Comparison of chemotherapy including escalated BEACOPP versus chemotherapy including ABVD for patients with early unfavourable or advanced stage Hodgkin lymphoma

Kathrin Bauer; Nicole Skoetz; Ina Monsef; Andreas Engert; Corinne Brillant

doi:10.1002/14651858.CD007941.pub2

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Figure 1

Study flow diagram.

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Figure 2

Forest plot of comparison: 1 Analysis of Overall Survival, outcome: 1.1 OS ‐ all ‐ same recruitment period between the 2 arms (HD9).

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Figure 3

Forest plot of comparison: 2 Analysis of Progression Free Survival, outcome: 2.1 PFS ‐ all ‐ same recruitment period between the 2 arms (HD9).

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Figure 4

Forest plot of comparison: 3 Analysis of complete response (CR) rate, outcome: 3.1 CR.

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Analysis 1.1

Comparison 1 Analysis overall survival, Outcome 1 OS ‐ all ‐ same recruitment period between the 2 arms (HD9).

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Analysis 1.2

Comparison 1 Analysis overall survival, Outcome 2 OS subgrouped by stage of disease.

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Analysis 1.3

Comparison 1 Analysis overall survival, Outcome 3 OS subgrouped by treatment.

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Analysis 1.4

Comparison 1 Analysis overall survival, Outcome 4 OS subgrouped by number of cycles of escalated BEACOPP.

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Analysis 1.5

Comparison 1 Analysis overall survival, Outcome 5 OS subgrouped by length of follow‐up.

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Analysis 1.6

Comparison 1 Analysis overall survival, Outcome 6 OS subgrouped by publication form.

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Analysis 1.7

Comparison 1 Analysis overall survival, Outcome 7 OS subgrouped by type of results.

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Analysis 1.8

Comparison 1 Analysis overall survival, Outcome 8 OS ‐ all recruited patients (HD9) with potential risk of bias due to different time periods of recruitment.

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Analysis 2.1

Comparison 2 Analysis of progression‐free survival (PFS), Outcome 1 PFS ‐ all ‐ same recruitment period between the 2 arms (HD9).

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Analysis 2.2

Comparison 2 Analysis of progression‐free survival (PFS), Outcome 2 PFS subgrouped by stage of disease.

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Analysis 2.3

Comparison 2 Analysis of progression‐free survival (PFS), Outcome 3 PFS subgrouped by treatment.

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Analysis 2.4

Comparison 2 Analysis of progression‐free survival (PFS), Outcome 4 PFS subgrouped by number of cycles of escalated BEACOPP.

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Analysis 2.5

Comparison 2 Analysis of progression‐free survival (PFS), Outcome 5 PFS subgrouped by length of follow‐up.

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Analysis 2.6

Comparison 2 Analysis of progression‐free survival (PFS), Outcome 6 PFS subgrouped by publication form.

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Analysis 2.7

Comparison 2 Analysis of progression‐free survival (PFS), Outcome 7 PFS subgrouped by type of results.

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Analysis 2.8

Comparison 2 Analysis of progression‐free survival (PFS), Outcome 8 PFS ‐ all recruited patients (HD9) with potential risk of bias due to different time periods of recruitment.

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Analysis 3.1

Comparison 3 Analysis of complete response (CR) rate, Outcome 1 CR.

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Analysis 3.2

Comparison 3 Analysis of complete response (CR) rate, Outcome 2 CR subgrouped by treatment.

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Analysis 3.3

Comparison 3 Analysis of complete response (CR) rate, Outcome 3 CR subgrouped by number of cycles of escalated BEACOPP.

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Analysis 3.4

Comparison 3 Analysis of complete response (CR) rate, Outcome 4 CR subgrouped by length of follow‐up.

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Analysis 3.5

Comparison 3 Analysis of complete response (CR) rate, Outcome 5 CR subgrouped by publication form.

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Analysis 4.1

Comparison 4 Analysis of freedom from first progression, Outcome 1 Freedom from first progression.

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Analysis 5.1

Comparison 5 Analysis of treatment‐related mortality, Outcome 1 Treatment‐related mortality.

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Analysis 6.1

Comparison 6 Analysis of secondary malignancies, Outcome 1 Secondary malignancies.

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Analysis 6.2

Comparison 6 Analysis of secondary malignancies, Outcome 2 Secondary malignancies subgrouped by stage of disease.

