Table 1.

Selected frontline treatment regimens

InductionConsolidationNORR (CR), %FFS/PFSMedian OSToxicities of interest or significanceTRM, %
Transplant eligible        
 Phase 2        
  R-HyperCVAD13,17  NA 97 97 (87) 5-y 49% FFS 5-y 52% 4 AML/MDS 8 
15-y 22% FFS 15-y 33% 5 deaths from acute toxicity 
  R-HyperCVAD15  NA 49 86 (58) 5-y 49% PFS 5-y 63% 39% did not complete treatment
Hematologic and infectious
2 MDS 1 death from acute toxicity 		2 
  R-HyperCVAD16  NA 60 83 (72) 5-y 61% PFS 5-y 73% 63% did not complete treatment
Hematologic and infectious
3 deaths from acute toxicity 		6.5 
  R-maxi-CHOP+RHiDAC20,21  ASCT 160 94 (54) 6-y 66% PFS 6-y 70% 5 did not proceed to ASCT due to
toxicity 1 MDS 		5 
   ASCT 60 95 (57) 7 y EFS 5-y 75% 3 did not proceed to ASCT due to toxicity 1.7 
  BR/RHiDAC29  ASCT 23 96 (96) 1-y 96 1-y 100%  0 
 Phase 3        
  RCHOP vs RCHOP/RDHAP25  ASCT 455 98 vs 97 (63 vs 61) 3.8-y PFS vs 7.3-y PFS 6.8 y vs not reached Hematologic and infectious 4 
  RDHAP28  ASCT vs ASCT + MR 299  4-y PFS 64% vs 83% 4-y OS 89% vs 80% 2 failed stem cell collection
38% received other platinum drug with first cycle 		 
Transplant ineligible        
 Phase 3        
  RCHOP vs RFC38  NA 455 86 vs 78 TTF 28 mo vs 26 mo 4-y 62% vs 47% Primary hematologic  
34 vs 40 
  RCHOP vs BR40,41  NA 94 91 vs 93 22.1 vs 35.4 mo (median) Median not reached   
30 vs 40 Median not reached 
  RCHOP vs VRCAP43  NA 487 89 vs 92 (42 vs 53) 14.4 vs 24.7 mo 4-y 54% vs 64% Primary hematologic  
 Phase 2        
  RBAC 50044  NA 57 91 2-y PFS 81% Median not reached Primary hematologic  
  Nonchemotherapeutic        
  Rituximab + lenalidomide46,47  LR 38 92 4-y PFS 70% 4-y 83% Primary hematologic  
64 Rash; tumor flare 
7 secondary malignancies 
InductionConsolidationNORR (CR), %FFS/PFSMedian OSToxicities of interest or significanceTRM, %
Transplant eligible        
 Phase 2        
  R-HyperCVAD13,17  NA 97 97 (87) 5-y 49% FFS 5-y 52% 4 AML/MDS 8 
15-y 22% FFS 15-y 33% 5 deaths from acute toxicity 
  R-HyperCVAD15  NA 49 86 (58) 5-y 49% PFS 5-y 63% 39% did not complete treatment
Hematologic and infectious
2 MDS 1 death from acute toxicity 		2 
  R-HyperCVAD16  NA 60 83 (72) 5-y 61% PFS 5-y 73% 63% did not complete treatment
Hematologic and infectious
3 deaths from acute toxicity 		6.5 
  R-maxi-CHOP+RHiDAC20,21  ASCT 160 94 (54) 6-y 66% PFS 6-y 70% 5 did not proceed to ASCT due to
toxicity 1 MDS 		5 
   ASCT 60 95 (57) 7 y EFS 5-y 75% 3 did not proceed to ASCT due to toxicity 1.7 
  BR/RHiDAC29  ASCT 23 96 (96) 1-y 96 1-y 100%  0 
 Phase 3        
  RCHOP vs RCHOP/RDHAP25  ASCT 455 98 vs 97 (63 vs 61) 3.8-y PFS vs 7.3-y PFS 6.8 y vs not reached Hematologic and infectious 4 
  RDHAP28  ASCT vs ASCT + MR 299  4-y PFS 64% vs 83% 4-y OS 89% vs 80% 2 failed stem cell collection
38% received other platinum drug with first cycle 		 
Transplant ineligible        
 Phase 3        
  RCHOP vs RFC38  NA 455 86 vs 78 TTF 28 mo vs 26 mo 4-y 62% vs 47% Primary hematologic  
34 vs 40 
  RCHOP vs BR40,41  NA 94 91 vs 93 22.1 vs 35.4 mo (median) Median not reached   
30 vs 40 Median not reached 
  RCHOP vs VRCAP43  NA 487 89 vs 92 (42 vs 53) 14.4 vs 24.7 mo 4-y 54% vs 64% Primary hematologic  
 Phase 2        
  RBAC 50044  NA 57 91 2-y PFS 81% Median not reached Primary hematologic  
  Nonchemotherapeutic        
  Rituximab + lenalidomide46,47  LR 38 92 4-y PFS 70% 4-y 83% Primary hematologic  
64 Rash; tumor flare 
7 secondary malignancies 

AML, acute myeloid leukemia; BR, bendamustine and rituximab; CRR, complete response rate; EFS, event-free survival; FC, rituximab, fludarabine, and cyclophosphamide; FFS, failure-free survival; LR, lenalidomide and rituximab; MDS, myelodysplastic syndrome; NA, not applicable; ORR, overall response rate; R-HyperCVAD, rituximab, fractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine; RBAC, rituximab, bendamustine, and cytarabine; RBAC500, rituximab, bendamustine, and cytarabine; RHiDAC, rituximab and high-dose cytarabine; TRM, treatment-related mortality; RDHAP, rituximab, dexamethasone, cytarabine, and cisplatin; TTF, time to treatment failure, VR-CAP, cyclophosphamide, doxorubicin, bortezomib, and prednisone.

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