Prognostic Subgroups for Disease-Free Survival With Cutaneous Squamous Cell Carcinoma of the Head and Neck: A Secondary Analysis of a Randomized Clinical Trial
Abstract
Importance
Cutaneous squamous cell carcinoma is a common cancer, and approximately 5% of cases present with high-risk features, such as regional nodal metastases. Postoperative radiotherapy (PORT) improves outcomes in this group, but the TROG 05.01 trial found no added benefit of concurrent chemotherapy. Identification of patients with poor disease-free survival (DFS) is critical to optimize future adjuvant treatment strategies.
Objective
To identify a subgroup of patients with poor DFS following PORT with or without concurrent chemotherapy who may be appropriate candidates for future adjuvant trials.
Design, Setting, and Participants
This was a secondary analysis of the prospective, randomized phase 3 TROG 05.01 trial, which enrolled 321 patients with high-risk cutaneous squamous cell carcinoma of the head and neck between April 2005 and July 2014 at multiple centers in Australia. Data were analyzed in January 2025. A recursive partitioning analysis using classification and regression trees was applied to identify prognostic subgroups. Disease-free and overall survival (OS) were measured from randomization until relapse or death, with appropriate censoring.
Main Outcomes and Measures
The primary outcome was DFS; secondary outcomes included OS and identification of prognostic subgroups.
Results
Of 321 patients randomized, 310 (23 female individuals [7%] and 287 male individuals [93%]; median [range] age, 64 [32-85] years) initiated the allocated treatment. The recursive…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 321 participants or records.
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