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Conference Paper: CALGB 170601: A phase III double blind trial of duloxetine to treat painful chemotherapy-induced peripheral neuropathy (CIPN)

TitleCALGB 170601: A phase III double blind trial of duloxetine to treat painful chemotherapy-induced peripheral neuropathy (CIPN)
Authors
Issue Date2012
PublisherLippincott Williams & Wilkins.
Citation
The 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO 2012), Chicago, IL., 1-5 June 2012. In Journal of Clinical Oncology, 2012, v. 30 n. 15 suppl., p. 570s, abstract CRA9013 How to Cite?
AbstractBACKGROUND: CALGB 170601 was a randomized, placebo-controlled phase III trial to determine whether duloxetine reduces painful chemotherapy-induced peripheral neuropathy (CIPN). The secondary study endpoint was treatment-related adverse events. METHODS: The study used a double-blinded placebo-controlled crossover design with equally weighted randomization to one of two arms. Arm A participants received duloxetine followed by placebo. Arm B participants received placebo followed by duloxetine. The initial and crossover periods each consisted of six weeks of drug/placebo followed by one week of washout. Randomization was stratified by neurotoxic agent and high risk for developing painful CIPN. Eligible patients were 18 years or older with an average CIPN pain score > 4/10 attributed to prior single agent taxane or platinum treatment. Participants took one capsule daily (30mg) for one week, and then two capsules (60mg) daily for four additional weeks. Participants completed the Brief Pain Inventory-Short Form (BPI-SF) at baseline and then weekly. The primary study endpoint was the change in BPI-SF scores within the initial treatment period. Analysis of covariance with an intent-to-treat approach was used to test the effect of treatment on change in pain score. RESULTS: The target accrual goal (N = 231) was met, of which 185 (80%) completed the initial treatment period. Oxaliplatin was the most commonly received neurotoxic agent (59%). Individuals receiving duloxetine over the initial treatment period had a larger average decrease in pain score (mean change score = -1.09; S.E. = 0.19) than those receiving placebo (mean change score = -0.33; S.E. = 0.18) (p = 0.004). There was no difference in duloxetine efficacy based on the specific neurotoxic agent received. Severe (Grade 3) non-hematologic toxicity was reported by 11%, and 41% reported moderate (Grade 2) toxicities. The incidence of Grade 2+ fatigue, the most commonly reported side effect, was significantly higher in the duloxetine arm as compared to placebo (11% vs. 3%, p = 0.029). CONCLUSIONS: Duloxetine 60mg daily is an efficacious and well-tolerated intervention for the treatment of taxane or platinum-related painful CIPN.
DescriptionThis journal suppl. entitled: 2012 ASCO Annual Meeting Abstracts
Persistent Identifierhttp://hdl.handle.net/10722/195781
ISSN
2015 Impact Factor: 20.982
2015 SCImago Journal Rankings: 9.204

 

DC FieldValueLanguage
dc.contributor.authorLavoie Smith, EMen_US
dc.contributor.authorPang, HMHen_US
dc.contributor.authorCirrincione, Cen_US
dc.contributor.authorFleishman, SBen_US
dc.contributor.authorPaskett, EDen_US
dc.contributor.authorFadul, CEen_US
dc.contributor.authorKnox, Cen_US
dc.contributor.authorShapiro, CLen_US
dc.contributor.authorGilman, Pen_US
dc.contributor.authorCancer and Leukemia Group Ben_US
dc.date.accessioned2014-03-10T04:52:57Z-
dc.date.available2014-03-10T04:52:57Z-
dc.date.issued2012en_US
dc.identifier.citationThe 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO 2012), Chicago, IL., 1-5 June 2012. In Journal of Clinical Oncology, 2012, v. 30 n. 15 suppl., p. 570s, abstract CRA9013en_US
dc.identifier.issn0732-183X-
dc.identifier.urihttp://hdl.handle.net/10722/195781-
dc.descriptionThis journal suppl. entitled: 2012 ASCO Annual Meeting Abstracts-
dc.description.abstractBACKGROUND: CALGB 170601 was a randomized, placebo-controlled phase III trial to determine whether duloxetine reduces painful chemotherapy-induced peripheral neuropathy (CIPN). The secondary study endpoint was treatment-related adverse events. METHODS: The study used a double-blinded placebo-controlled crossover design with equally weighted randomization to one of two arms. Arm A participants received duloxetine followed by placebo. Arm B participants received placebo followed by duloxetine. The initial and crossover periods each consisted of six weeks of drug/placebo followed by one week of washout. Randomization was stratified by neurotoxic agent and high risk for developing painful CIPN. Eligible patients were 18 years or older with an average CIPN pain score > 4/10 attributed to prior single agent taxane or platinum treatment. Participants took one capsule daily (30mg) for one week, and then two capsules (60mg) daily for four additional weeks. Participants completed the Brief Pain Inventory-Short Form (BPI-SF) at baseline and then weekly. The primary study endpoint was the change in BPI-SF scores within the initial treatment period. Analysis of covariance with an intent-to-treat approach was used to test the effect of treatment on change in pain score. RESULTS: The target accrual goal (N = 231) was met, of which 185 (80%) completed the initial treatment period. Oxaliplatin was the most commonly received neurotoxic agent (59%). Individuals receiving duloxetine over the initial treatment period had a larger average decrease in pain score (mean change score = -1.09; S.E. = 0.19) than those receiving placebo (mean change score = -0.33; S.E. = 0.18) (p = 0.004). There was no difference in duloxetine efficacy based on the specific neurotoxic agent received. Severe (Grade 3) non-hematologic toxicity was reported by 11%, and 41% reported moderate (Grade 2) toxicities. The incidence of Grade 2+ fatigue, the most commonly reported side effect, was significantly higher in the duloxetine arm as compared to placebo (11% vs. 3%, p = 0.029). CONCLUSIONS: Duloxetine 60mg daily is an efficacious and well-tolerated intervention for the treatment of taxane or platinum-related painful CIPN.-
dc.languageengen_US
dc.publisherLippincott Williams & Wilkins.-
dc.relation.ispartofJournal of Clinical Oncologyen_US
dc.titleCALGB 170601: A phase III double blind trial of duloxetine to treat painful chemotherapy-induced peripheral neuropathy (CIPN)en_US
dc.typeConference_Paperen_US
dc.identifier.emailPang, HMH: herbpang@hku.hken_US
dc.identifier.authorityPang, HMH=rp01857en_US
dc.identifier.volume30en_US
dc.identifier.issue15_suppl (May 20 Supplement)-
dc.identifier.spage570s, abstract CRA9013en_US
dc.identifier.epage570s, abstract CRA9013en_US
dc.publisher.placeUnited States-

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