Short course radiotherapy with simultaneous integrated boost for stage I-II breast cancer, early toxicities of a randomized clinical trial

Table 2 Occurrence of toxicity grade ≥1 change from baseline after radiation treatment, by intent to treat randomization arm

	Control			Tomotherapy			P-value 1 sided
	Number of patients evaluated	Observed grade ≥1	% grade ≥1	Number of patients evaluated	Observed grade ≥1	% grade ≥1
Skin
at 2 months	32	65.6	21	36	24	66.7	0.636
at 1 year	31	14	45.2	36	14	38.9	0.393
at 2 years	20	12	60.0	20	6	30.0	0.056
Breast/chest wall fibrosis
at 1 year	32	12	37.5	36	10	27.8	0.276
at 2 years	24	9	37.5	24	6	25.0	0.267
Arm lymphedema
at 2 months	32	2	6.2	36	1	2.8	0.455
at 1 year	32	2	6.2	36	2	5.6	0.647
at 2 years	24	3	12.5	24	3	12.5	0.667
Heart function
at 2 months	32	9	28.1	35	4	11.4	0.078
at 1 year	31	4	12.9	36	8	22.2	0.906
at 2 years	21	1	4.8	22	1	4.6	0.744
*Lung toxicity score based on change in FEV1 ()**
at 2 months	30	4	13.3	34	3	8.8	0.429
at 1 year	29	4	13.8	34	4	11.8	0.552
at 2 years	24	5	20.8	27	4	14.8	0.422
*Lung toxicity score based on change in DLco ()**
at 2 months	30	10	33.3	34	8	23.5	0.277
at 1 year	29	8	27.6	34	3	8.8	0.052
at 2 years	24	7	29.2	27	2	7.4	0.047
*Lung toxicity based on change in FEV1 and DLco ()**
at 2 months	30	12	40.0	34	10	34.3	0.266
at 1 year	29	12	41.4	34	6	28.6	0.036
at 2 years	24	10	41.7	27	5	22.2	0.066

(*) Cases who did not receive RT according to randomization arm were computed as missing.

ISSN: 1748-717X