June 1-5, 2012 Chicago, Illinois Lymphoma CCO Independent Conference Highlights of the 2012 American Society of Clinical Oncology Annual Meeting* This program is supported by an educational grant from This program is supported by educational grants from *CCO is an independent medical education company that provides state-of-the-art medical information to healthcare professionals through conference coverage and other educational programs.
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June 1-5, 2012Chicago, Illinois
Lymphoma CCO Independent Conference Highlightsof the 2012 American Society of Clinical Oncology Annual Meeting*
This program is supported by an educational grant fromThis program is supported by educational grants from
*CCO is an independent medical education company that provides state-of-the-art medical information to healthcare professionals through conference coverage and other educational programs.
clinicaloptions.com/oncologyLymphomas
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Outline
StiL NHL 1-2003: updated results of B-R vs CHOP-R for MCL and indolent lymphomas
CALGB 50401: lenalidomide ± rituximab for relapsed FL following prior rituximab-based therapy
CALGB 50102/SWOG S0016: exploratory subset analysis of CHOP-R vs CHOP-RIT as frontline therapy for FL
FOLL05: CHOP-R vs CVP-R vs FM-R for frontline treatment of active advanced-stage FL
Population-based study of FL transformation in the era of immunochemotherapy
EORTC 20012: first results for dose-escalated BEACOPP vs conventional ABVD in advanced-stage Hodgkin’s lymphoma
Ongoing phase II study of retreatment with brentuximab vedotin in CD30-positive Hodgkin’s lymphoma or ALCL
RICOVER-60: rituximab underdosing in subpopulations of elderly DLBCL patients
LNH 03-6B GELA: final analysis of CHOP-R-14 compared with CHOP-R-21 in elderly DLBCL patients
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StiL NHL 1-2003: Study Design
Updated results of randomized, open-label phase III trial– Median follow-up: 45 mos
Rummel M, et al. ASCO 2012. Abstract 3.
B-R: bendamustine 90 mg/m2 on Days 1-2; rituximab 375 mg/m2 on Day 1; 4-wk cycles for 6 cycles max
CHOP-R: cyclophosphamide 750 mg/m2 on Day 1; doxorubicin 50 mg/m2 on Day 1; vincristine 1.4 mg/m2 on Day 1; prednisone 100 mg on Days 1-5; rituximab 375 mg/m2 on Day 1; 3-wk cycles for 6 cycles max
Treatment-naive patients with
MCL or indolent CD20-positive
lymphoma(N = 549)
B-R(n = 261)
CHOP-R(n = 253)
Primary endpoint: noninferiority of B-R vs CHOP-R for PFS (decrease < 10% at 3 yrs) Secondary endpoints: response rate, time to next treatment, EFS, OS, adverse events, stem cell
mobilization capacity (younger patients)
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StiL NHL 1-2003: PFS
Superior median PFS with B-R vs CHOP-R in overall population
– 69.5 vs 31.2 mos (HR: 0.58; 95% CI: 0.44-0.74; P = .0000148)
B-R superiority maintained across several patient subgroups
Rummel M, et al. ASCO 2012. Abstract 3.
Patient Subgroup
HR*(95% CI)
P Value
FLFLIPI 0-2FLIPI 3-5
0.61 (0.42-0.87)0.56 (0.31-0.98)0.63 (0.38-1.04)
.0072
.0428
.0679
MCL 0.50 (0.29-0.81) .0061
MZL 0.70 (0.34-1.43) .3249
Waldenströms 0.33 (0.11-0.64) .0033*HR < 1 favors B-R vs CHOP-R.
Patient Subgroup
HR*(95% CI)
P Value
LDH, IU/L≤ 240> 240
0.48 (0.34-0.67)0.74 (0.49-1.08)
< .0001.1182
Age, yrs≤ 60> 60
0.52 (0.33-0.79)0.62 (0.45-0.84)
.0022
.0022
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StiL NHL 1-2003: Response and OS
Similar ORR with B-R vs CHOP-R: 92.7% vs 91.3%
– Higher CR with B-R: 39.8% vs 30.0% (P = .021)
No difference in OS over long-term follow-up
– Possibly due to indolent disease and use of various salvage therapies
Rummel M, et al. ASCO 2012. Abstract 3.