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Analysis 6.3

Comparison 6 Analysis of secondary malignancies, Outcome 3 Subgrouped by treatment.

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Analysis 6.4

Comparison 6 Analysis of secondary malignancies, Outcome 4 Subgrouped by number of cycles of escalated BEACOPP.

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Analysis 6.5

Comparison 6 Analysis of secondary malignancies, Outcome 5 Subgrouped by length of follow‐up.

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Analysis 6.6

Comparison 6 Analysis of secondary malignancies, Outcome 6 Subgrouped by publication form.

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Analysis 6.7

Comparison 6 Analysis of secondary malignancies, Outcome 7 Subgrouped by type of results.

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Analysis 7.1

Comparison 7 Analysis of AML or MDS, Outcome 1 AML or MDS.

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Analysis 8.1

Comparison 8 Analysis of fertility, Outcome 1 Secondary amenorrhoea.

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Analysis 9.1

Comparison 9 Analysis of anaemia, Outcome 1 Anaemia.

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Analysis 9.2

Comparison 9 Analysis of anaemia, Outcome 2 Subgrouped by stage of disease.

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Analysis 9.3

Comparison 9 Analysis of anaemia, Outcome 3 Subgrouped by treatment.

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Analysis 9.4

Comparison 9 Analysis of anaemia, Outcome 4 Subgrouped by number of cycles of escalated BEACOPP.

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Analysis 9.5

Comparison 9 Analysis of anaemia, Outcome 5 Subgrouped by length of follow‐up.

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Analysis 9.6

Comparison 9 Analysis of anaemia, Outcome 6 Subgrouped by publication form.

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Analysis 9.7

Comparison 9 Analysis of anaemia, Outcome 7 Subgrouped by type of results.

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Analysis 10.1

Comparison 10 Analysis of infection, Outcome 1 Infection.

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Analysis 10.2

Comparison 10 Analysis of infection, Outcome 2 Subgrouped by stage of disease.

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Analysis 10.3

Comparison 10 Analysis of infection, Outcome 3 Subgrouped by treatment.

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Analysis 10.4

Comparison 10 Analysis of infection, Outcome 4 Subgrouped by number of cycles of escalated BEACOPP.

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Analysis 10.5

Comparison 10 Analysis of infection, Outcome 5 Subgrouped by length of follow‐up.

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Analysis 10.6

Comparison 10 Analysis of infection, Outcome 6 Subgrouped by publication form.

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Analysis 10.7

Comparison 10 Analysis of infection, Outcome 7 Subgrouped by type of results.

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Analysis 11.1

Comparison 11 Analysis of leucopenia, Outcome 1 Leucopenia.

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Analysis 11.2

Comparison 11 Analysis of leucopenia, Outcome 2 Subgrouped by stage of disease.

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Analysis 11.3

Comparison 11 Analysis of leucopenia, Outcome 3 Subgrouped by treatment.

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Analysis 11.4

Comparison 11 Analysis of leucopenia, Outcome 4 Subgrouped by number of cycles of escalated BEACOPP.

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Analysis 11.5

Comparison 11 Analysis of leucopenia, Outcome 5 Subgrouped by length of follow‐up.

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Analysis 11.6

Comparison 11 Analysis of leucopenia, Outcome 6 Subgrouped by publication form.

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Analysis 11.7

Comparison 11 Analysis of leucopenia, Outcome 7 Subgrouped by type of results.

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Analysis 12.1

Comparison 12 Analysis of neutropenia, Outcome 1 Neutropenia.

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Analysis 13.1

Comparison 13 Analysis of thrombocytopenia, Outcome 1 Thrombocytopenia.

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Analysis 13.2

Comparison 13 Analysis of thrombocytopenia, Outcome 2 Subgrouped by stage of disease.

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Analysis 13.3

Comparison 13 Analysis of thrombocytopenia, Outcome 3 Subgrouped by treatment.

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Analysis 13.4

Comparison 13 Analysis of thrombocytopenia, Outcome 4 Subgrouped by number of cycles of escalated BEACOPP.

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Analysis 13.5

Comparison 13 Analysis of thrombocytopenia, Outcome 5 Subgrouped by length of follow‐up.

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Analysis 13.6

Comparison 13 Analysis of thrombocytopenia, Outcome 6 Subgrouped by publication form.

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Analysis 13.7

Comparison 13 Analysis of thrombocytopenia, Outcome 7 Subgrouped by type of results.

