summary
GRADE
treatment
patients
risk of bias
overview
deaths (OS) deaths (OS) (extension) DOR 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) SAE (any grade) STRAE (any grade) TRAE (any grade) TRAE (grade 3-4) TRAE leading to death (grade 5) TRAE leading to discontinuation (any grade) Abdominal pain TRAE (grade 3-4) Acute kidney injury TRAE (grade 3-4) Adrenal insufficiency TRAE (grade 3-4) Alopecia TRAE (grade 3-4) Anaemia TRAE (grade 3-4) Arthralgia TRAE (grade 3-4) Arthritis TRAE (grade 3-4) Asthenia TRAE (grade 3-4) Back pain (TRAE grade 3-4) Blood creatinine increased TRAE (grade 3-4) Chills TRAE (grade 3-4) Colitis TRAE (grade 3-4) Constipation TRAE (grade 3-4) Cough TRAE (grade 3-4) Decreased appetite TRAE (grade 3-4) Dermatitis acneiform TRAE (grade 3-4) Diabetes TRAE (grade 3-4) Diarrhoea TRAE (grade 3-4) Dizziness TRAE (grade 3-4) Dry skin TRAE (grade 3-4) Dysgeusia TRAE (grade 3-4) Dyspepsia TRAE (grade 3-4) Dyspnoea TRAE (grade 3-4) Epistaxis TRAE (grade 3-4) Fatigue TRAE (grade 3-4) Febrile neutropenia TRAE (grade 3-4) Headache TRAE (grade 3-4) Hepatitis TRAE (grade 3-4) Hypersensitivity 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 lacrimation (TRAE grade 3-4) Increased lipase level TRAE (grade 3-4) Infusion-related reactions TRAE (grade 3-4) Leucopenia TRAE (grade 3-4) Maculopapular rash TRAE (grade 3-4) Mucosal inflammation TRAE (grade 3-4) Myalgia TRAE (grade 3-4) Myositis 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) Paraesthesia TRAE (grade 3-4) Peripheral neuropathy TRAE (grade 3-4) Peripheral oedema TRAE (grade 3-4) Peripheral sensory neuropathy TRAE (grade 3-4) Pneumonia TRAE (grade 3-4) Pneumonitis TRAE (grade 3-4) Pruritic rash 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) Stomatitis TRAE (grade 3-4) Thrombocytopenia TRAE (grade 3-4) Thyroiditis TRAE (grade 3-4) Urticaria TRAE (grade 3-4) Vomiting TRAE (grade 3-4) Weight decreased TRAE (grade 3-4) hepatitis (Autoimmune) AE (grade 3-4) Rash AE (grade 3-4)
numeric
bar chart
forest plot
medians
frequency on treatment
benefit risk analysis
Study
study type
Pathology T1 T0 Patients sample sizes ROB
Results
OAK (PDL1 TC 1/2/3), 2016 NCT02008227 RCT mNSCLC - L2 - PDL1 positive atelozumab docetaxel patients with locally advanced or metastatic (IIIB and IV) non-small cell lung cancer (NSCLC) who have failed platinum therapy, only patients with PDL1 TC 1/2/3 347 / 337 some concern conclusif demonstrated 23 % decrease in deaths (OS) (PE) statistically significant 8.6-fold increase in DOR JAVELIN Lung 200 (PDL1 >1%), 2018 NCT02395172 RCT mNSCLC - L2 - PDL1 positive avelumab docetaxel patients with stage IIIB, IV, or recurrent NSCLC with disease progression after previous platinum doublet treatment PDL1 positive population 264 / 265 some concern suggested inconclusive 10 % decrease in deaths (OS),deaths (OS) (PE) KEYNOTE-010 (P:10 mg/kg), 2016 NCT01905657 RCT mNSCLC - L2 - PDL1 positive pembrolizumab 10 mg/kg docetaxel patients with previously treated (one line or more) non-small-cell lung cancer with PD-L1 expression on at least 1% of tumour cells 346 / 343 high conclusif demonstrated 39 % decrease in deaths (OS) (PE) suggested 21 % decrease in progression or deaths (PFS) (PE) KEYNOTE-010 (P:10 mg/kg ; PDL1>50%), 2016 NCT01905657 RCT mNSCLC - L2 - PDL1 positive pembrolizumab 10 mg/kg docetaxel patients with previously treated non-small-cell lung cancer with PD-L1 expression on at least 50% of tumour cells 151 / 152 high conclusif demonstrated 50 % decrease in deaths (OS) (PE) demonstrated 41 % decrease in progression or deaths (PFS) (PE) suggested 45 % decrease in deaths (OS) (extension) suggested 43 % decrease in PFS (extension) KEYNOTE-010 (P: 2mg/kg), 2016 NCT01905657 RCT mNSCLC - L2 - PDL1 positive pembrolizumab 2 mg/kg docetaxel patients with previously treated non-small-cell lung cancer with PD-L1 expression on at least 1% of tumour cells 344 / 343 high conclusif demonstrated 29 % decrease in deaths (OS) (PE) inconclusive 12 % decrease in progression or deaths (PFS) (PE) KEYNOTE-010 (P: 2mg/kg ; PDL1>50%), 2016 NCT01905657 RCT mNSCLC - L2 - PDL1 positive pembrolizumab 2 mg/kg docetaxel patients with previously treated non-small-cell lung cancer with PD-L1 expression on at least 50% of tumour cells 139 / 152 high conclusif demonstrated 46 % decrease in deaths (OS) (PE) demonstrated 41 % decrease in progression or deaths (PFS) (PE) ARCTIC (D ; study A ; PDL1>25% EXPLORATORY), 2020 NCT02352948 RCT mNSCLC - L2 - PDL1 positive durvalumab standard of care : erlotinib, gemcitabine or vinorelbine patients with PD-L1 positive locally advanced or metastatic non small cell lung cancer who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for stage IIIB/IV locally advanced or mNSCLC; 62 / 64 some concern suggested suggested 37 % decrease in deaths (OS)