ArticleTherapeutic advances in medical oncology2024
A non-inferiority, phase III trial of gemcitabine plus capecitabine
Article in Therapeutic advances in medical oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02207335 (A Multicenter Randomized Phase Ⅲ Clinical Trial of Gemcitabine in Combination With Capecitabine Versus Gemcitabine Plus Carboplatin as First-line Treatment in Triple-negative Recurrent or Metastatic Breast Cancer), which is not on this map. Cited by 2 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicenter Randomized Phase Ⅲ Clinical Trial of Gemcitabine in Combination With Capecitabine Versus Gemcitabine Plus Carboplatin as First-line Treatment in Triple-negative Recurrent or Metastatic Breast Cancer
Who cites it
2 citing papers in PubMed.
- Tumor-infiltrating lymphocyte therapy in triple-negative breast cancer: from mechanistic exploration to clinical translation.Frontiers in immunology · 2026Review
- Clinical Significance of Tumor-Infiltrating Lymphocytes in Malignant Peritoneal Mesothelioma: A Single-Center Study of 143 Cases.Annals of surgical oncology · 2025Article
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Authors and funding
10 authors.
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No grant is acknowledged in the PubMed record.
Abstract
Background: Gemcitabine plus capecitabine (GX) shows survival benefit and manageable safety in patients with advanced triple-negative breast cancer (TNBC) but there is a paucity of phase III trial evidence. We aimed to compare the efficacy and safety of GX with gemcitabine plus carboplatin (GC) as first-line treatment for patients with advanced TNBC and validate the prognostic value of tumor-infiltrating lymphocytes (TILs). Methods: Patients with advanced TNBC were randomly assigned 1:1 to receive gemcitabine (1000 mg/m Results: In all, 187 patients were randomly assigned, with 93 in GX and 94 in GC. Median PFS was 6.1 months in the GX arm compared with 6.3 months in the GC arm. The hazard ratio for PFS was 1.148, and a 95% CI was 0.856-1.539, exceeding the non-inferiority margin of 1.2. The median overall survival (OS) was 21.0 months in the GX arm compared with 21.5 months in the GC arm. The safety profile for the GX regimen was superior to the GC regimen, especially regarding hematological toxicity. Patients with high CD8 Conclusion: The trial did not meet the prespecified criteria for the primary endpoint of PFS in patients with advanced TNBC. Moreover, the GC regimen showed better efficacy compared with the GX regimen in patients with high CD8 Trial registration: ClinicalTrials.gov identifier: NCT02207335.
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