insulin resistance and altered energy metabolism is common in non-alcoholic fatty liver disease (nAfLD) and appears to also be associated with myocardial dysfunction. We aimed to evaluate prevalence, staging and clinical features correlated with nAfLD among patients with heart failure with preserved ejection fraction (Hfpef). Adults with Hfpef were prospectively enrolled. Demographic and clinical data were collected. NAFLD was defined based on liver biopsy, abdominal imaging or icD-coding and the absence of other liver diseases. Descriptive, bivariate and multivariable analyses were performed. 181 patients were analyzed. The median age was 70 with 89% white, 59% female, median BMI 35.1, and 48% with diabetes. NAFLD was present in 27% of the full cohort and 50% of those with imaging. In patients with imaging, multivariable analysis identified diabetes (OR 3.38, 95% CI 1.29-8.88) and BMI (OR 1.11, 95% CI 1.04-1.19) as independent correlates of NAFLD. 54% of NAFLD patients had a NAFLD fibrosis score consistent with advanced fibrosis. Cirrhosis was present in 6.6% of patients overall and 11.5% with imaging. NAFLD patients had a higher frequency of advanced heart failure (75% vs 55%, p 0.01). NAFLD has a twofold higher prevalence in HFpEF compared to the general population and is independently associated with BMi and diabetes. patients with HFpEF and NAFLD also appeared to have more advanced fibrosis including cirrhosis suggesting a potential synergistic effect of cardiac dysfunction on fibrosis risk in NAFLD. This data supports consideration for evaluation of underlying liver disease in Hfpef patients.

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86 Background: The Common Terminology Criteria for Adverse Events (CTCAE) is frequently used to grade the severity of acute radiation dermatitis (ARD), but has not been validated despite decades of clinical use. We sought to develop a photonumeric scale to consistently describe ARD in breast cancer patients undergoing radiation (RT). Methods: Patients enrolled on a prospective study that included photographs and quantitative measurements of erythema and hyperpigmentation using colorimetry. 209 photographs from 35 patients with white skin and 369 photographs from 50 patients with skin of color were used to develop two photonumeric scales. Predominant erythema (in white skin) OR hyperpigmentation (in skin of color) were rated on a 4 point scale, with grading of desquamation on a separate 3 point scale. Four raters used both CTCAE and photonumeric scales to independently score all photographs. Intra- and inter-rater agreements were assessed using weighted kappa scores. Results: Using the CTCAE, 95% of photos were rated as grade 1 or 2. There was a trend toward higher grade in patients with skin of color, with grade 2 toxicity in 43% vs. 24%. Intra-rater agreement for CTCAE ratings was 65—87% (kappa 0.34—0.67), with a wide range of inter-rater agreement (56—81% agreement fraction, kappa 0.04—0.58). Using the photonumeric scale, intra-rater agreement was high for erythema/hyperpigmentation in patients with white skin (74—82%, kappa 0.49—0.70) and skin of color (69—86%, kappa 0.55—0.79), along with desquamation (78—87%, kappa 0.52—0.66). There was moderate inter-rater agreement for erythema/hyperpigmentation (51—82%, kappa 0.15—0.71) and desquamation (63—88%, kappa 0.36—0.58). Colorimetric measurements correlated strongly with photonumeric grade. Conclusions: We report a new photonumeric scale for ARD in breast cancer patients with satisfactory reliability across the spectrum of skin pigmentation. Intra-physician ratings were consistent, with moderate inter-physician agreement. The CTCAE functions as a binary scale, with 95% of ARD rated as grade 1 or 2 toxicity. Future work includes correlation with patient-reported outcomes and physician ratings at the point-of-care. Funded by a Munn Idea Grant (G011480).

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Purpose Scales for rating acute radiation dermatitis (ARD) are inconsistent and have not been validated despite decades of clinical use, making ARD difficult to report reliably. We sought to design a photonumeric scale to consistently describe ARD in breast cancer patients undergoing radiation (RT). Methods Patients undergoing RT for breast cancer were enrolled on a prospective study that included photographs and reporting of physician-rated erythema, hyperpigmentation, and CTCAE toxicity score at baseline and 2, 4, and 6 weeks after initiating RT. Erythema and hyperpigmentation were also quantified using a hand-held colorimetric device. Photographs were taken using a standardized protocol that included 3 views to fully assess the breast/chest wall, axilla, and inframammary fold. 209 photographs from 35 patients with white skin (Fitzpatrick skin types I-IV) and 369 photographs from 50 patients with skin of color (Fitzpatrick skin types V-VI) were clustered according to the apparent severity of ARD. Due to the prevalence of hyperpigmentation that obscured erythema in patients with skin of color, separate images were used to illustrate ARD in this population. Two photonumeric scales (for white skin and skin of color) were developed via an iterative process until group consensus was achieved. Four raters with experience in the evaluation of ARD in breast cancer patients used the photonumeric scale to independently score the entire collection of photographs, sequenced in random order. Intra- and inter-rater agreements were assessed using weighted kappa scores. Results Of the 35 patients with white skin, 20% experienced severe erythema, and 40% experienced dry or moist desquamation. Of the 50 patients with skin of color, 34% experience severe hyperpigmentation, and 48% experienced dry or moist desquamation. Using the photonumeric scales, we observed high intra-rater agreement for independent ratings of erythema or hyperpigmentation (70 to 89% agreement fraction, kappa 0.55 to 0.81) and desquamation (79 to 87% agreement fraction, kappa 0.52 to 0.64). Similarly, we observed moderate to high inter-rater agreement for independent ratings of erythema or hyperpigmentation (61 to 76% agreement fraction, kappa 0.40 to 0.62) and desquamation (69 to 84% agreement fraction, kappa 0.36 to 0.58). Quantitative measurements of erythema in white patients using colorimetry correlated strongly with photonumeric grade (correlation coefficient 0.76, p<0.001), as did physician-rated erythema at the point-of-care (p<0.001). Fitzpatrick score was not significantly associated with maximum photonumeric erythema grade (p = 0.14). Conclusions We report a new photonumeric scale with high intra- and inter-rater reliability for acute radiation dermatitis in breast cancer patients. To our knowledge, this is the first rigorously evaluated scale that is applicable to patients across the spectrum of skin pigmentation, including white skin and skin of color. The photonumeric scale will facilitate consistent reporting of acute radiation dermatitis in research and clinical settings using a simple, standardized instrument. Future work will include prospective real-time clinical validation with multiple raters and correlation with patient-reported outcomes. Funded by a Munn Idea Grant (G011480). Citation Format: Dean Shumway, Eleanor M Walker, Nirav Kapadia, Thy Thy Do, Kent Griffith, Mary Feng, Bonnie DePalma, Reshma Jagsi, Yolanda Helfrich, Erin Gillespie, Alexandria Miller, Adam Liss, Lori J Pierce. Development of a photonumeric scale for acute radiation dermatitis in breast cancer patients [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P1-15-12.