title: Prolonged follow-up after initial therapy with 2-chlorodeoxyadenosine in patients with indolent non-Hodgkin lymphoma: results of Cancer and Leukemia Group B Study 9153.
abstract: BACKGROUND
  The objective of this study was to determine the efficacy and toxicity of 2-chlorodeoxyadenosine (2-CdA) in patients with untreated, indolent non-Hodgkin lymphoma (NHL).
  
  
  METHODS
  For this multicenter, single-arm, Phase II study, 44 patients with treatment-naive, stage III or IV, indolent NHL (International Working Formulation subtypes A, B, and C) were enrolled. Patients received 0.14 mg/kg per day of 2-CdA as a 2-hour bolus infusion for 5 consecutive days every 28 days until maximal response or a total of 6 cycles.
  
  
  RESULTS
  Thirty-eight patients were eligible for response evaluation. The overall response rate was 100% (95% confidence interval [95% CI], 90.8-100%), and the complete response rate was 31.6% (95% CI, 17.5-48.7%). In the intent-to-treat population, the median failure-free survival was 2.0 years (95% CI, 1.3-3.4 years), and the overall survival rate was 7.0 years (95% CI, 4.3-9.4 years). Six patients had sustained remissions that lasted a median of 8.7 years (range, from 5.9 years to > or =11 years). Although 68% of patients experienced at least 1 grade 3 or 4 event, consisting primarily of myelosuppression, severe infections were rare, with only 8 grade 3 infections. Four late malignancies (prostate adenocarcinoma, ductal carcinoma in situ, and myelodysplasia) and 4 patients with large cell transformation were reported.
  
  
  CONCLUSIONS
  2-CdA is an active, well-tolerated therapy for patients with untreated, indolent NHL.
authors.affiliation: Division of Hematology-Oncology, Department of Internal Medicine, The Ohio State University, Columbus, Ohio 43210, USA. kristie.blum@osumc.edu
authors.forename: Kristie A
authors.initials: KA
authors.lastname: Blum
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Johnson
authors.forename: Donna
authors.initials: D
authors.lastname: Niedzwiecki
authors.forename: Lawrence D
authors.initials: LD
authors.lastname: Piro
authors.forename: Alan
authors.initials: A
authors.lastname: Saven
authors.forename: Bruce A
authors.initials: BA
authors.lastname: Peterson
authors.forename: John C
authors.initials: JC
authors.lastname: Byrd
authors.forename: Bruce D
authors.initials: BD
authors.lastname: Cheson
mesh_terms: D000293:Adolescent; D000328:Adult; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D017338:Cladribine / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D017338:Cladribine