Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain:1
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|
|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.
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.
Intrathecal drug delivery proved significantly superior to CMM in clinical success:
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 their pain scores reduced from moderate-severe to mild (VAS < 4). The Smith et al. study of a similar design in 2005 confirmed these results.2
|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%||=.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.
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.3,4
In one study, the majority of high expenditures for CMM were attributed transdermal and transmucosal fentanyl products along with ambulatory, patient-controlled IV analgesia.4
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.
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.
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.
Hassenbusch SJ. Cost modeling for alternate routes of administration of opioids for cancer pain. Oncol. 1999;13(5 suppl 2):63-67.