This study was designed to test the hypothesis that administration of
granulocyte colony-stimulating factor (
G-CSF;
filgrastim) during
induction chemotherapy with CHOP (
cyclophosphamide,
vincristine,
doxorubicin,
prednisone) or CNOP (
doxorubicin replaced with
mitoxantrone) in elderly patients with aggressive
non-Hodgkin lymphoma (NHL) improves
time to treatment failure (TTF), complete remission (CR) rate, and overall survival (OS). Furthermore, the efficacy of CHOP versus CNOP
chemotherapy was compared. A total of 455 previously untreated patients older than 60 years with stages II to IV aggressive NHL were included in the analysis. Patients (median age, 71 years; range, 60-86 years) were randomized to receive CHOP (
doxorubicin 50 mg/m(2)) or CNOP (
mitoxantrone 10 mg/m(2)) with or without
G-CSF (5 microg/kg from day 2 until day 10-14 of each cycle every 3 weeks; 8 cycles). Forty-seven patients previously hospitalized for class I to II
congestive heart failure were randomized to receive CNOP with or without
G-CSF (not included in the CHOP versus CNOP analysis). The CR rates in the CHOP/CNOP plus
G-CSF and CHOP/CNOP groups were the same, 52%, and in the CHOP with or without
G-CSF and CNOP with or without
G-CSF groups, 60% and 43% (P <.001), respectively. No benefit of
G-CSF in terms of TTF and OS could be shown (P =.96 and P =.22, respectively), whereas CHOP was superior to CNOP (TTF/OS P <.001). The incidences of severe
granulocytopenia (World Health Organization grade IV) and granulocytopenic
infections were higher in patients not receiving
G-CSF. The cumulative proportion of patients receiving 90% or more of allocated
chemotherapy was higher (P <.05) in patients receiving
G-CSF. Concomitant
G-CSF treatment did not improve CR rate, TTF, or OS. Patients receiving CHOP fared better than those given CNOP
chemotherapy. The addition of
G-CSF reduces the incidence of severe
granulocytopenia and
infections in elderly patients with aggressive NHL receiving CHOP or CNOP
chemotherapy.