Erythropoietin for patients with malignant disease

Julia Bohlius; Simon Langensiepen; Guido Schwarzer; Jerome Seidenfeld; Margret Piper; C Bennet; Andreas Engert; Charles Bennett

doi:10.1002/14651858.CD003407.pub3

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Analysis 1.1

Comparison 1 Haematologic response, Outcome 1 Haematologic response ‐ all studies.

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Analysis 1.2

Comparison 1 Haematologic response, Outcome 2 Haematologic response ‐ baseline Hb.

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Analysis 1.3

Comparison 1 Haematologic response, Outcome 3 Haematologic response ‐ different malignancies.

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Analysis 1.4

Comparison 1 Haematologic response, Outcome 4 Haematologic response ‐ different therapies.

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Analysis 1.5

Comparison 1 Haematologic response, Outcome 5 Haematologic response ‐ iron supplementation.

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Analysis 1.6

Comparison 1 Haematologic response, Outcome 6 Haematological response ‐ CSF supplementation.

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Analysis 1.7

Comparison 1 Haematologic response, Outcome 7 Haematologic response ‐ allocation concealment.

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Analysis 1.8

Comparison 1 Haematologic response, Outcome 8 Haematologic response ‐ masking.

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Analysis 1.9

Comparison 1 Haematologic response, Outcome 9 Haematologic response ‐ completeness.

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Analysis 1.10

Comparison 1 Haematologic response, Outcome 10 Haematologic response ‐ intention‐to treat.

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Analysis 1.11

Comparison 1 Haematologic response, Outcome 11 Haematologic response ‐ publication.

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Analysis 1.12

Comparison 1 Haematologic response, Outcome 12 Haematologic response ‐ duration of study.

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Analysis 2.1

Comparison 2 Change of haemoglobin level, Outcome 1 Change in Hb values ‐ all studies.

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Analysis 2.2

Comparison 2 Change of haemoglobin level, Outcome 2 Change in Hb values ‐ baseline Hb.

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Analysis 2.3

Comparison 2 Change of haemoglobin level, Outcome 3 Change in Hb values ‐ different malignancies.

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Analysis 2.4

Comparison 2 Change of haemoglobin level, Outcome 4 Change in Hb values ‐ different therapies.

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Analysis 2.5

Comparison 2 Change of haemoglobin level, Outcome 5 Change in Hb values ‐ iron supplementation.

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Analysis 2.6

Comparison 2 Change of haemoglobin level, Outcome 6 Change in Hb values ‐ CSF supplementation.

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Analysis 2.7

Comparison 2 Change of haemoglobin level, Outcome 7 Change in Hb values ‐ allocation concealment.

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Analysis 2.8

Comparison 2 Change of haemoglobin level, Outcome 8 Change in Hb values ‐ masking.

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Analysis 2.9

Comparison 2 Change of haemoglobin level, Outcome 9 Change in Hb values ‐ completeness.

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Analysis 2.10

Comparison 2 Change of haemoglobin level, Outcome 10 Change in Hb values ‐ intention‐to‐treat.

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Analysis 2.11

Comparison 2 Change of haemoglobin level, Outcome 11 Change in Hb values ‐ publication.

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Analysis 2.12

Comparison 2 Change of haemoglobin level, Outcome 12 Change in Hb values ‐ duration of study.

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Analysis 3.1

Comparison 3 Participants receiving red blood cell transfusions, Outcome 1 Participants receiving red blood cell transfusions.

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Analysis 3.2

Comparison 3 Participants receiving red blood cell transfusions, Outcome 2 Participants receiving red blood cell transfusions ‐ baseline Hb.

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Analysis 3.3

Comparison 3 Participants receiving red blood cell transfusions, Outcome 3 Participants receiving red blood cell transfusions ‐ different malignancies.

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Analysis 3.4

Comparison 3 Participants receiving red blood cell transfusions, Outcome 4 Participants receiving red blood cell transfusions ‐ different therapies.

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Analysis 3.5

Comparison 3 Participants receiving red blood cell transfusions, Outcome 5 Participants receiving red blood cell transfusions ‐ iron supplementation.

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Analysis 3.6

Comparison 3 Participants receiving red blood cell transfusions, Outcome 6 Participants receiving red blood cell transfusions ‐ G‐CSF supplementation.

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Analysis 3.7

Comparison 3 Participants receiving red blood cell transfusions, Outcome 7 Participants receiving red blood cell transfusions ‐ allocation concealment.

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Analysis 3.8

Comparison 3 Participants receiving red blood cell transfusions, Outcome 8 Participants receiving red blood cell transfusions ‐ masking.

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Analysis 3.9

Comparison 3 Participants receiving red blood cell transfusions, Outcome 9 Participants receiving red blood cell transfusions ‐ completeness.

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Analysis 3.10

Comparison 3 Participants receiving red blood cell transfusions, Outcome 10 Participants receiving red blood cell transfusions ‐ intention‐to treat.

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Analysis 3.11

Comparison 3 Participants receiving red blood cell transfusions, Outcome 11 Participants receiving red blood cell transfusions ‐ publication.

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Analysis 3.12

Comparison 3 Participants receiving red blood cell transfusions, Outcome 12 Participants receiving red blood cell transfusions ‐ duration of study.

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Analysis 3.13

Comparison 3 Participants receiving red blood cell transfusions, Outcome 13 Participants receiving red blood cell transfusions ‐ including/excluding the first 4 weeks ‐ version 1.

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Analysis 3.14

Comparison 3 Participants receiving red blood cell transfusions, Outcome 14 Participants receiving red blood cell transfusions‐ including/excluding the first 4 weeks ‐version 2.

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Analysis 4.1

Comparison 4 Number of red blood cell units transfused, Outcome 1 Number of RBC units transfused ‐ all studies.

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Analysis 4.2

Comparison 4 Number of red blood cell units transfused, Outcome 2 Number of RBC units transfused ‐ baseline Hb.

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Analysis 4.3

Comparison 4 Number of red blood cell units transfused, Outcome 3 Number of RBC units transfused ‐ different malignancies.

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Analysis 4.4

Comparison 4 Number of red blood cell units transfused, Outcome 4 Number of RBC units transfused ‐ different therapies.

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Analysis 4.5

Comparison 4 Number of red blood cell units transfused, Outcome 5 Number of RBC units transfused ‐ iron supplementation.

