الفهرس 
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Abstract
Randomized Phase III Trial Of ACVBP Versus CHOP-VP16 In High Risk DLBCL. Abu-Taleb F.M.A, Khaled H.M.B , Zikry K.Z.B And Tarek M.A.A ; Medical Oncology Departments, Zagazig University A And NCI Cairo B , Egypt. Background: Patients With Poor Prognosis Aggressive NHL Still Have Poor Outcome When Treated With Standard CHOP Regimen. Many Studies Showed That Intensified Chemotherapy Regimens Could Improve The Outcome Of This Category Of Patients. In The Current Study, A Trial Has Been Made To Compare In A Randomized Prospective Phase III Clinical Trial, Two Intensified Conventional Chemotherapy Regimens; ACVBP And CHOP-VP16 As Regard CR Rate, DFS And OS For Patients With Poor Prognosis Aggressive NHL. Methods: Eligibility Criteria Included: Age Up To 60 Years, Patients With A Pathologically Proven DLBCL, Age Adjusted International Prognostic Index [ Aa IPI ] ≥ 2, PS Of 0 - 2, Normal Liver And Kidney Functions, Normal Cardiac Functions Assessed By Echocardiography And No Previous Chemotherapy Or Radiotherapy . Eligible Patients Were Randomized Between The CHOP-VP16 Regimen (Cyclophosphamide 750 Mg/M2 D1,Doxorubicin 50 Mg/M2 D1,Vincristine 1.4 Mg/M2 D1 And VP16 100 Mg/M2 D1-D3, Cycles Repeated Every 3 Weeks For A Total Of 8 Cycles ), And The ACVBP Regimen ( Induction Phase : Doxorubicin 75 Mg/M2 D1, Cyclophosphamide 1200 Mg/M2 D1 Vincristine 1.4 Mg/M2 D1&5, Bleomycin 10 Mg D1&5, Prednisone 60 Mg/M2 D1-5 And Methotrexate 15 Mg Intrathecal D2 To Be Repeated Every 3 Weeks For A Total Of 4 Cycles Followed By Consolidation Phase: High Dose Methotrexate At 3 Gm/M2 With Leucovorin Rescue Guided By Serum Methotrexate Level, To Be Repeated Every 2 Weeks For 2 Cycles, Followed By Ifosfamide 1500 Mg/M2 D1 With Mesna And VP16 300 Mg/M2 D1 Repeated Every 3 Weeks For 4 Cycles Followed By Cytarabine 100 Mg/M2 S.C from D1-D4, To Be Repeated Every 2 Weeks For 2 Cycles). Results: from The 87 Patients Randomized To This Study, 85 Patients Ended The First Four Cycles Of Chemotherapy (45 Patients In CHOP-VP16 group And 40 Patients In ACVBP Group). The Complete Remission (CR) Rate Was 60% (24/40 Patients) For The ACVBP group And 44.4% (20/45 Patients) For The CHOP-VP16 Group. Eleven Patients In ACVBP group (27.5%) And Thirteen Patients (28.9%) In The CHOP-VP16 group Had Partial Response On Therapy. Stable Disease Was Observed In One Patient In ACVBP group (2.5%) And Three Patients In CHOP-VP16 group (6.7%). Progressive Disease Was Observed In Four Patients In ACVBP group (10%) And Nine Patients In CHOP-VP16 group (20%), [P Value = 0.4]. At A Median Observation Time Of 14 Months, 7 Of 24 Of The CR Cases (29%) Have Relapsed In The ACVBP Arm, While 12 Relapses Occurred Among The 20 CR Cases (60%) Of The CHOP-VP16 Arm. The Probability Of Disease Free Survival (DFS) At 24 Months Was 62% For ACVBP Patients And 38% For CHOP-VP16 Patients [P Value =0.07], While The Overall Survival Rates Were 42% And 27% For Each group Respectively [P Value = 0.59]. The Patients Treated With ACVBP Had A Higher Rate Of Leucopenia, Thrombocytopenia As Well As Infection And Mucositis Than Those Treated With CHOP-VP16. The Incidence Of Grade 3 And 4 Leucopenia Was Significantly Higher In ACVBP Arm (78 %) Than CHOP-VP16 Arm (46 %) Leading To A Higher Incidence Of Severe Or Life Threatening Infections In The ACVBP Arm (32 %) Versus (12 %) In CHOP-VP16 Arm. Pulmonary Toxicity Was Observed Only In The ACVBP Arm (2 Patients Developed ARDS And One Patient Developed Pulmonary Embolism). Also Treatment Related Mortality Was Higher In ACVBP group (14%) Vs. (4%) In CHOP-VP16 Group. Conclusion: In Conclusion, This Randomized Study Does Not Prove The Superiority Of ACVBP Regimen Given As A Front Line Therapy For Aggressive NHL Patients Over CHOP-VP16 Regimen. So, The Concept Of Using Intensified Chemotherapy For Previously Untreated Aggressive NHL Patients Should Be Thought With Great Caution. Perhaps It Could Be Used In Young Patients With Good Performance Status To Reduce Treatment Related Mortality. In Addition, Risk Stratification Of Patients With DLBCL Should Be Identified By Models Respecting The Biologic And Genetic Background Of This Heterogeneous Disease E.G. Gene Expression Profiling (GEP).