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
3628 - Predictive model for survival in advanced non-small-cell lung cancer (NSCLC) treated with frontline pembrolizumab
Presenter: Xabier Mielgo Rubio
Session: Poster Display session 3
Resources:
Abstract
5705 - External validation and longitudinal extension of the LIPI (Lung Immune Prognostic Index) for immunotherapy outcomes in advanced non-small cell lung cancer.
Presenter: Jakob Riedl
Session: Poster Display session 3
Resources:
Abstract
5758 - Changes of TCR Repertoire in Metastatic Renal Cell Carcinoma and Metastatic Melanoma Patients Treated with Nivolumab
Presenter: Martin Klabusay
Session: Poster Display session 3
Resources:
Abstract
1743 - Expression of MHC class I, HLA-A and HLA-B identifies immune activated breast tumors with favorable outcome
Presenter: María Del Mar Noblejas López
Session: Poster Display session 3
Resources:
Abstract
2219 - Prognostic Significance of Tumor Tissue NeuGcGM3 Ganglioside Expression and Predictive Value of Circulating Tumor Cell Count Monitoring in Patients Receiving Racotumomab Immunotherapy
Presenter: Necdet Üskent
Session: Poster Display session 3
Resources:
Abstract
2996 - Evolution of Myeloid-Derived Suppressor Cells and Objective Response Rate in Relapsed/Refractory Diffuse Large B Cell Lymphoma (R/R DLBCL) patients after receiving immunotherapy
Presenter: Carlos Jiménez Cortegana
Session: Poster Display session 3
Resources:
Abstract
2110 - A Phase Ia/Ib trial of the anti-programmed death-ligand 1 (PD-L1) human monoclonal antibody (mAb), CS1001, in patients (pts) with advanced solid tumors or lymphomas
Presenter: Lin Shen
Session: Poster Display session 3
Resources:
Abstract
3515 - Results from a randomised Phase 1/2 trial evaluating the safety and antitumour activity of anti-PD-1 (MEDI0680)/anti-PD-L1 (durvalumab) vs anti-PD-1 (nivolumab) alone in metastatic clear cell renal cell carcinoma (ccRCC)
Presenter: Martin Voss
Session: Poster Display session 3
Resources:
Abstract
3566 - Pembrolizumab in Advanced Rare Cancers
Presenter: Aung Naing
Session: Poster Display session 3
Resources:
Abstract
3567 - High clinical benefit rates of pembrolizumab in very rare sarcoma histotypes: first results of the AcSé Pembrolizumab study
Presenter: Jean-Yves Blay
Session: Poster Display session 3
Resources:
Abstract