Preoperative Capecitabine, Oxaliplatin, and Irinotecan in Resectable Gastric or Gastroesophageal Junction Cancer: Pathological Response as Primary Endpoint and FDG-PET Predictions

Berenato, Rosa; Morano, Federica; Pietrantonio, Filippo; Cotsoglou, Christian; Caporale, Marta; Infante, Gabriele; Pellegrinelli, Alessandro; Alessi, Alessandra; Battiston, Carlo; Coppa, Jorgelina; Padovano, Barbara; Mennitto, Alessia; Niger, Monica; Fucà, Giovanni; Lazzati, Silvia; Greco, G; Delconte, Gabriele; Braud, Filippo de; Mazzaferro, Vincenzo; Bartolomeo, Maria Di

doi:10.1159/000479154

Cited by 10 publications

(5 citation statements)

References 23 publications

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“…Other studies evaluating neoadjuvant chemotherapy for GC also demonstrated comparable gastrectomy and disease progression rates [ 20 , 21 ]. The MPR rate in neoadjuvant nivolumab monotherapy (16%) was also comparable with those (6%–32%) in patients with GC receiving neoadjuvant chemotherapy [ 4 , 20 – 22 ]. However, such comparisons should be interpreted with caution, given that patients enrolled in the current study had GC at relatively early clinical stages.…”

Section: Discussionmentioning

confidence: 78%

“…In the FLOT4 study, the representative neoadjuvant chemotherapy achieved a 94% gastrectomy rate; however, 2% of patients suffered from disease progression or died during the neoadjuvant chemotherapy [3]. Other studies evaluating neoadjuvant chemotherapy for GC also demonstrated comparable gastrectomy and disease progression rates [20,21]. The MPR rate in neoadjuvant nivolumab monotherapy (16%) was also comparable with those (6%-32%) in patients with GC receiving neoadjuvant chemotherapy [4,[20][21][22].…”

Section: Considering Relatively High Rate Of Disease Progressionmentioning

confidence: 89%

“…The R0 resection rate was favorable at 90%. Meanwhile, more than 80% of the patients treated with neoadjuvant chemotherapy for GC reported treatment-related AEs [3,20,21]; the neoadjuvant nivolumab monotherapy in this study had a lower incidence of treatment-related AEs at 23%, which was comparable with the neoadjuvant nivolumab monotherapy for lung cancer (23%) [14]. The incidences of treatment-related AEs of special interest ranged from 0 to 6%, which were favorable compared with those observed during nivolumab monotherapy in the salvage line for advanced GC [8], although a direct comparison may be inappropriate given that only two doses of nivolumab were administered in this study.…”

Section: Discussionmentioning

confidence: 99%

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A multicenter, open-label, single-arm phase I trial of neoadjuvant nivolumab monotherapy for resectable gastric cancer

et al. 2022

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Background Nivolumab monotherapy has demonstrated superior efficacy in advanced unresectable gastric cancer (GC), but its impact on resectable GC remains unknown. This phase I study aimed to evaluate safety, feasibility, and potential biomarkers of neoadjuvant nivolumab monotherapy in resectable GC. Methods Untreated, resectable, cT2 or more advanced gastric adenocarcinomas with clinical stage I, II, or III were treated with two doses of nivolumab before gastrectomy. Patients were excluded if their tumors may be applicable to neoadjuvant chemotherapy. The primary endpoint was the incidence of adverse event (AE) categories of special interest. Results All of the 31 enrolled patients completed 2 doses of nivolumab monotherapy. While 30 (97%) patients underwent surgery with curative intent, 1 patient discontinued before the planned surgical intervention because of a newly emerging liver metastasis. Seven patients (23%) had nivolumab treatment-related AEs, and one patient had a treatment-related AE of grade 3–4. The incidences of treatment-related AE categories of special interest ranged from 0 to 6%. Notable surgical complications included two cases of grade 3 anastomotic leakage and two cases of pancreatic fistula. The major pathologic response (MPR) assessed by the independent pathology review committee was achieved in five (16%) patients, of which one patient had a pathologic complete response. The MPR was mostly observed in patients with positive PD-L1 expression, high microsatellite instability, and/or high tumor mutation burden. Conclusions Neoadjuvant nivolumab monotherapy is feasible with an acceptable safety profile and induces a MPR in certain patients with resectable GC. (Registration: clinicaltrials.jp, JapicCTI-183895).

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Section: Discussionmentioning

confidence: 78%

Section: Considering Relatively High Rate Of Disease Progressionmentioning

confidence: 89%

Section: Discussionmentioning

confidence: 99%

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A multicenter, open-label, single-arm phase I trial of neoadjuvant nivolumab monotherapy for resectable gastric cancer

et al. 2022

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“…Irinotecan is a DNA topoisomerase I inhibitor, which can treat tumors by inhibiting the mitosis of tumor cells and is suitable for advanced cancer chemotherapy [6][7][8][9]. As previously noted, CEA positivity was associated with lymph node involvement; the decrease of CA72-4 after neoadjuvant chemotherapy could predict pathologic response; elevated CA19-9 levels appeared to be of disease control after neoadjuvant chemotherapy.…”

Section: Introductionmentioning

confidence: 73%

Efficacy of Trastuzumab + Cisplatin Combined with Irinotecan on the Quality of Life of Patients with Advanced Her-2 Positive Gastric Cancer

