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Spinal Intraarterial Chemotherapy: Interim Results of a Phase I Clinical Trial CLINICAL ARTICLE J Neurosurg Spine 24:217–222, 2016 Spinal intraarterial chemotherapy: interim results of a Phase I clinical trial Athos Patsalides, MD, MPH,1 Yoshiya Yamada, MD,2 Mark Bilsky, MD,3 Eric Lis, MD,4 Ilya Laufer, MD,3 and Yves Pierre Gobin, MD1 1Interventional Neuroradiology, Department of Neurological Surgery, Weill Cornell Medical College; and Departments of 2Radiation Oncology, 3Neurological Surgery, and 4Radiology, Memorial Sloan Kettering Cancer Center, New York, New York OBJECTIVE Despite advances in therapies using radiation oncology and spinal oncological surgery, there is a sub- group of patients with spinal metastases who suffer from progressive or recurrent epidural disease and remain at risk for neurological compromise. In this paper the authors describe their initial experience with a novel therapeutic approach that consists of intraarterial (IA) infusion of chemotherapy to treat progressive spinal metastatic disease. METHODs The main inclusion criterion was the presence of progressive, metastatic epidural disease to the spine caus- ing spinal canal compromise in patients who were not candidates for the standard treatments of radiation therapy and/ or surgery. All tumor histological types were eligible for this trial. Using the transfemoral arterial approach and standard neurointerventional techniques, all patients were treated with IA infusion of melphalan in the arteries supplying the epi- dural tumor. The protocol allowed for up to 3 procedures repeated at 3- to 6-week intervals. Outcome measures included physiological measures: 1) periprocedural complications according to the National Cancer Institute’s Common Terminol- ogy Criteria for Adverse Events; and 2) MRI to assess for tumor response. RESULTs Nine patients with progressive spinal metastatic disease and cord compression were enrolled in a Phase I clinical trial of selective IA chemotherapy. All patients had metastatic disease from solid organs and were not candi- dates for further radiation therapy or surgery. A total of 19 spinal intraarterial chemotherapy (SIAC) procedures were performed, and the follow-up period ranged from 1 to 7 months (median 3 months). There was 1 serious adverse event (febrile neutropenia). Local tumor control was seen in 8 of 9 patients, whereas tumor progression at the treated level was seen in 1 patient. CONCLUSIOns These preliminary results support the hypothesis that SIAC is feasible and safe. Clinical trial registration no.: NCT01637766 (clinicaltrials.gov) http://thejns.org/doi/abs/10.3171/2015.5.SPINE14830 KEY WORDS intraarterial chemotherapy; spine; spinal metastasis; melphalan; oncology; technique PINE metastases from solid organ tumors are very tion when offered as definitive therapy or as a postopera- common in the population of patients with cancer, tive adjuvant. The integration of stereotactic radiosurgery and these lesions represent a major source of mor- (SRS) into treatment paradigms for metastatic tumors has Sbidity. Therapy for metastatic spine tumors is palliative, demonstrated durable local control rates greater than 90% with the goals of maintaining or improving neurological that are histology independent, providing better control function, providing mechanical stability, and achieving than that observed with conventional external-beam ra- local tumor control. The majority of spinal solid organ diation therapy.12,22 The availability of this treatment re- tumor metastases are treated with radiation therapy alone mains limited, however, and the vast majority of patients or a combination of surgery and radiation. Local tumor are still treated with conventional radiation therapy, with control is typically dependent on the response to radia- lower rates of local tumor control. Despite excellent tu- ABBREVIATIONS IA = intraarterial; IV = intravenous; PLT = platelet; SAE = severe adverse event; SIAC = spinal intraarterial chemotherapy; SRS = stereotactic radiosur- gery; WBC = white blood cell. ACCOMPANYING EDITORIAL See pp 215–216. DOI: 10.3171/2015.6.SPINE15565. SUBMITTED December 1, 2014. ACCEPTED May 13, 2015. INCLUDE WHEN CITING Published online October 23, 2015; DOI: 10.3171/2015.5.SPINE14830. ©AANS, 2016 J Neurosurg Spine Volume 24 • February 2016 217 Unauthenticated | Downloaded 09/30/21 05:09 PM UTC A. Patsalides et al. mor responses to radiation therapy, a subgroup of patients the following classification for epidural spinal cord com- will demonstrate tumor progression, leaving them with no pression: Grade 0, no subarachnoid space compression; effective treatment options and placing them at risk for Grade 1, subarachnoid space partially obliterated without progressive spinal cord or cauda equina compression and cord compression; Grade 