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Analysis 4.6

Comparison 4 Number of red blood cell units transfused, Outcome 6 number of RBC units transfused ‐ CSF supplementation.

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Analysis 4.7

Comparison 4 Number of red blood cell units transfused, Outcome 7 number of RBC units transfused ‐ completeness.

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Analysis 4.8

Comparison 4 Number of red blood cell units transfused, Outcome 8 Number of RBC units transfused ‐ allocation concealment.

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Analysis 4.9

Comparison 4 Number of red blood cell units transfused, Outcome 9 Number of RBC units transfused ‐ masking.

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Analysis 4.10

Comparison 4 Number of red blood cell units transfused, Outcome 10 Number of RBC units transfused ‐ intention‐to‐treat.

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Analysis 4.11

Comparison 4 Number of red blood cell units transfused, Outcome 11 Number of RBC units transfused ‐ publication.

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Analysis 4.12

Comparison 4 Number of red blood cell units transfused, Outcome 12 Number of RBC units transfused ‐ duration of study.

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Analysis 4.13

Comparison 4 Number of red blood cell units transfused, Outcome 13 Number of RBC units transfused ‐ including/excluding the first 4 weeks ‐ version 1.

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Analysis 4.14

Comparison 4 Number of red blood cell units transfused, Outcome 14 Number of RBC units transfused ‐ including/excluding the first 4 weeks ‐ version 2.

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Analysis 5.1

Comparison 5 Overall Survival, Outcome 1 Overall Survival ‐ all studies, adjusted data.

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Analysis 5.2

Comparison 5 Overall Survival, Outcome 2 Overall survival ‐ all studies, unadjusted data.

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Analysis 5.3

Comparison 5 Overall Survival, Outcome 3 Overall Survival ‐ baseline Hb.

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Analysis 5.4

Comparison 5 Overall Survival, Outcome 4 Overall Survival ‐ different malignancies.

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Analysis 5.5

Comparison 5 Overall Survival, Outcome 5 Overall Survival ‐ iron supplementation.

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Analysis 5.6

Comparison 5 Overall Survival, Outcome 6 Overall Survival ‐ different therapies.

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Analysis 5.7

Comparison 5 Overall Survival, Outcome 7 Overall Survival ‐ allocation concealment.

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Analysis 5.8

Comparison 5 Overall Survival, Outcome 8 Overall Survival ‐ masking.

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Analysis 5.9

Comparison 5 Overall Survival, Outcome 9 Overall Survival ‐ completeness.

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Analysis 5.10

Comparison 5 Overall Survival, Outcome 10 Overall Survival ‐ intention‐to‐treat.

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Analysis 5.11

Comparison 5 Overall Survival, Outcome 11 Overall Survival ‐ publication.

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Analysis 5.12

Comparison 5 Overall Survival, Outcome 12 Overall Survival ‐ median observation time.

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Analysis 5.13

Comparison 5 Overall Survival, Outcome 13 Overall survival ‐ time‐to‐event or binary mortality data.

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Analysis 6.1

Comparison 6 Tumor Response, Outcome 1 Complete Response.

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Analysis 7.1

Comparison 7 Adverse events, Outcome 1 Thrombotic events.

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Analysis 7.2

Comparison 7 Adverse events, Outcome 2 Hypertension.

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Analysis 7.3

Comparison 7 Adverse events, Outcome 3 Hemorrhage/Thrombocytopenia.

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Analysis 7.4

Comparison 7 Adverse events, Outcome 4 Rash/Irritation/Pruritus.

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Analysis 7.5

Comparison 7 Adverse events, Outcome 5 Seizure.

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Table 1. Study Validity

study	publication	allocation	treatment groups	blinding	drop outs	intention‐to‐treat	type of publication
Abels 1993	randomised	adequate randomization; adequate concealment	similar at baseline	double‐blind	information obtained from investigator	ITT analysis or less than 10% of patients excluded	journal publication, unpublished data
Carabantes 1999	stated to be randomised	unclear randomization and concealment	similar at baseline	unblinded	number of drop outs for each study arm not stated	ITT analysis	abstract publication
Cascinu 1994	randomised	adequate randomization; adequate concealment	similar at baseline	double‐blind	number of drop outs for each study arm stated	ITT analysis or less than 10% of patients excluded	journal publication, unpublished data
Case 1993	randomised	adequate randomization; adequate concealment	similar at baseline	double‐blind	number of drop outs for each study arm stated	ITT analysis or less than 10% of patients excluded	journal publication, unpublished data
Cazzola 1995	randomised	adequate randomization; adequate concealment	similar at baseline	unblinded	number of drop outs for each study arm stated	ITT analysis or less than 10% of patients excluded	journal publication, unpublished data
Coiffier 2001	randomised	adequate randomization; adequate concealment	similar at baseline	unblinded	number of drop outs for each study arm stated	ITT analysis	abstract publication, unpublished data
Dammacco 2001	randomised	adequate randomization, concealment of allocation unclear	similar at baseline	double‐blind	number of drop outs for each study arm stated	ITT analysis or less than 10% of patients excluded	journal publication, unpublished data
Del Mastro 1997	randomised	adequate randomization; adequate concealment	similar at baseline	unblinded	number of drop outs for each study arm stated	ITT analysis	journal publication, unpublished data
Dunphy 1999	stated to be randomised	unclear randomization and concealment	gender not distributed equally	unblinded	number of drop outs for each study arm stated	ITT analysis included or less than 10% of patients excluded	journal publication
Henke 1999	stated to be randomised	unclear randomization, unclear concealment	differences in baseline Hb between study groups	unblinded	number of drop outs for each study arm not stated	ITT analysis	journal publication
Henry 1995	randomised	adequate randomization; adequate concealment	similar at baseline	double‐blind	number of drop outs for each study arm stated	ITT analysis or less than 10% of patients excluded	journal publication, unpublished data
Italian coop 1998	randomised	adequate randomization; adequate concealment	similar at baseline	double‐blind	number of drop outs for each study arm stated	less than 10% of patients excluded	journal publication, unpublished data
Kunikane 2001	stated to be randomised	judged to be adequate	similar at baseline	double‐blind	not stated	no ITT analysis	journal publication
Kurz 1997	randomised	adequate randomization; adequate concealment	similar at baseline	double‐blind	number of drop outs for each study arm stated	ITT analysis	journal publication, unpublished data
Littlewood 2001	randomised	adequate randomization, adequate concealment of allocation	similar at baseline	double‐blind	number of drop outs for each study arm stated	ITT analysis or less than 10% of patients excluded	journal publication, unpublished data
Oberhoff 1998	randomised	adequate randomization; adequate concealment	similar at baseline	unblinded	number of drop outs for each study arm stated	ITT analysis	journal publication, unpublished data
Quirt 1996	stated to be randomised	unclear randomisation and concealment	unclear	double‐blind	number of drop outs for each study arm not stated	ITT analysis or less than 10% of participants excluded	abstract publication
Rose 1994	randomised	adequate randomisation, unclear concealment of allocation	similar at baseline	double‐blind	available from the clinical study report	ITT analysis	abstract publication, unpublished data
Silvestris 1995	stated to be randomised	adequate randomisation; unclear concealment of allocation	unclear	unblinded	number of drop outs for each study arm stated	no ITT analysis	journal publication
Ten Bokkel 1998	randomised	adequate randomisation; adequate concealment	similar at baseline	unblinded	number of drop outs for each study arm stated	ITT analysis or less than 10% of participants excluded	journal publication, unpublished data
Thatcher 1999	randomised	adequate randomisation; adequate concealment	similar at baseline	unblinded	data provided by the investigators, not stated in the publication	ITT analysis	journal publication, unpublished data
Thompson 2000	randomised	adequate randomisation; adequate concealment	similar at baseline	double‐blind	number of drop outs for each study arm not stated	ITT analysis	journal publication, unpublished data
Throuvalas 2000	randomised	adequate randomisation; adequate concealment	similar at baseline	unblinded	number of drop outs for each study arm stated	ITT analysis or less than 10% of participants excluded	abstract publication, unpublished data
Welch 1995	stated to be randomised	unclear randomisation and concealment	similar at baseline	unblinded	number of drop outs for each study arm stated	ITT analysis	journal publication
Wurnig 1996	stated to be randomised	adequate randomisation; unclear concealment	unclear	double‐blind	number of drop outs for each study arm stated	ITT analysis or less than 10% of participants excluded	journal publication
Österborg 1996	randomised	adequate randomisation; adequate concealment	similar at baseline	unblinded	number of drop outs for each study arm stated	ITT analysis	journal publication, unpublished data
Österborg 2002	randomised	adequate randomisation; adequate concealment	similar at baseline	double‐blind	number of drop outs for each study arm stated	ITT analysis or less than 10% of participants excluded	journal publication, unpublished data

