Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2024 Nov 18;32(12):801.
doi: 10.1007/s00520-024-09018-9.

Correlation of CTCAE and patient-reported breast radiation dermatitis symptom scores

Thenugaa Rajeswaran #  1 , Milena Gojsevic #  1 , Liying Zhang  2 , Samantha K F Kennedy  1 , Irene Karam  1 , Keyue Ding  3 , Patries Herst  4 , Henry Wong  5 , Jennifer Y Y Kwan  6   7 , Amir H Safavi  1 , Jacqueline Lam  8   9 , Silvana Spadafora  9 , Natalie Walde  9 , Katherine Carothers  1 , Francois Gallant  1 , Tara Behroozian  10 , Emily Lam  1 , Edward Chow  11
Affiliations
Randomized Controlled Trial

Correlation of CTCAE and patient-reported breast radiation dermatitis symptom scores

Thenugaa Rajeswaran et al. Support Care Cancer. .

Abstract

Background and purpose: Clinicians use the CTCAE scale to grade radiation dermatitis (RD) based on edema, erythema, and desquamation. The purpose of this study was to correlate the CTCAE scores with the severity of patient-reported symptoms using a skin symptom assessment (SSA) and the Radiation-Induced Skin Reaction Assessment Scale (RISRAS).

Materials and methods: This is a secondary analysis of a randomized controlled trial involving 376 patients receiving Mepitel Film or standard-of-care for RD prophylaxis. The highest symptom categories for SSA and patient-component RISRAS assessments were selected from all time points, and a summary analysis and Spearman correlation coefficient was calculated for patients with CTCAE Grades 0, 1, 2, 3, and Grade 2/3, respectively. Analyses were conducted across all patients, within each treatment arm, and between arms in patients with only Grade 2 or 3 toxicity.

Results: Weak correlations between CTCAE scores and all patient-reported skin symptoms were found across the entire cohort and each treatment arm (p < 0.05). Patients with Grade 2 (n = 72) and Grade 3 RD (n = 24) reported similar rates of patient-reported moderate-to-severe skin symptoms (11-72% vs 14-79%), with no significant difference in rates of individual moderate-to-severe symptom between these cohorts (p > 0.05). Between treatment arms, rates of patient-reported moderate-to-severe scores were similar for most symptoms.

Conclusion: CTCAE RD scores are weakly correlated with patient-reported skin symptoms and cannot distinguish between patients with severe patient-reported outcomes. Clinicians should consider the limitations of CTCAE grading and incorporate patient-reported outcomes within clinical practice.

Keywords: Breast cancer; Patient-reported outcomes; Radiation dermatitis; Skin toxicity.

PubMed Disclaimer

Conflict of interest statement

Declarations Ethics approval This research was conducted in accordance with the Declaration of Helsinki. Human ethics and consent to participate declarations were not applicable. Competing Interests The authors declare no competing interests.

References

    1. Ginsburg O, Bray F, Coleman MP et al (2017) The global burden of women’s cancers: a grand challenge in global health. Lancet 389(10071):847–860. https://doi.org/10.1016/S0140-6736(16)31392-7 - DOI - PubMed
    1. Shah C, Al-Hilli Z, Vicini F (2021) Advances in breast cancer radiotherapy: implications for current and future practice. JCO Oncol Pract 17(12):697–706. https://doi.org/10.1200/OP.21.00635 - DOI - PubMed
    1. Freedman GM (2018) Radiation complications and their management. The Breast 52:716–725. https://doi.org/10.1016/b978-0-323-35955-9.00052-0 - DOI
    1. Kluetz PG, Chingos DT, Basch EM, Mitchell SA (2016) Patient-reported outcomes in cancer clinical trials: measuring symptomatic adverse events with the National Cancer Institute’s Patient-reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Am Soc Clin Oncol Educ Book 36:67–73. https://doi.org/10.1200/edbk_159514 - DOI
    1. Huang CJ, Hou MF, Luo KH et al (2015) RTOG, CTCAE and WHO criteria for acute radiation dermatitis correlate with cutaneous blood flow measurements. Breast 24:230–236. https://doi.org/10.1016/j.breast.2015.01.008 - DOI - PubMed

Publication types

LinkOut - more resources