S645
ESTRO 36
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EP-1191 Postmastectomy locoregional irradiation to
temporary tissue-expander or permanent breast
implant
M.A. Gerardi
1
, D.P. Rojas
2
, R. Ricotti
1
, M.C. Leonardi
1
, G.
Riva
2
, D. Ciardo
1
, C.M. Francia
2
, R. Cambria
3
, R.
Luraschi
3
, F. Cattani
3
, C. Fodor
1
, F. De Lorenzi
4
, M.
Rietjens
4
, P. Veronesi
5
, A. Morra
1
, V. Dell'Acqua
1
, R.
Orecchia
6
, B.A. Jereczek-Fossa
2
1
European Institute of Oncology, Department of
Radiation Oncology, Milan, Italy
2
European Institute of Oncology - University of Milan,
Department of Radiation Oncology - Department of
Oncology and Hemato-oncology, Milan, Italy
3
European Institute of Oncology, Department of Medical
Physics, Milan, Italy
4
European Institute of Oncology, Department of Plastic
and Reconstructive Surgery, Milan, Italy
5
European Institute of Oncology, Department of Surgery,
Milan, Italy
6
European Institute of Oncology - University of Milan,
Department of Medical Imaging and Radiation Sciences -
Department of Oncology and Hemato-oncology-, Milan,
Italy
Purpose or Objective
The aim of the study (partially supported by a research
grant from Accuray Inc. entitled 'Data collection and
analysis of Tomotherapy and CyberKnife breast clinical
studies, breast physics studies and prostate study”) is to
evaluate acute and intermediate toxicity in
postmastectomy patients with implant-based immediate
breast reconstruction receiving locoregional intensity
modulated radiotherapy (IMRT) with a hypofractionated
scheme.
Material and Methods
Data of the first 121 consecutive post-mastectomy
locoregional patients treated with Helical Tomotherapy
between May 2012 and May 2015 with a hypofractionated
scheme (2.67Gy/fr, 15 fractions) have been prospectively
collected. Breast reconstruction was performed with
temporary tissue expander implantation in 57% of patients
(69/121 expander-patients) and with permanent
prosthesis in 43% of patients (52/121 prosthesis-patients).
Acute toxicity was evaluated using RTOG/EORTC criteria,
while late toxicity was recorded according to LENT/SOMA
scale.
Results
All patients completed the treatment course without
interruption for toxicity. In the expander group, one
patient died for leukemia 20.3 months after radiotherapy
and two had distant metastasis.Acute toxicity was
assessed in 121 patients (mean follow up: 2.4 months,
range: 0-8.1 months). No patient experienced grade >2
toxicities (edema, erythema or desquamation). No
significant difference (p=0.06) in acute toxicities were
observed between the type of allogenic reconstruction:
43.5% (30/69) of expander-patients and 26.9% (14/52) of
prosthesis-patients presented toxicities of grade 2. The
most common toxicity was edema, which was of grade 2
in 33.3% (23/69) of the expander-patients and 21.2%
(11/52) of prosthesis-patients (p=0.141). Grade 2 acute
erythema was observed in 14.5% (10/69) of expander-
patients and 7.7% (4/52) of prosthesis-patients (p=0.249).
Statistically significant (p=0.04) higher incidence of grade
2 edema was found in patients with high BMI. This was
found also in the prosthesis-patient subgroup
(p=0.05).Intermediate toxicity was evaluated at a median
follow up of 14.2 months (range: 5.8-35.0) on 85 patient
(54 expander-patients and 31 prosthesis-patients). No
grade ≥2 skin dryness, telangiectasia, ulcer, hypo- and
hyper-pigmentation were reported (Tab.1).
Conclusion
Acute toxicity of Helical Tomotherapy-based IMRT after
immediate breast reconstruction was satisfactory and
intermediate toxicity was acceptable. Based on this
preliminary analysis, hypofractionation might be
considered also in the settings of locoregional treatments,
providing advantages for patients’ convenience and for
fruitful use of resource.
EP-1192 Assessment of quality of life in phase III
clinical trials of radiation therapy in breast cancer
G.N. Marta
1,2
, F.Y. Moraes
3
, E.T. Leite
2
, E. Chow
4
, D.
Cella
5
, A. Bottomley
6
1
Hospital Sírio-Libanês, Radiation Oncology, São Paulo,
Brazil
2
Instituto do Câncer do Estado de São Paulo ICESP -
Faculdade de Medicina da Universidade de São Paulo,
Radiation Oncology, Sao Paulo, Brazil
3
Princess Margaret Cancer Center- University of Toronto,
Radiation Oncology, Toronto, Canada
4
Sunnybook Odette Cancer Centre- Sunnybrook Health
Sciences Centre, Radiation Oncology, Toronto, Canada
5
Northwestern University, Medical Social Sciences,
Chicago, USA
6
European Organisation for Research and Treatment of
Cancer Headquarters, Quality of Life, Brussels, Belgium
Purpose or Objective
The aim of this study was to investigate the magnitude to
which health-related quality of life (HRQOL) parameters
have been used in phase III studies on breast cancer
patients who received post-operative radiation therapy,
as well as the frequency and correlates of significant
HRQOL gains.
Material and Methods
A systematic review in accordance with The Cochrane
Collaboration Handbook of Interventions Systematic
Reviews was performed. Only prospective phase III clinical
trials in patients with breast cancer were included.
Eligible trials must state radiation therapy as the main
element of treatment in at least one of the groups. With
regard to HRQOL as an endpoint in the studies, we first
attempted to identify any mention in the paper of HRQOL
data collection during the trial, or, when no such mention
were found, the existence of a companion paper
dedicated to HRQOL analysis separately. When HRQOL was
a study endpoint, we collected data on the instruments
used for HRQOL analysis, assessing if there was formal
statistical comparison between study groups and the