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Clinical Trial
. 2023 Jul 27;23(1):335.
doi: 10.1186/s12886-023-03092-z.

Safety and efficacy of topical interferon alpha 2B and mitomycin C for localized conjunctival intraepithelial neoplasia: long-term report of their pharmacological safety and efficacy

Beatriz Alvarado-Castillo  1 , Francisco J Santa Cruz-Pavlovich  2 , Celia Gonzalez-Castillo  2 , Isaac Alejandro Vidal-Paredes  2 , Leonel Garcia-Benavides  3 , Maria Elena Rosales-Gradilla  1 , Jose Navarro-Partida  4
Affiliations
Clinical Trial

Safety and efficacy of topical interferon alpha 2B and mitomycin C for localized conjunctival intraepithelial neoplasia: long-term report of their pharmacological safety and efficacy

Beatriz Alvarado-Castillo et al. BMC Ophthalmol. .

Abstract

Purpose: Ocular surface squamous neoplasia (OSSN) comprises a wide spectrum of squamous tumors, from which corneal/conjunctival intraepithelial neoplasia (CIN) is the most common one. The classic treatment is complete excision, but recurrence rates are high. Antineoplastic drugs such as mitomycin C (MMC) and interferon alpha 2b (IFNα2b) have been used as adjuvants or as primary treatment. To evaluate the efficacy and safety of topical IFNα2b and MMC in patients with CIN, a phase IIb double-blind clinical trial was performed.

Methods: Patients diagnosed with localized CIN were evaluated by slit lamp and impression cytology and were randomly given MMC 0.04% or INF2b (1 million IU/mL) 4 times daily until neoplasia resolution. Time of resolution and frequency of adverse effects were analyzed to determine the pharmacological efficacy and safety of both medications.

Results: Seventeen patients were included. Nine patients were treated with MMC and 8 with IFNα2b. All patients responded to treatment. The resolution time in days was 59.11 ± 24.02 in patients treated with MMC and 143.50 ± 47.181 in those treated with IFNα2b (p < 0.001). In the MMC group, one recurrence was reported (11%). There were no recurrences at 2 years of follow-up in the IFNα2b group. Regarding adverse effects, one or more mild adverse reaction occurred in 77% of patients managed with MMC and in 50% of patients managed with IFNα2b (p > 0.05). No serious adverse effects were reported.

Conclusions: Topical chemotherapy with MMC and IFNα2b demonstrate pharmacological safety and efficacy. Therefore, these drugs could be considered as primary therapies for localized CIN .

Keywords: Efficacy; Eye drops; Interferon alpha 2b; Mitomycin C; Ocular surface squamous neoplasia; Safety.

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Conflict of interest statement

The authors have no competing interests to declare.

Figures

Fig. 1
Fig. 1
Effects of topical chemotherapy in the size of conjunctival intraepithelial neoplasia. Mean tumor size and percentage of tumor reduction are presented. A consistent reduction in the size of tumor was observed in the MMC group throughout time (A and C). Similar behavior was observed in the IFNα2b group (B and D). The shown significant differences are between the respective week and baseline (week 0). The changes in tumor size occurred earlier in the MMC group. Standard error of mean (SEM) is shown. MMC; mitomycin C, IFNα2b; interferon alpha-2b. *, p < 0.05; †, p < 0.01
Fig. 2
Fig. 2
Results of topical chemotherapy for conjunctival intraepithelial neoplasia. Representative cases of topical chemotherapy with MMC (A and B), and IFNα2b (C and D) are presented. Patient A required 6 cycles of MMC therapy (84 days) to resolution whereas patient B required 4 cycles (56 days). Patient C required 98 days of IFNα2b therapy to resolution while patient D required 126 days. MMC; mitomycin C, IFNα2b; interferon alpha-2b
Fig. 3
Fig. 3
Survival analysis of conjunctival intraepithelial neoplasia treated with topical chemotherapy. The median survival was 10 weeks for MMC and 20 weeks for IFNα2b groups. Survival curves are statistically different (P < 0.0001). MMC; mitomycin C, IFNα2b; interferon alpha-2b
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References

    1. Sayed-Ahmed IO, Palioura S, Galor A, Karp CL. Diagnosis and medical management of ocular surface squamous neoplasia. Expert Rev Ophthalmol. 2017;12(1):11–9. doi: 10.1080/17469899.2017.1263567. - DOI - PMC - PubMed
    1. Lee GA, Hirst LW. Ocular surface squamous neoplasia. Surv Ophthalmol. 1995;39:429–50. doi: 10.1016/S0039-6257(05)80054-2. - DOI - PubMed
    1. Hamam R, Bhat P, Foster CS. Conjunctival/Corneal intraepithelial neoplasia. Int Ophthalmol Clin. 2009;49(1):63–70. doi: 10.1097/IIO.0b013e3181924ec3. - DOI - PubMed
    1. Ateenyi-Agaba C. Conjunctival squamous-cell carcinoma associated with HIV infection in Kampala, Uganda. The Lancet. 1995;345(8951):695–6. doi: 10.1016/S0140-6736(95)90870-6. - DOI - PubMed
    1. Newton R, Reeves G, Beral V, Ferlay J, Parkin D. Effect of ambient solar ultraviolet radiation on incidence of squamous-cell carcinoma of the eye. The Lancet. 1996;347:1450–1. doi: 10.1016/S0140-6736(96)91685-2. - DOI - PubMed

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