R-CVP versus R-CHOP versus R-FM for the initial treatment of patients with advanced-stage follicular lymphoma : results of the FOLL05 trial conducted by the Fondazione Italiana Linfomi
PURPOSE: Although rituximab (R) is commonly used for patients with advanced follicular lymphoma (FL) requiring treatment, the optimal associated chemotherapy regimen has yet to be clarified.
PATIENTS AND METHODS: We conducted an open-label, multicenter, randomized trial among adult patients with previously untreated stages II to IV FL to compare efficacy of eight doses of R associated with eight cycles of cyclophosphamide, vincristine, and prednisone (CVP) or six cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or six cycles of fludarabine and mitoxantrone (FM). The principal end point of the study was time to treatment failure (TTF).
RESULTS: There were 534 patients enrolled onto the study. Overall response rates were 88%, 93%, and 91% for R-CVP, R-CHOP, and R-FM, respectively (P=.247). After a median follow-up of 34 months, 3-year TTFs were 46%, 62%, and 59% for the respective treatment groups (R-CHOP v R-CVP, P=.003; R-FM v R-CVP, P=.006; R-FM v R-CHOP, P=.763). Three-year progression-free survival (PFS) rates were 52%, 68%, and 63% (overall P=.011), respectively, and 3-year overall survival was 95% for the whole series. R-FM resulted in higher rates of grade 3 to 4 neutropenia (64%) compared with R-CVP (28%) and R-CHOP (50%; P< .001). Overall, 23 second malignancies were registered during follow-up: four in R-CVP, five in R-CHOP, and 14 in R-FM.
CONCLUSION: In this study, R-CHOP and R-FM were superior to R-CVP in terms of 3-year TTF and PFS. In addition, R-CHOP had a better risk-benefit ratio compared with R-FM.
| Errataetall: |
ErratumIn: J Clin Oncol. 2014 Apr 1;32(10):1095 Dosage error in article text |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2013 |
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| Erschienen: |
2013 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:31 |
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| Enthalten in: |
Journal of clinical oncology : official journal of the American Society of Clinical Oncology - 31(2013), 12 vom: 20. Apr., Seite 1506-13 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Federico, Massimo [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 20.06.2013 Date Revised 19.11.2015 published: Print-Electronic ErratumIn: J Clin Oncol. 2014 Apr 1;32(10):1095 Dosage error in article text Citation Status MEDLINE |
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| doi: |
10.1200/JCO.2012.45.0866 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM226141063 |
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| 100 | 1 | |a Federico, Massimo |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a R-CVP versus R-CHOP versus R-FM for the initial treatment of patients with advanced-stage follicular lymphoma |b results of the FOLL05 trial conducted by the Fondazione Italiana Linfomi |
| 264 | 1 | |c 2013 | |
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| 500 | |a Date Completed 20.06.2013 | ||
| 500 | |a Date Revised 19.11.2015 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ErratumIn: J Clin Oncol. 2014 Apr 1;32(10):1095 Dosage error in article text | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a PURPOSE: Although rituximab (R) is commonly used for patients with advanced follicular lymphoma (FL) requiring treatment, the optimal associated chemotherapy regimen has yet to be clarified | ||
| 520 | |a PATIENTS AND METHODS: We conducted an open-label, multicenter, randomized trial among adult patients with previously untreated stages II to IV FL to compare efficacy of eight doses of R associated with eight cycles of cyclophosphamide, vincristine, and prednisone (CVP) or six cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or six cycles of fludarabine and mitoxantrone (FM). The principal end point of the study was time to treatment failure (TTF) | ||
| 520 | |a RESULTS: There were 534 patients enrolled onto the study. Overall response rates were 88%, 93%, and 91% for R-CVP, R-CHOP, and R-FM, respectively (P=.247). After a median follow-up of 34 months, 3-year TTFs were 46%, 62%, and 59% for the respective treatment groups (R-CHOP v R-CVP, P=.003; R-FM v R-CVP, P=.006; R-FM v R-CHOP, P=.763). Three-year progression-free survival (PFS) rates were 52%, 68%, and 63% (overall P=.011), respectively, and 3-year overall survival was 95% for the whole series. R-FM resulted in higher rates of grade 3 to 4 neutropenia (64%) compared with R-CVP (28%) and R-CHOP (50%; P< .001). Overall, 23 second malignancies were registered during follow-up: four in R-CVP, five in R-CHOP, and 14 in R-FM | ||
| 520 | |a CONCLUSION: In this study, R-CHOP and R-FM were superior to R-CVP in terms of 3-year TTF and PFS. In addition, R-CHOP had a better risk-benefit ratio compared with R-FM | ||
| 650 | 4 | |a Comparative Study | |
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| 700 | 1 | |a Luminari, Stefano |e verfasserin |4 aut | |
| 700 | 1 | |a Dondi, Alessandra |e verfasserin |4 aut | |
| 700 | 1 | |a Tucci, Alessandra |e verfasserin |4 aut | |
| 700 | 1 | |a Vitolo, Umberto |e verfasserin |4 aut | |
| 700 | 1 | |a Rigacci, Luigi |e verfasserin |4 aut | |
| 700 | 1 | |a Di Raimondo, Francesco |e verfasserin |4 aut | |
| 700 | 1 | |a Carella, Angelo Michele |e verfasserin |4 aut | |
| 700 | 1 | |a Pulsoni, Alessandro |e verfasserin |4 aut | |
| 700 | 1 | |a Merli, Francesco |e verfasserin |4 aut | |
| 700 | 1 | |a Arcaini, Luca |e verfasserin |4 aut | |
| 700 | 1 | |a Angrilli, Francesco |e verfasserin |4 aut | |
| 700 | 1 | |a Stelitano, Caterina |e verfasserin |4 aut | |
| 700 | 1 | |a Gaidano, Gianluca |e verfasserin |4 aut | |
| 700 | 1 | |a Dell'olio, Matteo |e verfasserin |4 aut | |
| 700 | 1 | |a Marcheselli, Luigi |e verfasserin |4 aut | |
| 700 | 1 | |a Franco, Vito |e verfasserin |4 aut | |
| 700 | 1 | |a Galimberti, Sara |e verfasserin |4 aut | |
| 700 | 1 | |a Sacchi, Stefano |e verfasserin |4 aut | |
| 700 | 1 | |a Brugiatelli, Maura |e verfasserin |4 aut | |
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