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.

Détails

ID Serval
serval:BIB_7DD689C66188
Type
Article: article d'un périodique ou d'un magazine.
Sous-type
Etude de cas (case report): rapporte une observation et la commente brièvement.
Collection
Publications
Institution
Titre
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.
Périodique
Journal of Clinical Oncology
Auteur(s)
Smith T.J., Staats P.S., Deer T., Stearns L.J., Rauck R.L., Boortz-Marx R.L., Buchser E., Català E., Bryce D.A., Coyne P.J., Pool G.E.
ISSN
0732-183X
Statut éditorial
Publié
Date de publication
10/2002
Peer-reviewed
Oui
Volume
20
Numéro
19
Pages
4040-4049
Langue
anglais
Notes
Publication types: Clinical Trial ; Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Résumé
PURPOSE: Implantable intrathecal drug delivery systems (IDDSs) have been used to manage refractory cancer pain, but there are no randomized clinical trial (RCT) data comparing them with comprehensive medical management (CMM). PATIENTS AND METHODS: We enrolled 202 patients on an RCT of CMM versus IDDS plus CMM. Entry criteria included unrelieved pain (visual analog scale [VAS] pain scores >/= 5 on a 0 to 10 scale). Clinical success was defined as >/= 20% reduction in VAS scores, or equal scores with >/= 20% reduction in toxicity. The main outcome measure was pain control combined with change of toxicity, as measured by the National Cancer Institute Common Toxicity Criteria, 4 weeks after randomization. RESULTS: Sixty of 71 IDDS patients (84.5%) achieved clinical success compared with 51 of 72 CMM patients (70.8%, P =.05). IDDS patients more often achieved >/= 20% reduction in both pain VAS and toxicity (57.7% [41 of 71] v 37.5% [27 of 72], P =.02). The mean CMM VAS score fell from 7.81 to 4.76 (39% reduction); for the IDDS group, the scores fell from 7.57 to 3.67 (52% reduction, P =.055). The mean CMM toxicity scores fell from 6.36 to 5.27 (17% reduction); for the IDDS group, the toxicity scores fell from 7.22 to 3.59 (50% reduction, P =.004). The IDDS group had significant reductions in fatigue and depressed level of consciousness (P <.05). IDDS patients had improved survival, with 53.9% alive at 6 months compared with 37.2% of the CMM group (P =.06). CONCLUSION: IDDSs improved clinical success in pain control, reduced pain, significantly relieved common drug toxicities, and improved survival in patients with refractory cancer pain.
Mots-clé
Analgesics, Opioid/administration & dosage, Female, Humans, Infusion Pumps, Implantable, Linear Models, Male, Middle Aged, Neoplasms/complications, Pain/drug therapy, Pain/etiology, Pain Measurement, Prospective Studies, Statistics, Nonparametric, Survival Analysis, Treatment Outcome
Pubmed
Web of science
Création de la notice
28/01/2008 11:41
Dernière modification de la notice
20/08/2019 15:39
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