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Simultaneous Antiangiogenic Therapy and Singlefraction Radiosurgery In 2010 THE AUTHORS; BJU INTERNATIONAL 2010 BJU INTERNATIONAL Urological Oncology ANTI-ANGIOGENIC THERAPY AND RADIOSURGERY IN METASTATIC RCC STAEHLER ET AL. Simultaneous anti-angiogenic therapy and single-fraction radiosurgery in clinically relevant metastases from renal cell carcinoma BJUIBJU INTERNATIONAL Michael Staehler, Nicolas Haseke, Philipp Nuhn, Cordula Tüllmann, Alexander Karl, Michael Siebels, Christian G. Stief, Berndt Wowra* and Alexander Muacevic* Department of Urology, University of Munich, Klinikum Grosshadern, and *European CyberKnife Centre Munich, Max-Lebsche-Platz, Munich, Germany Accepted for publication 1 September 2010 RESULTS CONCLUSIONS Study Type – Therapy (case series) Level of Evidence 4 Median follow up was 14.7 months (range Simultaneous systemic anti-angiogenic 1–42 months). Forty-five patients were therapy and SRS for selected patients OBJECTIVES treated with sunitinb and 61 patients with with renal cell carcinoma who have spinal sorafenib. Two patients had asymptomatic and cerebral metastases is safe and To analyse the safety and efficacy of tumour haemorrhage after SRS. No skin effective. Single-fraction delivery allows simultaneous standard anti-angiogenic toxicity, neurotoxicity or myelopathy for efficacious integration of focal therapy and stereotactic radiosurgery (SRS) occurred after SRS, and SRS did not alter radiation treatment into oncological in patients with spinal and cerebral the adverse effects of anti-angiogenic treatment concepts without additional metastases from renal cell carcinoma. therapy. Local tumour control 15 months toxicity. Further studies are needed to after SRS was 98% (95% confidence determine the limits of SRS for renal cell PATIENTS AND METHODS interval 89–99%). The median pain score carcinoma metastases outside the brain before SRS was 5 (range 1–8) and was and spine. In all, 106 patients with spinal (n = 55) or lowered to 0 (range 0–2, P < 0.01) after cerebral (n = 51) metastatic lesions and an SRS. There were no treatment-related Eastern Cooperative Oncology Group status deaths or late complications after SRS. KEYWORDS of 0 or 1 were treated with sorafenib or Overall survival was 17.4 months in sunitinib and simultaneous SRS. The primary patients with spinal lesions and 11.1 renal cell cancer, cyberknife, sunitinib, endpoint was local control. Secondary month in patients with cerebral lesions sorafenib, stereotactic, robotic surgery, endpoints were toxicity and overall survival. (P = 0.038). spinal tumours, cerebral metastasis INTRODUCTION The role of conventional radiotherapy in angiogenic therapy and SRS in terms of metastatic RCC remains controversial. Local toxicity and local tumour control in patients Approximately 30% of patients with RCC have control of the tumour is rare, rendering with advanced disease. The present synchronous metastases, and about 40% will radiotherapy a palliative treatment for consecutive case series evaluated the toxicity develop metachronous metastatic spread [1]. selected patients [6]. Consequently and effectiveness of a combined systemic Anti-angiogenic treatment based on sunitinib, radiotherapy is considered to have only (angiogenic inhibitors) and local (SRS) sorafenib and temsirolimus can double minimal effects in controlling RCC metastases treatment of patients with metastatic RCC. progression-free survival while prolonging [7]. Stereotactic radiosurgery (SRS) is well overall survival [2–5] so it is regarded as established as an effective therapeutic standard therapy in patients with metastases method in patients with brain metastases PATIENTS AND METHODS who do not have further surgical treatment from renal cancer [8–10], and knowledge is choices. Nevertheless, the outcomes of anti- accumulating that spinal lesions can be A consecutive series of 106 patients with angiogenic treatment in patients with treated effectively with spinal SRS [11–20]. In spinal (n = 55) or cerebral (n = 51) metastatic cerebral metastases are limited and spinal the SRS series published to date, metastatic lesions from RCC underwent SRS using the lesions can result in pain, altered function or lesions from RCC have been included but little CyberKnife System (Accuray Incorporated, instability. is known about the combination of anti- Sunnyvale, CA, USA) from August 2005 to © 2010 THE AUTHORS BJU INTERNATIONAL © 2010 BJU INTERNATIONAL | doi:10.1111/j.1464-410X.2010.09895.x 1 STAEHLER ET AL. May 2009. All treatments were performed in 400 mg twice daily, suntinib was First clinical follow up occurred 1 week after an outpatient setting. administered orally at 50 mg daily for 4 treatment to assess the patient status with weeks with a subsequent 2-week wash-out particular emphasis on the pain level and All patients included had histological phase. Dose was not withheld or delayed adverse effects after SRS. Further clinical confirmation of RCC. Metastatic disease had while patients were simultaneously treated evaluation and CT and/or MRI imaging studies to be proven by CT scans according to the with SRS. Adverse effects were graded were done every 12 weeks according to