Chemotherapy plus Rituximab versus chemotherapy alone for B‐cell non‐Hodgkin's lymphoma

Holger Schulz; Julia Bohlius; Nicole Skoetz; Sven Trelle; Thilo Kober; Marcel Reiser; Martin Dreyling; Michael Herold; Guido Schwarzer; Michael Hallek; Andreas Engert

doi:10.1002/14651858.CD003805.pub2

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Figure 1

Forest plot of comparison: 1 Overall survival, outcome: 1.1 Overall survival Total group.

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Figure 2

Forest plot of comparison: 1 Overall survival, outcome: 1.5 Overall survival untreated vs treated patients.

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Figure 3

Forest plot of comparison: 1 Overall survival, outcome: 1.8 Overall survival_Alloc. concealment.

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Figure 4

Forest plot of comparison: 1 Overall survival, outcome: 1.3 Sensitivity: attrition bias.

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Figure 5

Forest plot of comparison: 1 Overall survival, outcome: 1.7 Overall survival_Full Text vs Abstract Publication.

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Figure 6

Forest plot of comparison: 1 Overall survival, outcome: 1.2 Overall survival FL vs MCL.

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Figure 7

Forest plot of comparison: 2 Disease Control, outcome: 2.1 FFS Total group.

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Figure 8

Forest plot of comparison: 2 Disease Control, outcome: 2.9 FFS_Endpoints according to start of measurement.

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Figure 9

Forest plot of comparison: 2 Disease Control, outcome: 2.2 FFS_FL vs MCL.

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Figure 10

Forest plot of comparison: 3 Overall Response, outcome: 3.1 Overall Response Total Group.

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Figure 11

Forest plot of comparison: 4 Complete Response, outcome: 4.1 Complete Response Total Group.

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Figure 12

Forest plot of comparison: 3 Overall Response, outcome: 3.2 Overall Response FL vs MCL.

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Figure 13

Forest plot of comparison: 4 Complete Response, outcome: 4.2 Complete Response FL vs MCL.

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Figure 14

Forest plot of comparison: 5 Toxicity Grade 3/4, outcome: 5.1 Adverse events (number of patients).

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Analysis 1.1

Comparison 1 Overall survival, Outcome 1 Overall survival Total group.

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Analysis 1.2

Comparison 1 Overall survival, Outcome 2 Overall survival FL vs MCL.

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Analysis 1.3

Comparison 1 Overall survival, Outcome 3 Sensitivity: attrition bias.

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Analysis 1.4

Comparison 1 Overall survival, Outcome 4 Overall survival_Doxorubicin vs Mitoxantrone.

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Analysis 1.5

Comparison 1 Overall survival, Outcome 5 Overall survival untreated vs treated patients.

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Analysis 1.6

Comparison 1 Overall survival, Outcome 6 Overall survival_Anthracylin vs no‐Anthracylin treatment.

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Analysis 1.7

Comparison 1 Overall survival, Outcome 7 Overall survival_Full Text vs Abstract Publication.

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Analysis 1.8

Comparison 1 Overall survival, Outcome 8 Overall survival_Alloc. concealment.

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Analysis 1.9

Comparison 1 Overall survival, Outcome 9 Overall Survival _with or without second randomisation.

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Analysis 2.1

Comparison 2 Disease Control, Outcome 1 FFS Total group.

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Analysis 2.2

Comparison 2 Disease Control, Outcome 2 FFS_FL vs MCL.

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Analysis 2.3

Comparison 2 Disease Control, Outcome 3 FFS_Sensitivity: attrition bias.

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Analysis 2.4

Comparison 2 Disease Control, Outcome 4 Disease control_Doxorubicin vs Mitoxantrone.

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Analysis 2.5

Comparison 2 Disease Control, Outcome 5 Disease control_untreated vs treated patients.

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Analysis 2.6

Comparison 2 Disease Control, Outcome 6 Disease control_Anthracylin vs no‐Anthracylin treatment.

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Analysis 2.7

Comparison 2 Disease Control, Outcome 7 Disease control_Full text vs abstract publication.

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Analysis 2.8

Comparison 2 Disease Control, Outcome 8 FFS_Sensitivity: Alloc. concealment.

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Analysis 2.9

Comparison 2 Disease Control, Outcome 9 FFS_Endpoints according to start of measurement.

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Analysis 2.10

Comparison 2 Disease Control, Outcome 10 FFS_Endpoints TTP, EFS, TTF, PFS.

