The primary objective was met as the CRR with BCP was significantly higher than the reference rate. Bevacizumab may be safely added to a preoperative program in patients deemed non-optimally resectable, whatever the final surgical decision. Bevacizumab's role in this setting should be further investigated.
This preliminary study shows that the assessment of small C fiber neuropathy can be performed non invasively, quickly and effectively in standard diabetes outpatient practice with very good reproducibility. The observation that electrochemical skin conductance improves with intensified insulin treatment must be confirmed in a clinical study performed on a larger population.
Background: The open-label, randomised Phase 2 AVATAXHER study (NCT01142778) demonstrated that early PET assessment identified HER2-positive breast cancer patients who responded poorly to neoadjuvant docetaxel plus trastuzumab. Adding neoadjuvant bevacizumab for PET-predicted poor-responders improved pathological complete response (pCR) rates (43.8% vs 24.0%). We investigated long-term study outcomes. Methods: Patients were treated in three groups. All patients initially received two cycles of standard neoadjuvant therapy with [ 1 ⁸F]-FDG PET conducted before each cycle. Those with 70% change in the maximum standardised uptake value (ΔSUVmax) received four further cycles of standard neoadjuvant therapy (PET responders). PET-predicted poor-responders (ΔSUVmax <70%) were randomised (2:1) to neoadjuvant therapy with (Group A) or without (Group B) bevacizumab for cycles 3À6. All patients received one further cycle of trastuzumab before surgery plus adjuvant trastuzumab (11 cycles). Findings: 142 patients were randomized and treated (PET responders, n = 69; Group A, n = 48; Group B, n = 25). 5-year disease-free survival rates were 90.5% (95% CI: 80.0À95.6%) in PET responders, 90.2% (95% CI: 75.9À96.2%) in Group A, and 76.0% (95% CI: 54.2À88.4%) in Group B. However, no difference was observed between randomised arms in a sensitivity analysis. During adjuvant therapy, the incidence of Grade 3 (Group A: 25.6%; Group B 12.5%) and serious adverse events (Group A: 18.6%; Group B 12.5%) was higher in Group A vs Group B, but with no apparent effect on cardiac events. Interpretation: In patients with HER2-positive breast cancer, an intervention based on early PET assessment and improvement of pCR does not modify disease-free survival.
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