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Analysis 14.1

Comparison 14 Analysis of alopecia, Outcome 1 Alopecia.

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Analysis 14.2

Comparison 14 Analysis of alopecia, Outcome 2 Subgrouped by stage of disease.

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Analysis 14.3

Comparison 14 Analysis of alopecia, Outcome 3 Subgrouped by treatment.

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Analysis 14.4

Comparison 14 Analysis of alopecia, Outcome 4 Subgrouped by number of cycles of escalated BEACOPP.

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Analysis 14.5

Comparison 14 Analysis of alopecia, Outcome 5 Subgrouped by length of follow‐up.

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Analysis 14.6

Comparison 14 Analysis of alopecia, Outcome 6 Subgrouped by publication form.

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Analysis 14.7

Comparison 14 Analysis of alopecia, Outcome 7 Subgrouped by type of results.

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Analysis 15.1

Comparison 15 Analysis of constipation, Outcome 1 Constipation.

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Analysis 16.1

Comparison 16 Analysis of mucositis, Outcome 1 Mucositis.

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Analysis 17.1

Comparison 17 Analysis of nausea/vomiting, Outcome 1 Nausea/vomiting.

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Analysis 18.1

Comparison 18 Analysis of neurologic, Outcome 1 Neurologic.

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Analysis 19.1

Comparison 19 Analysis of pain, Outcome 1 Pain.

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Analysis 20.1

Comparison 20 Analysis of respiratory, Outcome 1 Respiratory.

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Analysis 21.1

Comparison 21 Analysis of skin, Outcome 1 Skin.

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Chemotherapy including escalated BEACOPP compared with chemotherapy including ABVD for patients with early unfavourable or advanced stage Hodgkin lymphoma
Patient or population: patients with early unfavourable or advanced stage Hodgkin lymphoma Intervention: chemotherapy including escalated BEACOPP Comparison: chemotherapy including ABVD
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	ABVD	escalated BEACOPP
OS	Low risk population¹		HR 0.80 [0.59 to 1.09]	2586 (4 studies)	+++O moderate⁴
	100 deaths per 1000	81 per 1000 (60 to 108)
	High risk population²
	250 deaths per 1000	206 per 1000 (156 to 269)
PFS	Low risk population³		HR 0.53 [0.44 to 0.64]	2586 (4 studies)	+++O moderate⁵
	100 progressions or relapses per 1000	54 per 1000 (45 to 65)
	High risk population²
	330 progressions or relapses per 1000	191 per 1000 (162 to 226)
CR rate	High risk population²		RR 1.11 [1.06 to 1.16]	1245 (3 studies)	++++ high
	831 complete responses per 1000	922 per 1000 (881 to 964)
Adverse events WHO grade III or IV	See comment	See comment	See comment	2547 (3 studies)	+++O⁶ moderate	Escalated BEACOPP regimens cause more haematological toxicities, infections, alopecia, mucositis and pain. No differences were found for constipation, nausea, neurologic toxicity.
Incidence of secondary malignancies	Low risk population²		RR 0.95 (0.61 to 1.48)	2547 (3 studies)	++OO low⁷	As most of the trials had a median observation of less than 10 years, sufficient long term information on secondary malignancies cannot be expected.
	2 per 1000	2 per 1000 (2 to 2)
	High risk population²
	44 per 1000	42 per 1000 (25 to 65)
Incidence of infertility	375 per 1000	514 per 1000 (311 to 847)	RR 1.37 [0.83 to 2.26]	106 (1 study)	+OOO very low⁸	The subset of only 106 out of 608 eligible women of the HD9 were available for analyses regarding infertility. Reasons for availability are unknown and might have introduced bias in the results.
Treatment related mortality	See comment	See comment	RR 5.05 (0.25 to 103.87)	197 (1 study)	+OOO very low⁹	No participant died in the control group and 2 died in the intervention group of the only study that reported this outcome.
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk Ratio; HR: Hazard Ratio
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹The risk for the "low risk population" (i.e. patients with early unfavourable HL) was taken from the GHSG HD8 trial, because the HD14 trial did not provide sufficient information regarding the control risk. ²The risk for the "high risk population" (i.e. patients with advanced stage of HL) was approximately the risk of the GHSG HD9 trial. ³The risk for the "low risk population" (i.e. patients with early unfavourable HL) was taken from the GHSG HD14 trial. ⁴ The median follow‐up varied between the trials. Longer follow‐ups and the inclusion of the EORTC 20012 trial will lead to a more precise estimate of the effect. This uncertainty causes the downgrading here. ⁵The definition of how to assess progression of disease varied between the trials. These heterogeneous definitions lead to an imprecise estimate of the effect that causes the downgrading here. ⁶So far two of the four trials reported results regarding adverse effects. The inclusion of further trials might lead to a more precise estimate of the effect. This uncertainty causes the downgrading here. ⁷ So far two of the four trials reported results regarding secondary malignancies. Furthermore, as most of the trials had a median observation of less than 10 years, sufficient long term information on secondary malignancies cannot be expected. The inclusion of further trials and results of longer follow‐up might lead to a more precise estimate of the effect. This uncertainty causes the downgrading here. ⁸ So far only 106 patients of the HD9 were analysed regarding infertility. The inclusion of further trials will lead to a more precise estimate of the effect.This uncertainty causes the downgrading here. ⁹ So far one of the four trials reported results regarding treatment‐related mortality. The inclusion of further trials will lead to a more precise estimate of the effect.This uncertainty causes the downgrading here.

