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Impact of Breast Surgery in Primary Metastasized Breast Cancer: Outcomes of the Prospective Randomized Phase III ABCSG-28 POSYTIVE Trial

Fitzal, Florian, MD, MBA, FEBS*; Bjelic-Radisic, Vesna, MD; Knauer, Michael, MD, FEBS**; Steger, Günther, MD†,‡; Hubalek, Michael, MD††; Balic, Marija, MD||; Singer, Christian, MD§; Bartsch, Rupert, MD‡‡; Schrenk, Peter, MD§§; Soelkner, Lidija¶¶; Greil, Richard, MD||||; Gnant, Michael, MD, FEBS, MBA* on behalf of the ABCSG

doi: 10.1097/SLA.0000000000002771
Original Article: PDF Only

Background: Conflicting evidence exists regarding the value of surgical resection of the primary in stage IV breast cancer patients.

Objective: The prospective randomized phase III ABCSG-28 POSYTIVE trial evaluated median survival comparing primary surgery followed by systemic therapy to primary systemic therapy in de novo stage IV breast cancer.

Methods: Between 2011 and 2015, 90 previously untreated stage IV breast cancer patients were randomly assigned to surgical resection of the primary tumor followed by systemic therapy (Arm A) or primary systemic therapy (Arm B) in Austria. Overall survival (OS) was defined as the primary study endpoint.

Results: The trial was stopped early due to poor recruitment. Ninety patients (45 arm A, 45 arm B) were included; median follow-up was 37.5 months. Patients in the surgery arm had more cT3 breast cancer (22.2% vs 6.7%) and more cN2 staging (15.6% vs 4.4%). Both groups were well balanced with respect to the type of first-line systemic treatment. Median survival in arm A was 34.6 months, versus 54.8 months in the nonsurgery arm [hazard ratio (HR) 0.691, 95% confidence interval (95% CI) 0.358–1.333; P = 0.267]; time to distant progression was 13.9 months in the surgery arm and 29.0 months in the nonsurgery arm (HR 0.598, 95% CI 0.343–1.043; P = 0.0668).

Conclusion: The prospective phase III trial ABCSG-28 (POSYTIVE) could not demonstrate an OS benefit for surgical resection of the primary in breast cancer patients presenting with de novo stage IV disease.

*Department of Surgery, Medical University, Vienna, Austria

Medical Oncology, Medical University, Vienna, Austria

Gaston H. Glock Research Center, Medical University, Vienna, Austria

§Gynecology, Medical University, Graz, Austria

Department of Gynecology, Medical University, Graz, Austria

||Medical Oncology, Medical University, Graz, Austria

**Breast Health Center, St Gallen, Austria

††Department of Gynecology, Breast Health Center Hall, Tirol, Austria

‡‡German Breast Group, Breast Health Center Hall, Tirol, Austria

§§Department of Surgery, Medical University, Linz, Austria

¶¶Austrian Breast and Colorectal Cancer Study Group, Medical University, Linz, Austria

||||Department of Medical Oncology, Paracelsus Medical University, Salzburg, Austria.

Reprints: Florian Fitzal, MD, MBA, FEBS, Comprehensive Cancer Center Vienna, Medical University of Vienna 21A, Waehringer Guertel 18-20, Vienna A-1090, Austria. E-mail: florian.fitzal@meduniwien.ac.at.

Vesna Bjelic-Radisic contributed equally to the work (she is the second author).

This study was sponsored by the Austrian Breast and Colorectal Cancer Study Group. Indirectly, and via a multi-sponsoring basket structure, the following companies supported this trial financially: Novartis, Pfizer, Amgen, Roche, Bayer, Sanofi, Wyeth, Astra Zeneca, GlaxoSmithKline, and Merck Sharp & Dohme. In addition, this study was supported by the Bürgermeisterfonds der Stadt Wien (09057) and Krebshilfe Steiermark (Cancer Aid Styria).

The authors declare no conflict of interests.

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