Table 1. Study Validity

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Table 2. Participants receiving RBC transfusions: results of meta‐regression analysis

Variable	log(effect size)	Standard error	p.value
Intercept	‐0.5976	0.1106	<0.0001
Adequat allocation concealment	0.0798	0.0581	0.1696
Unclear method of concealment	‐0.0798	0.0581	0.1696
Data from full text report	0.2202	0.1166	0.0589
Data from abstract report	‐0.4240	0.2226	0.0568
Unreported data, personal communication	0.2037	0.1252	0.1036
Haematological disease	0.1624	0.0747	0.0297
MDS	0.0966	0.0745	0.1949
Solid and haematological tumours	0.0199	0.0726	0.7845
Solid tumours	‐0.2788	0.0748	0.0002

Table 2. Participants receiving RBC transfusions: results of meta‐regression analysis

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Table 3. Quality of Life

Study	randomised patients	evaluated patients	scale	result: QoL	Pts blinded for Hb	double‐blind
Abels 1993	124	92 (74%)	LASA visual analogue scales, energy level, ability to perform daily activities, overall QoL	Published data pooled Abels 1993, Case 1993 and Henry 1995. Significant difference for overall QoL, better hence without statistical significance for energy level and daily activity. Restricted to EPO responders against all placebo patients, significant improvement in all three parameters are found.	No	double‐blind
Carabantes 1999	35	28 (80%)	Nottingham Health Profile (NHP)	significant improved for energy (p<0.03), mobility (p<0.04), days of restricted activity (p<0.04) for the EPO group. Although there were no intergroup differences in QoL at inclusion, at the end of study there were statistical significant increases.	NR	no
Case 1993	157	124 (79%)	LASA visual analogue scales, energy level, ability to perform daily activities, overall QoL	Published data pooled Abels 1993, Case 1993 and Henry 1995. In the EPO group significant differences comparing pre‐study and post‐study for energy level, ability to perform daily activities. Better but without statistical significane for overall QoL. No statistical sginificant differences when compared to control group.	No	double‐blind
Coiffier 2001	262	NR	FACT‐An, LASA, SF‐36, FACT‐F	increased baseline‐to‐final‐visit changes in SF‐36 (p=0.018) and FACT‐F (p=0.003) scores when compared to control group. Changes in SF‐36 (p=0.006) and FACT‐F (p=0.001) scores were significantly correlated with Hb response.	No	no
Dammacco 2001	145	138 (95%)	NHP, LASA	no significant difference between the treatment groups for week 12 QoL scores, although nearly all trends favoured patients treated with epoetin alfa.	No	double‐blind
Del Mastro 1997	62	53 (86%)	Psychological Distress Inventory (PDI)	no significant difference between treatment groups concerning psychologic distress (p=0.4)	No	no
Henry 1995	132	86 (65%)	LASA visual analogue scales, energy level, ability to perform daily activities, overall QoL	Published data pooled Abels 1993, Case 1993 and Henry 1995. Significant difference for overall QoL, better hence without statistical significance for energy level and daily activity.	No	double‐blind
Kurz 1997	35	35 (100%)	LASA, unvalidated questionnaire	no significant difference between treatment groups	Yes	double‐blind
Littlewood 2001	375	336 (89.6%)	FACT‐An, LASA, SF‐36, FACT‐F, FACT‐G	Adjusting for multiple comparisons, statistically significant differences for epoetin alfa over placebo were found for all five primary QoL scales.	NR	double‐blind
Österborg 2002	349	206‐263 (59%‐75%)	FACT‐An, FACT‐F, FACT‐G	After 16 weeks of treatment statistically significant improved in the total FACT‐An, FACT‐G for the EPO group compared to the placebo group. No statistically significanct differences were found between the treatment groups on the FACT‐F and FACT‐An subsacles.	No	double‐blind
Quirt 1996	56	56 (100%)	Functional Living Index‐Cancer (FLI‐C), Health Utility Index (HUI)	no significant difference between treatment groups	NR	double‐blind
Rose 1994	221	214 (97%)	questionnaire with validated psychometric scales, including energy, physical/cognitive/social role function and mental health	For all participants, between group differences favouring the EPO group were found for energy scores (p < 0.05). EPO responders had significant improvement in energy, self‐rated health, physical function, role function/physical, role function/emotional, social function and mental health (p < 0.01 to p < 0.0004) compared to placebo patients.	?	double‐blind
Thatcher 1999	130	92 (71%)	VAS, QoL assessed with three domains: energy level, daily activity, overall QoL	no significant difference between treatment groups	No	single‐blind
Welch 1995	30	30 (100%)	VAS, QoL assessed with three domains: energy level, daily activity, overall QoL	no significant difference between treatment groups	NR	no

