Hypofractionation Flashcards

1
Q

OCOG 93-010 (Canadian, Whelan)

Reason for Trial?

A

Radiobiological models suggest that hypo-fractionation may be just as effective as 50 Gy in 25 fxs

More convenient

Improve compliance

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2
Q

OCOG 93-010 (Canadian, Whelan)

How many yrs of data is available?

A

5 and 10 yr

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3
Q

OCOG 93-010 (Canadian, Whelan)

Inclusion Criteria?

A

Invasive carcinoma w/ -ve LNs

tx’ed with lumpectomy and ALND

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4
Q

OCOG 93-010 (Canadian, Whelan)

Exclusion Criteria?

A

IDC or DCIS with +ve margins
Tumors > 5 cm
Breast width > 25 cm

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5
Q

OCOG 93-010 (Canadian, Whelan)

Why was the breast width chosen as such?

A

Larger breasts can cause dose heterogeneity

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6
Q

OCOG 93-010 (Canadian, Whelan)

RT Regimen?

A

50/25 vs. 42.5/16. No boost
Delivered via 2 opposed tangential beams (2D planning)
No RT to the LNs( (Supraclav, IM, or axillary)

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7
Q

OCOG 93-010 (Canadian, Whelan)

Patient stratification?

A
Age (<50 yrs or >50 yrs)
Tumor Size (<2cm or >2cm)
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8
Q

OCOG 93-010 (Canadian, Whelan)

Primary outcomes?

A

Local recurrence

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9
Q

OCOG 93-010 (Canadian, Whelan)

Secondary outcomes?

A
distant recurrence
contralateral breast recurrence
second cancers
breast cosmesis
late toxic effects of RT
Death
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10
Q

OCOG 93-010 (Canadian, Whelan)

How was RT toxicity assessed?

A

Using Late Radiation Morbidity Scoring Scheme

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11
Q

OCOG 93-010 (Canadian, Whelan)

How was breast cosmesis asessed?

A

Using EORTC Cosmetic rating system

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12
Q

OCOG 93-010 (Canadian, Whelan)

Type of Trial?

A

Non-inferiority trial

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13
Q

OCOG 93-010 (Canadian, Whelan)

How many pts?

A
  1. LOL
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14
Q

OCOG 93-010 (Canadian, Whelan)

Pt characteristics?

A
25% < 50 yrs
33% T2
26% ER-
11% Chemo (5 FU, Cyclophosphamide, MTX)
41% tamoxifen
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15
Q

OCOG 93-010 (Canadian, Whelan)

Results: Local Recurrence of invasive disease?

A

10 yr LR

hypo: 6.2%
conv: 6.7%

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16
Q

OCOG 93-010 (Canadian, Whelan)

Results: Cosmesis?

A

10 yr Cosmesis

Excellent or good cosmetic outcome

hypo: 70%
conv: 71%

Older age and larger tumors were associated with worse outcomes

17
Q

OCOG 93-010 (Canadian, Whelan)

Results: Skin G3 TOX?

A

10 yr TOX

hypo: 2.5%
conv: 2.7%

18
Q

OCOG 93-010 (Canadian, Whelan)

Results: DSS?

A

10 yr DSS

hypo: 87%
conv: 87%

19
Q

OCOG 93-010 (Canadian, Whelan)

Results: OS?

A

10 yr OS

hypo: 84%
conv: 84%

20
Q

OCOG 93-010 (Canadian, Whelan)

Conclusion?

A

Hypo WB RT okay for -ve margin, -ve LN, and breast separation < 25 cm

21
Q

OCOG 93-010 (Canadian, Whelan)

Was there any subanalysis?

A

Yes, subanalysis for high grade tumors (19% of tumors)
RT less effective for high-grade tumors

10 yr LR for HG

hypo: 15%
conv: 5%

22
Q

OCOG 93-010(Canadian, Whelan)

Limitations of the trial

A

No patients with DCIS alone!

23
Q

START A&B

How many trials?

A

2 PRT

24
Q

START A&B

When was the study run?

A

1999-2002

25
Q

START A&B

What does START stand for?

A

Standardization of Breast Radiotherapy

26
Q

START A&B

What RT doses were assessed?

A

START A: 50/25 vs. 41.6/13 or 39/13 QOD
START B: 50/25 vs. 40/15

Both permit a 10 Gy boost

27
Q

START A&B

Tumor characteristics?

A

pT 1-3a
pN 0-1
M0

28
Q

START A&B

What does the N mean?

A

N1

mi: >0.2 mm and/or >200cells, but < 2mm
a: 1-3 axillary LNs
b: IM LN +ve pathologically but -ve clinically
c: pN1a + pN1b

29
Q

START A&B

Primary end-points?

A
  1. Loco-regional relapse (relapse within the breast, chest wall, ip axilla, supraclav fossa, or within an irradiated volume
  2. Late normal tissue side-effects
30
Q

START A&B

Secondary end-points?

A
  1. Distant relapse
  2. DFS
  3. OS
31
Q

START A&B

of pt’s recrutied?

A

START A: 2236

START B: 2215

32
Q

START A&B

How many LN +ve pts?

A

START A: 29%

START B: 23%

33
Q

START A&B

How many % lumpectomy?

A

START A: 85%

START B: 92%

34
Q

START A&B

START A: Important pt characteristics?

A

START A:

  1. Age 57 (25-85)
  2. Adjuvant Chemo 35%
  3. Tamoxifen 79%
  4. Lumpectomy 85%
  5. RT Boost 61%
  6. LN RT 14%
35
Q

START A&B

How many yrs of data do we have?

A

5 and 10 yrs

36
Q

START A&B

Results of START A?

A

START A: No sig difference

10yr LRR: 6.3% (41.6 Gy) vs. 8.8% (39 Gy) vs. 7.4 (50 Gy)

37
Q

START A&B

START B: Important pt characteristics?

A

START B: Age 57 (23-86)

  1. Age 57 (23-86)
  2. Adjuvant Chemo 22%
  3. Tamoxifen 87%
  4. Lumpectomy 92%
  5. RT Boost 23%
  6. LN RT 7%
38
Q

START A&B

Results of START B?

A

START B

  1. 10yr LRR: 4.3% (40 Gy) vs. 5.5% (50 Gy). No sig.
  2. 10yr distant relapse: 12.3% (40) vs. 16% (50). Sig
  3. 10 yr all-cause mortality: 7.9& (40) vs. 10.9% (50). Sig
  4. Local side effects were significantly less common with 40 than 50.

2 and 3 were not observed START A.

39
Q

START A&B

Conclusions?

A

Hypo-fractionated WBI is safe and effective for early breast cancer. 40/15 is SOC in the UK.