All subjects were followed up on a regular basis.
#Atlas translation standard v14 trial registration
Safety monitoring was conducted at the time of registration of five research subjects. The incidence, characteristics and severity of side effects are graded in accordance with NCI CTCAE, version 4.0, and changes in biometric signals, physical examination results and clinical examination results are identified. The safety assessment is performed from the beginning of the study up to 90 days after the last injection of atezolizumab, in accordance with NCI CTCAE, version 4.03.
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This study assesses the efficacy of the neoadjuvant atezolizumab treatment in patients with muscle-invasive bladder cancer (MIBC) and the difference in the efficacy of neoadjuvant atezolizumab treatment according to the BASQ classification.Īdverse reactions due to the injection of anticancer drugs are as follows: adverse events reported in clinical trials, immune-mediated adverse events, infection, infusion-related reactions and immunogenicity. 14 However, there is not much evidence for this topic, particularly the clinical efficacy of neoadjuvant PD-L1 inhibitors according to the BASQ classification in patients with advanced UBC. Specifically, luminal type and basal type may have different treatment responses and prognosis after initial definitive treatment, such as neoadjuvant treatment. 14 This novel molecular classification can improve the identification of optimal patient populations for different treatment modalities. 10–13 A consensus was reached regarding the existence of a group of basal squamous-like tumours designated basal/squamous-like (BASQ) characterised by the high expression of KRT5/6 and KRT14 genes and the low/undetectable expression of FOXA1 and GATA3 genes.
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Recently, several research groups have conducted a detailed analysis of the molecular genetic characteristics of bladder cancer through The Cancer Genome Atlas (TCGA) study and are working to apply it to UBC treatment. 7 In the ABACUS 8 study of neoadjuvant atezolizumab in patients with T2–T4aN0M0 cisplatin chemotherapy inability, the pCR rate was 29% (95% CI: 19% to 42%). 6 In the PURE-01 (Pembrolizumab as Neoadjuvant Therapy Before Radical Cystectomy in Patients With Muscle-Invasive Urothelial Bladder Carcinoma) study to determine the activity of neoadjuvant pembrolizumab in 50 patients with T2–T3bN0 UBC, 21 patients showed a pathological complete remission (pCR) rate of 42% (95% CI: 28.2% to 56.8%). 5 Several treatments are currently being studied, and in addition to cisplatin-based chemotherapy as the first-line neoadjuvant treatment for advanced UBC, it is reported that the benefits of immune checkpoint inhibitors are positive.
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4 This new drug has become the standard therapy for patients with UBC who are not responding to cisplatin-based chemotherapy and is also used as a first-line treatment in cisplatin-ineligible patients. 1–3 Atezolizumab was first approved by the US Food and Drug Administration in May 2016 as a PD-L1 inhibitor for UBC. Blocking programmed cell death protein-1 (PD-1) and programmed death ligand-1 (PD-L1) is an effective way to treat advanced-stage urothelial bladder cancer (UBC).