Comparing immediate techniques of oncoplastic surgery (iTOP) with conventional breast conservation (CBC), the prospective controlled nonrandomized iTOP trial (NCT01396993)

Introduction: Immediate techniques of oncoplastic surgery (iTOP) may be performed during breast conservation called oncoplastic breast conservation (OPBC) or skin/nipple sparing mastectomy defined as immediate breast reconstruction (IBR). There are no prospective data comparing both oncoplastic groups with women undergoing conventional breast conservation (CBC). Hypothesis iTOP are able to resect larger breast cancers with a similar quality of life comparing CBC Methods: Women with unilateral breast cancer stage I-III were eligible. Upon written and signed informed consent all relevant data including the two quality of life scales breast image scale (BIS) and Breast Q, were recorded at baseline as well as 6 and 12 months after surgery. Women were separated into three groups according to their standard treatment plan: • conventional breast conservation (CBC) • breast conservation with level I or II oncoplastic surgery (OPBC) • immediate breast reconstruction (IBR) with implants/autologous tissue. Results (statistics will be presented at the meeting): 206 women entered the trial (116 CBC, 46 OPBC, 44 IBR), 117 had a 6 month follow up and 99 were followed for 12 months. There were more pT2 and pT3 cancers (pT2: 15% and 14% versus 10%; pT3 7%, 7% and 2%; p at SABCS), more nodal positive cases (39%, 23% versus 12% p at SABCS) and more multifocal and multicentric cases (39%, 38% versus 20% p at SABCS) in the OPBC and IBR group compared with the CBC group. In 63% of cases the planned resection volume in OPBC was above 25% compared with 19% of cases in the CBC group. All groups had similar R1 resection rate (11%, 11% versus 9% p at SABCS) and no difference of the tumor distance to the resection margin. All groups were well balanced regarding neoadjuvant and adjuvant treatment. Only women with an IBR had an increased time to adjuvant radiotherapy compared with the other two groups (93 days versus 191 days median p at SABCS). Morbidity in OPBC was twice as high compared with IBR and CBC because of skin/wound necrosis and infections (total morbidity: 28% versus 16% and 12% p at SABCS). Quality of life using BIS, BREAST Q and VAS pain score did not differ between the three groups. Conclusion: Oncoplastic surgery resects larger tumors with similar quality of life in women with breast cancer stage I-III but with a higher morbidity rate. Oncologic recurrence data will be presented after a follow up of 5 years. Citation Format: Michael Bolliger, Andreas Gleiss, Michael Schutz, Pia Lanmuller, Tanja Keusch, Bernhard Heilig, Werner Haslik, Daniela Dorfler, Lena Theresa Maghorndl, Florian Fitzal. Comparing immediate techniques of oncoplastic surgery (iTOP) with conventional breast conservation (CBC), the prospective controlled non-randomized iTOP trial (NCT01396993) [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P4-13-06.