title: Long-term follow up of the FL2000 study comparing CHVP-interferon to CHVP-interferon plus rituximab in follicular lymphoma.
abstract: Anti-CD20-containing chemotherapy regimens have become the standard of care for patients with follicular lymphoma needing cytotoxic therapy. Four randomized trials demonstrated a clinical benefit for patients treated with rituximab. However, no long-term follow up (i.e. > 5 years) of these trials is yet available. Between May 2000 and May 2002, 358 newly diagnosed patients with high tumor burden follicular lymphoma were randomized to receive cyclophosphamide, adriamycin, etoposide and prednisolone plus interferon-α2a or a similar chemotherapy-based regimen plus rituximab, and outcome was up-dated. With a median follow up of 8.3 years, addition of rituximab remained significantly associated with prolonged event-free survival (primary end point) (P=0.0004) with a trend towards a benefit for overall survival (P=0.076). The Follicular Lymphoma International Prognostic Index score was strongly associated with outcome for both event-free and overall survival in univariate analysis and its prognostic value remained highly significant after adjusting for other significant covariates in multivariate models (P<0.0001 and P=0.001, respectively). Considering long-term toxicity, the addition of rituximab in the first-line setting was confirmed as safe with regards to development of secondary malignancies. Long-term follow up of patients with follicular lymphoma treated in the FL2000 study confirms the sustained clinical benefit of rituximab without long-term toxicity.
authors: Hospices Civils de Lyon and Université Lyon 1, France.
authors: Emmanuel
authors: E
authors: Bachy
authors: Roch
authors: R
authors: Houot
authors: Franck
authors: F
authors: Morschhauser
authors: Anne
authors: A
authors: Sonet
authors: Pauline
authors: P
authors: Brice
authors: Karim
authors: K
authors: Belhadj
authors: Guillaume
authors: G
authors: Cartron
authors: Bruno
authors: B
authors: Audhuy
authors: Christophe
authors: C
authors: Fermé
authors: Pierre
authors: P
authors: Feugier
authors: Catherine
authors: C
authors: Sebban
authors: Vincent
authors: V
authors: Delwail
authors: Hervé
authors: H
authors: Maisonneuve
authors: Steven
authors: S
authors: Le Gouill
authors: Sophie
authors: S
authors: Lefort
authors: Nicole
authors: N
authors: Brousse
authors: Charles
authors: C
authors: Foussard
authors: Gilles
authors: G
authors: Salles
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D015331:Cohort Studies; D003520:Cyclophosphamide / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage*; D008224:Lymphoma, Follicular / Q000188:drug therapy* / Q000401:mortality*; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage; D011446:Prospective Studies; D000069283:Rituximab; D015996:Survival Rate / Q000639:trends; D013713:Teniposide / Q000008:administration & dosage; D013997:Time Factors; D055815:Young Adult
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D016898:Interferon-alpha; D000069283:Rituximab; D004317:Doxorubicin; D003520:Cyclophosphamide; D013713:Teniposide; D011241:Prednisone
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