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Erschienen in: Supportive Care in Cancer 2/2016

01.02.2016 | Original Article

Can pregabalin prevent paclitaxel-associated neuropathy?—An ACCRU pilot trial

verfasst von: Shivani S. Shinde, Drew Seisler, Gamini Soori, Pamela J. Atherton, Deirdre R. Pachman, Jacqueline Lafky, Kathryn J. Ruddy, Charles L. Loprinzi

Erschienen in: Supportive Care in Cancer | Ausgabe 2/2016

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Abstract

Purpose

Paclitaxel can cause an acute pain syndrome (P-APS), considered to be an acute form of neuropathy and chronic chemotherapy-induced peripheral neuropathy (CIPN). Anecdotal reports suggested that gabapentin may be helpful in the prevention of these toxicities. The purpose of this pilot study was to obtain data to support or refute the utility of pregabalin for the prevention of P-APS and CIPN.

Methods

Patients scheduled to receive weekly paclitaxel (80 mg/m2/dose) were randomized 1:1 to receive pregabalin 75 mg or a placebo, twice daily, during the 12 weeks of chemotherapy. Patients completed the European Organization of Research and Treatment of Cancer Quality of Life (EORTC QLQ) CIPN20 questionnaire at baseline, prior to each dose of paclitaxel and monthly for 6 months post-treatment. Patients completed a post-paclitaxel questionnaire for 6 days after each dose of paclitaxel and an acute pain syndrome symptom questionnaire on day 8. The primary end point was to determine the effect of pregabalin on the maximum of the worst acute pain scores for the week following paclitaxel administration for cycle 1.

Results

Forty-six patients were randomly assigned to the treatment or placebo arm. There was no suggestion of a difference between the two study arms with regard to P-APS measures. While there was a suggestion that pregabalin decreased numbness, there was no suggestion that it decreased tingling, pain, or the EORTC QLQ-CIPN20 subscale scores. There were no evident toxicity differences between the two study arms.

