"Best Ever" Survival Rates for Young People With T-Cell Leukemia, Lymphoma
NEW YORK (Reuters Health) - A large study of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LL) is finding survival rates never seen before, according to researchers.
In a large, federally funded, randomized phase 3 clinical trial, 90% of children and young adults with T-ALL or T-LL were alive four years after starting treatment regimens on the trial, and 84% were cancer free.
"T-cell ALL is a disease that requires the use of a very intense and complex chemotherapy regimen. Historically, about 80% of people live at least four years after being treated for their disease, but we felt we could and must do better. Our trial shows that we could further increase survival rates by about 10%, which is very encouraging," Dr. Kimberly Dunsmore from Virginia Tech Carilion School of Medicine in Roanoke said in a news release.
These are the "best survival data ever" in this group of patients, Dr. Dunsmore added during a media briefing at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, where the findings were presented June 3. With close to 1,900 patients, it's the largest clinical trial for children and young adults with T-ALL and T-LL, she noted.
All patients received the standard multi-drug Children's Oncology Group augmented Berlin-Frankfurt-Munster (aBFM) chemotherapy regimen plus either high-dose or escalating-dose methotrexate. In addition, patients at increased risk for recurrence were also randomly allocated to receive or not receive nelarabine, in addition to chemotherapy, and cranial radiation.
Nelarabine is already approved in the U.S. for relapsed or recurrent disease. The current trial tested nelarabine upfront in patients with newly diagnosed disease.
Across all groups, the overall survival rate at four years was 90.2% and the disease-free survival rate was 84.3%.
Adding nelarabine to standard chemotherapy provided further benefit for patients with T-ALL at moderate or high risk of recurrence. At four years, 88.9% of those who received nelarabine were disease-free versus 83.3 % of those who did not (P=0.03).
For T-ALL patients who received escalating doses of methotrexate, disease-free survival at four years was not significantly higher with nelarabine than without it (92.2% vs. 89.8%, P=0.38). For patients who received high dose methotrexate, four-year disease-free survival was 86.2% with nelarabine versus 78.0% without (P=0.02).
Patients with T-LL did not benefit from the addition of nelarabine, but they still had "very good" survival of 85% at four years, Dr. Dunsmore told the briefing.
"Overall toxicity and neurotoxicity were acceptable and not significantly different between all four arms," the researchers report in their meeting abstract. Based on these results, nelarabine "should become a new standard of care for this population," they conclude.
Commenting on the study during the briefing, ASCO President Dr. Bruce E. Johnson noted that this is a "rare disease" and the large size of the study "highlights how effective our pediatric and young adult oncologists are at accruing" patients.
"Nelarabine has been approved for relapsed or recurrent disease and in this particular setting, moving it up front closer to the initial treatment improved the outcomes for those patients," he added.
The study did not have commercial funding. Two of Dr. Dunsmore’s coauthors report financial ties to Novartis, which markets nelarabine as Arranon.
American Society of Clinical Oncology (ASCO) 2018.