作者
Atilla Soran,Vahit Ozmen,Serdar Özbaş,Hasan Karanlik,Mahmut Muslumanoglu,Abdullah Igci,Zafer Canturk,Zafer Utkan,Cihangir Özaslan,Turkkan Evrensel,Cihan Uras,Erol Aksaz,Aykut Soyder,Ümit Uğurlu,Cavit Çöl,Neslihan Cabioglu,Betül Bozkurt,Efe Sezgin,R. R. Johnson,Barry C. Lembersky
摘要
1005 Background: The MF07-01 trial is a multicenter phase III randomized trial of treatment naive stage IV BC patients comparing loco-regional surgery (LRS) followed by appropriate systemic therapy (ST) vs ST alone. Aims: To compare 3-year survival and loco-regional progression (LRP). Methods: At initial diagnosis patients were randomized 1:1 to LRS group or ST group. After consideration of retrospective studies, we hypothesized at 36 months a survival difference between the two groups to be 18%. Assuming a 10% drop out rate and with a one sided log-rank test with a 95% CI and a 90% power 271 patients needed to be randomized. Results: 274 patients were accrued; 138 in the LRS group and 136 in the ST group. The groups were comparable regarding age, BMI, HER2 neu, tumor type and size, histologic grade, and bone and visceral metastasis (all p > 0.05). There were 76 (55%) deaths in the LRS group and 101 (74%) in the ST group during the median 40 (20-51) months follow-up. At 36 months the survival rate was similar the LRS group and the ST group (60% and 51%, respectively; p = 0.5). Overall survival (OS) was 34% higher in the LRS group compared to the ST group (HR: 0.66, 95%CI 0.49-0.88: p = 0.005). In unplanned subgroup analyses, OS was statistically higher in LRS group than ST group; ER/PR (+) (HR: 0.64, 0.46-0.91, p = 0.01), HER2 neu (-) (HR: 0.64, 95%CI 0.45-0.91; p = 0.01), patients < 55 years (HR: 95%CI 0.57, 0.38-0.86; p = 0.006), and solitary bone only metastasis (HR: 0.47, 95%CI 0.23-0.98; p = 0.04). The median survival was 14 months higher in the LRS group comparing with the ST group in bone only metastasis (56 vs 42 months, respectively; HR 0.67, 95%CI 0.43-1.07; p = 0.09). LRP was 1% (n = 2) in the LRS group and it was 11% (n = 15) in the ST group (p = 0.001). Conclusion: In this trial we did not observe improvement in 36 month survival with surgery. However, longer follow up revealed statistically significant improvement in median survival with surgery (46 vs.37 months) at median 40 months follow up. Additionally, patients with a more indolent form of metastatic BC such as ER (+), HER2 neu (-), solitary bone metastasis, and patients < 55 years old have a significant survival benefit with initial surgery. Clinical trial information: NCT00557986.