a Response Evaluation Criteria in Solid Tumors according to the National Cancer Institute preplanned tumour restaging schedule for (RECIST) without a surgical treatment choice. Common Toxicity Criteria 3.0 and were systemic therapy. Any tumour growth or All patients had to have progressive disease as considered unrelated to SRS if they appeared recurrence of a treated tumour during seen in imaging over at least 1 month. before or later than 6 weeks after SRS follow up with imaging was classified as Patients had to have an Eastern Cooperative therapy. Local adverse effects at the site of treatment failure. Distant recurrences were Oncology Group performance status of 0 or 1 the SRS treatment were regarded as related disregarded for calculation of local tumour and a Karnofsky performance status of at to SRS no matter how much after SRS was control. least 60. Only patients with an estimated life the time of appearance. expectancy of 3 months or more were selected. All patients had to sign informed The SRS treatment procedure has been consent before SRS. Patients had to be on described in detail recently [15,20–22]. The RESULTS anti-angiogenic therapy for metastatic RCC. CyberKnife and the skeletal structure tracking Spinal lesions were included if they were software (XSIGHT, Accuray Inc.), were used for Median time from initial diagnosis to clinically relevant in the sense of causing pain, spinal radiosurgery in all patients. Previous metastatic spread was 0.6 years (range 0–3.5 infiltrating the neuroforamina, or when studies have shown the feasibility and years). Follow up information was verified in instability appeared imminent. submillimetre accuracy of this fiducial-free, all patients. Median follow up was 14.7 frameless method [15,20,21,23,24]. Planning months (range 1–42 months). Local tumour Patients were excluded if there was evidence and delivery of treatment were performed as control of 240 treated metastases 15 months of acute spinal instability or if lesions outpatient procedures. The planning CT was after SRS was 98% (95% CI 89–99%). As compressed the spinal cord and caused acquired with the patient in the supine previously reported, the statistical model neurological deficits. Patients were treated for position without any support. Gadolinium- failed to identify factors predictive of local metastatic lesions of the brain when there enhanced MRI scans were used in addition to tumour control [23]. Median overall survival were no more than five lesions and there was a dedicated thin-cut (1-mm slice thickness) was 15.2 months after SRS. Median time from no chance for surgical removal. Patients with CT investigation for treatment planning and initial diagnosis of RCC until SRS was 3.1 year. surgically removable lesions were not follow-up examinations of all patients. The Patients and treatment characteristics are included. planning target volume was the gross tumour given in Table 1. volume. The patient’s head was positioned Toxicity was graded according to the National during treatment using a custom-fitted face Forty-five patients were treated with oral Cancer Institute Common Toxicity Criteria, mask and patient movements of up to 10 mm sunitinib (50 mg daily, 4 weeks on, 2 weeks Version 3.0. in translation and 1 degree in rotation off) and 61 patients were treated with oral (3 degrees for yaw movements) were sorafenib (400 mg twice daily). The primary endpoint was local control. automatically corrected using the updated Lesions with at least 6 months of radiographic information of the image guidance system Systemic therapy caused adverse effects, as follow up were considered assessable for local [Lit]. The treatment volumes were prescribed previously published [25]. Grade three control. Secondary endpoints were toxicity to a median isodose of 70% (range 50–85%). adverse effects comprised hypertension, rash, and overall survival. The median number of beams during mucositis, diarrhoea, thrombocytopenia, treatment was 112 for cranial lesions and 127 anaemia, hand–foot syndrome, myocardial The SPSS 17.0 software (SPSS Inc., Chicago, IL, for spinal tumours (range 27–328). These infarction and thrombosis. They were not USA) was used for statistical analysis. The parameters where chosen on the basis of seen during SRS and were classified as endpoints of the study were local tumour suggested dose levels in the literature and unrelated to SRS because they did not appear control, local pain control and rate of adverse according to our personal experience over the within 6 weeks of SRS. All adverse effects effects of SRS. These outcome parameters years. were not related to SRS but to the underlying were estimated using the Kaplan–Meier systemic treatment. In none of our patients method and a log-rank test. Multivariate and All treatments were performed in a single did SRS influence the adverse effects of anti- univariate analyses were performed with the fraction. The procedure time was between 1 angiogenic therapy and in no patient was it Cox proportional hazard model. and 3 h. For treatment delivery the patients necessary to modify the dose of the systemic were placed on the CyberKnife treatment therapy.
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