RESULTS
tumor, skin metastatic lesions, toxicities, Twenty‐nine, toxicity, hepatic cirrhosis, mucositis, Toxicity, hepatitis, PD‐L1, diarrhea, fatigue, adenocarcinoma, colitis, nausea, vomiting, recurrence/metastatic disease, pneumonitis, neutropenia, Arthralgia, liver metastatic lesion
TUMOR, NEUROENDOCRINE TUMOR, CPS, ADRENAL INSUFFICIENCY, PATHOLOGY, SUDDEN DEATH, HEPATIC CIRRHOSIS, MUCOSITIS, PERITONEAL DISEASE, HEPATITIS, PRIMARY CANCER, ADENOCARCINOMA, DISEASE, COLITIS, DISEASE PROGRESSION, PNEUMONITIS, NEUTROPENIA, PERIPHERAL SENSORY NEUROPATHY, DISEASE, METASTATIC DISEASE
From 7/11/2018 to 11/21/2021, 37 patients were enrolled in the study and finished preoperative treatment as planned with mean age of 65 year's old (range 44–86 year's old) (Table Patient characteristics: (In those 37 patients who finished preoperative treatment evaluation, 8 patients did not have surgical resection. Two subjects non‐operable from medical reasons (one with hepatic cirrhosis and one because of physical unfitness) and six due to progression or non‐resectable disease. Ninety‐one patients have disease progression by the planned image assessment after neoadjuvant therapy, 1 found retroperitoneal LN; 1 with micro‐metastatic lesion in the surface of the liver which was not seen in the screening laparoscopy; 1 with peritoneal disease; 2 with aorta involvement and high risk for surgical resection. Twenty‐nine patients had curative intended operations, and all had R0 resection. Six of 29 (21%; 95% CI: 0.08–0.40) achieved ypCR with TRS of 0 in the primary cancer. All except three patients (26/29, 90%, 95% CI: 0.73–0.98) had shown pathologic response to the treatment with TRS ≤2. This ypRR rate of 90% was significantly higher than the hypothesized rate of 30% as assessed by a There were three patients who did not receive postoperative adjuvant treatment for various reasons: one patient's final pathology of the surgical specimen showed mixed adenocarcinoma with neuroendocrine tumor; one patient did not recover from surgery; and one patient suffered sudden death post operation which was not treatment related.Twenty‐six patients finished adjuvant therapy with a median follow‐up of 36.3 months (12.7–52.5 months). Three had recurrence/metastatic disease (at 9‐, 10‐, and 22 months enrollment) with one dead at 23 months, and the others are still alive at 28 and 36.5 months. In those three patients with recurrent and metastatic diseases, one had liver metastatic lesion at 10 months of enrollment, one had a splenic lesion at 9.5 months of enrollment, and one had skin metastatic lesions at 22 months from the enrollment. The remaining patients (23/26) are all free of disease with 3 years DFS of 88.5% and 3 years OS of 92.3%, the median follow‐up is 36.3 months (12.7–52.2 months) (Figures Disease Free Survival Median follow‐up of 36.3 months (12.7–52.2 months). Date of all 26 patients with finished postoperative adjuvant therapy, with the median follow‐up of 36.3 months (12.7–52.2 months).Overall Survival Median follow‐up of 36.3 months (12.7–52.2 months). Date of all 26 patients with finished postoperative adjuvant therapy; the median follow‐up with the median follow‐up of 36.3 months (12.7–52.2 months).Efficacy based on the tumor location. Date of all 26 patients with finished postoperative adjuvant therapy, the median follow‐up with the median follow‐up of 36.3 months (12.7–52.2 months).The toxicity data showed that the main toxicities from the combination were chemotherapy regimen mFOLFOX related: nausea, vomiting, diarrhea, peripheral sensory neuropathy, fatigue, mucositis, neutropenia. Arthralgia, pneumonitis, adrenal insufficiency, hepatitis, and colitis were observed and considered to be related to ICI, pembrolizumab, with one case of G3 of each. There were no unexpected toxicities. G3/4 toxicities were reported in 21 of all 37 treated patients (Table Toxicity of the combination treatment (in all patients, All patients (100%) completed preoperative treatment (68% completed without dose modification, and the 32% with mild (<10%) dose modification based on the protocol). All patients qualified for postoperative treatment completed the combination therapy (58% without dose modification, and 42% with mild (<10%) dose modification based on the protocol).Analyses of the expression of ICI treatment related markers PD‐L1 (CPS), CD8, and CD20 before and after preoperative therapy were performed in those patients who had surgery resection. Those patients achieved ypCR were excluded since no tumor was seen in their surgical specimens. The analyses demonstrated a significant increase in PD‐L1 (CPS ≥10) in the surgical specimens after the preoperative treatment over the biopsy specimens (