ArticleCancer management and research2021
Efficacy Analysis of Adjuvant Chemotherapy with Gemcitabine Plus Platinum or S-1 in Biliary Tract Carcinoma: A Multi-Center Retrospective Study.
Article in Cancer management and research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05430698 (PD-1 Antibody Plus Gemcitabine and Oxaliplatin), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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.
PD-1 Antibody Plus Gemcitabine and Oxaliplatin (GEMOX) as Postoperative Adjuvant Therapy in Perihilar Cholangiocarcinoma Patients With Positively Metastatic Lymph Nodes : a Single Arm, Phase II Trial
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14 authors at 3 institutions in 1 country.
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No grant is acknowledged in the PubMed record.
Abstract
purposeBiliary tract cancers (BTCs) have a poor overall prognosis, as patients who underwent curative surgery frequently experience disease recurrence. At present, there is a paucity of well-documented adjuvant chemotherapy regimen. This study aimed to assess whether gemcitabine plus platinum or S-1 adjuvant chemotherapy have different impact on relapse-free survival (RFS). PATIENTS AND
methodsWe selected patients undergoing radical biliary tract cancer surgery, pathologically confirmed adenocarcinoma and received gemcitabine plus platinum (cisplatin or oxaliplatin) or S-1 adjuvant chemotherapy from September 2013 to May 2020. The primary study endpoint was RFS. The secondary endpoint was safety.
resultsOverall 136 patients were enrolled. The median follow-up was 32.3 months and the median RFS was 17.0 months (95% CI 8.9-25.1). The median RFS was 14.1 months (95% CI 6.7-21.5) in gemcitabine plus platinum group and 33.0 months (95% CI 9.3-56.7) in gemcitabine plus S-1 (GS) group, a non-significant difference both in univariate (P=0.092) and in multivariate analysis (P=0.058). Lymph node status (N- vs N+: HR=0.477, 95% CI 0.285-0.799; P=0.005) and chemotherapy cycles (<6 vs 6-8: HR=1.828, 95% CI 1.117-2.993; P=0.016) were independent impact factors for RFS. GS group had lower incidence of adverse reactions.
conclusionCompared with gemcitabine plus platinum, GS regimen has a tendency to obtain longer RFS (although there is no statistically significant difference) and less toxic. GS regimen has the potential to be investigated as a standard regimen for adjuvant chemotherapy.
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