title: Common and rare side-effects of low-dose thalidomide in multiple myeloma: focus on the dose-minimizing peripheral neuropathy.
abstract: OBJECTIVE
  Thalidomide has demonstrated a remarkable efficacy in the treatment of multiple myeloma but its use may cause several toxicities. We have investigated the common and rare side-effects, especially analysing peripheral neuropathy, in order to optimise the thalidomide dose for minimizing this harmful side-effect.
  
  
  METHODS
  Fifty-nine patients were treated with thalidomide alone or combined with oral melphalan. The median age was 69 yr. The initial dose of thalidomide was 100 mg/day increasing weekly by 100 mg increments until a maximum dose of 400 mg was attained. Melphalan was administered at a dose of 0.20 mg/kg/d for 4 d every 28 d.
  
  
  CONCLUSIONS
  Nearly one-fourth of patients discontinued thalidomide because of toxicity. Constipation (71%), somnolence (36%) and fatigue (20%) were the most common side-effects and they were not dose dependent. Peripheral neuropathy occurred in 39% of patients and a thalidomide median daily dose of more than 150 mg was significantly associated with higher frequency and actuarial risk of peripheral neuropathy without improving the response rate. Deep venous thrombosis was observed in 7% of patients and other side-effects were rare. In patients with advanced multiple myeloma we found that a thalidomide daily dose of 150 mg minimizes peripheral neuropathy without jeopardizing response and survival.
authors.affiliation: Clinica di Ematologia, University of Ancona, Ancona, Italy. m.offidani@ao-umbertoprimo.marche.it
authors.forename: Massimo
authors.initials: M
authors.lastname: Offidani
authors.forename: Laura
authors.initials: L
authors.lastname: Corvatta
authors.forename: Monica
authors.initials: M
authors.lastname: Marconi
authors.forename: Lara
authors.initials: L
authors.lastname: Malerba
authors.forename: Anna
authors.initials: A
authors.lastname: Mele
authors.forename: Attilio
authors.initials: A
authors.lastname: Olivieri
authors.forename: Marino
authors.initials: M
authors.lastname: Brunori
authors.forename: Massimo
authors.initials: M
authors.lastname: Catarini
authors.forename: Marco
authors.initials: M
authors.lastname: Candela
authors.forename: Debora
authors.initials: D
authors.lastname: Capelli
authors.forename: Mauro
authors.initials: M
authors.lastname: Montanari
authors.forename: Serena
authors.initials: S
authors.lastname: Rupoli
authors.forename: Pietro
authors.initials: P
authors.lastname: Leoni
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003248:Constipation / Q000139:chemically induced; D006970:Disorders of Excessive Somnolence / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006801:Humans; D008297:Male; D008558:Melphalan / Q000008:administration & dosage; D008875:Middle Aged; D009101:Multiple Myeloma / Q000150:complications / Q000188:drug therapy*; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced* / Q000517:prevention & control; D011336:Probability; D013792:Thalidomide / Q000008:administration & dosage / Q000633:toxicity*; D020246:Venous Thrombosis / Q000139:chemically induced
chemical_list: D013792:Thalidomide; D008558:Melphalan