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Investigations, CTCAE

MedGen UID:
1643999
•Concept ID:
C4554620
•
Finding

Term Hierarchy

CClinical test,  RResearch test,  OOMIM,  GGeneReviews,  VClinVar  
  • CROGVInvestigations, CTCAE

Professional guidelines

PubMed

Composite grading algorithm for the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Basch E, Becker C, Rogak LJ, Schrag D, Reeve BB, Spears P, Smith ML, Gounder MM, Mahoney MR, Schwartz GK, Bennett AV, Mendoza TR, Cleeland CS, Sloan JA, Bruner DW, Schwab G, Atkinson TM, Thanarajasingam G, Bertagnolli MM, Dueck AC
Clin Trials 2021 Feb;18(1):104-114. Epub 2020 Dec 1 doi: 10.1177/1740774520975120. PMID: 33258687Free PMC Article
Response to trametinib treatment in progressive pediatric low-grade glioma patients.
Selt F, van Tilburg CM, Bison B, Sievers P, Harting I, Ecker J, Pajtler KW, Sahm F, Bahr A, Simon M, Jones DTW, Well L, Mautner VF, Capper D, Hernáiz Driever P, Gnekow A, Pfister SM, Witt O, Milde T
J Neurooncol 2020 Sep;149(3):499-510. Epub 2020 Oct 7 doi: 10.1007/s11060-020-03640-3. PMID: 33026636Free PMC Article
Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).
Basch E, Reeve BB, Mitchell SA, Clauser SB, Minasian LM, Dueck AC, Mendoza TR, Hay J, Atkinson TM, Abernethy AP, Bruner DW, Cleeland CS, Sloan JA, Chilukuri R, Baumgartner P, Denicoff A, St Germain D, O'Mara AM, Chen A, Kelaghan J, Bennett AV, Sit L, Rogak L, Barz A, Paul DB, Schrag D
J Natl Cancer Inst 2014 Sep;106(9) Epub 2014 Sep 29 doi: 10.1093/jnci/dju244. PMID: 25265940Free PMC Article

Recent clinical studies

Etiology

Hypofractionated, 3-week, preoperative radiotherapy for patients with soft tissue sarcomas (HYPORT-STS): a single-centre, open-label, single-arm, phase 2 trial.
Guadagnolo BA, Bassett RL, Mitra D, Farooqi A, Hempel C, Dorber C, Willis T, Wang WL, Ratan R, Somaiah N, Benjamin RS, Torres KE, Hunt KK, Scally CP, Keung EZ, Satcher RL, Bird JE, Lin PP, Moon BS, Lewis VO, Roland CL, Bishop AJ
Lancet Oncol 2022 Dec;23(12):1547-1557. Epub 2022 Nov 4 doi: 10.1016/S1470-2045(22)00638-6. PMID: 36343656Free PMC Article
Sequential Intravesical Gemcitabine and Docetaxel for bacillus Calmette-Guérin-Naïve High-Risk Nonmuscle-Invasive Bladder Cancer.
McElree IM, Steinberg RL, Martin AC, Richards J, Mott SL, Gellhaus PT, Nepple KG, O'Donnell MA, Packiam VT
J Urol 2022 Sep;208(3):589-599. Epub 2022 Jul 27 doi: 10.1097/JU.0000000000002740. PMID: 35892270
Composite grading algorithm for the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Basch E, Becker C, Rogak LJ, Schrag D, Reeve BB, Spears P, Smith ML, Gounder MM, Mahoney MR, Schwartz GK, Bennett AV, Mendoza TR, Cleeland CS, Sloan JA, Bruner DW, Schwab G, Atkinson TM, Thanarajasingam G, Bertagnolli MM, Dueck AC
Clin Trials 2021 Feb;18(1):104-114. Epub 2020 Dec 1 doi: 10.1177/1740774520975120. PMID: 33258687Free PMC Article
Randomized Phase III Trial of Dose-dense Methotrexate, Vinblastine, Doxorubicin, and Cisplatin, or Gemcitabine and Cisplatin as Perioperative Chemotherapy for Patients with Muscle-invasive Bladder Cancer. Analysis of the GETUG/AFU V05 VESPER Trial Secondary Endpoints: Chemotherapy Toxicity and Pathological Responses.
Pfister C, Gravis G, Fléchon A, Soulié M, Guy L, Laguerre B, Mottet N, Joly F, Allory Y, Harter V, Culine S; VESPER Trial Investigators
Eur Urol 2021 Feb;79(2):214-221. Epub 2020 Aug 28 doi: 10.1016/j.eururo.2020.08.024. PMID: 32868138
Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).
Basch E, Reeve BB, Mitchell SA, Clauser SB, Minasian LM, Dueck AC, Mendoza TR, Hay J, Atkinson TM, Abernethy AP, Bruner DW, Cleeland CS, Sloan JA, Chilukuri R, Baumgartner P, Denicoff A, St Germain D, O'Mara AM, Chen A, Kelaghan J, Bennett AV, Sit L, Rogak L, Barz A, Paul DB, Schrag D
J Natl Cancer Inst 2014 Sep;106(9) Epub 2014 Sep 29 doi: 10.1093/jnci/dju244. PMID: 25265940Free PMC Article

