ABSTRACT
BACKGROUND: Thalidomide is effective as a first-line therapy for the treatment of multiple myeloma (MM), but its use is limited by peripheral neurotoxicity. OBJECTIVE: To study the occurrence of both myeloma-related neuropathy and thalidomide-induced neuropathy in 31 patients with newly diagnosed MM. METHODS: Clinical and electrophysiologic examinations were performed in 31 patients with newly diagnosed MM before and after 4 months of therapy with thalidomide (200 mg/day, total dose: 21 g) aimed at debulking MM, before autologous transplantation. After transplantation, the patients took thalidomide, 200 mg/day for another 3 months (total dose over three months: 18 g) and then underwent a final clinical and electrophysiologic checkup. RESULTS: At baseline, four patients presented a mild sensorimotor peripheral neuropathy related to MM, which tended to worsen slightly during treatment with thalidomide. At the end of treatment, 83% of the patients had clinical and electrophysiologic evidence of a mild sensory rather than motor, axonal, length-dependent polyneuropathy, whereas 100% of the patients showed improvement to the basic pathology (>or=partial response). CONCLUSIONS: Peripheral neuropathy, sometimes subclinical, and mild in our patients, is a common, early side effect of thalidomide therapy. The high doses (21 g) used in all patients for a relatively short time (4 months) rule out any correlations between neuropathy, total dose, and duration of treatment.
Subject(s)
Angiogenesis Inhibitors/adverse effects , Antineoplastic Agents/adverse effects , Multiple Myeloma/drug therapy , Peripheral Nervous System Diseases/chemically induced , Thalidomide/adverse effects , Action Potentials , Adult , Aged , Angiogenesis Inhibitors/therapeutic use , Antineoplastic Agents/therapeutic use , Female , Follow-Up Studies , Hematopoietic Stem Cell Transplantation , Humans , Male , Middle Aged , Multiple Myeloma/surgery , Muscle Weakness/chemically induced , Neoadjuvant Therapy , Neural Conduction , Paresthesia/chemically induced , Prospective Studies , Remission Induction , Severity of Illness Index , Thalidomide/therapeutic use , Transplantation, AutologousABSTRACT
BACKGROUND AND OBJECTIVES: The introduction of high-dose therapy with stem cell support has significantly improved the outcome of patients with multiple myeloma (MM) in terms of increased complete remission (CR) rate and extended survival, both disease-free and overall. Few options, however, are presently available for patients who relapse after single or double autologous stem cell transplantation (SCT). Thalidomide, a glutamic acid derivative with anti-angiogenetic properties, has been recently proposed as salvage treatment for such patients. The present study was aimed at evaluating thalidomide as single agent therapy for patients who had previously received autologous peripheral blood stem cell transplantation. DESIGN AND METHODS: From October 1999 to August 2000, 11 patients (7 males/4 females) who had relapsed after single (n = 4) or double (n = 7) autologous peripheral blood SCT were enrolled in the trial. Thalidomide, always employed as a single agent, was initially administered at a dose of 100 mg/day; if well tolerated, the dose was increased serially by 200 mg every other week to a maximum of 800 mg/day. RESULTS: The median administered dose was 600 mg/day. WHO grade > II toxic effects were constipation, lethargy, and leukopenia. Four patients (36%) showed > 50% reduction in serum M protein concentration and 4 showed > 25% reduction, for a total response rate averaging 72%. After a median follow-up of 5 months, 3 out of 8 responding patients are alive and progression-free and 5 patients have relapsed. INTERPRETATION AND CONCLUSIONS; These data confirm that thalidomide is active in poor-prognosis MM patients such as those relapsing after autologous SCT, and could thus deserve further testing in combination therapy.
Subject(s)
Hematopoietic Stem Cell Transplantation , Multiple Myeloma/therapy , Thalidomide/administration & dosage , Adult , Angiogenesis Inhibitors/administration & dosage , Angiogenesis Inhibitors/toxicity , Female , Humans , Male , Middle Aged , Multiple Myeloma/complications , Recurrence , Salvage Therapy/methods , Thalidomide/toxicity , Transplantation, Autologous , Treatment OutcomeABSTRACT
BACKGROUND: Careful control of body temperature during anesthesia aims to prevent cardiocirculatory complications during the phase of recovery from anesthesia. Numerous studies have examined methods for warming the gases breathed by the patient, but the question of whether low flow anesthesia or heat and moisture exchanges can also influence the pattern of body temperature remains unresolved. METHODS: In this clinical trial we evaluated the mean body temperature profile measured at five points in 40 patients divided into two groups: Group I was ventilated with a non-rebreathing circuit and Group II was ventilated with a circle system using low flow rates of fresh gases. All patients were treated with a hydrophobic heat moisture exchanger. RESULTS: The results point out a significantly (P < 0.01) lower decrease in mean body temperature 40 min after the start of mechanical ventilation with the use of low flow rate anesthesia. CONCLUSIONS: This study shows that anesthesia carried out using low fresh gas flow rates and heat moisture exchanger is able to reduce the fall in mean body temperature, when compared with anesthesia carried out using high fresh gas flow rates and heat moisture exchanger.