0
60
70
80
90
OS
Rat
e (%
)
2 3 4 5Follow-Up (Yrs)
6 7
50
B-RCHOP-R
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StiL NHL 1-2003: Toxicity
More favorable overall toxicity profile with B-R vs CHOP-R
– Similar incidence of secondary malignancies (20 vs 23 cases)
Updated analysis continues to demonstrate B-R is a reasonable option for frontline treatment of FL and MCL patients
B-R regimen associated with lower rates of toxicity vs CHOP-R
Await final publication before frontline B-R regimen can be considered “state of the art”
Rummel M, et al. ASCO 2012. Abstract 3.
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CALGB 50401: Study Design
Randomized phase II trial– Median follow-up: 1.7 yrs (range: 0.1-4.1)
Leonard J, et al. ASCO 2012. Abstract 8000.
Rituximab: 375 mg/m2 on Days 8, 15, 22, 29 of cycle 1Lenalidomide: 15 mg cycle 1, then 20-25 mg cycles 2-12 on Days 1-21; dose escalated as toleratedAspirin or anticoagulation prophylaxis given to patients at high risk for deep vein or arterial thrombosis
Patients with FL who relapsed following ≥ 1 rituximab-based
regimen(N = 89)
Rituximab + Lenalidomide(n = 44)
Lenalidomide(n = 45)
Primary endpoint: ORR (≥ 35% ORR considered of statistical interest) Secondary endpoints: CR rate; EFS; toxicity; immunologic correlates; identify benchmarks for future
studies
12 x 28-day cycles
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CALGB 50401: Response and EFS
Lenalidomide active both as monotherapy and combined with rituximab– Outcomes improved with combination
Leonard J, et al. ASCO 2012. Abstract 8000. Reproduced with permission.
Efficacy Outcome Lenalidomide + Rituximab(n = 44)
Lenalidomide(n = 45)
ORR, %CRPR
72.736.436.4
51.113.337.8
EFSMedian EFS, yrs2-yr EFS, %
2.0*44
1.227
Unadjusted HR Adjusted HR†
2.1 (P = .010)1.9 (P = .061)
*P = .008†Adjusted for FLIPI risk category, to show difference in EFS not due to baseline differences.
Lenalidomide active in relapsed (nonrefractory) FL
– Efficacy outcomes (response and EFS) improved with combination of lenalidomide plus rituximab vs lenalidomide monotherapy
Comparison with rituximab alone not possible
– Study arm terminated early
Lenalidomide plus rituximab combination currently under investigation for both maintenance and upfront strategies in FL
Leonard J, et al. ASCO 2012. Abstract 8000.
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SWOG S0016/CALGB 50102: Study Design
Exploratory analysis of randomized phase III trial[1]
– Excellent PFS, OS associated with both regimens[2]
1. Press OW, et al. ASCO 2012. Abstract 8001. 2. Press O, et al. ASH 2011. Abstract 98.
CHOP-R: cyclophosphamide 750 mg/m2 on Day 1; doxorubicin 50 mg/m2 on Day 1; vincristine 1.4 mg/m2 on Day 1; prednisone 100 mg on Days 1-5; rituximab 375 mg/m2 on Days 1, 6, 48, 90, 134, and 141CHOP-RIT: cyclophosphamide 750 mg/m2 on Day 1; doxorubicin 50 mg/m2 on Day 1; vincristine 1.4 mg/m2 on Day 1; prednisone 100 mg on Days 1-5; rituximab 375 mg/m2 on Days 1, 6, 48, 90, 134, and 141; followed by dosimetric infusion of tositumomab/131I-tositumomab followed 1 wk later by 131I-tositumomab to a total dose of 75 cGY
Patients with untreated advanced FL (bulky stage II-IV)
(N = 554)
CHOP-R(n = 279)
CHOP(n = 275)
RIT
6 cycles
Stratified by 2-M level (elevated vs not elevated)
2 wks
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SWOG S0016/CALGB 50102: Predictive Factors for PFS Interaction With Treatment 2-M level only baseline factor significantly predictive of PFS
interaction with treatment arm in univariate analysis
No baseline factors significantly predictive of OS interactionPress OW, et al. ASCO 2012. Abstract 8001.
