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The research team at the Academia Sinica has proved that a combination of anti-cancermonoclonal antibodies (mAbs) with cytokines (natural hormones that help the immune system) is an effective anti-cancer therapy, according to a press statement released by Taiwan's research institute.

The new immunotherapy treatment pioneered by the research team headed by Alice Yu, deputy director of Academia Sinica's Genomics Research Center, is the first study in the world that confirms that immunotherapy is effective in improving cure rates for this childhood cancer, the statement said.

Yu, a pediatrician, has been working on the therapy for more than 20 years. She completed the Phase I and Phase II trials of this antibody at the University of California in San Diego.

The latest phase III trial was sponsored by the U.S.-based Children's Oncology Group (COG), a cancer research organization, and the National Cancer Institute of the National Institutes of Health in the United States. The latest results included children with neuroblastoma from many parts of the world.

Neuroblastoma is a malignant cancer of early childhood in which the cancer cells arise from the nerve cells in the neck, chest or abdomen.

It is the most common cancer diagnosed in the first year of life and is responsible for 15 percent of cancer-related deaths in children.

The Phase III study showed that children with high risk neuroblastoma receiving the new antibody-based immunotherapy (chimeric anti-GD2 antibody ch14.18) have a 20 percent better chance of living free of cancer, a significantly improved cure rate.

So far, Yu said, all U.S. Federal Drug Administration (FDA) approved therapeutic anti-cancer mAbs or vaccines are directed against protein or glycoprotein antigens. “The Phase III clinical trial is the first mAb targeting a glycolipid that has been shown to be effective,” Yu said.”

More importantly, she added, this is the first study that proves that immunotherapy is effective in improving cure rates for this childhood cancer, and her team is now focusing on making sure immunotherapy can be available to all children with this disease and on improving results in the future.

“In addition, we are hopeful that that this further study will result in commercialization and FDA approval and licensing of this experimental immunotherapeutic agent so that it can be made readily available as a standard therapy to all children with this dreaded disease,” Reaman said in the statement.

Conventional treatment for the disease includes surgery, intensive chemotherapy with stem cell rescue (in which patients' stem cells removed before treatment are returned after chemotherapy to repopulate the blood and immune system) and radiation therapy.

Despite these aggressive measures, only 30 percent of patients survive.

The immunotherapy evaluated in this study targets a specific glycolipid (sugar and fat) molecule on neuroblastoma cells called GD2, which inhibits the immune system from attacking cancer cells, with an antibody called ch14.18.

This antibody binds to GD2 and provokes an attack by different types of immune cells against the cancer.

In her study, Yu and her colleagues compared the two-year event-free survival rate (the ratio of patients who were still alive and did not experience a recurrence) of 113 neuroblastoma patients who received the standard treatment (retinoic acid) plus the newly developed immunotherapy to 113 similar patients who only received the standard treatment.

The event-free survival rate for the immunotherapy group was 66 percent, compared to 46 percent for the standard treatment group. The most common side effects in the immunotherapy group were pain, vascular leak syndrome and allergic reactions. As the study is the first effective immunotherapy reported for the disease and the first improvement on neuroblastoma cure rates for the last 10 years, it has drawn worldwide attention and was reported in USA Today and on the U.S. television network CBS.

It is estimated that it will take at least another two years to get FDA approval for the therapy.

The results of the Phase III clinical trial were announced in a worldwide Web press conference Thursday and will be presented at the annual meeting of the American Society of Clinical Oncology (ASCO) between May 29 and June 2.