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: Kristie A Blum, Jeffrey L Johnson, Donna Niedzwiecki, Lawrence D Piro, Alan Saven, Bruce A Peterson, John C Byrd, Bruce D Cheson, Cancer and Leukemia Group B Study 9153
• Journal: Cancer (Cancer) Vol. 107 Issue 12 Pg. 2817-25 (Dec 15 2006) ISSN: 0008-543X [Print] United States
• PMID: 17120198 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural)
• Copyright: Copyright 2006 American Cancer Society.

Chemical References

• Antineoplastic Agents
• Cladribine

Topics

• Adolescent
• Adult
• Antineoplastic Agents (adverse effects, therapeutic use)
• Cladribine (adverse effects, therapeutic use)
• Female
• Follow-Up Studies
• Humans
• Lymphoma, Non-Hodgkin (drug therapy, mortality)
• Male
• Middle Aged
• Neoplasm Staging
• Treatment Outcome