2, subarachnoid space partially paralysis. Recent experience with intraarterial (IA) che- obliterated with cord compression; and Grade 3, subarach- motherapy for retinoblastoma2 led us to investigate the noid space completely blocked, with severe cord compres- possibility of delivering IA chemotherapy to spine tumors sion.4 Only patients with Grades 1 and 2 were eligible in instances in which surgical and radiation options were for the trial. Exclusion criteria were Grade 3 spinal cord/ exhausted. This paper presents interim data from a Phase cauda equina compression, rapidly worsening neurological I clinical trial aimed to test the hypothesis that spinal in- symptoms, low white blood cell (WBC) counts, and life traarterial chemotherapy (SIAC) can be safely applied in expectancy less than 3 months. In patients with multifocal patients with metastatic spinal epidural tumors. spinal epidural disease, the target area was the one with the most significant degree of epidural disease based on Methods MRI. The primary objective of the trial was to evaluate the Patient Characteristics safety and feasibility of SIAC, and the secondary objective was to evaluate changes in epidural tumor size after treat- This single-arm, progressive, Phase I clinical trial was ment. The FDA approved enrollment of up to 20 patients. approved by the Weill Cornell Medical College Institution- The study was to be discontinued if a severe adverse event al Review Board and is listed on the clinical trials website (SAE) occurred in more than 3 of the first 10 patients. (Intra-arterial Chemotherapy for Spinal Metastases, www. clinicaltrials.gov; NCT01637766). A physician-sponsored The SIAC Procedure Investigational New Drug approval (No. 113342) was ob- tained from the FDA. The inclusion and exclusion criteria The spinal arterial catheterization was performed using are described in Table 1. All tumor histological types were standard interventional techniques via femoral arterial ac- eligible for this treatment. Nine patients (5 male; age range cess. Either conscious sedation or general anesthesia was 19–76 years, median age 48 years) were enrolled in the used, primarily depending on the patient’s ability to lie trial between July 2009 and June 2012. Informed consent flat for the duration of the procedure. The treatment area was obtained from all patients. was selected based on the MRI scans. Epidural tumor was All patients had MRI evidence of progressive spinal seen as enhancing area on T1-weighted sequences and epidural disease, and had already been treated with surgery high-signal-intensity area on T2-weighted sequences. The and SRS at that level. Each patient’s history, clinical condi- arterial territory to be treated with chemotherapy was de- tion, and imaging were reviewed at the spinal tumor board, termined by following basic knowledge of the spinal arte- and the consensus among neurosurgery and radiation on- rial anatomy, so that the entire targeted area was covered. cology experts was that these patients were not candidates The segmental (intercostal or lumbar) arteries supplying for further surgery or radiation. All patients underwent the epidural tumor at the level of compression, including spinal MRI scans with contrast within 4 weeks of study at least one vertebral body level above and one vertebral enrollment. The grading of epidural disease and spinal body level below, were catheterized and studied with digi- canal compromise was based on axial MR images, using tal subtraction angiography. Patients with vascular supply to the spinal cord (anterior and/or posterior spinal arteries) TABLE 1. Inclusion and exclusion criteria for patients with originating from the same segmental arteries supplying progressive spinal epidural tumor the tumor were excluded from the study and chemother- apy was not administered (angiographic exclusion crite- Inclusion criteria rion). Following diagnostic angiography, a microcatheter Patients w/ progressive metastatic disease to the spine causing was used to superselectively catheterize the ventral branch cord compression Grades 1 & 2 who are not candidates for the of the segmental arteries and permanently occlude it with standard treatment of radiation therapy or surgery detachable coils. This step was undertaken to minimize Patients older than 18 yrs the flow of chemotherapy into the normal paraspinal soft Patients able to give informed consent tissues and the thoracic or abdominal wall, thus allowing for maximum delivery of chemotherapy to the vessels of Exclusion criteria the dorsal branch supplying the tumor. Then, chemothera- MRI findings of Grade 3 epidural cord compression py was infused through the microcatheter using a pulsatile Vascular supply to the spinal cord from the same segmental arter- injection technique to avoid streamlining and
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