P2-16-01: A Multi-Centre Prospective Cohort Study Evaluating Health Related Quality of Life after Types of Immediate Latissimus Dorsi (LD) Breast Reconstruction.
Authors: Winters ZE , Haviland J , Reece-Smith A , Betambeau N , Choudhry K , Chaudhry A , Mills J , Benson J , Galea M , MacMannus P , Nicholson S , Weiler-Mithoff E , Rayter Z , Thomson HJ 
Published: June 2012

Abstract
Introduction: Evidence for the clinical effectiveness of breast reconstruction based on Patient Reported Outcome Measures (PROMS) is lacking. Methodology evaluating PROMS after types of breast reconstruction has been poor with respect to study design, statistics, missing data and absence of prospective documentation of pre-defined complication data in a systematic review of all studies since 19781. Furthermore, there is no reliable data on the effects of associated radiotherapy (RT) in this context. As a prelude to a proposed randomised trial in breast reconstruction, our aim was to conduct a ‘robust’ cohort study evaluating the effects of either implant-assisted LD (LDI) or tissue only (ALD) LD flap reconstruction in relation to key determinants including clinico-pathological parameters, complications and treatment schedules over a 36 month period.
Methods: An MREC approved prospective longitudinal cohort study involving 6 centres commenced in early 2007. Serial PROMS using the EORTC QLQ-C30, BR-23, FACT-B, BIS and HADS, were completed pre-operatively and at 3, 6, 12, 24 and 36 months after surgery. Data up to 12 months were included in this analysis as data were sparse beyond this point; follow-up is ongoing. Demographic and clinical data were compared between the surgical groups. Generalised estimating equations were used to investigate demographic and clinical predictors of HRQL over time.
Results: A total of 189 patients (107-ALD, 82-LDI) were recruited, with a mean age of 50 years (range 22–70). Baseline questionnaires were completed by 149 (79%) women, with 167 (88%) available at 12 months. Patients in the ALD group had a higher BMI (mean 27.3 versus 25.2 in LDI, p=0.001) and a greater likelihood of post-mastectomy RT (52% versus 30% in LDI, p=0.004).
Only role functioning (p=0.001) and pain (p=0.003) were significantly adversely affected in the ALD v LDI group, with no statistically significant effects from PMRT on HRQL, although chemotherapy impaired global QoL (p&lt;0.001) and social functioning (p=0.001), and increased fatigue (p=0.007). Early complications (&lt; 3 months) significantly impaired HRQL in general, as did poor baseline scores (p&lt;0.01 for various subscales). Significant improvements over time were noted for global QoL, role and social functioning, fatigue, pain and breast symptoms (p&lt;0.001 for all).
Conclusion: There is increasing evidence of clinical equipoise between types of LD breast reconstruction and despite acknowledged cosmetic disadvantages the overall effects of PMRT on HRQL are minimal. The identification of important variables that may affect HRQL is crucial in all studies evaluating the effects of surgery on PROMS. Their integration into study results is essential for correct interpretation of clinically based assessments. This remains a challenging aspect in cohort studies, and emphasises the need for pragmatism in design of trials in the field.
1. Winters ZE, Benson JR, Pusic AL. Annals of Surgery 2010;252(6):929–42
Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P2-16-01.