summary
GRADE
treatment
patients
risk of bias
overview
DCR deaths (OS) deaths (OS) (extension) DOR irORR irPFS objective responses (ORR) PFS (extension) progression or deaths (PFS) AE (any grade) AE (grade 3-4) AE leading to death (grade 5) AE leading to treatment discontinuation (any grade) AE leading to treatment discontinuation (grade 3-4) SAE (any grade) SAE (grade 3-4) STRAE (any grade) STRAE (grade 3-4) TRAE (any grade) TRAE (grade 3-4) TRAE leading to death (grade 5) TRAE leading to discontinuation (any grade) TRAE leading to discontinuation (grade 3-4) Alopecia TRAE (grade 3-4) Anaemia TRAE (grade 3-4) Asthenia TRAE (grade 3-4) Colitis TRAE (grade 3-4) Decreased appetite TRAE (grade 3-4) Diabetes TRAE (grade 3-4) Diarrhoea TRAE (grade 3-4) Endocrine disorders TRAE (grade 3-4) Fatigue TRAE (grade 3-4) Febrile neutropenia TRAE (grade 3-4) Hepatitis TRAE (grade 3-4) Hyperthyroidism TRAE (grade 3-4) Hypophysitis TRAE (grade 3-4) Hypothyroidism TRAE (grade 3-4) Increase AST TRAE (grade 3-4) Increased ALT TRAE (grade 3-4) Increased lipase level TRAE (grade 3-4) Infusion-related reactions TRAE (grade 3-4) Maculopapular rash TRAE (grade 3-4) Myalgia TRAE (grade 3-4) Nausea TRAE (grade 3-4) Neutropenia TRAE (grade 3-4) Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4) Pancreatitis TRAE (grade 3-4) Peripheral neuropathy TRAE (grade 3-4) Pneumonitis TRAE (grade 3-4) Pruritus TRAE (grade 3-4) Pyrexia TRAE (grade 3-4) Rash TRAE (grade 3-4) Severe skin reaction TRAE (grade 3-4) Thyroiditis TRAE (grade 3-4) Vomiting TRAE (grade 3-4) Weight decreased TRAE (grade 3-4) Abdominal pain AE (grade 3-4) Anaemia AE (grade 3-4) Asthenia AE (grade 3-4) Back pain AE (grade 3-4) Constipation AE (grade 3-4) Decreased appetite AE (grade 3-4) Diarrhoea AE (grade 3-4) Dyspepsia AE (grade 3-4) Dyspnoea AE (grade 3-4) Fatigue AE (grade 3-4) Increase AST AE (grade 3-4) Increased ALT AE (grade 3-4) Nausea AE (grade 3-4) Peripheral oedema AE (grade 3-4) Pruritus AE (grade 3-4) Pyrexia AE (grade 3-4) Rash AE (grade 3-4) Vomiting AE (grade 3-4) Weight decreased AE (grade 3-4)
endpoints
numeric
bar chart
forest plot
medians
frequency on treatment
benefit risk analysis
Study
study type
Pathology T1 T0 Patients sample sizes ROB
Results
JAVELIN Gastric 300, 2018 NCT02625623 RCT mGC or mGEJC - L2 - all population avelumab physician's choice of chemotherapy (paclitaxel or irinotecan) patients with unresectable, recurrent, locally advanced, or metastatic gastric cancer/gastro-oesophageal junction cancer with disease progression after second-line treatment 185 / 186 some concern inconclusive inconclusive 10 % increase in deaths (OS) (PE) statistically significant 73 % increase in progression or deaths (PFS) statistically significant 63 % decrease in DCR KEYNOTE-061 (all population), 2018 NCT02370498 RCT mGC or mGEJC - L2 - all population pembrolizumab paclitaxel patients with advanced gastric or gastro-oesophageal junction cancer that progressed on first-line chemotherapy with a platinum and fluoropyrimidine 296 / 296 some concern inconclusive statistically significant 49 % increase in progression or deaths (PFS) ATTRACTION-2 (Kang), 2017 NCT02267343 RCT mGC or mGEJC - L2 - all population nivolumab placebo patients with advanced gastric or gastro-oesophageal junction cancer who had been previously been treated with two or more chemotherapy regimens 330 / 163 low inconclusive suggested 37 % decrease in deaths (OS) (PE) suggested 38 % decrease in deaths (OS) (extension) suggested 40 % decrease in PFS (extension) suggested 40 % decrease in progression or deaths (PFS) CA184-162, 2017 NCT01585987 RCT mGC or mGEJC - L2 - all population ipilimumab SoC (maintenance) patients with unresectable locally advanced/ metastatic gastric or gastroesophageal junction (GEJ) cancer who achieved at least stable disease (SD) following first-line treatment with combination platinum-fluoropyrimidine chemotherapy 57 / 57 some concern inconclusive statistically significant 59 % increase in progression or deaths (PFS) statistically significant 44 % increase in irPFS (PE) KEYNOTE-061 (PDL1 CPS>1), 2018 NCT02370498 RCT mGC or mGEJC - L2 - PDL1 positive pembrolizumab paclitaxel patients with advanced gastric or gastro-oesophageal junction cancer that progressed on first-line chemotherapy with a platinum and fluoropyrimidine (PDL1 CPS>1 population) 196 / 199 some concern inconclusive inconclusive 18 % decrease in deaths (OS) (PE) statistically significant 27 % increase in progression or deaths (PFS) (PE)