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

R A N D O M I Z E. Observation (OBS) vs Rituximab Maintenance (MR). CVP x 6-8 → PR/CR (cyclophosphamide, vincristine, prednisone). Rituximab Maintenance: Stage III/IV Follicular Lymphoma (ECOG/CALGB E1496). Subset: 237 FL pts. P = .03 (one-sided).

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

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  1. R A N D O M I Z E Observation (OBS) vs Rituximab Maintenance (MR) CVP x 6-8 → PR/CR (cyclophosphamide, vincristine, prednisone) Rituximab Maintenance: Stage III/IV Follicular Lymphoma (ECOG/CALGB E1496) Subset: 237 FL pts P = .03 (one-sided) • Hochster H et al. ASH 2005. Abstract 349.

  2. R A N D O M I Z E R E S T A G E CVP x 4 vs R-CVP x4 CVP x 4 vs R-CVP x 4 Stage III/IV FL→ CR/PR → CVP + Rituximab:Stage III/IV Follicular Lymphoma CVP = cyclophosphamide, vincristine, prednisone • Solal-Celigny P et al. ASH 2005. Abstract 350.

  3. 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 2005. Abstract 353. Hiddemann et al. ASH 2005. Abstract 920.

  4. 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 = .000025) 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 2005. Abstract 13. • Sonneveld, P et al. ASH 2005. Abstract 16.

  5. 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 2005. Abstracts 2974 and 447.

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