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Recommendations for use of

Statements of evidence

Below are the statements of evidence on which the clinical practice recommendations are based.

STATEMENTS LEVEL OF EVIDENCE13 REFERENCE
In women with early (operable) breast cancer who have undergone total mastectomy:
There is insufficient evidence to inform the safety and efficacy of hypofractionated chest wall irradiation in women who have undergone mastectomy. Cancer Australia systematic review15
In women with early (operable) breast cancer who have undergone breast conserving surgery:
Patient and tumour characteristics
Hypofractionated radiotherapy is equivalent to conventional fractionated regimens* of radiotherapy in women aged over 50 years, with pathological stage T1-2, N0, M0 and low to intermediate histologic grade tumours. I Cancer Australia systematic review15

Due to the relatively small numbers of patients in sub-group analyses of randomised trials, there is insufficient evidence to inform the safety and efficacy of hypofractionated radiotherapy for women:

  • aged less than 50 years
  • with locally advanced breast cancer
  • with a high histologic grade (grade 3) tumour
  • with node positive disease
  • who receive chemotherapy and/or targeted biological therapies.

Refer to patient characteristics table.

Cancer Australia systematic review15
Local recurrence
There are similar rates of local recurrence for women treated with hypofractionated radiotherapy and conventionally fractionated radiotherapy at 5-12 years follow-up. I Cancer Australia systematic review15
A hypofractionated radiotherapy regimen of 39 Gy in 13 fractions over 35 days is associated with a statistically significant higher rate of local recurrence compared with a hypofractionated radiotherapy regimen of 42.9 Gy in 13 fractions over 35 days at 10 years follow- up. II RMH/GOC, 20067

Subgroup analysis of a randomised controlled trial showed that for patients with high grade tumours, the hypofractionated radiotherapy regimen of 42.5 Gy in 16 fractions over 22 days was associated with a higher local recurrence rate compared with conventionally fractionated radiotherapy regimens at 12 years follow-up.


This finding has not been confirmed in the START A or START B trials.

II





III

Canadian6





Haviland17
Loco-regional recurrence
There are similar rates of loco-regional recurrence for women treated with hypofractionated radiotherapy and conventionally fractionated radiotherapy regimens at 5 years follow-up. I Cancer Australia systematic review15
Distant recurrence
One randomised controlled trial reported that a hypofractionated radiotherapy regimen of 40 Gy in 15 fractions over 21 days is associated with a statistically significant lower rate of distant relapse than the conventionally fractionated regimen at 6 years median follow- up. II START B12
Overall survival
There are similar overall survival rates reported for women treated with hypofractionated radiotherapy compared with patients treated with conventionally fractionated radiotherapy at 5-12 years follow-up. I Cancer Australia systematic review15
One randomised controlled trial reported that a hypofractionated radiotherapy regimen of 40 Gy in 15 fractions over 21 days was associated with a statistically significant lower all-cause mortality at 6 years median follow-up compared with the conventionally fractionated regimen. II START B12
Adverse events and cosmetic outcomes
One randomised controlled trial reported that global cosmetic outcome worsened over time for women treated with either hypofractionated radiotherapy or conventionally fractionated radiotherapy, however there were no significant differences observed over 10 years between the hypofractionated regimen of 42.5 Gy in 16 fractions over 22 days and the conventionally fractionated regimen II Canadian6

One randomised controlled trial reported that the hypofractionated radiotherapy regimen of 39 Gy in 13 fractions over 35 days was associated with a lower risk of developing any late radiation effect than a conventionally fractionated radiotherapy regimen at 10 years follow-up.


However, the hypofractionated regimen of 42.9 Gy in 13 fractions over 35 days was associated with a higher risk of developing any late radiation effect than a conventionally fractionated radiotherapy regimen at 10 years follow-up.

II





II

RMH/GOC9





RMH/GOC9

At 5 years follow-up, measuring changes in skin appearance, there was a statistically significant difference favouring the hypofractionated regimens of 39 Gy in 13 fractions over 35 days (START A) and 40 Gy in 15 fractions over 21 days (START B) compared to the conventionally fractionated regimen. II

START A10
START B12

Hopwood18

Cardiac toxicity
Evidence was insufficient or inconclusive about cardiac toxicity related to hypofractionated radiotherapy in comparison with conventionally fractionated radiotherapy. However, the heart was protected from exposure to radiation in randomised controlled trials. START A10
START B12
Quality of life
No statistically significant differences in quality of life scores were found in women undergoing radiotherapy after surgery between hypofractionated and conventionally fractionated radiotherapy regimens at 5 years follow-up. II START A10
START B12
Regional nodal radiotherapy
There is insufficient evidence to support the use of hypofractionated regional nodal radiotherapy. Cancer Australia systematic review15
Tumor bed boost
There is insufficient evidence to determine the safety and efficacy of a tumour bed boost administered in sequence after hypofractionated whole breast radiotherapy Cancer Australia systematic review15
Chemotherapy/Targeted therapies
There is insufficient evidence to determine the safety and efficacy of hypofractionated radiotherapy for women who receive chemotherapy and/or targeted biological therapies Cancer Australia systematic review15

*Conventional regimens of radiotherapy usually involve a dose of 50 Gy in 25 fractions over 5 weeks.

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