Long-Term Results of the FOLL05 Trial Comparing R-CVP Versus R-CHOP Versus R-FM for the Initial Treatment of Patients With Advanced-Stage Symptomatic Follicular Lymphoma

S. Luminari, A. Ferrari, M. Manni, A. Dondi, A. Chiarenza, F. Merli, C. Rusconi, V. Tarantino, A. Tucci, U. Vitolo, S. Kovalchuk, E. Angelucci, A. Pulsoni, L. Arcaini, F. Angrilli, G. Gaidano, C. Stelitano, G. Bertoldero, N. Cascavilla, F. SalviA. J. M. Ferreri, D. Vallisa, L. Marcheselli, M. Federico

Research output: Contribution to journalArticle

Abstract

Purpose The FOLL05 trial compared R-CVP (rituximab plus cyclophosphamide, vincristine, and prednisone) with R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) and R-FM (rituximab plus fludarabine and mitoxantrone) regimens without rituximab maintenance as initial therapy for patients with advanced-stage follicular lymphoma (FL). A previous analysis with a median follow-up of 34 months showed a superior 3-year time to treatment failure, the primary study end point, with R-CHOP and R-FM versus R-CVP and showed R-CHOP to have a better risk-benefit ratio in terms of toxicity than R-FM. We report a post hoc analysis of this trial after a median follow-up of 7 years. Patients and Methods Of the 534 enrolled patients, 504 were evaluable. At the time of analysis, the median follow-up was 84 months (range, 1 to 119 months). Results The 8-year time to treatment failure and progression-free survival rates were 44% (95% CI, 39% to 49%) and 48% (95% CI, 43% to 53%), respectively. The hazard ratio for progression-free survival adjusted by FL International Prognostic Index 2 versus R-CVP was 0.73 for R-CHOP (95% CI, 0.54 to 0.98; P = .037) and 0.67 for R-FM (95% CI, 0.50 to 0.91; P = .009). The 8-year overall survival (OS) rate was 83% (95% CI, 79% to 87%), with no significant differences among study arms. Overall, we observed a higher risk of dying as a result of causes unrelated to lymphoma progression with R-FM versus R-CVP. Conclusion With an 83% 8-year OS rate, long-term follow-up of the FOLL05 trial confirms the favorable outcome of patients with advanced-stage FL treated with immunochemotherapy. The three study arms had similar OS but different activity and toxicity profiles. Patients initially treated with R-CVP had a higher risk of lymphoma progression compared with those receiving R-CHOP, as well as a higher risk of requiring additional therapy.
Original languageEnglish
Pages (from-to)689-696
Number of pages8
JournalJournal of Clinical Oncology
Volume36
Issue number7
DOIs
Publication statusPublished - Mar 1 2018

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Mitoxantrone
Follicular Lymphoma
Vincristine
Prednisone
Cyclophosphamide
Therapeutics
Survival Rate
Treatment Failure
Disease-Free Survival
fludarabine
Rituximab
Lymphoma
Doxorubicin

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Long-Term Results of the FOLL05 Trial Comparing R-CVP Versus R-CHOP Versus R-FM for the Initial Treatment of Patients With Advanced-Stage Symptomatic Follicular Lymphoma. / Luminari, S.; Ferrari, A.; Manni, M.; Dondi, A.; Chiarenza, A.; Merli, F.; Rusconi, C.; Tarantino, V.; Tucci, A.; Vitolo, U.; Kovalchuk, S.; Angelucci, E.; Pulsoni, A.; Arcaini, L.; Angrilli, F.; Gaidano, G.; Stelitano, C.; Bertoldero, G.; Cascavilla, N.; Salvi, F.; Ferreri, A. J. M.; Vallisa, D.; Marcheselli, L.; Federico, M.

In: Journal of Clinical Oncology, Vol. 36, No. 7, 01.03.2018, p. 689-696.

