This section describes safety outcomes from the published literature that the committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
Overall, acute toxicity including skin tenderness, redness, peeling, or mild pain was reported in 50% (n=8, denominator not stated) of patients in a case series of 17 patients (treated with 21 Gy of radiation) that collected self-report questionnaire data.
Dry skin or redness was reported in 38% (76/198) of hands in a randomised controlled trial (RCT) of 129 patients treated with 30 Gy or 21 Gy of radiation within a 4‑week follow-up.
Dry desquamation was reported in 5% (10/198) of hands and wet desquamation in 2% (3/198) of hands in the RCT of 129 patients treated with 30 Gy or 21 Gy of radiation within a 4‑week follow-up.
Extensive erythema was reported in 6% (12/198) of hands in the RCT of 129 patients treated with 30 Gy or 21 Gy of radiation within a 4‑week follow-up. Erythema was reported in 20% (42/206) of patients in a case series of 206 patients treated with 32 Gy of radiation within a 4-week follow-up.
Pronounced swelling was reported in 2% (3/198) of hands in the RCT of 129 patients treated with 30 Gy or 21 Gy of radiation within a 4‑week follow-up.
Tenderness was reported in 3% (2/60) of sites in a case series of 33 patients.
Overall, chronic toxicity including mild tightness of the skin, dryness, skin thickening, mild swelling and decreased sensation was reported in 31% (n=5, denominator not stated) of patients in the case series of 17 patients, with a mean follow-up of 35 months.
Overall, chronic toxicity events occurred in 16% (15/95) of hands treated with 30 Gy of radiation and in 11% (11/103) of hands treated with 21 Gy within 3 months and in 4% (4/95), and 5% (5/103) of hands treated with 30 Gy or 21 Gy respectively within 12 months of radiation therapy, in the RCT of 129 patients. Most of these events were skin dryness, increased desquamation, mild skin atrophy or slight subcutaneous fibrosis needing topical treatment (type of treatment not stated).
Dry skin was reported in 20% (41/206) of patients in the case series of 206 patients treated with 32 Gy of radiation, in more than 4 weeks of follow-up. Desquamation was reported in 2% (5/206) of patients in the same case series of 206 patients. Dry skin and increased desquamation were reported in 23% (47/208) of hands in a case series of 135 patients within a median follow-up of 13 years.
Lack of sweating was reported in 4% (8/206) of patients in the case series of 206 patients treated with 32 Gy of radiation within a median follow-up of 40 months.
Skin atrophy was reported in 3% (7/206) of patients in the case series of 206 patients treated with 32 Gy of radiation, in more than 4 weeks of follow-up. In the same study, telangiectasia was reported in 3% (6/206) of patients, in more than 4 weeks of follow-up. Mild skin atrophy with occasional telangiectasia was reported in 7% (14/208) of hands in the case series of 135 patients within a median follow-up of 13 years.
Alteration of heat and pain sensation was reported in 4% (8/198) of hands in the RCT of 129 patients treated with 30 Gy or 21 Gy (minimum follow-up of 1 year). Sensory affection was reported in 2% (4/206) of patients in the case series of 206 patients treated with 32 Gy of radiation, in more than 4 weeks of follow‑up. Erythema was reported in 2% (5/208) of patients in the case series of 135 patients at up to 1 year.
Weakness (subjective 10–20% reduction in strength) was reported in 3% (2/60) of sites in the case series of 33 patients within a median follow-up of 31 months.
Reduced nail health was reported in 3% (2/60) of sites in the case series of 33 patients within a median follow-up of 31 months.
Hyperpigmentation was reported in 3% (2/60) of sites in the case series of 33 patients within a median follow-up of 31 months.
In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers did not list any new anecdotal adverse events. They considered that the following were theoretical adverse events: radiation‑induced malignancy and adverse surgical outcome due to poor wound healing in irradiated skin.
Thirty-four commentaries from patients who had experience of this procedure were received, which were discussed by the committee.