Abstract 1427P
Background
The evidence of combining neoadjuvant chemoradiotherapy (CRT) and targeted therapy for adenocarcinoma of esophagogastric junction (AEG) is inadequate. The objective of this study was to investigate the efficacy and safety of neoadjuvant CRT with apatinib for HER-2 negative, Siewert type II and III AEG.
Methods
Patients with resectable, locally advanced, HER-2 negative and Siewert type II or III AEG were enrolled. Patients received two cycles of apatinib (250 mg/day on days 1-28) and two cycles of capecitabine (1,000 mg/m2 twice daily on days 1-14) plus oxaliplatin (130 mg/m2 on day 1). Radiotherapy (45 Gy in 25 fractions) started on day 1 of chemotherapy. Surgery was performed within 8-12 weeks after completion of CRT. The primary endpoint was the pathological complete response rate (pCR). Clinical effects were assessed using the objective response rate (ORR), disease control rate (DCR), and R0 resection rate. (NCT03349866).
Results
Thirty-one patients were enrolled and 28 received surgery. One withdrew during the treatment and 2 developed metastases (1 hepatic and 1 peritoneal) after completing the neoadjuvant therapy. The ORR, DCR, R0 resection, pCR, near pCR were 60.0% (18/30), 96.7% (29/30), 93.3% (28/30), 33.3% (10/30), and 20.0% (6/30), respectively. The most common grade 3 events were leukopenia (16.7%), neutropenia (6.7%), nausea (6.7%), and vomiting (6.7%). There have been no grade 4 or 5 events.
Conclusions
Neoadjuvant concurrent CRT and apatinib results in high R0 resection and pCR rates in patients with resectable HER-2 negative AEG with manageable safety. A randomized controlled trial in locally advanced AEG is ongoing (NCT03986385).
Clinical trial identification
HRA-G01 11/21/2017.
Editorial acknowledgement
Legal entity responsible for the study
Fourth Hospital of Hebei Medical University.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.