Diagnosis

Characteristics of Immune Checkpoint Inhibitor-Induced Colitis: A Systematic Review.
Nakane T, Mitsuyama K, Yamauchi R, Kakuma T, Torimura T
Kurume Med J 2023 Jul 3;68(2):43-52. Epub 2023 Apr 26 doi: 10.2739/kurumemedj.MS682006. PMID: 37100606
Composite grading algorithm for the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Basch E, Becker C, Rogak LJ, Schrag D, Reeve BB, Spears P, Smith ML, Gounder MM, Mahoney MR, Schwartz GK, Bennett AV, Mendoza TR, Cleeland CS, Sloan JA, Bruner DW, Schwab G, Atkinson TM, Thanarajasingam G, Bertagnolli MM, Dueck AC
Clin Trials 2021 Feb;18(1):104-114. Epub 2020 Dec 1 doi: 10.1177/1740774520975120. PMID: 33258687Free PMC Article
Chemotherapy-induced peripheral neuropathy-patient-reported outcomes compared with NCI-CTCAE grade.
Tan AC, McCrary JM, Park SB, Trinh T, Goldstein D
Support Care Cancer 2019 Dec;27(12):4771-4777. Epub 2019 Apr 10 doi: 10.1007/s00520-019-04781-6. PMID: 30972648
Evaluation of Bortezomib-Induced Neuropathy Using Total Neuropathy Score (Reduced and Clinical Versions) and NCI CTCAE v4.0 in Newly Diagnosed Patients With Multiple Myeloma Receiving Bortezomib-Based Induction.
Lakshman A, Modi M, Prakash G, Malhotra P, Khadwal A, Jain S, Kumari S, Varma N, Varma S
Clin Lymphoma Myeloma Leuk 2017 Aug;17(8):513-519.e1. Epub 2017 Jul 6 doi: 10.1016/j.clml.2017.06.035. PMID: 28842138
Comparison of cardiac events associated with liposomal doxorubicin, epirubicin and doxorubicin in breast cancer: a Bayesian network meta-analysis.
Yamaguchi N, Fujii T, Aoi S, Kozuch PS, Hortobagyi GN, Blum RH
Eur J Cancer 2015 Nov;51(16):2314-20. Epub 2015 Sep 3 doi: 10.1016/j.ejca.2015.07.031. PMID: 26343314

Therapy

Hypofractionated, 3-week, preoperative radiotherapy for patients with soft tissue sarcomas (HYPORT-STS): a single-centre, open-label, single-arm, phase 2 trial.
Guadagnolo BA, Bassett RL, Mitra D, Farooqi A, Hempel C, Dorber C, Willis T, Wang WL, Ratan R, Somaiah N, Benjamin RS, Torres KE, Hunt KK, Scally CP, Keung EZ, Satcher RL, Bird JE, Lin PP, Moon BS, Lewis VO, Roland CL, Bishop AJ
Lancet Oncol 2022 Dec;23(12):1547-1557. Epub 2022 Nov 4 doi: 10.1016/S1470-2045(22)00638-6. PMID: 36343656Free PMC Article
Reproducible safety and efficacy of atezolizumab plus bevacizumab for HCC in clinical practice: Results of the AB-real study.
Fulgenzi CAM, Cheon J, D'Alessio A, Nishida N, Ang C, Marron TU, Wu L, Saeed A, Wietharn B, Cammarota A, Pressiani T, Personeni N, Pinter M, Scheiner B, Balcar L, Napolitano A, Huang YH, Phen S, Naqash AR, Vivaldi C, Salani F, Masi G, Bettinger D, Vogel A, Schönlein M, von Felden J, Schulze K, Wege H, Galle PR, Kudo M, Rimassa L, Singal AG, Sharma R, Cortellini A, Gaillard VE, Chon HJ, Pinato DJ
Eur J Cancer 2022 Nov;175:204-213. Epub 2022 Sep 20 doi: 10.1016/j.ejca.2022.08.024. PMID: 36148739
Sequential Intravesical Gemcitabine and Docetaxel for bacillus Calmette-Guérin-Naïve High-Risk Nonmuscle-Invasive Bladder Cancer.
McElree IM, Steinberg RL, Martin AC, Richards J, Mott SL, Gellhaus PT, Nepple KG, O'Donnell MA, Packiam VT
J Urol 2022 Sep;208(3):589-599. Epub 2022 Jul 27 doi: 10.1097/JU.0000000000002740. PMID: 35892270
Randomized Phase III Trial of Dose-dense Methotrexate, Vinblastine, Doxorubicin, and Cisplatin, or Gemcitabine and Cisplatin as Perioperative Chemotherapy for Patients with Muscle-invasive Bladder Cancer. Analysis of the GETUG/AFU V05 VESPER Trial Secondary Endpoints: Chemotherapy Toxicity and Pathological Responses.
Pfister C, Gravis G, Fléchon A, Soulié M, Guy L, Laguerre B, Mottet N, Joly F, Allory Y, Harter V, Culine S; VESPER Trial Investigators
Eur Urol 2021 Feb;79(2):214-221. Epub 2020 Aug 28 doi: 10.1016/j.eururo.2020.08.024. PMID: 32868138
Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).
Basch E, Reeve BB, Mitchell SA, Clauser SB, Minasian LM, Dueck AC, Mendoza TR, Hay J, Atkinson TM, Abernethy AP, Bruner DW, Cleeland CS, Sloan JA, Chilukuri R, Baumgartner P, Denicoff A, St Germain D, O'Mara AM, Chen A, Kelaghan J, Bennett AV, Sit L, Rogak L, Barz A, Paul DB, Schrag D
J Natl Cancer Inst 2014 Sep;106(9) Epub 2014 Sep 29 doi: 10.1093/jnci/dju244. PMID: 25265940Free PMC Article

