Primary operation in synchroneous metastasized invasive breast cancer patients: First oncologic outcomes of the prospective randomized phase III ABCSG 28 POSYTIVE trial.

Abstract

557 Background: The ABCSG 28 Posytive trial compared primary surgery versus primary systemic therapy without surgery in stage IV breast cancer patients. The primary aim was to investigate whether immediate resection of the primary tumor followed by standard systemic therapy improves median survival compared with no surgical resection (NCT01015625). The trial had to be stopped early due insufficient recruitment. Methods: Untreated stage IV breast cancer patients with the primary in situ were randomly assigned to either surgery of the primary versus no surgery followed by systemic therapy between 2011 and 2015 in 15 breast health centers in Austria. Systemic therapy included endocrine therapy or chemotherapy. Patients were routinely followed every 3-6 months. Primary endpoint was median survival. Results: 90 patients (45 with surgery, 45 with primary systemic therapy without surgery) were randomized. Stratification criteria were age, endocrine responsiveness, her2 expression, planned first line therapy and bone only versus other metastases. Patients in the surgery arm had more cT3 breast cancer (22% versus 7%) and more cN2 staging (16% versus 4%) as well as more her2 positive breast cancer cases (27% versus 18%). The median follow up was 37.5 months and immunohistochemical subtype analysis showed 9% basal like, 22% her2 positive, 51% luminal A and 13% luminal B cancers. Both groups were well balanced regarding first line treatment (endocrine versus chemotherapy) however, there were more taxane treated patients in the no surgery group (24.4 versus 15.6%). The median survival in the surgery arm was 34.6 months versus 54.8 months in the no surgery arm without statistical significance (HR 0.691 CI 0.358 – 1.333; p=0.267). Time to distant progression was insignificantly longer in the no surgery arm (surgery arm 13.9 versus no surgery arm 29.0 months). Conclusions: This first analysis of the prospective randomized phase III trial POSYTIVE-ABCSG-28 demonstrated no benefit in overall survival for immediate surgery of the primary in de novo stage IV breast cancer patients. Clinical trial information: NCT01015625.

Primary Tumor Surgery for Patients with De Novo Stage IV Breast Cancer can Decrease Local Symptoms and Improve Quality of Life

“…5 The recent Austrian ABCSG-28 POSITIVE study did not mention relevant local problems. 6 Therefore, in the Discussion of the Turkish study, the authors mentioned that the role of local resection in the control of local symptoms was an unsolved issue worthy of examination and research. Therefore, in our retrospective study, we proposed the research term ''local progress/recurrence of symptoms'' (LPRS) to represent the local symptoms caused by tumor progression/recurrence.…”

“…To date, several prospective studies have focused on whether local resection can improve prognosis of patients diagnosed with de novo stage IV BC, [4][5][6] but the final results have not been consistent, and other retrospective analyses have also yielded controversial results in answer to this question. [7][8][9][10] Aside from survival, no studies have focused on the effect of surgery on local symptoms caused by tumor progression/recurrence.…”

Surgery for Primary Tumor Benefits Survival for Breast Cancer Patients With Bone Metastases: A Large Cohort Retrospective Study

“…However, a limited number of prospective randomized controlled clinical trials have produced con icting results. A recently published study in Austria indicates no OS bene t of surgical resection of the primary tumor in primary stage IV breast cancer [25]. No credible conclusions can be drawn from these studies because they are small and non-randomized, and all of them have cohorts selected from a single institution.…”

Restaging Patients With Locoregional Relapse: Is There Any Benefit?

“…However, this trial was ended early because of poor accrual of patients, raising questions regarding the power of its statistical analysis. 10 One notable recent study of surgery for de novo stage 4 breast cancer is the MF07-01 trial sponsored by the Turkish Federation of the National Societies for Breast Disease. 11 In this study, the last statistical analysis in a median followup period of 40 months showed results that differed from those of the previous 36-month follow-up period, in which no difference in survival was noted between the surgery and no-surgery groups.…”