summary
GRADE
treatment
patients
risk of bias
overview
DCR deaths (OS) deaths (OS) (extension) DOR objective responses (ORR) objective responses (ORR) (extension) 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) TRAE leading to discontinuation (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) Asthenia TRAE (grade 3-4) Blood and lymphatic system disorders TRAE (grade 3-4) Blood creatinine increased TRAE (grade 3-4) Cardiac disorders 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) Diarrhoea TRAE (grade 3-4) Dry skin TRAE (grade 3-4) Dyspepsia TRAE (grade 3-4) Dyspnoea TRAE (grade 3-4) Eczema TRAE (grade 3-4) Endocrine disorders TRAE (grade 3-4) Epistaxis TRAE (grade 3-4) Erythema TRAE (grade 3-4) Eye disorders TRAE (grade 3-4) Fatigue TRAE (grade 3-4) Febrile neutropenia TRAE (grade 3-4) Gastritis TRAE (grade 3-4) Gastrointestinal disorders TRAE (grade 3-4) General disorders and administration site conditions TRAE (grade 3-4) Guillain-Barré syndrome TRAE (grade 3-4) Headache TRAE (grade 3-4) Hepatitis TRAE (grade 3-4) Hepatobiliary disorders TRAE (grade 3-4) Hypersensitivity TRAE (grade 3-4) Hypertension 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) Leucopenia TRAE (grade 3-4) Maculopapular rash TRAE (grade 3-4) Metabolism and nutrition disorders TRAE (grade 3-4) Mucosal inflammation TRAE (grade 3-4) Musculoskeletal and connective tissue disorders TRAE (grade 3-4) Myalgia TRAE (grade 3-4) Nausea TRAE (grade 3-4) Nervous system disorders TRAE (grade 3-4) Neutropenia TRAE (grade 3-4) Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4) Pancytopenia TRAE (grade 3-4) Paraesthesia TRAE (grade 3-4) Peripheral neuropathy TRAE (grade 3-4) Peripheral oedema TRAE (grade 3-4) Pneumonitis TRAE (grade 3-4) Pruritic rash TRAE (grade 3-4) Pruritus generalised TRAE (grade 3-4) Pruritus TRAE (grade 3-4) Pyrexia TRAE (grade 3-4) Rash TRAE (grade 3-4) Renal and urinary disorders TRAE (grade 3-4) Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) Sepsis TRAE (grade 3-4) Severe skin reaction TRAE (grade 3-4) Skin and subcutaneous tissue disorders TRAE (grade 3-4) Skin exfoliation TRAE (grade 3-4) Stevens-Johnson syndrome TRAE (grade 3-4) Stomatitis TRAE (grade 3-4) Thrombocytopenia TRAE (grade 3-4) Thyroiditis TRAE (grade 3-4) Urticaria TRAE (grade 3-4) Vascular disorders TRAE (grade 3-4) Vomiting TRAE (grade 3-4) Weight decreased TRAE (grade 3-4) Back pain AE (grade 3-4) Dizziness 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
EAGLE (D vs ICC), 2019 NCT02369874 RCT mHNSCC - L2 - all population durvalumab investigator’s choice: cetuximab, taxane, methotrexate, or fluoropyrimidine-based regimen patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).of the oral cavity, oropharynx, hypopharynx, or larynx not amenable to curative therapy who had progression or recurrence during or after only one systemic treatment regimen containing a platinum agent 240 / 249 some concern inconclusive inconclusive 12 % decrease in deaths (OS),deaths (OS) (PE) EAGLE (DT vs ICC), 2019 NCT02369874 RCT mHNSCC - L2 - all population durvalumab plus tremelimumab investigator’s choice: cetuximab, taxane, methotrexate, or fluoropyrimidine-based regimen patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).of the oral cavity, oropharynx, hypopharynx, or larynx not amenable to curative therapy who had progression or recurrence during or after only one systemic treatment regimen containing a platinum agent 247 / 249 some concern inconclusive inconclusive 4 % increase in deaths (OS),deaths (OS) (PE) CheckMate 141, 2016 NCT02105636 RCT mHNSCC - L2 - all population nivolumab ICC (methotrexate, docetaxel or cetuximab) patients with recurrent squamous-cell carcinoma of the head and neck whose disease had progressed within 6 months after platinum-based chemotherapy 240 / 121 some concern conclusif demonstrated 30 % decrease in deaths (OS) (PE) suggested 32 % decrease in deaths (OS) (extension) KEYNOTE-040 (all population), 2018 NCT02252042 RCT mHNSCC - L2 - all population pembrolizumab chemotherapy (methotrexate, docetaxel or cetuximab) patients with recurrent or metastatic head and neck squamous cell cancer that progressed during or after platinum-containing treatment : all population 247 / 248 some concern conclusif demonstrated 20 % decrease in deaths (OS) (PE)