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      Considerations for establishing and maintaining international research collaboration: the example of chemotherapy-induced peripheral neurotoxicity (CIPN)—a white paper

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          Abstract

          Purpose

          This white paper provides guidance regarding the process for establishing and maintaining international collaborations to conduct oncology/neurology-focused chemotherapy-induced peripheral neurotoxicity (CIPN) research.

          Methods

          An international multidisciplinary group of CIPN scientists, clinicians, research administrators, and legal experts have pooled their collective knowledge regarding recommendations for establishing and maintaining international collaboration to foster advancement of CIPN science.

          Results

          Experts provide recommendations in 10 categories: (1) preclinical and (2) clinical research collaboration; (3) collaborators and consortiums; (4) communication; (5) funding; (6) international regulatory standards; (7) staff training; (8) data management, quality control, and data sharing; (9) dissemination across disciplines and countries; and (10) additional recommendations about feasibility, policy, and mentorship.

          Conclusion

          Recommendations to establish and maintain international CIPN research collaboration will promote the inclusion of more diverse research participants, increasing consideration of cultural and genetic factors that are essential to inform innovative precision medicine interventions and propel scientific discovery to benefit cancer survivors worldwide.

          Relevance to inform research policy

          Our suggested guidelines for establishing and maintaining international collaborations to conduct oncology/neurology-focused chemotherapy-induced peripheral neurotoxicity (CIPN) research set forth a challenge to multinational science, clinical, and policy leaders to (1) develop simple, streamlined research designs; (2) address logistical barriers; (3) simplify and standardize regulatory requirements across countries; (4) increase funding to support international collaboration; and (5) foster faculty mentorship.

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          Most cited references37

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          Cancer treatment and survivorship statistics, 2022

          The number of cancer survivors continues to increase in the United States due to the growth and aging of the population as well as advances in early detection and treatment. To assist the public health community in better serving these individuals, the American Cancer Society and the National Cancer Institute collaborate triennially to estimate cancer prevalence in the United States using incidence and survival data from the Surveillance, Epidemiology, and End Results cancer registries, vital statistics from the Centers for Disease Control and Prevention's National Center for Health Statistics, and population projections from the US Census Bureau. Current treatment patterns based on information in the National Cancer Database are presented for the most prevalent cancer types by race, and cancer-related and treatment-related side-effects are also briefly described. More than 18 million Americans (8.3 million males and 9.7 million females) with a history of cancer were alive on January 1, 2022. The 3 most prevalent cancers are prostate (3,523,230), melanoma of the skin (760,640), and colon and rectum (726,450) among males and breast (4,055,770), uterine corpus (891,560), and thyroid (823,800) among females. More than one-half (53%) of survivors were diagnosed within the past 10 years, and two-thirds (67%) were aged 65 years or older. One of the largest racial disparities in treatment is for rectal cancer, for which 41% of Black patients with stage I disease receive proctectomy or proctocolectomy compared to 66% of White patients. Surgical receipt is also substantially lower among Black patients with non-small cell lung cancer, 49% for stages I-II and 16% for stage III versus 55% and 22% for White patients, respectively. These treatment disparities are exacerbated by the fact that Black patients continue to be less likely to be diagnosed with stage I disease than White patients for most cancers, with some of the largest disparities for female breast (53% vs 68%) and endometrial (59% vs 73%). Although there are a growing number of tools that can assist patients, caregivers, and clinicians in navigating the various phases of cancer survivorship, further evidence-based strategies and equitable access to available resources are needed to mitigate disparities for communities of color and optimize care for people with a history of cancer. CA Cancer J Clin. 2022;72:409-436.
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            Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy in Survivors of Adult Cancers: ASCO Guideline Update

            To update the ASCO guideline on the recommended prevention and treatment approaches in the management of chemotherapy-induced peripheral neuropathy (CIPN) in adult cancer survivors. An Expert Panel conducted targeted systematic literature reviews to identify new studies. The search strategy identified 257 new references, which led to a full-text review of 87 manuscripts. A total of 3 systematic reviews, 2 with meta-analyses, and 28 primary trials for prevention of CIPN in addition to 14 primary trials related to treatment of established CIPN, are included in this update. The identified data reconfirmed that no agents are recommended for the prevention of CIPN. The use of acetyl-l-carnitine for the prevention of CIPN in patients with cancer should be discouraged. Furthermore, clinicians should assess the appropriateness of dose delaying, dose reduction, substitutions, or stopping chemotherapy in patients who develop intolerable neuropathy and/or functional impairment. Duloxetine is the only agent that has appropriate evidence to support its use for patients with established painful CIPN. Nonetheless, the amount of benefit from duloxetine is limited. Additional information is available at www.asco.org/survivorship-guidelines .
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              The chemotherapy-induced peripheral neuropathy outcome measures standardization study: from consensus to the first validity and reliability findings.

