Program Book

Conclusions. In this series, treatment of radiation maculopathy with
intravitreal injection of bevacizumab was useful in all the five patients;
macular function and macular thickness were better since the second
injection and resulted in a stable situation at six month of follow-up.
Longer follow-up and a larger number of cases are necessary for definitive
results.
Financial disclosure. None
327 Ump123
EPIDEMIOLOGICAL ANALYSIS OF BRAZILIAN
PATIENTS WITH UVEAL MELANOMA SUBMITTED TO
PRIMARY ENUCLEATION IN A REFERRAL CENTER
Priscilla L. Ballalai, Kelcia Kieffer, Ricardo Filippo, Rafaello Salla, Maria
C. Martins, Márcia Lowen (pbbordon@terra.com.br)
Ocular Oncology Unit, Federal University of Sao Paulo
Pathology Unit, Federal University of Sao Paulo
Purpose. To analyze the epidemiological characteristics of patients with
uveal melanoma submitted to primary enucleation in a referral center
in Brazil.
Methods. Retrospective, non-comparative case series. Review of
charts of patients submitted to primary enucleation from 2001 to 2011.
Epidemiological data such as age, gender, race, histological type,
presence of extra ocular extension and predisposing conditions were
analyzed.
Results. Eighty-four patients were submitted to primary enucleation
from 2001 to 2011. The mean age was 48.8 years-old (range, 19-84 yo);
45 were male and 39 females. Fifty-five patients were white, 11 black
and 1 Brazilian Indian. The information about the race was not found in
17 cases. Two patients had Oculodermal melanosis as a predisposing
condition (2.3 %) and one tumor originated from a melanocytoma (1.2
%). Nine patients had tumors at the cilliary body (11 %). Regarding
the histological type, 63 (75 %) patients had mixed type tumors, with
predominancy of epithelioid cells in 19 (30%), and spindle cells in 17
(27%). Fifteen (18 %) tumors were epithelioid type and 5 were spindle
cell type (6 %) . Extra-ocular extension was found in 7 patients (8 %).
Conclusions. Although Brazilian population is multi-racial, in this group,
uveal melanoma was more frequent in middle-aged white patients, as
previously reported. The mixed type was more prevalent. Oculodermal
melanosis and melanocytoma were rarely found as predisposing factors
for uveal melanoma.
Financial disclosure. None
2252 Ump124
UVEAL MELANOMA CLINICAL TRIALS AT MD
ANDERSON CANCER CENTER
Scott E. Woodman1A, Michael Tetzlaff1B, Xiaoxing Yu1A, Chandrani
Chattopadhyay1A, Michelle Williams1B, Nancy Poindexter1A, Elizabeth
Grimm1A, Dan Gombos3, Bita Esmaeli3, Agop Bedikian1A, Sapna Patel1A
(sewmdphd@yahoo.com)
1A. Melanoma Medical Oncology;1B, Pathology, MD Anderson Cancer
Center, Houston, TX; 2. Ophthalmology, Leiden University Med Center,
Leiden, The Netherlands; 3. Head & Neck Surgery/Ophthalmology, MD
Anderson Cancer Center, Houston, TX.
Purpose. Metastatic uveal melanoma has a very poor prognosis and
115
no effective treatment. We have designed two phase II clinical trials
specifically for patients with metastatic uveal melanoma. The first
study attempts to capitalize on the observation that metastatic uveal
melanoma cells have a propensity for elevated IGF-1R levels which may
be associated with worse outcome. The second study capitalizes on the
observation that the anti-apoptotic molecule Bcl-2 may be a mediator of
resistance to melanoma cell death after cytotoxic therapy.
Methods. Study I is a pilot study of IMC-A12 in patients with metastatic
uveal melanoma. It is designed as a prospective, multi-institutional,
two-stage, Phase II trial with 18 patients in stage I and 14 patients in
stage II. IMC-A12 is a recombinant human IgG1 monoclonal antibody
which specifically targets the human IGF-1R resulting in blockade of
ligand binding and internalization and degradation of IGF-1R. IMC A-12 is
administered at 10 mg/kg by intravenous (IV) infusion over 1 hour every
two weeks.
A treatment cycle is defined as 4 weeks. Response evaluation is
performed every two cycles. Study II is a pilot study of Genasense-
Carboplatin-Paclitaxel (GCP) in patients with metastatic uveal
melanoma. It is designed as a prospective, single-institution, twostage
Phase II trial with 15 patients in each stage. Genasense is an
antisense molecule that blocks Bcl-2 function. Genasense (900 mg) is
administered on a fixed-dose basis as over 1 hour by IV infusion on days
1, 3, and 5 of each cycle. Paclitaxel 175 mg/m2 is administered in 250 mL
NS over 1 hour by IV infusion on Day 3 of each cycle immediately upon
completion of administration of Genasense. Carboplatin (AUC= 6) is
administered in150 mL D5W over 30 minutes (+/- 5 mins) by IV infusion
after paclitaxel on day 3 of each cycle. A treatment cycle is defined as 3
weeks. Response evaluation will be performed every two cycles.
Results IMC-A12 study: The primary endpoint is objective response rate.
The secondary endpoints are safety and tolerability, disease control rate,
duration of response, progression-free survival, and overall survival.
The exploratory endpoints are to correlate response to mutation status,
correlate response to IGF-1R expression, determine the effect of IMC-
A12 on expression of proteins involved in initiation, growth, and spread
of uveal melanoma cells, determine potential resistance mechanisms to
IMC-A12. GCP study: The primary endpoint is objective response rate.
The secondary endpoints are overall survival, time to progression, time
to treatment failure, duration of response, and safety profile of GCP
in this patient population. The exploratory endpoints are correlation
of response to blood and tumor markers and potential correlation of
response to mutation status.
Conclusions. We have designed two Phase II clinical trials using more
targeted therapeutic approaches in an attempt to improve outcome.
In addition, these studies have incorporated robust correlative studies
to better interrogate molecular markers that may be associated with
clinical outcome.
Financial disclosure. None
1912 Ump125
UVEAL MELANOMA: TRENDS IN INCIDENCE,
TREATMENT, AND SURVIVAL
Arun D. Singh, Mary E. Turell, Allan K. Topham (singha@ccf.org)
Department of Ophthalmic Oncology, Cole Eye Institute, Cleveland Clinic,
Cleveland, OH and Coalition of National Cancer Cooperative Group Inc.,
Philadelphia, PA.
Purpose. To determine trends in incidence, treatment, and survival with
primary uveal melanoma in the
United States over a 36-year period from 1973 to 2008.