Table 3. Quality of Life

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Comparison 1. Haematologic response

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Haematologic response ‐ all studies Show forest plot	16	2347	Risk Ratio (M‐H, Fixed, 95% CI)	3.60 [3.07, 4.23]

2 Haematologic response ‐ baseline Hb Show forest plot	16	2347	Risk Ratio (M‐H, Fixed, 95% CI)	3.60 [3.07, 4.23]

2.1 Hb < 10 g/dL	16	2347	Risk Ratio (M‐H, Fixed, 95% CI)	3.60 [3.07, 4.23]
2.2 Hb 10 to 12 g/dL	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.3 Hb > 12 g/dL	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Haematologic response ‐ different malignancies Show forest plot	16	2347	Risk Ratio (M‐H, Fixed, 95% CI)	3.60 [3.07, 4.23]

3.1 solid tumors	3	445	Risk Ratio (M‐H, Fixed, 95% CI)	3.93 [2.60, 5.94]
3.2 haematological malignancies	8	1093	Risk Ratio (M‐H, Fixed, 95% CI)	3.30 [2.68, 4.06]
3.3 MDS	2	151	Risk Ratio (M‐H, Fixed, 95% CI)	4.27 [0.86, 21.19]
3.4 mixed	4	658	Risk Ratio (M‐H, Fixed, 95% CI)	4.08 [2.96, 5.63]
4 Haematologic response ‐ different therapies Show forest plot	16	2347	Risk Ratio (M‐H, Fixed, 95% CI)	3.60 [3.07, 4.23]

4.1 chemotherapy with platinum	4	510	Risk Ratio (M‐H, Fixed, 95% CI)	6.31 [3.93, 10.13]
4.2 chemotherapy without platinum	8	1306	Risk Ratio (M‐H, Fixed, 95% CI)	3.21 [2.66, 3.87]
4.3 radiotherapy	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.5 no therapy	3	269	Risk Ratio (M‐H, Fixed, 95% CI)	3.22 [1.53, 6.77]
4.6 unclear/part of population	1	262	Risk Ratio (M‐H, Fixed, 95% CI)	3.59 [2.23, 5.80]
5 Haematologic response ‐ iron supplementation Show forest plot	16	2347	Risk Ratio (M‐H, Fixed, 95% CI)	3.60 [3.07, 4.23]

5.1 fixed iron supplementation	2	394	Risk Ratio (M‐H, Fixed, 95% CI)	3.92 [2.67, 5.74]
5.2 iron supplementation as necessary	11	1743	Risk Ratio (M‐H, Fixed, 95% CI)	3.61 [3.00, 4.33]
5.3 no explicit statement on iron supplementation	3	210	Risk Ratio (M‐H, Fixed, 95% CI)	2.73 [1.44, 5.16]
6 Haematological response ‐ CSF supplementation Show forest plot	16	2347	Risk Ratio (M‐H, Fixed, 95% CI)	3.60 [3.07, 4.23]

6.1 CSF supplementation	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.2 no CSF supplementation	16	2347	Risk Ratio (M‐H, Fixed, 95% CI)	3.60 [3.07, 4.23]
7 Haematologic response ‐ allocation concealment Show forest plot	16	2347	Risk Ratio (M‐H, Fixed, 95% CI)	3.60 [3.07, 4.23]

7.1 adequate	12	1908	Risk Ratio (M‐H, Fixed, 95% CI)	3.47 [2.91, 4.12]
7.2 unclear	4	439	Risk Ratio (M‐H, Fixed, 95% CI)	4.32 [2.85, 6.54]
8 Haematologic response ‐ masking Show forest plot	16	2347	Risk Ratio (M‐H, Fixed, 95% CI)	3.60 [3.07, 4.23]

8.1 double‐blind	10	1637	Risk Ratio (M‐H, Fixed, 95% CI)	3.47 [2.90, 4.16]
8.2 unblinded	6	710	Risk Ratio (M‐H, Fixed, 95% CI)	4.02 [2.87, 5.63]
9 Haematologic response ‐ completeness Show forest plot	16	2347	Risk Ratio (M‐H, Fixed, 95% CI)	3.60 [3.07, 4.23]

9.1 drop‐outs and withdrawals in each group stated	15	2281	Risk Ratio (M‐H, Fixed, 95% CI)	3.62 [3.08, 4.25]
9.2 no information on drop‐outs and withdrawals	1	66	Risk Ratio (M‐H, Fixed, 95% CI)	1.87 [0.22, 15.70]
10 Haematologic response ‐ intention‐to treat Show forest plot	16	2347	Risk Ratio (M‐H, Fixed, 95% CI)	3.60 [3.07, 4.23]

10.1 ITT or less than 10% of participants per studyarm excluded	15	2215	Risk Ratio (M‐H, Fixed, 95% CI)	3.49 [2.97, 4.12]
10.2 more than 10% of participants per studyarm excluded	1	132	Risk Ratio (M‐H, Fixed, 95% CI)	6.33 [2.87, 13.96]
11 Haematologic response ‐ publication Show forest plot	16	2347	Risk Ratio (M‐H, Fixed, 95% CI)	3.60 [3.07, 4.23]

11.1 peer reviewed publication	7	988	Risk Ratio (M‐H, Fixed, 95% CI)	4.32 [3.31, 5.64]
11.2 abstract publication	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
11.3 unpublished data	9	1359	Risk Ratio (M‐H, Fixed, 95% CI)	3.18 [2.61, 3.88]
12 Haematologic response ‐ duration of study Show forest plot	16	2347	Risk Ratio (M‐H, Fixed, 95% CI)	3.60 [3.07, 4.23]