Baseline Factors Significantly Associated With Improved PFS
Univariate HR(95% CI)
P Value P Value for PFS Interaction With Treatment Arm
SWOG S0016/CALGB 50102: Treatment Outcome by Patient Subgroup Patient subgroups defined by 2-M levels and lab-based risk
categories may experience different outcomes to treatment
Press OW, et al. ASCO 2012. Abstract 8001.
5-Yr PFS Rate, % CHOP-R(n = 279)
CHOP-RIT(n = 275)
P Value for Interaction
β2-M levelsNormalElevated
6159
7657
.02
Lab-based risk model*LowIntermediateHigh
635430
705810
.03
*Using 150% of IULN.
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SWOG S0016/CALGB 50102: Expert Perspectives Similar outcomes achieved with CHOP-R vs CHOP-RIT in
previously untreated FL
Factors found to be significant for PFS interaction with treatment arm
– 2-M
– Lab-based risk model
Patient subgroups defined by β2-M levels and lab-based risk categories may experience different outcomes to treatment
Press OW, et al. ASCO 2012. Abstract 8001.
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FOLL05: Study Design
Randomized phase III trial
– Median follow-up: 34 mos (range: 1-70)
Federico M, et al. ASCO 2012. Abstract 8006.
CVP-R: cyclophosphamide 750 mg/m2 on Day 1; vincristine 1.4 mg/m2 on Day 1; prednisone 40 mg/m2 on Days 1-5; rituximab 375 mg/m2 on Day 1CHOP-R: cyclophosphamide 750 mg/m2 on Day 1; doxorubicin 50 mg/m2 on Day 1; vincristine 1.4 mg/m2 on Day 1; prednisone 100 mg/m2 on Days 1-5; rituximab 375 mg/m2 on Day 1FM-R: fludarabine 25 mg/m2 on Days 1-3; mitoxantrone 10 mg/m2 on Day 1; rituximab 375 mg/m2 on Day 1
Primary endpoint: TTF from registration date
Patients with previously untreated, active
stage II-IV FL(N = 504)
CVP-R(n = 168)
CHOP-R(n = 165)
3 x 21-day cycles
FM-R(n = 171)
CVP-R foradditional 5 cycles
CHOP-R foradditional 3 cycles*
FM-R foradditional 3 cycles*
≥ PRStratified by FLIPI score (0-2 vs 3-5)
*Followed by 2 cycles of rituximab.
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FOLL05: TTF and PFS
Improved 3-yr TTF and PFS with CHOP-R and FM-R vs CVP-R
Significant superiority of CHOP-R or FM-R vs CVP-R
– Consistent across all patient subgroups tested
Federico M, et al. ASCO 2012. Abstract 8006.
Efficacy Outcome, % CVP-R(n = 168)
CHOP-R(n = 165)
FM-R(n = 171)
3-yr TTF 45 63 59
3-yr PFS 52 68 63
Comparison TTF PFS
HR (95% CI) P Value* HR (95% CI) P Value
CHOP-R vs CVP-R 0.60 (0.43-0.83) .007 0.61 (0.43-0.87) .006
FM-R vs CVP-R 0.64 (0.46-0.88) .020 0.67 (0.47-0.94) .022
CHOP-R vs FM-R 0.94 (0.66-1.33) .971 0.91 (0.63-1.33) .628
*Adjusted.
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FOLL05: Response
Federico M, et al. ASCO 2012. Abstract 8006.
0
10
20
30
40
50
60
70
80
90
Res
po
nse
Rat
e (%
)
OR CR PR SD, PD, or EW
Depth of Response
10088
93 91 91
6772 72 70
21 21 19 20
88611
CVP-R
CHOP-R
FM-R
Overall
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FOLL05: Toxicity
Grade 3/4 adverse events highest in FM-R arm
– Neutropenia (most frequent) increased with treatment duration
Progressive disease most frequent cause of death on-study
Secondary malignancies reported in all treatment arms
– Highest rate in FM-R arm (P = .030)Federico M, et al. ASCO 2012. Abstract 8006.
