The addition of nelarabine (Arranon) to standard chemotherapy provided further benefit for patients with moderate or high risk of disease recurrence.
A new chemotherapy regimen produced the highest survival rates for children and young adults with T-cell cancers reported to date, according to data from a phase 3 clinical study.
The study, performed by the Children’s Oncology Group (COG), examined the addition of nelarabine (Arranon) to standard chemotherapy for patients with moderate or high risk of T-cell acute lymphoblastic leukemia (T-ALL) recurrence.
Nelarabine was approved by the FDA in 2005 for the treatment of patients with T-ALL and T-cell lymphoblastic lymphoma (T-LL) that progressed after at least 2 chemotherapy regimens. In this trial, unlike the ones that led to approval, nelarabine was given to patients who were newly diagnosed.
Starting in 2007, the trial enrolled 1895 patients 1 to 30 years of age with either T-ALL or T-LL. In all 4 arms of the trial, patients received the standard, complex, multi-drug chemotherapy regimen known as COG augmented Berlin-Frankfurter-Munster (aBFM) chemotherapy. In addition to the regimen, patients were randomly assigned to receive either high-dose methotrexate in a hospital or escalating dose methotrexate in an outpatient setting.
The group of patients with moderate or high risk of cancer recurrence were also randomly assigned to receive or not receive nelarabine, in addition to chemotherapy and cranial radiation.
At 4 years, 89% of patients who received nelarabine were leukemia-free versus 83% of patients who did not receive nelarabine, according to the data.
Overall, 90.2% of patients treated in the trial lived at least 4 years and 84.3% of patients had no sign of cancer at 4 years.
Other findings include:
· Patients with T-ALL who received escalating doses of methotrexate had better outcomes than those who received high-dose methotrexate.
· Of the patients with T-ALL who received both nelarabine and escalating doses of methotrexate, 92.2% were cancer-free at 4 years.
· Although the patients with T-LL did not benefit from nelarabine, more than 85% lived for 4 years without signs of disease.
Additionally, 54.8% of patients who did not have cancer remission following the initial phase of chemotherapy and were assigned to receive a high-dose of methotrexate and nelarabine survived 4 years without signs of disease. According to the researchers, historically only 20% of patients with T-ALL who did not experience cancer remission lived another 3 years.
“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 4 years after being treated for their disease, but we felt we could and must do better,” Kimberly Dunsmore, MD, lead study author, said in a press release. “Our trial shows that we could further increase survival rates by about 10%, which is very encouraging.”
New Regimens Improve Survival for Children and Young Adults With T-Cell Cancers [news release]. ASCO’s website. https://www.asco.org/about-asco/press-center/news-releases/new-regimens-improve-survival-children-and-young-adults-t-cell. Accessed May 21, 2018.