12.1 6 to 9 weeks	5	414	Risk Ratio (M‐H, Fixed, 95% CI)	5.71 [3.24, 10.04]
12.2 12 to 16 weeks	8	1430	Risk Ratio (M‐H, Fixed, 95% CI)	3.38 [2.79, 4.09]
12.3 more than 20 weeks	3	503	Risk Ratio (M‐H, Fixed, 95% CI)	3.46 [2.48, 4.83]

Comparison 1. Haematologic response

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Comparison 2. Change of haemoglobin level

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Change in Hb values ‐ all studies Show forest plot	10		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

2 Change in Hb values ‐ baseline Hb Show forest plot	10		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

2.1 Hb < 10g/dL	4	534	Mean Difference (IV, Fixed, 95% CI)	1.55 [1.51, 1.59]
2.2 Hb 10 to 12 g/dL	4	106	Mean Difference (IV, Fixed, 95% CI)	2.71 [2.49, 2.92]
2.3 Hb >12 g/dL	3	115	Mean Difference (IV, Fixed, 95% CI)	2.05 [1.88, 2.22]
3 Change in Hb values ‐ different malignancies Show forest plot	10		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

3.1 solid tumors	7	357	Mean Difference (IV, Fixed, 95% CI)	1.66 [1.60, 1.72]
3.2 haematological malignancies	4	398	Mean Difference (IV, Fixed, 95% CI)	1.69 [1.62, 1.76]
4 Change in Hb values ‐ different therapies Show forest plot	10		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

4.1 chemotherapy with platinum	3	198	Mean Difference (IV, Fixed, 95% CI)	2.03 [1.86, 2.20]
4.2 chemotherapy without platinum	4	507	Mean Difference (IV, Fixed, 95% CI)	1.66 [1.62, 1.71]
4.3 radiotherapy	3	50	Mean Difference (IV, Fixed, 95% CI)	2.89 [1.88, 3.89]
5 Change in Hb values ‐ iron supplementation Show forest plot	10		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

5.1 fixed iron supplementation	4	409	Mean Difference (IV, Fixed, 95% CI)	1.74 [1.70, 1.79]
5.2 iron supplementation as necessary	4	293	Mean Difference (IV, Fixed, 95% CI)	0.70 [0.52, 0.87]
5.3 no explicit statement on iron supplementation	2	53	Mean Difference (IV, Fixed, 95% CI)	2.04 [1.86, 2.22]
6 Change in Hb values ‐ CSF supplementation Show forest plot	10		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

6.1 CSF supplementation	1	62	Mean Difference (IV, Fixed, 95% CI)	2.25 [1.64, 2.86]
6.2 no CSF supplementation	9	693	Mean Difference (IV, Fixed, 95% CI)	1.69 [1.64, 1.73]
7 Change in Hb values ‐ allocation concealment Show forest plot	10		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

7.1 adequate	4	474	Mean Difference (IV, Fixed, 95% CI)	1.76 [1.72, 1.81]
7.2 unclear	6	281	Mean Difference (IV, Fixed, 95% CI)	0.63 [0.46, 0.81]
8 Change in Hb values ‐ masking Show forest plot	10		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

8.1 double‐blind	4	557	Mean Difference (IV, Fixed, 95% CI)	1.76 [1.72, 1.81]
8.2 unblinded	6	198	Mean Difference (IV, Fixed, 95% CI)	0.64 [0.47, 0.82]
8.3 unclear	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
9 Change in Hb values ‐ completeness Show forest plot	10		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

9.1 drop‐outs and withdrawals in each group stated	5	652	Mean Difference (IV, Fixed, 95% CI)	1.67 [1.62, 1.71]
9.2 no information on drop‐outs and withdrawals	5	103	Mean Difference (IV, Fixed, 95% CI)	2.06 [1.89, 2.24]
10 Change in Hb values ‐ intention‐to‐treat Show forest plot	10		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

10.1 ITT or less than 10% of participants per studyarm excluded	8	702	Mean Difference (IV, Fixed, 95% CI)	1.67 [1.62, 1.71]
10.2 more than 10% of participants per studyarm excluded	2	53	Mean Difference (IV, Fixed, 95% CI)	2.04 [1.86, 2.22]
11 Change in Hb values ‐ publication Show forest plot	10		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

11.1 peer reviewed publication	8	251	Mean Difference (IV, Fixed, 95% CI)	1.33 [1.21, 1.46]
11.2 abstract publication	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
11.3 unpublished data	2	504	Mean Difference (IV, Fixed, 95% CI)	1.74 [1.69, 1.79]
12 Change in Hb values ‐ duration of study Show forest plot	10		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

12.1 6 to 9 weeks	7	189	Mean Difference (IV, Fixed, 95% CI)	1.29 [1.16, 1.42]
12.2 12 to 16 weeks	2	207	Mean Difference (IV, Fixed, 95% CI)	2.12 [1.70, 2.54]
12.3 more than 20 weeks	1	359	Mean Difference (IV, Fixed, 95% CI)	1.74 [1.69, 1.79]

Comparison 2. Change of haemoglobin level

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Comparison 3. Participants receiving red blood cell transfusions

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants receiving red blood cell transfusions Show forest plot	30	3069	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.62, 0.73]

2 Participants receiving red blood cell transfusions ‐ baseline Hb Show forest plot	30	3069	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.62, 0.73]

2.1 Hb < 10 g/dL	17	2475	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.66, 0.78]
2.2 Hb 10 to 12 g/dL	6	292	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.23, 0.47]
2.3 Hb > 12 g/dL	7	302	Risk Ratio (M‐H, Fixed, 95% CI)	0.56 [0.40, 0.80]
3 Participants receiving red blood cell transfusions ‐ different malignancies Show forest plot	30	3069	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.62, 0.73]

3.1 solid tumors	16	1095	Risk Ratio (M‐H, Fixed, 95% CI)	0.49 [0.41, 0.59]
3.3 haematological malignancies	8	1111	Risk Ratio (M‐H, Fixed, 95% CI)	0.74 [0.66, 0.84]
3.4 MDS	2	151	Risk Ratio (M‐H, Fixed, 95% CI)	0.80 [0.68, 0.96]
3.5 mixed	5	712	Risk Ratio (M‐H, Fixed, 95% CI)	0.73 [0.62, 0.86]
4 Participants receiving red blood cell transfusions ‐ different therapies Show forest plot	30	3069	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.62, 0.73]

