Topical 5-Fluorouracil 1% as Primary Treatment for Ocular Surface Squamous Neoplasia

Madhura G. Joag, Adam Sise, Juan Carlos Murillo, Ibrahim Osama Sayed-Ahmed, James R. Wong, Carolina Mercado, Anat Galor, Carol Karp

Research output: Contribution to journalArticle

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Abstract

Purpose: To determine the efficacy of topical 5-fluorouracil 1% (5-FU) as a primary treatment of ocular surface squamous neoplasia (OSSN). Design: Retrospective study. Participants: Topical 5-FU was used as primary therapy in 44 patients with OSSN. Methods: 5-Fluorouracil 1% administered topically 4 times daily for 1 week followed by a drug holiday of 3 weeks. Patients were identified through a pharmacy database. Patients were excluded if 5-FU was used as adjuvant therapy, if they did not complete therapy, or if they were still actively receiving treatment for OSSN at the time of last follow-up. Main Outcome Measures: The primary outcome measures were the frequency of complete resolution with topical 5-FU treatment and the rate of OSSN recurrence. Results: Of the 44 patients identified, 32 were men and 12 were women. The mean age was 68 years. Complete resolution of OSSN was noted in 82% of patients (36/44); 18% (8/44) were considered treatment nonresponders. Patients were treated with a median of 4 cycles (range, 2-9 cycles). Nasal location was the only risk factor identified for nonresponse to therapy (P = 0.04). The median follow-up after resolution was 10 months (range, 2-77 months). In the 36 patients who showed complete resolution, 4 experienced tumor recurrence. Recurrence rates at 1 and 2 years were 6% and 15%, respectively, using Kaplan-Meier survival analysis. At least 1 side effect from the medication was reported by 61% of patients (21/44), but only 1 patient discontinued the medication because of intolerance. The most common side effect was pain (n = 17; 39%), followed by tearing (n = 10; 23%), photophobia (n = 6; 14%), itching (n = 4; 9%), swelling (n = 2; 5%), and infection (n = 1; 2%). No long-term complications were reported. Conclusions: 5-Fluorouracil is effective and well tolerated as a primary treatment for OSSN, with 82% of tumors responding completely to therapy.

Original languageEnglish (US)
JournalOphthalmology
DOIs
StateAccepted/In press - Dec 2 2015

Fingerprint

Fluorouracil
Neoplasms
Therapeutics
Recurrence
Outcome Assessment (Health Care)
Photophobia
Holidays
Kaplan-Meier Estimate
Pruritus
Survival Analysis
Nose
Retrospective Studies
Databases
Pain
Infection

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Joag, M. G., Sise, A., Murillo, J. C., Sayed-Ahmed, I. O., Wong, J. R., Mercado, C., ... Karp, C. (Accepted/In press). Topical 5-Fluorouracil 1% as Primary Treatment for Ocular Surface Squamous Neoplasia. Ophthalmology. https://doi.org/10.1016/j.ophtha.2016.02.034

Topical 5-Fluorouracil 1% as Primary Treatment for Ocular Surface Squamous Neoplasia. / Joag, Madhura G.; Sise, Adam; Murillo, Juan Carlos; Sayed-Ahmed, Ibrahim Osama; Wong, James R.; Mercado, Carolina; Galor, Anat; Karp, Carol.

In: Ophthalmology, 02.12.2015.

Research output: Contribution to journalArticle

Joag, Madhura G. ; Sise, Adam ; Murillo, Juan Carlos ; Sayed-Ahmed, Ibrahim Osama ; Wong, James R. ; Mercado, Carolina ; Galor, Anat ; Karp, Carol. / Topical 5-Fluorouracil 1% as Primary Treatment for Ocular Surface Squamous Neoplasia. In: Ophthalmology. 2015.
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abstract = "Purpose: To determine the efficacy of topical 5-fluorouracil 1{\%} (5-FU) as a primary treatment of ocular surface squamous neoplasia (OSSN). Design: Retrospective study. Participants: Topical 5-FU was used as primary therapy in 44 patients with OSSN. Methods: 5-Fluorouracil 1{\%} administered topically 4 times daily for 1 week followed by a drug holiday of 3 weeks. Patients were identified through a pharmacy database. Patients were excluded if 5-FU was used as adjuvant therapy, if they did not complete therapy, or if they were still actively receiving treatment for OSSN at the time of last follow-up. Main Outcome Measures: The primary outcome measures were the frequency of complete resolution with topical 5-FU treatment and the rate of OSSN recurrence. Results: Of the 44 patients identified, 32 were men and 12 were women. The mean age was 68 years. Complete resolution of OSSN was noted in 82{\%} of patients (36/44); 18{\%} (8/44) were considered treatment nonresponders. Patients were treated with a median of 4 cycles (range, 2-9 cycles). Nasal location was the only risk factor identified for nonresponse to therapy (P = 0.04). The median follow-up after resolution was 10 months (range, 2-77 months). In the 36 patients who showed complete resolution, 4 experienced tumor recurrence. Recurrence rates at 1 and 2 years were 6{\%} and 15{\%}, respectively, using Kaplan-Meier survival analysis. At least 1 side effect from the medication was reported by 61{\%} of patients (21/44), but only 1 patient discontinued the medication because of intolerance. The most common side effect was pain (n = 17; 39{\%}), followed by tearing (n = 10; 23{\%}), photophobia (n = 6; 14{\%}), itching (n = 4; 9{\%}), swelling (n = 2; 5{\%}), and infection (n = 1; 2{\%}). No long-term complications were reported. Conclusions: 5-Fluorouracil is effective and well tolerated as a primary treatment for OSSN, with 82{\%} of tumors responding completely to therapy.",
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AU - Joag, Madhura G.

