A Multi Centre Prospective Longitudinal Study Establishing Level II Evidence of Health Related Quality of Life after Types of Immediate Latissimus Dorsi (LD) Breast Reconstruction.

Abstract

Abstract Introduction: NICE recommends that the majority of women undergoing mastectomy should be offered immediate breast reconstruction with its potential benefits to improve health related quality of life (HRQL). A systematic review shows poor and conflicting evidence with a lack of 'hard' data to best inform both clinicians and their patients. Our aim was to evaluate the effects of implant-assisted LD (LDI) versus autologous LD (ALD) breast reconstruction on HRQL over 36 months. Recently, with the exception of the USA Breast-Q module there is a lack of a validated Breast reconstruction questionnaire.Methods: An MREC approved prospective longitudinal cohort study involving 6 centres commenced in early 2007. Serial patient reported outcome measures using the EORTC C30 (global QoL, physical functioning, fatigue, pain), BR-23 (breast and arm symptoms), 10 item Body Image Scale (BIS) and HADS, were completed pre-operatively and at 3, 6, 12, 24 and 36 months after surgery. Overall cosmetic satisfaction of the breast reconstruction was measured by a study-specific question on a 5 point Likert scale. Generalised estimating equations were used to assess change over time and differences between treatment groups.The Spearman's rank correlation coefficient was used to assess associations between patient reported cosmetic satisfaction with BIS and breast symptoms.Results: 118 patients (65 – ALD, 53 – LDI) were recruited to the study with a mean age of 50 years (range 22-70). Compliance with questionnaires at all time points was between 85-90%. There were no significant differences in HRQL domains between LDI and ALD, except a tendency for worse pain with ALD (p=0.06). Significant improvements over time were seen for overall HRQL (p<0.001), fatigue (p<0.001), breast symptoms (p=0.04), arm symptoms (p=0.001), as well as anxiety (p=0.017) and depression (p<0.001). Preliminary data shows that overall cosmetic satisfaction was significantly correlated with better body image and fewer breast symptoms. The study is ongoing in terms of 24 and 36 months follow-up and the evaluation of RT.Conclusion: There is an important need for cumulative clinical evidence in this field on which to base patient informed consent and clinical recommendations. Further analyses will assess whether there is an independent effect of RT on HRQL. A validated EORTC breast reconstruction module is in development. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 3106.