Yang

Yin

et al. 2022

Journal of Oncology

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Objective. To observe the effect of trastuzumab and cisplatin combined with irinotecan in the treatment of advanced Her-2 positive gastric cancer and its influence on disease control rate. Methods. From January 2018 to January 2021, 120 patients with advanced Her-2 positive gastric cancer admitted to our hospital were selected as the research subjects. According to the treatment plan of the patients, they were divided into a control group and a joint group, with 60 cases in each group; the control group was given trastuzumab + cisplatin, the joint group was treated with irinotecan on this basis, and the clinical effects and disease control rate of the two groups were observed. Results. After treatment, there were 4 patients with CR in the joint group and 0 patients with CR in the control group. The ORR and DCR of the joint group were significantly higher than those of the control group ( P < 0.05 ). The expression levels of CA199, CEA, and CA724 after treatment in the two groups were significantly reduced ( P < 0.05 ), and the reduction in the joint group after treatment was more evident as compared with the control group ( P < 0.05 ). The joint group witnessed better memory function, physical function, behavioral function, emotional function, and communication function than the control group ( P < 0.05 ), and the scores of all dimensions of the two groups of patients after treatment were superior to those before treatment ( P < 0.05 ). The occurrence of side effects was not statistically different between the two groups of patients ( P > 0.05 ). The 1-year survival rate of the control group was 41.67%, the PFS was 6.33 ± 1.02 months, and the OS was 15.51 ± 2.16 months; the 1-year survival rate of the joint group was 43.33%, and the PFS was 8.05 ± 1.07 months, and OS was 16.03 ± 2.44 months; there was no significant difference in the 1-year survival rate between the two groups ( P > 0.05 ), the difference in PFS between the groups was significant (t = 9.013, P < 0.001 ), and the difference in OS between the groups was not significant (t = 1.236, P = 0.219 ). Conclusion. Trastuzumab + cisplatin combined with irinotecan yields a promising result in the treatment of advanced gastric cancer. It can effectively regulate the expression level of tumor markers, delay disease progression, and improve the quality of life of patients. Moreover, irinotecan will not bring more toxic side effects.

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“…The use of PET CT in gastric cancer in assessing the response to preoperative therapies is under investigation. A study from Italy published in 2017 showed that in patients with resectable T3-T4 and/or N+, M0 gastric or EGJ adenocarcinoma undergoing perioperative chemotherapy with irinotecan-oxaliplatin-capecitabine, pathologic response correlated with the baseline SUV level of the primary tumor and not with the SUV change following treatment [41]. In another study from Germany published in 2010, the authors did not identify a statistically significant association between pre-and post-treatment SUV levels and histologic response or prognosis in patients with LAGC undergoing neoadjuvant treatment with cisplatin-leucovorin-5FU (PLF) [42].…”

Section: Radiographic and Endoscopic Response To Chemotherapy And Pro...mentioning

confidence: 99%

Interpretation of Tumor Response Grade following Preoperative Therapy for Gastric Cancer: An Overview

Tsagkalidis

Blaszczyk

2023

Cancers

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Gastric cancer is among the top five causes of cancer-related death worldwide. Preoperative chemotherapy has been established as an option in patients with locally advanced gastric cancer. However, chemotherapy yields variable results, owing to the cellular and molecular heterogeneity of this disease. Identifying patients who did or did not respond to preoperative therapy can allow clinicians to alter treatment modalities and provide important information related to prognostication. A pathologic response to preoperative therapies, called the Tumor Response Grade (TRG), has been evaluated to quantify treatment response. Multiple systems for TRG have been established. However, the literature has demonstrated inconsistent results for TRG systems and prognosis, possibly due to variability in interpretation of tumor response between systems and interobserver variability. Radiographic responses to preoperative therapies using RECIST 1.1 criteria and endoscopically assessed tumor response have demonstrated association with survival; however, their use in gastric cancer remains challenging given the inability to accurately and consistently identify and measure the tumor, especially in the setting of neoadjuvant therapy, where treatment-related changes can obscure the gastric wall layers. While the response to preoperative therapies with positron emission tomography (PET) has shown promising results in esophageal and esophagogastric junction (EGJ) malignancies, its role in gastric cancer is still under investigation. This review is focused on summarizing the available literature related to evaluating TRG in gastric cancer, as well as providing a brief overview of the use of radiographic and endoscopic methods to assess response to preoperative therapies. Lastly, we outline future directions regarding the use of a universal TRG system to guide care and assist with prognosis.

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Preoperative Capecitabine, Oxaliplatin, and Irinotecan in Resectable Gastric or Gastroesophageal Junction Cancer: Pathological Response as Primary Endpoint and FDG-PET Predictions

Cited by 10 publications

References 23 publications

A multicenter, open-label, single-arm phase I trial of neoadjuvant nivolumab monotherapy for resectable gastric cancer

A multicenter, open-label, single-arm phase I trial of neoadjuvant nivolumab monotherapy for resectable gastric cancer

Efficacy of Trastuzumab + Cisplatin Combined with Irinotecan on the Quality of Life of Patients with Advanced Her-2 Positive Gastric Cancer

Interpretation of Tumor Response Grade following Preoperative Therapy for Gastric Cancer: An Overview

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