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Comparison 1. Analysis overall survival

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 OS ‐ all ‐ same recruitment period between the 2 arms (HD9) Show forest plot	4	2583	Hazard Ratio (Fixed, 95% CI)	0.80 [0.59, 1.09]

2 OS subgrouped by stage of disease Show forest plot	4	2583	Hazard Ratio (Fixed, 95% CI)	0.80 [0.59, 1.09]

2.1 early unfavourable stage	1	1623	Hazard Ratio (Fixed, 95% CI)	1.02 [0.54, 1.91]
2.2 advanced stage	3	960	Hazard Ratio (Fixed, 95% CI)	0.74 [0.52, 1.06]
3 OS subgrouped by treatment Show forest plot	4	2583	Hazard Ratio (Fixed, 95% CI)	0.80 [0.59, 1.09]

3.1 only ABVD regimen	3	2141	Hazard Ratio (Fixed, 95% CI)	1.03 [0.67, 1.59]
3.2 ABVD including regimen	1	442	Hazard Ratio (Fixed, 95% CI)	0.62 [0.40, 0.96]
4 OS subgrouped by number of cycles of escalated BEACOPP Show forest plot	4	2583	Hazard Ratio (Fixed, 95% CI)	0.80 [0.59, 1.09]

4.1 eight cycles of escalated BEACOPP	1	442	Hazard Ratio (Fixed, 95% CI)	0.62 [0.40, 0.96]
4.2 four cycles of escalated BEACOPP	2	518	Hazard Ratio (Fixed, 95% CI)	1.05 [0.58, 1.90]
4.3 two cycles of escalated BEACOPP	1	1623	Hazard Ratio (Fixed, 95% CI)	1.02 [0.54, 1.91]
5 OS subgrouped by length of follow‐up Show forest plot	4	2583	Hazard Ratio (Fixed, 95% CI)	0.80 [0.59, 1.09]

5.1 short term follow‐up (median length up to 5 years)	3	2141	Hazard Ratio (Fixed, 95% CI)	1.03 [0.67, 1.59]
5.2 long term follow‐up (median length 10 years)	1	442	Hazard Ratio (Fixed, 95% CI)	0.62 [0.40, 0.96]
6 OS subgrouped by publication form Show forest plot	4	2583	Hazard Ratio (Fixed, 95% CI)	0.80 [0.59, 1.09]

6.1 full text publication	2	639	Hazard Ratio (Fixed, 95% CI)	0.67 [0.45, 1.01]
6.2 abstract publication	2	1944	Hazard Ratio (Fixed, 95% CI)	1.02 [0.64, 1.65]
7 OS subgrouped by type of results Show forest plot	4	2583	Hazard Ratio (Fixed, 95% CI)	0.80 [0.59, 1.09]

7.1 preliminary results	2	1944	Hazard Ratio (Fixed, 95% CI)	1.02 [0.64, 1.65]
7.2 mature results	2	639	Hazard Ratio (Fixed, 95% CI)	0.67 [0.45, 1.01]
8 OS ‐ all recruited patients (HD9) with potential risk of bias due to different time periods of recruitment Show forest plot	4		Hazard Ratio (Fixed, 95% CI)	0.66 [0.50, 0.88]

