ABSTRACT
Objective:
Compare the
clinical efficacy and
safety of
bendamustine combined with
rituximab (BR regimen) and
rituximab combined with standard CHOP regimen (R-CHOP regimen) in the
treatment of newly diagnosed
follicular lymphoma (FL).
Methods:
Adopting a prospective
case-control study method. 104 newly diagnosed FL
patients admitted to
Beijing Aerospace
General Hospital from January 2018 to January 2022 were selected and randomly divided into an
observation group and a
control group using a random number table
method, with 52
patients in each group. The
observation group was treated with
bendamustine combined with
rituximab, while the
control group was treated with
rituximab combined with standard CHOP regimen. Both groups were treated for 6 consecutive
courses of
treatment, with a 21 day
treatment period. Compare the
serum lactate dehydrogenase (LDH) levels before and
after treatment between two groups β 2-Microglobulin (β 2-microglobulin, β 2-MG level, improvement in
quality of life after treatment, long-term
survival,
clinical efficacy, and
incidence of adverse reactions. Measurement data is represented by paired t-tests for intra group comparisons, and independent sample t-tests for inter group comparisons; Counting data is represented as an example (%), and inter group comparisons are made using χ 2-
test, Wilcoxon rank sum test was used for comparing rank data.
Survival analysis was conducted using the Log Rank test.
Results:
After treatment,
serum LDH and The levels of β 2-MG were lower than before
treatment [LDH (262.34±37.24) U/L ratio (323.45±44.46) U/L, (287.23±43.19) U/L ratio (318.28±52.35) U/L; β 2-MG (2.72±0.30) mg/L compared to (3.45±0.37) mg/L, (2.93±0.28) mg/L compared to (3.37±0.42) mg/L, t-values of 7.60, 3.30, 11.05, 6.29, P values of <0.001, 0.001, <0.001, <0.001, <0.001], and the
observation group was lower than the
control group ( t-values of 3.15, 3.69, P values of 0.002, <0.001, respectively). After 6
courses of
treatment, the
quality of life in the
observation group improved in 27 cases, stabilized in 22 cases, and decreased in 3 cases; The
quality of life in the
control group improved in 18 cases, stabilized in 26 cases, and decreased in 8 cases. The improvement of
quality of life in the
observation group was better than that in the
control group ( Z=-2.03, P=0.042). The
progression free survival period in the
observation group was longer than that in the
control group [52.53 months (95%
confidence interval 49.16-55.89 months) compared to 38.84 months (95%
confidence interval 32.44-45.24 months)], and the difference was statistically significant (Log Rank χ 2=4.06, P=0.044), there was no statistically significant difference in overall
survival between the two groups ( P=0.217). The complete remission rate in the
observation group was higher than that in the
control group [88.46%(46/52) vs 71.15%(37/52)], χ 2=4.83, P=0.028], there was no statistically significant difference in objective response rates between the two groups ( P=0.485). The
incidence of
nausea,
vomiting,
leukopenia,
neutropenia,
alopecia, and
fatigue in the
observation group was lower than that in the
control group, and the differences were statistically significant (all P<0.05).
Conclusions:
Both the BR regimen and R-CHOP regimen can significantly reduce
serum tumor marker levels in the
treatment of newly diagnosed FL. However, the BR regimen has a higher complete response rate, better
patient quality of life, longer PFS, fewer toxic side effects, and more significant overall
efficacy.