Dataset Information

Immune checkpoint inhibitors plus chemotherapy for HER2-negative advanced gastric/gastroesophageal junction cancer: a cost-effectiveness analysis.

ABSTRACT:

Background

Nivolumab plus chemotherapy (NC) was recently approved as the first-line intervention for human epidermal growth factor receptor 2-negative advanced gastric/gastroesophageal junction cancer (GC/GEJC). Moreover, in the latest KEYNOTE-859 (NCT03675737), pembrolizumab plus chemotherapy (PC) was demonstrated to produce remarkable patient survival outcomes.

Objectives

The clinicians and patients need to assess NC and PC preference for cancer drugs.

Design

The cost-effective analysis.

Methods

In an economic assessment of the United States, United Kingdom, and Chinese healthcare systems using a Markov model simulated patients with GC/GEJC, two treatment decision branches with three health states and a tracked time horizon of 15 years were developed. The overall cost and efficacy outcomes of first-line strategies PC and NC were evaluated at willingness-to-pay (WTP) thresholds of different national, including life-years (LYs), quality-adjusted life-years (QALYs), incremental cost-effectiveness ratios (ICERs), and incremental net-health benefit (INHB). Sensitivity and subgroup analyses were considered.

Results

Given a WTP threshold of $150,000, $60,161, and $37,653 per QALY in the United States, United Kingdom, and China, respectively, both PC and NC achieved QALYs of 1.67 and 1.65 (2.51 and 2.48 LYs), 1.65 and 1.63 (2.48 and 2.45 LYs), and 1.60 and 1.58 (2.40 and 2.37 LYs), with total costs of $242,444 and $232,617, $148,367 and $127,737, and $16,693 and $24,016, respectively. Based on our sensitivity analysis, the programmed death-1 inhibitors cost produced the largest impact on the outcome. In addition, the cost-effectiveness probabilities of PC were 38.3%, 4.1%, and 100% in the three aforementioned countries, respectively.

Conclusion

In the case of the Chinese payers' perspective, PC appeared more dominant as first-line therapy for advanced GC/GEJC patients, whereas NC was preferred in the United States and United Kingdom.

SUBMITTER: Zhu Y

PROVIDER: S-EPMC10624011 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Publications

Immune checkpoint inhibitors plus chemotherapy for HER2-negative advanced gastric/gastroesophageal junction cancer: a cost-effectiveness analysis.

Zhu Youwen Y Liu Kun K Zhu Hong H Wu Haijun H

Therapeutic advances in gastroenterology 20231102

<h4>Background</h4>Nivolumab plus chemotherapy (NC) was recently approved as the first-line intervention for human epidermal growth factor receptor 2-negative advanced gastric/gastroesophageal junction cancer (GC/GEJC). Moreover, in the latest KEYNOTE-859 (NCT03675737), pembrolizumab plus chemotherapy (PC) was demonstrated to produce remarkable patient survival outcomes.<h4>Objectives</h4>The clinicians and patients need to assess NC and PC preference for cancer drugs.<h4>Design</h4>The cost-eff ...[more]

PMID: 37928895

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Project description:BackgroundThe Chinese Society of Clinical Oncology (CSCO) has recommended sintilimab plus chemotherapy (SINT + Chemo) as a standard first-line therapy for advanced gastric cancer or gastroesophageal junction cancer (GC/GEJC), based on the proven effectiveness and safety in the ORINT-16 trail. Its cost-effectiveness, however, remains to be evaluated.MethodsWe established a partitioned survival approach (PartSA) model with a 10-year time horizon to determine whether SINT + Chemo (vs. chemotherapy) was more cost-effective as a first-line treatment for unresectable advanced or metastatic GC/GEJC. Survival data was generated from the ORIENT-16 trail. Cost calculation was limited to direct medical costs. Database of Hunan Public Resources Trading Service Platform was used as the source for obtaining drug prices. Other cost and utility values were gathered from established literature. Incremental cost-effectiveness ratio (ICER) was the primary output. Additionally, we conducted sensitivity analysis, subgroup analysis, and scenario analysis.ResultsIn the base-case analysis, group SINT + Chemo showed an increase in utility value by 0.32 quality-adjusted life-years (QALYs) at an extra cost of $7988.43, resulting in an ICER of $25239.29/QALY, below the Chinese cost-effective willingness-to-pay (WTP) threshold of $38223.34. Upon further subgroup analysis according to patients' programmed death 1 ligand (PD-L1) combined positive score (CPS), the ICERs were $26341.01/QALY for patients highly expressing PD-L1 (CPS ≥5) and $17658.26/QALY for patients lowly expressing PD-L1 (CPS <5). Based on the sensitivity analysis, we found the PFS utility was the parameter that had the most significant impact on the model's outcomes. Moreover, in scenario analysis, the results remained consistent despite variations in the model's time frame.ConclusionIn China, SINT + Chemo is a more cost-effective option (vs. chemotherapy) as a first-line therapy for unresectable advanced or metastatic GC/GEJC, irrespective of PD-L1 expression levels.

