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Blood, 1 November 2001, Vol. 98, No. 9, pp. 2640-2644
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Multicenter, randomized comparative trial of fludarabine and the
combination of cyclophosphamide-doxorubicin-prednisone in 92 patients
with Waldenström macroglobulinemia in first relapse or
with primary refractory disease
Véronique Leblond,
Vincent Lévy,
Frédéric Maloisel,
Bruno Cazin,
Jean-Paul Fermand,
Jean-Luc Harousseau,
Liliane Remenieras,
Raphaël Porcher,
Martine Gardembas,
Gérald Marit,
Eric Deconinck,
Bernard Desablens,
François Guilhot,
Guilaine Philippe,
Aspasia Stamatoullas, and
Odile Guibon for the French Cooperative Group on
Chronic Lymphocytic Leukemia and Macroglobulinemia
From Département d'hématologie,
Hôpital Pitié-Salpétrière, AP-HP, Paris;
Département de biostatistique et informatique médicale,
Hôpital Saint-Louis, U 444 INSERM, Paris; Centre
Hospitalier Régional Universitaire, Hôpital Hautepierre,
Strasbourg; Centre Hospitalier Régional Universitaire,
Hôpital Claude Huriez, Lille; Service
d'immuno-hématologie, Hôpital Saint-Louis, AP-HP
Paris; Centre Hospitalier Universitaire, Hôtel-Dieu, Nantes;
Centre Hospitalier Universitaire, Limoges; Centre Hospitalier
Universitaire, Angers; Centre Hospitalier Universitaire, Bordeaux;
Centre Hospitalier Universitaire, Besançon; Centre Hospitalier
Universitaire, Amiens; Centre Hospitalier Universitaire, Poitiers;
Centre Hospitalier, Pontoise; Centre anti-cancéreux Becquerel,
Rouen; and Laboratoire Schering, Lys-lez-Lannoy, France.
Few reports are available on the treatment of patients with
Waldenström macroglobulinemia (WM) and primary or secondary
resistance to alkylating-agent-based regimens. From December 1993 through December 1997, 92 patients with WM resistant to first-line
therapy (42) or with first relapse (50) after alkylating-agent therapy were randomly assigned to receive fludarabine (25 mg/m2 of
body-surface area on days 1-5) or cyclophosphamide, doxorubicin (Adriamycin), and prednisone (CAP; 750 mg/m2
cyclophosphamide and 25 mg/m2 doxorubicin on day 1 and 40 mg/m2 prednisone on days 1-5). The first end point
evaluated was the response rate after 6 treatment courses. Forty-five
patients received CAP and 45 received fludarabine. Two patients died
before the first course of chemotherapy. No statistical differences
were observed between the 2 treatment arms with respect to hematologic toxicity or infections. Mucositis and alopecia occurred significantly more often in patients treated with CAP. Partial responses were obtained in 14 patients (30%) treated with fludarabine and 5 patients (11%) treated with CAP (P = .019). Responses were more
durable in patients treated with fludarabine (19 months versus 3 months), and the event-free survival rate was significantly higher in
this group (P < .01). Forty-four patients died, 22 in
the fludarabine group and 22 in the CAP group. There was no statistical
difference in the median overall survival time in the 2 study arms.
Fludarabine was thus more active than CAP in salvage therapy of WM and
should be tested as first-line therapy in a randomized comparison with alkylating agents.
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