Comparison 1. Analysis overall survival

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Comparison 2. Analysis of progression‐free survival (PFS)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 PFS ‐ all ‐ same recruitment period between the 2 arms (HD9) Show forest plot	4	2583	Hazard Ratio (Fixed, 95% CI)	0.53 [0.44, 0.64]

2 PFS subgrouped by stage of disease Show forest plot	4	2583	Hazard Ratio (Fixed, 95% CI)	0.53 [0.44, 0.64]

2.1 early unfavourable stage	1	1623	Hazard Ratio (Fixed, 95% CI)	0.49 [0.34, 0.71]
2.2 advanced stage	3	960	Hazard Ratio (Fixed, 95% CI)	0.54 [0.43, 0.67]
3 PFS subgrouped by treatment Show forest plot	4	2583	Hazard Ratio (Fixed, 95% CI)	0.53 [0.44, 0.64]

3.1 only ABVD regimen	3	2141	Hazard Ratio (Fixed, 95% CI)	0.54 [0.43, 0.67]
3.2 ABVD including regimen	1	442	Hazard Ratio (Fixed, 95% CI)	0.50 [0.34, 0.72]
4 PFS subgrouped by number of cycles of escalated BEACOPP Show forest plot	4	2583	Hazard Ratio (Fixed, 95% CI)	0.53 [0.44, 0.64]

4.1 eight cycles of escalated BEACOPP	1	442	Hazard Ratio (Fixed, 95% CI)	0.50 [0.34, 0.72]
4.2 four cycles of escalated BEACOPP	2	518	Hazard Ratio (Fixed, 95% CI)	0.57 [0.43, 0.74]
4.3 two cycles of escalated BEACOPP	1	1623	Hazard Ratio (Fixed, 95% CI)	0.49 [0.34, 0.71]
5 PFS subgrouped by length of follow‐up Show forest plot	4	2583	Hazard Ratio (Fixed, 95% CI)	0.53 [0.44, 0.64]

5.1 short term follow‐up (median length up to 5 years)	3	2141	Hazard Ratio (Fixed, 95% CI)	0.54 [0.43, 0.67]
5.2 long term follow‐up (median length 10 years)	1	442	Hazard Ratio (Fixed, 95% CI)	0.50 [0.34, 0.72]
6 PFS subgrouped by publication form Show forest plot	4	2583	Hazard Ratio (Fixed, 95% CI)	0.53 [0.44, 0.64]

6.1 full text publication	2	639	Hazard Ratio (Fixed, 95% CI)	0.51 [0.39, 0.65]
6.2 abstract publication	2	1944	Hazard Ratio (Fixed, 95% CI)	0.56 [0.42, 0.75]
7 PFS subgrouped by type of results Show forest plot	4	2583	Hazard Ratio (Fixed, 95% CI)	0.53 [0.44, 0.64]

7.1 preliminary results	2	1944	Hazard Ratio (Fixed, 95% CI)	0.56 [0.42, 0.75]
7.2 mature results	2	639	Hazard Ratio (Fixed, 95% CI)	0.51 [0.39, 0.65]
8 PFS ‐ all recruited patients (HD9) with potential risk of bias due to different time periods of recruitment Show forest plot	4		Hazard Ratio (Fixed, 95% CI)	0.48 [0.40, 0.58]

Comparison 2. Analysis of progression‐free survival (PFS)

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Comparison 3. Analysis of complete response (CR) rate

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 CR Show forest plot	3	1245	Risk Ratio (M‐H, Fixed, 95% CI)	1.11 [1.06, 1.16]

2 CR subgrouped by treatment Show forest plot	3	1245	Risk Ratio (M‐H, Fixed, 95% CI)	1.11 [1.06, 1.16]

2.1 only ABVD regimen	2	518	Risk Ratio (M‐H, Fixed, 95% CI)	1.08 [1.00, 1.16]
2.2 ABVD including regimen	1	727	Risk Ratio (M‐H, Fixed, 95% CI)	1.13 [1.07, 1.19]
3 CR subgrouped by number of cycles of escalated BEACOPP Show forest plot	3	1245	Risk Ratio (M‐H, Fixed, 95% CI)	1.11 [1.06, 1.16]

