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Immunocryosurgery for non-superficial basal cell carcinomas ≤ 20 mm in maximal diameter: Five-year follow-up

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Abstract

Objective

To report the five-year follow up results of a prior prospective clinical trial (NCT01212562) on immunocryosurgery for the treatment of non-superficial basal cell carcinoma (BCC) ≤20 mm in diameter.

Materials and Methods

Immunocryosurgery consists of five weeks daily 5% imiquimod cream and a cryosurgery session on day fourteen. This combination cleared 95 ± 2% of BCCs at the eighteen month follow up. Herein, we present the results of the five year follow-up or per last available information of the aforementioned cohort.

The primary study outcome was treatment failure (non-complete response or relapse); failure rates were calculated per intention to treat and per protocol.

Results and Conclusion

Data for at least five years after initial treatment were available for 55% of the patients (53.4% of per protocol treated tumors) as actualized up to 31th July 2016. Age at recruitment was the only significant predictor of follow-up availability.

Nine treatment failures were documented after one immunocryosurgery cycle. The five-year tumor free rate after one immunocryosurgery cycle was 91.4 ± 2.8% and 87.7 ± 3.1% according to per protocol and per intention to treat analysis, respectively. Sex, tumor size or high-risk anatomical localization within the ‘H-area’ of the face did not affect treatment outcome.

With repeat immunocryosurgery cycles only 3 sites were not tumor free at last follow up (effectiveness: 97.1 ± 1.6% per protocol or 93.2 ± 2.3% per intention to treat analysis).

Immunocryosurgery is an effective, minimally invasive treatment alternative to surgical modalities for most BCC ≤20 mm in diameter, including those in high risk localizations.

Section snippets

Background

Surgery with histopathological control of resection margins is currently the standard of care for the treatment of uncomplicated basal cell carcinoma (BCC). Micrographic controlled (Mohs') surgery is recommended for relapses or larger tumors with centrofacial localization [1]. Non-surgical modalities are reserved for the treatment of non-invasive superficial tumors [1] or as palliative approaches, due to generally inferior tumor clearance and increased relapse rates. Among others, these

Materials and Methods

By May 31, 2015 all patients recruited in the initial trial NCT01212562 [3] and reported herein had reached at least five years potential follow up. Thus, cohort information was actualized up to July 31th 2016 and is presently reported. The study (trial registration: NCT01212562) was approved by the University Hospital of Ioannina Scientific Committee (Ethics and Clinical Trials Review Section) according to the Declaration of Helsinki Principles [approval number: 4/8-4-2007 (θ.18)]. Study

Results

Four initially recruited patients with five tumors (4.0% of the per ITT tumor sites [3]) did not comply with major treatment prerequisites and were excluded from per protocol analysis. Data on the outcome of the therapeutic intervention for a follow up period of at least five years (≥60 months) after initial treatment were available for 55% of the patients; 9% of the patients deceased and 36% were lost to reexamination prior to completing the five years follow-up. The mean age (±standard

Discussion

The present five year follow up data further confirm the efficacy of immunocryosurgery for non-superficial basal cell carcinomas ≤20 mm in maximal diameter, irrespective of their localization and histology. With a five-year tumor clearance rate of 91.4 ± 2.8% after a single treatment cycle (97.1 ± 1.6% after retreatment of therapy failures) immunocryosurgery is not inferior to surgical modalities for this neoplasm [5,6]. Notably, reports of Mohs' surgery for BCC included tumors of largely

Ethics Approval and Consent to Participate

The original study (trial registration: NCT01212562) was approved by the University Hospital of Ioannina Scientific Committee (Ethics and Clinical Trials Review Section) according to the Declaration of Helsinki Principles: Approval number: 4/8-4-2007 (θ.18).

Consent for Publication

The patients presented in Fig. 3 cannot be recognized or identified, yet we have obtained written informed consent for the presentation of their clinical pictures that will be freely available on the internet and may be seen by the general public.

Competing Interests

Both authors have received travel grants from MEDA, Hellas, to present relevant data at international and local conferences.

Funding

This study was partially supported by the Special Research Committee Account of University of Ioannina No. 22195.

Authors' Contributions

GG gathered the clinical information and wrote the first draft of the manuscript. IDB designed the study, performed the statistics and critically revised the manuscript.

Acknowledgements

None.

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