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Blood, 15 October 2006, Vol. 108, No. 8, pp. 2540-2544.
Prepublished online as a Blood First Edition Paper on July 11, 2006; DOI 10.1182/blood-2006-03-013193.
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CLINICAL TRIALS AND OBSERVATIONS
Standard chemotherapy with interferon compared with CHOP followed by high-dose therapy with autologous stem cell transplantation in untreated patients with advanced follicular lymphoma: the GELF-94 randomized study from the Groupe d'Etude des Lymphomes de l'Adulte (GELA)
Catherine Sebban,
Nicolas Mounier,
Nicole Brousse,
Coralie Belanger,
Pauline Brice,
Corinne Haioun,
Herve Tilly,
Pierre Feugier,
Redah Bouabdallah,
Chantal Doyen,
Gilles Salles, and
Bertrand Coiffier
From the Departments of Hematology of Centre Léon Bérard, Lyon, France; Hôpital Saint-Louis, Paris, France; Hôpital Necker, Paris, France; Centre Hospitalo-Universitaire (CHU) Henri Mondor, Créteil, France; Centre Becquerel, Rouen, France; CHU de Brabois, Vandoeuvre les Nancy, France; Institut Paoli Calmette, Marseille, France; Université Catholique de Louvain, Yvoir, Belgium; and Hospices Civils de Lyon, Pierre Bénite, France.
The purpose of this study is to compare our standard chemotherapy regimen (CHVP [cyclophosphamide, doxorubicin, teniposide, and prednisone]) plus interferon with 4 courses of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) followed by high-dose therapy with autologous stem cell transplantation (ASCT) in treatment-naive patients with advanced follicular lymphoma. Four hundred one patients were included from July 1994 to March 2001: 209 received 12 cycles of CHVP plus interferon  for 18 months (CHVP-I arm) and 192 received 4 cycles of CHOP followed by high-dose therapy (HDT) with total body irradiation and ASCT (CHOP-HDT arm). Overall response rates were similar in both groups (79% and 78% after induction chemotherapy, respectively). One hundred thirty-one of the 150 patients eligible for HDT underwent transplantation (87%). Intent-to-treat analysis after a median follow-up of 7.5 years showed that there was no difference between the 2 arms for overall survival (P = .53) or event-free survival (P = .11). Patients with a complete response at the end of the induction therapy had a statistically longer event-free survival and overall survival (P = .02 and < .001, respectively). After long-term follow-up, our study showed that there was no statistically significant benefit in favor of first-line high-dose therapy in patients with follicular lymphoma. High-dose therapy should be reserved for relapsing patients.
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