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
2001; Elsevier BV; Volume: 98; Issue: 9 Linguagem: Inglês
10.1182/blood.v98.9.2640
ISSN1528-0020
AutoresVéronique Leblond, Vincent Lévy, Frédéric Maloisel, Bruno Cazin, Jean‐Paul Fermand, Jean‐Luc Harousseau, Liliane Réménieras, Raphaël Porcher, Martine Gardembas, Gérald Marit, Éric Deconinck, B Desablens, François Guilhot, G Philippe, Aspasia Stamatoullas, Odile Guibon,
Tópico(s)Viral-associated cancers and disorders
ResumoFew 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/m2cyclophosphamide 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. Subjects: Clinical Trials and Observations, Neoplasia Topics: cyclophosphamide, doxorubicin, fludarabine, prednisone, treatment resistant disorders, waldenstrom macroglobulinemia, alkylating agents, infections, mucositis, alopecia
Referência(s)