Abstract

Abstract Objective Cosmetic outcome is an important quality of life related endpoint following breast conserving surgery (BCS). We aim to compare the cosmetic outcome evaluated by panel and objective evaluation (BCCT.core software). Second patient reported outcome measures (PROMs) are compared to cosmetic evaluation by panel and BCCT.core. Methods Sixty-eight breast cancer patients were included after breast conserving surgery between 2007-2012. Cosmetic outcome was evaluated by; two independent 6-member panels, the BCCT.core by two observers and PROMs (EORTC-QLQ-C30/BR23, EQ-5D-5L and BREAST-Q 'breast conserving module'). First, reproducibility, repeatability and overall agreement of panel and BCCT.core was analysed using the interclass correlation coefficient (ICC). Second, the correlation between panel/BCCT.core with PROMs was analysed using the Spearman's rank correlation coefficient (spearman's ρ). Sensitivity of all PROMs to differentiate between a 'good' or 'bad' cosmetic outcome was evaluated. Results Sixty-four patients (94.1%) completed the EORTC-QLQ-C30/B23, 58 (85.3%) the EQ-5D-5L and BREAST-Q. Repeatability between both panels and BCCT.core observers was respectively 0.93 and 0.86 (ICC). Reproducibility for panel 1 and BCCT.core 1 was respectively 0.93 and 0.96. Overall agreement between panel and BCCT.core ranged between 0.59 – 0.69. Table 1. Inter- and intra-observer agreement for cosmetic outcome - Interclass Correlation Coefficient (95% CI) Panel 1Panel 2BCCT.core 1BCCT.core 2Panel 10.99 (0.98-0.99)0.94 (0.90-0.96)0.69 (0.54-0.79)0.61 (0.43-0.73)Panel 2 0.66 (0.5-0.77)0.59 (0.42-0.72)BCCT.core 1 0.93 (0.84-0.97)0.85 (0.77-0.91)BCCT.core 2 For PROMs the BREAST-Q showed the strongest correlation with panel and BCCT.core, 0.32-047 spearman's ρ. The BREAST-Q significantly differentiated between a 'good' or 'bad' cosmetic outcome based on panel and BCCT.core (p<0.05). Table 2 PROMs according to a 'good' or 'bad' cosmetic outcome Panel 1 BCCT. core 1 Good - median (IQR)Bad median (IQR)p-valueGood - median (IQR)Bad - median (IQR)p-valueEORTC-QLQ-C30; Global Health Status*83.3 (75-100)83.3 (66.7-100)0.9283.3 (75-100)83.3 (66.7-100)0.82EORTC-QLQ-B23; Body image*95.8 (72.9-100)75 (50-100)0.1595.8 (68.8-100)83.3 (66.7-100)0.31EQ-5D-5L; Health score*80 (68.5-91)90 (72.5-95)0.1980 (71.3-90)90 (65-95)0.38EQ-5D-5L; Index value*0.87 (0.76-1)0.84 (0.82-1)10.85 (0.74-1)0.843 (0.811-1)0.81BREAST-Q; satisfaction with breast*68.5 (56.5-90)52 (41.5-67)0.0268.5 (57.5-89.5)52 (41-68)0.03IQR = Interquartile range *Higher scores represent higher quality of life Conclusion Comparable good reproducibility and repeatability was found for panel and BCCT. PROMs showed limited agreement but the PROM BREAST-Q was able to differentiate between a good or bad cosmetic evaluation. Combining PROMs with panel or BCCT.core in future trials evaluating cosmetic outcome following BCS could further improve and evaluate the use of PROMs. Citation Format: Lagendijk M, Vos EL, Corten EML, Verhoef C, Koppert LB. Evaluating cosmetic outcome following breast conserving surgery in trials; panel verus objective evaluation and the role of patient reported outcome measures (PROMs) [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P1-11-11.

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