In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 6_suppl ( 2022-02-20), p. 484-484
Abstract:
484 Background: Atezolizumab is a monoclonal antibody with proven efficacy in clinical trials for advanced or metastatic urothelial carcinoma (UC) after progression to platinum-based chemotherapy. Following EMA marketing authorization and before prizing and reimbursement was granted in Spain, the Spanish Medicines Agency authorized a compassionate use program. We describe the patient characteristics and atezolizumab effectiveness in this compassionate use program. Methods: It was a multicentre cohort study based on the retrospective chart review of patients with inoperable locally advanced or metastatic UC who received atezolizumab, following progression to platinum-based chemotherapy, under the compassionate use program in Spain. The primary endpoint was their demographic and clinical characterization. Secondary endpoints included the best response to atezolizumab, progression-free survival (PFS) and overall survival (OS). Results: 109 evaluable patients were included, with a median age (interquartile range, IQR) of 68.0 years (62.0-75.0), 87 males (79.8%) and 96 Caucasians (88.1%). Median age (IQR) at diagnosis was 64.0 years (58.0-72.0) and 92 (84.4%) had pure urothelial carcinoma. Twenty-four (22.0%) had received BCG, 18 (16.5%) neoadjuvant treatment, 19 (17.4%) adjuvant treatment, and 19 (17.4%) radiotherapy for primary tumour. Regarding prior metastatic treatments, 98 (89.9%) had received first-line chemotherapy, 46 (42.2%) second line, 19 (17.4%) third line, and 5 (4.6%) more lines. When starting atezolizumab, median age (IQR) was 69.0 years (62.0-74.0) and 105 (96.3%) had metastases: 71 (65.1%) in lymph nodes and 64 (58.7%) visceral (skeletal n = 31, lung n = 29, liver n = 26, other n = 13). Atezolizumab was used for a median (IQR) of 2.8 (1.4-8.4) months and 5.0 (3.0-13.0) administered doses. The overall response rate was 23.8%, with 6 patients (5.5%) achieving complete response and 20 (18.3%) partial response. Stable disease was observed in 21 (19.3%), progression in 44 (40.4%) and response was not evaluable in 18 (16.5%). The median PFS (95% CI) was 3.7 months (2.8-5.8), with PFS rates at months 3, 6, 9 and 12 of 57.5%, 38.0%, 30.5% and 26.1%, respectively. The median OS (95% CI) reached 8.5 (6.6-12.6) months, with a 12-month OS of 43.4%. Twenty-three patients (21.1%) reported 26 delays (adverse event n = 16, intercurrent event n = 10) and 2 (1.8%) interruptions (adverse event n = 1, intercurrent event n = 1). Atezolizumab was discontinued in 64 (58.7%) due to disease progression (n = 43, 67.2%), death (n = 13, 20.3%), adverse events (n = 7, 10.9%) and lost to follow-up (n = 1, 1.6%). Conclusions: This study provides real-world evidence on the characteristics of patients with advanced or metastatic UC treated with atezolizumab under the Spanish compassionate use program, supporting its effectiveness in the clinical setting.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/JCO.2022.40.6_suppl.484
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2022
detail.hit.zdb_id:
2005181-5
Permalink
