Efficacy of lamotrigine in the management of chemotherapy-induced peripheral neuropathy: A phase 3 randomized, double-blind, placebo-controlled trial, N01C3

Ravi D. Rao, Patrick J. Flynn, Jeff A Sloan, Gilbert Y. Wong, Paul Novotny, David B. Johnson, Howard M. Gross, Samer I. Renno, Mohammed Nashawaty, Charles Lawrence Loprinzi

Research output: Contribution to journalArticle

129 Citations (Scopus)

Abstract

BACKGROUND. Lamotrigine, an antiepileptic agent, has been reported as being effective in reducing symptoms of neuropathy associated with various etiologies. Based on such data, a multicenter double-blind, placebo-controlled, randomized trial was conducted to evaluate the effect of lamotrigine on pain and other neuropathic symptoms due to chemotherapy-induced peripheral neuropathy (CIPN). METHODS. Patients with symptomatic CIPN with symptom scores of either 1) >3 on a 0-10 Numerical Rating Scale (NRS) or 2) >1 on the 0-3 the Eastern Cooperative Oncology Group (ECOG) neuropathy scale (ENS) were eligible (higher numbers corresponding to greater severity of symptoms in both scales). Patients were randomly assigned to receive lamotrigine (target dose of 300 mg/day) or placebo for 10 weeks. Endpoints were measured biweekly. RESULTS. In all, 131 patients were enrolled. Both groups were well matched at baseline. Over the 10-week period of the trial, the average pain scores (NRS) for the lamotrigine and placebo arms declined in both arms, with no statistically significant difference noted between the changes in the 2 groups (0.3 and 0.5 unit reduction from baseline, respectively; P = .56). Similarly, decreases in the ENS with therapy were not statistically different (0.4 and 0.3, respectively; P = .3). Changes in other subjective symptom scales were also not found to be statistically different between the 2 groups. Toxicities were mild and similar in each group. CONCLUSIONS. The results suggest that lamotrigine is not effective for relieving neuropathic symptoms in patients because of CIPN.

Original languageEnglish (US)
Pages (from-to)2802-2808
Number of pages7
JournalCancer
Volume112
Issue number12
DOIs
StatePublished - Jun 15 2008

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Peripheral Nervous System Diseases
Placebos
Drug Therapy
Neuralgia
Anticonvulsants
Randomized Controlled Trials
lamotrigine
Pain

Keywords

  • Carboplatin
  • Chemotherapy-induced peripheral neuropathy
  • Cisplatin
  • Lamotrigine
  • Neurotoxicity
  • Paclitaxel
  • Pain
  • Peripheral neuropathy
  • Taxanes
  • Vinca alkaloids

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Efficacy of lamotrigine in the management of chemotherapy-induced peripheral neuropathy : A phase 3 randomized, double-blind, placebo-controlled trial, N01C3. / Rao, Ravi D.; Flynn, Patrick J.; Sloan, Jeff A; Wong, Gilbert Y.; Novotny, Paul; Johnson, David B.; Gross, Howard M.; Renno, Samer I.; Nashawaty, Mohammed; Loprinzi, Charles Lawrence.

In: Cancer, Vol. 112, No. 12, 15.06.2008, p. 2802-2808.

Research output: Contribution to journalArticle

Rao, Ravi D. ; Flynn, Patrick J. ; Sloan, Jeff A ; Wong, Gilbert Y. ; Novotny, Paul ; Johnson, David B. ; Gross, Howard M. ; Renno, Samer I. ; Nashawaty, Mohammed ; Loprinzi, Charles Lawrence. / Efficacy of lamotrigine in the management of chemotherapy-induced peripheral neuropathy : A phase 3 randomized, double-blind, placebo-controlled trial, N01C3. In: Cancer. 2008 ; Vol. 112, No. 12. pp. 2802-2808.
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abstract = "BACKGROUND. Lamotrigine, an antiepileptic agent, has been reported as being effective in reducing symptoms of neuropathy associated with various etiologies. Based on such data, a multicenter double-blind, placebo-controlled, randomized trial was conducted to evaluate the effect of lamotrigine on pain and other neuropathic symptoms due to chemotherapy-induced peripheral neuropathy (CIPN). METHODS. Patients with symptomatic CIPN with symptom scores of either 1) >3 on a 0-10 Numerical Rating Scale (NRS) or 2) >1 on the 0-3 the Eastern Cooperative Oncology Group (ECOG) neuropathy scale (ENS) were eligible (higher numbers corresponding to greater severity of symptoms in both scales). Patients were randomly assigned to receive lamotrigine (target dose of 300 mg/day) or placebo for 10 weeks. Endpoints were measured biweekly. RESULTS. In all, 131 patients were enrolled. Both groups were well matched at baseline. Over the 10-week period of the trial, the average pain scores (NRS) for the lamotrigine and placebo arms declined in both arms, with no statistically significant difference noted between the changes in the 2 groups (0.3 and 0.5 unit reduction from baseline, respectively; P = .56). Similarly, decreases in the ENS with therapy were not statistically different (0.4 and 0.3, respectively; P = .3). Changes in other subjective symptom scales were also not found to be statistically different between the 2 groups. Toxicities were mild and similar in each group. CONCLUSIONS. The results suggest that lamotrigine is not effective for relieving neuropathic symptoms in patients because of CIPN.",
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T1 - Efficacy of lamotrigine in the management of chemotherapy-induced peripheral neuropathy

