The National Cancer Institute Clinical Trials Planning Meeting for Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy

Susan G. Dorsey, Ian R. Kleckner, Debra Barton, Karen Mustian, Ann O'Mara, Diane St Germain, Guido Cavaletti, Suzanne C. Danhauer, Dawn L. Hershman, Andrea G. Hohmann, Ahmet Hoke, Judith O. Hopkins, Katherine P. Kelly, Charles L. Loprinzi, Howard L. McLeod, Supriya Mohile, Judith Paice, Julia H. Rowland, Daniela Salvemini, Rosalind A. Segal & 3 others Ellen Lavoie Smith, Worta Mc Caskill Stevens, Michelle C. Janelsins

Research output: Contribution to journalReview article

Abstract

Although recent scientific advances have improved our understanding of basic biological mechanisms underlying chemotherapy-induced peripheral neuropathy (CIPN), few interventions are available to prevent or treat CIPN. Although some biological targets from preclinical studies show promise in nonhuman animal models, few targets have been translated to successful clinical trials. To address this problem, the National Cancer Institute's Symptom Management and HealthRelated Quality of Life Steering Committee convened a meeting of experts in the CIPN and oncology symptom management fields to participate in a Clinical Trials Planning Meeting (CTPM). Investigators presented data from preclinical and translational studies for possible CIPN interventions; these were evaluated for readiness of randomized clinical trial testing by experts, and recommendations were provided. Breakout sessions were convened to discuss and develop future studies. The CTPM experts concluded that there is compelling evidence to move forward with selected pharmacological and nonpharmacological clinical trials for the prevention and treatment of CIPN. Several key feasibility issues need to be addressed, however. These include identification of optimal outcome measures to define the CIPN phenotype, establishment of parameters that guide the evaluation of clinically meaningful effects, and adoption of approaches for inclusion of translational and biomarker and/or genetic measures. The results of the CTPM provide support for conducting clinical trials that include both pharmacological and nonpharmacological approaches, alone or in combination, with biomarkers, genetics, or other measures designed to inform underlying CIPN mechanisms. Several working groups were formed to design rigorous CIPN clinical trials, the results of which are ongoing.

Original languageEnglish (US)
Pages (from-to)531-537
Number of pages7
JournalJournal of the National Cancer Institute
Volume111
Issue number6
DOIs
StatePublished - Jun 1 2019

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National Cancer Institute (U.S.)
Peripheral Nervous System Diseases
Clinical Trials
Drug Therapy
Therapeutics
Biomarkers
Pharmacology
Randomized Controlled Trials
Animal Models
Quality of Life
Research Personnel
Outcome Assessment (Health Care)
Phenotype

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

The National Cancer Institute Clinical Trials Planning Meeting for Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy. / Dorsey, Susan G.; Kleckner, Ian R.; Barton, Debra; Mustian, Karen; O'Mara, Ann; St Germain, Diane; Cavaletti, Guido; Danhauer, Suzanne C.; Hershman, Dawn L.; Hohmann, Andrea G.; Hoke, Ahmet; Hopkins, Judith O.; Kelly, Katherine P.; Loprinzi, Charles L.; McLeod, Howard L.; Mohile, Supriya; Paice, Judith; Rowland, Julia H.; Salvemini, Daniela; Segal, Rosalind A.; Smith, Ellen Lavoie; Stevens, Worta Mc Caskill; Janelsins, Michelle C.

In: Journal of the National Cancer Institute, Vol. 111, No. 6, 01.06.2019, p. 531-537.

