Phase 2 Trial of Stereotactic Ablative Radiotherapy for Patients with Primary Renal Cancer.
Eur Urol
; 84(3): 275-286, 2023 09.
Article
en En
| MEDLINE
| ID: mdl-36898872
ABSTRACT
BACKGROUND:
Most renal cell carcinomas (RCCs) are localized and managed by active surveillance, surgery, or minimally invasive techniques. Stereotactic ablative radiation (SAbR) may provide an innovative non-invasive alternative although prospective data are limited.OBJECTIVE:
To investigate whether SAbR is effective in the management of primary RCCs. DESIGN, SETTING, ANDPARTICIPANTS:
Patients with biopsy-confirmed radiographically enlarging primary RCC (≤5 cm) were enrolled. SAbR was delivered in either three (12 Gy) or five (8 Gy) fractions. OUTCOME MEASUREMENTS AND STATISTICALANALYSIS:
The primary endpoint was local control (LC) defined as a reduction in tumor growth rate (compared with a benchmark of 4 mm/yr on active surveillance) and pathologic evidence of tumor response at 1 yr. Secondary endpoints included LC by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), safety, and preservation of kidney function. Exploratory tumor cell-enriched spatial protein and gene expression analysis were conducted on pre- and post-treatment biopsy samples. RESULTS ANDLIMITATIONS:
Target accrual was reached with the enrollment of 16 ethnically diverse patients. Radiographic LC at 1 yr was observed in 94% of patients (15/16; 95% confidence interval 70, 100), and this was accompanied by pathologic evidence of tumor response (hyalinization, necrosis, and reduced tumor cellularity) in all patients. By RECIST, 100% of the sites remained without progression at 1 yr. The median pretreatment growth rate was 0.8 cm/yr (interquartile range [IQR] 0.3, 1.4), and the median post-treatment growth rate was 0.0 cm/yr (IQR -0.4, 0.1, p < 0.002). Tumor cell viability decreased from 4.6% to 0.7% at 1 yr (p = 0.004). With a median follow-up of 36 mo for censored patients, the disease control rate was 94%. SAbR was well tolerated with no grade ≥2 (acute or late) toxicities. The average glomerular filtration rate declined from a baseline of 65.6 to 55.4 ml/min at 1 yr (p = 0.003). Spatial protein and gene expression analyses were consistent with the induction of cellular senescence by radiation.CONCLUSIONS:
This clinical trial adds to the growing body of evidence suggesting that SAbR is effective for primary RCC supporting its evaluation in comparative phase 3 clinical trials. PATIENTSUMMARY:
In this clinical trial, we investigated a noninvasive treatment option of stereotactic radiation therapy for the treatment of primary kidney cancer and found that it was safe and effective.Palabras clave
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Carcinoma de Células Renales
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Radiocirugia
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Neoplasias Renales
Tipo de estudio:
Clinical_trials
/
Observational_studies
Límite:
Humans
Idioma:
En
Revista:
Eur Urol
Año:
2023
Tipo del documento:
Article