Abstract
Objective: To assess the efficacy and toxicity of nimotuzumab combined with neoadjuvant or induction chemotherapy for head and neck squamous cell carcinoma (HNSCC). Methods: Patients received intravenous nimotuzumab (400 mg, weekly for 1–3 weeks) combined with chemotherapy (5-fluorouracil/paclitaxel/docetaxel + nedaplatin/cisplatin for 1–2 cycles), prior to definitive surgical resection, radiotherapy or other treatments. The primary endpoint was the objective response rate (ORR). The secondary endpoints were tumor downstaging, complete response rate (CRR), partial response rate (PRR), disease control rate (DCR), R0 resection rate, pathological complete response (pCR), larynx preservation rate, overall survival (OS), progression-free survival (PFS), and safety. Results: A total of 71 HNSCC patients with T1-4N0-2M0 were enrolled. After neoadjuvant/induction chemotherapy, the ORR in patients with hypopharyngeal and laryngeal cancer was 100% and 76.1%, respectively. The DCR was 100% in both groups. The T downstaging in patients with hypopharyngeal and laryngeal cancer was 64.0% and 50.0%, the N downstaging was 28.0% and 2.2% (p = 0.001), respectively. At the early stage and locally advanced stage, the T downstaging was 66.7% and 50.0%, the N downstaging was 0% and 16.0% (p = 0.128), respectively. The R0 resection rate and pCR in 39 patients receiving surgery were 94.9% and 20.5%, respectively. The larynx preservation rate was 73.2%. The median PFS was 29.2 months in patients with laryngeal cancer. A mild rash occurred in a single patient and no grade 4 adverse events were encountered. Conclusion: Nimotuzumab combined with neoadjuvant or induction chemotherapy achieved similar short-term efficacy and less adverse events compared with previous studies. The N downstaging rate in patients with hypopharyngeal cancer was significantly higher compared with patients with laryngeal cancer.
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