Project description:BackgroundNivolumab combined with chemotherapy has been shown to improve prognosis in patients with untreated, human epidermal growth factor receptor 2 (HER2)-negative advanced gastric cancer (GC) and programmed death ligand-1 (PD-L1) combined positive score (CPS) ≥5. However, the available first-line treatment options for advanced GC are limited. Analysis of efficacy and safety of other programmed cell death protein 1 (PD-1) antibodies combined with chemotherapy may provide alternative treatment options.MethodsThis retrospective study included patients with untreated, HER2-negative, unresectable locally advanced, or metastatic GC or gastroesophageal junction (GEJ) cancer who received either camrelizumab combined with oxaliplatin plus S-1 (SOX)/capecitabine plus oxaliplatin (CapeOX) or SOX/CapOX alone between November 2020 and April 2022. The objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety were evaluated.ResultsThis study included 49 patients in camrelizumab plus chemotherapy group and 54 in chemotherapy group. The baseline clinical characteristics beyond Epstein-Barr virus (EBV) status and PD-L1 CPS had no difference between combination group and chemotherapy group. ORR and DCR were significantly higher in combination therapy group than in chemotherapy group (59.18% vs. 38.89%, P=0.048; 83.67% vs. 62.96%, P=0.018). The median PFS in combination group was significantly longer than chemotherapy group [10.03 vs. 6.24 months, hazard ratio (HR) 0.603, 95% confidence interval (CI): 0.368-0.989, P=0.045]. The OS was not mature at the time of the OS analysis, with 40% patients died. Subgroup analyses showed that PFS was longer in patients with PD-L1 CPS ≥1 compared with CPS <1 and in patients with a neutrophil-lymphocyte ratio (NLR) <2.38 compared with ≥2.38. The most common grade 3-4 treatment-related adverse events (TRAEs) were granulocytopenia (57% in combination group vs. 54% in chemotherapy group), anemia (39% vs. 33%, respectively), and thrombocytopenia (39% vs. 33%, respectively). The proportion of reactive cutaneous capillary endothelial proliferation (RCCEP, 73% vs. 0%) was higher in combination group relative to chemotherapy group; all were grades 1-2.ConclusionsAmong patients treated with camrelizumab combined with chemotherapy, the clinical outcomes were superior to those patients treated with chemotherapy. However, these promising findings need to be confirmed in future clinical trials.

