Abstract 2628
Background
To evaluate the efficacy and safety of apatinib in treating patients with platinum-resistant or platinum-refractory recurrent or metastatic nasopharyngeal carcinoma.
Methods
In this phase 2, single-arm, prospective study, we recruited patients aged 18–65 years with platinum-resistant or platinum-refractory recurrent /metastatic nasopharyngeal carcinoma. Patients were treated with apatinib at an initial dose of 500 mg once daily and continued until disease progression, patient withdrawal, or unacceptable toxic effects. The primary endpoint was clinical benefit rate (CBR) and toxicity. Secondary endpoints included progression-free survival (PFS) at 3 months and overall survival (OS). We used Simon’s two-stage design, and analysed efficacy and toxicity in the per-protocol populations and intention-to-treat. This study is registered with ClinicalTrials.gov, number NCT03213587.
Results
Between Aug 5,2017 and Apr 17,2019, we enrolled 16 patients. Until the final follow-up (Apr 17, 2019), the CBR (complete response + partial response+ stable disease) was 61.5% (8/13) in the per-protocol population. Median PFS and 3-month PFS rate were 5.53 (95% CI, 2.57-8.49) months and 68.7%, respectively. Median OS and 1-year OS rate were 12.67 (95% CI 8.22-17.12) months and 44.4%, respectively. The most common grade 3-4 adverse events were neutropenia (1[6.25%]), hand-foot syndrome (3[18.7%]), albuminuria (2[12.5%]), hypertension (1[6.25%]), hyponatremia (1[6.25%]), artery dissection (1[6.25%]), Oral mucosal pain (2[12.5%]) and nasopharyngeal hemorrhage (2[12.5%]) in the intention-to-treat population. Serious adverse event was reported in one patient who died of nasopharyngeal hemorrhage.
Conclusions
Apatinib achieved excellent disease control in platinum-resistant or platinum-refractory recurrent or metastatic nasopharyngeal carcinoma. More attention needs to be paid to toxicity management.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Funding
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
1984 - Induction chemotherapy (IC) followed by concurrent chemoradiotherapy (CCRT) in nasopharyngeal carcinoma (NPC)
Presenter: Gizem Kaval
Session: Poster Display session 3
Resources:
Abstract
4822 - Efficiacy of different nutritional intervention on nutritional status and quality of life for local advanced nasopharyngeal carcinoma patients: a prospective clinical trial
Presenter: Yuan-yuan Chen
Session: Poster Display session 3
Resources:
Abstract
4887 - Impact of tumor site and adjuvant radiotherapy on survival of adenoid cystic carcinoma: a SEER database analysis
Presenter: Jason Tasoulas
Session: Poster Display session 3
Resources:
Abstract
2634 - Efficacy and safety of anlotinib for patients with recurrent and/or metastatic salivary gland carcinomas
Presenter: Wen Jiang
Session: Poster Display session 3
Resources:
Abstract
3568 - ACCURACY a phase (P) 2 trial of AL101, a pan-Notch inhibitor, in recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC) patients (pts) with Notch activating mutations (Notch act mut): preliminary safety and efficacy data.
Presenter: Renata Ferrarotto
Session: Poster Display session 3
Resources:
Abstract
683 - Pathologic Staging Changes in Oral Cavity Squamous Cell Carcinoma—Stage Migration and Implications for Adjuvant Treatment
Presenter: Zain Husain
Session: Poster Display session 3
Resources:
Abstract
563 - Expression of immune response biomarkers in head and neck squamous cell carcinoma (HNSCC) in irradiated area
Presenter: Carole Pflumio
Session: Poster Display session 3
Resources:
Abstract
4030 - HLA-Ligandome analysis reveals target antigens of oropharyngeal squamous cell carcinoma
Presenter: Simon Laban
Session: Poster Display session 3
Resources:
Abstract
2979 - Topographical distribution of sentinel lymph nodes in early tongue squamous cell carcinomas
Presenter: Hiroyuki Goda
Session: Poster Display session 3
Resources:
Abstract
3517 - Role of follow-up (FU) FDG-PET/CT (FU-FDG-PET/CT) in patients with locoregionally advanced squamous cell carcinoma of the head and neck (LA-HNSCC) treated with chemotherapy and radiotherapy (RT), either concurrent (CRT) or sequential (ST).
Presenter: Bert Van Den Heuvel
Session: Poster Display session 3
Resources:
Abstract