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Dexamethasone-based therapy for childhood acute lymphoblastic leukaemia: results of the prospective Dutch Childhood Oncology Group (DCOG) protocol ALL-9 (1997â??2004)
The Lancet Oncology - Online First, 09/11/09

Veerman AJ et al. – The results for NHR patients were achieved with high cumulative doses of dexamethasone and vincristine, but without the use of anthracyclines, etoposide, cyclophosphamide, or cranial irradiation, therefore minimising the risk of side-effects.

• From a January 1997 to 1 November 2004, 859 patients with ALL were treated according to the ALL-9 protocol
• Patients were stratified into NHR and high risk (HR) groups
• HR criteria were white-blood-cell count of ≥ 50 000 cells per ?L, T-cell phenotype, mediastinal mass, CNS or testicular involvement, and Philadelphia chromosome or MLL rearrangement
• The NHR group was treated with a three-drug induction (dexamethasone, vincristine, and asparaginase) for 6 weeks, medium-dose methotrexate for 3 weeks, then maintenance therapy
• HR patients received a four-drug induction (as for the NHR patients plus daunorubicin) for 6 weeks, high-dose methotrexate for 8 weeks, and two intensification courses before receiving maintenance therapy
• No patient received cranial irradiation
• Maintenance therapy was given until 109 weeks for all patients and consisted of mercaptopurine and methotrexate for 5 weeks, alternated with dexamethasone and vincristine for 2 weeks

• Complete remission was achieved in 592 (98·5%) of the 601 patients in the NHR group and 250 (96·9%) of the 258 in the HR group
• Five patients in the NHR group and four in the HR group died during induction
• The median f/u for patients alive was 72·2 mos (range, 4·8—132·7 mos)
• 5-year event-free survival was 81% in all patients: 84% in NHR patients, and 72% in HR patients
• Isolated CNS relapses occurred in 22 (2·6%) of 842 patients
• DNA index was the strongest predictor of outcome (<1·16 vs ?1·16; relative risk 0·42), followed by age (1—9 vs ?10 years; 2·23) and WBC count (<50 000 vs ?50 000 cells per ?L; 1·60)

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