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)

T. J. Smith, P. J. Coyne, P. S. Staats, T. Deer, L. J. Stearns, R. L. Rauck, R. L. Boortz-Marx, E. Buchser, E. Català, D. A. Bryce, M. Cousins, G. E. Pool, M. Wallace, T. Yaksh, S. Magnuson, A. Leung, F. Ahadian, S. Bullock, M. McBeth, A. HoyeR. Miguel, M. A. Weitzner, L. Balducci, K. Follett, P. Hitchon, W. S. Minore, H. Weiss, J. Jaworowicz, S. Croy, S. Davis, S. Grossman, M. Grieb, L. Carson, S. Mitchell, M. Stuckey, S. Charapata, M. McCracken, R. Sorensen, J. Calava, J. Dunn, P. Kosek, S. Weinstein, T. K. Banerjee, D. Caraway, C. Kim, M. Serafini, K. McNeil, J. Frame, G. Orlandini, A. Siragusa, F. Aliaga, A. Lopez-Pousa, C. Pericay, L. Perey, C. Muriel, F. Boyle, A. Molloy, C. Brooker, S. E. Walker

Research output: Contribution to journalArticle

114 Citations (Scopus)

Abstract

Background: The randomized clinical trial of implantable drug delivery systems (IDDS) plus comprehensive medical management (CMM) versus CMM alone showed better clinical success at 4 weeks for IDDS patients. This 'as treated' analysis assessed if improvements in pain control, drug toxicity and survival were maintained over time. Patients and methods: We compared those who received IDDS with those who did not receive IDDS (non-IDDS). All patients had Visual Analogue Scores (VAS) for pain ≥5/10 on at least 200 mg morphine or equivalent daily. Results: At 4 weeks, 46 of 52 (88.5%) IDDS patients achieved clinical success compared with 65 of 91 (71.4%; P=0.02) non-IDDS patients, and more often achieved ≥20% reduction in both pain VAS and toxicity [35 of 52 (67.3%) versus 33 of 91 patients (36.3%); P = 0.0003]. By 12 weeks, 47 of 57 (82.5%) IDDS patients had clinical success compared with 35 of 45 (77.8%; P=0.55) non-IDDS patients, and more often had a ≥20% reduction in both pain VAS and toxicity [33 of 57 (57.9%) versus 15 of 45 patients (33.3%); P=0.01]. At 12 weeks the IDDS VAS pain scores decreased from 7.81 to 3.89 (47% reduction) compared with 7.21 to 4.53 for non-IDDS patients (42% reduction; P = 0.23). The 12 week drug toxicity scores for IDDS patients decreased from 6.68 to 2.30 (66% reduction), and for non-IDDS patients from 6.73 to 4.13 (37% reduction; P = 0.01). All individual drug toxicities improved with IDDS at both 4 and 12 weeks. At 6 months, only 32% of the group randomized to CMM and who did not cross over to IDDS were alive, compared with 52%-59% for patients in those groups who received IDDS. Conclusions: IDDS improved clinical success, reduced pain scores, relieved most toxicity of pain control drugs, and was associated with increased survival for the duration of this 6 month trial.

Original languageEnglish (US)
Pages (from-to)825-833
Number of pages9
JournalAnnals of Oncology
Volume16
Issue number5
DOIs
StatePublished - May 1 2005

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Implantable Infusion Pumps
Intractable Pain
Drug-Related Side Effects and Adverse Reactions
Pain
Survival
Drug Delivery Systems
Cancer Pain
Drug and Narcotic Control

Keywords

  • Cancer
  • Implantable devices
  • Intraspinal therapy
  • Intrathecal therapy
  • Opioids
  • Pain

