The Collaborative Ocular Melanoma Study

Dr. Finger is a Principal Investigator in the Collaborative Ocular Melanoma Study Group

Collaborative Ocular Melanoma Study Publications: Peer-review papers only.

1. Collaborative Ocular Melanoma Study Group: Accuracy of diagnosis of choroidal melanomas in the Collaborative Ocular Melanoma Study. COMS Report No. 1. Arch Ophthalmol 108:1268-1273, 1990.

2. Collaborative Ocular Melanoma Study Group: Complications of enucleation surgery. COMS Report No. 2. In: Proceedings of the Symposium on Retina and Vitreous (Rudolph M. Franklin, ed.). New Orleans Academy of Ophthalmology. Kugler Publications, New York, 1993; pp. 181-190.

3. Collaborative Ocular Melanoma Study Group: Design and methods of a clinical trial for a rare condition: The Collaborative Ocular Melanoma Study. COMS Report No. 3. Controlled Clin Trials 14:362-391, 1993.

4. Collaborative Ocular Melanoma Study Group: Mortality in patients with small choroidal melanoma. COMS Report No. 4. Arch Ophthalmol 115:886-893, 1997.

5. Collaborative Ocular Melanoma Study Group: Factors predictive of growth and treatment of small choroidal melanoma. COMS Report No. 5. Arch Ophthalmol 115:1537-1544, 1997.

6. Collaborative Ocular Melanoma Study Group: Histopathologic characteristics of uveal melanomas in eyes enucleated from the Collaborative Ocular Melanoma Study. COMS Report No. 6. Am J Ophthalmol 125:745-766, 1998.

7. Collaborative Ocular Melanoma Study Group: Sociodemographic and clinical predictors of participation in two randomized trials: Findings from the Collaborative Ocular Melanoma Study. COMS Report No. 7. Controlled Clin Trials 22:526-537, 2001.

8. Grossniklaus HE, Albert DM, Green WR, Conway BP, Hovland KR for the Collaborative Ocular Melanoma Study Group: Clear cell differentiation in choroidal melanoma. COMS Report No. 8. Arch Ophthalmol 115:894-898, 1997.

9. Collaborative Ocular Melanoma Study Group: The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma. I: Characteristics of patients enrolled and not enrolled. COMS Report No. 9. Am J Ophthalmol 125:767-778,1998.

10. Collaborative Ocular Melanoma Study Group: The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma. II. Initial mortality findings. COMS Report No. 10. Am J Ophthalmol 125:779-796,1998.

11. Collaborative Ocular Melanoma Study Group: The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma. III. Local complications and observations following enucleation. COMS Report No. 11. Am J Ophthalmol 126:362-372, 1998.

12. Collaborative Ocular Melanoma Study Group: Echography (ultrasound) procedures for the Collaborative Ocular Melanoma Study. COMS Report No. 12. J Ophth Nurs Technol Part I, 18(4):143-149, Part II, 18(5):219-232, 1999.

13. Collaborative Ocular Melanoma Study Group: Consistency of observations from echograms made centrally in the Collaborative Ocular Melanoma Study. COMS Report No. 13. Ophthalmic Epidemiol 9:11-27, 2002.

14. Collaborative Ocular Melanoma Study Group: Cause-specific mortality coding: Methods in the Collaborative Ocular Melanoma Study. COMS Report No. 14. Control Clin Trials 22: 248-262, 2001.

15. Collaborative Ocular Melanoma Study Group: Assessment of metastatic disease status at death in 435 patients with large choroidal melanoma in the Collaborative Ocular Melanoma Study. COMS Report No. 15. Arch Ophthalmol 119:670-676, 2001.

16. Collaborative Ocular Melanoma Study Group: Collaborative Ocular Melanoma Study (COMS) randomized trial of I-125 brachytherapy for medium choroidal melanoma. I. Visual acuity after 3 years. COMS Report No. 16. Ophthalmology 108(2):348-366, 2001.

17. Collaborative Ocular Melanoma Study Group: The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma. II. Characteristics of patients enrolled and not enrolled. COMS Report No. 17. Arch Ophthalmol 119: 951-965, 2001.

18. Collaborative Ocular Melanoma Study Group: The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma. III. Initial mortality findings. COMS Report No. 18. Arch Ophthalmol 119: 969-982, 2001.

