Electrocardiograms (ECGs) in phase I anticancer drug development: The MD anderson cancer center experience with 8518 ECGs

Annals of Oncology

Volumn 23, Issue 11, 2012, Pages 2960-2963

  Naing, A ^a   Veasey Rodrigues, H ^a   Hong, D S ^a   Fu, S ^a   Falchook, G S ^a   Wheler, J J ^a   Tsimberidou, A M ^a   Wen, S ^a   Fessahaye, S N ^a   Golden, E C ^a   Aaron, J ^a   Ewer, M S ^a   Kurzrock, R ^a  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

Anticancer; Development; Drug; Electrocardiogram; Phase I

Indexed keywords

ANTINEOPLASTIC AGENT; CYTOTOXIC AGENT; HEAT SHOCK PROTEIN 90 INHIBITOR; HISTONE DEACETYLASE INHIBITOR; MAMMALIAN TARGET OF RAPAMYCIN INHIBITOR; MITOGEN ACTIVATED PROTEIN KINASE INHIBITOR; PHOSPHATIDYLINOSITOL 3 KINASE INHIBITOR; PROTEASOME INHIBITOR; PROTEIN KINASE B INHIBITOR;

ADULT; AGED; ARTICLE; BREAST CANCER; CANCER OF UNKNOWN PRIMARY SITE; CARDIOVASCULAR DISEASE; COMORBIDITY; DIGESTIVE SYSTEM CANCER; ELECTROCARDIOGRAM; ELECTROCARDIOGRAPHY MONITORING; FEMALE; GYNECOLOGIC CANCER; HEAD AND NECK CANCER; HUMAN; LUNG CANCER; LYMPHOMA; MAJOR CLINICAL STUDY; MALE; MEDICAL RECORD REVIEW; MELANOMA; MULTIPLE CYCLE TREATMENT; NEUROENDOCRINE TUMOR; NEUROFIBROMATOSIS; PHASE 1 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; QT INTERVAL; QT PROLONGATION; SARCOMA; SIDE EFFECT; THYMOMA; THYROID CANCER;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; CLINICAL TRIALS, PHASE I AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG EVALUATION, PRECLINICAL; ELECTROCARDIOGRAPHY; FEMALE; HEART; HEART RATE; HUMANS; LONG QT SYNDROME; MALE; MIDDLE AGED; NEOPLASMS; YOUNG ADULT;

EID: 84868113707     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mds130     Document Type: Article

References (16)

1. Craft BS, Kurzrock K, Lei X et al. The changing face of phase 1 cancer clinical trials: new challenges in study requirements. Cancer 2009; 115: 1592-1597.
2. Haverkamp W, Breithardt G, Camm AJ et al. The potential for QT prolongation and pro-arrhythmia by non-anti-arrhythmic drugs: clinical and regulatory implications. Report on a Policy Conference of the European Society of Cardiology. Cardiovasc Res 2000; 47: 219-233.
3. Fingert H, Varterasian M. Safety biomarkers and the clinical development of oncology therapeutics: considerations for cardiovascular safety and risk management. AAPS J 2006; 8: E89-E94.
4. US Food and Drug Administration (FDA). Guidance for Industry on the Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. http://www.fda.gov/downloads/RegulatoryInformation/ Guidances/ucm129357.pdf, 2005.
5. Strevel EL, Ing DJ, Siu LL. Molecularly targeted oncology therapeutics and prolongation of the QT interval. J Clin Oncol 2007; 25: 3362-3371.
6. Yap YG, Camm AJ. Drug induced QT prolongation and torsades de pointes. Heart 2003; 89: 1363-1372.
7. Horstmann E, McCabe MS, Grochow L et al. Risks and benefits of phase 1 oncology trials, 1991 through 2002. N Engl J Med 2005; 352: 895-904.
8. Funck-Brentano C, Jaillon P. Rate-corrected QT interval: techniques and limitations. Am J Cardiol 1993; 72: 17B-22B.
9. Sanguinetti MC, Tristani-Firouzi M. hERG potassium channels and cardiac arrhythmia. Nature 2006; 440: 463-469.
10. Goldberg I, Moss AJ, Zareba W. QT interval: how to measure it and what is "normal". J Cardiovasc Electrophysiol 2006; 17: 333-336.
11. Mirvis DM, Goldberger AL. Electrocardiography. In Zipes DP, Libby P, Bonow RO et al.. (eds), Braunwald's Heart Disease: A Textbook of Cardiovascular Medicine, 7th edition. Philadelphia, PA: Saunders, 2005; 107-151.
12. Belardinelli L, Antzelevitch C, Vos MA. Assessing predictors of drug-induced torsade de pointes. Trends Pharmacol Sci 2003; 24: 619-625.
13. Bakke OM, Manocchia M, de Abajo F et al. Drug safety discontinuations in the United Kingdom, the United States, and Spain from 1974 through 1993: a regulatory perspective. Clin Pharmacol Ther 1995; 58: 108-117.
14. Varterasian M, Meyer M, Fingert H et al. Baseline heart rate-Corrected QT and eligibility for clinical trials in oncol. J Clin Oncol 2003; 21: 3378-3379.
15. Barbey JT, Pezzullo JC, Soignet SL. Effect of arsenic trioxide on QT interval in patients with advanced malignancies. J Clin Oncol 2003; 21: 3609-3615.
16. Stewart DJ, Whitney SN, Kurzrock R. Equipoise lost: ethics, costs, and the regulation of cancer clinical research. J Clin Oncol 2010; 17: 1925-1935.