title: Phase II trial of high-dose topotecan, melphalan and CY with autologous stem cell support for multiple myeloma.
abstract: In spite of high-dose chemotherapy followed by autologous hematopoietic SCT multiple myeloma (MM) eventually recurs, highlighting the need for more effective treatment approaches. Patients received topotecan 3.5 mg/m(2) intravenously on days -6 to -2, melphalan 70 mg/m(2) intravenously on days -3 and -2 and CY 1 g/m(2) intravenously on days -6, -5 and -4. Overall response rate (ORR) consisting of complete response and partial response (CR+PR, PFS, OS and toxicity are reported. Between August 2002 to March 2004, 60 patients (34 men and 26 women) with a median age of 61 years (range 45-72) were enrolled. Forty-one patients were treated for consolidation of first remission, while 19 patients had relapsed/refractory disease. ORR was 85% (CR 12%, very good PR 43% and PR 30%). Median time to neutrophil (ANC>0.5 × 10(9)/L) and plt engraftment (>20 × 10(9)/L) was 10 (range 7-12 days) and 9 days (range 6-79 days), respectively. A majority of the common adverse events were grade 1-3 mucositis/stomatitis (65%), grade 1 or 2 nausea (59%) and grade 1 or 2 diarrhea (41%). Median PFS was 18.5 months and median OS has yet not been reached. In conclusion, topotecan, melphalan and CY is a safe and active conditioning regimen for auto hematopoietic SCT in MM. The ORR and PFS were comparable to high-dose melphalan.
authors.affiliation: Department of Internal Medicine, University of Texas Health Science Center at Houston, Houston, TX, USA.
authors.forename: S M A
authors.initials: SM
authors.lastname: Kazmi
authors.forename: R M
authors.initials: RM
authors.lastname: Saliba
authors.forename: M
authors.initials: M
authors.lastname: Donato
authors.forename: M
authors.initials: M
authors.lastname: Wang
authors.forename: C
authors.initials: C
authors.lastname: Hosing
authors.forename: S
authors.initials: S
authors.lastname: Qureshi
authors.forename: P
authors.initials: P
authors.lastname: Anderlini
authors.forename: U
authors.initials: U
authors.lastname: Popat
authors.forename: R E
authors.initials: RE
authors.lastname: Champlin
authors.forename: S A
authors.initials: SA
authors.lastname: Giralt
authors.forename: M H
authors.initials: MH
authors.lastname: Qazilbash
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use* / Q000633:toxicity; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D006085:Graft Survival; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D008297:Male; D008558:Melphalan / Q000008:administration & dosage; D008875:Middle Aged; D009101:Multiple Myeloma / Q000150:complications / Q000628:therapy*; D012008:Recurrence; D012074:Remission Induction; D019772:Topotecan / Q000008:administration & dosage; D014182:Transplantation, Autologous; D016896:Treatment Outcome
chemical_list: D019772:Topotecan; D003520:Cyclophosphamide; D008558:Melphalan