19. Collaborative Ocular Melanoma Study Group: The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma. Local treatment failure and enucleation in the first 5 years after brachytherapy. COMS Report No. 19. Ophthalmology 198:2197-2206, 2002.

20. Collaborative Ocular Melanoma Study Group: Trends in size and treatment of recently diagnosed choroidal melanoma, 1987-1997. Findings from patients evaluated at Collaborative Ocular Melanoma Study centers. COMS Report No. 20. Arch Ophthalmol 121:1156-1162, 2003.

21. Collaborative Ocular Melanoma Study Group: Comparison of clinical, echographic, and histologic measurements from eyes with medium-sized choroidal melanoma in the Collaborative Ocular Melanoma Study. COMS Report No. 21. Arch Opthalmol 121:1163-1171, 2003.

22. Collaborative Ocular Melanoma Study Group: Ten-year follow-up of fellow eyes of patients enrolled in Collaborative Ocular Melanoma Study (COMS) randomized trials. COMS Report No. 22. Ophthalmology 111:996-976, 2004.

23. Diener-West M, Reynolds SM, Agugliaro DJ, Caldwell R, Cumming K, Earle JD, Green DL, Hawkins BS, Hayman I, Jaiyesimi I, Kirkwood JM, Koh W-J, Robertson DM, Shaw JM, Thoma J. Screening for metastasis from choroidal melanoma: Experience of the Collaborative Ocular Melanoma Study. Collaborative Ocular Melanoma Study Report No. 23. Am J Clin Oncol 22:2438-2444, 2004.

24. Collaborative Ocular Melanoma Study Group. The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma. IV. Ten-year mortality findings and prognostic factors. COMS Report No. 24. Am J Ophthalmol 138:936-951, 2004.

25. Melia BM, Moy CS, McCaffrey L: Quality of life in patients with choroidal melanoma: A pilot study. Ophthalmic Epidemiol 6:19-28, 1999.

26. COMS Quality of Life Study Group: Quality of life assessment in the Collaborative Ocular Melanoma Study: Design and methods. COMS-QOLS Report No. 1. Ophthalmic Epidemiol 6:5-17, 1999.

27. COMS Quality of Life Study Group: Development and validation of disease-specific measures for choroidal melanoma. COMS-QOLS Report No. 2. Arch Ophthalmol 121:1010-1020, 2003.

28. Collaborative Ocular Melanoma Study Quality of Life Study Group. Quality of life after iodine 125 brachytherapy versus enucleation for choroidal melanoma: 5-year results from the Collaborative Ocular Melanoma Study prospective study. COMS-QOLS Report No. 3. Arch Ophthalmol (under revision for resubmission, July 2004).

29. Collaborative Ocular Melanoma Study Group: The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma. IV. Ten-year Mortality findings and prognostic factors. COMS Report No. 24. Am J Ophthalmol 138:936-951, 2004.

30. Collaborative Ocular Melanoma Study Group: Second Primary Cancers after Enrollment in the COMS Trials for Treatment of Choroidal Melanoma. COMS Report No. 25. Archives of Ophthalmology 2005:123:601-4.

Related Links

• Search for scientific articles about COMS and Choroidal Melanoma
• Search PubMed for Collaborative Ocular Melanoma Study (COMS) – Publications
• Search Google for Collaborative Ocular Melanoma Study (COMS) – Publications

Small-sized Choroidal Melanoma Study

Small melanomas can be watched for growth prior to treatment. Should growth occur, then the patient knows the melanoma will eventually destroy the vision and increase the chance that cancer cells will spread to other parts of the body. The Collaborative Ocular Melanoma Study (COMS) was interested in how many small melanomas would grow and over what period of time. The COMS found that more than 25% of small melanomas were found to grow (within 2 years of follow-up). Since choroidal melanoma growth is the best predictor for vision loss and increased risk of metastasis, this COMS finding underscores the need to follow patients with small melanomas closely after diagnosis.

Medium-sized Choroidal Melanoma Study

The medium-sized tumor study was designed to determine if iodine-125 plaque-irradiation is better, equal, or worse than enucleation (removal of the eye) for the prevention of metastasis. In this study, half of enrolled patients were treated by enucleation and the other half underwent plaque radiation therapy. Patients were followed for evidence of recurrence and metastatic melanoma.

