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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