Journal article
Avelumab and taxol chemotherapy in platinum-refractory or ineligible metastatic urothelial carcinoma (AVETAX trial)
Urologic oncology, Vol.43(9), pp.520.e9-520.e18
09/01/2025
DOI: 10.1016/j.urolonc.2025.04.005
PMID: 40451703
Abstract
Background and objective: This study investigates the role of taxanes and immunotherapy for inoperable advanced or metastatic urothelial carcinoma in patients unable to tolerate or refractory to platinum-based regimens. We aimed to determine the safety and estimate the efficacy of a combination of avelumab and docetaxel in treating advanced or metastatic urothelial carcinoma.
Methods: This phase 1b, single-arm, open-label clinical trial involved adults with advanced or metastatic urothelial carcinoma, progressing during or after platinum-containing chemotherapy, within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy, or ineligible for platinum regimens. Primary objectives were determining the maximum tolerated dose (MTD) of docetaxel with avelumab and estimating efficacy via the objective response rate (ORR). In Phase I, docetaxel (45, 60, 75 mg/m(2)) was combined with 10 mg/kg avelumab every 3 weeks for 6 cycles, followed by avelumab biweekly as maintenance. The expansion cohort received treatment at the MTD of 75 mg/m(2) docetaxel with 10 mg/kg of avelumab.
Results: Twenty-one patients with advanced or metastatic urothelial carcinoma were studied: 8 cisplatin-refractory and 13 cisplatin-ineligible. The 75 mg/m(2) dose of docetaxel with 10 mg/kg avelumab was safe, with 1 dose-limiting toxicity (neutropenic fever). The ORR was 52.4% (95% CI: 29.8%-74.3%). Median progression-free survival and overall survival were 14.6 months (95% CI: 2.8-15.8) and 16.6 months (95% CI: 13.2-not reached), respectively.
Conclusion: The combination of avelumab and docetaxel shows favorable safety and efficacy in treating advanced or metastatic bladder cancer. (c) 2025 Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.
Details
- Title: Subtitle
- Avelumab and taxol chemotherapy in platinum-refractory or ineligible metastatic urothelial carcinoma (AVETAX trial)
- Creators
- Rohan Garje - University of IowaAditya Ravindra - University of IowaBilal Rahim - University of IowaMathew Kroll - University of Iowa Hospitals and ClinicsJeffrey S. Johnson - University of Iowa Hospitals and ClinicsJulie Torres - University of Iowa Hospitals and ClinicsJaime Bonner - University of IowaVignesh T. Packiam - University of IowaSarah Mott - University of IowaMichael O'Donnell - Univ Iowa Hlth Care, Div Hematol Oncol & Blood Bone Marrow Transplanta, Iowa City, IA 52242 USAYousef Zakharia - University of IowaMatthew R Kroll - Internal Medicine
- Resource Type
- Journal article
- Publication Details
- Urologic oncology, Vol.43(9), pp.520.e9-520.e18
- DOI
- 10.1016/j.urolonc.2025.04.005
- PMID
- 40451703
- ISSN
- 1078-1439
- eISSN
- 1873-2496
- Publisher
- Elsevier
- Number of pages
- 10
- Language
- English
- Date published
- 09/01/2025
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Urology; Internal Medicine
- Record Identifier
- 9985237608102771
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