Adding Rituximab Helps Treat Mediastinal B-Cell Lymphoma
Adding Rituximab Helps Treat Mediastinal B-Cell Lymphoma
NEW YORK (Reuters Health) Apr 10 - A phase II trial in patients with primary mediastinal B-cell lymphoma has found that rituximab can improve the effectiveness of a six-drug anti-cancer cocktail, nearly eliminating the need for radiotherapy.
The five-year event-free survival rate was 93%, with overall survival of 97%.
"This is giving us cure rates without radiation pushing 95%. And with radiation, everybody on our study has been fine," said senior author Dr. Wyndham Wilson of the National Cancer Institute.
"It certainly does represent an advance in terms of how this disease is treated," said Dr. Len Lichtenfeld, deputy chief medical officer of the American Cancer Society, who was not connected with the research.
The results were released online today in the New England Journal of Medicine.
A separate international trial of the regimen in children, designed to confirm the findings, is underway.
The aggressive tumor affects perhaps 2,000 to 3,000 people per year, Dr. Wilson told Reuters Health in a telephone interview. "In fact, this disease is so poorly studied, this is the first actual formal prospective study of it."
"There is no standard therapy out there, and what has been looked at has worked poorly," he said.
Conventional therapy involves radiation because immunochemotherapy is typically inadequate. Even with combination therapy, 20% of patients have tumor progression.
The monoclonal antibody, also known as Rituxan and MabThera, was combined with an older treatment regimen known as DA-EPOCH, which includes infusions of etoposide, doxorubicin, and cyclophosphamide with vincristine, and prednisone and filgrastim. The doses were gradually adjusted upward to as high as the patient could tolerate.
Fifty-one patients who had not received any earlier therapy received the treatment.
Enrollment took nearly 13 years. All of the masses were at least 5 cm at the widest point. Fifteen patients had stage IV disease and 33 had a bulky tumor at least 10 cm wide.
The researchers said the patients have now been followed for between 10 months and 14 years. All but two had a sustained complete remission. In those other two cases, the patients stayed disease-free after radiotherapy.
The researchers also did a retrospective look at 16 patients treated at Stanford University Medical Center, where the DA-EPOCH-R regimen began after doctors there heard about the NCI work. In that group, the event-free survival rate was 100% without any radiation.
"Based on the data reported here -- which is certainly over a long period of time; this study was started in 1999 -- clearly they've had an approach that has demonstrated effectiveness," Dr. Lichtenfeld told Reuters Health in a telephone interview. "It's a very intense treatment, but the results are excellent."
There was no evidence of ejection fraction problems, but neutrophil counts dropped below 500 cells/mm3 during 50% of the cycles, hospitalization for fever and neutropenia occurred in 13% of the cycles, and thrombocytopenia appeared during 6% of the cycles.
One patient, while in remission, developed and died from acute myeloid leukemia 49 months after lymphoma treatment.
"The patient with leukemia is concerning, but you're always balancing benefits and risks," said Dr. Lichtenfeld. "It's sad that somebody died of leukemia but that is a risk of chemotherapy. It's nothing we accept easily. But other patients in the study have all done well."
SOURCE: http://bit.ly/ZGxLtt
N Engl J Med 2013; 368:1408-1416.
NEW YORK (Reuters Health) Apr 10 - A phase II trial in patients with primary mediastinal B-cell lymphoma has found that rituximab can improve the effectiveness of a six-drug anti-cancer cocktail, nearly eliminating the need for radiotherapy.
The five-year event-free survival rate was 93%, with overall survival of 97%.
"This is giving us cure rates without radiation pushing 95%. And with radiation, everybody on our study has been fine," said senior author Dr. Wyndham Wilson of the National Cancer Institute.
"It certainly does represent an advance in terms of how this disease is treated," said Dr. Len Lichtenfeld, deputy chief medical officer of the American Cancer Society, who was not connected with the research.
The results were released online today in the New England Journal of Medicine.
A separate international trial of the regimen in children, designed to confirm the findings, is underway.
The aggressive tumor affects perhaps 2,000 to 3,000 people per year, Dr. Wilson told Reuters Health in a telephone interview. "In fact, this disease is so poorly studied, this is the first actual formal prospective study of it."
"There is no standard therapy out there, and what has been looked at has worked poorly," he said.
Conventional therapy involves radiation because immunochemotherapy is typically inadequate. Even with combination therapy, 20% of patients have tumor progression.
The monoclonal antibody, also known as Rituxan and MabThera, was combined with an older treatment regimen known as DA-EPOCH, which includes infusions of etoposide, doxorubicin, and cyclophosphamide with vincristine, and prednisone and filgrastim. The doses were gradually adjusted upward to as high as the patient could tolerate.
Fifty-one patients who had not received any earlier therapy received the treatment.
Enrollment took nearly 13 years. All of the masses were at least 5 cm at the widest point. Fifteen patients had stage IV disease and 33 had a bulky tumor at least 10 cm wide.
The researchers said the patients have now been followed for between 10 months and 14 years. All but two had a sustained complete remission. In those other two cases, the patients stayed disease-free after radiotherapy.
The researchers also did a retrospective look at 16 patients treated at Stanford University Medical Center, where the DA-EPOCH-R regimen began after doctors there heard about the NCI work. In that group, the event-free survival rate was 100% without any radiation.
"Based on the data reported here -- which is certainly over a long period of time; this study was started in 1999 -- clearly they've had an approach that has demonstrated effectiveness," Dr. Lichtenfeld told Reuters Health in a telephone interview. "It's a very intense treatment, but the results are excellent."
There was no evidence of ejection fraction problems, but neutrophil counts dropped below 500 cells/mm3 during 50% of the cycles, hospitalization for fever and neutropenia occurred in 13% of the cycles, and thrombocytopenia appeared during 6% of the cycles.
One patient, while in remission, developed and died from acute myeloid leukemia 49 months after lymphoma treatment.
"The patient with leukemia is concerning, but you're always balancing benefits and risks," said Dr. Lichtenfeld. "It's sad that somebody died of leukemia but that is a risk of chemotherapy. It's nothing we accept easily. But other patients in the study have all done well."
SOURCE: http://bit.ly/ZGxLtt
N Engl J Med 2013; 368:1408-1416.
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