Sequential therapy of neoadjuvant biochemotherapy with cetuximab, paclitaxel, and cisplatin followed by cetuximab-based concurrent bioradiotherapy in high-risk locally advanced oral squamous cell carcinoma: Final analysis of a phase 2 clinical trial

Head Neck. 2019 Jun;41(6):1703-1712. doi: 10.1002/hed.25640. Epub 2019 Jan 12.

Abstract

Background: The prognosis of advanced oral squamous cell carcinoma is poor. We investigated the effect of cetuximab-based sequential therapy as a primary treatment.

Methods: Forty-seven treatment-naive patients with advanced tumors originating from the oral cavity or oropharynx were enrolled. Neoadjuvant cetuximab, paclitaxel, and cisplatin were administered, followed by cetuximab-based radiotherapy. Immunohistochemical staining was applied to study the tissues.

Results: The best overall response rate was 70.2%, including 4 patients with a complete response and 29 with a partial response. The median progression-free and overall survival rates were 10.3 and 15.2 months, respectively. Patients with more than 50% tumor reduction with neoadjuvant therapy had better survival outcomes. Twenty-two patients had severe adverse events with mostly dermatological complications. Of the 16 patients who received operations, 9 had increased PD-L1 staining compared to pretreatment biopsy in the post hoc study.

Conclusion: The regimen was effective in selected patients. Increased PD-L1 suggested altered tumor features.

Keywords: PD-L1; cetuximab; head and neck cancer; locally advanced; sequential therapy.

Publication types

  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / administration & dosage*
  • Carcinoma, Squamous Cell / mortality
  • Carcinoma, Squamous Cell / pathology
  • Carcinoma, Squamous Cell / therapy*
  • Cetuximab / administration & dosage*
  • Chemoradiotherapy
  • Cisplatin / administration & dosage*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Mouth Neoplasms / mortality
  • Mouth Neoplasms / pathology
  • Mouth Neoplasms / therapy*
  • Neoadjuvant Therapy
  • Neoplasm Staging
  • Paclitaxel / administration & dosage*
  • Survival Rate

Substances

  • Antineoplastic Agents
  • Paclitaxel
  • Cetuximab
  • Cisplatin