Adjuvant Durvalumab for Localized Urothelial Cancer
Posted: Friday, April 2, 2021
In a small phase II trial, Monika Joshi, MD, of the Penn State Hershey Cancer Institute, and colleagues investigated the efficacy of concurrent durvalumab and radiation therapy in patients with bladder cancer, followed by adjuvant durvalumab. The concurrent therapy followed by adjuvant durvalumab yielded a “promising” 1-year progression-free survival probability of 73% along with a disease control rate of 70%. These findings were presented during the virtual edition of the 2021 Genitourinary (GU) Cancers Symposium (Abstract 398).
“Efficacy was also seen in node-positive patients,” the investigators noted. Thus, the ongoing EA8185 clinical trial is comparing induction chemotherapy followed by chemotherapy plus durvalumab/radiotherapy along with adjuvant durvalumab with chemoradiotherapy alone in these patients with node-positive bladder cancer.
This study enrolled 26 patients with pure or mixed urothelial bladder cancer who were cisplatin eligible (89%), unfit for surgery (50%), or had an unresectable tumor (35%). Patients were required to have a large tumor (T2 to T4), possible cancer in the lymph nodes (N0 to N2), and no metastasis (M0). Participants were administered 1,500 mg of durvalumab and 36 fractions of definitive radiotherapy at 64.8 Gy to the bladder and involved nodes, followed by adjuvant durvalumab.
At the time of data cutoff, 20 patients were evaluable for disease control rate, 25 were analyzed for progression-free survival, and all 26 were included in the overall survival analysis. “Durvalumab and radiotherapy followed by adjuvant durvalumab demonstrated promising efficacy, with 1-year progression-free survival probability of 73%, 1-year overall survival probability of 83.8%, and [a] disease control rate of 70% in muscle-invasive bladder cancer and locally advanced bladder cancer patients with comorbidities,” the researchers concluded. The median progression-free survival was 18.5 months, and the 2-year overall survival probability was 76.8%. The median overall survival has not been reached.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.