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Second-line therapy in advanced upper gastrointestinal cancers: current status and new prospects.

ABSTRACT: The prognosis of patients with advanced upper gastrointestinal cancers (UGC) remains poor. Current available systemic armamentarium is limited, and little progress has been made over the last decades. Main achievements have been obtained in first-line setting, however an increasingly proportion of patients are considered for second-line therapy, although data from randomized trials are scarce or even lacking. In this comprehensive review we examine the literature to summarize the efficacy and limitations of second-line systemic options in patients with advanced UGC, with a glimpse into the innovations.

SUBMITTER: Saletti P

PROVIDER: S-EPMC5934153 | biostudies-other | 2018 Apr

REPOSITORIES: biostudies-other

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Second-line therapy in advanced upper gastrointestinal cancers: current status and new prospects.

Saletti Piercarlo P Zaniboni Alberto A

Journal of gastrointestinal oncology 20180401 2

The prognosis of patients with advanced upper gastrointestinal cancers (UGC) remains poor. Current available systemic armamentarium is limited, and little progress has been made over the last decades. Main achievements have been obtained in first-line setting, however an increasingly proportion of patients are considered for second-line therapy, although data from randomized trials are scarce or even lacking. In this comprehensive review we examine the literature to summarize the efficacy and li ...[more]

PMID: 29755778

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Project description:BackgroundPatients with advanced urothelial carcinoma that progresses after platinum-based chemotherapy have a poor prognosis and limited treatment options.MethodsIn this open-label, international, phase 3 trial, we randomly assigned 542 patients with advanced urothelial cancer that recurred or progressed after platinum-based chemotherapy to receive pembrolizumab (a highly selective, humanized monoclonal IgG4κ isotype antibody against programmed death 1 [PD-1]) at a dose of 200 mg every 3 weeks or the investigator's choice of chemotherapy with paclitaxel, docetaxel, or vinflunine. The coprimary end points were overall survival and progression-free survival, which were assessed among all patients and among patients who had a tumor PD-1 ligand (PD-L1) combined positive score (the percentage of PD-L1-expressing tumor and infiltrating immune cells relative to the total number of tumor cells) of 10% or more.ResultsThe median overall survival in the total population was 10.3 months (95% confidence interval [CI], 8.0 to 11.8) in the pembrolizumab group, as compared with 7.4 months (95% CI, 6.1 to 8.3) in the chemotherapy group (hazard ratio for death, 0.73; 95% CI, 0.59 to 0.91; P=0.002). The median overall survival among patients who had a tumor PD-L1 combined positive score of 10% or more was 8.0 months (95% CI, 5.0 to 12.3) in the pembrolizumab group, as compared with 5.2 months (95% CI, 4.0 to 7.4) in the chemotherapy group (hazard ratio, 0.57; 95% CI, 0.37 to 0.88; P=0.005). There was no significant between-group difference in the duration of progression-free survival in the total population (hazard ratio for death or disease progression, 0.98; 95% CI, 0.81 to 1.19; P=0.42) or among patients who had a tumor PD-L1 combined positive score of 10% or more (hazard ratio, 0.89; 95% CI, 0.61 to 1.28; P=0.24). Fewer treatment-related adverse events of any grade were reported in the pembrolizumab group than in the chemotherapy group (60.9% vs. 90.2%); there were also fewer events of grade 3, 4, or 5 severity reported in the pembrolizumab group than in the chemotherapy group (15.0% vs. 49.4%).ConclusionsPembrolizumab was associated with significantly longer overall survival (by approximately 3 months) and with a lower rate of treatment-related adverse events than chemotherapy as second-line therapy for platinum-refractory advanced urothelial carcinoma. (Funded by Merck; KEYNOTE-045 ClinicalTrials.gov number, NCT02256436 .).

Dataset Information

Second-line therapy in advanced upper gastrointestinal cancers: current status and new prospects.

Publications

Second-line therapy in advanced upper gastrointestinal cancers: current status and new prospects.

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