Phase 2 Multicenter Randomized Clinical Trial: Neoadjuvant Chemoradiotherapy Followed by D2 Gastrectomy and Adjuvant Chemotherapy in Patients With Locally Advanced Gastric Cancer

Скоропад, В. Ю.; Afanasyev, S. G.; Gamayunov, S. V.; Силантьева, Н. К.; Agababyan, T. A.; Соколов, П. В.; Иванов, С. А.; Каприн, А. Д.

doi:10.21294/1814-4861-2020-19-1-5-14

Cited by 4 publications

(1 citation statement)

References 9 publications

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“…Prognostic data for LAGC are less abundant than those for esophageal and EGJ cancers. Notably, several clinical trials exploring the efficacy and safety of NCRT in LAGC are ongoing [ 20 , 21 , 22 , 23 ]. This paper presents a narrative review of studies on NCRT for LAGC, examining its efficacy, adverse effects, technical aspects, and perioperative and oncological outcomes.…”

Section: Introductionmentioning

confidence: 99%

Neoadjuvant Chemoradiotherapy for Locally Advanced Gastric Cancer: Where Are We at?

Yeh

Tsai

et al. 2022

Cancers

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Locally advanced gastric cancer (LAGC) has a poor prognosis with surgical resection alone, and neoadjuvant treatment has been recommended to improve surgical and oncological outcomes. Although neoadjuvant chemotherapy has been established to be effective for LAGC, the role of neoadjuvant chemoradiotherapy (NCRT) remains under investigation. Clinical experience and research evidence on esophagogastric junction adenocarcinoma (e.g., cardia gastric cancers) indicate that the likelihood of achieving sustainable local control is higher through NCRT than through resection alone. Furthermore, NCRT also has an acceptable treatment-related toxicity and adverse event profile. In particular, it increases the likelihood of achieving an R0 resection and a pathological complete response (pCR). Moreover, NCRT results in higher overall and recurrence-free survival rates than surgery alone; however, evidence on the survival benefits of NCRT versus neoadjuvant chemotherapy (NCT) remains conflicting. For noncardia gastric cancer, the efficacy of NCRT has mostly been reported in retrospective studies, and several large clinical trials are ongoing. Consequently, NCRT might play a more essential role in unresectable LAGC, for which NCT alone may not be adequate to attain disease control. The continual improvements in systemic treatments, radiotherapy techniques, and emerging biomarkers can also lead to improved personalized therapy for NCRT. To elucidate the contributions of NCRT to gastric cancer treatment in the future, the efficacy, potential toxicity, predictive biomarkers, and clinical considerations for implementing NCRT in different types of LAGC were reviewed.

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Section: Introductionmentioning

confidence: 99%

Neoadjuvant Chemoradiotherapy for Locally Advanced Gastric Cancer: Where Are We at?

Yeh

Tsai

et al. 2022

Cancers

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Analysis of Safety of Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Gastric Cancer (Results of a Multicenter Randomized Trial)

et al. 2020

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the purpose of the study was to immediate results of neoadjuvant chemoradiotherapy in patients with locally advanced gastric cancer were analyzed in a multicenter randomized trial. material and methods. the comparative analysis of neoadjuvant chemotherapy regimens, toxicity and postoperative complications was carried out. patients of the study group received conformal radiation therapy (46 Gy in 2 Gy daily fractions) concurrently with chemotherapy with Capecitabine at a dose of 1850 mg/m 2 divided in two equal doses during the course of radiation therapy, and Oxaliplatin at a dose of 85 mg/m2 on days 1 and 21. After an interval of 4-6 weeks and a control examination, in the absence of evident disease progression, patients were scheduled for surgery (gastrectomy or subtotal gastrectomy with d2 lymph node dissection) and 4 cycles of adjuvant chemotherapy according to the FOLFOX4 or CApOX regimen. the treatment program for patients in the control group included surgery (gastrectomy or subtotal gastrectomy with d2 lymph node dissection) after randomization, and 6 cycles of adjuvant chemotherapy using the same regimens. the study included 70 patients with an equal distribution between groups. results. Among the patients of the study group, grade 1 and 2 toxicity was the most common; grade 3 toxicity occurred in 9 cases; grade 4 and 5 toxicity was not observed. Among the manifestations of hematological toxicity, thrombocytopenia and leukopenia were the most common (57-60 % of patients), and grade 3 hematological toxicity was observed in 6 (17.1 %) cases. Among the manifestations of gastrointestinal toxicity, nausea, vomiting and decreased appetite prevailed; grade 3 toxicity was observed only in 3 (8.6 %) cases. the radiation component of neoadjuvant therapy was completed in 32 (91 %) patients. Both protocol-prescribed oxaliplatin infusions were performed in 34 (97 %) patients. Changes in capecitabine administration were required in 8 patients. Immediately before surgery, some patients had grade 1-2 toxicity, which did not prevent performing surgery. there were no statistically significant differences in the frequency and severity of complications in the early postoperative period between the comparison groups. Grade 1-2 postoperative complications were the most common.

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Spleen-preserving D2 subtotal distal resection of the stomach and corpocaudal resection of the pancreas after neoadjuvant induction chemotherapy and chemoradiotherapy: case report and literature review

et al. 2022

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Background. Stomach cancer is one of the most common cancers worldwide. Long-term treatment outcomes in patients with locally advanced gastric cancer with invasion to adjacent structures are poor. In clinical recommendations of the Ministry of Health of the Russian Federation, it is recommended to treat these patients with perioperative chemotherapy according to the FLOT scheme. The effectiveness of neoadjuvant chemoradiotherapy is studied in many multicenter studies involving randomized clinical trials. Case description. We present a case of a successful treatment of a patient with locally advanced gastric cancer (сT4bN2M0 – IVA stage). The patient received neoadjuvant therapy (2 cycles according to the FLOT scheme) followed by chemoradiotherapy (total dose of 46 Gy with the concurrent chemotherapy with capecitabine and oxaliplatin). Neoadjuvant therapy was well tolerated (grade 1 gastrointestinal and hematological toxicity). The patient underwent distal subtotal resection of the stomach with D2 lymph node dissection and distal subtotal resection of the pancreas with preservation of the spleen. No postoperative complications were observed. Histological examination revealed complete pathological response of the primary tumor, including the area of earlier invasion into the pancreas; metastasis in one lymph node of the small omentum. The patient is alive with no evidence of disease 20 months after surgery. Conclusion. The feasibility of conducting safe multimodal neoadjuvant therapy followed by organ-preserving surgery in a patient with locally advanced gastric cancer (сT4bN2M0) was shown. The effective neoadjuvant therapy resulted in the achievement of complete pathologic response, which is a favorable prognostic factor.

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Phase 2 Multicenter Randomized Clinical Trial: Neoadjuvant Chemoradiotherapy Followed by D2 Gastrectomy and Adjuvant Chemotherapy in Patients With Locally Advanced Gastric Cancer

Cited by 4 publications

References 9 publications

Neoadjuvant Chemoradiotherapy for Locally Advanced Gastric Cancer: Where Are We at?

Neoadjuvant Chemoradiotherapy for Locally Advanced Gastric Cancer: Where Are We at?

Analysis of Safety of Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Gastric Cancer (Results of a Multicenter Randomized Trial)

Spleen-preserving D2 subtotal distal resection of the stomach and corpocaudal resection of the pancreas after neoadjuvant induction chemotherapy and chemoradiotherapy: case report and literature review

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