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Neoadjuvant intravitreal ranibizumab treatment in high-risk ocular melanoma patients: a two-stage single-centre phase
Rumana N Hussain1, Heinrich Heimann, Bertil Damato
1Liverpool Ocular Oncology Centre, St Pauls Eye Unit, Royal Liverpool University Hospital, Liverpool, UK.
Abstract:
Despite an established history of intraocular antivascular endothelial growth factor (anti-VEGF) agents therapy in a variety of ocular pathologies as well as other cancer forms, use in the primary treatment of uveal melanoma has not been well assessed. This was a two-stage therapeutic and exploratory phase II, non-randomised, single centre trial involving intraocular treatment with 0.5 mg in 0.05 ml of ranibizumab via six intravitreous injections over 6 months in patients with primary ocular melanoma that otherwise required radical surgery because of tumour size. Seven patients were recruited with a median age of 66 years. At baseline, the longest basal diameter was 15.1 mm (mean, range 10-20.4 mm) with a height measured by ultrasonography of 9.2 mm (mean, range 6.6-12.7 mm). No patients achieved complete or partial response at any visit. All required enucleation. Histopathological analysis revealed mixed cell melanoma in 5/7 (71%) and spindle cell morphology in 2/7 (29%) with ciliary body involvement in 4/7 (57%) and the presence of closed loops also in 4/7 (57%). Genetic analysis demonstrated loss of chromosome 3 in 5/7 (71%) but abnormalities in chromosome 1,6 or 8 in all cases. Our study was terminated early as alternative treatments were clearly superior for local tumour control. There continues to be a role of intravitreal anti-VEGF for the treatment of the sequelae of local radiotherapy in the form of radiation retinopathy and so these agents may be used as adjuncts in the treatment of uveal melanoma rather than as a primary treatment.
Insights
Intraocular anti-vascular endothelial growth factor (anti-VEGF) agents are not effective as a primary treatment for uveal melanoma. This study found ranibizumab ineffective, leading to early termination and enucleation for all patients.
Area of Science:
- Ophthalmology
- Oncology
- Medical Research
Background:
- Intraocular anti-vascular endothelial growth factor (anti-VEGF) agents are used for various eye conditions and cancers.
- Their efficacy as a primary treatment for uveal melanoma has not been well-established.
Purpose of the Study:
- To assess the effectiveness of ranibizumab as an intraocular primary treatment for primary uveal melanoma.
- To evaluate ranibizumab's impact on tumor size and patient outcomes in this context.
Main Methods:
- A phase II, non-randomized, single-center trial involving six intravitreous injections of ranibizumab over six months.
- Seven patients with primary uveal melanoma requiring surgery were recruited.
Main Results:
- No complete or partial response was observed in any patient.
- All patients ultimately required enucleation (eye removal).
- Histopathological and genetic analyses revealed specific melanoma characteristics and chromosomal abnormalities.
Conclusions:
- Ranibizumab is not a suitable primary treatment for uveal melanoma.
- Alternative treatments offer superior local tumor control.
- Intraocular anti-VEGF agents may serve as adjuncts for managing radiation retinopathy secondary to uveal melanoma treatment.
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