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Analysis 3.1

Comparison 3 Overall Response, Outcome 1 Overall Response Total Group.

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Analysis 3.2

Comparison 3 Overall Response, Outcome 2 Overall Response FL vs MCL.

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Analysis 3.3

Comparison 3 Overall Response, Outcome 3 Sensitivity: attrition bias.

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Analysis 3.4

Comparison 3 Overall Response, Outcome 4 Overall Response_Doxorubicin vs Mitoxantrone.

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Analysis 3.5

Comparison 3 Overall Response, Outcome 5 Overall Response_untreated vs treated patients.

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Analysis 3.6

Comparison 3 Overall Response, Outcome 6 Overall response_Anthracyclin vs no‐Anthracyclin treatment.

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Analysis 3.7

Comparison 3 Overall Response, Outcome 7 Overall Response_Full text vs Abstract publication.

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Analysis 3.8

Comparison 3 Overall Response, Outcome 8 Overall Response Allocation concealment.

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Analysis 4.1

Comparison 4 Complete Response, Outcome 1 Complete Response Total Group.

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Analysis 4.2

Comparison 4 Complete Response, Outcome 2 Complete Response FL vs MCL.

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Analysis 4.3

Comparison 4 Complete Response, Outcome 3 Complete Response_Doxorubicine vs Mitoxantrone.

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Analysis 4.4

Comparison 4 Complete Response, Outcome 4 Complete Response_anthracycline vs no anthracyclin treatment.

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Analysis 4.5

Comparison 4 Complete Response, Outcome 5 Complete Response _untreated vs treated patients.

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Analysis 5.1

Comparison 5 Toxicity Grade 3/4, Outcome 1 Adverse events (number of patients).

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Table 1. Trials included in the Meta‐Analysis

Author	Total Group (N)	FL (N)	MCL (N)	Unspecified lymphoma
Forstpointner 2004	128	65	48	15
Herold 2004	358	201	90	67
Hiddemann 2005	428	428	not included	none
Lenz 2005	122	none	122	none
Marcus 2005	321	321	none	none
Rivas‐Vera 2005	121	not applicable	not applicable	121
van Oers 2006	465	465	none	none
Total amount	1943	1480	260	203

Table 1. Trials included in the Meta‐Analysis

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Table 2. Characteristics of the included studies

Author	Therapy	Previous therapy	Ann Arbor stage	High FLIPI risk	Observation time
Forstpointner 2004	4 x R‐FCM vs 4 x FCM	Yes	III/IV	not applicable	18 months
Herold 2004	8 x R‐MCP vs 8 x MCP	No	III/IV	55%	36 months
Hiddemann 2005	6‐8 x R‐CHOP vs 6 to 8 x CHOP	No	III/IV	45%	36 months
Lenz 2005	6 x R‐CHOP vs 6 x CHOP	No	III/IV	35 % (IPI high and high‐intermediate risk)	18 months
Marcus 2005	8 x R‐CVP vs 8 CVP	No	III/IV	45%	18 months
Rivas‐Vera 2005	6 x R‐CNOP vs 6 x CNOP vs 6 x R	No	III/IV	not applicable	24 months
van Oers 2006	8 x R‐CHOP vs 8 x CHOP	Yes	III/IV	37%	39 months

Table 2. Characteristics of the included studies

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Table 3. Quality assessment of the included studies

Author	ITT‐ Analysis	Allocation concealed	Drop outs	Source of data
Forstpointner 2004	Yes	Yes	13%	Full text
Herold 2004	Yes	Yes	0	Abstract
Hiddemann 2005	Yes	Yes	0	Full text
Lenz 2005	Yes	Yes	5%	Full text
Marcus 2005	Yes	Yes	1%	Full text
Rivas‐Vera 2005	No	No	13%	Abstract
van Oers 2006	Yes	Yes	0	Full text

Table 3. Quality assessment of the included studies

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Comparison 1. Overall survival

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Overall survival Total group Show forest plot	7	1943	Peto Odds Ratio (95% CI)	0.65 [0.54, 0.78]

2 Overall survival FL vs MCL Show forest plot	6	1740	Peto Odds Ratio (95% CI)	0.63 [0.51, 0.77]

2.1 Follicular lymphoma	5	1480	Peto Odds Ratio (95% CI)	0.63 [0.51, 0.79]
2.2 Mantlecell lymphoma	3	260	Peto Odds Ratio (95% CI)	0.60 [0.37, 0.98]
3 Sensitivity: attrition bias Show forest plot	7	1943	Peto Odds Ratio (95% CI)	0.65 [0.54, 0.78]