AU - Sise, Adam

AU - Murillo, Juan Carlos

AU - Sayed-Ahmed, Ibrahim Osama

AU - Wong, James R.

AU - Mercado, Carolina

AU - Galor, Anat

AU - Karp, Carol

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N2 - Purpose: To determine the efficacy of topical 5-fluorouracil 1% (5-FU) as a primary treatment of ocular surface squamous neoplasia (OSSN). Design: Retrospective study. Participants: Topical 5-FU was used as primary therapy in 44 patients with OSSN. Methods: 5-Fluorouracil 1% administered topically 4 times daily for 1 week followed by a drug holiday of 3 weeks. Patients were identified through a pharmacy database. Patients were excluded if 5-FU was used as adjuvant therapy, if they did not complete therapy, or if they were still actively receiving treatment for OSSN at the time of last follow-up. Main Outcome Measures: The primary outcome measures were the frequency of complete resolution with topical 5-FU treatment and the rate of OSSN recurrence. Results: Of the 44 patients identified, 32 were men and 12 were women. The mean age was 68 years. Complete resolution of OSSN was noted in 82% of patients (36/44); 18% (8/44) were considered treatment nonresponders. Patients were treated with a median of 4 cycles (range, 2-9 cycles). Nasal location was the only risk factor identified for nonresponse to therapy (P = 0.04). The median follow-up after resolution was 10 months (range, 2-77 months). In the 36 patients who showed complete resolution, 4 experienced tumor recurrence. Recurrence rates at 1 and 2 years were 6% and 15%, respectively, using Kaplan-Meier survival analysis. At least 1 side effect from the medication was reported by 61% of patients (21/44), but only 1 patient discontinued the medication because of intolerance. The most common side effect was pain (n = 17; 39%), followed by tearing (n = 10; 23%), photophobia (n = 6; 14%), itching (n = 4; 9%), swelling (n = 2; 5%), and infection (n = 1; 2%). No long-term complications were reported. Conclusions: 5-Fluorouracil is effective and well tolerated as a primary treatment for OSSN, with 82% of tumors responding completely to therapy.

AB - Purpose: To determine the efficacy of topical 5-fluorouracil 1% (5-FU) as a primary treatment of ocular surface squamous neoplasia (OSSN). Design: Retrospective study. Participants: Topical 5-FU was used as primary therapy in 44 patients with OSSN. Methods: 5-Fluorouracil 1% administered topically 4 times daily for 1 week followed by a drug holiday of 3 weeks. Patients were identified through a pharmacy database. Patients were excluded if 5-FU was used as adjuvant therapy, if they did not complete therapy, or if they were still actively receiving treatment for OSSN at the time of last follow-up. Main Outcome Measures: The primary outcome measures were the frequency of complete resolution with topical 5-FU treatment and the rate of OSSN recurrence. Results: Of the 44 patients identified, 32 were men and 12 were women. The mean age was 68 years. Complete resolution of OSSN was noted in 82% of patients (36/44); 18% (8/44) were considered treatment nonresponders. Patients were treated with a median of 4 cycles (range, 2-9 cycles). Nasal location was the only risk factor identified for nonresponse to therapy (P = 0.04). The median follow-up after resolution was 10 months (range, 2-77 months). In the 36 patients who showed complete resolution, 4 experienced tumor recurrence. Recurrence rates at 1 and 2 years were 6% and 15%, respectively, using Kaplan-Meier survival analysis. At least 1 side effect from the medication was reported by 61% of patients (21/44), but only 1 patient discontinued the medication because of intolerance. The most common side effect was pain (n = 17; 39%), followed by tearing (n = 10; 23%), photophobia (n = 6; 14%), itching (n = 4; 9%), swelling (n = 2; 5%), and infection (n = 1; 2%). No long-term complications were reported. Conclusions: 5-Fluorouracil is effective and well tolerated as a primary treatment for OSSN, with 82% of tumors responding completely to therapy.

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