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University Hospital Erlangen

Ad 1.

a) Retrospective analysis and the inherent selection bias

b) Patient

selection criteria

according ASTRO and GEC-ESTRO has not been

satisfied by

60-70% of pts.

(cautionary and not suitable group…)

b) Particularly number of patients with risk factors

as pN+, R1, age < 50y

. not reported.

c) No informations about target related

QA

presented. Different safety margins by different resection margins not

respected…

Ad 2.

No data available about

OAR

-related quality assurance:

No data about doses on the ribs.

No data about the dosis on the skin – distance balloon-skin etc..

Ad 3.

Patients has been treated as „out-patient“

without antibiosis

~ infection rate 10-20%.

Using peri- and postop. antibiosis and „in-patient“ basis ~ infection rate <1-2%.

Benjamin D. Smith, M.D., MD Anderson Cancer Center, Houston

Retrospective analysis based upon a review of

Medicare claims data

:

1. Brachytherapy treatment was the “most important factor”affecting

mastectomy

risk

(4% vs. 2%).

2.

Brachytherapy was associated with an increased risk for postoperative

nonifectious side effects

(16,2% vs. 9% - fat necrosis, rib fracture…)

3.

Patients treated with brachytherapy also had an increased

risk for infection

.

(16,2% vs. 10.3% etc.)

Zain A. Husain et al.

Accelerated partial breast irradiation via brachytherapy: A patterns-of-

care analysis with ASTRO consensus statement groupings

Brachytherapy

,

10, 2011

,

479-485

General: We are dealing with Medicare payment records rather than medical healthcare records

Balloon – Mammosite-System