A randomized phase II study of CEOP with or without semustine as induction chemotherapy in patients with stage IE/IIE extranodal NK/T-cell lymphoma, nasal type in the upper aerodigestive tract.

Abstract

PURPOSE:

In this randomized phase II study, we evaluated the efficacy of semustine added to CEOP regimen as induction chemotherapy in patients with stage I(E)/II(E) extranodal NK/T-cell lymphoma, nasal type in the upper aerodigestive tract.

PATIENTS AND METHODS:

Seventy-five eligible patients were randomized to receive either CEOP or CEOP plus semustine followed by involved-field radiotherapy.

RESULTS:

The overall response rate of induction chemotherapy was 57.9% in CEOP arm compared with 62.2% in CEOP plus semustine arm (P=0.71). With a median follow-up of 30.1 months, 2-year overall survival was 73.3% and 62.2%, respectively (P=0.37). Toxicities in both arms were comparable and manageable. Through univariate and multivariate analysis, PS of 2, Stage II(E) and elevated LDH level were identified to be adverse prognostic factors. A new prognostic index categorized three groups of patients (low risk, no adverse factors; intermediate risk, one factor; and high risk, 2 or 3 factors) with highly significant difference of prognosis. Two-year overall survival was 87.5%, 60.6% and 30%, respectively (P=0.0002).

CONCLUSIONS:

The addition of semustine to CEOP regimen was not associated with improved efficacy. More effective treatment needs to be explored in patients with intermediate or high risk.

• Authors: Xuejun Ma, Ye Guo, Ziqiang Pang, Biyun Wang, Hongfen Lu, Ya-Jia Gu, Xiaomao Guo
• Journal: Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology (Radiother Oncol) Vol. 93 Issue 3 Pg. 492-7 (Dec 2009) ISSN: 1879-0887 [Electronic] Ireland
• PMID: 19782419 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial)

Chemical References

• Semustine
• Epirubicin
• Vincristine
• Cyclophosphamide
• Prednisone

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
• Cyclophosphamide (administration & dosage, adverse effects)
• Epirubicin (administration & dosage, adverse effects)
• Female
• Humans
• Lymphoma, Extranodal NK-T-Cell (drug therapy, mortality, radiotherapy)
• Male
• Middle Aged
• Neoplasm Invasiveness
• Nose Neoplasms (drug therapy, radiotherapy)
• Pharyngeal Neoplasms (drug therapy, radiotherapy)
• Prednisone (administration & dosage, adverse effects)
• Prognosis
• Radiation Injuries
• Semustine (administration & dosage, adverse effects)
• Survival Rate
• Vincristine (administration & dosage, adverse effects)
• Young Adult