OBJECTIVE

To evaluate the safety and efficacy of a new method for neoadjuvant therapy in locally advanced gastric cancer.

MATERIAL AND METHODS

A phase II clinical trial (2019—2021) was completed at the A.F. Tsyba MRNC, including 47 patients aged 40 to 75 years with histologically confirmed locally advanced gastric cancer. The majority of tumors were proximally located, and in over half of the cases, poorly differentiated adenocarcinoma was present. Patients received 2 cycles of FLOT chemotherapy followed by a course of 3D conformal radiotherapy (dose 2 Gy per fraction, total dose 46 Gy) in the setting of capecitabine and oxaliplatin chemotherapy. Surgical gastrectomy/subtotal gastric resection (D2) was planned after a follow-up examination (5—7 weeks). Toxic reactions were evaluated according to NCI CTCAE version 5.0 toxicity criteria.

RESULTS

After 2 cycles of FLOT chemotherapy, toxic reactions were observed in 21.2% of patients, predominantly hematological (21.2%), gastrointestinal (17.0%), and hepatic (12.8%) toxicity. Only 1 patient (2.1%) experienced grade 4 hematological toxicity, which was successfully managed. Chemoradiotherapy was initiated in 97.8% of patients, and adverse events were recorded in 95.6% of cases, mostly not exceeding grade 1—2. Grade 3 or higher reactions included hematological toxicity in 11% of patients, gastrointestinal toxicity in 23.9%, and hepatic toxicity in 4.3%, all of which were successfully managed. Other types of toxic reactions were rare.

CONCLUSION

This method is characterized by an acceptable level of toxicity, which does not hinder the subsequent surgical stage of treatment.