Grade 3/4 Adverse Event, %
CVP-R(n = 168)
CHOP-R(n = 165)
FM-R(n = 171)
Neutropenia* 27.7 50.0 63.5
Thrombocytopenia* 0 3.0 7.6
Anemia 0.6 3.0 4.1
Infections 2.4 3.0 4.7
*P < .001
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FOLL05[1]: Expert Perspectives
3-yr PFS rate similar to observation arm and lower than rituximab maintenance arm in PRIMA study (rituximab maintenance for 2 yrs vs observation only after response to rituximab plus chemotherapy)[2]
– PRIMA rituximab maintenance arm: 74.9%
– PRIMA observation arm: 57.6%
– FOLL05: 58.9%
CHOP-R remains a standard therapy for induction treatment of patients with FL
1. Federico M, et al. ASCO 2012. Abstract 8006. 2. Salles G, et al. Lancet. 2011;377:42-51.
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Impact of Immunochemotherapy on FL Transformation: Study Design Retrospective population-based study to determine impact of
immunochemotherapy on risk of FL transformation to aggressive lymphoma
Patients with FL identified from British Columbia Cancer Agency Lymphoid Cancer Database (N = 261)
– Advanced stage (III/IV, B symptoms or bulky disease ≥ 10 cm), grades 1-3A
– Symptomatic at diagnosis requiring systemic therapy
– Previous anthracycline-based regimen not permitted
Transformation diagnosed by biopsy confirmation or predefined clinical assessment (rapid nodal growth, increased LDH, new hypercalcemia, extensive involvement of new extranodal sites)
Al-Tourah AJ, et al. ASCO 2012. Abstract 8049.
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Impact of Immunochemotherapy on FL Transformation: Initial FL Treatment CVP-R and CVP-R followed by maintenance R most common initial therapy
regimens
– CVP-R followed by rituximab maintenance: 55%
– CVP-R: 38%
– Fludarabine-R: 4%
– Fludarabine-R followed by R maintenance: 0.8%
– Bendamustine-R followed by R maintenance: 0.8%
– CPF-R: 0.8%
– Chlorambucil-R: 0.4%
– Chlorambucil-R followed by R maintenance: 0.4%
– FCR followed by R maintenance: 0.4%
Al-Tourah AJ, et al. ASCO 2012. Abstract 8049.
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Impact of Immunochemotherapy on FL Transformation: Incidence & Prognosis[1]
Overall risk of transformation
– ~ 2% per yr
– 10% at 5 yrs (vs 20% in pre-rituximab era[2])
Lower transformation risk with use of maintenance rituximab (n = 151) compared with chemotherapy-rituximab at induction only (n = 110)
– 8% vs 20% at 5 yrs (P = .003)
Poor prognosis after transformation regardless of use of immunochemotherapy
– Median posttransformation OS: 6 mos
1. Al-Tourah AJ, et al. ASCO 2012. Abstract 8049. 2. Montoto S, et al. J Clin Oncol. 2011;29:1827-1834.
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EORTC 20012: Study Design
First results of randomized phase III trial
Carde PP, et al. ASCO 2012. Abstract 8002.
ABVD: 56-day cycles of doxorubicin 25 mg/m2 on Days 29, 43; bleomycin 10 mg/m2 on Days 29, 43; vinblastine 6 mg/m2 on Days 29, 43; dacarbazine 375 mg/m2 on Days 29, 43Dose-escalated BEACOPP: 21-day cycles of bleomycin 10 mg/m2 on Day 8; etoposide 200 mg/m2 on Days 1-3; doxorubicin 35 mg/m2 on Day 1; cyclophosphamide 1200 mg/m2 on Day 1; vincristine 1.4 mg/m2 on Day 8; procarbazine 100 mg/m2 on Days 1-7; prednisone 40 mg/m2 on Days 1-14BEACOPP: 21-day cycles of bleomycin 10 mg/m2 on Day 8; etoposide 100 mg/m2 on Days 1-3; doxorubicin 25 mg/m2 on Day 1; cyclophosphamide 650 mg/m2 on Day 1; vincristine 1.4 mg/m2 on Day 8; procarbazine 100 mg/m2 on Days 1-7; prednisone 40 mg/m2 on Days 1-14
Patients with previously untreated, poor-risk, stage III/IV
Hodgkin’s lymphoma(N = 549)
ABVD(n = 275)
BEACOPPdose-escalated
(n = 274)
Primary endpoint: EFS from time of randomization
BEACOPPbaseline
BEACOPPbaseline
ABVD ABVD
4 cycles 2 cycles 2 cycles
Stratified by institution and IPS (3 vs ≥ 4)
If PR≥ 50%
If PR≥ 75%or CRu
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EORTC 20012: Survival Outcomes
Similar 4-yr EFS and OS with ABVD vs BEACOPP
– Superior PFS with BEACOPP (not a defined study endpoint)
First EFS events well distributed among treatment arms
– Early discontinuation, no CR/CR after 8 cycles, disease progression or relapse, or death
Carde PP, et al. ASCO 2012. Abstract 8002.