4.1 chemotherapy with platinum	16	1101	Risk Ratio (M‐H, Fixed, 95% CI)	0.53 [0.46, 0.62]
4.2 chemotherapy without platinum	9	1383	Risk Ratio (M‐H, Fixed, 95% CI)	0.76 [0.67, 0.85]
4.3 radiotherapy	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.5 no therapy	3	269	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.68, 0.99]
4.6 unclear	2	316	Risk Ratio (M‐H, Fixed, 95% CI)	0.61 [0.46, 0.81]
5 Participants receiving red blood cell transfusions ‐ iron supplementation Show forest plot	30	3069	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.62, 0.73]

5.1 fixed iron supplementation	3	437	Risk Ratio (M‐H, Fixed, 95% CI)	0.57 [0.43, 0.76]
5.2 iron supplementation as necessary	18	2151	Risk Ratio (M‐H, Fixed, 95% CI)	0.68 [0.61, 0.75]
5.3 no explicit statement on iron supplementation	9	481	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.59, 0.80]
6 Participants receiving red blood cell transfusions ‐ G‐CSF supplementation Show forest plot	30	3069	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.62, 0.73]

6.1 G‐CSF supplementation	2	128	Risk Ratio (M‐H, Fixed, 95% CI)	0.78 [0.61, 0.99]
6.2 no G‐CSF supplementation	28	2941	Risk Ratio (M‐H, Fixed, 95% CI)	0.66 [0.61, 0.72]
7 Participants receiving red blood cell transfusions ‐ allocation concealment Show forest plot	30	3069	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.62, 0.73]

7.1 adequate	21	2442	Risk Ratio (M‐H, Fixed, 95% CI)	0.68 [0.63, 0.75]
7.2 unclear	9	627	Risk Ratio (M‐H, Fixed, 95% CI)	0.61 [0.50, 0.73]
8 Participants receiving red blood cell transfusions ‐ masking Show forest plot	30	3069	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.62, 0.73]

8.1 double‐blind	15	1901	Risk Ratio (M‐H, Fixed, 95% CI)	0.70 [0.64, 0.78]
8.2 unblinded	15	1168	Risk Ratio (M‐H, Fixed, 95% CI)	0.61 [0.53, 0.70]
9 Participants receiving red blood cell transfusions ‐ completeness Show forest plot	30	3069	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.62, 0.73]

9.1 drop‐outs and withdrawals in each group stated	25	2861	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.62, 0.73]
9.2 no sufficient information on drop‐outs and withdrawals	5	208	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.49, 0.84]
10 Participants receiving red blood cell transfusions ‐ intention‐to treat Show forest plot	30	3069	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.62, 0.73]

10.1 ITT or less than 10% of participants per studyarm excluded	28	3016	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.61, 0.72]
10.2 more than 10% of participants per studyarm excluded	2	53	Risk Ratio (M‐H, Fixed, 95% CI)	2.33 [0.28, 19.54]
11 Participants receiving red blood cell transfusions ‐ publication Show forest plot	30	3069	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.62, 0.73]

11.1 fulltext publication	18	1401	Risk Ratio (M‐H, Fixed, 95% CI)	0.63 [0.55, 0.72]
11.2 abstract publication	3	143	Risk Ratio (M‐H, Fixed, 95% CI)	0.28 [0.15, 0.52]
11.3 unpublished data	9	1525	Risk Ratio (M‐H, Fixed, 95% CI)	0.73 [0.66, 0.81]
12 Participants receiving red blood cell transfusions ‐ duration of study Show forest plot	30	3069	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.62, 0.73]

12.1 6 to 9 weeks	9	523	Risk Ratio (M‐H, Fixed, 95% CI)	0.63 [0.50, 0.78]
12.2 12 to 16 weeks	11	1683	Risk Ratio (M‐H, Fixed, 95% CI)	0.70 [0.63, 0.78]
12.3 more than 20 weeks	10	863	Risk Ratio (M‐H, Fixed, 95% CI)	0.62 [0.54, 0.72]
13 Participants receiving red blood cell transfusions ‐ including/excluding the first 4 weeks ‐ version 1 Show forest plot	30		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

13.1 first 4 weeks included	28	2549	Risk Ratio (M‐H, Fixed, 95% CI)	0.68 [0.62, 0.74]
13.2 first 4 weeks excluded	13	1858	Risk Ratio (M‐H, Fixed, 95% CI)	0.59 [0.52, 0.67]
13.3 the first 4 weeks	12	298	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.70, 1.33]
14 Participants receiving red blood cell transfusions‐ including/excluding the first 4 weeks ‐version 2 Show forest plot	11		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

14.1 first 4 weeks included	11	1450	Risk Ratio (M‐H, Fixed, 95% CI)	0.72 [0.65, 0.81]
14.2 first 4 weeks excluded	11	1338	Risk Ratio (M‐H, Fixed, 95% CI)	0.59 [0.51, 0.68]

Comparison 3. Participants receiving red blood cell transfusions

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Comparison 4. Number of red blood cell units transfused

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number of RBC units transfused ‐ all studies Show forest plot	16	2056	Mean Difference (IV, Fixed, 95% CI)	‐1.00 [‐1.31, ‐0.70]

2 Number of RBC units transfused ‐ baseline Hb Show forest plot	16	2056	Mean Difference (IV, Fixed, 95% CI)	‐1.00 [‐1.31, ‐0.70]

2.1 Hb < 10g/dL	14	1936	Mean Difference (IV, Fixed, 95% CI)	‐1.02 [‐1.36, ‐0.69]
2.2 Hb 10 to 12g/dL	2	120	Mean Difference (IV, Fixed, 95% CI)	‐0.89 [‐1.63, ‐0.15]
2.3 Hb > 12g/dL	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Number of RBC units transfused ‐ different malignancies Show forest plot	16	2056	Mean Difference (IV, Fixed, 95% CI)	‐1.00 [‐1.31, ‐0.70]

3.1 solid tumours	5	473	Mean Difference (IV, Fixed, 95% CI)	‐1.14 [‐1.54, ‐0.74]
3.2 haematological malignancies	7	925	Mean Difference (IV, Fixed, 95% CI)	‐0.71 [‐1.37, ‐0.06]
3.3 mixed	4	658	Mean Difference (IV, Fixed, 95% CI)	‐0.90 [‐1.59, ‐0.21]
4 Number of RBC units transfused ‐ different therapies Show forest plot	16	2056	Mean Difference (IV, Fixed, 95% CI)	‐1.00 [‐1.31, ‐0.70]