The COMS medium-tumor trial concluded that there is no significant difference between these two treatment options with respect to survival. COMS centers had followed 80% of patients for at least 5 years at the time they issued their report. Therefore, COMS found no evidence that removing the eye is a better treatment than iodine-125 plaque radiation therapy for preventing spread of choroidal melanomas.

Large-sized Choroidal Melanoma Study

Large-melanoma trial was designed to see if radiation before enucleation (removal of the eye) would prevent metastasis. The idea was to see if pre-operative irradiation would sterilize any cells that might break free during surgery. The other half of the patients did not receive radiation before their surgery.

The Large-sized Choroidal Melanoma Study concluded that patients who received 2000 rads (cGy) of external irradiation to their eye before it was removed, had an equal chance of developing metastatic disease as compared to those who were treated by enucleation (removal of the eye) alone.

Related Links

• COMS Publications
• Search PubMed for Collaborative Ocular Melanoma Study (COMS)
• Search Google for Collaborative Ocular Melanoma Study (COMS)

COMS-type gold seed carriers typically can be ordered in 6 sizes in 10-20 mm diameters (Trachsel DentalStudios, 1-507-288-2362).

Rice-sized radioactive seeds are purchased and glued into the eye-plaque or seed carrier.

The gold of the eye-plaque will block more than 99% of the radiation to the back and sides, creating a directional source. The active surface (facing us) is sewn onto the eye beneath the base of the intraocular tumor.

• Guidelines for Low Energy Plaque Usage
• Comparison of Does Calculation Methods
• Search PubMed for Low-Energy Plaque Construction
• Search Google for Low-Energy Plaque Construction

Description

Tumors of the eyelids may be benign cysts, inflammations (stye’s), or malignant tumors (skin cancers). The most common type of eyelid cancer is basal cell carcinoma. Most basal cell carcinomas can be removed with surgery. If left untreated, these tumors can grow around the eye and into the orbit, sinuses and brain. Other eyelid cancers include squamous cell carcinoma, sebaceous cell carcinoma, and malignant melanoma. Together, these tumors make up the remaining 10% of eyelid malignancies.

Treatment

A simple biopsy can determine if your eyelid tumor is malignant. Then, malignant tumors are completely removed and the eyelid is repaired using plastic surgery techniques. Additional cryotherapy (freezing-therapy) and radiation are sometimes required after surgery.

A Typical Work-Up for a Suspected Malignant Eyelid Tumor

• Biopsy
• Medical Work-up (as indicated)
• Surgery and/or Radiotherapy of Tumor and Margins
• Reconstruction

Surgery for Eyelid Tumors

• General: The goal should be total removal of the cancer. This usually involves primary excision with either frozen section control or Moh’s technique.
• Small tumors are usually removed by pentagonal wedge resection.
• Medium-sized tumors often require reconstruction with transpositional flaps (Tenzel, Mustarde, Glabellar).
• Large-tumor resections are typically reconstructed with Hughes, Hewes, or Cutler-Beard Techniques.

References

1. Hughes WL. New method for rebuilding a lower lid: Report of a case. The Archives of Ophthalmology 17:1008-1017, 1937.
2.  Hewes EH, Sullivan JH, Beard C. Lower eyelid reconstruction by tarsal transposition. American Journal of Ophthalmology 85:1164-1169, 1978.
3. Cutler NL, Beard C. A method for partial and total upper lid reconstruction. American Journal of Ophthalmology 39:1-7, 1955.
4. Tenzel RR, Stewart WB. Eyelid reconstruction by the semicircle flap technique. Ophthalmology 85:1164-1169, 1978.
5. Harrington JN. Reconstruction of the medial canthus by spontaneous granulation (laissez-faire): A review. Annals Ophthalmology 14:956-960, 1982.

Related Links

• Search PubMed for Surgical Techniques for Eyelid Tumors
• Search Google for Surgical Techniques for Eyelid Tumors

If you are newly diagnosed with a primary choroidal “intraocular” melanoma, you are likely to have no signs or symptoms of metastatic melanoma. According to a recent study utilizing total body PET/CT to stage uveal melanoma patients at diagnosis, 1% of (T1 and T2) sized tumors and 4% of (T3 and T4) size tumors were found to have their melanomas spread to other parts of their body at the time diagnosis of their eye tumor. But, up to 50% will subsequently be found to have metastasis over the following years. Be assured that many patients diagnosed and treated for choroidal melanoma will not develop metastatic melanoma.

