974P - Prospective study of cetuximab with cisplatin plus docetaxel followed by concurrent radiotherapy plus cetuximab and cisplatin in patients with chem...

Date 09 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Head and Neck Cancers
Surgical oncology
Therapy
Radiation oncology
Presenter Tongyu Lin
Citation Annals of Oncology (2016) 27 (6): 328-350. 10.1093/annonc/mdw376
Authors T. Lin, M. Zhang, H. Huang, X. Li, Y. Huang, C. Chen, Z. Wang, X. Fang
  • Department Of Medical Oncology, Cancer Centre Sun Yat-Sen University, 510060 - Guangzhou/CN

Abstract

Background

Metastatic nasopharyngeal carcinoma (mNPC) is generally considered as incurable using conventional therapy. We incorporated cetuximab into the induction therapy and subsequent chemoradiotherapy to treat mNPC in a prospective study.

Methods

Between Jul 2006 to Dec 2014, eligible patients (≥18 years old) with chemotherapy-naive mNPC, including initial metastases (IM) and first relapse metastases (RM), entered into the trial according to their willingness. Patients in the study group were treated with docetaxel 75 mg/m2, cisplatin 75 mg/m2, and cetuximab 250 mg/m2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m2), repeated every 3 weeks up to a maximum of 6 cycles, followed by IMRT (68-70 Gy) with concurrent cetuximab 250 mg/m2 weekly for six cycles and cisplatin 75 mg/m2 per three weeks for two cycles, and maintenance capecitabine plus celecoxib for 3 years. Patients in the control group received conventional chemoradiotherapy.

Results

Totally 43 patients in the study group (17 IM and 26 RM patients), and 66 patients in the control group were enrolled. The ORR and CRR after induction chemotherapy were 79.1% and 34.9% for the study group and 47% and 3% for the control group respectively. With a median follow-up of 60 months, 5yOS and PFS were 28.9% and 16.7% in the study group and 10.9% and 0% in the control group, respectively. In the study group the ORR and CRR were higher in the IM than in the RM subgroup (94.1% vs. 69.2%, 52.9% vs. 23.1%, both p 36 months, 10 of them were still alive with disease-free survival time ranging from 46 to 92+ months. Five patients (11.6%) had grade 3 cetuximab-related acneiform rash. Occurrence of other most common toxicities were similar between the two groups.

Conclusions

The cetuximab-containing induction and consolidation chemoradiation in patients with chemotherapy-naive mNPC resulted in excellent long-term disease-free survival and safety, indicating that mNPC is potential curable, especially in patients with initial metastases.

Clinical trial identification

Legal entity responsible for the study

Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China

Funding

Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China; Sun Yat-sen University Cancer Center

Disclosure

All authors have declared no conflicts of interest.