Characteristics of the Evidence Base

Table 2 summarises the trial populations and primary outcomes measured in the six RCTs comparing hypofractionated radiotherapy to conventionally fractionated radiotherapy. Of note:

Six trials identified the patient population characteristics as early invasive breast cancer T1-3, N0-1, M0.^{6,7,10,11,13,16-18,21}
The Spooner trial, UK FAST trial, the Canadian trial and the RMH/GOC, limited the trial populations to those who had breast conserving surgery only.^{6,7,11,13,18,21}
Women participating in the START A or START B trials had breast conserving surgery or mastectomy.^10,16,17

Table 2 - Trial characteristics

Trial	Population	Median follow-up (range) years	Intervention	Comparator	Outcomes measured
Studies Post Breast conserving surgery only
Spooner 2012¹¹	Early breast cancer stage I and II	16.9 (3.7-21.8)	40 Gy in 15 daily fractions over 3wks (n=181) Supplementary boost of direct 10-14 MeV electron field of 15 Gy in five daily fractions	50Gy in 25 fractions over 5 weeks (n=177) Supplementary boost of direct 10-14 MeV electron field of 15 Gy in five daily fractions	Primary outcomes: Locoregional relapse rate at 5 years Secondary outcomes: Survival and locoregional tumour control
Spooner 2012¹¹	Early breast cancer stage I and II	16.9 (3.7-21.8)	n=707 randomised to: radiotherapy (n=358) or no radiotherapy (n=349)
UK FAST trial, 2011²¹	Early stage breast cancer Tumour size <3.0cm	3.1	30 Gy in 5 once weekly fractions of 6 Gy over 5 weeks (n=308) OR 28.5 Gy in 5 once weekly fractions of 5.7 Gy over 5 weeks (n=305)	50 Gy in 25 fractions of 2 Gy over 5 weeks (n=302)	Primary outcomes: Change in photographic breast appearance Secondary outcomes: Radiation-induced changes in the breast Local tumour control
Canadian trial6,13	Invasive carcinoma with negative axillary nodes	12 (range NR)	42.5 Gy in 16 fractions over 22 days (n=622)	50 Gy in 25 fractions over 35 days (n=612)	Local recurrence Overall survival Adverse events and toxicity Cosmetic outcome
RMH/GOC trial^7,18	Early breast cancer, T1-3, N0-1, M0 <75 years	9.7 (7.8-11.8)	39 Gy in 13 fractions over 5 weeks (n=474) 42.9 Gy in 13 fractions over 5 weeks (n=466)	50 Gy in 25 fractions over 5 weeks (n=470)	Local recurrence Cosmetic outcomes
Post Breast conserving surgery or post mastectomy
START A^10,16	Early breast cancer T1-3a, N0-1, M0	9.3	39 Gy in 13 fractions over 5 weeks (n=737) OR 41.6 Gy in 13 fractions over 5 weeks (n=750)	50 Gy in 25 fractions over 5 weeks (n=749)	Primary outcomes: Local recurrence Late normal tissue effects Secondary outcomes: Local-regional relapse Distant relapse Disease free survival Overall survival Adverse events and toxicity Cosmetic outcome Quality of life
START B^10,17	Early breast cancer T1-3a, N0-1, M0	9.9	40 Gy in 15 fractions over 3 weeks (n=1110)	50 Gy in 25 fractions over 5 weeks (n=1105)	Primary outcomes: Local recurrence Late normal tissue effects Secondary outcomes: Local-regional relapse Distant relapse Disease free survival Overall survival Adverse events and toxicity Cosmetic outcome Quality of life

Table 3 identifies key characteristics of patients involved in the six randomised controlled trials.

Table 3: Patient characteristics

	N=1410		N=1234		N=2235		N=2215		N=358		N=915
	RMH/GOC^7,18		Canadian trial^6,13		START A^10,16		START B^10,17		Spooner 2012¹¹		UK FAST trial²¹
	n	%	n	%	n	%	n	%	n	%	n	%
Treated with breast conserving surgery	1410	100%	1234	100%	1900	85%	2038	92%	358	100%	915	100%
Age ≥ 50 years	987	70%	929	75%	1727	77%	1758	79%			915	100%
T1-2	1383	98%	904	73%	1572	70%	1667	75%	173	48%	812	89%
N0	564	40%	1234	100%²³	1547	69%	1635	74%	358	100%	915	100%
N1					643	29%	504	23%
Adjuvant treatment None Tamoxifen Chemotherapy	289 1074 196	21% 76% 14%	593 505 136	48% 41% 11%	172 1758 793	8% 79% 35%	84 1928 491	4% 87% 22%	358	100%	106 694	12% 76%
High tumour grade			233	19%	629	28%	509	23%	62	17%	98	11%

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Characteristics of the Evidence Base