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S163

ESTRO 36

_______________________________________________________________________________________________

5

Beatson West of Scotland Cancer Centre, Oncology

Department, Glasgow, United Kingdom

6

Royal Stoke Hospital, Oncology Department, Stoke-on-

Trent, United Kingdom

7

Aukland Hospital, Physics Department, Aukland, New

Zealand

8

Nuffield Health Cheltenham Hospital, Department of

Surgery, Cheltenham, United Kingdom

9

Norfolk and Norwich University Hopsitals NHS

Foundation Trust, Oncology Department, Norwich,

United Kingdom

11

Kings College London, Oncology Department, London,

United Kingdom

12

Clatterbridge Cancer Centre, Oncology Department,

Bebington, United Kingdom

13

Mount Vernon Cancer Centre, Radiotherapy

Department, Northwood, United Kingdom

14

Royal Cornwall Hospital, Oncology Department, Truro,

United Kingdom

15

Independent Cancer Patient Voice, London, United

Kingdom

16

Institute of Cancer Research, Academic Department of

Radiotherapy, London, United Kingdom

Background: Local cancer relapse rates after breast

conservation surgery followed by radiotherapy have fallen

sharply in many countries with risk influenced by patient

age and clinico-pathological factors. In women at lower

than average risk of local relapse, partial breast

radiotherapy restricted to the vicinity of the original

tumour is hypothesised to improve the balance of

beneficial versus adverse effects compared with whole

breast radiotherapy.

Methods: The IMPORT LOW trial (ISRCTN12852634)

recruited women aged ≥50 years after breast conserving

surgery for invasive ductal adenocarcinoma pT≤3cm, pN0-

3, G1-3 and ≥2mm resection margins. Using 15 daily

treatments, patients were randomly allocated (1:1:1) to

40 Gy whole breast radiotherapy (control), 36 Gy whole

breast plus 40 Gy to partial breast (reduced dose) or 40 Gy

partial breast only (partial breast). Primary endpoint was

ipsilateral local relapse rate (80% power to exclude a

+2.5% non-inferiority margin at 5 years for each test

group).

Findings: Between May 2007 and October 2010, 2018

women were recruited (control n=675, reduced dose:

n=674, partial breast: n=669). With a 72.2 month median

follow-up (IQR 61.7-83.2), 5-year local relapse rates were

1.1% (95%CI 0.5-2.3), 0.2% (0.02-1.2) and 0.5% (0.2-1.4) in

control, reduced dose and partial breast groups. Absolute

differences in local relapse rate compared with the

control group were -0.73% (-0.99, 0.22) for the reduced

dose and -0.38% (-0.84, 0.90) for the partial breast groups,

demonstrating non-inferiority for both test groups.

Photographs, patients and clinicians reported similar or

lower levels of adverse effects after reduced dose or

partial breast radiotherapy compared with whole breast

radiotherapy (see Table 1).

Interpretation: At 5 years, partial breast and reduced dose

radiotherapy showed local relapse rates non-inferior to

that observed following whole breast radiotherapy and

produced equivalent or milder late normal tissue side

effects. This simple radiotherapy technique is

implementable in radiotherapy centres worldwide.

Funding: Cancer Research UK (CRUK/06/003).

SP-0315 Partial breast radiotherapy after breast

conservation for breast cancer: early results from the

randomised DBCG PBI trial

B. Offersen

1

, H.M. Nielsen

1

, M.S. Thomsen

2

, E.H.

Jacobsen

3

, M.H. Nielsen

4

, L. Stenbygaard

5

, A.N.

Pedersen

6

, M. Krause

7

, M.B. Jensen

8

, J. Overgaard

9

1

Aarhus University Hospital, Dept Oncology, Aarhus C,

Denmark

2

Aarhus University Hospital, Dept Physics, Aarhus C,

Denmark

3

Lillebaelt Hospital, Dept Oncology, Vejle, Denmark

4

Odense University Hospital, Dept Oncology, Odense,

Denmark

5

Aalborg University Hospital, Dept Oncology, Aalborg,

Denmark

6

Copenhagen University Hospital- Rigshospitalet, Dept

Oncology, Copenhagen, Denmark

7

University Clinic Carl Gustav Carus- Technical University

Dresden, Clinic for Radiotherapy and Oncology, Dresden,

Germany

8

Copenhagen University Hospital- Rigshospitalet, DBCG,

Copenhagen, Denmark

9

Aarhus University Hospital, Dept Expt. Clin. Oncology,

Aarhus C, Denmark

Objective

The risk of local recurrence after adjuvant

radiation therapy (RT) of early breast cancer (BC) is now

so low that ESTRO and ASTRO have suggested guidelines

to select patients who may be safely treated with partial

breast (PBI) and not whole breast irradiation (WBI). In the

Danish Breast Cancer Group (DBCG) the randomized DBCG

PBI trial was initiated to safely introduce PBI as standard

in DK.

Material/Methods

Patients ≥60 years operated with breast

conservation for early non-lobular breast cancer (BC) pT1

pN0, ER+, grade 1 or 2, HER2-, margin ≥2mm were enrolled

and randomized to PBI vs WBI, all cases based on 40Gy/15

fr. Strata were institution and endocrine therapy. The

primary endpoint was breast induration 3 years after RT,

secondary endpoints were other morbidities, genetic risk

profile for RT-induced fibrosis and recurrences.

ClinicalTrial NCT00892814.

Results

In 6 RT departments in DK and D 882 pts were

enrolled in 2009-16. At analysis 353 pts (40%) had ≥ 3 years

follow up. At 3 years grade 2-3 induration was detected in

6.4% in the PBI arm and in 7.7% in the WBI arm (HR 0.76,

95% CI, 0.39-1.47). At 3 years, comparing the PBI with the

WBI arm there were no differences in dyspigmentation

(8.1% vs 11.0%), telangiectasia grade 2-3 (5.3% vs 8.9%),

edema grade 2-3 (0.6% vs 0.6%), scar grade 2-3 (21.5% vs

17.1%), and global cosmetic outcome (excellent/good)

was 84.3% vs 83.9%, respectively. At 3 years patients

treated with PBI or WBI reported excellent/good

satisfaction with the treated breast in 92.5% vs 91.2% of

cases, and 83.2% vs 81.8% when reporting satisfaction with

the treated breast compared with the non-treated breast.

In the PBI / WBI arm local recurrence was reported in 1

pt/ 2 pts, regional recurrences 0 pt / 0 pt, distant failure

1 pt / 2 pts, new contralateral BC / DCIS 2 pts / 2 pts and

other malignancy 8 pts / 16 pts. One patient had died from

BC, 7 from other malignancy, 7 from non-cancer causes.

Updated results will be provided at ESTRO 36.

Conclusion

Using 40/15 fr for PBI in selected early node-

negative BC patients results in few late RT induced

morbidities with no difference compared with WBI. These

results are in harmony with results from the large UK

IMPORT LOW trial using the same RT technique. Thus 40

Gy/15 fr external beam PBI is now DBCG standard for

breast RT in patients fulfilling the inclusion criteria for the

DBCG PBI trial.