3.1 Less than 10% excluded from analysis	5	1694	Peto Odds Ratio (95% CI)	0.68 [0.55, 0.83]
3.2 More than 10% excluded from analysis	2	249	Peto Odds Ratio (95% CI)	0.50 [0.30, 0.83]
4 Overall survival_Doxorubicin vs Mitoxantrone Show forest plot	6	1622	Peto Odds Ratio (95% CI)	0.64 [0.52, 0.79]

4.1 Doxorubicin based regimen	3	1015	Peto Odds Ratio (95% CI)	0.70 [0.54, 0.91]
4.2 Mitoxantrone based regimen	3	607	Peto Odds Ratio (95% CI)	0.56 [0.40, 0.77]
5 Overall survival untreated vs treated patients Show forest plot	7	1943	Peto Odds Ratio (95% CI)	0.65 [0.54, 0.78]

5.1 Untreated patients	5	1350	Peto Odds Ratio (95% CI)	0.66 [0.52, 0.84]
5.2 Treated patients	2	593	Peto Odds Ratio (95% CI)	0.63 [0.46, 0.86]
6 Overall survival_Anthracylin vs no‐Anthracylin treatment Show forest plot	7	1943	Peto Odds Ratio (95% CI)	0.65 [0.54, 0.78]

6.1 Anthracyclin based regimen	6	1622	Peto Odds Ratio (95% CI)	0.64 [0.52, 0.79]
6.2 No anthracylin based regimen	1	321	Peto Odds Ratio (95% CI)	0.70 [0.40, 1.23]
7 Overall survival_Full Text vs Abstract Publication Show forest plot	7	1943	Peto Odds Ratio (95% CI)	0.65 [0.54, 0.78]

7.1 Full‐text	5	1464	Peto Odds Ratio (95% CI)	0.65 [0.52, 0.81]
7.2 Abstract Form	2	479	Peto Odds Ratio (95% CI)	0.64 [0.43, 0.94]
8 Overall survival_Alloc. concealment Show forest plot	7	1943	Peto Odds Ratio (95% CI)	0.65 [0.54, 0.78]

8.1 Adaequate	6	1822	Peto Odds Ratio (95% CI)	0.64 [0.53, 0.78]
8.2 Not adaequate	1	121	Peto Odds Ratio (95% CI)	0.96 [0.32, 2.91]
9 Overall Survival _with or without second randomisation Show forest plot	7	1943	Peto Odds Ratio (95% CI)	0.65 [0.54, 0.78]

9.1 No second randomisation	3	800	Peto Odds Ratio (95% CI)	0.66 [0.48, 0.91]
9.2 Second randomisation	4	1143	Peto Odds Ratio (95% CI)	0.64 [0.51, 0.81]

Comparison 1. Overall survival

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Comparison 2. Disease Control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 FFS Total group Show forest plot	7	1913	Peto Odds Ratio (95% CI)	0.62 [0.55, 0.71]

2 FFS_FL vs MCL Show forest plot	5	1537	Peto Odds Ratio (95% CI)	0.58 [0.50, 0.67]

2.1 Follicular lymphoma	4	1415	Peto Odds Ratio (95% CI)	0.58 [0.50, 0.68]
2.2 Mantlecell lymphoma	1	122	Peto Odds Ratio (95% CI)	0.54 [0.33, 0.88]
3 FFS_Sensitivity: attrition bias Show forest plot	7	1913	Peto Odds Ratio (95% CI)	0.62 [0.55, 0.71]

3.1 Less than 10% excluded from analysis	5	1694	Peto Odds Ratio (95% CI)	0.60 [0.52, 0.69]
3.2 More than 10% excluded from analysis	2	219	Peto Odds Ratio (95% CI)	0.76 [0.55, 1.06]
4 Disease control_Doxorubicin vs Mitoxantrone Show forest plot	6	1592	Peto Odds Ratio (95% CI)	0.62 [0.54, 0.72]

4.1 Doxorubicin based regimen	3	1015	Peto Odds Ratio (95% CI)	0.60 [0.49, 0.72]
4.2 Mitoxantrone based regimen	3	577	Peto Odds Ratio (95% CI)	0.66 [0.53, 0.84]
5 Disease control_untreated vs treated patients Show forest plot	7	1913	Peto Odds Ratio (95% CI)	0.62 [0.55, 0.71]

