Topical Corticosteroid Therapy for the Prevention of Acute Radiation Dermatitis

A Systematic Review of Randomized Controlled Trials

Chandra F Meghrajani; Henri Cartier S Co; Charlene Marie U Ang-Tiu; Francisca C Roa

Expert Rev Clin Pharmacol. 2013;6(6):641-649.

Abstract

Acute radiation dermatitis (ARD) is a common side effect of radiation therapy and is characterized by erythema, dry desquamation or moist desquamation. This wet desquamation is a very painful condition for the patient and often leads to interruption of radiotherapy. The objective of this article is to assess the efficacy of topical corticosteroids in the prevention of ARD compared with placebo, other topical medication or no treatment. The prophylactic application of topical corticosteroid among patients undergoing radiotherapy appears to significantly reduce the incidence of ARD, specifically moist desquamation, compared with other treatments. Future trials with a more standardized measure of radiation dermatitis grading are recommended. Further research may also be conducted to determine if a mildly potent, midpotent or super potent topical steroid will be more effective in preventing ARD.

1 2 3 4 5 6 7 8 9 10 11

Next Section

Table 1. Acute radiation dermatitis scoring criteria (CTCAE v3.0).
Grade
	0	1	2	3	4
Radiation dermatitis	None	Faint erythema or dry desquamation	Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema	Confluent moist desquamation, other than skin folds and creases; bleeding induced by minor trauma or abrasion	Skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site
Hyperpigmentation	None	Slight or localized	Marked or generalized
Hypopigmentation	None	Slight or localized	Marked or generalized

Table 2. Study characteristics of included trials.
	Bostrom e t al. (2001) [16]	Schmuth et al. (2002) [17]	Farhan et al. (2003) [18]	Shukla et al. (2006) [19]	Omidvari et al. (2007) [1]	Miller et al. (2011) [20]
Population characteristics
Subjects (n)	49 (24 MMF/25 placebo)	23 (12 methyl/11 dex)	76 (38 beta/38 placebo)	60 (30 beclo/30 no tx)	36 (19 beta/17 pet)	169 (85 MMF/84 placebo)
Age range (years)	47–76	29–75	27–70	28–60	35–66	27–89
Gender	All female	All female	All female	All female	All female	All female
Surgery	BCS	BCS	MRM & BCS	MRM & BCS	MRM	MRM & BCS
RT machine	Linear accelerator	Linear accelerator	Cobalt machine	Cobalt machine	Cobalt machine	Linear accelerator
RT dose (Gy)	54–56	50–60	50–60	50	50	50–60
Duration of RT (days)	39	30	25–30	25	25	25–30
Intervention
Topical steroid	Mometasone 0.1% cream	Metyhlprednisolone 0.1% cream	Betamethasone 0.1% ointment	Beclomethasone aerosol100 μg/puff	Betamethasone 0.1% ointment	Mometasone 0.1% cream
Comparator	Placebo cream	Dexpanthenol	Placebo ointment	No treatment	Petrolatum	Placebo cream
Frequency of application	2×/week × 2 weeks, then once daily	Twice daily	Twice daily	2 puffs Twice daily	Twice daily	Once daily
Duration of treatment	8 weeks	8 weeks	7–8 weeks	5 weeks	7 weeks	7–8 weeks
Outcome assessment
Scale used	Clinical scale	Clinical scale	RTOG	Clinical scale	RTOG	CTCAE
Study duration	8 weeks	8 weeks	8 weeks	9 weeks	7 weeks	7 weeks
Dropout rate (%)	0	8.7 (methyl)	3.9 (placebo)	0	0	1.76 (1.17 MMF/2.38 placebo)

BCS: Breast conservation surgery; beclo: Beclomethasone; beta: Betamethsone; CTCAE: Common terminology criteria for adverse events; dex: Dexpanthenol; Gy: Gray; methyl: Methylprednisolone; MMF: Mometasone furoate; MRM: Modified radical mastectomy; no tx: No treatment; pet: Petrolatum; RT: Radiotherapy; RTOG: Radiation therapy oncology group.

Table 3. Primary and secondary outcomes.
Outcome	Bostrom et al. (2001) [16] MMF versus placebo	Schmuth et al. (2002) [17] methyl versus dex	Farhan et al. (2003) [18] beta versus placebo	Shukla et al. (2006) [19] beclo versus no tx	Omidvari et al. (2007) [1] Beta versus pet	Miller et al. (2011) [20] MMF versus placebo
Primary outcomes
Incidence of moist desquamation	MMF 16%Placebo 40%		Beta 0%Placebo 2.9%	Beclo 13.3%No tx 36.6%	Beta 0%Pet 6%	MMF 4.8%Placebo 4.9%
*Secondary outcomes*
ARD scores(mean + SD)	1.8 ± 0.7 versus 2.3 ± 0.63	1.6 ± 0.25 versus 2.2 ± 0.4	1.0 ± 0.37 versus 1.4 ± 0.56		1.3 ± 0.3 versus 1.5 ± 0.3	1.2 ± 0.85 versus 1.3 ± 0.80
Quality of life		methyl: 4 out of 7 worseneddex: 7 out of 7 worsened				1.4 versus 1.7 (p = 0.07)
Patient-reported symptoms
Pruritus	Less in MMF, p = 0.087		Less in beta, p < 0.05			1.5 versus 2.2 (p = 0.002)
Burning	Less in MMF, p = 0.069		Less in beta, p < 0.05			1.5 versus 2.1 (p = 0.02)
Pain	No difference		No difference			2.1 versus 2.5 (p = 0.11)

Beclo: Beclomethasone; Beta: Betamethsone; Dex: Dexpanthenol; Methyl: Methylprednisolone; MMF: Mometasone furoate; No tx: No treatment; Pet: Petrolatum; SD: Standard deviation.

Table 4. Methodological quality summary: review authors' judgments about each methodological quality item for each included study.
Methodologicalquality item	Bostrom et al. (2001) [16]	Schmuth et al. (2002) [17]	Farhan et al. (2003) [18]	Shukla et al. (2006) [19]	Omidvari et al. (2007) [1]	Miller et al. (2011) [20]
Sequence generation	Yes	Yes	Yes	Unclear	Yes	Yes
Allocation concealment	Yes	Yes	Yes	Unclear	Yes	Yes
Blinding	Yes	Yes	Yes	Unclear	Yes	Yes
Outcome dataadequate	Yes	No	No	Yes	Yes	Yes
Free of reporting bias	Yes	No	No	Yes	Yes	Yes
Free of other bias	Yes	Yes	Yes	Yes	Yes	Yes
Overall risk	Low	High	High	Moderate	Low	Low