ASJC Scopus subject areas

  • Hematology
  • Oncology

Cite this

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). / Smith, T. J.; Coyne, P. J.; Staats, P. S.; Deer, T.; Stearns, L. J.; Rauck, R. L.; Boortz-Marx, R. L.; Buchser, E.; Català, E.; Bryce, D. A.; Cousins, M.; Pool, G. E.; Wallace, M.; Yaksh, T.; Magnuson, S.; Leung, A.; Ahadian, F.; Bullock, S.; McBeth, M.; Hoye, A.; Miguel, R.; Weitzner, M. A.; Balducci, L.; Follett, K.; Hitchon, P.; Minore, W. S.; Weiss, H.; Jaworowicz, J.; Croy, S.; Davis, S.; Grossman, S.; Grieb, M.; Carson, L.; Mitchell, S.; Stuckey, M.; Charapata, S.; McCracken, M.; Sorensen, R.; Calava, J.; Dunn, J.; Kosek, P.; Weinstein, S.; Banerjee, T. K.; Caraway, D.; Kim, C.; Serafini, M.; McNeil, K.; Frame, J.; Orlandini, G.; Siragusa, A.; Aliaga, F.; Lopez-Pousa, A.; Pericay, C.; Perey, L.; Muriel, C.; Boyle, F.; Molloy, A.; Brooker, C.; Walker, S. E.

In: Annals of Oncology, Vol. 16, No. 5, 01.05.2005, p. 825-833.

Research output: Contribution to journalArticle

Smith, TJ, Coyne, PJ, Staats, PS, Deer, T, Stearns, LJ, Rauck, RL, Boortz-Marx, RL, Buchser, E, Català, E, Bryce, DA, Cousins, M, Pool, GE, Wallace, M, Yaksh, T, Magnuson, S, Leung, A, Ahadian, F, Bullock, S, McBeth, M, Hoye, A, Miguel, R, Weitzner, MA, Balducci, L, Follett, K, Hitchon, P, Minore, WS, Weiss, H, Jaworowicz, J, Croy, S, Davis, S, Grossman, S, Grieb, M, Carson, L, Mitchell, S, Stuckey, M, Charapata, S, McCracken, M, Sorensen, R, Calava, J, Dunn, J, Kosek, P, Weinstein, S, Banerjee, TK, Caraway, D, Kim, C, Serafini, M, McNeil, K, Frame, J, Orlandini, G, Siragusa, A, Aliaga, F, Lopez-Pousa, A, Pericay, C, Perey, L, Muriel, C, Boyle, F, Molloy, A, Brooker, C & Walker, SE 2005, '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)', Annals of Oncology, vol. 16, no. 5, pp. 825-833. https://doi.org/10.1093/annonc/mdi156
Smith, T. J. ; Coyne, P. J. ; Staats, P. S. ; Deer, T. ; Stearns, L. J. ; Rauck, R. L. ; Boortz-Marx, R. L. ; Buchser, E. ; Català, E. ; Bryce, D. A. ; Cousins, M. ; Pool, G. E. ; Wallace, M. ; Yaksh, T. ; Magnuson, S. ; Leung, A. ; Ahadian, F. ; Bullock, S. ; McBeth, M. ; Hoye, A. ; Miguel, R. ; Weitzner, M. A. ; Balducci, L. ; Follett, K. ; Hitchon, P. ; Minore, W. S. ; Weiss, H. ; Jaworowicz, J. ; Croy, S. ; Davis, S. ; Grossman, S. ; Grieb, M. ; Carson, L. ; Mitchell, S. ; Stuckey, M. ; Charapata, S. ; McCracken, M. ; Sorensen, R. ; Calava, J. ; Dunn, J. ; Kosek, P. ; Weinstein, S. ; Banerjee, T. K. ; Caraway, D. ; Kim, C. ; Serafini, M. ; McNeil, K. ; Frame, J. ; Orlandini, G. ; Siragusa, A. ; Aliaga, F. ; Lopez-Pousa, A. ; Pericay, C. ; Perey, L. ; Muriel, C. ; Boyle, F. ; Molloy, A. ; Brooker, C. ; Walker, S. E. / 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). In: Annals of Oncology. 2005 ; Vol. 16, No. 5. pp. 825-833.
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title = "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)",
abstract = "Background: The randomized clinical trial of implantable drug delivery systems (IDDS) plus comprehensive medical management (CMM) versus CMM alone showed better clinical success at 4 weeks for IDDS patients. This 'as treated' analysis assessed if improvements in pain control, drug toxicity and survival were maintained over time. Patients and methods: We compared those who received IDDS with those who did not receive IDDS (non-IDDS). All patients had Visual Analogue Scores (VAS) for pain ≥5/10 on at least 200 mg morphine or equivalent daily. Results: At 4 weeks, 46 of 52 (88.5{\%}) IDDS patients achieved clinical success compared with 65 of 91 (71.4{\%}; P=0.02) non-IDDS patients, and more often achieved ≥20{\%} reduction in both pain VAS and toxicity [35 of 52 (67.3{\%}) versus 33 of 91 patients (36.3{\%}); P = 0.0003]. By 12 weeks, 47 of 57 (82.5{\%}) IDDS patients had clinical success compared with 35 of 45 (77.8{\%}; P=0.55) non-IDDS patients, and more often had a ≥20{\%} reduction in both pain VAS and toxicity [33 of 57 (57.9{\%}) versus 15 of 45 patients (33.3{\%}); P=0.01]. At 12 weeks the IDDS VAS pain scores decreased from 7.81 to 3.89 (47{\%} reduction) compared with 7.21 to 4.53 for non-IDDS patients (42{\%} reduction; P = 0.23). The 12 week drug toxicity scores for IDDS patients decreased from 6.68 to 2.30 (66{\%} reduction), and for non-IDDS patients from 6.73 to 4.13 (37{\%} reduction; P = 0.01). All individual drug toxicities improved with IDDS at both 4 and 12 weeks. At 6 months, only 32{\%} of the group randomized to CMM and who did not cross over to IDDS were alive, compared with 52{\%}-59{\%} for patients in those groups who received IDDS. Conclusions: IDDS improved clinical success, reduced pain scores, relieved most toxicity of pain control drugs, and was associated with increased survival for the duration of this 6 month trial.",
keywords = "Cancer, Implantable devices, Intraspinal therapy, Intrathecal therapy, Opioids, Pain",
author = "Smith, {T. J.} and Coyne, {P. J.} and Staats, {P. S.} and T. Deer and Stearns, {L. J.} and Rauck, {R. L.} and Boortz-Marx, {R. L.} and E. Buchser and E. Catal{\`a} and Bryce, {D. A.} and M. Cousins and Pool, {G. E.} and M. Wallace and T. Yaksh and S. Magnuson and A. Leung and F. Ahadian and S. Bullock and M. McBeth and A. Hoye and R. Miguel and Weitzner, {M. A.} and L. Balducci and K. Follett and P. Hitchon and Minore, {W. S.} and H. Weiss and J. Jaworowicz and S. Croy and S. Davis and S. Grossman and M. Grieb and L. Carson and S. Mitchell and M. Stuckey and S. Charapata and M. McCracken and R. Sorensen and J. Calava and J. Dunn and P. Kosek and S. Weinstein and Banerjee, {T. K.} and D. Caraway and C. Kim and M. Serafini and K. McNeil and J. Frame and G. Orlandini and A. Siragusa and F. Aliaga and A. Lopez-Pousa and C. Pericay and L. Perey and C. Muriel and F. Boyle and A. Molloy and C. Brooker and Walker, {S. E.}",
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TY - JOUR

