title: Pegylated liposomal doxorubicin, rituximab, cyclophosphamide, vincristine, and prednisone in AIDS-related lymphoma: AIDS Malignancy Consortium Study 047.
abstract: OBJECTIVE
  Infusional chemotherapy is efficacious in patients with AIDS-related lymphoma, but it may be difficult to administer. We studied standard agents with rituximab plus pegylated liposomal doxorubicin (DR-COP) in an attempt to provide a more practical approach to therapy while ascertaining rates of response, potential infectious complications, and prognostic role of biologic markers.
  
  
  METHODS
  We conducted a prospective, multi-institutional phase II trial, employing (day 1) pegylated liposomal doxorubicin 40 mg/m(2), rituximab 375 mg/m(2), cyclophosphamide 750 mg/m(2), vincristine 1.4 mg/m(2) (not > 2 mg), and prednisone 100 mg orally on days 1 through 5, with concomitant antiretroviral therapy.
  
  
  RESULTS
  In 40 evaluable patients, median CD4 cells was 114/μL (range, 5 to 1,026/μL), and median HIV-1 viral load (VL) was 25,000 copies/mL. High or intermediate/high age-adjusted International Prognostic Index was present in 28%. Overall response was 67.5%, with complete remission in 47.5% (95% CI, 31.5 to 63.9). Of 19 complete responders, 84% had extranodal disease, 47% had CD4 < 100/μL, and 47% had VL > 50,000 copies/mL; one relapsed. With 25.5-month median follow-up, 62% (95% CI, 44 to 75) of patients remain alive. Sixteen patients (40%) experienced 22 infections, with grade 4 in only two (5%). No patient died as a result of infection during treatment; one had opportunistic infection.
  
  
  CONCLUSIONS
  Profound immunodeficiency and high HIV-1 viral load do not preclude attainment of complete response after DR-COP with highly active antiretroviral therapy. The regimen is tolerable, and use of rituximab was not associated with death as a result of infection during treatment. This approach may be useful in patients in whom the more intensive infusional regimens are impractical.
authors.affiliation: City of Hope National Medical Center, Duarte, CA 91010, USA. alevine@coh.org
authors.forename: Alexandra M
authors.initials: AM
authors.lastname: Levine
authors.forename: Ariela
authors.initials: A
authors.lastname: Noy
authors.forename: Jeannette Y
authors.initials: JY
authors.lastname: Lee
authors.forename: Wayne
authors.initials: W
authors.lastname: Tam
authors.forename: Juan Carlos
authors.initials: JC
authors.lastname: Ramos
authors.forename: David H
authors.initials: DH
authors.lastname: Henry
authors.forename: Samir
authors.initials: S
authors.lastname: Parekh
authors.forename: Erin G
authors.initials: EG
authors.lastname: Reid
authors.forename: Ronald
authors.initials: R
authors.lastname: Mitsuyasu
authors.forename: Timothy
authors.initials: T
authors.lastname: Cooley
authors.forename: Bruce J
authors.initials: BJ
authors.lastname: Dezube
authors.forename: Lee
authors.initials: L
authors.lastname: Ratner
authors.forename: Ethel
authors.initials: E
authors.lastname: Cesarman
authors.forename: Anil
authors.initials: A
authors.lastname: Tulpule
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000150:complications* / Q000473:pathology / Q000821:virology; D015497:HIV-1 / Q000472:pathogenicity*; D006801:Humans; D016483:Lymphoma, AIDS-Related / Q000188:drug therapy* / Q000401:mortality / Q000821:virology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality / Q000821:virology; D009367:Neoplasm Staging; D011092:Polyethylene Glycols / Q000008:administration & dosage; D011241:Prednisone / Q000008:administration & dosage; D011379:Prognosis; D011446:Prospective Studies; D012074:Remission Induction; D000069283:Rituximab; D015996:Survival Rate; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D000069283:Rituximab; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D011241:Prednisone