Vincristine and dexamethasone pulses might be eliminated during second year of treatment for children with low-risk disease
MONDAY, Aug. 2, 2021 (HealthDay News) — For patients with low-risk childhood acute lymphoblastic leukemia, the omission of seven pulses of therapy with vincristine and oral dexamethasone during the second year of maintenance therapy might not worsen treatment outcomes, according to a study published online July 27 in The Lancet Oncology.
Wenyu Yang, M.D., from the Chinese Academy of Medical Sciences & Peking Union Medical College, and colleagues enrolled patients aged 0 to 18 years from 20 medical centers across China with newly diagnosed acute lymphoblastic leukemia that was in continuous remission for one year after initial treatment and classified them as having low-, intermediate-, or high-risk acute lymphoblastic leukemia. Patients were randomly assigned to receive (control group) or not receive (experimental group) seven pulses of intravenous vincristine plus oral dexamethasone during the second year of treatment (1,442 and 1,481 patients, respectively, in the low-risk cohort; 1,071 and 1,060 patients, respectively, in the intermediate- to high-risk cohort).
The researchers observed no difference in five-year event-free survival between the control and experimental groups among patients with low-risk acute lymphoblastic leukemia (90.3 versus 90.2 percent; P = 0.90); the one-sided 95 percent upper confidence interval was 0.024, establishing noninferiority. For patients with intermediate- to high-risk disease, five-year event-free survival did not differ between the groups (82.8 versus 80.8 percent; P = 0.90), but the one-sided 95 percent upper confidence interval was 0.055, which was borderline inferior for the experimental group.
“These findings are very good news for patients and families because shortening this pulse therapy will substantially reduce neuropsychological side effects, emotional disturbances, and many other neurological and metabolic late effects,” a coauthor said in a statement.
One author disclosed financial ties to the pharmaceutical industry.
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