3.1 eight cycles of escalated BEACOPP	1	727	Risk Ratio (M‐H, Fixed, 95% CI)	1.13 [1.07, 1.19]
3.2 four cycles of escalated BEACOPP	2	518	Risk Ratio (M‐H, Fixed, 95% CI)	1.08 [1.00, 1.16]
4 CR subgrouped by length of follow‐up Show forest plot	3	1245	Risk Ratio (M‐H, Fixed, 95% CI)	1.11 [1.06, 1.16]

4.1 short term follow‐up (median length up to 5 years)	2	518	Risk Ratio (M‐H, Fixed, 95% CI)	1.08 [1.00, 1.16]
4.2 long term follow‐up (median length 10 years)	1	727	Risk Ratio (M‐H, Fixed, 95% CI)	1.13 [1.07, 1.19]
5 CR subgrouped by publication form Show forest plot	3	1245	Risk Ratio (M‐H, Fixed, 95% CI)	1.11 [1.06, 1.16]

5.1 full text publication	2	924	Risk Ratio (M‐H, Fixed, 95% CI)	1.12 [1.07, 1.18]
5.2 abstract publication	1	321	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.97, 1.19]

Comparison 3. Analysis of complete response (CR) rate

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Comparison 4. Analysis of freedom from first progression

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Freedom from first progression Show forest plot	1	321	Hazard Ratio (Fixed, 95% CI)	0.51 [0.31, 0.85]

Comparison 4. Analysis of freedom from first progression

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Comparison 5. Analysis of treatment‐related mortality

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Treatment‐related mortality Show forest plot	1	197	Risk Ratio (M‐H, Fixed, 95% CI)	5.05 [0.25, 103.87]

Comparison 5. Analysis of treatment‐related mortality

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Comparison 6. Analysis of secondary malignancies

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Secondary malignancies Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.61, 1.48]

2 Secondary malignancies subgrouped by stage of disease Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.61, 1.48]

2.1 early unfavourable stage	1	1623	Risk Ratio (M‐H, Fixed, 95% CI)	0.86 [0.44, 1.65]
2.2 advanced stage	2	924	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.58, 1.89]
3 Subgrouped by treatment Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.61, 1.48]

3.1 only ABVD regimen	2	1820	Risk Ratio (M‐H, Fixed, 95% CI)	0.86 [0.46, 1.64]
3.2 ABVD including regimen	1	727	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.57, 1.92]
4 Subgrouped by number of cycles of escalated BEACOPP Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.61, 1.48]

4.1 eight cycles of escalated BEACOPP	1	727	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.57, 1.92]
4.2 four cycles of escalated BEACOPP	1	197	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.06, 15.92]
4.3 two cycles of escalated BEACOPP	1	1623	Risk Ratio (M‐H, Fixed, 95% CI)	0.86 [0.44, 1.65]
5 Subgrouped by length of follow‐up Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.61, 1.48]

5.1 short term follow‐up (median length up to 5 years)	2	1820	Risk Ratio (M‐H, Fixed, 95% CI)	0.86 [0.46, 1.64]
5.2 long term follow‐up (median length 10 years)	1	727	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.57, 1.92]
6 Subgrouped by publication form Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.61, 1.48]

6.1 full text publication	2	924	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.58, 1.89]
6.2 abstract publication	1	1623	Risk Ratio (M‐H, Fixed, 95% CI)	0.86 [0.44, 1.65]
7 Subgrouped by type of results Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.61, 1.48]

7.1 preliminary results	1	1623	Risk Ratio (M‐H, Fixed, 95% CI)	0.86 [0.44, 1.65]
7.2 mature results	2	924	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.58, 1.89]

Comparison 6. Analysis of secondary malignancies

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Comparison 7. Analysis of AML or MDS

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 AML or MDS Show forest plot	2	924	Risk Ratio (M‐H, Fixed, 95% CI)	7.84 [1.04, 59.29]

Comparison 7. Analysis of AML or MDS

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Comparison 8. Analysis of fertility

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Secondary amenorrhoea Show forest plot	1	106	Risk Ratio (M‐H, Fixed, 95% CI)	1.37 [0.83, 2.26]

Comparison 8. Analysis of fertility

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Comparison 9. Analysis of anaemia

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Anaemia Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	10.47 [7.06, 15.54]