Research output: Contribution to journalArticle

Luminari, S, Ferrari, A, Manni, M, Dondi, A, Chiarenza, A, Merli, F, Rusconi, C, Tarantino, V, Tucci, A, Vitolo, U, Kovalchuk, S, Angelucci, E, Pulsoni, A, Arcaini, L, Angrilli, F, Gaidano, G, Stelitano, C, Bertoldero, G, Cascavilla, N, Salvi, F, Ferreri, AJM, Vallisa, D, Marcheselli, L & Federico, M 2018, 'Long-Term Results of the FOLL05 Trial Comparing R-CVP Versus R-CHOP Versus R-FM for the Initial Treatment of Patients With Advanced-Stage Symptomatic Follicular Lymphoma', Journal of Clinical Oncology, vol. 36, no. 7, pp. 689-696. https://doi.org/10.1200/JCO.2017.74.1652 [doi]
Luminari, S. ; Ferrari, A. ; Manni, M. ; Dondi, A. ; Chiarenza, A. ; Merli, F. ; Rusconi, C. ; Tarantino, V. ; Tucci, A. ; Vitolo, U. ; Kovalchuk, S. ; Angelucci, E. ; Pulsoni, A. ; Arcaini, L. ; Angrilli, F. ; Gaidano, G. ; Stelitano, C. ; Bertoldero, G. ; Cascavilla, N. ; Salvi, F. ; Ferreri, A. J. M. ; Vallisa, D. ; Marcheselli, L. ; Federico, M. / Long-Term Results of the FOLL05 Trial Comparing R-CVP Versus R-CHOP Versus R-FM for the Initial Treatment of Patients With Advanced-Stage Symptomatic Follicular Lymphoma. In: Journal of Clinical Oncology. 2018 ; Vol. 36, No. 7. pp. 689-696.
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title = "Long-Term Results of the FOLL05 Trial Comparing R-CVP Versus R-CHOP Versus R-FM for the Initial Treatment of Patients With Advanced-Stage Symptomatic Follicular Lymphoma",
abstract = "Purpose The FOLL05 trial compared R-CVP (rituximab plus cyclophosphamide, vincristine, and prednisone) with R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) and R-FM (rituximab plus fludarabine and mitoxantrone) regimens without rituximab maintenance as initial therapy for patients with advanced-stage follicular lymphoma (FL). A previous analysis with a median follow-up of 34 months showed a superior 3-year time to treatment failure, the primary study end point, with R-CHOP and R-FM versus R-CVP and showed R-CHOP to have a better risk-benefit ratio in terms of toxicity than R-FM. We report a post hoc analysis of this trial after a median follow-up of 7 years. Patients and Methods Of the 534 enrolled patients, 504 were evaluable. At the time of analysis, the median follow-up was 84 months (range, 1 to 119 months). Results The 8-year time to treatment failure and progression-free survival rates were 44{\%} (95{\%} CI, 39{\%} to 49{\%}) and 48{\%} (95{\%} CI, 43{\%} to 53{\%}), respectively. The hazard ratio for progression-free survival adjusted by FL International Prognostic Index 2 versus R-CVP was 0.73 for R-CHOP (95{\%} CI, 0.54 to 0.98; P = .037) and 0.67 for R-FM (95{\%} CI, 0.50 to 0.91; P = .009). The 8-year overall survival (OS) rate was 83{\%} (95{\%} CI, 79{\%} to 87{\%}), with no significant differences among study arms. Overall, we observed a higher risk of dying as a result of causes unrelated to lymphoma progression with R-FM versus R-CVP. Conclusion With an 83{\%} 8-year OS rate, long-term follow-up of the FOLL05 trial confirms the favorable outcome of patients with advanced-stage FL treated with immunochemotherapy. The three study arms had similar OS but different activity and toxicity profiles. Patients initially treated with R-CVP had a higher risk of lymphoma progression compared with those receiving R-CHOP, as well as a higher risk of requiring additional therapy.",
author = "S. Luminari and A. Ferrari and M. Manni and A. Dondi and A. Chiarenza and F. Merli and C. Rusconi and V. Tarantino and A. Tucci and U. Vitolo and S. Kovalchuk and E. Angelucci and A. Pulsoni and L. Arcaini and F. Angrilli and G. Gaidano and C. Stelitano and G. Bertoldero and N. Cascavilla and F. Salvi and Ferreri, {A. J. M.} and D. Vallisa and L. Marcheselli and M. Federico",
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TY - JOUR

T1 - Long-Term Results of the FOLL05 Trial Comparing R-CVP Versus R-CHOP Versus R-FM for the Initial Treatment of Patients With Advanced-Stage Symptomatic Follicular Lymphoma

AU - Luminari, S.

AU - Ferrari, A.

AU - Manni, M.

AU - Dondi, A.

AU - Chiarenza, A.

AU - Merli, F.

AU - Rusconi, C.

AU - Tarantino, V.

AU - Tucci, A.

AU - Vitolo, U.

AU - Kovalchuk, S.

AU - Angelucci, E.

