Stereotactic Radiotherapy for Oligoprogression in Metastatic Renal Cell Cancer Patients Receiving Tyrosine Kinase Inhibitor Therapy: A Phase 2 Prospective Multicenter Study,European Urology

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Stereotactic Radiotherapy for Oligoprogression in Metastatic Renal Cell Cancer Patients Receiving Tyrosine Kinase Inhibitor Therapy: A Phase 2 Prospective Multicenter Study
European Urology ( IF 25.3 ) Pub Date : 2021-08-13 , DOI: 10.1016/j.eururo.2021.07.026
Patrick Cheung ₁ , Samir Patel ₂ , Scott A North ₃ , Arjun Sahgal ₁ , William Chu ₁ , Hany Soliman ₁ , Belal Ahmad ₄ , Eric Winquist ₅ , Tamim Niazi ₆ , Francois Patenaude ₇ , Gerald Lim ₈ , Daniel Yick Chin Heng ₉ , Arbind Dubey ₁₀ , Piotr Czaykowski ₁₁ , Rebecca K S Wong ₁₂ , Anand Swaminath ₁₃ , Scott C Morgan ₁₄ , Rupi Mangat ₁₅ , Sareh Keshavarzi ₁₆ , Georg A Bjarnason ₁₇

Affiliation

Department of Radiation Oncology, Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, ON, Canada.
Division of Radiation Oncology, Department of Oncology, Cross Cancer Institute, University of Alberta, Edmonton, AB, Canada.
Division of Medical Oncology, Department of Oncology, Cross Cancer Institute, University of Alberta, Edmonton, AB, Canada.
Division of Radiation Oncology, Department of Oncology, London Health Sciences Centre, Western University, London, ON, Canada.
Division of Medical Oncology, Department of Oncology, London Health Sciences Centre, Western University, London, ON, Canada.
Division of Radiation Oncology, Department of Oncology, Jewish General Hospital, McGill University, Montreal, QC, Canada.
Department of Oncology, Jewish General Hospital, McGill University, Montreal, QC, Canada.
Division of Radiation Oncology, Department of Oncology, Tom Baker Cancer Centre, University of Calgary, Calgary, AB, Canada.
Division of Medical Oncology, Department of Oncology, Tom Baker Cancer Centre, University of Calgary, Calgary, AB, Canada.
Department of Radiation Oncology, CancerCare Manitoba, University of Manitoba, Winnipeg, MB, Canada.
Department of Medical Oncology and Hematology, CancerCare Manitoba, University of Manitoba, Winnipeg, MB, Canada.
Radiation Medicine Program, Department of Radiation Oncology, Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada.
Department of Oncology, Juravinski Cancer Centre, McMaster University, Hamilton, ON, Canada.
Division of Radiation Oncology, Department of Radiology, The Ottawa Hospital Cancer Centre, University of Ottawa, Ottawa, ON, Canada.
Ozmosis Research Inc., Toronto, ON, Canada.
Department of Biostatistics, Princess Margaret Cancer Centre, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.
Division of Medical Oncology, Department of Medicine, Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, ON, Canada.

Background

Despite the paucity of prospective evidence, stereotactic radiotherapy (SRT) is increasingly being considered in the setting of oligoprogression to delay the need to change systemic therapy.

Objective

To determine the local control (LC), progression-free survival (PFS), cumulative incidence of changing systemic therapy, and overall survival (OS) after SRT to oligoprogressive metastatic renal cell carcinoma (mRCC) lesions in patients who are on tyrosine kinase inhibitor (TKI) therapy.

Design, setting, and participants

A prospective multicenter study was performed to evaluate the use of SRT in oligoprogressive mRCC patients. Patients with mRCC who had previous stability or response after ≥3 mo of TKI therapy were eligible if they developed progression of five of fewer metastases. Thirty-seven patients with 57 oligoprogressive tumors were enrolled.

Intervention

Oligoprogressive tumors were treated with SRT, and the same TKI therapy was continued afterward.

Outcome measurements and statistical analysis

Competing risk analyses and the Kaplan-Meir methodology were used to report the outcomes of interest.

Results and limitations

The median duration of TKI therapy prior to study entry was 18.6 mo; 1-yr LC of the irradiated tumors was 93% (95% confidence interval [CI] 71–98%). The median PFS after SRT was 9.3 mo (95% CI 7.5–15.7 mo). The cumulative incidence of changing systemic therapy was 47% (95% CI 32–68%) at 1 yr, with a median time to change in systemic therapy of 12.6 mo (95% CI 9.6–17.4 mo). One-year OS was 92% (95% CI 82–100%). There were no grade 3–5 SRT-related toxicities.

Conclusions

LC of irradiated oligoprogressive mRCC tumors was high, and the need to change systemic therapy was delayed for a median of >1 yr.

Patient summary

The use of stereotactic radiotherapy in metastatic kidney cancer patients, who develop growth of a few tumors while on oral targeted therapy, can significantly delay the need to change to the next line of drug therapy.

中文翻译：

接受酪氨酸激酶抑制剂治疗的转移性肾细胞癌患者寡进展的立体定向放射治疗：一项 2 期前瞻性多中心研究

背景

尽管缺乏前瞻性证据，但在寡进展的情况下越来越多地考虑立体定向放射治疗（SRT），以推迟改变全身治疗的需要。

客观的

确定接受酪氨酸激酶抑制剂治疗的少进展性转移性肾细胞癌 (mRCC) 病变的局部控制 (LC)、无进展生存期 (PFS)、改变全身治疗的累积发生率以及 SRT 后的总生存期 (OS) （TKI）治疗。

设计、设置和参与者

进行了一项前瞻性多中心研究，以评估 SRT 在少进展性 mRCC 患者中的应用。既往在 TKI 治疗 3 个月后具有稳定性或缓解的 mRCC 患者，如果出现 5 个或较少转移灶的进展，则符合资格。共有 37 名患有 57 个寡进展性肿瘤的患者入组。

干涉

少进行性肿瘤采用 SRT 治疗，随后继续进行相同的 TKI 治疗。

结果测量和统计分析

使用竞争风险分析和 Kaplan-Meir 方法来报告感兴趣的结果。

结果和局限性

进入研究前 TKI 治疗的中位持续时间为 18.6 个月；受辐射肿瘤的 1 年 LC 为 93%（95% 置信区间 [CI] 71-98%）。SRT 后的中位 PFS 为 9.3 个月（95% CI 7.5-15.7 个月）。1 年时改变全身治疗的累积发生率为 47%（95% CI 32-68%），改变全身治疗的中位时间为 12.6 个月（95% CI 9.6-17.4 个月）。一年 OS 为 92% (95% CI 82–100%)。没有 3-5 级 SRT 相关毒性。