Prospective, multicenter randomized GITMO/IIL trial comparing intensive (R-HDS) versus conventional (CHOP-R) chemoimmunotherapy in high-risk follicular lymphoma at diagnosis: the superior disease control of R-HDS does not translate into an overall survival advantage
American Society of Hematology:1900 M Street Northwest, Suite 200:Washington, DC 20036:(800)633-4931, (202)776-0544, EMAIL: publishing@hematology.org, ash@hematology.org, INTERNET: http://www.hematology.org, Fax: (202)776-0551, 2008
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Zugriff:
In this randomized multicenter study of 136 patients, 6 courses of CHOP (cyclo-phosphamide/doxorubicin/vincristine/prednisone) followed by rituximab (CHOP-R) were compared with rituximab-supplemented high-dose sequential chemotherapy with autografting (R-HDS) to assess the value of intensified chemo-therapy as a first-line treatment for high-risk follicular lymphoma (FL) after the introduction of monoclonal antibodies. The analysis was intention to treat with event-free survival (EFS) as the primary endpoint. Complete remission (CR) was 62% with CHOP-R and 85% with R-HDS (P < .001). At a median follow-up (MFU) of 51 months, the 4-year EFS was 28% and 61%, respectively (P < .001), with no difference in overall survival (OS). Molecular remission (MR) was achieved in 44% of CHOP-R and 80% of R-HDS patients (P < .001), and was the strongest independent outcome predictor. Patients relapsing after CHOP-R underwent salvage R-HDS in 71% of cases. Salvage R-HDS had an 85% CR rate and a 68% 3-year EFS (MFU, 30 months). We conclude that (1) achieving MR is critical for effective disease control, regardless of which treatment is used; (2) R-HDS ensures superior disease control and molecular outcome than CHOP-R, but no OS improvement; and (3) CHOP-R failures have a good outcome after salvage R-HDS, suggesting that relapsed/refractory FL could be the most appropriate setting for R-HDS–like treatments. This trial was registered at www.clinicaltrials.gov as no. NCT00435955.
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Prospective, multicenter randomized GITMO/IIL trial comparing intensive (R-HDS) versus conventional (CHOP-R) chemoimmunotherapy in high-risk follicular lymphoma at diagnosis: the superior disease control of R-HDS does not translate into an overall survival advantage
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Autor/in / Beteiligte Person: | Ladetto, M ; DE MARCO, F ; Benedetti, F ; Vitolo, U ; Patti, C ; Rambaldi, A ; Pulsoni, Alessandro ; Musso, M ; Liberati, Am ; Olivieri, A ; Gallamini, A ; Pogliani, E ; Scalabrini, Dr ; Callea, V ; DI RAIMONDO, F ; Pavone, V ; Tucci, A ; Cortelazzo, S ; Levis, A ; Boccadoro, M ; Majolino, I ; Pileri, A ; Gianni, Am ; Passera, R ; Corradini, P ; Tarella, C ; GRUPPO ITALIANO TRAPIANTO DI MIDOLLO OSSEO, GITMO ; INTERGRUPPO ITALIANO LINFOMI, IIL ; Foa, Roberto ; De Marco, F ; Pulsoni, A ; Liberati, A ; Scalabrini, D ; Di Raimondo, F ; Gianni, A |
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Veröffentlichung: | American Society of Hematology:1900 M Street Northwest, Suite 200:Washington, DC 20036:(800)633-4931, (202)776-0544, EMAIL: publishing@hematology.org, ash@hematology.org, INTERNET: http://www.hematology.org, Fax: (202)776-0551, 2008 |
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