A phase I study evaluating combined nimotuzumab and neoadjuvant chemoradiotherapy followed by surgery in locally advanced esophageal cancer

Cancer Chemother Pharmacol. 2019 Nov;84(5):1115-1123. doi: 10.1007/s00280-019-03944-w. Epub 2019 Sep 9.

Abstract

Objective: The aim of this study was to evaluate the safety and efficacy of combined nimotuzumab and neoadjuvant chemoradiotherapy followed by surgery in locally advanced esophageal cancer.

Methods: Patients with clinically resectable, locally advanced esophageal cancer treated with neoadjuvant chemoradiotherapy plus nimotuzumab were eligible for study participation. Radiotherapy was administered in 1.8 Gy once daily for 5 days per week up to a total dose of 41.4 Gy. Weekly nimotuzumab (200 mg/week) was administered following paclitaxel and carboplatin on the same day for 5 weeks. The primary end-point was the pathological complete response (pCR) rate and the secondary end-point was the safety, progression-free survival (PFS) and overall survival (OS).

Results: A total of 64 patients with a median age of 58 years were enrolled in this study. pCR was observed in 51.6% patients. Grade 3 acute toxicities were observed in 6 patients (9.4%), shown as bone marrow suppression. 7 patients experienced grade 1 transient skin rash during nimotuzumab treatment. The median PFS time and OS time were 64.6 and 68.2 months.

Conclusions: Combined nimotuzumab and neoadjuvant chemoradiotherapy for clinically resectable, locally advanced esophageal cancer showed a significant anticancer effect with tolerable toxicities.

Keywords: Esophageal squamous cell carcinoma; Neoadjuvant chemoradiotherapy; Nimotuzumab; Pathological response.

Publication types

  • Clinical Trial, Phase I

MeSH terms

  • Adult
  • Aged
  • Antibodies, Monoclonal, Humanized / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Carboplatin / administration & dosage
  • Chemoradiotherapy*
  • Esophageal Neoplasms / pathology
  • Esophageal Neoplasms / therapy*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Neoadjuvant Therapy
  • Paclitaxel / administration & dosage
  • Progression-Free Survival
  • Survival Rate

Substances

  • Antibodies, Monoclonal, Humanized
  • nimotuzumab
  • Carboplatin
  • Paclitaxel