Phase 1 trial of the proteasome inhibitor bortezomib and pegylated liposomal doxorubicin in patients with advanced hematologic malignancies

Blood. 2005 Apr 15;105(8):3058-65. doi: 10.1182/blood-2004-07-2911. Epub 2004 Dec 30.

Abstract

Proteasome inhibitors, a novel class of chemotherapeutic agents, enhance the antitumor efficacy of anthracyclines in vitro and in vivo. We therefore sought to determine the maximum tolerated dose (MTD) and dose-limiting toxicities of bortezomib and pegylated liposomal doxorubicin (PegLD). Bortezomib was given on days 1, 4, 8, and 11 from 0.90 to 1.50 mg/m2 and PegLD on day 4 at 30 mg/m2 to 42 patients with advanced hematologic malignancies. Grade 3 or 4 toxicities in at least 10% of patients included thrombocytopenia, lymphopenia, neutropenia, fatigue, pneumonia, peripheral neuropathy, febrile neutropenia, and diarrhea. The MTD based on cycle 1 was 1.50 and 30 mg/m2 of bortezomib and PegLD, respectively. However, due to frequent dose reductions and delays at this level, 1.30 and 30 mg/m2 are recommended for further study. Pharmacokinetic and pharmacodynamic studies did not find significant drug interactions between these agents. Antitumor activity was seen against multiple myeloma, with 8 of 22 evaluable patients having a complete response (CR) or near-CR, including several with anthracycline-refractory disease, and another 8 having partial responses (PRs). One patient with relapsed/refractory T-cell non-Hodgkin lymphoma (NHL) achieved a CR, whereas 2 patients each with acute myeloid leukemia and B-cell NHL had PRs. Bortezomib/PegLD was safely administered in this study with promising antitumor activity, supporting further testing of this regimen.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antibiotics, Antineoplastic / administration & dosage*
  • Antibiotics, Antineoplastic / adverse effects
  • Antibiotics, Antineoplastic / pharmacokinetics
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / pharmacokinetics
  • Boronic Acids / administration & dosage*
  • Boronic Acids / adverse effects
  • Boronic Acids / pharmacokinetics
  • Bortezomib
  • Doxorubicin / administration & dosage*
  • Doxorubicin / adverse effects
  • Doxorubicin / pharmacokinetics
  • Female
  • Hematologic Neoplasms / drug therapy*
  • Humans
  • Liposomes
  • Male
  • Middle Aged
  • Polyethylene Glycols
  • Protease Inhibitors / administration & dosage*
  • Protease Inhibitors / adverse effects
  • Protease Inhibitors / pharmacokinetics
  • Proteasome Inhibitors
  • Pyrazines / administration & dosage*
  • Pyrazines / adverse effects
  • Pyrazines / pharmacokinetics
  • Treatment Outcome

Substances

  • Antibiotics, Antineoplastic
  • Boronic Acids
  • Liposomes
  • Protease Inhibitors
  • Proteasome Inhibitors
  • Pyrazines
  • Polyethylene Glycols
  • Bortezomib
  • Doxorubicin