Superficial Basal Cell Carcinoma Treated with Two Cycles of Ingenol Mebutate Gel 0.015%

Jung, Yu Seok; Lee, Ji Hae; Bae, Jung Min; Kim, Gyong Moon

doi:10.5021/ad.2016.28.6.796

Cited by 11 publications

(9 citation statements)

References 4 publications

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“…Ablative fractional laser pretreatment of sBCC in our study resulted in clearance rates similar to sBCC treated with IM alone reported in the literature, possibly suggesting limited advantaged of AFL pretreatment for this subtype. For nBCC, however, our data could indicate a potential benefit of AFL pretreatment prior to IM application .…”

Section: Discussionsupporting

confidence: 82%

“…Ingenol mebutate was previously applied to sBCCs in concentrations of 0.05% for two consecutive days in several, mostly small studies or case reports reporting cure rates ranging from 63% to 100% at 3-to 15-month follow-up. [4][5][6][7][8][9][10] Single applications of 0.05% to sBCCs in 8 days intervals resulted in low clinical (13%) and histological (35%) clearance rates, 5 suggesting importance of applying IM consecutively within few days. Few cases of nBCCs treated with IM have been reported and concentrations of both 0.015% and 0.05% cleared nBCCs.…”

Section: Discussionmentioning

confidence: 99%

“…IM concentration of 0.015% applied for three consecutive days is approved for AKs on the scalp and face and IM concentration of 0.05% applied for two consecutive days is approved for trunk and extremities. In case reports and phase I/II trials, off‐label application of IM to superficial and nodular BCCs resulted in cure rates ranging from 13% to 100% evaluated at 3‐ to 15‐month follow‐up, suggesting that IM may be effective for treatment of low‐risk BCCs . IM has a dual mechanism of action, causing initial cell death followed by immune activation .…”

Section: Introductionmentioning

confidence: 99%

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Basal cell carcinoma treated with combined ablative fractional laser and ingenol mebutate – an exploratory study monitored by optical coherence tomography and reflectance confocal microscopy

Banzhaf

Phothong

Suku

et al. 2019

Acad Dermatol Venereol

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Background Basal cell carcinomas (BCCs) have previously been treated off‐label with ingenol mebutate (IM). Ablative fractional laser (AFL) may improve efficacy of IM by increasing drug uptake in the tumour. Optical coherence tomography (OCT) and reflectance confocal microscopy (RCM) detect BCC non‐invasively. Our aim was to investigate BCC response and tolerability after combined AFL and IM treatment of low‐risk BCCs. Methods Twenty patients with histologically verified superficial (n = 7) and nodular (n = 13) BCCs were treated with combined fractional CO2‐laser (10 600 nm) and IM 0.015% or 0.05%, the concentration depending on anatomical location. BCC response was evaluated clinically, by OCT and RCM at day 29 and 90 after first treatment, and histologically at day 90. Treatment was repeated at day 29 if BCC persisted. Local skin reactions (LSRs) were assessed using LSR scale at all visits. Results At day 29, 18/20 patients received a second treatment due to residual BCC detected clinically, by OCT or RCM. OCT and RCM presented subclinical BCCs in five of 20 cases (25%). At day 90, overall histological cure rate was 70%, corresponding to clinical (65%) and OCT/RCM (60%) cure rates, and agreement between evaluation methods was substantial (kappa ≥ 0.796, P < 0.0001). Clearance rates were similar for sBCCs and nBCCs (P = 0.354) and for lesions treated with IM 0.015% and 0.05% (P = 0.141). LSRs were tolerable, but scarring was observed in the majority of cleared patients. Conclusion Two treatments of combined AFL and IM show potential to treat low‐risk BCCs with acceptable tolerability. OCT and RCM show promise to detect subclinical BCCs at short‐term follow‐up.

