Efficacy and safety of camrelizumab combined with FOLFOX as neoadjuvant therapy for patients with resectable locally advanced gastric and gastroesophageal junction adenocarcinoma who received D2 radical gastrectomy.

Abstract

e16549 Background: Neoadjuvant chemotherapy for patients with locally advanced gastric and gastroesophageal junction adenocarcinoma (GC/GEJC) can improve the overall survival without increasing operation risk. Nowadays, immunotherapy has become a new promising neoadjuvant treatment. Therefore, we intended to evaluate the safety and efficacy of camrelizumab (anti-PD-1 antibody) combined with FOLFOX as the neoadjuvant therapy for patients with locally advanced GC/GEJC who received D2 radical gastrectomy. Methods: Patients who were diagnosed as resectable locally advanced GC/GEJC received the neoadjuvant treatment of camrelizumab and FOLFOX every 2 weeks for 4 cycles. Imaging evaluation was performed in 2-4 weeks after neoadjuvant therapy. Patients who had no progression disease (PD) were recruited. Eligible patients underwent gastrectomy with D2 lymph node dissection through laparotomy or laparoscopic surgery. The primary end points were safety and R0 resection rate. Results: From July 24 2019 to January 31 2020, 15 patients were recruited. The mean age was 57 years. A total of 10(67%) were males and 5(33%) were females. According to AJCC 8th, cT3 and cT4 were confirmed in 7(47%) patients and 8(53%) patients, N1 and N2 in 7(47%) patients and 8(53%) patients, respectively. During operation, intraperitoneal metastases were found in 2 patients. Of the 13 surgeries, only 2 were laparoscopic and the others were laparotomy. The surgical procedures included Roux-en-Y (9, 69.2%), Billroth II (1, 7.7%) and jejunum interposition (3, 23.1%). Thirteen patients underwent gastrectomy with D2 lymph node dissection and all of them were confirmed R0 resection by postoperative pathology results. The mean lymph node yield was 44.1±13.2 nodes, positive lymph node yield was 1.8±2.8 nodes. Duration time of surgery was 186.5±45.5 minutes, mean blood loss was 219.2±109 ml during the operation. Mean hospital stays were 13.2±2.4 days. Only 1 patient experienced grade 3 pneumonia. Neither serious intraoperative complications nor immune-related adverse events both prior and post operation were observed. There was no treatment-related death. Conclusions: Camrelizumab combined with FLOFOX as neoadjuvant treatment for patients with locally advanced GC/GEJC showed acceptable toxicity and promising efficacy with low complications and mortality. Clinical trial information: NCT03939962 .

Perioperative treatment and biomarker analysis of LP002, an anti‐PD‐L1 antibody, plus chemotherapy in resectable gastric and gastroesophageal junction cancer

“…In recent years, based on the growing evidence of the clinical activity of immune checkpoint inhibitors (ICI) in metastatic gastric or GEJ cancer, 6–8 there has also been great interest in adding ICIs to neoadjuvant or perioperative chemotherapy for treating patients with locally advanced, resectable disease. Currently, reports on the outcomes of neoadjuvant or perioperative ICI plus chemotherapy in gastric or GEJ cancer are few and limited to early‐phase trials 9–15 . The preliminary results from these trials seemed promising, with margin‐free (R0) resection rates between 97% and 100% and pathological complete response (pCR) rates between 10% and 33% 9–15 .…”

“…Currently, reports on the outcomes of neoadjuvant or perioperative ICI plus chemotherapy in gastric or GEJ cancer are few and limited to early‐phase trials. 9 , 10 , 11 , 12 , 13 , 14 , 15 The preliminary results from these trials seemed promising, with margin‐free (R0) resection rates between 97% and 100% and pathological complete response (pCR) rates between 10% and 33%. 9 , 10 , 11 , 12 , 13 , 14 , 15 However, a number of important questions remain unanswered, including the optimal choice of ICI and chemotherapy backbone and the impact of preoperative ICI plus chemotherapy on the tumor immune microenvironment.…”

“… 9 , 10 , 11 , 12 , 13 , 14 , 15 The preliminary results from these trials seemed promising, with margin‐free (R0) resection rates between 97% and 100% and pathological complete response (pCR) rates between 10% and 33%. 9 , 10 , 11 , 12 , 13 , 14 , 15 However, a number of important questions remain unanswered, including the optimal choice of ICI and chemotherapy backbone and the impact of preoperative ICI plus chemotherapy on the tumor immune microenvironment. More importantly, although PD‐L1 expression has been recognized as a potential biomarker to select patients who may derive greater benefit from PD‐1 blockade in metastatic gastric or GEJ cancer, 7 , 8 , 16 , 17 its predictive role for the resectable disease has not been established, and reliable biomarkers for response and survival are lacking for these patients.…”