EFFICACY AND SAFETY OF IMMUNOTHERAPY IN PATIENTS WITH GASTROINTESTINAL TUMORS

M.A. Lyadova1,2, D.S. Fedorinov1,2, V.K. Lyadov1-3, D.S. Shakirova4, R.R. Shakirov4, A.I. Tekeeva4, T.R. Eynullaeva4, M.E. Ivannikov5, E.S. Chernyshova4, K.V. Lyadov4, V.N. Galkin1

1City Clinical Oncological Hospital №1, Moscow

2Russian Medical Academy of Continuous Professional Education, Moscow

3Novokuznetsk State Institute for Postgraduate Medical Education ― Branch Campus of the FSBEI FPE RMACPE MOH Russia, Novokuznetsk

4Moscow Treatment and Rehabilitation Center, Moscow

5Moscow Regional Oncological Dispensary, Balashikha

Lyadova Marina A. ― Cand. of Sci. (Med.), oncologist, Head of Chemotherapeutic Department №1 of the City Clinical Oncological Hospital №1

18A Zagorodnoe highway, Moscow, 117152, Russian Federation, e-mail: dr.lyadova@gmail.com

Abstract

Objective ― to evaluate the effectiveness and safety of the use of immune checkpoint inhibitors (ICTI) in patients with tumors of the gastrointestinal tract.

Material and methods. The study included 103 patients (57 men and 46 women) aged 26 to 83 years with stomach and esophageal cancer (n=40), colorectal cancer (CRC; n=42) and hepatocellular carcinoma (HCC; n=21) who received ICTI as monotherapy (pembrolizumab, nivolumab), and in the form of combined treatment (nivolumab and ipilimumab, FOLFOX+nivolumab, paclitaxel+carboplatin+pembrolizumab, atezolizumab and bevacizumab). The objective response of the tumor to treatment was recorded in the presence of partial or complete regression of the tumor. The tumor response to treatment was determined in accordance with the iRECIST criteria.

Results. Complete regression was observed in 2,5%, 14,3% and 14,3% of patients, partial ― in 5,0%, 4,8% and 0%, stabilization was detected in 35,0%, 61,9% and 28,6% and progression ― in 57,5%, 19,0% and 57,1% of patients with gastric and esophageal cancer, CRC and HCC, respectively. The median response time was 2,6, 3,5 and 2,0 months, the median response duration was 10,3, 14,0 and 9,0 months. For patients with stomach and esophageal cancer, CRC and HCC, respectively. Immuno-mediated adverse events (IMAE) of 3-4 art. were observed in 5 (4,85%) patients (in 3 with CRC and 2 with HCC). With cancer of the stomach and esophagus , Ionia 3-4 tbsp . they were not registered.

Conclusions. Immunotherapy of oncological diseases of the gastrointestinal tract allows achieving high rates of objective response and disease control (13,1% and 56,1%, respectively) in gastric and esophageal cancers, CRC and HCC. This method of treatment is characterized by an insignificant amount of ion 3-4 art. (4,85% according to our data), which indicates an acceptable safety profile.

Key words: stomach and esophageal cancer, colorectal cancer, hepatocellular carcinoma, immunotherapy, immuno-mediated adverse events.