4-Yr Survival Outcome, %
ABVD(n = 275)
BEACOPP(n = 274)
HR(95% CI)
P Value
EFS 63.7 69.30.86
(0.64-1.15).313
PFS 69.4 84.00.50
(0.34-0.73).0003
OS 86.7 90.30.71
(0.42-1.21).208
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EORTC 20012: Response and Mortality Incidence CR/CRu incidence similar with ABVD vs BEACOPP
– Sensitivity analysis: 82.5% vs 82.8%
– Primary analysis: 73.5% vs 69.0%
No significant difference in 4-yr cumulative incidence of deaths between ABVD and BEACOPP arms
Incidence rates for different causes of death generally similar between treatment arms
– ≈ 25% to 30% of deaths occurred ≤ 3 mos after treatment
Similar cumulative 4-yr incidence of secondary malignancies in ABVD and BEACOPP arms: 3.4% vs 4.7% (Gray test P = .584)
Carde PP, et al. ASCO 2012. Abstract 8002.
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EORTC 20012: Expert Perspectives
BEACOPP offered no efficacy advantage over ABVD
– No difference in OS
ABVD remains acceptable therapeutic regimen for treatment of high-risk patients with advanced-stage Hodgkin’s lymphoma
Carde PP, et al. ASCO 2012. Abstract 8002.
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Phase II Brentuximab Vedotin Retreatment Trial: Study Design Ongoing phase II trial (N = 24)
– Enrolled patients achieved CR/PR with brentuximab vedotin in previous pivotal phase II trial
– Treatment discontinued during remission
– Enrollment in current study following disease progression/relapse
Treatment: 1.2 or 1.8 mg/kg brentuximab vedotin every 21 days
– No maximum number of cycles
Median time between previous brentuximab vedotin treatment and current retreatment
– 7.7 mos (range: 1-44)
Bartlett N, et al. ASCO 2012. Abstract 8027.
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Phase II Brentuximab Vedotin Retreatment Trial: Response Durable responses associated with brentuximab vedotin
Phase II Brentuximab Vedotin Retreatment Trial: Toxicity Median duration of retreatment: 6.5 mos (range: 1.3-28.6) Most frequent grade 3/4 adverse events during
retreatment– Anemia, fatigue, nausea, arthralgia, back pain, dyspnea
46% incidence of peripheral sensory neuropathy– All cases grade 1 or 2
– 50% experienced improvement or resolution of symptoms during retreatment
– 54% of patients had existing peripheral neuropathy at baseline prior to retreatment
– 31% experienced worsening of symptoms during retreatment
Bartlett N, et al. ASCO 2012. Abstract 8027.
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Phase II Brentuximab Vedotin Retreatment Trial: Expert Perspectives Brentuximab vedotin is an important advance in the
treatment of patients with CD30-positive lymphomas
Current study demonstrates efficacy of retreatment with brentuximab vedotin
– Similar to other antibody-based therapies, many of which can also be administered multiple times (eg, rituximab)
Bartlett N, et al. ASCO 2012. Abstract 8027.
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Elderly Subpopulations of RICOVER-60: Study Rationale Little pharmacokinetic data available for rituximab in
DLBCL
– Dosing of rituximab with CHOP based on empiric data only
– Carries risk of suboptimal dosing and not achieving full efficacy potential of rituximab
Current study investigated serum levels and pharmacokinetic parameters of rituximab when combined with CHOP among elderly patients treated in RICOVER-60 study
Pfreundschuh M, et al. ASCO 2012. Abstract 8024.
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Elderly Subpopulations of RICOVER-60: Rituximab Clearance and Elimination More rapid clearance of rituximab in male vs female
patients
– T1/2 in serum: 24.7 vs 33.4 days (P = .003)
– Correlated with poorer PFS in males (RR: 1.59; P < .01)
Simulation of rituximab serum levels showed gradual rituximab accumulation over treatment cycles
Significantly improved PFS observed with addition of rituximab among females < 60 kg (P = .002) but not among females >77 kg
Pfreundschuh M, et al. ASCO 2012. Abstract 8024.