Tumor size is the most well-verified predictor of a patient’s risk for metastatic melanoma. It makes sense that treatments that limit the tumor’s ability to enlarge will decrease the chance of metastasis. This is why most eye cancer specialists believe destroying or removing an eye cancer offers the best method to prevent future spread from that tumor.

Treatment is not thought to affect micrometastasis (too small to find) already present at the time of the eye treatment. This is why patients need periodic general medical examinations (surveys) after treatment for their intraocular melanoma.

Eighty-five percent of metastatic choroidal melanoma will be initially found in the liver. Metastases can be discovered by blood tests (liver function studies) when a patient has no symptoms. Other patients may notice abdominal fullness, discomfort and a loss of appetite. Though the liver may be the first place tumors are found, it is likely that other organs are affected. Your doctor should look for other tumor sites (e.g. subcutaneous nodules, lung, bone and brain metastasis). If a liver or skin metastasis is suspected a biopsy can be used to aspirate tumor cells for cytopathologic examination.

Since most patients start with liver tumors, therapy typically depends on the presence or absence of metastases outside of the liver, the number (size and location) of tumors within the liver, and how they affect liver function.

Treatment Options

The liver is (initially) the exclusive site of choroidal melanoma metastasis in about 40% of patients. Of those patients, most have diffuse or multi-focal tumors which cannot be removed. Treatment options depend on the size, location and rate of tumor growth.

Local Surgery: If a patient has a slow growing solitary metastasis, surgical excision may be an option. There have been no evidence-based studies that prove whether this type of surgery prolongs survival or improves the quality of life of patients. All patients who undergo surgery for a solitary liver, lung or brain metastasis have to recover from a major surgery.

Systemic Chemotherapy: When tumors are found in different parts of the body, then treatment is directed at the whole body. In these cases, your doctor may offer injection of standard intravenous chemotherapy. Unfortunately, standard chemotherapy drugs usually do not cure metastatic choroidal melanoma. There are clinical trials of new chemotherapy drugs which may be more effective.

Chemo-embolization: This treatment involves injecting a combination of chemotherapy and particles into the arteries that feed the metastatic tumors within the liver. For example, cisplatin chemotherapy and polyvinyl sponge particles are injected intra-arterially to the liver. Side effects have typically included fever, right upper quadrant abdominal pain, elevation of liver enzymes and paralysis of the intestine lasting 1 to 2 days after the procedure. It is important to understand that this is a local treatment aimed at shrinking the liver metastasis and prolonging life. It is not considered curative.

Biologic Therapy: Biologic therapy treats cancer by helping the immune system function better. The immune system is your body’s natural defense. It is a network of organs and cells distributed throughout your body. It not only defends against bacteria and viruses but also helps find and destroy cancer cells. Recent investigations focused on metastatic cutaneous melanoma have been very promising.

Observation

It is a patient’s right to choose or refuse treatment. Since many of the previously mentioned treatments can decrease a patient’s quality of life, each decision to treat must be weighed against potential side effects. You should always discuss the risk of possible side-effects and the potential benefits with your medical oncologist prior to treatment.

Related Links

• Gerson
• Search PubMed about Metastatic Choroidal Melanoma
• Search PubMed for Overview of the Treatment of Metastatic Melanoma
• Search Google for Overview of the Treatment of Metastatic Melanoma
• National Cancer Institute Clinical Trial Articles

General Information

For starters call the National Cancer Information Center in Austin at 1-800-227-2345 and make sure you ask for a Cancer Information Specialist (CIS). The specialist must have been there a year and pass certification exams to be called a CIS.

Lodging

For lodging patients can try http://www.nahhh.org and they will provide a list of lodges/hotels/motels across the nation that offer a reduced cost place to stay.

Air Transportation

For transportation, patients can try http://www.airlifeline.org. They will try and find private pilots or commercial airlines to fly patients or provide discounts.

Financial assistance and referrals

The American Cancer Society also has a program called the “road to recovery” where volunteers will drive patients to and from appointments. When distances are great, patients may also request mileage reimbursement which may cover gas. Receipts are typically required.

Referrals for financial assistance may found at http://www.cancercare.org or call them at 1800-813-HOPE.

