In a Dutch trial reported in The Lancet Oncology, Adan et al found that optical coherence tomography (OCT)-guided diagnosis and treatment of basal cell carcinoma was noninferior to that with punch biopsy, currently the guideline-recommended standard for diagnosis and treatment.
Study Details
In the multicenter trial, 553 evaluable patients (modified intention-to-treat [ITT] population) with an indication for biopsy of a suspected basal cell carcinoma outside the high-risk zone of the face were randomly assigned between February 2019 and September 2020 to receive punch biopsy (regular-care group, n = 268) or OCT (n = 285). The primary endpoint was the proportion of patients free from a recurrent or residual lesion (malignant or premalignant) 12 months after treatment in the modified ITT and per-protocol populations, with a predefined noninferiority margin of –10%. The per-protocol population excluded 12 patients from the modified ITT population who did not start treatment, including 7 patients in the regular-care group and 5 in the OCT group.
OCT-guided diagnosis and treatment of basal cell carcinoma is noninferior to regular-care punch biopsy. Implementation of OCT for diagnosis of basal cell carcinoma could reduce the number of consultations and invasive procedures.— Adan et al
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Key Findings
Median follow-up was 12.7 months (interquartile range [IQR] = 11.2–14.1 months) in the OCT group and 12.6 months (IQR = 10.8–14.3 months) in the regular-care group.
In the modified ITT analysis, at 12 months after treatment, 253 (94%) of 268 patients in the OCT group and 266 (93%) of 285 in the regular-care group were free from recurrent or residual lesions; the absolute difference between the OCT vs regular-care group was 1.07% (95% confidence interval [CI] = –2.93% to 5.06%, P = .30), with the lower limit of the 95% confidence interval not exceeding the predefined noninferiority margin of –10%.
In the per-protocol analyses, 250 (95%) of 263 patients in the OCT group vs 262 (94%) of 278 in the regular-care group were free from residual or recurrent lesions at 12 months; the absolute difference was 0.81% (95% CI = –2.98% to 4.60%, P = .34), meeting the noninferiority criterion.
The investigators concluded, “OCT-guided diagnosis and treatment of basal cell carcinoma is noninferior to regular-care punch biopsy. Implementation of OCT for diagnosis of basal cell carcinoma could reduce the number of consultations and invasive procedures.”
Fieke Adan, MD, of the Department of Dermatology, Maastricht University Medical Centre+, is the corresponding author for The Lancet Oncology article.
Disclosure: The study was funded by The Netherlands Organization for Health Research and Development and Maurits en Anna de Kock Stichting. For full disclosures of the study authors, visit thelancet.com.
