1429P Phase II trial of perioperative mdcf + avelumab in locally advanced gastroesophageal adenocarcinoma: Safety/efficacy

Abstract

Background: Antiangiogenic therapy in combination with chemotherapy has shown improved clinical benefit in advanced cancer. In third-line therapy, apatinib(a TKI against VEGFR-2) has shown good safety and efficacy for advanced gastric cancer. However, the safety and efficacy of apatinib combined with docetaxel in second-line treatment of advanced gastric cancer remains unclear.Methods: From Mar 2017 to Dec 2018, 40 patients with advanced gastric cancer after failure of first-line chemotherapy were enrolled in this open-lable, prospective study. All patients were treated by apatinib (500mg, qd, adjust the dosage to 250mg according to the patient's tolerance) with docetaxel (60mg/m 2 ,d1, q21d). According to the docetaxel course of treatment, study treatment was continued as a 21-day cycle. After 6 cycles, apatinib alone maintenance. Efficacy was evaluated every 2 cycle based on RECIST version 1.1. The primary endpoint was progression-free survival (PFS). The secondary endpoints were objective response rate (ORR), disease control rate (DCR), overall survival (OS), safety and quality of life.Results: During the experiment, it was found that efficacy of apatinib 500 mg group was better than 250 mg group. Stratified analysis showed that the median PFS in the 500 mg (n ¼ 24) group was 1.5m longer than that in the 250 mg (n ¼ 16) group(4.6m vs 3.1m). In terms of safety, the incidence of adverse events in the 500mg group was similar to that in the 250mg group, mainly hypertension (75.0% vs 62.5%), vomiting (50.0% vs 31.3%) and hematological toxicity (37.5% vs 37.5%); Adverse events were manageable and there were no treatment-related deaths.Conclusions: Data demonstrated that patients given apatinib at the dose level of 500 mg once daily showed better effectiveness to 250 mg. Besides, the toxicities could be tolerable and controllable.

Evaluation of neoadjuvant immunotherapy in resectable gastric/gastroesophageal junction tumors: a meta-analysis and systematic review

“…Drug toxicity is the other important factor used to evaluate the safety of neoadjuvant immunotherapy. In the current analysis, two ( 26 , 32 ) studies mentioned grade G3/4 toxicity, including stomatitis, nausea, vomiting, diarrhea, hypothyroidism, arthralgia, neutropenia, and pneumonia, but no instances of postponement of surgery or death due to drug toxicity.…”