T1 - 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)

AU - Smith, T. J.

AU - Coyne, P. J.

AU - Staats, P. S.

AU - Deer, T.

AU - Stearns, L. J.

AU - Rauck, R. L.

AU - Boortz-Marx, R. L.

AU - Buchser, E.

AU - Català, E.

AU - Bryce, D. A.

AU - Cousins, M.

AU - Pool, G. E.

AU - Wallace, M.

AU - Yaksh, T.

AU - Magnuson, S.

AU - Leung, A.

AU - Ahadian, F.

AU - Bullock, S.

AU - McBeth, M.

AU - Hoye, A.

AU - Miguel, R.

AU - Weitzner, M. A.

AU - Balducci, L.

AU - Follett, K.

AU - Hitchon, P.

AU - Minore, W. S.

AU - Weiss, H.

AU - Jaworowicz, J.

AU - Croy, S.

AU - Davis, S.

AU - Grossman, S.

AU - Grieb, M.

AU - Carson, L.

AU - Mitchell, S.

AU - Stuckey, M.

AU - Charapata, S.

AU - McCracken, M.

AU - Sorensen, R.

AU - Calava, J.

AU - Dunn, J.

AU - Kosek, P.

AU - Weinstein, S.

AU - Banerjee, T. K.

AU - Caraway, D.

AU - Kim, C.

AU - Serafini, M.

AU - McNeil, K.

AU - Frame, J.

AU - Orlandini, G.

AU - Siragusa, A.

AU - Aliaga, F.

AU - Lopez-Pousa, A.

