TAME: development of a new method for summarising adverse events of cancer treatment by the Radiation Therapy Oncology Group

Andy Trotti, Thomas F. Pajak, Clement K. Gwede, Rebecca Paulus, Jay Cooper, Arlene A. Forastiere, John A. Ridge, Deborah Watkins-Bruner, Adam S. Garden, K. Kian Ang, Wally Curran

Research output: Contribution to journalArticle

Abstract

Background: We aimed to examine deficiencies in established methods of summarising adverse events, and to create a new reporting system (TAME) for summarising the toxicity burden of cancer treatment. TAME consolidates traditional adverse-event data into three risk domains: short-term (acute) Toxicity (T), Adverse long-term (late) effects (A), and Mortality risk (M) generated by a treatment programme (E=End results); and assigns treatments to risk classes for each risk domain. Methods: We examined formally an established method for summarising adverse events (the max-grade method) in five trials of patients with head and neck cancer done between September, 1991, and August, 2000, by the Radiation Therapy Oncology Group (RTOG) that involved 13 treatment groups (2304 patients). We calculated TAME summary metrics that included time and multiplicity factors in the same patient groups. We compared relative T values with relative values for toxic effects from the max-grade approach. We also calculated the range of individual patient T scores in two groups from one of the trials (the laryngeal-preservation trial). Results: The max-grade method systematically excluded 29-70% of total reported high-grade (grade 3-4) acute adverse events, contained progressive bias, and favoured higher toxicity programmes. Relative T values in the 13 treatment programmes tested showed an increase of almost 500% in acute toxicity burden (100-590) between treatment groups compared with a 170% increase (100-270) between treatment groups by use of the max-grade method. The difference between these two summary systems was statistically significant (mean difference -102 [95% CI -167 to -37], p=0·005, t test for paired differences). Four risk classes were designated for acute and relative late effects: low (100-140), moderate (150-390), high (400-490), and extreme (≥500). The distribution of individual patient T scores showed that 82 (60%) patients who received concurrent platinum-radiotherapy for larynx preservation reported two or more high-grade events, and 34 (20%) reported four or more high-grade events; these findings differed significantly from the distribution of individual patient T scores for patients who received radiotherapy alone, in which 32 (19%) reported two or more high-grade events and 3 (3%) reported four or more high-grade events (p

Original languageEnglish (US)
Pages (from-to)613-624
Number of pages12
JournalThe Lancet Oncology
Volume8
Issue number7
DOIs
StatePublished - Jul 2007

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Radiation Oncology
Radiotherapy
Neoplasms
Therapeutics
Poisons
Head and Neck Neoplasms
Larynx
Platinum
Mortality

ASJC Scopus subject areas

  • Oncology

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TAME : development of a new method for summarising adverse events of cancer treatment by the Radiation Therapy Oncology Group. / Trotti, Andy; Pajak, Thomas F.; Gwede, Clement K.; Paulus, Rebecca; Cooper, Jay; Forastiere, Arlene A.; Ridge, John A.; Watkins-Bruner, Deborah; Garden, Adam S.; Ang, K. Kian; Curran, Wally.

In: The Lancet Oncology, Vol. 8, No. 7, 07.2007, p. 613-624.

Research output: Contribution to journalArticle

Trotti, A, Pajak, TF, Gwede, CK, Paulus, R, Cooper, J, Forastiere, AA, Ridge, JA, Watkins-Bruner, D, Garden, AS, Ang, KK & Curran, W 2007, 'TAME: development of a new method for summarising adverse events of cancer treatment by the Radiation Therapy Oncology Group', The Lancet Oncology, vol. 8, no. 7, pp. 613-624. https://doi.org/10.1016/S1470-2045(07)70144-4
Trotti, Andy ; Pajak, Thomas F. ; Gwede, Clement K. ; Paulus, Rebecca ; Cooper, Jay ; Forastiere, Arlene A. ; Ridge, John A. ; Watkins-Bruner, Deborah ; Garden, Adam S. ; Ang, K. Kian ; Curran, Wally. / TAME : development of a new method for summarising adverse events of cancer treatment by the Radiation Therapy Oncology Group. In: The Lancet Oncology. 2007 ; Vol. 8, No. 7. pp. 613-624.
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AU - Forastiere, Arlene A.

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