Radiotherapy vs.No Radiotherapy

after breast conserving surgery (BCS)

for in-situ breast cancer.Luc Vakaet

Clash of the titans

Bernard Fisher Melvin Silverstein

EBCTCG: RT vs no RT for DCIS

Study Name Inclusion criteria Entry # pts Prescription Margins clear?

NSABP B-17 Lumpectomy 1985-1990 818 50 Gy to breast No

EORTC 10853 Local Excision; Age < 70

1986-1996 1010 50 Gy to breast No

Swedish DCIS Study

Quadrantectomy 1988 1046 50 Gy to breast No

Stockholm 8 Breast-Conserving Surgery

1990-1999 188 50 Gy to breast No

UK DCIS Trial Screen-Detected; Complete Local

Excision;

1990 1030 50 Gy to breast Yes

Total 4092

EBCTCG Preliminary results. Not for publication or

citation

Results: Isolated local recurrenceRelative risk

event total ev/tot event total ev/tot

NSABP B-17 76 413 18% 138 405 34% 54%

EORTC 10853 72 507 14% 126 503 25% 57%

Swedish BCCG 42 526 8% 114 520 22% 36%

Stockholm 8 13 95 14% 25 93 27% 51%

UK DCIS 29 522 6% 69 508 14% 41%

Totals 232 2063 11% 472 2029 23% 48%

Radiation Control

Preliminary results. Not for publication or

citation

EBCTCG Preliminary results. Not for publication or

citation

EBCTCG Preliminary results. Not for publication or

citation

EBCTCG Preliminary results. Not for publication

or citation

RT prevents only clinically unimportant non-invasive recurrences?

Age

At riskLocal

recurrence Percent At riskLocal

recurrence Percent

Non-invasve 403 51 13% 411 30 7%

Invasive 403 53 13% 411 17 4%

Lumpectomy Lumpectomy + RT

NSABP B-17 JCO 1998

Can we select patients that would not or very little benefit from RT

• Does DCIS size matter?= > Only for DCIS > 5 cm

• Does patient age matter?= > Unnecessary for patients older than 70

• Does margin width matter?= > Margins more than 1 cm is OK

• Does differentiation matter?= > Only for patients with Grade 3

Margin width < 1 cm

Silverstein et al. NEJM 1999

What about theVan Nuys Prognostic Index (VNPI)?

Does DCIS size matter?

EBCTCG Preliminary results. Not for publication

or citation

Does age matter?

NSABP B-17 JCO 1998

Age

At riskLocal

recurrence Percent At riskLocal

recurrence Percent

<50 137 36 26% 137 21 15%

50-59 115 33 29% 131 12 9%

>59 151 35 23% 143 14 10%

Lumpectomy Lumpectomy + RT

UKNZL DCIS Study: Always re-excision when margins are positive

Lancet 2003

EORTC 10 yrs FU of local recurrence

26%54%

25%37%

13%30%37%

24%43%

18%34%35%

JCO 2006

JCO 2006

Summary of the scientific evidence

• 10.6 % (p < 0.0001) absolute gain in any recurrence by year 10. 50% relative reduction of the risk of recurrence.

• no difference in breast cancer mortality or any death by year 10.

• The gain in recurrence is statistically significant in any subgroup analysed.

• There are no prospectively verified prognostic indices for local recurrence.

• We cannot (yet) define a subgroup of patients with sufficiently low risk to exclude radiation after BCS.