Spinal intraarterial chemotherapy: interim results of a Phase I clinical trial

Abstract

<jats:sec> <jats:title>OBJECT</jats:title> <jats:p>Despite advances in therapies using radiation oncology and spinal oncological surgery, there is a subgroup 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.</jats:p></jats:sec> <jats:sec> <jats:title>METHODS</jats:title> <jats:p>The main inclusion criterion was the presence of progressive, metastatic epidural disease to the spine causing 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 epidural 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 Terminology Criteria for Adverse Events; and 2) MRI to assess for tumor response.</jats:p></jats:sec> <jats:sec> <jats:title>RESULTS</jats:title> <jats:p>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 candidates 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.</jats:p></jats:sec> <jats:sec> <jats:title>CONCLUSIONS</jats:title> <jats:p>These preliminary results support the hypothesis that SIAC is feasible and safe.</jats:p></jats:sec>

Neurosurgery concepts: Key perspectives on intrathecal fluorescein for detecting intraoperative cerebrospinal fluid leak during endoscopic endonasal surgery, spinal intraarterial chemotherapy, oligoastrocytoma classification by in situ molecular genetics, and prenatal myelomeningocele closure and the need for cerebrospinal fluid shunt placement

“…[1] Pregnant women with a fetus prenatally diagnosed with MMC between 19 and 25 weeks of gestation were randomized at one of the 3 maternal-fetal surgery centers to either prenatal or postnatal surgical MMC repair. In the trial, the primary outcome was defined as a composite of fetal loss or any of the following: Infant death, cerebrospinal fluid (CSF) shunt placement, or meeting prespecified criteria for shunt placement before 1 year of age.…”

Metastatic Complications of Cancer Involving the Central and Peripheral Nervous Systems

“…A phase I study in patients with progressive epidural disease despite surgery and RT found that spinal intra-arterial chemotherapy (melphalan) was safe and feasible, and effective at stabilizing epidural disease. 49 MR-guided spinal laser interstitial thermal therapy is also being explored as a less invasive alternative to surgery for ESCC; it achieved significant decompression months after the procedure in a select patient population. 50 Percutaneous kyphoplasty does not treat ESCC, but it is safe and effective for spinal metastases 51 , and may be useful in preventing ESCC.…”