5.1 Untreated patients	5	1320	Peto Odds Ratio (95% CI)	0.61 [0.52, 0.72]
5.2 Treated patients	2	593	Peto Odds Ratio (95% CI)	0.65 [0.52, 0.80]
6 Disease control_Anthracylin vs no‐Anthracylin treatment Show forest plot	7	1913	Peto Odds Ratio (95% CI)	0.62 [0.55, 0.71]

6.1 Anthracyclin based regimen	6	1592	Peto Odds Ratio (95% CI)	0.62 [0.54, 0.72]
6.2 No anthracylin based regimen	1	321	Peto Odds Ratio (95% CI)	0.62 [0.47, 0.83]
7 Disease control_Full text vs abstract publication Show forest plot	7	1913	Peto Odds Ratio (95% CI)	0.62 [0.55, 0.71]

7.1 Full ‐Text	5	1464	Peto Odds Ratio (95% CI)	0.61 [0.52, 0.71]
7.2 Abstract form	2	449	Peto Odds Ratio (95% CI)	0.68 [0.52, 0.89]
8 FFS_Sensitivity: Alloc. concealment Show forest plot	7	1913	Peto Odds Ratio (95% CI)	0.62 [0.55, 0.71]

8.1 Allocation concealment adaequate	6	1822	Peto Odds Ratio (95% CI)	0.60 [0.53, 0.69]
8.2 Not adaequate	1	91	Peto Odds Ratio (95% CI)	0.98 [0.59, 1.61]
9 FFS_Endpoints according to start of measurement Show forest plot	6	1785	Peto Odds Ratio (95% CI)	0.62 [0.55, 0.72]

9.1 Start of treatment	5	1427	Peto Odds Ratio (95% CI)	0.63 [0.54, 0.74]
9.2 End of treatment	1	358	Peto Odds Ratio (95% CI)	0.59 [0.43, 0.81]
10 FFS_Endpoints TTP, EFS, TTF, PFS Show forest plot	6		Peto Odds Ratio (95% CI)	Subtotals only

10.1 Time to progression	2	412	Peto Odds Ratio (95% CI)	0.69 [0.54, 0.89]
10.2 Progression free survival	2	587	Peto Odds Ratio (95% CI)	0.63 [0.51, 0.78]
10.3 Time to treatment failure	2	550	Peto Odds Ratio (95% CI)	0.51 [0.37, 0.70]
10.4 Event free survival	1	201	Peto Odds Ratio (95% CI)	0.41 [0.26, 0.64]

Comparison 2. Disease Control

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Comparison 3. Overall Response

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Overall Response Total Group Show forest plot	7	1914	Risk Ratio (M‐H, Fixed, 95% CI)	1.21 [1.16, 1.27]

2 Overall Response FL vs MCL Show forest plot	7	1830	Risk Ratio (M‐H, Fixed, 95% CI)	1.19 [1.14, 1.24]

2.1 follicular	6	1570	Risk Ratio (M‐H, Fixed, 95% CI)	1.19 [1.13, 1.24]
2.2 Mantle cell	3	260	Risk Ratio (M‐H, Fixed, 95% CI)	1.22 [1.05, 1.42]
3 Sensitivity: attrition bias Show forest plot	7	1914	Odds Ratio (M‐H, Fixed, 95% CI)	2.76 [2.17, 3.51]

3.1 Less than 10% excluded from analysis	5	1693	Odds Ratio (M‐H, Fixed, 95% CI)	2.88 [2.22, 3.74]
3.2 More than 10% excluded from analysis	2	221	Odds Ratio (M‐H, Fixed, 95% CI)	2.10 [1.10, 4.01]
4 Overall Response_Doxorubicin vs Mitoxantrone Show forest plot	6	1593	Odds Ratio (M‐H, Fixed, 95% CI)	2.63 [1.99, 3.46]

4.1 Doxorubicin based regimen	3	1014	Odds Ratio (M‐H, Fixed, 95% CI)	2.58 [1.76, 3.76]
4.2 Mitoxantrone based regimen	3	579	Odds Ratio (M‐H, Fixed, 95% CI)	2.69 [1.80, 4.03]
5 Overall Response_untreated vs treated patients Show forest plot	7	1914	Risk Ratio (M‐H, Fixed, 95% CI)	1.21 [1.16, 1.27]

