ASCO GU 2021: Fixed dose of Durvalumab single drug for the treatment of urethra tumors has good safety (STRONG study)

For tumors treated by oncologists of the genitourinary system, the prognostic prognostic of advanced urethroid skin cancer was the worst, and the standard treatment was platinum-induced chemotherapy.
, however, even with this treatment, the recurrence rate and disease progression are still high due to the development of chemotherapy resistance, and the total survival period is still very short.
In 2018, the U.S. Food and Drug Administration (FDA) approved accelerated approval of durvalumab for the treatment of patients with locally advanced or metastatic urethra skin cancer who develop the disease during or after platinum-containing chemotherapy, or within 12 months of treatment with a new aid or aid for platinum-containing chemotherapy.
JAVELIN Bladder 100 study, reported at ASCO's 2020 annual meeting, increased the use of the PD-L1 targeted therapy drug avelumab as the best support treatment, demonstrating an improvement in the overall survival of patients who did not progress during this period.
Following advances in platinum chemotherapy (CT), durvalumab (anti-PD-L1) has been approved for the treatment of metastatic urethra skin cancer (mUC) (see: NEJM:avelumab for maintenance treatment after chemotherapy in patients with advanced urethra) (ASCO 2020 advanced urethrial skin cancer has made new progress, and Avel Aumab maintenance therapy combined with BSC can extend total survival by 7.1 months! ）。
poster presentation at the 2021 ASCO Urological Cancer Symposium (ASCO GU), Dr Sonpavde and colleagues presented data from the STRONG Study (NCT03084471) to understand the long-term safety and stability of durvalumab in platinum and non-platinum pre-treatment.
study was designed to observe the safety of a fixed dose of durvalumab (1500 mg, Q4W) in patients with urethra and non-urinary tract cancer who progressed after treatment with platinum/non-platinum drugs or non-platinum drugs.
the authors assessed the main endpoints of so-called adverse events of special concern (AESI), which are associated with inflammatory or immuno-mediated mechanisms (e.g., steroids/immunosuppressants) that may require intervention, including immuno-mediated adverse events (imAE).
authors include AE patients with a date of onset on or after the first drug delivery and up to 90 days after the termination of the study.
, the authors examined serious adverse events and total survival (OS) and further explored endpoints, including objective response rates (ORRs) and disease control rates (DCR; the researchers evaluated them on RECIST 1.1).
study included 867 patients treated with durvalumab single-drug treatment.
was consistent with the patient population, with a medium age of 68.1 years and an 80.0% male age.
ECOG PS 0-1 is 87.1% and ECOG PS 2 is 12.7%.
The vast majority of patients, including patients (96.3%) had urethra cortical histology, including urethra endosperm variants, and 41.4% of patients with available data had high expression of PD-L1 tumors (defined as ≥25%) (239/577).
12.1 weeks (range 1-128) and 13.8 months (range 0.0-28.8), respectively, accounted for 8% of patients in queues with AESI grade 3 or higher.
treatment-related deaths occurred in nine patients.
as of March 31, 2020, 30.8% of patients had received lifetime follow-up, with a medium overall survival of 7.0 months (95% CI: 6.4-8.2).
35.8 per cent (95 per cent CI: 32.5-39.2) and 20.2 per cent (95 per cent CI: 16.5-24.1), respectively.
the medium total survival of patients with PD-L1 high expression was higher (9.3 mo (95%CI:6.7-12.7) vs 6.5 mo (95% CI:5.8-8.1).
interestingly, the total survival of both urethra and non-urethra patients was 7.0.
, it is convenient to have a fixed dose of durvalumab monotherapy every 4 weeks with acceptable safety in this patient group.