Anti-epidermal growth factor receptor (EGFR) monoclonal antibody combined with chemoradiotherapy for induction chemotherapy resistant locally advanced nasopharyngeal carcinoma: A prospective phase II study

Xiaoshuang Niu; Peiyao Liu; Xin Zhou; Dan Ou; Xiaoshen Wang; Chaosu Hu

Translational Oncology (Jan 2024)

Anti-epidermal growth factor receptor (EGFR) monoclonal antibody combined with chemoradiotherapy for induction chemotherapy resistant locally advanced nasopharyngeal carcinoma: A prospective phase II study

Xiaoshuang Niu,
Peiyao Liu,
Xin Zhou,
Dan Ou,
Xiaoshen Wang,
Chaosu Hu

Affiliations

Xiaoshuang Niu: Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China; Department of Radiation Oncology, Shanghai Clinical Research Center for Radiation Oncology, Shanghai, China; Shanghai Key Laboratory of Radiation Oncology, Shanghai, China
Peiyao Liu: Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China; Department of Radiation Oncology, Shanghai Clinical Research Center for Radiation Oncology, Shanghai, China; Shanghai Key Laboratory of Radiation Oncology, Shanghai, China
Xin Zhou: Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China; Department of Radiation Oncology, Shanghai Clinical Research Center for Radiation Oncology, Shanghai, China; Shanghai Key Laboratory of Radiation Oncology, Shanghai, China
Dan Ou: Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China; Department of Radiation Oncology, Shanghai Clinical Research Center for Radiation Oncology, Shanghai, China; Shanghai Key Laboratory of Radiation Oncology, Shanghai, China
Xiaoshen Wang: Department of Radiation Oncology, Eye & ENT Hospital, Fudan University, Shanghai, China; Corresponding authors.
Chaosu Hu: Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China; Department of Radiation Oncology, Shanghai Clinical Research Center for Radiation Oncology, Shanghai, China; Shanghai Key Laboratory of Radiation Oncology, Shanghai, China; Corresponding authors.

Journal volume & issue: Vol. 39
p. 101797

Abstract

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Objectives: To investigate the efficacy and safety of nimotuzumab (NTZ) combined with concurrent chemo-radiotherapy (CCRT) in induction chemotherapy (IC) resistant locally advanced nasopharyngeal carcinoma (LANPC). Materials and methods: A single-arm, open-label phase II clinical trial was conducted (NCT04508816). Eligible patients were 18–70 years old, pathologically confirmed NPC at stage III-IVA, stable disease or progressive disease after IC by imaging evaluation, and ECOG performance status with 0–1. All patients received intensity-modulated radiotherapy (IMRT) concurrent with chemotherapy and NTZ (200 mg/w). The primary endpoint was progression-free survival (PFS). The secondary endpoints were overall survival (OS), objective response rate (ORR) and safety. Results: From May 2015 to July 2020, 56 NPC patients were enrolled. With the median follow-up of 34 months (range from 8 to 77 months), the 3-year and 5-year PFS and OS rates were 79.3 % and 72.1 %, 94.0 % and 87.2 %, respectively. ORR of the nasopharynx and cervical lymph nodes involvement were 98.2 % and 98.1 % three months after IMRT. Univariate analysis revealed that pretreatment PET/CT was the factor that influenced PFS (P = 0.038). Patients treated with ≥6 weeks of NTZ showed improved 3‐year PFS rate (83.0% vs. 73.9 %, P > 0.05) and 5-year PFS rate (83.0% vs. 61.6 %, P>0.05) compared with <6 weeks NTZ. The acute toxicities were mainly grade 1/2 hematologic. Severe toxicities were uncommon. The major grade 3/4 AE was neutropenia (26.8 %). Conclusions: The results demonstrated that NTZ combined with CCRT in IC resistant LANPC was effective with mild toxicity.

Published in Translational Oncology

ISSN: 1944-7124 (Print); 1936-5233 (Online)
Publisher: Elsevier
Country of publisher: Netherlands
LCC subjects: Medicine: Internal medicine: Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Website: https://www.journals.elsevier.com/translational-oncology/

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