Yamamoto,
Masaaki Motoori,
Yutaka Kimura,
Yuki Ushimaru,
Motohiro Hirao,
Jin Matsuyama,
Yusuke Akamaru,
Yukinori Kurokawa,
Hidetoshi Eguchi,
Yuichiro Doki

摘要

Background

Real-world clinical outcomes of and prognostic factors for nivolumab treatment for esophageal squamous-cell carcinoma (ESCC) remain unclear. This study aimed to evaluate real-world outcomes of nivolumab monotherapy in association with relevant clinical parameters in recurrent/unresectable advanced ESCC patients.

Methods

This population-based multicenter cohort study included a total of 282 patients from 15 institutions with recurrent/unresectable advanced ESCC who received nivolumab as a second-line or later therapy between 2014 and 2022. Data, including the best overall response, progression-free survival (PFS), and overall survival (OS), were retrospectively collected from these patients.

Results

Objective response and disease control rates were 17.0% and 47.9%, respectively. The clinical response to nivolumab treatment significantly correlated with development of overall immune-related adverse events (P < .0001), including rash (P < .0001), hypothyroidism (P = .03), and interstitial pneumonia (P = .004). Organ-specific best response rates were 20.6% in lymph nodes, 17.4% in lungs, 15.4% in pleural dissemination, and 13.6% in primary lesions. In terms of patient survival, the median OS and PFS was 10.9 and 2.4 months, respectively. Univariate analysis of OS revealed that performance status (PS; P < .0001), number of metastatic organs (P = .019), C-reactive protein-to-albumin ratio (CAR; P < .0001), neutrophil–lymphocyte ratio (P = .001), and PMI (P = .024) were significant. Multivariate analysis further identified CAR [hazard ratio (HR) = 1.61, 95% confidence interval (CI) 1.15–2.25, P = .0053)] in addition to PS (HR = 1.65, 95% CI 1.23–2.22, P = .0008) as independent prognostic parameters.

Conclusions

CAR and PS before nivolumab treatment are useful in predicting long-term survival in recurrent/unresectable advanced ESCC patients with second-line or later nivolumab treatment.

Trial Registration

UMIN000040462