AU - Pulsoni, A.

AU - Arcaini, L.

AU - Angrilli, F.

AU - Gaidano, G.

AU - Stelitano, C.

AU - Bertoldero, G.

AU - Cascavilla, N.

AU - Salvi, F.

AU - Ferreri, A. J. M.

AU - Vallisa, D.

AU - Marcheselli, L.

AU - Federico, M.

N1 - LR: 20180226; JID: 8309333; 2017/11/03 06:00 [pubmed]; 2017/11/03 06:00 [medline]; 2017/11/03 06:00 [entrez]; ppublish

PY - 2018/3/1

Y1 - 2018/3/1

N2 - Purpose The FOLL05 trial compared R-CVP (rituximab plus cyclophosphamide, vincristine, and prednisone) with R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) and R-FM (rituximab plus fludarabine and mitoxantrone) regimens without rituximab maintenance as initial therapy for patients with advanced-stage follicular lymphoma (FL). A previous analysis with a median follow-up of 34 months showed a superior 3-year time to treatment failure, the primary study end point, with R-CHOP and R-FM versus R-CVP and showed R-CHOP to have a better risk-benefit ratio in terms of toxicity than R-FM. We report a post hoc analysis of this trial after a median follow-up of 7 years. Patients and Methods Of the 534 enrolled patients, 504 were evaluable. At the time of analysis, the median follow-up was 84 months (range, 1 to 119 months). Results The 8-year time to treatment failure and progression-free survival rates were 44% (95% CI, 39% to 49%) and 48% (95% CI, 43% to 53%), respectively. The hazard ratio for progression-free survival adjusted by FL International Prognostic Index 2 versus R-CVP was 0.73 for R-CHOP (95% CI, 0.54 to 0.98; P = .037) and 0.67 for R-FM (95% CI, 0.50 to 0.91; P = .009). The 8-year overall survival (OS) rate was 83% (95% CI, 79% to 87%), with no significant differences among study arms. Overall, we observed a higher risk of dying as a result of causes unrelated to lymphoma progression with R-FM versus R-CVP. Conclusion With an 83% 8-year OS rate, long-term follow-up of the FOLL05 trial confirms the favorable outcome of patients with advanced-stage FL treated with immunochemotherapy. The three study arms had similar OS but different activity and toxicity profiles. Patients initially treated with R-CVP had a higher risk of lymphoma progression compared with those receiving R-CHOP, as well as a higher risk of requiring additional therapy.

AB - Purpose The FOLL05 trial compared R-CVP (rituximab plus cyclophosphamide, vincristine, and prednisone) with R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) and R-FM (rituximab plus fludarabine and mitoxantrone) regimens without rituximab maintenance as initial therapy for patients with advanced-stage follicular lymphoma (FL). A previous analysis with a median follow-up of 34 months showed a superior 3-year time to treatment failure, the primary study end point, with R-CHOP and R-FM versus R-CVP and showed R-CHOP to have a better risk-benefit ratio in terms of toxicity than R-FM. We report a post hoc analysis of this trial after a median follow-up of 7 years. Patients and Methods Of the 534 enrolled patients, 504 were evaluable. At the time of analysis, the median follow-up was 84 months (range, 1 to 119 months). Results The 8-year time to treatment failure and progression-free survival rates were 44% (95% CI, 39% to 49%) and 48% (95% CI, 43% to 53%), respectively. The hazard ratio for progression-free survival adjusted by FL International Prognostic Index 2 versus R-CVP was 0.73 for R-CHOP (95% CI, 0.54 to 0.98; P = .037) and 0.67 for R-FM (95% CI, 0.50 to 0.91; P = .009). The 8-year overall survival (OS) rate was 83% (95% CI, 79% to 87%), with no significant differences among study arms. Overall, we observed a higher risk of dying as a result of causes unrelated to lymphoma progression with R-FM versus R-CVP. Conclusion With an 83% 8-year OS rate, long-term follow-up of the FOLL05 trial confirms the favorable outcome of patients with advanced-stage FL treated with immunochemotherapy. The three study arms had similar OS but different activity and toxicity profiles. Patients initially treated with R-CVP had a higher risk of lymphoma progression compared with those receiving R-CHOP, as well as a higher risk of requiring additional therapy.

U2 - 10.1200/JCO.2017.74.1652 [doi]

DO - 10.1200/JCO.2017.74.1652 [doi]

M3 - Article

VL - 36

SP - 689

EP - 696

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 7

ER -