Intraperitoneal Chemotherapy for Gastric Cancer With Peritoneal Carcinomatosis: Study Protocol of a Phase Ii Trial

Ramos, Marcus Fernando Kodama Pertille; Pereira, Marina Alessandra; Charruf, Amir Zeide; Victor, Carolina Ribeiro; Gregório, João Vitor Antunes; Alban, Luciana Bastos Valente; Moniz, Camila Motta Venchiarutti; Zilberstein, Bruno; Mello, Evandro Sobroza de; Hoff, Paulo M.; Ribeiro, Ulysses; Dias, André Roncon

doi:10.1590/0102-672020230026e1744

Cited by 3 publications

(4 citation statements)

References 38 publications

(112 reference statements)

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“…For patients with PM from GC, a peritoneal cancer index (PCI) of a maximum of 10 to 12 has been suggested [ 4 , 5 ]. In our ongoing phase II clinical trial, a PCI of 12 was adopted as an inclusion criterion for the indication of peritoneal CMT followed by gastrectomy in patients with GC [ 14 ]. Unfortunately, in this retrospective study, we did not have a PCI available for all patients, so we were not able to verify whether the burden of peritoneal disease influenced early mortality and survival.…”

Section: Discussionmentioning

confidence: 99%

“…Finally, the treatment of PM from GC continues to evolve, and understanding the factors that lead to worse outcomes in these patients is still required to guide the selection of the most appropriate treatment in an attempt to better control the disease. Since there is continuous progress in the field of CMT in stage IV GC, we intend to test the performance of our risk score in our patients included in an ongoing clinical trial with intraperitoneal CMT for GC (NCT05541146) [ 14 ]. In any case, the exact value and purpose of any scoring system need to be defined.…”

Section: Discussionmentioning

confidence: 99%

“…Recently, in light of the need for additional therapies in the setting of peritoneal dissemination, the evolution and refinement of treatment options—such as cytoreductive surgery (CRS), hyperthermic intraperitoneal chemotherapy (HIPEC), pressurized intraperitoneal aerosol chemotherapy (PIPAC), and normothermic intraperitoneal chemotherapy—has generated new interest in the treatment of gastric PM [ 4 , 9 , 11 , 12 ]. Conversion therapy emerged as an alternative treatment for these patients, which included the administration of systemic CMT with intraperitoneal CMT followed by surgery [ 13 , 14 ]. This option has achieved promising results for these patients, with complete resection of the tumor and associated lesions (R0) [ 15 , 16 , 17 ].…”

Section: Introductionmentioning

confidence: 99%

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Risk Scoring System to Predict Mortality in Gastric Cancer with Peritoneal Carcinomatosis

Pereira,

Ramos,

Charruf

et al. 2024

Medical Sciences

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Gastric cancer (GC) with peritoneal carcinomatosis (PC) has a particularly unfavorable prognosis. This limited survival raises doubts about which factors confer an extremely worse outcome and which patients could benefit from more aggressive treatments, in an attempt to improve survival and better control the disease. This study aimed to evaluate the survival outcomes of patients with PC due to GC and develop a prognostic score to predict 6-month mortality. We performed an analysis of clinical stage IV GC with PC. Scores were assigned to risk factors and calculated for each patient from nine variables. Among 326 IVB GC, 211 (64.7%) had PC and were included. After calculating the score, 136 (64.5%) GCs were classified as a low-risk group and 75 (35.5%) as a high-risk group. Median OS was 7.9 and 1.9 months for low- and high-risk patients (p < 0.001). In the high-risk group, 77.3% of the patients died in <6 mo (p < 0.001). Palliative surgery and chemotherapy were associated with better survival, and the prognostic groups maintained statistical significance even when the same type of treatment was performed. In conclusion, the scoring system developed with variables related to patient performance status and clinical data was able to distinguish GC with PC with a high risk of 6-month mortality. Accordingly, verifying and validating our findings in a large cohort of patients is necessary to confirm and guarantee the external validation of the results.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Risk Scoring System to Predict Mortality in Gastric Cancer with Peritoneal Carcinomatosis

Pereira,

Ramos,

Charruf

et al. 2024

Medical Sciences

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“…Similar to the STOPGAP I study, Dias et al have recently started a single center, single-arm phase II trial in Brazil evaluating the safety, tolerability, and peritoneal response rate of systemic chemotherapy with the addition of IP PTX (40 mg/m 2 ) on days 1 and 8 (NCT05541146) [ 53 , 54 ]. This study aims to enroll 30 GC patients with cyt + or PC (PCI ≤ 12).…”

