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Annals of Oncology 14:615-622, 2003
© 2003 European Society for Medical Oncology

Original Paper

Clinical and pharmacokinetic phase II study of fotemustine in refractory and relapsing multiple myeloma patients

C. Dumontet1,+, J. Jaubert2, C. Sebban3, F. Bouafia1, C. Ardiet3, B. Tranchand3, E. Berger4, C. Lucas4, D. Guyotat2 and B. Coiffier1

1 Service d’Hématologie, CHU de Pierre Bénite, Lyon; 2 Service d’Hématologie, CHU de Saint Etienne, Saint Etienne; 3 Service de Médecine, Centre Léon Bérard, Lyon; 4 IRI Servier, Courbevoie, France

Received 21 May 2002; revised 24 October 2002; accepted 20 November 2002

Background:

Patients with relapsing or refractory multiple myeloma have poor prognosis. Few compounds are active in these patients and response duration remains short. We report the results of an open phase II trial evaluating the efficacy and safety of fotemustine monotherapy.

Patients and methods:

Twenty-one patients with relapsing (17) or refractory (four) multiple myeloma received fotemustine 100 mg/m2 on an outpatient basis on days 1 and 8 of the induction cycle, followed after a 6-week rest period by fotemustine 100 mg/m2 every 3 weeks until progression or unacceptable toxicity. Fotemustine pharmacokinetics during the first day of induction was compared between patients with normal or abnormal renal function.

Results:

Five of 20 eligible patients had an objective response giving an intention-to-treat response rate of 25% [95% confidence interval (CI) 6% to 44%] and a 35.7% response rate (95% CI 11% to 61%) in the 14 patients having received at least four injections of fotemustine. The median time to objective response was 8.9 months. The median times to progression and survival were 13.8 and 23.1 months, respectively, with a 2-year survival rate of 49%. The main toxicity was myelosuppression with grade 3–4 neutropenia and thrombocytopenia in 66% and 71% of patients, respectively. There was one toxic death by sepsis after induction. The pharmacokinetic parameters in renal-impaired patients were not significantly different from those in patients with normal renal function with a similar incidence of grade 3–4 toxicity in both groups.

Conclusions:

Fotemustine as a single agent has definite activity in patients with relapsing or refractory multiple myeloma, with acceptable toxicity and can be administered at conventional doses in patients with mild or moderate renal impairment.

Key words: fotemustine, multiple myeloma, pharmacokinetic, phase II


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