              Chemotherapy-induced peripheral neuropathy (CIPN) is a debilitating and dose-limiting complication of cancer treatment. Thus far, the impact of CIPN has not been studied in a systematic clinimetric manner. The objective of the study was to select outcome measures for CIPN evaluation and to establish their validity and reproducibility in a cross-sectional multicenter study. After literature review and a consensus meeting among experts, face/content validity were obtained for the following selected scales: the National Cancer Institute-Common Toxicity Criteria (NCI-CTC), the Total Neuropathy Score clinical version (TNSc), the modified Inflammatory Neuropathy Cause and Treatment (INCAT) group sensory sumscore (mISS), the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, and CIPN20 quality-of-life measures. A total of 281 patients with stable CIPN were examined. Validity (correlation) and reliability studies were carried out. Good inter-/intra-observer scores were obtained for the TNSc, mISS, and NCI-CTC sensory/motor subscales. Test-retest values were also good for the EORTC QLQ-C30 and CIPN20. Acceptable validity scores were obtained through the correlation among the measures. Good validity and reliability scores were demonstrated for the set of selected impairment and quality-of-life outcome measures in CIPN. Future studies are planned to investigate the responsiveness aspects of these measures.
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                Author and article information

                Contributors
                esmith3@uab.edu
                Journal
                Support Care Cancer
                Support Care Cancer
                Supportive Care in Cancer
                Springer Berlin Heidelberg (Berlin/Heidelberg )
                0941-4355
                1433-7339
                20 January 2024
                20 January 2024
                2024
                : 32
                : 2
                : 117
                Affiliations
                [1 ]University of Milano-Bicocca, School of Medicine and Surgery, ( https://ror.org/01ynf4891) Monza, Italy
                [2 ]GRID grid.415025.7, ISNI 0000 0004 1756 8604, Fondazione IRCCS San Gerardo dei Tintori, ; Monza, Italy
                [3 ]GRID grid.413414.7, Neurology Department, Agios Andreas General Hospital, ; Patras, Greece
                [4 ]Hospital Universitari de Bellvitge, Neuro-Oncology Unit, Institut Catala d’Oncologia (IDIBELL), L’Hospitalet del Llobregat, ( https://ror.org/00epner96) Barcelona, Spain
                [5 ]Department of Pharmacology and Toxicology and Translational Research Initiative for Pain and Neuropathy, Virginia Commonwealth University, ( https://ror.org/02nkdxk79) Richmond, VA USA
                [6 ]Trinity College Dublin, School of Medicine, ( https://ror.org/02tyrky19) Dublin, Ireland
                [7 ]University of Dublin, Trinity Centre for Health Sciences St. James’s Hospital Campus, ( https://ror.org/02tyrky19) Dublin, Ireland
                [8 ]University of Alabama at Birmingham, Office of Sponsored Programs, ( https://ror.org/008s83205) Birmingham, AL USA
                [9 ]GRID grid.21107.35, ISNI 0000 0001 2171 9311, Department of Neurology, Johns Hopkins School of Medicine, ; Baltimore, MD USA
                [10 ]Department of Health Behavior and Biological Sciences, University of Michigan School of Nursing, ( https://ror.org/00jmfr291) Ann Arbor, MI USA
                [11 ]Department of Neurological Sciences, University of Vermont Robert Larner College of Medicine, ( https://ror.org/0155zta11) Burlington, VT USA
                [12 ]Faculty of Medicine and Health, University of Sydney, Brain and Mind Centre and School of Medical Sciences, ( https://ror.org/0384j8v12) Sydney, Australia
                [13 ]Department of Neurology, Mayo Clinic, ( https://ror.org/02qp3tb03) Rochester, MN USA
                [14 ]Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, ( https://ror.org/039bp8j42) Verona, Italy
                [15 ]GRID grid.21107.35, ISNI 0000 0001 2171 9311, Department of Neurology, Johns Hopkins School of Medicine, ; Baltimore, MD USA
                [16 ]Department of Acute, Chronic & Continuing Care, University of Alabama at Birmingham School of Nursing, ( https://ror.org/008s83205) Birmingham, AL USA
                Author information
                https://orcid.org/0000-0001-6106-6183
                https://orcid.org/0000-0003-2131-7114
                https://orcid.org/0000-0001-6895-5047
                https://orcid.org/0000-0002-7951-0243
                https://orcid.org/0000-0003-1215-3373
                https://orcid.org/0000-0002-6996-5068
                https://orcid.org/0000-0003-2651-2349
                https://orcid.org/0000-0003-1138-1489
                https://orcid.org/0000-0003-0218-4707
                https://orcid.org/0000-0001-6760-3859
                https://orcid.org/0000-0002-1561-2187
                https://orcid.org/0000-0002-6519-6636
                Article
                8301
                10.1007/s00520-023-08301-5
                10799817
                38244122
                ce943b42-d13f-4326-ae3e-956df5c5ee62
                © The Author(s) 2024

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

                History
                : 14 September 2023
                : 28 December 2023
                Categories
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                © Springer-Verlag GmbH Germany, part of Springer Nature 2024

                Oncology & Radiotherapy
                international collaboration,chemotherapy-induced peripheral neurotoxicity,research

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