Breast conserving therapy using Accelerated Partial Breast Irradiation (APBI) in elderly patients: a feasibility study

The treatment policy for elderly patients with early stage breast cancer is
largely intuitive and is just partly based on evidence as these patients are
often not included in phase II/III studies. As a consequence a relative large
proportion is treated by breast ablation and sentinel node biopsy. Accelerated
partial breast irradiation (APBI) either by intra-operative or external beam
radiotherapy might be a good alternative for elderly patients offering less
treatment burden in a shortened treatment time and a limited chance of
recurrence. International studies using APBI claim equivalent tumor control and
cosmetic results compared to conventional fractionated radiotherapy.
The elderly patient is a complex patient due to the age, the (geriatric)
condition with frequent co-morbidity and usage of multiple medications. The
collection of information of these (geriatric) conditions in Dutch radiotherapy
centers will give us a solid base to construct algorithms to predict patient
outcome (tumor related, morbidity and intercurrent disease)

Confirm favorable treatment results of international studies.
Relate (loco regional) tumor control, side effects and (inter current) death to
geriatric questionnaires/condition, co-morbidity and usage of medication.

registration study applying treatment modalities with proven efficacy in
international phase III studies in an elderly study population
Intervention: depending on the facilities of the centre either intra-operative
radiotherapy at lumpectomy (21 Gy 90% isodose, *ELIOT procedure*) or
postoperative external beam radiotherapy (3DCRT or IMRT, 10x3,4 Gy ICRU, 10
fractions in 2 weeks).

This registration study is aimed to confirm the favorable treatment results of
randomized international studies so tumor control and cosmesis will be
comparable with the conventional approach. As such the treatment will be less
extensive than routinely applied (lumpectomy instead of ablation; less
radiation treatments (1 intra-operative fraction or 10 external beam fractions
in 2 weeks instead of 25 in 5 weeks). The extra burden will be the
questionnaires and two digital pictures after 3 and 5 years to evaluate the
cosmetic result. The EORTC C30 and breast module are basic and need 5-10
minutes of time (at start, at the end of treatment and every half year
afterwards). The geriatric questionnaires (Groningen FI, G8 and VES 13) will
take approx. 10 minutes to complete and will be offered at start, at the end of
treatment and every half year. The co-morbidity and medication questionnaire
will be offered at start (5-10 minutes) and checked for changes afterwards. A
major effort will be done to convert the paper questionnaires to electronic
questionnaires to facilitate the practical implementation of this study and
future studies.