Abstract P1-20-01: Primary surgery in patients with de novo stage IV BC; finalizing the protocol MF07-01 randomized clinical trial

Soran, Atilla; Özmen, Vahit; Özbaş, Serdar; Karanlık, Hasan; Müslümanoğlu, Mahmut; İğci, Abdullah; Cantürk, Zafer; Utkan, Zafer; Özaslan, Cihangir; Evrensel, Türkkan; Uras, Cihan; Aksaz, Erol; Soyder, Aykut; Uğurlu, Ümit; Çöl, Cavit; Cabıoğlu, Neslihan; Erdem, Ergün; Gurleyik, Gunay; Sezgın, Efe

doi:10.1158/1538-7445.sabcs19-p1-20-01

Cited by 3 publications

(2 citation statements)

References 12 publications

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“…This group recently presented updated results at the San Antonio BC Symposium in 2019. 20 This final analysis showed significant 10-year OS benefit with LRT, 46 months vs 35 months, HR = 0.71. This study looked at many prognostic factors including LRT, hormone receptor positivity, disease burden, and sites of metastases.…”

Section: Prospective Studiesmentioning

confidence: 76%

Role of Locoregional Treatment in De Novo Stage IV Breast Cancer

Lee

Toktaş

Soran

2020

Clin Med Insights Oncol

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It is estimated that approximately 154000 women in the United States have stage IV breast cancer (BC). A subset of this group has metastatic disease at presentation, known as de novo stage IV disease. De novo stage IV BC accounts for approximately 6% of all BC diagnoses in the United States. Traditionally, stage IV BC patients are treated with primary systemic therapy with a palliative intent reserving possible locoregional treatment (LRT) as last resort. There has been a lot of interest in the role of LRT in de novo stage IV BC for the past decade with mixed conclusions. Although this review is not intended to be a comprehensive overview of all literature regarding this topic to date, we will review the recent findings in literature focusing on the studies with larger sample sizes to investigate the role of LRT in de novo stage IV BC.

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Section: Prospective Studiesmentioning

confidence: 76%

Role of Locoregional Treatment in De Novo Stage IV Breast Cancer

Lee

Toktaş

Soran

2020

Clin Med Insights Oncol

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“…Several studies have suggested that by obtaining loco-regional control in metastatic breast cancer, overall survival in advanced disease would be improved. [9][10][11] However, randomised controlled trials have contradicted this. 12 13 A recent presentation at ASCO 2020 14 confirmed that local treatment in addition to systemic therapy did not improve survival.…”

Section: Introductionmentioning

confidence: 99%

Phase I feasibility study of Magnetic Resonance guided High Intensity Focused Ultrasound-induced hyperthermia, Lyso-Thermosensitive Liposomal Doxorubicin and cyclophosphamide in de novo stage IV breast cancer patients: study protocol of the i-GO study

et al. 2020

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IntroductionIn breast cancer, local tumour control is thought to be optimised by administering higher local levels of cytotoxic chemotherapy, in particular doxorubicin. However, systemic administration of higher dosages of doxorubicin is hampered by its toxic side effects. In this study, we aim to increase doxorubicin deposition in the primary breast tumour without changing systemic doxorubicin concentration and thus without interfering with systemic efficacy and toxicity. This is to be achieved by combining Lyso-Thermosensitive Liposomal Doxorubicin (LTLD, ThermoDox, Celsion Corporation, Lawrenceville, NJ, USA) with mild local hyperthermia, induced by Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU). When heated above 39.5°C, LTLD releases a high concentration of doxorubicin intravascularly within seconds. In the absence of hyperthermia, LTLD leads to a similar biodistribution and antitumour efficacy compared with conventional doxorubicin.Methods and analysisThis is a single-arm phase I study in 12 chemotherapy-naïve patients with de novo stage IV HER2-negative breast cancer. Previous endocrine treatment is allowed. Study treatment consists of up to six cycles of LTLD at 21-day intervals, administered during MR-HIFU-induced hyperthermia to the primary tumour. We will aim for 60 min of hyperthermia at 40°C–42°C using a dedicated MR-HIFU breast system (Profound Medical, Mississauga, Canada). Afterwards, intravenous cyclophosphamide will be administered. Primary endpoints are safety, tolerability and feasibility. The secondary endpoint is efficacy, assessed by radiological response.This approach could lead to optimal loco-regional control with less extensive or even no surgery, in de novo stage IV patients and in stage II/III patients allocated to receive neoadjuvant chemotherapy.Ethics and disseminationThis study has obtained ethical approval by the Medical Research Ethics Committee Utrecht (Protocol NL67422.041.18, METC number 18-702). Informed consent will be obtained from all patients before study participation. Results will be published in an academic peer-reviewed journal.Trial registration numbersNCT03749850, EudraCT 2015-005582-23.

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