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P-104 Risk of nausea and vomiting in a real-world data cohort of chemotherapy-treated patients with metastatic gastric or gastroesophageal junction adenocarcinoma by medical history of gastrectomy

2021; Elsevier BV; Volume: 32; Linguagem: Inglês

10.1016/j.annonc.2021.05.159

1569-8041

Stefan de Vogel, James Van Schyndle, David Nimke, Mohamed A. Khalil, Ahsan M. Arozullah, N. Robinson,

Helicobacter pylori-related gastroenterology studies

Gastric cancer is the fifth most common cancer worldwide, representing ∼6% of new cancer cases. Zolbetuximab, an IgG1 monoclonal antibody, is being evaluated with chemotherapy for the treatment of advanced gastric or gastroesophageal junction (G/GEJ) cancer. Nausea and vomiting are commonly reported in these populations, and many of the patients underwent gastrectomy as prior treatment. The study aim was to assess the association between history of gastrectomy (total vs partial vs none) and risk of nausea and vomiting during first-line chemotherapy in a population with metastatic G/GEJ cancer in a real-world setting. A patient cohort was built from an administrative insurance claims database (IQVIA PharMetrics Plus [US]). Patients included had ≥1 claim of G/GEJ cancer and ≥1 claim indicative of metastasis between 2007 and 2017. Patients (with/without gastrectomy) were matched for chemotherapy regimen, sex, prior diagnosis of gastric ulcer, days from cancer diagnosis to chemotherapy initiation, and propensity for gastrectomy, conditional on baseline covariates. Time at risk was defined as date of first-line treatment initiation through date of end of enrollment, switch to second-line treatment, or end of therapy. Univariate and multivariate Cox proportional hazard models were used to examine time to first nausea and vomiting claim. Andersen-Gill intensity modeling was used to examine the risk of >1 event of nausea and vomiting in each patient. Sensitivity analyses were conducted to examine patient differences by type of gastrectomy (total vs partial) and treatment regimen. At baseline, 2,233 patients met inclusion/exclusion criteria; 661 had history of gastrectomy; 76.6% were male and 48.7% were ≥60 years. Patients with/without history of gastrectomy were matched (n=566 each). Common chemotherapy regimens were fluorouracil–leucovorin calcium–oxaliplatin (25.3%), fluorouracil–leucovorin calcium (17.5%), fluorouracil (13.3%), capecitabine (13.1%), capecitabine-epirubicin-oxaliplatin (7.2%), and fluorouracil-oxaliplatin (3.5%). During first-line therapy, 42.9% and 40.1% of patients with versus without gastrectomy had nausea/vomiting claims. No difference was observed in hazard ratios (HRs) for time to first event with versus without gastrectomy from the matched univariate model (HR: 1.04; 95% CI: 0.86-1.27) or matched multivariate model (HR: 0.96; 95% CI: 0.78-1.18). Additionally, no difference was observed in HRs for time to each event with versus without gastrectomy from the matched univariate (HR: 1.11; 95% CI: 0.85-1.44) or matched multivariate models (HR: 1.04; 95% CI: 0.80-1.36). Sensitivity analyses showed no differences in HRs for time to first event with total versus no gastrectomy or partial versus no gastrectomy in the matched univariate models (HR: 1.19; 95% CI: 0.93-1.52 and HR: 0.82; 95% CI: 0.59-1.15) or matched multivariate models (HR: 1.11; 95% CI: 0.85-1.46 and HR: 0.77; 95% CI: 0.54-1.12). Across chemotherapy regimens, no differences were observed in HRs for time to each event with versus without gastrectomy, except for fluorouracil alone (HR: 2.24; 95% CI: 1.09-4.58), although CIs tended to be large. These results suggest prior gastrectomy is not associated with a different risk of nausea and vomiting in patients with metastatic G/GEJ cancer treated with first-line chemotherapy. This study, which utilized real-world data, expands the understanding of gastrectomy as a risk factor for nausea and vomiting in this study population.