GIMEMA ALL 0183: a multicentric study on adult acute lymphoblastic leukaemia in Italy. GIMEMA Cooperative Group.
In 1983 a multicentre trial for adult patients with ALL (excluding the B-phenotype) was initiated to evaluate: (a) complete remission (CR) rate and length in a protocol with a mild induction and an intensive consolidation therapy; (b) the efficacy of a mild versus an intensive post consolidation treatment in prolonging disease-free survival; (c) CNS relapse rate on a protocol substituting intrathecal chemotherapy and intermediate dose i.v. methotrexate (MTX) and cytosine arabinoside (ARA-C) for cranial radiotherapy. 358 patients entered the protocol between January 1983 and April 1987: 284 (79.3%) attained complete remission, 26 (7.3%) died during induction and 48 (13.4%) had resistant disease. Median overall survival was 21.7 months, with a projection that 29.4% of the patients will survive more than 55 months. The median duration of complete remission was 19.2 months: 21.9% of responders are projected to remain in continuing complete response for more than 50.6 months. Among the 284 responding patients, 154 (54.2%) relapsed (95 while on therapy, 59 off-therapy): major sites of relapse were bone marrow (103), CNS alone (23), or both (11). 14 patients died while in CR. Only 12 patients (2.2%) were lost to follow-up, while therapy was interrupted in 7 (2%) because of side effects and in 12 (3.3%) because of the patient's refusal. By multivariate analysis increasing age and presence of infection at diagnosis were associated with a lower remission rate; risk of relapse was greater in L2 subtypes and in patients with higher WBC at diagnosis; survival was inversely correlated to age. The high response rate was not achieved at expense of an increased risk of induction death. The low incidence of isolated CNS relapse (8.0% of responding patients) suggests that CNS prophylaxis as used in this study is effective. No statistically significant difference in survival and relapse rate emerged between the two arms of post consolidation therapy. Moreover, the protocol therapy was well tolerated, required minimal supportive care, which could be provided even in small centres, and compliance proved acceptance for patients and staff.
D000293:Adolescent; D000328:Adult; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000401:mortality / Q000628:therapy*; D011379:Prognosis; D011897:Random Allocation; D012074:Remission Induction; D013997:Time Factors