Abstract

Interim analysis of the iTOP trial - immediate techniques of oncoplastic surgery: A prospective comparison with custom breast conservation in breast cancer patients

Florian Fitzal, Pia Lanmüller, Michael Schütz, Bernahrd Heilig, Amadeus Windischbauer, Theresa Häusler, Tanja Keusch, Michael Bolliger, Kerstin Wimmer, Ruth Exner, Stephanie Strobl, Peter Dubsky, Raimund Jakesz, Michael Gnant

Introduction

Retrospective analyses suggest an improved cosmetic outcome but worse morbidity for oncoplastic procedures in breast cancer patients, however prospective data are lacking.

Methods

We prospectively included women with unilateral breast cancer and a necessary resection volume of at least 10% into our observational trial (NCT0139699). Patients and physicians were able to chooses between oncoplastic surgery (iTOP) or custom breast conservation (BCT). iTOP included breast conservation with local parenchymal flaps (iTOP1/2) or mastectomy with immediate reconstruction (iTOP3) based on the necessary oncologic resection volume. Primary endpoint was breast image scale satisfaction after 1 year, secondary endpoints were Breast Q quality of life, morbidity and objectively measured breast symmetry.

Results

This planed interim analysis of secondary endpoints demonstrates that women in the iTOP group had larger tumors (pT1: iTOP 40% versus BCT 44%; pT2 iTOP 19% versus BCT 10%; p<0.05) followed by a larger resection volume (>25% resection volume iTOP 60% versus BCT 22%; p<0.05). Cosmetic outcome did not differ significantly between the two groups (BreastQ after 1 year iTOP 83.16 versus BCT 73.11 p>0.05). Morbidity was significantly increased in the iTOP groups (28% iTOP versus 16% BCT p<0.05) without an increased re-operation rate between the two groups.

Conclusion

Oncoplastic techniques might reduce mastectomy rates as larger tumors can be resected with similar cosmetic outcome compared with breast conservation in smaller tumors.