Active surveillance in metastatic renal-cell carcinoma: a prospective, phase 2 trial.
Date
2016-09ICR Author
Author
Rini, BI
Dorff, TB
Elson, P
Rodriguez, CS
Shepard, D
Wood, L
Humbert, J
Pyle, L
Wong, Y-N
Finke, JH
Rayman, PA
Larkin, JMG
Garcia, JA
Plimack, ER
Type
Journal Article
Metadata
Show full item recordAbstract
Background A subset of patients with metastatic renal-cell carcinoma show indolent growth of metastases. Because of the toxicity and non-curative nature of systemic therapy, some of these patients could benefit from initial active surveillance. We aimed to characterise the time to initiation of systemic therapy in patients with metastatic renal-cell carcinoma under active surveillance.Methods In this prospective phase 2 trial, we enrolled patients with treatment-naive, asymptomatic, metastatic renal-cell carcinoma from five hospitals in the USA, Spain, and the UK. Patients were radiographically assessed at baseline, every 3 months for year 1, every 4 months for year 2, then every 6 months thereafter. Patients continued on observation until initiation of systemic therapy for metastatic renal-cell carcinoma; a decision that was made at the discretion of the treating physician and patient. The primary endpoint of the study was time to initiation of systemic therapy in the per-protocol population. The follow-up of patients is ongoing.Findings Between Aug 21, 2008, and June 7, 2013, we enrolled 52 patients. Median follow-up of patients in the study was 38·1 months (IQR 29·4-48·9). In the 48 patients included in analysis, median time on surveillance from registration on study until initiation of systemic therapy was 14·9 months (95% CI 10·6-25·0). Multivariate analysis showed that higher numbers of International Metastatic Database Consortium (IMDC) adverse risk factors (p=0·0403) and higher numbers of metastatic disease sites (p=0·0414) were associated with a shorter surveillance period. 22 (46%) patients died during the study period, all from metastatic renal-cell carcinoma.Interpretation A subset of patients with metastatic renal-cell carcinoma can safely undergo surveillance before starting systemic therapy. Additional investigation is required to further define the benefits and risks of this approach.Funding None.
Collections
Subject
Humans
Carcinoma, Renal Cell
Kidney Neoplasms
Tomography, X-Ray Computed
Neoplasm Staging
Prognosis
Nephrectomy
Population Surveillance
Survival Rate
Follow-Up Studies
Prospective Studies
Aged
Middle Aged
United States
Spain
Female
Male
United Kingdom
Research team
Melanoma and Kidney Cancer
Language
eng
Date accepted
2016-05-19
License start date
2016-09
Citation
The Lancet. Oncology, 2016, 17 (9), pp. 1317 - 1324