Urothelial cancer |
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Front-line maintenance therapy with avelumab (Bavencio) after platinum-based chemotherapy is similar in patients with locally advanced or metastatic urothelial cancer treated in routine clinical practice and in patients treated in a focal point setting. of progression-free survival (PFS) and overall survival (OS) results. Based on results from the Phase 3 JAVELIN Bladder 100 trial (NCT02603432), the US PATRIOT-II trial, which investigated real-world outcomes of immunotherapy in the US.1
The results of the exam have been announced. 2024 Genitourinary Cancer Symposiumdemonstrated that the real-world median PFS and OS from initiation of avelumab were 5.4 months (95% CI, 3.8-6.9) and 24.4 months (95% CI, 20.4-28.4), respectively. Median OS from initiation of platinum-based chemotherapy was 30.5 months (95% CI, 23.4 to 37.6).
“These real-world results further support the use of avelumab as front-line maintenance therapy in patients with locally advanced or metastatic urothelial cancer who have not progressed after first-line platinum-based chemotherapy. “Yes,” the study authors said in their poster.
Avelumab received regulatory approval from the FDA in June 2020 Based on data from the JAVELIN Bladder 100, avelumab in combination with best supportive care (BSC) compared to It showed significantly improved PFS and OS compared to BSC alone.2 In the latest results from this trial, the median OS from the start of chemotherapy was 29.7 months (95% CI, 25.2-34.0) in the avelumab/BSC group and 20.5 months (95% CI, 19.0-23.5) in the BSC alone group. (HR, 0.77). ; 95% CI, 0.636-0.921).3
PATRIOT-II is a retrospective chart review study conducted at 37 U.S.-based community oncology and academically affiliated centers.1 A total of 160 patient records were included in the analysis. To be eligible, patients must be at least 18 years of age at diagnosis and have histologically confirmed locally advanced or metastatic disease that has not progressed on front-line platinum-based chemotherapy. They must also have started avelumab as first-line treatment.
Patients were followed from the start of platinum-based chemotherapy until 52 weeks after initiation of avelumab, death, or end of study.
In addition to PFS and OS, researchers investigated treatment patterns, reasons for treatment discontinuation, adverse effects (AEs), immune-related AEs (irAEs), high-dose steroid use, as well as healthcare resource utilization, hospitalizations, and emergency department visits. were also evaluated. , actual time until treatment discontinuation, and actual time until next treatment.
Regarding baseline characteristics, the median age of patients was 70 years (range, 40-90 years), and more than half (76.9%) were male. Most patients were white (89.4%), non-Hispanic or Latino (78.1%), and had an ECOG performance status of 0 (42.5%) or 1 (33.1%). A similar proportion of patients had a creatinine clearance of at least 60 mL/min (40.0%) or less than 60 mL/min (41.3%). Approximately half of patients had unknown PD-L1 status (51.9%), had visceral metastases at initiation of platinum-based chemotherapy (44%), and were receiving cisplatin (62.5%) rather than carboplatin and gemcitabine (37.5%). Ta. Furthermore, most patients achieved complete or partial response to front-line chemotherapy (81.3%). 10.6% had stable disease as the best response, and 8.1% of responses were unclear.
Landmark analysis demonstrated PFS rates of 48.1%, 33.0%, 27.3%, 21.8%, 19.2%, and 19.2% at 6, 12, 18, 24, 30, and 36 months from the start of avelumab treatment. I did. , Each. The OS rates at 6, 12, 18, 24, 30, and 36 months from the start of avelumab treatment were 88.1%, 75.7%, 62.5%, 53.4%, 44.0%, and 31.4%, respectively.
For actual OS from initiation of platinum-based chemotherapy, rates at 6, 12, 18, 24, 30, and 36 months were 99.4%, 85.6%, 74.9%, 65.4%, and 50.9%. % and 44.9%, respectively.
From a safety perspective, 39% of patients received high-dose steroids due to avelumab-related AEs, 22% received irAEs, 14% received high-dose steroids due to treatment-related AEs (TRAEs), 8% were hospitalized due to TRAEs, and 10% were hospitalized. . % of treatment discontinued due to AEs. The study authors noted that the rate of avelumab-related AEs in their real-world experience was lower than the rate reported in the JAVELIN Bladder 100 trial (78%). However, they stated that this was likely because AE was not positively evaluated in real-world experience.
The most common TRAEs were fatigue (4.4%), hypothyroidism (4.4%), anemia (3.8%), infusion-related reactions (3.8%), nausea (3.8%), elevated creatinine (3.1%), and diarrhea ( 2.5%). , rash (2.5%).
During maintenance treatment with avelumab, 28% of patients were hospitalized for an average of 11.5 days per person-year. Avelumab-related AEs were the main reason for hospitalization (8%), followed by disease progression, surgical procedures, and comorbidities. A total of 16% of patients were hospitalized for an average of 3 days per her person-year during platinum-based chemotherapy.
During platinum-based chemotherapy and avelumab, 7% and 8% of patients required an emergency department visit, respectively. Healthcare resource utilization was higher during and 90 days after patients finished avelumab compared to the platinum-based chemotherapy period, and the study authors attribute this to potential cofounders such as disease progression. I thought it was caused by.
References
- Grivas P, Barata P, Moon H Avelumab first-line maintenance therapy for locally advanced/metastatic urothelial carcinoma: Results from the real-world US PATRIOT-II study. J Clin Oncor. 2024;42(suppl 4):697. doi:10.1200/JCO.2024.42.4_suppl.697
- The FDA has approved avelumab as maintenance therapy for urothelial cancer. F.D.A. June 30, 2020. Accessed March 1, 2024. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-avelumab-urothelial-carcinoma-maintenance-treatment
- Sridhar SS, Powles T, Gupta S, et al. Avelumab first-line (1L) maintenance therapy for advanced urothelial carcinoma (UC): JAVELIN Bladder 100 study in subgroups defined by 1L chemotherapy regimen and analysis of overall survival (OS) from initiation of 1L chemotherapy long-term follow-up study. J Clin Oncor. 2023;41(suppl 6):508. doi:10.1200/JCO.2023.41.6_suppl.508