Sequential four-drug chemotherapy and intensity-modulated radiotherapy for larynx preservation in resectable advanced larynx and hypopharynx cancer: A pilot study.

Objective: The value of additional use of cetuximab with the classical cisplatin, docetaxel and 5-fluorouracil regimen in larynx preservation remains unknown. This study was designed to resolve this issue and appraise its toxicity.

Methods: Thirteen untreated patients with stage III-IV larynx or hypopharynx squamous cell carcinoma were recruited and received two cycles of C+TPF regimen (cetuximab plus docetaxel, cisplatinand and 5-fluorouracil), followed by one more cycle of C+TPF and intensity-modulated radiotherapy (70Gy). Primary endpoint was larynx preservation (LP) rate at 3months. Secondary endpoints were larynx function preservation (LFP) and overall survival (OS) at 12, 36 and 60months.

Results: With a two-cycle induction treatment of C+TPF protocol, four (31%) and nine (69%) patients achieved complete and partial response, respectively. The top three toxicities were dermatitis (9 cases), nausea/vomiting (6 cases), and anemia (4 cases). After the full-course treatment, 12 out of 13 patients (92.3%) obtained LP at 3months. This strategy demonstrated relatively high LFP rates of 92.3%, 69.2% and 54.5% and satisfactory OS rates of 100%, 84.6% and 54.5% at 12, 36 and 60months, respectively.

Conclusions: These preliminary results suggest induction treatment with C+TPF regimens, followed by intensity-modulated radiotherapy is well-tolerated, which warrants further evaluation.