title: Final results of phase II trial of doxorubicin HCl liposome injection followed by bexarotene in advanced cutaneous T-cell lymphoma.
abstract: BACKGROUND
  High response rates for doxorubicin HCl liposome injection (DLI) in cutaneous T-cell lymphoma (CTCL) have been reported with vague criteria until recently. Approximately 50% of CTCL patients respond to bexarotene (Bex).
  
  
  METHODS
  A phase II trial was carried out to clarify the true overall response rate (ORR) for DLI and to assess the role of sequential Bex. Patients were treated with DLI 20 mg/m(2) i.v. every 2 weeks for 16 weeks (8 doses) followed by 16 weeks with Bex 300 mg/m(2) orally. Response assessments were carried out after 16 (DLI) and 32 weeks (Bex). Skin responses were measured by the modified Severity-Weighted Assessment Tool (mSWAT) and the Composite Assessment of Index Lesion Severity (CA).
  
  
  RESULTS
  Thirty-seven patients were treated: stage IV (22, 8 with Sézary syndrome), IIB (10), earlier stage refractory to skin-directed therapies or radiation therapy (5). For 34 assessable patients: ORR 14/34 [41%: partial response (PR) 12, clinical complete response (CCR) 2]. Maximum responses were all seen after 16 weeks DLI. Median progression-free survival (PFS) was 5 months. There were 22 deaths: 21 of disease and 1 of heart failure. Twenty-seven grade 3 and 5 grade 4 toxic events were observed.
  
  
  CONCLUSIONS
  With strict criteria, DLI ORR is among the highest reported for single agents in CTCL. Sequential Bex did not increase the response rate or duration.
authors.affiliation: Department of Medicine, Division of Hematologic Oncology, Lymphoma Service, Memorial Sloan-Kettering Cancer Center, New York.
authors.forename: D J
authors.initials: DJ
authors.lastname: Straus
authors.forename: M
authors.initials: M
authors.lastname: Duvic
authors.forename: S M
authors.initials: SM
authors.lastname: Horwitz
authors.forename: K
authors.initials: K
authors.lastname: Hymes
authors.forename: A
authors.initials: A
authors.lastname: Goy
authors.forename: F J
authors.initials: FJ
authors.lastname: Hernandez-Ilizaliturri
authors.forename: T
authors.initials: T
authors.lastname: Feldman
authors.forename: B
authors.initials: B
authors.lastname: Wegner
authors.forename: P L
authors.initials: PL
authors.lastname: Myskowski
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000077610:Bexarotene; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D007267:Injections; D016410:Lymphoma, T-Cell, Cutaneous / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000401:mortality; D013764:Tetrahydronaphthalenes / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D013764:Tetrahydronaphthalenes; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin; D000077610:Bexarotene
keywords: bexarotene; cutaneous T-cell lymphoma; doxorubicin HCl liposome injection