Primary Investigation Of ProMACE-CytaBOM Modified Regimen In Treating Relapsed Or Refractory Aggressive NHL

Objectives: relapsed or refractory aggressive NHL remains no standard treatment currently.The purpose of this study was to evaluate the efficacy and safety of standard ProMACE-CytaBOM regimen modified for patients with relapsed or refractory aggressive NHL.Methods:Retrospective analysis fourty-one patients with relapsed or refractory NHL from December 2001 to September 2010 used ProMACE-CytaBOM regimens. There were 20 patients in standard regimen group. There were 21 patients in modified group. Standard regimen consisted of cyclophosphamide 650mg/m~2 iv. d1,doxorubicin 30 mg/m~2 or epirubicin 40 mg/m~2 iv. d1,etoposide 120 mg/m~2 iv. d1,prednisone 60 mg/m~2 po.d1-14, cytarabine 300 mg/m~2 iv.d8,blecmycin 10 mg/m~2 iv.d8,vincristine 1.4 mg/m~2 iv.d8,methotrexate 120mg/m~2 iv.d8, leucovorin 15 mg/m~2 iv.after MTX 24h(q6h),every 21 days. Modified treatment improved two of above drugs those were prednisone 60 mg/m~2 po.d1-5,and methotrexate≥1g/m~2 iv.d8. Comparison of response rate, PFS, OS and adverse effects of two groups were estimated by SPSS 17.0 statistics analysis sofeware system. The chi-square test and Fisher's exact probabilites in 2*2 table were used to evaluate the association between two groups'quantitative datas. The t-test was used between two groups'measurement data. The progression-free survival and overall survival were calculated using the Kaplan-Meier method. The log rank test was used to compare survival rates between subgroups of patients. All P values given are 2-sided.Result: The ORR of standard group was 60%( CR35%), respectively. The median PFS was 4 (range1.1～6.9) months,the median OS was 21 (range 9.4～32.6) months. The ORR of modified group was 66.7%( CR 23.8%). The median PFS was 5.5 (range 1.8～9.2) months,the median OS was 17 (range 13.0～21.0) months.There are statistical nonsignificance in comparison of two groups'overall effective(P>0.05).The median PFS of modified regimen were higher than standard regimen in subgroups patients with normal LDH and B symptoms NHL ( P<0.05).The median OS of modified regimen were higher than standard regimen in subgroups patients withⅡstage,normal LDH and B symptoms( P<0.05). The major chemotherapy side effects wereⅡ～Ⅲgrades of tolerable bone marrow suppression andⅠ～Ⅱgrades of non-myeloid toxicities,and the contrasts between the two groups were not statistically significant;while the modified group was lower in the adverse reactions related with glucocorticoid than the standard.Conclusion: Standard or modified ProMACE-CytaBOM regimens are feasible, tolerable and effective in patients with relapsed refractory and aggressive NHL.These patients should be used individualized treatments basing on their stage,IPI score,serum LDH level and B symptoms. The investigative modified regimen have not yet losed its curative effects,but reduced the adverse reactions related with glucocorticoid.Further investigation is warranted.