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Elderly Subpopulations of RICOVER-60: Expert Perspectives Data emphasizes the fact that patients may not
necessarily require new drugs to achieve better outcomes
Simply ensuring the existing agents (eg, rituximab) are given with an optimal dose and schedule may help to improve patient outcomes
Current study limited by lack of data demonstrating how rituximab serum levels could be successfully altered to achieve better concentrations
Pfreundschuh M, et al. ASCO 2012. Abstract 8024.
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LNH 03-6B GELA: Study Design
Final analysis of a multicenter, prospective, randomized phase III trial– Median follow-up: 56 mos
Delarue R, et al. ASCO 2012. Abstract 8021.
Treatment-naive patients with
CD20-positive stage II-IV DLBCL
aged 60-80 yrs(N = 600)
CHOP-14 + Rituximab+ Methotrexate*
(n = 304)
CHOP-21 + Rituximab+ Methotrexate†
(n = 296)
CHOP-14 + Rituximab
CHOP-21 + Rituximab
Induction Consolidation
*Induction phase: 8 wks; consolidation phase: 10 wks. †Induction phase: 12 wks; consolidation phase 13 wks.Response assessed at beginning of consolidation phase in both arms.
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LNH 03-6B GELA: Efficacy Outcomes
No efficacy difference between different CHOP dosing regimens when combined with rituximab in elderly DLBCL patients
Delarue R, et al. ASCO 2012. Abstract 8021.
Efficacy Outcome CHOP-14 + Rituximab(n = 304)
CHOP-21 + Rituximab(n = 296)
OR, %CR/CRuPR
877116
867412
3-yr EFS, % 56 60
HR (95% CI) 1.04 (0.82-1.31; P = .76)
3-yr PFS, % 60 62
HR (95% CI) 0.99 (0.78-1.26; P = .90)
3-yr DFS, % 72 67
HR (95% CI) 0.80 (0.58-1.10; P =.16)
3-yr OS, % 69 72
HR (95% CI) 0.96 (0.73-1.26; P = .75)
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LNH 03-6B GELA: Safety Outcomes
14 patients in each arm died due to toxicity of study treatment
Delarue R, et al. ASCO 2012. Abstract 8021.
Adverse Events, % CHOP-14 + Rituximab(n = 304)
CHOP-21 + Rituximab(n = 296)
Hematologic toxicitiesGrade 3/4 anemiaGrade 3/4 leukocytopeniaGrade 3/4 neutropeniaGrade 3/4 thrombocytopeniaFebrile neutropeniaNeed for RBC transfusionNeed for platelet transfusion
22787416214711
1873642019328
Grade ≥ 3 nonhematologic toxicities 15 13
Grade 3/4 mucositis 5 3
≥ 1 adverse event 77 74
≥ 1 serious adverse event 51 47
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LNH 03-6B GELA: Expert Perspectives
In the pre-rituximab era, superior OS seen with dose-dense CHOP-14 regimen vs CHOP-21
However, current study shows no survival difference between CHOP-14 and CHOP-21 when rituximab is added
Thus, R + CHOP-21 remains the standard of care
Delarue R, et al. ASCO 2012. Abstract 8021.
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Take-Home Points
After further follow-up, bendamustine-rituximab appears to have less toxicity and better PFS but still no OS benefit compared with CHOP-R for patients with low-grade FL
Lenalidomide + rituximab has a 70% response rate in patients with FL relapsing after a rituximab-containing regimen
In the series presented here, transformation of FL to DLBCL is lower with initial therapy containing rituximab and lower still with maintenance rituximab
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Take-Home Points
The EORTC found no significant difference in median OS or EFS using BEACOPP versus ABVD in patients with stage 3-4 Hodgkin lymphoma
Retreatment with brentuximab vedotin after progression following an initial response yielded a response rate of 60% in Hodgkin’s lymphoma and 88% in ALCL
Rituximab clearance varies by sex and weight in elderly patients and this variation may impact treatment outcome, but we currently lack a practical approach to adjust dosing
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