Treatment per DeLOS-II protocol improves outcome of patients with locally advanced Laryngeal and Hypopharyngeal squamous cell carcinoma compared to conventional regimens

Introduction: Advanced laryngeal and hypopharyngeal squamous cell carcinoma (LA-LHSCC) and its treatment can lead to impaired function or ablative surgery (total laryngectomy, TL). 10 years after closing the larynx organ-preservation trial DeLOS-II, their long term follow-up data was compared to propensity score (PS)-matched controls undergoing conventional treatment at the University Hospital Leipzig.

Material/Methods: DeLOS-II used TPF-induction chemotherapy (IC) followed by radiotherapy (RT) ± cetuximab for responders according to endoscopically estimated tumor surface shrinkage ≥ 30% after cycle 1. Non-responders received TL plus postoperative radio-(chemo)-therapy (TL+POR(C)T). Follow-up data of 382 LA-LHSCC including n=52 DeLOS-II patients treated at the University Hospital Leipzig from electronic health records and the Saxonian cancer registry were analyzed using SPSS. Overall (OS) and tumor-specific survival (TSS) was assessed after PS-matching of DeLOS-II- and 52 patients each treated by either chemoradiation (CRT), TL+PORT or TL+PORCT considering main risk factors.

Results: OS and TSS were superior in DeLOS-II patients (p= .045, p= .022). Their mean OS was 87.7 (95% CI 70.8-104.6) months, median OS 86.2 (95% CI 39.0-133.4) months; mean TSS 143.0 (95% CI 122.1-163.9) months, median not reached. Comparing the 4 treatment protocols directly, OS and TSS in DeLOS-II were improved but not in general, i.e. compared to TL+PORCT (p= .349; p= .076), TL+PORT (p= .049, p= .131) or CRT (p= .024; p= .007).

Conclusion: DeLOS-II patients had superior OS and TSS compared to patients treated with TL+PORCT, TL+PORT or CRT. A disease-specific gain in survival from DeLOS-II was observed but decreased over time. Further analyses of subgroups and confounding factors are intended.

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