GoBreast I - A randomized controlled trial in delayed breast reconstruction after cancer

Abstract

Delayed breast reconstruction (DBR) after mastectomy (MRM) for breast cancer is integral in the Swedish breast cancer care. This thesis compares complications within 30 days, changes in long-term health-related quality of life (HRQoL), and cost-effectiveness. In addition, long-term survival of implants is studied retrospectively for implant-based DBR in an ancillary study. Participants of the prospective study were assigned to one arm for those with previous radiotherapy (RT) and another for those with no RT. In the RT arm, participants were randomized to either autologous reconstruction with a deep inferior epigastric artery perforator flap (DIEP) or a combined procedure with a pedicled latissimus dorsi flap plus implant (LD). In the non-RT arm participants were randomized to either two-stage expander-to-implant procedure (EXP) or to thoracodorsal flap plus implant (TD). There were similar complication rates and severity between methods within arms as measured by the Clavien-Dindo classification (CDC) or the Comprehensive Complication Index (CCI), but the panorama of complications was different. Disease specific HRQoL as measured by BreastQ improved in most dimensions at follow-up 7-9 years after reconstruction, and improved psychological well-being was found in generic HRQoL instruments RAND36 and EQ5D. DIEP reported statistically significantly higher satisfaction with outcome than LD, while no statistically significant difference was found for EXP and TD. In a cost-effectiveness analysis, DIEP and EXP were more cost-effective in their respective arms. Small sample size limits the certainty of conclusions about HRQoL change for the RT arm. The retrospective follow-up of 677 implant-based DBR and found that a majority of implants (57%) survived for 20 years, but successive implant failures were not uncommon, and more than 50% of the first implants that failed did fail a second time. Direct to implant (DTI) predicted failure as compared to other methods (EXP, LD, TD, and permanent expander (PE). In conclusion, DBR by any of the methods under study is a safe procedure with findings of improved long-term HRQoL, albeit the exact contribution to the scores was not determinable. DIEP and EXP were more cost-effective. Implant failure is often serial and somewhat dependent on the method.