Radiation Oncology/Skin/Randomized

Non-melanoma Skin Cancer Randomized Evidence

Surgery vs RT

Gustave Roussy (1982-1988) -- surgery vs RT
- Randomized. 347 patients, primary BCC of the face, <4 cm, confirmed by bx. Arm 1) Surgical resection, at least 2 mm margin vs Arm 2) RT using 3 available techniquest: interstitial brachytherapy Ir-192 65-70 Gy over 5 days (55%), superficial contact RT 50 kV 36/2-40/2 over 2 weeks (33%), orthovoltage RT 8-250 kV 60 Gy in 2-4 Gy/fx 3x/week (12%).
- 1997 PMID 9218740 -- "Basal cell carcinoma of the face: surgery or radiotherapy? Results of a randomized study." (Avril MF, Br J Cancer. 1997;76(1):100-6.)
  - Outcome: 4-year local failure surgery 0.7% vs RT 7.5% (SS), by modality interstitial BT 9% vs contact RT 7% vs orthovoltage RT 5%.
  - Toxicity: Cosmesis significantly better after surgery than RT, good result according to patients surgery 87% vs RT 69% (SS). Dyspigmentation and telangiectasia in 65%
  - Conclusion: Surgery preferred to RT in smaller BCC of the face

Germany -- Imiquimod x 8 weeks vs Imiquimod x 12 weeks
- Randomized. 90/102 patients with nodular basal cell. Arm 1) imiquimod TIW x8 weeks vs. Arm 2) imiquimod TIW x12 weeks. Both followed by excsion
- 2007 PMID 17610993 -- "A phase III, randomized, open label study to evaluate the safety and efficacy of imiquimod 5% cream applied thrice weekly for 8 and 12 weeks in the treatment of low-risk nodular basal cell carcinoma." (Eigentler TK, J Am Acad Dermatol. 2007 Oct;57(4):616-21.)
  - Outcome: No difference between arms. Clinical clearance 78%, histological clearance 64%. Residual tumor in 17% of clinical CR
  - Toxicity: minor/moderate local inflammation in 92%
  - Conclusion: No difference between arms. Modest activity, due to 17% residual tumor after clinical CR, recommend excision for all