Use of the Toxicity Index in Evaluating Adverse Events in Anal Cancer Trials: Analysis of RTOG 9811 and RTOG 0529

Jordan R. Kharofa; Greg Yothers; Lisa A. Kachnic; Jaffer Ajani; Joshua E. Meyer; Mark E. Augspurger; Gordon S. Okawara; Madhur K. Garg; Tracey E. Schefter; Todd A. Swanson; Desiree E. Doncals; Hyun Kim; Bassem I. Zaki; Samir Narayan; R. Jeffery Lee; Harvey J. Mamon; Michael A. Schwartz; Jennifer Moughan; Christopher H. Crane

doi:10.1097/COC.0000000000000955

Use of the Toxicity Index in Evaluating Adverse Events in Anal Cancer Trials: Analysis of RTOG 9811 and RTOG 0529

Jordan R. Kharofa, Greg Yothers, Lisa A. Kachnic, Jaffer Ajani, Joshua E. Meyer, Mark E. Augspurger, Gordon S. Okawara, Madhur K. Garg, Tracey E. Schefter, Todd A. Swanson, Desiree E. Doncals, Hyun Kim, Bassem I. Zaki, Samir Narayan, R. Jeffery Lee, Harvey J. Mamon, Michael A. Schwartz, Jennifer Moughan, Christopher H. Crane

Research output: Contribution to journal › Article › peer-review

Abstract

Novel toxicity metrics that account for all adverse event (AE) grades and the frequency of may enhance toxicity reporting in clinical trials. The Toxicity Index (TI) accounts for all AE grades and frequencies for categories of interest. We evaluate the feasibility of using the TI methodology in 2 prospective anal cancer trials and to evaluate whether more conformal radiation (using Intensity Modulated Radiation Therapy) results in improved toxicity as measured by the TI. Patients enrolled on NRG/RTOG 0529 or nonconformal RT enrolled on the 5-Fluorouracil/Mitomycin arm of NRG/RTOG 9811 were compared using the TI. Patients treated on NRG/RTOG 0529 had lower median TI compared with patients treated with nonconformal RT on NRG/RTOG 9811 for combined GI/GU/Heme/Derm events (3.935 vs 3.996, P=0.014). The TI methodology is a feasible method to assess all AEs of interest and may be useful as a composite metric for future efforts aimed at treatment de-escalation or escalation.

Original language	English (US)
Pages (from-to)	534-536
Number of pages	3
Journal	American Journal of Clinical Oncology: Cancer Clinical Trials
Volume	45
Issue number	12
DOIs	https://doi.org/10.1097/COC.0000000000000955
State	Published - Dec 1 2022
Externally published	Yes

Keywords

anal cancer
intensity modulated radiation therapy
toxicity index

ASJC Scopus subject areas

Oncology
Cancer Research

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1097/COC.0000000000000955

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Kharofa, J. R., Yothers, G., Kachnic, L. A., Ajani, J., Meyer, J. E., Augspurger, M. E., Okawara, G. S., Garg, M. K., Schefter, T. E., Swanson, T. A., Doncals, D. E., Kim, H., Zaki, B. I., Narayan, S., Lee, R. J., Mamon, H. J., Schwartz, M. A., Moughan, J., & Crane, C. H. (2022). Use of the Toxicity Index in Evaluating Adverse Events in Anal Cancer Trials: Analysis of RTOG 9811 and RTOG 0529. American Journal of Clinical Oncology: Cancer Clinical Trials, 45(12), 534-536. https://doi.org/10.1097/COC.0000000000000955

Kharofa, JR, Yothers, G, Kachnic, LA, Ajani, J, Meyer, JE, Augspurger, ME, Okawara, GS, Garg, MK, Schefter, TE, Swanson, TA, Doncals, DE, Kim, H, Zaki, BI, Narayan, S, Lee, RJ, Mamon, HJ, Schwartz, MA, Moughan, J & Crane, CH 2022, 'Use of the Toxicity Index in Evaluating Adverse Events in Anal Cancer Trials: Analysis of RTOG 9811 and RTOG 0529', American Journal of Clinical Oncology: Cancer Clinical Trials, vol. 45, no. 12, pp. 534-536. https://doi.org/10.1097/COC.0000000000000955

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abstract = "Novel toxicity metrics that account for all adverse event (AE) grades and the frequency of may enhance toxicity reporting in clinical trials. The Toxicity Index (TI) accounts for all AE grades and frequencies for categories of interest. We evaluate the feasibility of using the TI methodology in 2 prospective anal cancer trials and to evaluate whether more conformal radiation (using Intensity Modulated Radiation Therapy) results in improved toxicity as measured by the TI. Patients enrolled on NRG/RTOG 0529 or nonconformal RT enrolled on the 5-Fluorouracil/Mitomycin arm of NRG/RTOG 9811 were compared using the TI. Patients treated on NRG/RTOG 0529 had lower median TI compared with patients treated with nonconformal RT on NRG/RTOG 9811 for combined GI/GU/Heme/Derm events (3.935 vs 3.996, P=0.014). The TI methodology is a feasible method to assess all AEs of interest and may be useful as a composite metric for future efforts aimed at treatment de-escalation or escalation.",

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AU - Ajani, Jaffer

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AU - Kim, Hyun

AU - Zaki, Bassem I.

AU - Narayan, Samir

AU - Lee, R. Jeffery

AU - Mamon, Harvey J.

AU - Schwartz, Michael A.

AU - Moughan, Jennifer

AU - Crane, Christopher H.

PY - 2022/12/1

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AB - Novel toxicity metrics that account for all adverse event (AE) grades and the frequency of may enhance toxicity reporting in clinical trials. The Toxicity Index (TI) accounts for all AE grades and frequencies for categories of interest. We evaluate the feasibility of using the TI methodology in 2 prospective anal cancer trials and to evaluate whether more conformal radiation (using Intensity Modulated Radiation Therapy) results in improved toxicity as measured by the TI. Patients enrolled on NRG/RTOG 0529 or nonconformal RT enrolled on the 5-Fluorouracil/Mitomycin arm of NRG/RTOG 9811 were compared using the TI. Patients treated on NRG/RTOG 0529 had lower median TI compared with patients treated with nonconformal RT on NRG/RTOG 9811 for combined GI/GU/Heme/Derm events (3.935 vs 3.996, P=0.014). The TI methodology is a feasible method to assess all AEs of interest and may be useful as a composite metric for future efforts aimed at treatment de-escalation or escalation.

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Use of the Toxicity Index in Evaluating Adverse Events in Anal Cancer Trials: Analysis of RTOG 9811 and RTOG 0529

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

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