Background and Objectives. _x000D_ Intensive multiagent chemotherapy has resulted in significant progress in Burkitt’s lymphoma and leukemia (BL), however prognosis of HIV-associated BL is considered to be poor. PETHEMA-LAL3/97 protocol was designed to obtain evidence that response to therapy and survival of adult patients with BL were similar in HIV infected and in immunocompetent individuals. Furthermore, the LAL3/LB04 PETHEMA trial explored if the introduction of rituximab in the prior chemotherapeutic scheme had an impact in the outcome and toxicity of HIV-positive patients with BL._x000D_ Design and Methods. _x000D_ Patients were uniformly diagnosed and treated and were included prospectively in the study database. The first analysis of the PETHEMA-LAL3/97 included fifty-three consecutive patients with advanced stage BL. The second analysis of the trial extended follow-up of HIV-positive patients in order to elucidate the role of HAART in their survival. The subsequent trial (LAL3/LB04) analyzed thirty-six patients, stratified according to HIV infection status. Response to therapy, survival and toxicity were evaluated according to the HIV infection status of the patients for the three analysis._x000D_ Results. _x000D_ First analysis: There were no differences in complete remission (CR) rates between HIV-negative (77%) and HIV-positive patients (71%). The 2-year overall survival (OS) probability was 51% (95% confidence interval [CI], 38%-64%) for the 53 patients. The 2-year disease free survival (DFS) for the 40 patients achieving CR was 60% (95%CI, 45%-75%). No differences were observed according to HIV status. HIV-infected patients who received highly active antiretroviral therapy (HAART) seemed to have a slightly better disease-free survival than those who did not (p=0.051). _x000D_ Second analysis: Nine patients who (47%) did not receive or discontinued HAART, 5 patients who had started HAART before the diagnosis of BL and 4 patients who started HAART along with chemotherapy were included. Thirteen patients (68%) achieved a CR, The 2-year OS probability was 46% (95%CI, 28%-64%) and the 2-year DFS for patients achieving CR was 71% (95%CI, 45%-94%). The OS of HAART responders (85% at 2 years; 95%CI, 55%-98%) and non-responders (27% at 2 years; 95%CI, 3%-52%) differed significantly (p=0.035)._x000D_ Third analysis: Nineteen of the patients (53%) were HIV-infected. Their clinical characteristics were comparable to those of the HIV-negative patients. CR rates were 88% and 84% respectively for HIV-negative and –positive patients. HIV-infected_x000D_ patients presented higher incidences of grade 3–4 mucositis (27% vs 7% of cycles,_x000D_ P=0.0005) and severe infectious episodes (26% vs 8%, P=0.0025). However, there_x000D_ were no statistically significant differences in 2-year overall survival (82%, 95%CI 65%–99% and 73%, 95% CI, 54%–92%, respectively) or 2-year disease-free survival (93%, 95% CI, 82%–99% and 87%, 95% CI 72%–99%, respectively)._x000D_ Interpretation and conclusions._x000D_ The studies confirmed the feasibility and effectiveness of intensive strategies in adult patients with BL with HIV infection with comparable results to those of the immunocompetent population. Proved that response to HAART prolongs OS in HIV-infected patients and showed that intensive immunochemotherapy can be administered safely to patients with HIV infection with remission and survival rates were comparable to those observed in HIV-negative patients.
Tractament de la leucèmia i el limfoma de Burkitt associats a la infecció pel VIH. Resultats de dos protocols prospectius
Oriol i Rocafiguera, A. (Author). 19 Jul 2012
Student thesis: Doctoral thesis
Student thesis: Doctoral thesis