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.

ABSTRACT:

Purpose

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).

Methods

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/m² (equivalent to 70 mg/m² of irinotecan base), LV 400 mg/m², and 5-FU 2400 mg/m² until progression or unacceptable toxicity. The primary endpoint was the objective response rate (ORR).

Results

In the intent-to-treat analysis, the ORR and disease cont

SUBMITTER: Yang MH 

PROVIDER: S-EPMC12538807 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature