Rituximab Maintenance: Stage III/IV Follicular Lymphoma (ECOG/CALGB E1496)

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Rituximab Maintenance Stage III/IV Follicular
Lymphoma (ECOG/CALGB E1496)

• Subset 237 FL pts

OBS MR
CVP ORR 83 86
PFS (4 yr) 33 56
PFS median (mo) 13 61
OS (42 mo) 75 91
P .03 (one-sided)
Hochster H et al. ASH 2005. Abstract 349.
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CVP RituximabStage III/IV Follicular Lymphoma
CVP cyclophosphamide, vincristine, prednisone
CVP N159 R-CVP N162 P value
CR 7.5 30
ORR 56 81
PFS median (mo) 20.5 44.8
OS (42 mo) 81 89 .0553
Solal-Celigny P et al. ASH 2005. Abstract 350.
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Maintenance RituximabRelapsed Stage III/IV
Follicular Lymphoma

• Intergroup Phase 3 (update)
• CHOP vs R-CHOP ? Observation vs Maintenance
  Rituximab
• Randomization 1 R-CHOP vs CHOP
• CR 29 vs 16 (P lt .0001)
• PFS, median 33 months vs 20 months
• Randomization 2 Maintenance Rituximab vs
  Observation
• PFS 52 months vs 15 months, P lt .0001
• OS, 3 years 85 months vs 77 months, P .01
• Benefit with maintenance rituximab even after
  R-CHOP
• GLGLSG Phase 3 Relapsed/refractory FL Mantle
  cell
• FCM vs R-FCM ? Observation vs Maintenance
  Rituximab
• Overall benefit of MR median response duration
  for MR not reached
• ( vs 17 months in the observation arm)
• Role of MR following R-FCM in FL median response
  duration
• for MR not reached (vs 26 months in the
  observation arm)

Van Oers et al. ASH 2005. Abstract
353. Hiddemann et al. ASH 2005. Abstract 920.
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R-CHOP-14 vs CHOP-14 DLBCL

• RICOVER-60 Interim analysis (n828)
• Results
• 6 CYCLES vs 8 CYCLES
• -No differences for entire population
• -Small nonsignificant benefit for CHOP-14, 8 vs 6
• -No benefit for R-CHOP-14, 8 vs 6
• R-CHOP-14 vs CHOP-14
• -CR, 81 vs 73 (P .008)
• -Time to treatment failure (at 26 months), 70
  vs 57 (P .000025)
• HOVON/Nordic Lymphoma Group Interim analysis
  (n250)DLBCL, FL, MCL
• Results
• CHOP-14 x 8 v R-CHOP-14 x 8
• -CR, No difference
• Failure-free survival (at 18 months) favors
  R-CHOP-14 51 vs 33, P .005

Pfreundschuh M et al. ASH 2005. Abstract
13. Sonneveld, P et al. ASH 2005. Abstract 16.
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Immunomodulatory Drugs in CLL

• Phase 1/2 Initial Therapy With Fludarabine
• and Thalidomide in Stage I-IV CLL
• N13 (evaluable)
• -10 CR (77), 3 PR (23)
• -Overall response rate, intent-to-treat
  population 100
• Flare reaction, 46
• Nonhematologic grade 3/4 toxicities, 11
• (diarrhea, fatigue, pedal edema)
• Phase 2 Study of Lenalidomide
• in Relapsed/Refractory CLL
• N17 (evaluable)
• -2 CR (11.7), 9 PR (52.9), 5 SD (24.9), 1 PD
• Flare reaction, most patients
• Grade 3/4 hematologic toxicity (7), tumor lysis
  syndrome (2), febrile neutropenia (3)

Chanan-Khan AA. ASH 2005. Abstracts 2974 and 447.