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No significant differences were seen between Arm A and Arm B regarding fibrosis, breast edema, retraction, ulceration, lymphedema, hyperpigmentation, and pain. Arm B), fibrosis had a cumulative rate of 5.9 versus 37.5 versus 18.4 %, respectively (38.2 % IORT boost control group), at 3 years. The hazard ratio of higher grade toxicity as first event was 0.46 (95 % CI, 0.26–0.83) for Arm A IORT as compared to Arm B ( = 0.010).
Arm A had significantly less telangiectases compared to Arm B ( = 0.049). No telangiectases were seen after IORT alone (0 % Arm A IORT vs. No recurrences were seen after a median follow-up of 40 months (Arm A) and 42 months (Arm B).
Between 02/2002 and 12/2008, 305 patients were treated within TARGIT A (Arm A: = 196) at a single center.
Toxicity was assessed according to the LENT SOMA scales.