Conclusions

The results of this pilot trial do not support that pregabalin is helpful for preventing P-APS or paclitaxel-associated CIPN.
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Literatur
1.
Zurück zum Zitat Loprinzi CL, Reeves BN, Dakhil SR et al (2011) Natural history of paclitaxel-associated acute pain syndrome: prospective cohort study NCCTG N08C1. J Clin Oncol 29(11):1472–1478PubMedPubMedCentralCrossRef Loprinzi CL, Reeves BN, Dakhil SR et al (2011) Natural history of paclitaxel-associated acute pain syndrome: prospective cohort study NCCTG N08C1. J Clin Oncol 29(11):1472–1478PubMedPubMedCentralCrossRef
2.
Zurück zum Zitat Loprinzi CL, Maddocks-Christianson K, Wolf SL et al (2007) The paclitaxel acute pain syndrome: sensitization of nociceptors as the putative mechanism. Cancer J 13(6):399–403PubMedCrossRef Loprinzi CL, Maddocks-Christianson K, Wolf SL et al (2007) The paclitaxel acute pain syndrome: sensitization of nociceptors as the putative mechanism. Cancer J 13(6):399–403PubMedCrossRef
3.
Zurück zum Zitat Reeves BN, Dakhil SR, Sloan JA et al (2012) Further data supporting that paclitaxel-associated acute pain syndrome is associated with development of peripheral neuropathy: North Central Cancer Treatment Group trial N08C1. Cancer 118(20):5171–5178PubMedPubMedCentralCrossRef Reeves BN, Dakhil SR, Sloan JA et al (2012) Further data supporting that paclitaxel-associated acute pain syndrome is associated with development of peripheral neuropathy: North Central Cancer Treatment Group trial N08C1. Cancer 118(20):5171–5178PubMedPubMedCentralCrossRef
4.
Zurück zum Zitat Caraceni A, Zecca E, Bonezzi C et al (2004) Gabapentin for neuropathic cancer pain: a randomized controlled trial from the Gabapentin Cancer Pain Study Group. J Clin Oncol 22(14):2909–2917PubMedCrossRef Caraceni A, Zecca E, Bonezzi C et al (2004) Gabapentin for neuropathic cancer pain: a randomized controlled trial from the Gabapentin Cancer Pain Study Group. J Clin Oncol 22(14):2909–2917PubMedCrossRef
5.
Zurück zum Zitat Ross JR, Goller K, Hardy J et al (2005) Gabapentin is effective in the treatment of cancer-related neuropathic pain: a prospective, open-label study. J Palliat Med 8(6):1118–1126PubMedCrossRef Ross JR, Goller K, Hardy J et al (2005) Gabapentin is effective in the treatment of cancer-related neuropathic pain: a prospective, open-label study. J Palliat Med 8(6):1118–1126PubMedCrossRef
6.
Zurück zum Zitat Guay DR (2005) Pregabalin in neuropathic pain: a more “pharmaceutically elegant” gabapentin? Am J Geriatr Pharmacother 3(4):274–287PubMedCrossRef Guay DR (2005) Pregabalin in neuropathic pain: a more “pharmaceutically elegant” gabapentin? Am J Geriatr Pharmacother 3(4):274–287PubMedCrossRef
7.
Zurück zum Zitat Rao RD, Michalak JC, Sloan JA et al (2007) Efficacy of gabapentin in the management of chemotherapy-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled, crossover trial (N00C3). Cancer 110(9):2110–2118PubMedCrossRef Rao RD, Michalak JC, Sloan JA et al (2007) Efficacy of gabapentin in the management of chemotherapy-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled, crossover trial (N00C3). Cancer 110(9):2110–2118PubMedCrossRef
8.
Zurück zum Zitat van Deventer H, Bernard S (1999) Use of gabapentin to treat taxane-induced myalgias. J Clin Oncol 17(1):434–435PubMed van Deventer H, Bernard S (1999) Use of gabapentin to treat taxane-induced myalgias. J Clin Oncol 17(1):434–435PubMed
9.
Zurück zum Zitat Nguyen VH, Lawrence HJ (2004) Use of gabapentin in the prevention of taxane-induced arthralgias and myalgias. J Clin Oncol 22(9):1767–1769PubMedCrossRef Nguyen VH, Lawrence HJ (2004) Use of gabapentin in the prevention of taxane-induced arthralgias and myalgias. J Clin Oncol 22(9):1767–1769PubMedCrossRef
10.
Zurück zum Zitat Matsumoto M, Inoue M, Hald A, Xie W, Ueda H (2006) Inhibition of paclitaxel-induced A-fiber hypersensitization by gabapentin. J Pharmacol Exp Ther 318(2):735–740PubMedCrossRef Matsumoto M, Inoue M, Hald A, Xie W, Ueda H (2006) Inhibition of paclitaxel-induced A-fiber hypersensitization by gabapentin. J Pharmacol Exp Ther 318(2):735–740PubMedCrossRef
11.
Zurück zum Zitat Clarke H, Bonin RP, Orser BA, Englesakis M, Wijeysundera DN, Katz J (2012) The prevention of chronic postsurgical pain using gabapentin and pregabalin: a combined systematic review and meta-analysis. Anesth Analg 115(2):428–442PubMedCrossRef Clarke H, Bonin RP, Orser BA, Englesakis M, Wijeysundera DN, Katz J (2012) The prevention of chronic postsurgical pain using gabapentin and pregabalin: a combined systematic review and meta-analysis. Anesth Analg 115(2):428–442PubMedCrossRef