Research output: Contribution to journalReview article

Dorsey, SG, Kleckner, IR, Barton, D, Mustian, K, O'Mara, A, St Germain, D, Cavaletti, G, Danhauer, SC, Hershman, DL, Hohmann, AG, Hoke, A, Hopkins, JO, Kelly, KP, Loprinzi, CL, McLeod, HL, Mohile, S, Paice, J, Rowland, JH, Salvemini, D, Segal, RA, Smith, EL, Stevens, WMC & Janelsins, MC 2019, 'The National Cancer Institute Clinical Trials Planning Meeting for Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy', Journal of the National Cancer Institute, vol. 111, no. 6, pp. 531-537. https://doi.org/10.1093/jnci/djz011
Dorsey, Susan G. ; Kleckner, Ian R. ; Barton, Debra ; Mustian, Karen ; O'Mara, Ann ; St Germain, Diane ; Cavaletti, Guido ; Danhauer, Suzanne C. ; Hershman, Dawn L. ; Hohmann, Andrea G. ; Hoke, Ahmet ; Hopkins, Judith O. ; Kelly, Katherine P. ; Loprinzi, Charles L. ; McLeod, Howard L. ; Mohile, Supriya ; Paice, Judith ; Rowland, Julia H. ; Salvemini, Daniela ; Segal, Rosalind A. ; Smith, Ellen Lavoie ; Stevens, Worta Mc Caskill ; Janelsins, Michelle C. / The National Cancer Institute Clinical Trials Planning Meeting for Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy. In: Journal of the National Cancer Institute. 2019 ; Vol. 111, No. 6. pp. 531-537.
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abstract = "Although recent scientific advances have improved our understanding of basic biological mechanisms underlying chemotherapy-induced peripheral neuropathy (CIPN), few interventions are available to prevent or treat CIPN. Although some biological targets from preclinical studies show promise in nonhuman animal models, few targets have been translated to successful clinical trials. To address this problem, the National Cancer Institute's Symptom Management and HealthRelated Quality of Life Steering Committee convened a meeting of experts in the CIPN and oncology symptom management fields to participate in a Clinical Trials Planning Meeting (CTPM). Investigators presented data from preclinical and translational studies for possible CIPN interventions; these were evaluated for readiness of randomized clinical trial testing by experts, and recommendations were provided. Breakout sessions were convened to discuss and develop future studies. The CTPM experts concluded that there is compelling evidence to move forward with selected pharmacological and nonpharmacological clinical trials for the prevention and treatment of CIPN. Several key feasibility issues need to be addressed, however. These include identification of optimal outcome measures to define the CIPN phenotype, establishment of parameters that guide the evaluation of clinically meaningful effects, and adoption of approaches for inclusion of translational and biomarker and/or genetic measures. The results of the CTPM provide support for conducting clinical trials that include both pharmacological and nonpharmacological approaches, alone or in combination, with biomarkers, genetics, or other measures designed to inform underlying CIPN mechanisms. Several working groups were formed to design rigorous CIPN clinical trials, the results of which are ongoing.",
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T1 - The National Cancer Institute Clinical Trials Planning Meeting for Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy

AU - Dorsey, Susan G.

AU - Kleckner, Ian R.

AU - Barton, Debra

AU - Mustian, Karen

AU - O'Mara, Ann

AU - St Germain, Diane

AU - Cavaletti, Guido

AU - Danhauer, Suzanne C.

AU - Hershman, Dawn L.

AU - Hohmann, Andrea G.

AU - Hoke, Ahmet

AU - Hopkins, Judith O.

AU - Kelly, Katherine P.

AU - Loprinzi, Charles L.

AU - McLeod, Howard L.

AU - Mohile, Supriya

AU - Paice, Judith

AU - Rowland, Julia H.

AU - Salvemini, Daniela

AU - Segal, Rosalind A.

AU - Smith, Ellen Lavoie

AU - Stevens, Worta Mc Caskill

AU - Janelsins, Michelle C.

PY - 2019/6/1

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N2 - Although recent scientific advances have improved our understanding of basic biological mechanisms underlying chemotherapy-induced peripheral neuropathy (CIPN), few interventions are available to prevent or treat CIPN. Although some biological targets from preclinical studies show promise in nonhuman animal models, few targets have been translated to successful clinical trials. To address this problem, the National Cancer Institute's Symptom Management and HealthRelated Quality of Life Steering Committee convened a meeting of experts in the CIPN and oncology symptom management fields to participate in a Clinical Trials Planning Meeting (CTPM). Investigators presented data from preclinical and translational studies for possible CIPN interventions; these were evaluated for readiness of randomized clinical trial testing by experts, and recommendations were provided. Breakout sessions were convened to discuss and develop future studies. The CTPM experts concluded that there is compelling evidence to move forward with selected pharmacological and nonpharmacological clinical trials for the prevention and treatment of CIPN. Several key feasibility issues need to be addressed, however. These include identification of optimal outcome measures to define the CIPN phenotype, establishment of parameters that guide the evaluation of clinically meaningful effects, and adoption of approaches for inclusion of translational and biomarker and/or genetic measures. The results of the CTPM provide support for conducting clinical trials that include both pharmacological and nonpharmacological approaches, alone or in combination, with biomarkers, genetics, or other measures designed to inform underlying CIPN mechanisms. Several working groups were formed to design rigorous CIPN clinical trials, the results of which are ongoing.

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