 

Owing to the lack of a prognosis related classification for radiation retinopathy, and the need for a common language for comparative studies, this study prompted the creation of the classification presented in the table below. There are certain preproliferative findings associated with radiation treatment of the eye.

Ophthalmoscopy is best used to view such common findings as cotton wool spots, retinal haemorrhages, ghost vessels, exudates and the less frequent retinal microaneurysms and uveal effusions. Fluorescein and indocyaninegreen angiography are typically used to define the extent of retinal ischaemia and vascular anomalies (table 5).

When located outside the macula, stage 1 findings are consistent with excellent central vision and a good visual prognosis (mild risk). In contrast, stage 2 radiation retinopathy requires that these pathological findings are located in the macula and therefore carry a more guarded prognosis for vision (moderate risk). When the eye enters stage 3, some vision loss has probably occurred and the prognosis for return to pretreatment vision is poor (severe risk). Despite its location, the presence of retinal neovascularisation is ominous. It suggests a profound ischaemic drive and carries a worse prognosis for long term visual acuity (table 5). Vitreous haemorrhage, large areas of retinal ischaemia, and iris neovascularisation are associated with a worse prognosis for vision and globe salvage (table 5). Vitreous haemorrhage clouds our ability to use laser treatment and to monitor the progression of radiation retinopathy. Patients who present with vitreous haemorrhage often have occult neovascularisation and are at risk for ghost cell or neovascular glaucoma.

The Finger Classification of Radiation Retinopathy

Table from Finger and Kurli, Br J Ophthalmol 2005;89:730–738. doi: 10.1136/bjo.2004.052159

Related Links

• Laser treatment for radiation retinopathy
• Search PubMed about Radiation Retinopathy
• Search PubMed for The Finger Classification of Radiation Retinopathy
• Search Google for The Finger Classification of Radiation Retinopathy

Q: How do I remove my prosthesis?

1) First, wash your hands.

2) Then you should place a towel over your lap or sink to act as a net for the prosthesis if it slips out of your hand. Should it fall it could scratch, break or get lost.

Manual Technique

3) Place one finger on the temporal (towards the ear) aspect of the lower lid on top of the cheek bone.

4) Look up.

5) Cup your other hand under your eye (to catch the prosthesis).

6) Gently press your finger in and pull the eyelid skin towards your ear (on that side).

7) The edge of your prosthesis will likely be emerging at the edge of the lower eyelid, or less likely it has fallen into your cupped hand.

8) If the prosthesis is just barely out, you can use a finger on your other hand to rotate it out of the socket.

9) Don’t be surprised if some discharge comes along with the prosthesis.

Suction Technique

1) Hard contact lens suction devices are commercially available in drug stores and vision centers.

2) These devices can be squeezed to create a vacuum that attaches the device to the front of the prosthesis.

3) Once attached, the patient can lift the bottom portion of the prosthesis out from beneath the lower lid, then slide the superior portion down towards the cheek.

Once the Prosthesis is Out

1) Commercially available sterile saline solution should be used to clean your eye socket.

2) Now you can consider cleaning the prosthesis.

Q: How do I clean my prosthesis?

1) Place the prosthetic eye into a container that can be filled with liquid as to cover the prosthesis.

2) Full or half strength hydrogen peroxide solution can be used to soak the prosthesis for 10 to 15 minutes. After soaking, remove the prosthesis from the container and rinse it with sterile saline solution.

3) Prosthesis cleaning is typically performed once or twice a week (as instructed by your eye care professionals).

4) Continuous and consistent periodic cleaning of the prosthesis will increase your comfort, decrease secretions, prevent secondary conjunctivitis and extend the life of your ocular prosthesis.

Q: How often do I need to have my prosthesis professionally cleaned or replaced?

1) You should return to your ocularist for professional cleaning and polishing 2 times each year.

2) Most patients get a new prosthesis every 3 to 5 years because even with excellent maintenance, the tissues around the prosthesis can change and the artificial eye can become scratched.

Warning

If you notice excessive discharge, swelling or irritation, you should call your eye care professional immediately.

For the more medically minded, you can go to a medical library, or order a copy of our comprehensive review of:

A Review of Enucleation
by Moshfeghi DM, Moshfeghi AA, Finger PT.

Related Links

• Survey of Ophthalmology 2000:44:277-301
• Search PubMed for Enucleation: About Ocular Prosthesis Care
• Search Google for Enucleation: About Ocular Prosthesis Care