Preliminary results from a phase II study comparing sunitinib alone or with stereotactic body radiotherapy (SBRT) for newly diagnosed oligometastatic renal cell carcinoma.

Authors

null

Yang Liu

Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, China

Yang Liu , Wensu Wei , Zhiling Zhang , Ruiqi Liu , Jianming Gao , Shengjie Guo , Hui Han , Pei Dong , Liru He , Fangjian Zhou

Organizations

Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, China, Department of Urology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, China, Department of Urology, Sun Yat-Sen University Cancer Center, Guangzhou, China, Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, China

Research Funding

No funding received
None.

Background: Although SBRT has become an option for oligometastatic renal cell carcinoma (oligoRCC), current trials supporting SBRT haven’t been adequately persuasive given their single-arm, non-first-line design. Our study aimed to explore if SBRT improves oncologic outcomes compared with standard first-line systemic therapy in oligoRCC. Methods: This an open-label, double-arm phase II controlled trial enrolling treatment naïve oligoRCC patients (pts), defined as ≤ 5 metastatic lesions (ChiCTR1800017136). No liver or brain metastasis was allowed. Nephrectomy was mandatory before enrollment. Pts were allocated 1:1 to receive either sunitinib alone (control arm) or sunitinib plus SBRT (SBRT arm). Sunitinib was started as 50 mg daily for 4 weeks, followed by 2 weeks off treatment. SBRT was delivered to all metastatic sites within 2 months after sunitinib initiation, with 35-50Gy in 5 fractions. Primary endpoint was objective response rate (ORR); secondary endpoints were disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety. Data from pts with ≥ 1 year of follow-up were reported this time. Results: Starting in 2018, the trial has currently completed its accrual, with 48 pts enrolled. Forty-two pts had ≥ 1 year of follow-up and were evaluable for the present analysis. Pt characteristics for SBRT and control arms: median age 51 vs 59 years (p=0.094); synchronous metastasis 31.8% vs 10.0% (p=0.179); clear cell carcinoma 77.3% vs 80.0% (p=1.000); IMDC low or intermediate risk 86.4% vs 80.0% (p=1.000); solitary metastasis 45.5% vs 25.0% (p=0.167). Thirty-four sites received SBRT, most frequently to bone (61.8%) and soft tissue (17.6%) metastasis. The 1-year local control rate after SBRT was 93.8%. ORR (81.8% vs. 25.0%, p=0.000) and DCR (90.9% vs. 60.0%, p=0.047) were significantly higher in SBRT arm than those in control arm. The 1y-PFS was 72.7% for SBRT arm and 35.0% for control arm (HR 0.33, 95% CI 0.16-0.69, p= 0.003). And the 1y-OS was 95.5% for SBRT arm and 80.0% for control arm (HR 1.06, 95% CI 0.31-3.67, p=0.923). Grade 3-4 treatment-related AEs occurred in 66.7% and 62.5% pts in SBRT arm and control arm (p=0.763), respectively. SBRT-related Grade 3-4 toxicity included radiation enteritis (n=1, grade 3) and radiation pneumonitis (n=1, grade 3). Conclusions: Our results showed promising efficacy and acceptable toxicity of SBRT plus sunitinib when compared with sunitinib alone for oligoRCC. Complete results are awaited in 2023 after follow-up completion of the entire cohort. Clinical trial information: ChiCTR1800017136.

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Abstract Details

Meeting

2023 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Genitourinary Cancer—Kidney and Bladder

Track

Genitourinary Cancer—Kidney and Bladder

Sub Track

Kidney Cancer

Clinical Trial Registration Number

ChiCTR1800017136

Citation

J Clin Oncol 41, 2023 (suppl 16; abstr 4533)

DOI

10.1200/JCO.2023.41.16_suppl.4533

Abstract #

4533

Poster Bd #

25

Abstract Disclosures