Rituximab Maintenance: Stage III/IV Follicular Lymphoma (ECOG/CALGB E1496) Subset: 237 FL pts CVP x 6-8 → PR/CR (cyclophosphamide, vincristine, prednisone)

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Presentation transcript:

Rituximab Maintenance: Stage III/IV Follicular Lymphoma (ECOG/CALGB E1496) Subset: 237 FL pts CVP x 6-8 → PR/CR (cyclophosphamide, vincristine, prednisone) Observation (OBS) vs Rituximab Maintenance (MR) RANDOMIZERANDOMIZE Hochster H et al. ASH Abstract 349. OBSMR CVP ORR83%86% PFS (4 yr)33%56% PFS median (mo)1361 OS (42 mo)75%91% P =.03 (one-sided)

CVP = cyclophosphamide, vincristine, prednisone CVP N=159 R-CVP N=162 P value CR7.5%30% ORR56%81% PFS median (mo) OS (42 mo)81%89%.0553 Stage III/IV FL → CVP x 4 vs R-CVP x4 RANDOMIZERANDOMIZE RESTAGERESTAGE CR/PR → CVP x 4 vs R-CVP x 4 CVP + Rituximab: Stage III/IV Follicular Lymphoma Solal-Celigny P et al. ASH Abstract 350.

Maintenance Rituximab: Relapsed 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 <.0001) PFS, median: 33 months vs 20 months –Randomization 2: Maintenance Rituximab vs Observation PFS: 52 months vs 15 months, P <.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 Abstract 353. Hiddemann et al. ASH Abstract 920.

R-CHOP-14 vs CHOP-14: DLBCL * RICOVER-60: Interim analysis (n=828) 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 = ) HOVON/Nordic Lymphoma Group: Interim analysis (n=250)–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 Conclusion: Dose-dense R-CHOP is feasible and produces results superior to dose-dense CHOP. Results need to be confirmed. *61-80 years of age RICOVER-60: Interim analysis (n=828) 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 = ) HOVON/Nordic Lymphoma Group: Interim analysis (n=250)–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 Conclusion: Dose-dense R-CHOP is feasible and produces results superior to dose-dense CHOP. Results need to be confirmed. *61-80 years of age Pfreundschuh M et al. ASH Abstract 13. Sonneveld, P et al. ASH Abstract 16.

Immunomodulatory Drugs in CLL Phase 1/2 Initial Therapy With Fludarabine and Thalidomide in Stage I-IV CLL N=13 (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 N=17 (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 Abstracts 2974 and 447.