REFRACTORY CANCER PAIN: STUDY HIGHLIGHTS
Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain:1
- Prospective, multicenter, randomized
- 200 patients with advanced cancer and refractory pain
- Patients randomly assigned to receive comprehensive medical management (CMM) or intrathecal drug delivery (IDDS) plus CMM.
- Intrathecal drug delivery was delivered by the SynchroMed™ programmable infusion system
- Entry criteria included Visual Analogue Scale (VAS) pain score of ≥ 5 on a 0-10 scale despite 200 mg/day of oral morphine or its equivalent, or lower doses with intolerable side effects
Demographic and clinical characteristics were well balanced.
| Characteristic | IDDS Group (n = 101) | CMM Group (n = 99) |
|---|---|---|
| Age | 56.2 ± 13.2 | 57.8 ± 13.7 |
| Male (%) | 51.5% | 59.6% |
| Baseline VAS | 7.44 ± 1.97 | 7.59 ± 1.97 |
| Baseline Composite Toxicity Score** | 6.95 ± 4.91 | 6.65 ± 5.58 |
** The added scores of all the toxicity scales measured that were related to the treatment.
Conclusion
The data indicate that intrathecal drug delivery plus comprehensive medical management is more clinically effective than CMM alone in treating intractable cancer pain.
During this trial, complications with the infusion system were similar to those seen in clinical use.
Results
Intrathecal drug delivery proved significantly better than CMM in clinical success:
- ≥ 20% reduction in VAS scores or
- Equal scores with ≥ 20% reduction in toxicity
Intrathecal drug delivery patients more often achieved reduction in both pain and toxicity. At 4 weeks after randomization, 60.6% of intrathecal drug delivery system patients, compared to 41.7% of CMM patients had pain scores of <4.
| Study Parameter | Randomized to IDDS + CMM | Randomized to CMM | P Values |
|---|---|---|---|
| ≥ 20% reduction in Pain VAS or equal VAS with ≥ 20% reduction in mean toxicity score | 84.5% (n = 60/71) | 70.8% (n = 51/72) | 0.05 |
| ≥ 20% reduction in both Pain VAS and Toxicity | 57.7% (n = 41/71) | 37.5% (n = 27/72) | 0.02 |
| Mean VAS pain score | Reduced 51.5% | Reduced 39.1% | 0.055 |
| Mean composite toxicity criteria (CTC) scores | Reduced 50.3% | Reduced 17.1% | =0.004 |
All of the measured opioid side effects were reduced more in the IDDS group than in the CMM group.
Significantly larger reductions (p < 0.05) in the IDDS group were noted for fatigue and reduced consciousness.
Reduction in Mean Severity of Side Effects
COST BENEFIT COMPARED TO CONVENTIONAL THERAPY
Evidence suggests that targeted drug delivery (TDD) for intractable cancer pain is characterized by high initial costs followed by low maintenance costs, whereas conventional medical management (CMM) is associated with steadily increasing, cumulative costs that, over time, can equal the costs of TDD.3
In one study, the majority of high expenditures for CMM were attributed transdermal and transmucosal fentanyl products along with ambulatory, patient-controlled IV analgesia.3
- In contrast, 69% of patients discontinued their systemic opioid pain medications after implantation of the TDD drug infusion system.3
- Likewise, 72% of patients receiving TDD completely stopped taking fast-onset opioids to control breakthrough pain, instead relying on myPTM.3
1
Smith TJ, Staats PS, Deer T, et al. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002;20(19):4040-4049.
2
Smith TJ, Coyne PJ, Staats PS, et al. An implantable drug delivery system (IDDS) for refractory cancer pain provides sustained pain control, less drug-related toxicity, and possibly better survival compared with comprehensive medical management (CMM). Ann. Oncol. 2005;16(5):825-833.
3
Brogan SE, Winter NB, Ablodun A, Safapour R. Therapy for refractory cancer pain: identifying factors associated with cost benefit. Pain Med. 2013;14:478-486.
Brief Statement
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When ITB is mentioned, we are considering Intrathecal baclofen (an anti-spastic) administered by an intrathecal drug delivery pump therapy. Medtronic provides only the intrathecal drug delivery pump and the catheter; the intrathecal baclofen, morphine or ziconotide is provided by an external company.