Nanoliposomal Irinotecan in Combination With 5-Fluorouracil and Leucovorin for Advanced Head and Neck and Esophageal Squamous Cell Carcinoma After Prior Platinum-Based Chemotherapy or Chemoradiotherapy: A Multicenter Phase II Trial.
Journal
Cancer medicine
Journal Volume
14
Journal Issue
20
Start Page
Article number e71307
ISSN
2045-7634
Date Issued
2025-10
Author(s)
Yang, Muh-Hwa
Wu, Shang-Yin
Ho, I-Wei
Chiang, Nai-Jung
Hsaio, Chin-Fu
Lin, Chen-Yuan
Lien, Ming-Yu
Chang, Peter Mu-Hsin
Chen, Jia-Hong
Hsieh, Ching-Yun
Lee, Chao-Tung
Chen, Li-Tzong
Liu, Tsang-Wu
Chiu, Chang-Fang
Bai, Li-Yuan
Abstract
To evaluate the efficacy and safety of nanoliposomal irinotecan (nal-IRI) plus 5-fluorouracil (5-FU) and leucovorin (LV) in patients with platinum-refractory or intolerant head and neck squamous cell carcinoma (HNSCC) and esophageal squamous cell carcinoma (ESCC).
In this multicenter, phase 2 study (NCT03712397), patients with advanced HNSCC (n = 43) or ESCC (n = 16) who had failed or were intolerant to platinum-based chemotherapy received biweekly nal-IRI 80 mg/m (equivalent to 70 mg/m of irinotecan base), LV 400 mg/m, and 5-FU 2400 mg/m until progression or unacceptable toxicity. The primary endpoint was the objective response rate (ORR).
In the intent-to-treat analysis, the ORR and disease control rate were 8.5% and 59.3% for the entire group. In the HNSCC subgroup, ORR and disease control rate were 11.6% and 65.1%, with a median progression-free survival (PFS) of 2.7 months and an overall survival (OS) of 8.1 months. By contrast, no objective responses were observed in ESCC (ORR 0%, disease control rate 43.8%, median OS 4.2 months). The most common grade 3/4 toxicities were lymphopenia (50.8%), neutropenia (42.4%), leukopenia (33.9%), anemia (28.8%), and anorexia (8.5%).
Nal-IRI/5-FU/LV demonstrates modest activity with acceptable safety profiles in patients with platinum-refractory or intolerable advanced HNSCC. The exploratory findings warrant confirmation in larger, randomized studies.
ClinicalTrials.gov: NCT03712397.
Subjects
esophageal cancer
head and neck cancer
nanoliposomal irinotecan
platinum
squamous cell carcinoma
Type
journal article