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Memorial Sloan-Kettering Cancer Center
Press Release
Randomized Trial of Two Therapies for Acute Lymphocytic Leukemia
Finds Survival Advantage
ORLANDO, May 16, 2005 - A prospective, randomized trial comparing a novel regimen with a standard treatment for
adult patients with acute lymphocytic leukemia (ALL) showed a distinct
advantage that continued to show superior results at three-, four-, and
five-year intervals in the investigational arm of the trial. The drugs
were given as induction therapy, an initial chemotherapy treatment with
the goal of putting a patient's leukemia into complete remission.
Patients who received the investigational regimen, comprised of
cytarabine with high-dose mitoxantrone, also experienced a higher
frequency of complete remission compared with patients on a standard, vincristine plus prednisone-based regimen. Mark A. Weiss, MD, a leukemia
specialist at Memorial Sloan-Kettering Cancer Center and lead author of
the eight-year, multicenter study, presented the study results today at
the annual meeting of the American Society for Clinical Oncology.
"There have been very few randomized trials in adult ALL. This is
probably the first study in 20 years that focuses on induction therapy,
and it appears to show that one treatment is superior to another in
putting the disease in remission," explained Dr. Weiss. "Although the
survival rates for these patients were initially similar in both arms,
the results diverged after two years. Patients treated with cytarabine
plus high-dose mitoxantrone appeared to have a survival advantage at
three, four, and five years. The difference in survival rates seemed
even more pronounced for the subset of ALL patients with the
Philadelphia chromosome, a genetic predisposition that makes the disease
more difficult to treat," he said.
The trial looked at two regimens to be used as induction therapy. One
hundred and sixty-four patients with ALL, who were able to participate
in the trial, were randomized to receive either a standard regimen
(L-20) of vincristine, prednisone, cyclophosphamide, and doxorubicin or
the ALL-2 regimen of cytarabine with high-dose mitoxantrone. After 24
months of treatment, 83 percent of the 78 patients who received the
ALL-2 regimen achieved a complete remission versus 71 percent of the 86
patients on L-20. Median survival rates were comparable at 24 months for
ALL-2 treated patients versus 22 months for patients treated with L-20.
However, the survival curve begins to show a change after patients
undergo two years on the trial. This trend continues through five years
following initiation of treatment.
- After three years, 45 percent of the ALL-2 patients were alive versus
33 percent of the L-20 patients.
- After four years, 35 percent of the ALL-2 patients were alive versus 24
percent of the L-20 patients.
- After five years, 34 percent of the ALL-2 patients were alive versus 21
percent of the L-20 patients.
Therapy with the ALL-2 regimen also resulted in superior outcomes for
the 30 ALL patients with the Philadelphia chromosome. It improved the
frequency of complete remission and also appeared to result in superior
survival rates after six years. Eighty-five percent of the patients with
the Philadelphia chromosome on ALL-2 achieved a complete remission
compared with 47 percent of patients on L-20. The six-year survival rate
for patients with the Philadelphia chromosome was 26 percent for the
ALL-2 patients, with no patients alive after six years on the other
regimen.
In addition to Dr. Weiss, members of the ALL-4 Consortium, comprised
of physicians from Memorial Sloan-Kettering Cancer Center, the Cleveland
Clinic Foundation, Duke University Medical Center, Emory University
Medical Center, the University of California, Los Angeles, the Stanford
University Medical Center, and Westchester Medical Center participated
in this study. The study was funded, in part, by grants from Victoria's
Smile Foundation, Immunex (Amgen), Rhone-Poulenc (Sanofi-Aventis),
Berlex, and OSI Pharmaceuticals.
Acute lymphocytic leukemia (also called acute lymphoblastic leukemia)
is the most common type of leukemia found in children, but it is less
common among adults. According to American Cancer Society estimates,
approximately 3,970 people will be diagnosed with ALL this year, and
1,490 will die from the disease. Treatment approaches for adult leukemia
typically include chemotherapy, and may include stem cell
transplantation.
Memorial Sloan-Kettering Cancer Center is the world's oldest and
largest institution devoted to prevention, patient care, research, and
education in cancer. Our scientists and clinicians generate innovative
approaches to better understand, diagnose, and treat cancer. Our
specialists are leaders in biomedical research and in translating the
latest research to advance the standard of cancer care worldwide.
Journalists may contact the Department of Public Affairs for more
information.
Telephone: 212-639-3573
E-mail: publicaffairs@mskcc.org |