4.1 chemotherapy with platinum	7	730	Mean Difference (IV, Fixed, 95% CI)	‐1.06 [‐1.42, ‐0.70]
4.2 chemotherapy without platinum	7	946	Mean Difference (IV, Fixed, 95% CI)	‐0.73 [‐1.46, 0.00]
4.3 radiotherapy	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.4 no therapy	1	118	Mean Difference (IV, Fixed, 95% CI)	‐0.67 [‐1.81, 0.47]
4.5 unclear	1	262	Mean Difference (IV, Fixed, 95% CI)	‐1.67 [‐3.08, ‐0.26]
5 Number of RBC units transfused ‐ iron supplementation Show forest plot	16	2056	Mean Difference (IV, Fixed, 95% CI)	‐1.00 [‐1.31, ‐0.70]

5.1 fixed iron supplementation	1	35	Mean Difference (IV, Fixed, 95% CI)	‐2.27 [‐4.61, 0.07]
5.2 iron supplementation as necessary	12	1777	Mean Difference (IV, Fixed, 95% CI)	‐0.78 [‐1.14, ‐0.41]
5.3 no explicit statement on iron supplementation	3	244	Mean Difference (IV, Fixed, 95% CI)	‐1.50 [‐2.08, ‐0.92]
6 number of RBC units transfused ‐ CSF supplementation Show forest plot	16	2056	Mean Difference (IV, Fixed, 95% CI)	‐1.00 [‐1.31, ‐0.70]

6.1 CSF supplementation	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.2 no CSF supplementation	16	2056	Mean Difference (IV, Fixed, 95% CI)	‐1.00 [‐1.31, ‐0.70]
7 number of RBC units transfused ‐ completeness Show forest plot	16	2056	Mean Difference (IV, Fixed, 95% CI)	‐1.00 [‐1.31, ‐0.70]

7.1 drop‐outs and withdrawals stated in each group	16	2056	Mean Difference (IV, Fixed, 95% CI)	‐1.00 [‐1.31, ‐0.70]
7.2 no sufficient information on drop‐outs and withdrawals	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
8 Number of RBC units transfused ‐ allocation concealment Show forest plot	16	2056	Mean Difference (IV, Fixed, 95% CI)	‐1.00 [‐1.31, ‐0.70]

8.1 adequate	12	1617	Mean Difference (IV, Fixed, 95% CI)	‐1.04 [‐1.37, ‐0.71]
8.2 unclear	4	439	Mean Difference (IV, Fixed, 95% CI)	‐0.74 [‐1.57, 0.09]
9 Number of RBC units transfused ‐ masking Show forest plot	16	2056	Mean Difference (IV, Fixed, 95% CI)	‐1.00 [‐1.31, ‐0.70]

9.1 double‐blind	8	1226	Mean Difference (IV, Fixed, 95% CI)	‐1.08 [‐1.47, ‐0.69]
9.2 unblinded	8	830	Mean Difference (IV, Fixed, 95% CI)	‐0.88 [‐1.37, ‐0.39]
10 Number of RBC units transfused ‐ intention‐to‐treat Show forest plot	16	2056	Mean Difference (IV, Fixed, 95% CI)	‐1.00 [‐1.31, ‐0.70]

10.1 ITT or less than 10% of participants per studyarm excluded	16	2056	Mean Difference (IV, Fixed, 95% CI)	‐1.00 [‐1.31, ‐0.70]
10.2 more than 10% of participants per studyarm excluded	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
11 Number of RBC units transfused ‐ publication Show forest plot	16	2056	Mean Difference (IV, Fixed, 95% CI)	‐1.00 [‐1.31, ‐0.70]

11.1 peer reviewed publication	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
11.2 abstract publication	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
11.3 unpublished data	16	2056	Mean Difference (IV, Fixed, 95% CI)	‐1.00 [‐1.31, ‐0.70]
12 Number of RBC units transfused ‐ duration of study Show forest plot	16	2056	Mean Difference (IV, Fixed, 95% CI)	‐1.00 [‐1.31, ‐0.70]

12.1 6 to 9 weeks	4	304	Mean Difference (IV, Fixed, 95% CI)	‐1.27 [‐1.77, ‐0.77]
12.2 12 to 16 weeks	8	1488	Mean Difference (IV, Fixed, 95% CI)	‐0.81 [‐1.27, ‐0.36]
12.3 more than 20 weeks	4	264	Mean Difference (IV, Fixed, 95% CI)	‐0.92 [‐1.64, ‐0.20]
13 Number of RBC units transfused ‐ including/excluding the first 4 weeks ‐ version 1 Show forest plot	16		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

13.1 including the first 4 weeks	16	2056	Mean Difference (IV, Fixed, 95% CI)	‐1.00 [‐1.31, ‐0.70]
13.2 excluding the first 4 weeks	9	1099	Mean Difference (IV, Fixed, 95% CI)	‐0.61 [‐0.97, ‐0.25]
14 Number of RBC units transfused ‐ including/excluding the first 4 weeks ‐ version 2 Show forest plot	9		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

14.1 including the first 4 weeks	9	1172	Mean Difference (IV, Fixed, 95% CI)	‐0.83 [‐1.28, ‐0.38]
14.2 excluding the first 4 weeks	9	1099	Mean Difference (IV, Fixed, 95% CI)	‐0.61 [‐0.97, ‐0.25]

Comparison 4. Number of red blood cell units transfused

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Comparison 5. Overall Survival

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Overall Survival ‐ all studies, adjusted data Show forest plot	21	2865	Peto Odds Ratio (95% CI)	0.81 [0.67, 0.99]

2 Overall survival ‐ all studies, unadjusted data Show forest plot	21	2865	Peto Odds Ratio (95% CI)	0.84 [0.69, 1.02]

3 Overall Survival ‐ baseline Hb Show forest plot	21	2865	Peto Odds Ratio (95% CI)	0.81 [0.67, 0.99]

3.1 Hb </= 10 g/dL	15	2468	Peto Odds Ratio (95% CI)	0.83 [0.68, 1.01]
3.2 Hb 10 to 12 g/dL	2	175	Peto Odds Ratio (95% CI)	0.59 [0.12, 2.96]
3.3 Hb > 12 g/dL	4	222	Peto Odds Ratio (95% CI)	0.61 [0.20, 1.87]
4 Overall Survival ‐ different malignancies Show forest plot	21	2865	Peto Odds Ratio (95% CI)	0.81 [0.67, 0.99]