5.1 Untreated patients	5	1319	Risk Ratio (M‐H, Fixed, 95% CI)	1.21 [1.15, 1.28]
5.2 Treated patients	2	595	Risk Ratio (M‐H, Fixed, 95% CI)	1.20 [1.10, 1.32]
6 Overall response_Anthracyclin vs no‐Anthracyclin treatment Show forest plot	7	1914	Odds Ratio (M‐H, Fixed, 95% CI)	2.76 [2.17, 3.51]

6.1 Anthracyclin based regimen	6	1593	Odds Ratio (M‐H, Fixed, 95% CI)	2.63 [1.99, 3.46]
6.2 No Anthracyclin based regimen	1	321	Odds Ratio (M‐H, Fixed, 95% CI)	3.24 [1.96, 5.35]
7 Overall Response_Full text vs Abstract publication Show forest plot	7	1914	Risk Ratio (M‐H, Fixed, 95% CI)	1.21 [1.16, 1.27]

7.1 Full Text	5	1465	Risk Ratio (M‐H, Fixed, 95% CI)	1.20 [1.14, 1.26]
7.2 Abstract form	2	449	Risk Ratio (M‐H, Fixed, 95% CI)	1.24 [1.12, 1.38]
8 Overall Response Allocation concealment Show forest plot	7	1914	Risk Ratio (M‐H, Fixed, 95% CI)	1.21 [1.16, 1.27]

8.1 Adaequate	6	1823	Risk Ratio (M‐H, Fixed, 95% CI)	1.22 [1.16, 1.28]
8.2 Not adaequate	1	91	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.90, 1.23]

Comparison 3. Overall Response

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Comparison 4. Complete Response

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Complete Response Total Group Show forest plot	7	1914	Risk Ratio (M‐H, Fixed, 95% CI)	2.03 [1.71, 2.40]

2 Complete Response FL vs MCL Show forest plot	6	2043	Risk Ratio (M‐H, Fixed, 95% CI)	2.26 [1.89, 2.71]

2.1 Follicula lymphoma	5	1701	Risk Ratio (M‐H, Fixed, 95% CI)	2.16 [1.77, 2.63]
2.2 Mantle cell lymphoma	3	342	Risk Ratio (M‐H, Fixed, 95% CI)	2.90 [1.80, 4.67]
3 Complete Response_Doxorubicine vs Mitoxantrone Show forest plot	6	1593	Risk Ratio (M‐H, Fixed, 95% CI)	1.85 [1.55, 2.21]

3.1 Mitixantrone based regimen	3	579	Risk Ratio (M‐H, Fixed, 95% CI)	2.02 [1.58, 2.59]
3.2 Doxorubicine based regimen	3	1014	Risk Ratio (M‐H, Fixed, 95% CI)	1.71 [1.33, 2.21]
4 Complete Response_anthracycline vs no anthracyclin treatment Show forest plot	7	1914	Risk Ratio (M‐H, Fixed, 95% CI)	2.03 [1.71, 2.40]

4.1 Anthracyclin based regimen	6	1593	Risk Ratio (M‐H, Fixed, 95% CI)	1.85 [1.55, 2.21]
4.2 No Anthracyclin based regimen	1	321	Risk Ratio (M‐H, Fixed, 95% CI)	4.01 [2.22, 7.25]
5 Complete Response _untreated vs treated patients Show forest plot	7	1914	Risk Ratio (M‐H, Fixed, 95% CI)	2.03 [1.71, 2.40]

5.1 Complete remission untreated patients	5	1319	Risk Ratio (M‐H, Fixed, 95% CI)	2.03 [1.66, 2.48]
5.2 Complete remission_treated patients	2	595	Risk Ratio (M‐H, Fixed, 95% CI)	2.01 [1.45, 2.77]

Comparison 4. Complete Response

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Comparison 5. Toxicity Grade 3/4

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Adverse events (number of patients) Show forest plot	4		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 Infection	4	1267	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.74, 1.48]
1.2 Fever	2	481	Risk Ratio (M‐H, Fixed, 95% CI)	3.79 [1.47, 9.78]
1.3 Leukocytopenia	2	681	Risk Ratio (M‐H, Fixed, 95% CI)	1.31 [1.11, 1.55]
1.4 Thrombocytopenia	4	1267	Risk Ratio (M‐H, Fixed, 95% CI)	1.14 [0.76, 1.72]
1.5 Granulocytopenia	3	907	Risk Ratio (M‐H, Fixed, 95% CI)	1.18 [1.00, 1.38]

Comparison 5. Toxicity Grade 3/4

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