Image guidance improves freedom from recurrence in superficial radiation therapy for non-melanoma skin cancer

Abstract

Importance: This is the first study to quantify the 2-year recurrence rate of non-melanoma skin cancers (NMSCs) treated with image-guided superficial radiation therapy (IGSRT) and compare it to existing data on SRT, which is key to demonstrating the efficacy of IGSRT. Objective: To quantify the 2-year recurrence rate for individuals with basal cell carcinoma (BCC), squamous cell carcinoma (SCC), and squamous carcinoma in-situ (SCCIS) treated with IGSRT versus SRT without image guidance. Design: A retrospective cohort study that collected data from a standardized electronic medical record (Modernizing Medicine - EMA), written radiation treatment records, and record/verify system (Sensus Healthcare - Sentinel) to evaluate the 2-year recurrence rate of NMSCs treated by IGSRT (March 2016 to January 2022) and compare it to existing data on NMSCs treated by SRT via one sample proportion tests. Setting: Multi-institution outpatient dermatology practices. Participants: Individuals > 18 years old with biopsy-proven SCC, SCCIS, and/or BCC treated with IGSRT. 1602 patients with a total of 2,880 treated lesions were followed until 1/14/2022. As of that date, 22 lesions had recurred, and 2858 lesions were still at risk for recurrence. An 18-month cutoff for recency of assessment was utilized, resulting in 1204 lesions (41.8%) that were lost to follow-up. Exposure: Treatment with IGSRT or SRT. Main Outcomes: The overall 2-year recurrence probability of 2880 NMSCs treated by IGSRT was 0.7%, which is statistically significantly lower than two previously reported SRT studies (p < 0.001). Results: All NMSCs (SCC, SCCIS, BCC) treated by IGSRT in this cohort had an aggregate 2-year freedom from recurrence of 99.23%. When stratified by NMSC histologic type, the recurrence rate for BCC was 1.1% (N=1382), for SCC 0.8% (N=904) and for SCC 0.0% (N=594). These rates of recurrence are significantly improved compared to a pooled study that evaluated NMSCs across histology (Cognetta) and BCCs alone (Silverman) treated without image guidance (standard SRT) (p < 0.001). Conclusions and relevance: Image-guided superficial radiation (IGSRT) therapy offers a paradigm-shifting treatment option for patients with NMSCs - offering statistically significantly improved outcomes compared to standard SRT, and a more desirable toxicity profile to surgical options. This study demonstrates that this treatment modality is associated with remarkably low recurrence rates, which are statistically significantly improved from the previous generation of SRT, and in line with modern outcomes for Mohs micrographic surgery, though a head-to-head comparison has yet to be performed.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

Drs. Yu, and Kattan are paid consultants for SkinCure oncology. The sponsor of the study (SkinCure Oncology) was not involved in the study design, collection, analysis, interpretation of data, or writing of the manuscript.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethics committee/IRB of WCG IRB waived ethical approval for this work. WCG IRBs IRB Affairs Department reviewed the study under the Common Rule and applicable guidance. The response state this study is exempt under 45 CFR | 46.104(d)(4), because the research involves the use of identifiable private information; and information is recorded by the investigator in such a manner that the identity of the human subjects cannot readily by ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors

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