T2 - A phase 3 randomized, double-blind, placebo-controlled trial, N01C3

AU - Rao, Ravi D.

AU - Flynn, Patrick J.

AU - Sloan, Jeff A

AU - Wong, Gilbert Y.

AU - Novotny, Paul

AU - Johnson, David B.

AU - Gross, Howard M.

AU - Renno, Samer I.

AU - Nashawaty, Mohammed

AU - Loprinzi, Charles Lawrence

PY - 2008/6/15

Y1 - 2008/6/15

N2 - BACKGROUND. Lamotrigine, an antiepileptic agent, has been reported as being effective in reducing symptoms of neuropathy associated with various etiologies. Based on such data, a multicenter double-blind, placebo-controlled, randomized trial was conducted to evaluate the effect of lamotrigine on pain and other neuropathic symptoms due to chemotherapy-induced peripheral neuropathy (CIPN). METHODS. Patients with symptomatic CIPN with symptom scores of either 1) >3 on a 0-10 Numerical Rating Scale (NRS) or 2) >1 on the 0-3 the Eastern Cooperative Oncology Group (ECOG) neuropathy scale (ENS) were eligible (higher numbers corresponding to greater severity of symptoms in both scales). Patients were randomly assigned to receive lamotrigine (target dose of 300 mg/day) or placebo for 10 weeks. Endpoints were measured biweekly. RESULTS. In all, 131 patients were enrolled. Both groups were well matched at baseline. Over the 10-week period of the trial, the average pain scores (NRS) for the lamotrigine and placebo arms declined in both arms, with no statistically significant difference noted between the changes in the 2 groups (0.3 and 0.5 unit reduction from baseline, respectively; P = .56). Similarly, decreases in the ENS with therapy were not statistically different (0.4 and 0.3, respectively; P = .3). Changes in other subjective symptom scales were also not found to be statistically different between the 2 groups. Toxicities were mild and similar in each group. CONCLUSIONS. The results suggest that lamotrigine is not effective for relieving neuropathic symptoms in patients because of CIPN.

AB - BACKGROUND. Lamotrigine, an antiepileptic agent, has been reported as being effective in reducing symptoms of neuropathy associated with various etiologies. Based on such data, a multicenter double-blind, placebo-controlled, randomized trial was conducted to evaluate the effect of lamotrigine on pain and other neuropathic symptoms due to chemotherapy-induced peripheral neuropathy (CIPN). METHODS. Patients with symptomatic CIPN with symptom scores of either 1) >3 on a 0-10 Numerical Rating Scale (NRS) or 2) >1 on the 0-3 the Eastern Cooperative Oncology Group (ECOG) neuropathy scale (ENS) were eligible (higher numbers corresponding to greater severity of symptoms in both scales). Patients were randomly assigned to receive lamotrigine (target dose of 300 mg/day) or placebo for 10 weeks. Endpoints were measured biweekly. RESULTS. In all, 131 patients were enrolled. Both groups were well matched at baseline. Over the 10-week period of the trial, the average pain scores (NRS) for the lamotrigine and placebo arms declined in both arms, with no statistically significant difference noted between the changes in the 2 groups (0.3 and 0.5 unit reduction from baseline, respectively; P = .56). Similarly, decreases in the ENS with therapy were not statistically different (0.4 and 0.3, respectively; P = .3). Changes in other subjective symptom scales were also not found to be statistically different between the 2 groups. Toxicities were mild and similar in each group. CONCLUSIONS. The results suggest that lamotrigine is not effective for relieving neuropathic symptoms in patients because of CIPN.

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KW - Neurotoxicity

KW - Paclitaxel

KW - Pain

KW - Peripheral neuropathy

KW - Taxanes

KW - Vinca alkaloids

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