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5 years review of periocular basal cell carcinoma and proposed follow-up protocol.

ABSTRACT: (1) To investigate the recurrence of periocular basal cell carcinoma (BCC) reported as completely excised on histology. (2) To identify risks associated with recurrence. (3) To recommend a rational follow-up protocol.This is a cohort study by case note review of consecutive patients undergoing excision of periocular BCC between 2000 and 2006 at University Hospitals of Leicester. All lesions were excised with 3 mm clinical margin and the defect reconstructed only after the excision margin was declared clear.A total of 413 episodes of surgical excision were recorded for 270 patients over the 7-year period of 2000-2006. All of them have 5 years follow-up. Mean age 73.7 (±12.5). In all, 67% were nodular BCC and 45.4% located in the lower eyelid. The main outcome measure was the recurrence rate. None of the patients with primary nodular BCC suffered recurrence. The recurrence rate for primary morphoeaform BCC following complete excision is 3.8%. In total, 8.1% of patients had several lesions simultaneously whereas 7.8% patients had BCC in multiple locations subsequently (metachronous). Three patients who had previously recurrent BCC (rBCC) treated elsewhere or not using this method had orbital/lacrimal drainage system involvement requiring exenteration.We recommend that patients with a single, completely excised primary solid or nodular BCC can be discharged after one 6-monthly review, although they should be instructed to monitor for the development of further lesions. The incidence of recurrence for primary morphoeaform BCC is 3.8% and for rBCC is 3.6% over 5 years and these patients should stay under review for this period.

SUBMITTER: Ho SF

PROVIDER: S-EPMC3545370 | biostudies-other | 2013 Jan

REPOSITORIES: biostudies-other

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Project description:ImportanceThe outcomes of vismodegib treatment in a relatively large cohort of study participants with periocular locally advanced basal cell carcinoma (POLA-BCC) may guide physicians when considering this treatment.ObjectiveTo report the outcomes of vismodegib treatment in patients with POLA-BCC in the Safety Events in Vismodegib (STEVIE) study.Design, setting, and participantsThis post hoc subgroup analysis from the STEVIE single-arm, multicenter, open-label cohort study screened all 1215 participants for ocular or periocular involvement and identified 244 participants with POLA-BCC or metastatic BCC. Data for the first STEVIE trial were collected from 167 treatment locations in 36 countries from June 30, 2011, to June 14, 2017. This post hoc analysis was performed from April 1 to August 31, 2019.Main outcomes and measuresResponse to treatment and adverse events.ResultsOcular or periocular involvement was found in 244 of 1215 STEVIE participants (20.1%), who constituted the analytic sample. The median age of the study participants was 72.0 (interquartile range [IQR], 60.0-82.0]) years, and they included 143 men (58.6%). Locally advanced BCC was diagnosed in 238 of the 244 participants (97.5%) and metastatic BCC, in 6 (2.5%). The median duration of exposure to vismodegib was 40.0 (IQR, 20.0-78.0) weeks, specifically 39.7 (IQR, 19.9-76.0) weeks for POLA-BCC and 92.4 (IQR, 53.2-163.0) weeks for metastatic BCC. Sixty-nine participants (28.3%) sustained serious adverse events (alopecia, muscle spasms, dysgeusia, weight loss, decreased appetite, asthenia, ageusia, nausea, fatigue, and diarrhea). Two hundred thirty-two study participants (95.1%) sustained more than 1 adverse effect. The overall mean (SD) number of drug-related adverse effects per study participant by first adverse event, regardless of the severity, was 5.48 (3.84). Discontinuation of vismodegib treatment owing to an adverse event was recorded in 58 participants (23.8%). During the study, 22 participants (9.0%) died, 70 (28.7%) achieved complete response, and 94 (38.5%) achieved partial response.Conclusions and relevanceVismodegib was well tolerated by the study participants with POLA-BCC. The safety of vismodegib treatment according to the STEVIE trial findings is consistent with that reported in previous studies. These data may be helpful when considering vismodegib for patients with POLA-BCC.

Project description:BackgroundBasal cell carcinoma (BCC) is a common skin cancer often curable by excision; however, for patients with BCC around the eye, excision places visual organs and function at risk. In this article, we test the hypothesis that use of the hedgehog inhibitor vismodegib will improve vision-related outcomes in patients with orbital and extensive periocular BCC (opBCC).Materials and methodsIn this open-label, nonrandomized phase IV trial, we enrolled patients with globe- and lacrimal drainage system-threatening opBCC. To assess visual function in the context of invasive periorbital and lacrimal disease, we used a novel Visual Assessment Weighted Score (VAWS) in addition to standard ophthalmic exams. Primary endpoint was VAWS with a score of 21/50 (or greater) considered successful, signifying globe preservation. Tumor response was evaluated using RECIST v1.1. Surgical specimens were examined histologically by dermatopathologists.ResultsIn 34 patients with opBCC, mean VAWS was 44/50 at baseline, 46/50 at 3 months, and 47/50 at 12 months or postsurgery. In total, 100% of patients maintained successful VAWS outcome at study endpoint. Compared with baseline, 3% (95% confidence interval [CI], 0.1-15.3) experienced major score decline (5+ points), 14.7% (95% CI, 5 to 31.1) experienced a minor decline (2-4 points), and 79.4% experienced a stable or improved score (95% CI, 62.1-91.3). A total of 56% (19) of patients demonstrated complete tumor regression by physical examination, and 47% (16) had complete regression by MRI/CT. A total of 79.4% (27) of patients underwent surgery, of which 67% (18) had no histologic evidence of disease, 22% (6) had residual disease with clear margins, and 11% (3) had residual disease extending to margins.ConclusionVismodegib treatment, primary or neoadjuvant, preserves globe and visual function in patients with opBCC. Clinical trail identification number.NCT02436408.Implications for practiceUse of the antihedgehog inhibitor vismodegib resulted in preservation of end-organ function, specifically with regard to preservation of the eye and lacrimal apparatus when treating extensive periocular basal cell carcinoma. Vismodegib as a neoadjuvant also maximized clinical benefit while minimizing toxic side effects. This is the first prospective clinical trial to demonstrate efficacy of neoadjuvant antihedgehog therapy for locally advanced periocular basal cell carcinoma, and the first such trial to demonstrate end-organ preservation.

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5 years review of periocular basal cell carcinoma and proposed follow-up protocol.

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