Section: Normothermic Intraperitoneal Chemotherapy (Nipec)mentioning

confidence: 99%

Regional Therapy Approaches for Gastric Cancer with Limited Peritoneal Disease

Li,

Sedighim,

Tajik

et al. 2024

J Gastrointest Canc

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Purpose Despite advances in systemic therapy, outcomes of patients with gastric cancer (GC) peritoneal carcinomatosis (PC) remain poor, in part because of poor penetrance of systemic therapy into peritoneal metastasis due to the plasma-peritoneal barrier and anarchic intra-tumoral circulation. Hence, regional treatment approach with administration of chemotherapy directly into the peritoneal cavity (intraperitoneal, IP) under various conditions, combined with or without cytoreductive surgery (CRS) has remained an area of significant research interest. The purpose of this review is to provide high-level evidence for regional treatment approaches in the management of GCPC with limited peritoneal disease. Methods A review of the current literature and ongoing clinical trials for regional IP therapies for GCPC was performed. Studies included in this review comprise of phase III randomized controlled trials, non-randomized phase II studies, high-impact retrospective studies, and active ongoing clinical trials for each available IP modality. Results The three common IP approaches are heated intraperitoneal chemotherapy (HIPEC), normothermic intraperitoneal chemotherapy (NIPEC) and more recently introduced, pressurized intraperitoneal aerosolized chemotherapy (PIPAC). These IP approaches have been combined with systemic therapy and/or CRS with varying degrees of promising results, demonstrating evidence of improvements in survival rates and peritoneal disease control. Patient selection, optimization of systemic therapy, and completeness of cytoreduction have emerged as major factors influencing the design of contemporary and ongoing trials. Conclusion IP chemotherapy has a clear role in the management of patients with GCPC, and when combined with CRS in appropriately selected patients has the potential to significantly improve survival. Ongoing and upcoming IP therapy clinical trials hold great promise to shape the treatment paradigm for GCPC.

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Serum basic fibroblast growth factor and interleukin-1β predict the effect of first-line chemotherapy in patients with advanced gastric cancer

Zheng,

Gan,

Yao

et al. 2023

World J Clin Cases

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Fasting during the month of Ramadan is one of the five fundamental principles of Islam, and it is obligatory for healthy Muslim adults and adolescents. During the fasting month, Muslims usually have two meals a day, suhur (before dawn) and iftar (after dusk). However, diabetic patients may face difficulties when fasting, so it is important for medical staff to educate them on safe fasting practices. Prolonged strict fasting can increase the risk of hypoglycemia and diabetic ketoacidosis, but with proper knowledge, careful planning, and medication adjustment, diabetic Muslim patients can fast during Ramadan. For this review, a literature search was conducted using PubMed and Google Scholar until May 2023. Articles other than the English language were excluded. Current strategies for managing blood sugar levels during Ramadan include a combination of patient education on nutrition, regular monitoring of blood glucose, medications, and insulin therapy. Insulin therapy can be continued during fasting if properly titrated to the patients’ needs, and finger prick blood sugar levels should be assessed regularly. If certain symptoms such as hypoglycemia, hyperglycemia, dehydration, or acute illness occur, or blood glucose levels become too high (> 300 mg/dL) or too low (70 mg/dL), the fast should be broken. New insulin formulations such as pegylated insulin and medications like tirzepatide, a dual agonist of gastric-inhibitory peptideand glucagonlike-peptide 1 receptors, have shown promise in managing blood sugar levels during Ramadan. Non-insulin-dependent medications like sodium-glucose-cotransporter-2 inhibitors, including the Food and Drug Administration-approved ertugliflozin, are also being used to provide additional cardiovascular benefits in patients with type 2 diabetes.

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Intraperitoneal Chemotherapy for Gastric Cancer With Peritoneal Carcinomatosis: Study Protocol of a Phase Ii Trial

Cited by 3 publications

References 38 publications

Risk Scoring System to Predict Mortality in Gastric Cancer with Peritoneal Carcinomatosis

Risk Scoring System to Predict Mortality in Gastric Cancer with Peritoneal Carcinomatosis

Regional Therapy Approaches for Gastric Cancer with Limited Peritoneal Disease

Serum basic fibroblast growth factor and interleukin-1β predict the effect of first-line chemotherapy in patients with advanced gastric cancer

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