Intrathecal Drug Delivery Systems for Cancer Pain

An Analysis of a Prospective, Multicenter Product Surveillance Registry

Lisa M. Stearns, MD; Alaa Abd-Elsayed, MD, MPH; Christophe Perruchoud, MD; Robert Spencer, MS, MBA; Krisstin Hammond, BS; Katherine Stromberg, MS; Todd Weaver, PhD, MPH

Disclosures

Anesthesiology. 2020;132(2):289-297. 

In This Article

Abstract and Introduction

Abstract

Background: The safety and efficacy of intrathecal drug delivery systems (IDDSs) for the treatment of cancer-related pain have been demonstrated in randomized controlled clinical trials (RCTs). Despite positive evidence for this therapy, IDDS remains underutilized to treat cancer pain. Real-world registry data augment existing safety and effectiveness data and are presented here to broaden awareness of this therapeutic option, needed for adequate cancer-related pain treatment, and as a viable tool addressing concerns with systemic opioid use.

Methods: This prospective, long-term, multicenter (United States, Western Europe, and Latin America) registry started in 2003 to monitor the performance of SynchroMed Infusion Systems. Patient-reported outcomes were added in 2013. Before data acquisition, all sites obtained Ethics Committee/Institutional Review Board approval and written patient consent. The study was registered (NCT01524276 at clinicaltrials.gov) before patients were enrolled. Patients who provided informed consent were enrolled in the registry at initial IDDS implant or replacement.

Results: Through July 2017, 1403 patients with cancer pain were enrolled and implanted. The average (minimum/maximum) age of patients was 59 years (13/93 years), with 56.6% female. The most frequent cancer types were lung, breast, colon/rectal, pancreatic, and prostate. The majority of patients whose registry follow-up ended (87%; 1141/1311) were followed through death, with 4.3% (n = 57) exiting due to device explant or therapy discontinuation; the remaining 113 (8.6%) discontinued for reasons such as transfer of care, lost to follow-up, and site closure. Pain scores within the cohort of patients providing baseline and follow-up data improved significantly at 6 (P = .0007; n = 103) and 12 (P = .0026; n = 55) months compared to baseline, with EuroQol with 5 dimensions (EuroQol-5D) scores showing significant improvement at 6 months (P = .0016; n = 41). Infection requiring surgical intervention (IDDS explant, replacement, pocket revision, irrigation and debridement, etc) was reported in 3.2% of patients.

Conclusions: Adequate and improved pain control in patients with cancer, even in advanced stages, with concurrent quality of life maintenance is attainable. Results from this large-scale, multicenter, single-group cohort supplement existing RCT data that support IDDS as a safe and effective therapeutic option with a positive benefit–risk ratio in the treatment of cancer pain.

Introduction

The World Health Organization (WHO) cancer pain treatment guidelines[1] identified inadequate cancer pain management as a global health concern, with the WHO analgesic ladder developed to support stepwise progression to strong opioids as necessary to adequately control cancer-related pain. The 2018 National Comprehensive Cancer Network (NCCN) pain guidelines recommend a similar stepwise algorithm, and link survival to disease/symptom control, including pain management, and to quality of life.[2] Recent studies, however, indicate that cancer pain remains undertreated in 25%[3] to 77%[4] of patients (lack of adherence to WHO guidelines), with undertreatment rates unchanged over the past 20 years.[5] In addition, the 5-year survival rate for all cancer types has increased to 65%,[6] and many survivors experience chronic pain—with the American Society of Clinical Oncology (ASCO) policy indicating their possible need for long-term use of opioids.[7,8] The current US opioid epidemic has increased scrutiny of systemic opioid use,[9] so finding acceptable alternative treatments for refractory cancer pain and chronic pain is pressing.

Intrathecal drug delivery systems (IDDSs) administer Food and Drug Administration (FDA)-approved preservative-free morphine sulfate or ziconotide directly to the spinal cord. IDDS has demonstrated improved cancer pain management compared to conventional medical management (CMM) and placebo[10–12] and in retrospective and observational studies[13,14] for patients unresponsive to escalating systemic opioid doses or experiencing intolerable side effects. For those patients, IDDS facilitates systemic medication reduction or elimination with associated risk reduction[13,15] and significant cost savings.[16] This single-group cohort study presents a compilation of 14 years of observational IDDS data, prospectively collected and monitored for compliance, on 1403 registry participants with cancer pain.

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