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Health & Medicine for Senior Citizens

Vaccination Fails to Improve Stage II Melanoma Patients

Idea of treating cancer with a vaccine has been around since first vaccines against infectious disease were developed

By John Bean, PhD, EORTC Medical Science Writer

Sept. 13, 2013 - Results of an EORTC study published in the Journal of Clinical Oncology show that vaccination with GM2/KLH-QS-21 does not benefit patients with stage II melanoma.  Vaccination with GM2/KLH-QS-21 stimulates the production of antibodies to the GM2 ganglioside, an antigen expressed by many melanomas. Serological response to GM2 was shown to be a positive prognostic factor in patients with melanoma and was the rationale for this trial.

The idea of treating cancer with a vaccine has been around since the first vaccines against infectious disease were developed. The GM2 ganglioside, an antigen expressed in most melanomas but with limited expression in normal tissues, was thought to offer a suitable target for such therapeutic vaccination.

 

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Previous studies had shown that serological response against GM2 was a favorable prognostic factor. The five and ten year survival rates for patients with melanoma having primary tumors with a Breslow thickness greater than 1.5 mm are just of 74% and 61%, respectively, so EORTC trial 18961 was launched to compare vaccination to observation in these patients.

 “These results clearly indicate that we do not fully comprehend the impact, on the whole, of multiple vaccinations” according to Prof. Alexander M.M. Eggermont of the Institut Gustave Roussy, Villejuif, Paris-Sud, and Université Paris-Sud, Kremlin Bicêtre, France and Coordinator of this study.

“The effects of such vaccinations might well be detrimental as was clear at the time of the interim analysis that stopped this trial. Now that we have entered a new era in immunotherapy in melanoma with checkpoint inhibitors like anti-CTLA4, and especially with anti-PD1/PDL1, a new opportunity for vaccine development may have arrived.”

In this phase III EORTC 18961 trial, 1314 patients with stage II melanoma (primary melanoma thicker than 1.5 mm, T3-4N0M0; AJCC Stage II) were randomized to either vaccination with GM2-KLH-QS21, 657 patients, or observation, 657 patients. The vaccination treatment consisted of subcutaneous injections given once a week during the first month, then once every three months for the first two years, and once every six months during the third year.

Analyses were by intent to treat, and at a median follow-up of 1.8 years the trial was stopped for futility and patients did not receive further vaccinations. For relapse-free survival, the primary endpoint, the hazard ratio (HR) was 1.00 and P = 0.99, and an unfavorable outcome was seen for patients in the vaccination arm compared to the observation arm in terms of overall survival (HR 1.66; P=0.02). Following the IDMC recommendations, all patients in the vaccination arm stopped their treatment.

At final analysis, the median follow-up was 4.2 years. There were 400 relapses, nine deaths without relapse, and a total of 236 deaths. Decreases in both the relapse-free, 1.2%, and overall, 2.1%, survival rates were observed in the vaccination arm at 4 years. For these two endpoints, the estimated HRs were 1.03 and 1.16, respectively.

Toxicity was acceptable; 4.6% of patients went off study because of toxicity.

EORTC trial 18961 was coordinated by the EORTC Melanoma Group and was conducted in 78 sites located in 18 countries: Australia, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Israel, Italy, Norway, Poland, Portugal, Russia, Serbia, Spain, Switzerland, The Netherlands, and the United Kingdom. This trial was fully supported by Progenics Pharmaceuticals, Inc.

Source: The European Organisation for Research and Treatment of Cancer (EORTC)

Links to More Archived Stories on Melanoma Cancer

About Melanoma

Melanoma is a form of cancer that begins in melanocytes (cells that make the pigment melanin). It may begin in a mole (skin melanoma), but can also begin in other pigmented tissues, such as in the eye or in the intestines.

About 76,250 men and women (44,250 men and 32,000 women) were expected to be diagnosed with and 9,180 men and women to die of melanoma of the skin in 2012.

From 2005-2009, the median age at diagnosis for melanoma of the skin was 61 years of age.

Approximately 0.6% were diagnosed under age 20; 6.8% between 20 and 34; 10.7% between 35 and 44; 18.2% between 45 and 54; 21.6% between 55 and 64; 18.8% between 65 and 74; 16.7% between 75 and 84; and 6.6% 85+ years of age.

The age-adjusted incidence rate was 21.0 per 100,000 men and women per year.

US Mortality

From 2005-2009, the median age at death for melanoma of the skin was 68 years of age. Approximately 0.1% died under age 20; 2.6% between 20 and 34; 5.6% between 35 and 44; 13.5% between 45 and 54; 19.9% between 55 and 64; 21.2% between 65 and 74; 24.1% between 75 and 84; and 12.9% 85+ years of age.

The age-adjusted death rate was 2.7 per 100,000 men and women per year. These rates are based on patients who died in 2005-2009 in the US.

Lifetime Risk

Based on rates from 2007-2009, 1.99% of men and women born today will be diagnosed with melanoma of the skin at some time during their lifetime. This number can also be expressed as 1 in 50 men and women will be diagnosed with melanoma of the skin during their lifetime. These statistics are called the lifetime risk of developing cancer.

Sometimes it is more useful to look at the probability of developing melanoma of the skin between two age groups. For example, 0.99% of men will develop melanoma of the skin between their 50th and 70th birthdays compared to 0.60% for women

Prevalence

On January 1, 2009, in the United States there were approximately 876,344 men and women alive who had a history of melanoma of the skin - 427,810 men and 448,534 women.

>> See the online booklet What You Need To Know About™ Melanoma and Other Skin Cancers

>> Melanoma home page at American Cancer Society

>> Melanoma Home Page at National Cancer Institute

>> Melanoma at Wikipedia

>> American Academy of Dermatology

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Discovery of Biomarker for Deadly Melanoma Skin Cancer Offers New Hope

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Aspirin, Painkillers Ward Off Skin Cancer; Second Study Lets Immune System Stop Melanoma

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Early Success in Curing Melanoma in Mice Spurs Mayo Vaccine Development

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New Therapies May Mean More Life for Patients with Advanced Melanoma

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Metastatic Melanoma Patients Live Almost Twice as Long with New Drug

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Cancer Survivors Face Increased Risk of Melanoma; Melanoma Survivors Even More

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Pre-Melanoma Skin Lesion Found Mostly in Elderly Successfully Removed with Laser

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Melanoma Skin Cancer a Chronic Disease Causing Long-Term Problems for Women

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