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Section: Discussionsupporting

confidence: 82%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Basal cell carcinoma treated with combined ablative fractional laser and ingenol mebutate – an exploratory study monitored by optical coherence tomography and reflectance confocal microscopy

Banzhaf

Phothong

Suku

et al. 2019

Acad Dermatol Venereol

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“…There are some case reports and short patient series with BCCs, treated with different ingenol mebutate gel posology (0.015 or 0.05%), time length and number of cycles with complete clearance outcomes …”

Section: Discussionmentioning

confidence: 99%

“…In actinic keratosis, ingenol mebutate gel 0.05% is applied once daily for two consecutive days to the affected areas of upto 25 cm 2 . Although ingenol mebutate gel is not considered a first‐line option for the treatment of BCC, there is some evidence supporting its efficacy and safety …”

Section: Introductionmentioning

confidence: 99%

Characterisation of the inflammatory response triggered by topical ingenol mebutate 0.05% gel in basal cell carcinoma

et al. 2020

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Background/Objective: Ingenol mebutate gel is approved for actinic keratosis field therapy, but little has been published as a treatment of basal cell carcinoma (BCC). Our objective is to characterise the histopathological changes and the infiltrating cell populations to better understand its mechanism of action.Methods: Sixteen patients with various BCC subtypes were prospectively evaluated and treated once daily for two consecutive days with ingenol mebutate gel 0.05% under occlusion. Patients were randomised to two arms: the first arm was biopsied between the third and the tenth day after treatment initiation ('early immune response'), and the second arm was biopsied at day 30 after treatment initiation ('late immune response'). The immunopathology was evaluated by immunohistochemistry: anti-CD3, anti-CD4, anti-CD8, anti-CD20, anti-CD56, anti-CD68, anti-Bcl-2, anti-CASP3, anti-FoxP3, anti-GrzB and anti-TIA-1.Results: Ten BCCs were in complete remission after 2 years of follow-up. The early immune response was characterised by a quick recruitment of T lymphocytes, macrophages and natural killer cells. At later time-points, T-regulatory cells and some pro-apoptotic markers were detected. Treatment-related adverse events were described.Conclusion: Ingenol mebutate gel produces a transient immuno-inflammatory response and an important necrosis reaction in BCCs. Larger studies will be required to determine the maximum effective tolerated dose of ingenol mebutate gel for BCC.

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Efficacy assessment of oxygen flow assisted administration of topical methotrexate (OFA‐MTX5%) for superficial basal cell carcinoma assessed by optical coherence tomography

Absil

Lebas

Nikkels

2023

JEADV Clinical Practice

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Background Oxygen‐flow‐assisted topical administration of 5% methotrexate (OFAMTX5%) was recently described as a painless therapeutic option with good cosmetic results for superficial basal cell carcinoma (sBCC). Objectives To assess the efficacy and cosmetic outcome of OFAMTX5% for small (<2 cm) and large (>2 cm) sBCCs of the trunk. Methods Patients with a least two sBCCs, as diagnosed by clinical, dermatoscopic and optical coherence tomography (OCT) examination, were included. One target lesion was treated 2×/week for 2 weeks. Complete (CR), partial (PR) and no (NR) responses, respectively defined as a total absence, improvement or a similar OCT aspect compared to baseline, were evaluated by OCT at 3 and 12 months postprocedure. Cosmetic outcome was evaluated at 1 year. Results At 3 months in a cohort of 32 patients (mean age: 54 years, min: 44 years, max: 89 years), the small sBCC lesion group presented a 94.4% (17/18) CR and a 5.5% PR (1/18), whereas the large lesion group revealed a CR of 64.3% (9/14) and PR of 35.7% (5/14). At 12 months, 3/14 large lesions presented recurrent sBCC at the border of the target lesion, but none in the small lesion group (0/18). No treatment‐related cutaneous nor systemic adverse events were observed. No OCT changes were noted at 3 and 12 months in control sBCC lesions. Cosmetic results were scored as good and excellent in 19.4% and 80.1%, respectively. Conclusions OFAMTX5% represents an interesting therapeutic alternative for sBCC on the trunk, without pain sensations and treatment‐related adverse effects. The place of OFAMTX5% in the therapeutic armamentarium against sBCC remains to be determined in larger series.

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Superficial Basal Cell Carcinoma Treated with Two Cycles of Ingenol Mebutate Gel 0.015%

Cited by 11 publications

References 4 publications

Basal cell carcinoma treated with combined ablative fractional laser and ingenol mebutate – an exploratory study monitored by optical coherence tomography and reflectance confocal microscopy

Basal cell carcinoma treated with combined ablative fractional laser and ingenol mebutate – an exploratory study monitored by optical coherence tomography and reflectance confocal microscopy

Characterisation of the inflammatory response triggered by topical ingenol mebutate 0.05% gel in basal cell carcinoma

Efficacy assessment of oxygen flow assisted administration of topical methotrexate (OFA‐MTX5%) for superficial basal cell carcinoma assessed by optical coherence tomography

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