Prognosis

Characteristics of Immune Checkpoint Inhibitor-Induced Colitis: A Systematic Review.
Nakane T, Mitsuyama K, Yamauchi R, Kakuma T, Torimura T
Kurume Med J 2023 Jul 3;68(2):43-52. Epub 2023 Apr 26 doi: 10.2739/kurumemedj.MS682006. PMID: 37100606
Reproducible safety and efficacy of atezolizumab plus bevacizumab for HCC in clinical practice: Results of the AB-real study.
Fulgenzi CAM, Cheon J, D'Alessio A, Nishida N, Ang C, Marron TU, Wu L, Saeed A, Wietharn B, Cammarota A, Pressiani T, Personeni N, Pinter M, Scheiner B, Balcar L, Napolitano A, Huang YH, Phen S, Naqash AR, Vivaldi C, Salani F, Masi G, Bettinger D, Vogel A, Schönlein M, von Felden J, Schulze K, Wege H, Galle PR, Kudo M, Rimassa L, Singal AG, Sharma R, Cortellini A, Gaillard VE, Chon HJ, Pinato DJ
Eur J Cancer 2022 Nov;175:204-213. Epub 2022 Sep 20 doi: 10.1016/j.ejca.2022.08.024. PMID: 36148739
Sequential Intravesical Gemcitabine and Docetaxel for bacillus Calmette-Guérin-Naïve High-Risk Nonmuscle-Invasive Bladder Cancer.
McElree IM, Steinberg RL, Martin AC, Richards J, Mott SL, Gellhaus PT, Nepple KG, O'Donnell MA, Packiam VT
J Urol 2022 Sep;208(3):589-599. Epub 2022 Jul 27 doi: 10.1097/JU.0000000000002740. PMID: 35892270
The impact of sarcopenia on adverse events associated with gastric endoscopic submucosal dissection.
Hisada H, Tamura N, Tsuji Y, Nagao S, Fukagawa K, Miura Y, Mizutani H, Ohki D, Yakabi S, Minatsuki C, Takahashi Y, Sakaguchi Y, Yamamichi N, Fujishiro M
Surg Endosc 2022 Sep;36(9):6387-6395. Epub 2022 Jan 7 doi: 10.1007/s00464-021-08965-2. PMID: 34997343
Nephrotoxicity after PRRT with (177)Lu-DOTA-octreotate.
Bergsma H, Konijnenberg MW, van der Zwan WA, Kam BL, Teunissen JJ, Kooij PP, Mauff KA, Krenning EP, Kwekkeboom DJ
Eur J Nucl Med Mol Imaging 2016 Sep;43(10):1802-11. Epub 2016 May 10 doi: 10.1007/s00259-016-3382-9. PMID: 27160225Free PMC Article

