A prospective phase I dose-escalation trial of stereotactic ablative radiotherapy (SABR) as an alternative to cytoreductive nephrectomy for inoperable patients with metastatic renal cell carcinoma

Radiation Oncology

Mary J. MacKenzie¹  George B. Rodrigues²  Craig Johnson²  Glenn S. Bauman²  Alexander V. Louie²  Belal Ahmad²  Andrew Warner²  Rohann J. M. Correa²  Stephen E. Pautler³ 

[1] Department of Medical Oncology, London Regional Cancer Program;Department of Radiation Oncology, London Regional Cancer Program;Division of Urology, Western University;

关键词: Primary tumour;    Renal cell;    Metastatic;    Stereotactic ablative radiotherapy;   

DOI  :  10.1186/s13014-018-0992-3

来源: DOAJ

【 摘 要 】

Abstract Background Cytoreductive nephrectomy is thought to improve survival in metastatic renal cell carcinoma (mRCC). As many patients are ineligible for major surgery, we hypothesized that SABR could be a safe alternative. Methods In this dose-escalation trial, inoperable mRCC patients underwent SABR targeting the entire affected kidney. Toxicity (CTCAE v3.0), quality of life (QoL), renal function, and tumour response (RECIST v1.0) were assessed. Results Twelve patients of mostly intermediate (67%) or poor (25%) International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prognostic class, median KPS of 70%, and median tumour size of 8.7 cm (range: 4.8–13.8) were enrolled in successive dose cohorts of 25 (n = 3), 30 (n = 6), and 35 Gy (n = 3) in 5 fractions. SABR was well tolerated with 3 grade 3 events: fatigue (2) and bone pain (1). QoL decreased for physical well-being (p = 0.016), but remained unchanged in other domains. SABR achieved a median tumour size reduction of − 17.3% (range: + 5.3 to − 54.4) at 5.3 months. All patients progressed systemically and median OS was 6.7 months. Crude median follow-up was 5.8 months. Conclusions In non-operable mRCC patients, renal-ablative SABR to 35 Gy in 5 fractions yielded acceptable toxicity, renal function preservation, and stable QoL. SABR merits further prospective investigation as an alternative to cytoreductive nephrectomy. Trial Registration ClinicalTrials.gov NCT02264548. Registered July 22 2014 – Retrospectively registered: https://clinicaltrials.gov/ct2/show/NCT02264548

【 授权许可】

Unknown