AU - Pericay, C.

AU - Perey, L.

AU - Muriel, C.

AU - Boyle, F.

AU - Molloy, A.

AU - Brooker, C.

AU - Walker, S. E.

PY - 2005/5/1

Y1 - 2005/5/1

N2 - Background: The randomized clinical trial of implantable drug delivery systems (IDDS) plus comprehensive medical management (CMM) versus CMM alone showed better clinical success at 4 weeks for IDDS patients. This 'as treated' analysis assessed if improvements in pain control, drug toxicity and survival were maintained over time. Patients and methods: We compared those who received IDDS with those who did not receive IDDS (non-IDDS). All patients had Visual Analogue Scores (VAS) for pain ≥5/10 on at least 200 mg morphine or equivalent daily. Results: At 4 weeks, 46 of 52 (88.5%) IDDS patients achieved clinical success compared with 65 of 91 (71.4%; P=0.02) non-IDDS patients, and more often achieved ≥20% reduction in both pain VAS and toxicity [35 of 52 (67.3%) versus 33 of 91 patients (36.3%); P = 0.0003]. By 12 weeks, 47 of 57 (82.5%) IDDS patients had clinical success compared with 35 of 45 (77.8%; P=0.55) non-IDDS patients, and more often had a ≥20% reduction in both pain VAS and toxicity [33 of 57 (57.9%) versus 15 of 45 patients (33.3%); P=0.01]. At 12 weeks the IDDS VAS pain scores decreased from 7.81 to 3.89 (47% reduction) compared with 7.21 to 4.53 for non-IDDS patients (42% reduction; P = 0.23). The 12 week drug toxicity scores for IDDS patients decreased from 6.68 to 2.30 (66% reduction), and for non-IDDS patients from 6.73 to 4.13 (37% reduction; P = 0.01). All individual drug toxicities improved with IDDS at both 4 and 12 weeks. At 6 months, only 32% of the group randomized to CMM and who did not cross over to IDDS were alive, compared with 52%-59% for patients in those groups who received IDDS. Conclusions: IDDS improved clinical success, reduced pain scores, relieved most toxicity of pain control drugs, and was associated with increased survival for the duration of this 6 month trial.

AB - Background: The randomized clinical trial of implantable drug delivery systems (IDDS) plus comprehensive medical management (CMM) versus CMM alone showed better clinical success at 4 weeks for IDDS patients. This 'as treated' analysis assessed if improvements in pain control, drug toxicity and survival were maintained over time. Patients and methods: We compared those who received IDDS with those who did not receive IDDS (non-IDDS). All patients had Visual Analogue Scores (VAS) for pain ≥5/10 on at least 200 mg morphine or equivalent daily. Results: At 4 weeks, 46 of 52 (88.5%) IDDS patients achieved clinical success compared with 65 of 91 (71.4%; P=0.02) non-IDDS patients, and more often achieved ≥20% reduction in both pain VAS and toxicity [35 of 52 (67.3%) versus 33 of 91 patients (36.3%); P = 0.0003]. By 12 weeks, 47 of 57 (82.5%) IDDS patients had clinical success compared with 35 of 45 (77.8%; P=0.55) non-IDDS patients, and more often had a ≥20% reduction in both pain VAS and toxicity [33 of 57 (57.9%) versus 15 of 45 patients (33.3%); P=0.01]. At 12 weeks the IDDS VAS pain scores decreased from 7.81 to 3.89 (47% reduction) compared with 7.21 to 4.53 for non-IDDS patients (42% reduction; P = 0.23). The 12 week drug toxicity scores for IDDS patients decreased from 6.68 to 2.30 (66% reduction), and for non-IDDS patients from 6.73 to 4.13 (37% reduction; P = 0.01). All individual drug toxicities improved with IDDS at both 4 and 12 weeks. At 6 months, only 32% of the group randomized to CMM and who did not cross over to IDDS were alive, compared with 52%-59% for patients in those groups who received IDDS. Conclusions: IDDS improved clinical success, reduced pain scores, relieved most toxicity of pain control drugs, and was associated with increased survival for the duration of this 6 month trial.

KW - Cancer

KW - Implantable devices

KW - Intraspinal therapy

KW - Intrathecal therapy

KW - Opioids

KW - Pain

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DO - 10.1093/annonc/mdi156

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