OBJECTIVETo analyze the main reason of failure in treatment and compliance to protocol in children with acute lymphoblastic leukemia (ALL) at a single institute which is located at the most developed city of China.

METHODSAll the ALL patients who were diagnosed at the hospital from October 1998 to June 2003 were analyzed. The data were extracted from the department's tumor registry database. Failure in protocol compliance and treatment was analyzed within different risk groups, patients' resident area, and time period. The patients who had not received any therapy after ALL diagnosis were accounted as early protocol compliance failure, those who received therapy for less than 15 days were regarded as interim failure in protocol compliance, and those who gave up therapy or were lost in follow-up after 15 days with stable disease or complete remission (CR) were accounted as late compliance failure.

RESULTSTotally 224 patients were diagnosed to have ALL, of them 38 patients went home without receiving any therapy, i.e., the rate of early protocol compliance failure was 17.1%. Of the remaining 186 patients, 22 (10.5%) belonged to interim protocol compliance failure, and 6 cases discontinued the therapy after 15 days treatment, who were classified into late compliance failure. Six cases (10.5%) were regarded as protocol compliance failure among 57 Shanghainese, and so were 22 cases (17.1%) out of 129 non-Shanghainese. There was no significant difference between the two groups (chi(2) = 1.332, P > 0.05). Up to a median 40 months follow-up showed that in 52 patients (31.7%) the treatment failed, of which 37 cases (22.6%) died of incomplete response and relapse, and 15 cases (9.5%) died of therapy complication. Among different risk groups, 24 cases (47.1%) came from high risk group, 18 (34.0%) from medium risk group, and 5 (9.4%) from low risk group. Very significant difference was found among the different risk group (chi(2) = 21.463, P < 0.01). Treatment failure was 28.6% (32/112) in non-Shanghainese and 38.5% (20/52) in Shanghainese. Total failure in protocol compliance and treatment was 42.9% (32 + 22/129) in non-Shanghainese and 45.6% (20 + 6/57) in Shanghainese. The difference of treatment failure was not significant different between the two groups (chi(2) = 1.354, P > 0.05).

CONCLUSIONProtocol compliance failure is the reason as important as the treatment failure for childhood ALL management failure. Either failure should not be neglected. Death from complications was relatively high which needs more attention, especially during induction period. Unusually high death rate occurred in high and medium risk group patients. The grouping criteria may need modification.