Future oncology (London, England) · 2026
Neoadjuvant nedaplatin and paclitaxel regimen with concurrent radiotherapy for esophageal squamous cell carcinoma: a single-arm phase II clinical trial.
СтатьяКлиническое исследование II фазыНазвание и аннотация: Перевод в очереди
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Liu Ting, Dan Xiao, Li Qing, Wang Peipei, Chen Yueyun, Tian Jiangfang, Lin Zhen, Hu Yang, Shi Huashan, Ding Zhenyu
Аннотация
AIMS: To evaluate the efficacy and safety of neoadjuvant concurrent chemoradiotherapy (CCRT) utilizing nedaplatin and paclitaxel in patients with locally advanced esophageal squamous cell carcinoma (ESCC).
PATIENTS & METHODS: Locally advanced ESCC patients received two cycles of nedaplatin plus paclitaxel or albumin-bound paclitaxel with concurrent radiotherapy (41.4-50.4 Gy) as neoadjuvant treatment. Immunohistochemical profiling was performed on biopsies and surgical specimens. The primary endpoint was the pathological complete response (pCR) rate.
RESULTS: Among 49 enrolled patients, 33 underwent surgery, yielding a pCR rate of 30.3%. Overall survival was inferior in resected patients with positive postoperative lymph nodes (HR 3.92, 95% CI 1.30-11.80, p = 0.02, log-rank p = 0.009). Higher FOXP3 expression before (HR 0.14, 95% CI 0.02-1.26, p = 0.08, log-rank p = 0.041) and after (HR 0.23, 95% CI 0.07-0.84, p = 0.03, log-rank p = 0.015) treatment nominally contributed to favorable outcomes. Upregulated TIGIT post-treatment trended toward a poorer prognosis in this surgical cohort (HR 7.10, 95% CI 0.79-63.65, p = 0.08, log-rank p = 0.041).
CONCLUSION: Neoadjuvant nedaplatin and paclitaxel-based CCRT demonstrates encouraging preliminary antitumor efficacy. Tumor microenvironment profiling highlights FOXP3 and TIGIT dynamics as potential prognostic indicators. These hypothesis-generating insights warrant further validation in large-scale, randomized controlled trials. Clinical trial registration: Chinese Clinical Trial Registry (http://www.chictr.org.cn), identifier is ChiCTR1900024628. Date of registration: 19 July 2019.
PATIENTS & METHODS: Locally advanced ESCC patients received two cycles of nedaplatin plus paclitaxel or albumin-bound paclitaxel with concurrent radiotherapy (41.4-50.4 Gy) as neoadjuvant treatment. Immunohistochemical profiling was performed on biopsies and surgical specimens. The primary endpoint was the pathological complete response (pCR) rate.
RESULTS: Among 49 enrolled patients, 33 underwent surgery, yielding a pCR rate of 30.3%. Overall survival was inferior in resected patients with positive postoperative lymph nodes (HR 3.92, 95% CI 1.30-11.80, p = 0.02, log-rank p = 0.009). Higher FOXP3 expression before (HR 0.14, 95% CI 0.02-1.26, p = 0.08, log-rank p = 0.041) and after (HR 0.23, 95% CI 0.07-0.84, p = 0.03, log-rank p = 0.015) treatment nominally contributed to favorable outcomes. Upregulated TIGIT post-treatment trended toward a poorer prognosis in this surgical cohort (HR 7.10, 95% CI 0.79-63.65, p = 0.08, log-rank p = 0.041).
CONCLUSION: Neoadjuvant nedaplatin and paclitaxel-based CCRT demonstrates encouraging preliminary antitumor efficacy. Tumor microenvironment profiling highlights FOXP3 and TIGIT dynamics as potential prognostic indicators. These hypothesis-generating insights warrant further validation in large-scale, randomized controlled trials. Clinical trial registration: Chinese Clinical Trial Registry (http://www.chictr.org.cn), identifier is ChiCTR1900024628. Date of registration: 19 July 2019.