Background
Prospective phase II single-arm study. 46 patients with large, unresectable, or multiply recurrent keloids not amenable to standard excision + postoperative RT. Treated with primary RT (without surgical excision) using a hypofractionated regimen. Aimed to evaluate whether definitive RT alone can induce keloid regression without surgery in challenging cases. Malaker K et al.
Interventions and follow up
Arm A: Definitive RT without surgery: 15 Gy in 3 fractions (5 Gy/fraction) over 3 alternate days, orthovoltage X-rays; repeated for large keloids (>5 cm) after 6 week
Primary endpoint: Keloid volume reduction at 12 months, symptom relief
mFollow up: 12 month
Primary endpoint: Keloid volume reduction at 12 months, symptom relief
mFollow up: 12 month
Results
Keloid volume reduction >50%: 62% of patients
Complete flattening: 15%
Symptom relief (pruritus, pain): 80% improvement
No response: 15% (predominantly sternal/deltoid large keloids)
Complete flattening: 15%
Symptom relief (pruritus, pain): 80% improvement
No response: 15% (predominantly sternal/deltoid large keloids)
Adverse events
Main adverse events: Acute: erythema grade 1–2 in 52%, dry desquamation 10%. Late: hyperpigmentation 30%, telangiectasia 10% at 12 months. No grade ≥3 toxicity. No secondary malignancies in this short follow-up period.
Conclusions
Primary RT without surgery achieves meaningful volume reduction and symptom relief in the majority of large/unresectable keloids. It is a valid approach for patients in whom surgical excision would be technically challenging or in whom prior excision has failed repeatedly.
Key Limitations
Key Limitations: Small sample, single-arm, short follow-up. Definition of "response" not standardized. Long-term durability of volume reduction is uncertain — keloid regrowth after RT alone may occur at higher rates than excision + RT. Not randomized against surgery + RT.
Clinical Context
Primary definitive RT is an option for large unresectable keloids or multiply recurrent post-excision keloids, particularly in young patients where repeated surgery is undesirable. Surgery + postoperative RT remains the standard for resectable keloids. Intralesional triamcinolone may be combined with RT for smaller keloids at some centers.
References
References: Malaker K et al, IJROBP 2004 (keloid primary RT)