A treatment for Non-Hodgkin's Lymphoma
- Conditions
- on-Hodgkin lymphoma, unspecified.Non-Hodgkin lymphoma, unspecified
- Registration Number
- IRCT2016010125791N1
- Lead Sponsor
- Vice chancellor for research, Kermanshah University Of Medical Sciences and Health Services
- Brief Summary
BACKGROUND:A combination of rituximab to cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) is one of the most effective front-line therapies to treat B-cell non-Hodgkin's lymphoma (NHL). The aim of this trial was to evaluate overall survival (OS), progression free survival (PFS) and toxicity of R-CHOP-14 compared to R-CHOP-21 in untreated stage III and IV B-cell NHL patients with Iranian ethnicity.MATERIALS AND METHODS:In a phase III trial, patients with previously untreated stage III and IV indolent and aggressive B-cell NHL were randomly assigned by using a minimization method to receive six to eight cycles of either R-CHOP-21 (administered every 21 days) or R-CHOP-14 (administered every 14 days with granulocyte colony-stimulating factor).RESULTS:A total of 143 patients were randomly enrolled in our study (66 patients in R-CHOP-14 group and 77 patients in R-CHOP-21), between 2011 and 2014. The mean follow-up was 45 months at the time of treatment analysis. The 2-year and 5-year PFS rates for the R-CHOP-14 group were 83.6% vs 73.6% and for R-CHOP-21 group were 75% vs 54%. The 2-year and 5-year OS rates for R-CHOP-14 group were 98% vs 89% and for R-CHOP-21 group were 84.4% vs 67.5%. There was a significant correlation for PFS and OS in the two arms. There was no significant difference between adverse events with the two regimens.CONCLUSIONS:In our research improved survival was found with CHOP-14 as compared to CHOP-21. It is possible that drug metabolism in different races/ethnicities may be one important factor.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 143
Age; sex; type of NHL; subtype; Ki-67 index; organomegaly; lymphadenopathy; radiotherapy; anatomic sites of NHL; recurrence
Exclusion criteria: cardiovascular; renal; hepatic disease (hepatitis B or hepatitis C; T-cell lymphoma;patients with initial neutrophil count <1.5×109 per L; initial platelet count <100×109 per
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival. Timepoint: 2 and 5 years. Method of measurement: Observtion.
- Secondary Outcome Measures
Name Time Method eutropenia. Timepoint: every 14 days and every 21 days. Method of measurement: Experimental.