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Drug Delivery Through the Ophthalmic Artery Successful in Advanced Retinoblastoma Paediatric Patients: Presented at SIR

By Crina Frincu-Mallos, PhD

WASHINGTON, DC -- March 26, 2008 -- A new interventional radiology treatment successfully treats advanced retinoblastoma in children and often spares these patients from having their eyes surgically removed, researchers reported here at the Society of Interventional Radiology (SIR) 33rd Annual Scientific Meeting.

Retinoblastoma is the seventh most common paediatric cancer, with 80% being diagnosed in children aged less than 3 years. Approximately 350 new cases are diagnosed each year in the United States and 40% of patients have the genetic form. Five-year survival is 98% in the United States and less than 50% in third-world countries, said Pierre Gobin, MD, Attending Radiologist, Professor of Radiology and Neurosurgery, and Director of Interventional Neuroradiology, NewYork-Presbyterian Hospital/Weill Cornell Medical Center, New York, New York.

Current treatment options range from photocoagulation and cryotherapy to radiation or chemotherapy. However, they either result in serious systemic toxicity or involve extreme measures such as eye removal to stop tumour growth, Dr. Gobin said.

In the new interventional radiology approach, the drug is delivered directly to the eye via the ophthalmic artery.

"This new interventional radiology treatment is a tremendous advance in treating retinoblastoma. It allows many children to keep their eyes and -- in some cases -- restores vision," said Dr. Gobin, who presented the data on March 17 on behalf of his colleagues from NewYork-Presbyterian Hospital/Weill Cornell Medical Center and from Memorial Sloan-Kettering Cancer Center, New York, New York.

In their phase 1/2 trial, Dr. Gobin and colleagues aimed to develop a technique that would allow them to catheterise the ophthalmic artery of young children with advanced retinoblastoma, hence avoiding enucleation. Using direct ophthalmic artery drug infusion, the researchers are also seeking to minimise the toxicity of current radiation and chemotherapy regimens.

Catheterisation of the ophthalmic artery was performed by a femoral approach while the patients were under general anaesthesia. A catheter was placed in the ophthalmic artery and a 16-mg/m² IV dose of melphalan was infused over a 30-minute period.

Intravenous chemotherapy is not very effective. "Giving 3 mg in a 6-month-old (S = 0.4 m²) represents 47% IV dose and giving 5 mg in a 4-year-old with a body surface of 1 m² represents 31% IV dose; perhaps less than 1% actually reaches the eye," explained Dr. Gobin. By delivering the drug directly to the ophthalmic artery, a curative drug concentration can be achieved, he noted.

A total of 22 patients have been accrued since May 2006, when the trial was initiated. The patients range in age from 1 month to 10 years. Half of the patients were diagnosed with bilateral retinoblastoma. All patients on trial, with 1 exception, had advanced eye cancer at enrolment. Five patients previously underwent contralateral enucleation, said Dr. Gobin.

A total of 23 eyes were treated in these 22 patients. Treatment was completed in 20 patients; 2 patients are still under treatment. The ophthalmic arteries were successfully cannulated in 18 of 20 patients (90%); the procedure failed in 2 patients. Most patients had 3 treatments, at 3-week intervals.

Local toxicity was assessed through ophthalmic exams, retinal photography, and electroretinography, while systemic toxicity was evaluated through physical examinations and complete blood counts.

No procedure-related complications occurred in the 64 procedures performed. None of the usual complications of chemotherapy occurred, such as infection, transfusion, and hair loss. In terms of local toxicity, the adverse events consisted of transient skin discoloration (n = 2) and retinopathy (n = 4), resulting in dose de-escalation.

In terms of tumour control, the treatment was successful in 16 out of the 18 patients (88.9%). Dramatic regression of tumours, vitreous seeds, and subretinal seeds were seen in each of the treated cases.

A total of 14 patients have kept their eye(s), whereas 2 patients required enucleation. In most cases, vision stabilised or improved after treatment. Out of the 14 cured eyes, 9 eyes had vision and 5 had no vision on follow-up, said Dr. Gobin.

Talking about the accomplishment of this treatment so far, Dr. Gobin noted that it saved 78% of eyes destined to be enucleated and preserved vision in 50%.

Future directions of this study are to extend indications to less-severe tumours, using the existing protocol, and "to develop new protocols to entirely replace intravenous chemotherapy and radiation therapy," concluded Dr. Gobin.


[Presentation title: Treatment of Eye Cancer in Children With Chemosurgery. Abstract 60]

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