4.1 solid tumors	9	750	Peto Odds Ratio (95% CI)	0.49 [0.25, 0.94]
4.2 haematological malignancies	6	999	Peto Odds Ratio (95% CI)	1.00 [0.67, 1.49]
4.3 MDS	1	66	Peto Odds Ratio (95% CI)	4.52 [0.38, 53.37]
4.4 mixed	5	1050	Peto Odds Ratio (95% CI)	0.80 [0.63, 1.01]
5 Overall Survival ‐ iron supplementation Show forest plot	21	2865	Peto Odds Ratio (95% CI)	0.81 [0.67, 0.99]

5.1 fixed iron supplementation	3	440	Peto Odds Ratio (95% CI)	0.76 [0.58, 0.99]
5.2 iron supplementation as necessary	14	2115	Peto Odds Ratio (95% CI)	0.82 [0.61, 1.12]
5.3 no explicit statement on iron supplementation	4	310	Peto Odds Ratio (95% CI)	1.18 [0.61, 2.29]
6 Overall Survival ‐ different therapies Show forest plot	21	2865	Peto Odds Ratio (95% CI)	0.81 [0.67, 0.99]

6.1 chemotherapy with platinum	10	965	Peto Odds Ratio (95% CI)	0.51 [0.30, 0.86]
6.2 chemotherapy without platinum	8	1448	Peto Odds Ratio (95% CI)	0.86 [0.69, 1.07]
6.3 radiotherapy	0	0	Peto Odds Ratio (95% CI)	0.0 [0.0, 0.0]
6.4 no therapy	2	190	Peto Odds Ratio (95% CI)	1.06 [0.47, 2.38]
6.5 unclear	1	262	Peto Odds Ratio (95% CI)	1.02 [0.38, 2.72]
7 Overall Survival ‐ allocation concealment Show forest plot	21	2865	Peto Odds Ratio (95% CI)	0.81 [0.67, 0.99]

7.1 adequate	17	2323	Peto Odds Ratio (95% CI)	0.82 [0.68, 1.01]
7.2 unclear	4	542	Peto Odds Ratio (95% CI)	0.67 [0.30, 1.50]
8 Overall Survival ‐ masking Show forest plot	21	2865	Peto Odds Ratio (95% CI)	0.81 [0.67, 0.99]

8.1 double‐blind	10	1698	Peto Odds Ratio (95% CI)	0.83 [0.67, 1.03]
8.2 unblinded	11	1167	Peto Odds Ratio (95% CI)	0.75 [0.49, 1.15]
8.3 unclear	0	0	Peto Odds Ratio (95% CI)	0.0 [0.0, 0.0]
9 Overall Survival ‐ completeness Show forest plot	21	2865	Peto Odds Ratio (95% CI)	0.81 [0.67, 0.99]

9.1 drop‐outs and withdrawals in each group stated	20	2799	Peto Odds Ratio (95% CI)	0.81 [0.66, 0.98]
9.2 no information on drop‐outs and withdrawals	1	66	Peto Odds Ratio (95% CI)	4.52 [0.38, 53.37]
10 Overall Survival ‐ intention‐to‐treat Show forest plot	21	2865	Peto Odds Ratio (95% CI)	0.81 [0.67, 0.99]

10.1 ITT or less than 10% of participants per studyarm excluded	21	2865	Peto Odds Ratio (95% CI)	0.81 [0.67, 0.99]
10.2 more than 10% of participants per studyarm excluded	0	0	Peto Odds Ratio (95% CI)	0.0 [0.0, 0.0]
11 Overall Survival ‐ publication Show forest plot	21	2865	Peto Odds Ratio (95% CI)	0.81 [0.67, 0.99]

11.1 peer reviewed publication	6	746	Peto Odds Ratio (95% CI)	0.75 [0.58, 0.97]
11.2 abstract publication	0	0	Peto Odds Ratio (95% CI)	0.0 [0.0, 0.0]
11.3 unpublished data	15	2119	Peto Odds Ratio (95% CI)	0.90 [0.68, 1.21]
12 Overall Survival ‐ median observation time Show forest plot	21	2865	Peto Odds Ratio (95% CI)	0.81 [0.67, 0.99]

12.1 </= 1 year	19	2428	Peto Odds Ratio (95% CI)	0.89 [0.67, 1.17]
12.2 > 1 year	2	437	Peto Odds Ratio (95% CI)	0.75 [0.58, 0.99]
13 Overall survival ‐ time‐to‐event or binary mortality data Show forest plot	21	2865	Peto Odds Ratio (95% CI)	0.81 [0.67, 0.99]

13.1 binary mortality data at end of study	12	1195	Peto Odds Ratio (95% CI)	0.87 [0.57, 1.32]
13.2 </= 1 year	7	1233	Peto Odds Ratio (95% CI)	0.90 [0.62, 1.31]
13.3 > 1 year	2	437	Peto Odds Ratio (95% CI)	0.75 [0.58, 0.99]

Comparison 5. Overall Survival

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Comparison 6. Tumor Response

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Complete Response Show forest plot	9	1150	Risk Ratio (M‐H, Fixed, 95% CI)	1.36 [1.07, 1.72]

Comparison 6. Tumor Response

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Comparison 7. Adverse events

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Thrombotic events Show forest plot	15	1738	Risk Ratio (M‐H, Fixed, 95% CI)	1.58 [0.94, 2.66]

2 Hypertension Show forest plot	16	1656	Risk Ratio (M‐H, Fixed, 95% CI)	1.19 [0.96, 1.49]

3 Hemorrhage/Thrombocytopenia Show forest plot	11	1082	Risk Ratio (M‐H, Fixed, 95% CI)	1.26 [0.85, 1.86]

4 Rash/Irritation/Pruritus Show forest plot	10	675	Risk Ratio (M‐H, Fixed, 95% CI)	1.17 [0.63, 2.18]

5 Seizure Show forest plot	3	389	Risk Ratio (M‐H, Fixed, 95% CI)	1.19 [0.33, 4.35]

Comparison 7. Adverse events

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