Affiliated Hospital of Guilin Medical University, Guilin, China
Wei Jiang , Jinghui Liang , Yufei Pan , Xiaolan Ruan , Rui Cai , Zhuokai He , Qiuqiu Chen , Rongjun Zhang , Xi Yang , Meilian Liu , Bo Zhao , Zhengchun Liu , Zhijie Niu
Background: Concordant programs for patients with nasopharyngeal carcinoma (NPC) who failed to first-line chemotherapy after locoregional recurrence or metastasis are not yet available. Here, we investigated the efficacy and safety of apatinib as an second-line treatment in these patients. Methods: In this multicenter, phase II trial, patients of NPC with disease progression after failure of first-line chemotherapy were treated with apatinib (500mg/d).The primary endpoint of this study was objective response rate (ORR), secondary endpoints included progression free survival (PFS), overall survival (OS) and toxicity. Results: Between January and December 2017, 33 patients were finally enrolled onto the analysis from three centers in China. The baseline characteristics were summarized in Table. Of the 12 patients achieved a partial response and no complete responses were observed, yielding an ORR of 36.3%. Additionally, 6 patients (18.2%) experienced stable disease of at least 5 months in duration, and the disease control rate was 54.5%. At a median follow-up time of 14 months (range 1-22), median PFS was 5.0 months (95% CI, 2.3 to 7.7). The median OS had not reached, and the 1-year OS rate was 83.1%. The most common adverse events (grade 1 to 2) related to apatinib were hypetension (42.4%), hand-foot syndrome (54.5%), proteinuria (12.1%) and oral ulcer (24.2%). Conclusions: Apatinib showed a well therapeutic effect and a manageable safety profile for patients of advanced NPC after previous chemotherapy. Further study in combination with chemotherapy and other targeted agents in patients with NPC is warranted. Baseline demographic and disease characteristics. Clinical trial information: NCT03130270
contents | Apatinib (n=33) |
---|---|
Age in years, median (range) | 48(23-70) |
Male/female, n (%) | 28(84.8%)/5(15.2%) |
NPC histology, n (%) | |
Non-keratinization Differentiated/Undifferentiatied | 3(9.1%)/30(90.9%) |
Recurrent or metastatic sites, n (%) | |
Nasopharynx/Regional lymph nodes | 5(15.2%)/6(21.2%) |
Lung/Bone/Liver | 13(39.4%)/6(18.2%)/10(30.3%) |
Previous chemotherapy, n (%) | |
Platinum/ Gemcitabine/Docetaxel/Fluorouracil | 33(100%)14(42.4%)/23(69.7%)/17(51.5%) |
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