Targeted Drug Delivery for Cancer Pain: Characterizing Safety and Performance for Patients with Colon Cancer

Introduction: Colon cancer pain can manifest in various locations and adequate pain management in patients has been associated with longer survival rate. (1-3) Currently, systemic opioid therapy remains the primary approach for managing pain; however, it is often accompanied by significant side effects, including drug intolerance, impaired gut motility, respiratory depression, and opioid-refractory pain. Targeted drug delivery with intrathecal drug delivery systems (IDDS) presents an alternative for patients experiencing severe pain that is inadequately managed by conventional treatments or when side effects become intolerable.1 Research on cancer-related pain has demonstrated the benefits of IDDS therapy, which includes reductions in systemic opioid use, minimized side effects, potential cost savings, and improved quality of life (QoL).(1-3)

Methods: The Product Surveillance Registry (PSR), a prospective multi-center registry, enrolled patients who had been implanted with an IDDS after obtaining informed consent. Participants were monitored over time for events related to the device, implantation procedure, and therapy. Pain scores (rated on a 0-10 scale) were collected at baseline and at 1-3, 6-, and 12-months post-implant. This analysis aims to evaluate the safety and effectiveness of IDDS in managing pain for patients with colon cancer.

Results: As of April 30, 2025, there were 112 patients with colon cancer enrolled in the PSR. Mean (SD) age at enrollment was 56 (12) years and 54.5% (n=61) were male. All 112 patients were enrolled after April 2010, when the registry expanded data collection of serious adverse events (SAEs); 6.25% (7/112) of these patients had experienced at least one SAE related to the device, implant procedure or delivery of therapy (Table 1). Ninety-eight patients passed away while enrolled in the registry and around 96% of these deaths (94/98) were attributed to some form of neoplasm with no deaths related to the device (Table 2). There were 21 device events in 8 patients during follow-up in the registry (Table 3). There was observed improvement in generalized pain (Table 4), back pain (Table 5), and QoL (Table 6) at 6-months. Compared to baseline, generalized pain scores significantly improved at 1-3 months (p =0.001) but not at 6 months (p=0.053). Given the limited amount of data, other statistical comparisons could not be made.

Conclusion: This prospective, real-world device registry demonstrated a favorable safety profile, with promising patient outcomes. Further data collection and analysis could provide additional evidence supporting the benefits of using IDDS for colon cancer, including enhanced therapeutic performance.