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

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

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