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Blood, 15 May 2001, Vol. 97, No. 10, pp. 2991-2997
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Mitoxantrone is superior to doxorubicin in a multiagent weekly
regimen for patients older than 60 with high-grade lymphoma: results of
a BNLI randomized trial of PAdriaCEBO versus PMitCEBO
Paul N. Mainwaring,
David Cunningham,
Walter Gregory,
Peter Hoskin,
Barry Hancock,
Andrew J. Norton,
Ken MacLennan,
Paul Smith,
Gillian Vaughan Hudson, and
David Linch
From the Lymphoma Trials Office at the CRC and UCL
Cancer Trials Office, London, United Kingdom.
A prospective, multicenter, randomized trial was undertaken to
compare the efficacy and toxicity of adriamycin with mitoxantrone within a 6-drug combination chemotherapy regimen for elderly patients (older than 60 years) with high-grade non-Hodgkin lymphoma (HGL) given
for a minimum of 8 weeks. A total of 516 previously untreated patients
aged older than 60 years were randomized to receive 1 of 2 anthracycline-containing regimens: adriamycin, 35 mg/m2
intravenously (IV) on day 1 (n = 259), or mitoxantrone, 7 mg/m2 IV on day 1 (n = 257); with prednisolone, 50 mg
orally on days 1 to 14; cyclophosphamide, 300 mg/m2 IV on
day 1; etoposide, 150 mg/m2 IV on day 1; vincristine, 1.4 mg/m2 IV on day 8; and bleomycin, 10 mg/m2 IV
on day 8. Each 2-week cycle was administered for a minimum of 8 weeks
in the absence of progression. Forty-three patients were ineligible for
analysis. The overall and complete remission rates were 78% and 60%
for patients receiving PMitCEBO and 69% and 52% for patients
receiving PAdriaCEBO (P = .05, P = .12,
respectively). Overall survival was significantly better with PMitCEBO
than PAdriaCEBO (P = .0067). However, relapse-free
survival was not significantly different (P = .16). At 4 years, 28% of PAdriaCEBO patients and 50% of PMitCEBO patients were
alive (P = .0001). Ann Arbor stage III/IV, World Health
Organization performance status 2-4, and elevated lactate dehydrogenase
negatively influenced overall survival from diagnosis. In conclusion,
the PMitCEBO 8-week combination chemotherapy regimen offers high
response rates, durable remissions, and acceptable toxicity in elderly
patients with HGL.
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