Children With Advanced Hodgkin's Disease Respond Favorably to New Drug Regimen

Morgan Stanley Children's Hospital of NewYork-Presbyterian Physician-Scientist Leads Children's Oncology Group Study<br><br>Demonstrates Increased Survival Rate and No Disease Progression for Children on Regimen<br><br>First Use of Drug Regimen in US

Sep 20, 2004

NEW YORK

The drug regimen BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone) has shown to be a safe and effective treatment for children and adolescents with advanced Hodgkin's disease, according to an international pilot study involving more than 200 centers, led by Morgan Stanley Children's Hospital of NewYork-Presbyterian pediatric oncologist Dr. Kara Kelly.

Findings of the study, which is the first in the U.S. to investigate BEACOPP, will be presented at the 6th International Symposium on Hodgkin's Lymphoma in Cologne, Germany, the most important international meeting on Hodgkin's disease. The presentation, one of the few selected to be presented at the Symposium's press conference, will be made by Dr. Kelly on September 20.

Conducted through the Children's Oncology Group (COG), the study finds that patients receiving the BEACOPP regimen had a three-year 95 percent survival, compared with 80 to 85 percent survival for other regimens1. Secondly, 100 percent of children on the regimen exhibited no disease progression within the first three months of completing the therapy, compared with 5 to 10 percent progression for other regimens1. Thirdly, BEACOPP-treated patients demonstrated a 77 percent early remission rate, which compares favorably to other regimens, and few complications or toxicities.

"While Hodgkin's disease is one of the most curable cancers, treatments for advanced forms of the disease leave room for improvement. This trial demonstrates that children and adolescents with the disease can now expect improved survival and recovery," says Dr. Kara Kelly, the study's principal investigator, Associate Attending Pediatrician at Morgan Stanley Children's Hospital of NewYork-Presbyterian and Associate Professor of Clinical Pediatrics at Columbia University College of Physicians & Surgeons. Dr. Kelly, who is a member of the Children's Oncology Group Hodgkin's Committee, will chair the next High-Risk Hodgkin's disease trial, which is currently under development.

Ninety-nine children with Stage IV Hodgkin's disease or Stage IIB/IIIB Hodgkin's disease with bulk disease (presence of a tumor of 6 cm or greater) were enrolled in the study. The regimen, which had previously shown to be an effective treatment for adults in a German study, was administered using an initial higher dosage in order to improve early response rates. Forty-four percent of patients responded to the therapy after two treatment cycles; 77 percent responded after four cycles.

After patients responded favorably to the treatment, they were given a lower dosage, which was stratified by gender: male patients were given treatment without one kind of chemotherapy (alkylating agent) in order to compensate for their increased risk for infertility, and female patients were given treatment without radiation in order to compensate for their increased risk for breast cancer.

"With regard to toxicities, BEACOPP has more negative effects on normal blood counts (more anemia, need for platelet transfusions and more low white-blood counts), but the other toxicities are relatively low and therefore in a tolerable range, compared to other regimens," says Dr. Michael Weiner, a co-investigator in the study and Chief of Pediatric Oncology at Morgan Stanley Children's Hospital of NewYork-Presbyterian and Hettinger Professor of Clinical Pediatrics at Columbia University College of Physicians & Surgeons.

Hodgkin's Disease

Hodgkin's disease or Hodgkin's lymphoma is a malignant (cancerous) growth of cells in the lymphoid system. The lymphoid system is made up of various tissues and organs, including the bone marrow, spleen, thymus, and lymph nodes. These produce, store, and carry white blood cells to fight infection and disease. Hodgkin's disease is the better-known form of lymphoma (the other lymphomas are grouped into what is called the non-Hodgkin's lymphomas), although Hodgkin's occurs less frequently than non-Hodgkin's. There are approximately 625 cases of childhood Hodgkin's disease (5 percent of all childhood cancers) diagnosed in the U.S. every year.

The cause of Hodgkin's disease is unknown. Whether Hodgkin's disease has one or more causes is also unresolved. Studies that examine the rates of disease within populations, called epidemiologic studies, suggest some possible factors that may be at work. However, there is no evidence that any one particular factor is responsible.

Hodgkin's disease has been reported in infants and very young children, but is considered rare before the age of five. The number of cases increases significantly in the second decade of life. Hodgkin's disease occurs more frequently in boys than in girls up to the preteen years; after that, the numbers are about even. The highest rates of Hodgkin's disease in children occur in some countries in Central and South America, Africa, and the Middle East.

Hodgkin's was named after Thomas Hodgkin (1798-1866), an English scholar and Quaker physician, who was the first to extensively document the disease.

1. ABVD, COPP/ABV, and IFRT

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