12.
Zurück zum Zitat Tarride JE, Gordon A, Vera-Llonch M, Dukes E, Rousseau C (2006) Cost-effectiveness of pregabalin for the management of neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia: a Canadian perspective. Clin Ther 28(11):1922–1934PubMedCrossRef Tarride JE, Gordon A, Vera-Llonch M, Dukes E, Rousseau C (2006) Cost-effectiveness of pregabalin for the management of neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia: a Canadian perspective. Clin Ther 28(11):1922–1934PubMedCrossRef
13.
Zurück zum Zitat Athanasakis K, Petrakis I, Karampli E, Vitsou E, Lyras L, Kyriopoulos J (2013) Pregabalin versus gabapentin in the management of peripheral neuropathic pain associated with post-herpetic neuralgia and diabetic neuropathy: a cost effectiveness analysis for the Greek healthcare setting. BMC Neurol 13:56PubMedPubMedCentralCrossRef Athanasakis K, Petrakis I, Karampli E, Vitsou E, Lyras L, Kyriopoulos J (2013) Pregabalin versus gabapentin in the management of peripheral neuropathic pain associated with post-herpetic neuralgia and diabetic neuropathy: a cost effectiveness analysis for the Greek healthcare setting. BMC Neurol 13:56PubMedPubMedCentralCrossRef
14.
Zurück zum Zitat Lavoie Smith EM, Barton DL, Qin R, Steen PD, Aaronson NK, Loprinzi CL (2013) Assessing patient-reported peripheral neuropathy: the reliability and validity of the European Organization for Research and Treatment of Cancer QLQ-CIPN20 questionnaire. Qual Life Res 22(10):2787–2799PubMedPubMedCentralCrossRef Lavoie Smith EM, Barton DL, Qin R, Steen PD, Aaronson NK, Loprinzi CL (2013) Assessing patient-reported peripheral neuropathy: the reliability and validity of the European Organization for Research and Treatment of Cancer QLQ-CIPN20 questionnaire. Qual Life Res 22(10):2787–2799PubMedPubMedCentralCrossRef
15.
Zurück zum Zitat Postma TJ, Aaronson NK, Heimans JJ et al (2005) The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: the QLQ-CIPN20. Eur J Cancer 41(8):1135–1139PubMedCrossRef Postma TJ, Aaronson NK, Heimans JJ et al (2005) The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: the QLQ-CIPN20. Eur J Cancer 41(8):1135–1139PubMedCrossRef
17.
Zurück zum Zitat Hershman DL, Lacchetti C, Dworkin RH et al (2014) Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol 32(18):1941–1967PubMedCrossRef Hershman DL, Lacchetti C, Dworkin RH et al (2014) Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol 32(18):1941–1967PubMedCrossRef
18.
Zurück zum Zitat Moulin D, Boulanger A, Clark AJ et al (2014) Pharmacological management of chronic neuropathic pain: revised consensus statement from the Canadian Pain Society. Pain Res Manag 19(6):328–335PubMedPubMedCentral Moulin D, Boulanger A, Clark AJ et al (2014) Pharmacological management of chronic neuropathic pain: revised consensus statement from the Canadian Pain Society. Pain Res Manag 19(6):328–335PubMedPubMedCentral
19.
Zurück zum Zitat Hershman DL, Weimer LH, Wang A et al (2011) Association between patient reported outcomes and quantitative sensory tests for measuring long-term neurotoxicity in breast cancer survivors treated with adjuvant paclitaxel chemotherapy. Breast Cancer Res Treat 125(3):767–774PubMedCrossRef Hershman DL, Weimer LH, Wang A et al (2011) Association between patient reported outcomes and quantitative sensory tests for measuring long-term neurotoxicity in breast cancer survivors treated with adjuvant paclitaxel chemotherapy. Breast Cancer Res Treat 125(3):767–774PubMedCrossRef
20.
Zurück zum Zitat Bockbrader HN, Wesche D, Miller R, Chapel S, Janiczek N, Burger P (2010) A comparison of the pharmacokinetics and pharmacodynamics of pregabalin and gabapentin. Clin Pharmacokinet 49(10):661–669PubMedCrossRef Bockbrader HN, Wesche D, Miller R, Chapel S, Janiczek N, Burger P (2010) A comparison of the pharmacokinetics and pharmacodynamics of pregabalin and gabapentin. Clin Pharmacokinet 49(10):661–669PubMedCrossRef
22.
Metadaten
Titel
Can pregabalin prevent paclitaxel-associated neuropathy?—An ACCRU pilot trial
verfasst von
Shivani S. Shinde
Drew Seisler
Gamini Soori
Pamela J. Atherton
Deirdre R. Pachman
Jacqueline Lafky
Kathryn J. Ruddy
Charles L. Loprinzi
Publikationsdatum
01.02.2016
Verlag
Springer Berlin Heidelberg
Erschienen in
Supportive Care in Cancer / Ausgabe 2/2016
Print ISSN: 0941-4355
Elektronische ISSN: 1433-7339
DOI
https://doi.org/10.1007/s00520-015-2807-5

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