summary
GRADE
treatment
patients
risk of bias
overview
deaths (OS) deaths (OS) (extension) events or deaths (EFS) iDFS pCR 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) Adrenal insufficiency TRAE (grade 3-4) Alopecia TRAE (grade 3-4) Anaemia TRAE (grade 3-4) Asthenia TRAE (grade 3-4) Colitis TRAE (grade 3-4) Constipation TRAE (grade 3-4) Decreased appetite TRAE (grade 3-4) Diabetes TRAE (grade 3-4) Diarrhoea TRAE (grade 3-4) Dysgeusia TRAE (grade 3-4) Fatigue TRAE (grade 3-4) Febrile neutropenia TRAE (grade 3-4) Guillain-Barré syndrome 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) Infusion-related reactions TRAE (grade 3-4) Leucopenia TRAE (grade 3-4) Myocarditis TRAE (grade 3-4) Myositis TRAE (grade 3-4) Nausea TRAE (grade 3-4) Nephritis TRAE (grade 3-4) Neutropenia TRAE (grade 3-4) Pancreatitis TRAE (grade 3-4) Peripheral neuropathy TRAE (grade 3-4) Peripheral sensory neuropathy TRAE (grade 3-4) Pneumonitis TRAE (grade 3-4) Pyrexia TRAE (grade 3-4) Rash TRAE (grade 3-4) Sarcoidosis TRAE (grade 3-4) Severe skin reaction TRAE (grade 3-4) Stomatitis TRAE (grade 3-4) Thyroiditis TRAE (grade 3-4) Uveitis TRAE (grade 3-4) Vomiting TRAE (grade 3-4) hepatitis (Autoimmune) AE (grade 3-4) Abdominal pain AE (grade 3-4) Alopecia AE (grade 3-4) Anaemia AE (grade 3-4) Arthralgia AE (grade 3-4) Asthenia AE (grade 3-4) Back pain AE (grade 3-4) Blood creatinine increased AE (grade 3-4) Constipation AE (grade 3-4) Cough AE (grade 3-4) Decreased appetite AE (grade 3-4) Diarrhoea AE (grade 3-4) Dry skin AE (grade 3-4) Dysgeusia AE (grade 3-4) Dyspepsia AE (grade 3-4) Dyspnoea AE (grade 3-4) Epistaxis AE (grade 3-4) Fatigue AE (grade 3-4) Febrile neutropenia AE (grade 3-4) Headache AE (grade 3-4) Hypertension AE (grade 3-4) Hyperthyroidism AE (grade 3-4) Hypophysitis AE (grade 3-4) Hypothyroidism AE (grade 3-4) Increase AST AE (grade 3-4) Increased ALT AE (grade 3-4) Infusion-related reaction AE (grade 3-4) Injury, poisoning and procedure AE (grade 3-4) Lacrimation increased AE (grade 3-4) Leucopenia AE (grade 3-4) Mucosal inflammation AE (grade 3-4) Myalgia AE (grade 3-4) Nausea AE (grade 3-4) Neutropenia AE (grade 3-4) Oropharyngeal pain AE (grade 3-4) Paraesthesia AE (grade 3-4) Peripheral neuropathy AE (grade 3-4) Peripheral oedema AE (grade 3-4) Peripheral sensory neuropathy AE (grade 3-4) Pneumonitis AE (grade 3-4) Pruritus AE (grade 3-4) Pyrexia AE (grade 3-4) Rash AE (grade 3-4) Stomatitis AE (grade 3-4) Thrombocytopenia AE (grade 3-4) Vomiting 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
NeoTRIPaPDLA unpublished NCT02620280 RCT es-BC - TNBC - NA - all population atezolizumab plus carboplatine plus nab-paclitaxel carboplatine plus nab-paclitaxel Neoadjuvant Therapy in TRIPle Negative Breast Cancer (early or locally advanced) 88 / 86 NA inconclusive no statistically significant result GeparNuevo, 2019 NCT02685059 RCT es-BC - TNBC - NA - all population durvalumab followed by nab-paclitaxel placebo followed by nab-paclitaxel Patients with previously untreated uni- or bilateral primary, non-metastatic invasive TNBC with a tumour of at least 2 cm (cT2-cT4a-d) treated as neoadjuvant 88 / 86 some concern suggested suggested 76 % decrease in deaths (OS) (extension) inconclusive 45 % increase in pCR (PE) OlympiA (BIG 6-13, NSABP B-55) unpublished NCT02032823 RCT es-BC - TNBC - NA - all population olaparib placebo patients with human epidermal growth factor receptor 2 (HER2)–negative early breast cancer with BRCA1 or BRCA2 germline pathogenic or likely pathogenic variants and high-risk clinicopathological factors 921 / 915 NA conclusif demonstrated 32 % decrease in deaths (OS) (PE) demonstrated 42 % decrease in iDFS (PE) KEYNOTE-522, 2020 NCT03036488 RCT es-BC - TNBC - NA - all population pembrolizumab placebo previously previously untreated, nonmetastatic disease, stage II or stage III, triple-negative breast cancer treated with paclitaxel and carboplatin, treated for neoadjuvant phase and an adjuvant phase; 784 / 390 low conclusif demonstrated 12.6-fold increase in pCR (PE) suggested 37 % decrease in events or deaths (EFS) (PE) IMpassion-031 (all population), 2020 NCT03197935 RCT es-BC - TNBC - NA - all population Atezolizumab plus nab-paclitaxel followed by doxorubicin and cyclophosphamide with filgrastim or pegfilgrastim support placebo plus nab-paclitaxel followed by doxorubicin and cyclophosphamide with filgrastim or pegfilgrastim support neoadjuvant setting in participants with early stage (stage II-III) triple negative breast cancer 165 / 168 low conclusif demonstrated 95 % increase in pCR (PE)