Project description:ImportanceCombining immune checkpoint blockade (ICB) with chemotherapy improves outcomes in patients with metastatic gastric and gastroesophageal junction (G/GEJ) adenocarcinoma; however, whether this combination has activity in the perioperative setting remains unknown.ObjectiveTo evaluate the safety and preliminary activity of perioperative chemotherapy and ICB followed by maintenance ICB in resectable G/GEJ adenocarcinoma.Design, setting, and participantsThis investigator-initiated, multicenter, open-label, single-stage, phase 2 nonrandomized controlled trial screened 49 patients and enrolled 36 patients with resectable G/GEJ adenocarcinoma from February 10, 2017, to June 17, 2021, with a median (range) follow-up of 35.2 (17.4-73.0) months. Thirty-four patients were deemed evaluable for efficacy analysis, with 28 (82.4%) undergoing curative resection. This study was performed at 4 referral institutions in the US.InterventionsPatients received 3 cycles of capecitabine, 625 mg/m2, orally twice daily for 21 days; oxaliplatin, 130 mg/m2, intravenously and pembrolizumab, 200 mg, intravenously with optional epirubicin, 50 mg/m2, every 3 weeks before and after surgery with an additional cycle of pembrolizumab before surgery. Patients received 14 additional doses of maintenance pembrolizumab.Main outcomes and measuresThe primary end point was pathologic complete response (pCR) rate. Secondary end points included overall response rate, disease-free survival (DFS), overall survival (OS), and safety.ResultsA total of 34 patients (median [range] age, 65.5 [25-90] years; 23 [67.6%] male) were evaluable for efficacy. Of these patients, 28 (82.4%) underwent curative resection, 7 (20.6%; 95% CI, 10.1%-100%) achieved pCR, and 6 (17.6%) achieved a pathologic near-complete response. Of the 28 patients who underwent resection, 4 (14.3%) experienced disease recurrence. The median DFS and OS were not reached. The 2-year DFS was 67.8% (95% CI, 0.53%-0.87%) and the OS was 80.6% (95% CI, 0.68%-0.96%). Treatment-related grade 3 or higher adverse events for evaluable patients occurred in 20 patients (57.1%), and 12 (34.3%) experienced immune-related grade 3 or higher adverse events.Conclusion and relevanceIn this trial of unselected patients with resectable G/GEJ adenocarcinoma, capecitabine, oxaliplatin, and pembrolizumab resulted in a pCR rate of 20.6% and was well tolerated. This trial met its primary end point and supports the development of checkpoint inhibition in combination with perioperative chemotherapy in locally advanced G/GEJ adenocarcinoma.Trial registrationClinicalTrials.gov Identifier: NCT02918162.

Project description:Recently, the treatment plan of pembrolizumab plus chemotherapy was regarded as a promising treatment for patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJC). However, the efficacy and side effects of pembrolizumab plus chemotherapy still lack evidence-based medical evidence to support. Therefore, a meta-analysis was conducted to evaluate the hot issue. By searching PubMed, EMBASE, Cochrane Library, Web of Science, any randomized clinical studies of pembrolizumab plus chemotherapy versus chemotherapy in patients with advanced GC/GEJC met the inclusion criteria were included. The quality of the literature was evaluated and the data was extracted. A correlative software was also used to analyze the data and to draw a conclusion. After screening 14,015 studies, four studies were eligible for the meta-analysis. Compared with chemotherapy alone group, the overall survival (OS) rate was significantly longer. In programmed cell death ligand 1 (PD-L1) combined positive score (CPS) ≥1 subgroup and PD-L1 CPS ≥10 subgroup analyses, the results showed that the response rate (RR) and complete response rate (CR) were both higher in pembrolizumab plus chemotherapy group compared with chemotherapy alone group. There were not significant differences in the CR, the treatment-related adverse events, succumbed to drug-related events and succumbed to immune-mediated events between the two groups. However, the effect events such as the treatment-related adverse events led to discontinuation, the 3-5 treatment-related adverse events and the immune-mediated adverse events and infusion reactions were more common in pembrolizumab plus chemotherapy group. In conclusion, the current meta-analysis revealed that, in treating advanced GC/GEJC, pembrolizumab plus chemotherapy had improved therapeutic efficacies than chemotherapy alone, as evidenced by the significantly longer OS. Furthermore, the patients in PD-L1 CPS ≥1 subgroup and PD-L1 CPS ≥10 subgroup appeared to benefit from pembrolizumab plus chemotherapy treatment because of higher RR and CR. However, side effects such as the treatment-related adverse events leading to discontinuation, the 3-5 treatment-related adverse events, and immune-mediated adverse events and infusion reactions deserved more attention.

Dataset Information

Immune checkpoint inhibitors plus chemotherapy for HER2-negative advanced gastric/gastroesophageal junction cancer: a cost-effectiveness analysis.

Background

Objectives

Design

Methods

Results

Conclusion

Publications

Immune checkpoint inhibitors plus chemotherapy for HER2-negative advanced gastric/gastroesophageal junction cancer: a cost-effectiveness analysis.

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