title: The addition of oral idarubicin to a chlorambucil/dexamethasone combination has a significant impact on time to treatment failure but none on overall survival in patients with low grade non-Hodgkin's lymphoma: Results of the Scotland and Newcastle Lymphoma Group randomized NHL VIII trial.
abstract: Two hundred untreated patients with low grade NHL (KIEL), including 155 follicular NHL, were randomized to six courses of treatment with chlorambucil 20 mg m-2 for 3 days and dexamethasone 4 mg bd for 5 days (CD) vs the same regimen plus oral idarubicin 10 mg m-2 for 3 days (CID). Responding patients could be randomized to no further treatment or maintenance treatment for up to 36 months with alpha interferon. Complete remissions/CRu were more frequent in the CID arm (35% vs 24%) but the overall response rate was similar; 87/91 (96%) vs 86/92 (93%). Overall survival (OS) did not differ between the two arms. Time to treatment failure (TTTF) was prolonged in the CID arm, p = 0.03; median time 28 vs 19 months. TTTF for the B-cell follicular group alone was for CID (77 patients) 33 months vs 18 months for CD (78 patients). Interferon conferred no apparent benefit. The Follicular Lymphoma International Prognostic Index (FLIPI) is confirmed as a good predictor of risk groups including a group of 23% with shorter survival. The addition of the oral anthracycline, idarubicin, led to a significant improvement in TTTF with low toxicity. The use of radiotherapy in this sub-group may have contributed to this result. CID is a potential for combination with antibody therapy particularly in older patient groups.
authors.affiliation: Newcastle Hospitals Trust and Newcastle University, Newcastle upon Tyne, UK.
authors.forename: P R A
authors.initials: PR
authors.lastname: Taylor
authors.forename: J M
authors.initials: JM
authors.lastname: White
authors.forename: R J
authors.initials: RJ
authors.lastname: Prescott
authors.forename: B
authors.initials: B
authors.lastname: Angus
authors.forename: M J
authors.initials: MJ
authors.lastname: Galloway
authors.forename: G H
authors.initials: GH
authors.lastname: Jackson
authors.forename: A M
authors.initials: AM
authors.lastname: Lessells
authors.forename: H H
authors.initials: HH
authors.lastname: Lucraft
authors.forename: G P
authors.initials: GP
authors.lastname: Summerfield
authors.forename: S J
authors.initials: SJ
authors.lastname: Proctor
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D002699:Chlorambucil / Q000009:adverse effects / Q000627:therapeutic use*; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D004359:Drug Therapy, Combination; D004739:England; D005260:Female; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy* / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D015996:Survival Rate; D013997:Time Factors; D017211:Treatment Failure
chemical_list: D002699:Chlorambucil; D003907:Dexamethasone; D015255:Idarubicin