Clinical prediction guides

Capivasertib and fulvestrant for patients with hormone receptor-positive, HER2-negative advanced breast cancer (CAPItello-291): patient-reported outcomes from a phase 3, randomised, double-blind, placebo-controlled trial.
Oliveira M, Rugo HS, Howell SJ, Dalenc F, Cortes J, Gomez HL, Hu X, Toi M, Jhaveri K, Krivorotko P, Loibl S, Morales Murillo S, Okera M, Nowecki Z, Park YH, Sohn JH, Tokunaga E, Yousef S, Zhukova L, Fulford M, Andrews H, Wadsworth I, D'Cruz C, Turner NC; CAPItello-291 study group
Lancet Oncol 2024 Sep;25(9):1231-1244. doi: 10.1016/S1470-2045(24)00373-5. PMID: 39214106
Reproducible safety and efficacy of atezolizumab plus bevacizumab for HCC in clinical practice: Results of the AB-real study.
Fulgenzi CAM, Cheon J, D'Alessio A, Nishida N, Ang C, Marron TU, Wu L, Saeed A, Wietharn B, Cammarota A, Pressiani T, Personeni N, Pinter M, Scheiner B, Balcar L, Napolitano A, Huang YH, Phen S, Naqash AR, Vivaldi C, Salani F, Masi G, Bettinger D, Vogel A, Schönlein M, von Felden J, Schulze K, Wege H, Galle PR, Kudo M, Rimassa L, Singal AG, Sharma R, Cortellini A, Gaillard VE, Chon HJ, Pinato DJ
Eur J Cancer 2022 Nov;175:204-213. Epub 2022 Sep 20 doi: 10.1016/j.ejca.2022.08.024. PMID: 36148739
Composite grading algorithm for the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Basch E, Becker C, Rogak LJ, Schrag D, Reeve BB, Spears P, Smith ML, Gounder MM, Mahoney MR, Schwartz GK, Bennett AV, Mendoza TR, Cleeland CS, Sloan JA, Bruner DW, Schwab G, Atkinson TM, Thanarajasingam G, Bertagnolli MM, Dueck AC
Clin Trials 2021 Feb;18(1):104-114. Epub 2020 Dec 1 doi: 10.1177/1740774520975120. PMID: 33258687Free PMC Article
Randomized Phase III Trial of Dose-dense Methotrexate, Vinblastine, Doxorubicin, and Cisplatin, or Gemcitabine and Cisplatin as Perioperative Chemotherapy for Patients with Muscle-invasive Bladder Cancer. Analysis of the GETUG/AFU V05 VESPER Trial Secondary Endpoints: Chemotherapy Toxicity and Pathological Responses.
Pfister C, Gravis G, Fléchon A, Soulié M, Guy L, Laguerre B, Mottet N, Joly F, Allory Y, Harter V, Culine S; VESPER Trial Investigators
Eur Urol 2021 Feb;79(2):214-221. Epub 2020 Aug 28 doi: 10.1016/j.eururo.2020.08.024. PMID: 32868138
Safety of high-dose-rate stereotactic body radiotherapy.
Stieb S, Lang S, Linsenmeier C, Graydon S, Riesterer O
Radiat Oncol 2015 Jan 23;10:27. doi: 10.1186/s13014-014-0317-0. PMID: 25614416Free PMC Article

Recent systematic reviews

Adverse Event Reporting in Cancer Clinical Trials: Incorporating Patient-Reported Methods. A Systematic Scoping Review.
Grahvendy M, Brown B, Wishart LR
Patient 2024 Jul;17(4):335-347. Epub 2024 Apr 8 doi: 10.1007/s40271-024-00689-4. PMID: 38589749Free PMC Article
Characteristics of Immune Checkpoint Inhibitor-Induced Colitis: A Systematic Review.
Nakane T, Mitsuyama K, Yamauchi R, Kakuma T, Torimura T
Kurume Med J 2023 Jul 3;68(2):43-52. Epub 2023 Apr 26 doi: 10.2739/kurumemedj.MS682006. PMID: 37100606
Single or combined immune checkpoint inhibitors compared to first-line platinum-based chemotherapy with or without bevacizumab for people with advanced non-small cell lung cancer.
Ferrara R, Imbimbo M, Malouf R, Paget-Bailly S, Calais F, Marchal C, Westeel V
Cochrane Database Syst Rev 2021 Apr 30;4(4):CD013257. doi: 10.1002/14651858.CD013257.pub3. PMID: 33930176Free PMC Article
Single or combined immune checkpoint inhibitors compared to first-line platinum-based chemotherapy with or without bevacizumab for people with advanced non-small cell lung cancer.
Ferrara R, Imbimbo M, Malouf R, Paget-Bailly S, Calais F, Marchal C, Westeel V
Cochrane Database Syst Rev 2020 Dec 14;12(12):CD013257. doi: 10.1002/14651858.CD013257.pub2. PMID: 33316104Free PMC Article
Comparison of cardiac events associated with liposomal doxorubicin, epirubicin and doxorubicin in breast cancer: a Bayesian network meta-analysis.
Yamaguchi N, Fujii T, Aoi S, Kozuch PS, Hortobagyi GN, Blum RH
Eur J Cancer 2015 Nov;51(16):2314-20. Epub 2015 Sep 3 doi: 10.1016/j.ejca.2015.07.031. PMID: 26343314

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