Toxicity burden score: A novel approach to summarize multiple toxic effects

Annals of Oncology

Volumn 23, Issue 2, 2012, Pages 537-541

  Lee, S M ^a   Hershman, D L ^b   Martin, P ^c   Leonard, J P ^c   Cheung, Y K ^a  

^a Columbia University ^*  (United States)

^b Weill Medical College of Cornell University ^*  (United States)

^c WEILL CORNELL MEDICAL COLLEGE   (United States)

Author keywords

Adverse event summary; Dose limiting toxicity; Toxicity; Toxicity types and grades

Indexed keywords

BORTEZOMIB; CYCLOPHOSPHAMIDE; DOXORUBICIN; PREDNISONE; RITUXIMAB; VINCRISTINE;

ARTICLE; DATA ANALYSIS; DECISION MAKING; DISEASE SEVERITY; DRUG DOSE ESCALATION; DRUG RESEARCH; HUMAN; LARGE CELL LYMPHOMA; MANTLE CELL LYMPHOMA; MULTIPLE CYCLE TREATMENT; NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; NEUROPATHY; NONHODGKIN LYMPHOMA; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PROBABILITY; REGRESSION ANALYSIS; THROMBOCYTOPENIA; TOXICITY BURDEN SCORE; TREATMENT OUTCOME;

EID: 84863012762     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdr146     Document Type: Article

References (18)

1. National Cancer Institute: CTEP. Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Bethesda, MD: National Institutes of Health 2003.
2. Dent SF, Eisenhauer EA. Phase I trial design: are new methodologies being put into practice? Ann Oncol 1996; 7: 561-566.
3. Rogatko A, Babb JS, Wang H et al. Patient characteristics compete with dose as predictors of acute treatment toxicity in early phase clinical trials. Clin Cancer Res 2004; 10: 4645-4651.
4. Eisenhauer EA, O'Dwyer PJ, Christian M, Humphrey JS. Phase I clinical trial design in cancer drug development. J Clin Oncol 2000; 18: 684-692.
5. Trotti A, Bentzen SM. The need for adverse events reporting standards in oncology clinical trials. J Clin Oncol 2004; 22(1): 19-22.
6. Cheung YK, Chappell R. Sequential designs for phase I clinical trials with late-onset-toxicities. Biometrics 2000; 56: 1177-1182.
7. Trotti A, Pajak T, Gwede C et al. TAME: development of a new method for summarising adverse events of cancer treatment by the Radiation Therapy Oncology Group. Lancet Oncol 2007; 8(7): 613-624.
8. Bekele B, Thall P. Dose-finding based on multiple toxicities in a soft tissue sarcoma trial. J Am Stat Assoc 2004; 60: 684-693.
9. Townsley CA, Pond GR, Oza AM et al. Evaluation of adverse events experienced by older patients participating in studies of molecularly targeted agents alone or in combination. Clin Cancer Res 2006; 12: 2141-2149.
10. Pond GR, Siu LL, Moore M et al. Nomograms to predict serious adverse events in phase II clinical trials of molecularly targeted agents. J Clin Oncol 2008; 26(8): 1324-1330.
11. Leornard JP, Furman RR, Cheung YKK et al. Phase I/II trial of botezomib plus CHOP-Rituximab in diffuse large B cell (DLBCL) and mantle cell lymphona (MCL): phase I results. Blood 2005; 106: (Abstr 491).
12. Yuan Z, Chappell R, Bailey H. The continual reassessment method for multiple toxicity grades: a bayesian quasi-likelihood approach. Biometrics 2007; 63: 173-179.
13. SAS Institute Inc.. SAS Version 9.0. Cary, NC: SAS Institute Inc. 2004.
14. O'Quigley J, Pepe M, Fisher L. Continual reassessment method: a practical design for phase I clinical trials in cancer. Biometrics 1990; 46: 33-48.
15. Lee SM, Cheung YK. Model calibration in the continual reassessment method. Clin Trials 2009; 6: 227-238.
16. R Development Core Team. R: A language and environment for statistical computing., Vienna, Austria: R Foundation for Statistical Computing 2008.
17. Lee SM, Cheng B, Cheung YK. Continual reassessment method with multiple toxicity constraints. Biostatistics 2011; 12: 386-398.
18. Basch E. The missing voice of patients in drug-safety reporting. N Engl J Med 2010; 362(10): 865-869.