2 Subgrouped by stage of disease Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	10.47 [7.06, 15.54]

2.1 early unfavourable stage	1	1623	Risk Ratio (M‐H, Fixed, 95% CI)	9.15 [4.43, 18.86]
2.2 advanced stage	2	924	Risk Ratio (M‐H, Fixed, 95% CI)	10.96 [6.86, 17.51]
3 Subgrouped by treatment Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	10.47 [7.06, 15.54]

3.1 only ABVD regimen	2	1820	Risk Ratio (M‐H, Fixed, 95% CI)	6.87 [3.87, 12.18]
3.2 ABVD including regimen	1	727	Risk Ratio (M‐H, Fixed, 95% CI)	13.27 [7.78, 22.63]
4 Subgrouped by number of cycles of escalated BEACOPP Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	10.47 [7.06, 15.54]

4.1 eight cycles of escalated BEACOPP	1	727	Risk Ratio (M‐H, Fixed, 95% CI)	13.27 [7.78, 22.63]
4.2 four cycles of escalated BEACOPP	1	197	Risk Ratio (M‐H, Fixed, 95% CI)	3.23 [1.23, 8.48]
4.3 two cycles of escalated BEACOPP	1	1623	Risk Ratio (M‐H, Fixed, 95% CI)	9.15 [4.43, 18.86]
5 Subgrouped by length of follow‐up Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	10.47 [7.06, 15.54]

5.1 short term follow‐up (median length up to 5 years)	2	1820	Risk Ratio (M‐H, Fixed, 95% CI)	6.87 [3.87, 12.18]
5.2 long term follow‐up (median length 10 years)	1	727	Risk Ratio (M‐H, Fixed, 95% CI)	13.27 [7.78, 22.63]
6 Subgrouped by publication form Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	10.47 [7.06, 15.54]

6.1 full text publication	2	924	Risk Ratio (M‐H, Fixed, 95% CI)	10.96 [6.86, 17.51]
6.2 abstract publication	1	1623	Risk Ratio (M‐H, Fixed, 95% CI)	9.15 [4.43, 18.86]
7 Subgrouped by type of results Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	10.47 [7.06, 15.54]

7.1 preliminary results	1	1623	Risk Ratio (M‐H, Fixed, 95% CI)	9.15 [4.43, 18.86]
7.2 mature results	2	924	Risk Ratio (M‐H, Fixed, 95% CI)	10.96 [6.86, 17.51]

Comparison 9. Analysis of anaemia

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Comparison 10. Analysis of infection

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Infection Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	3.67 [2.57, 5.24]

2 Subgrouped by stage of disease Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	3.67 [2.57, 5.24]

2.1 early unfavourable stage	1	1623	Risk Ratio (M‐H, Fixed, 95% CI)	2.14 [1.38, 3.32]
2.2 advanced stage	2	924	Risk Ratio (M‐H, Fixed, 95% CI)	7.13 [3.78, 13.45]
3 Subgrouped by treatment Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	3.67 [2.57, 5.24]

3.1 only ABVD regimen	2	1820	Risk Ratio (M‐H, Fixed, 95% CI)	2.47 [1.63, 3.74]
3.2 ABVD including regimen	1	727	Risk Ratio (M‐H, Fixed, 95% CI)	7.14 [3.53, 14.43]
4 Subgrouped by number of cycles of escalated BEACOPP Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	3.67 [2.57, 5.24]

4.1 eight cycles of escalated BEACOPP	1	727	Risk Ratio (M‐H, Fixed, 95% CI)	7.14 [3.53, 14.43]
4.2 four cycles of escalated BEACOPP	1	197	Risk Ratio (M‐H, Fixed, 95% CI)	7.07 [1.65, 30.30]
4.3 two cycles of escalated BEACOPP	1	1623	Risk Ratio (M‐H, Fixed, 95% CI)	2.14 [1.38, 3.32]
5 Subgrouped by length of follow‐up Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	3.67 [2.57, 5.24]

5.1 short term follow‐up (median length up to 5 years)	2	1820	Risk Ratio (M‐H, Fixed, 95% CI)	2.47 [1.63, 3.74]
5.2 long term follow‐up (median length 10 years)	1	727	Risk Ratio (M‐H, Fixed, 95% CI)	7.14 [3.53, 14.43]
6 Subgrouped by publication form Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	3.67 [2.57, 5.24]

6.1 full text publication	2	924	Risk Ratio (M‐H, Fixed, 95% CI)	7.13 [3.78, 13.45]
6.2 abstract publication	1	1623	Risk Ratio (M‐H, Fixed, 95% CI)	2.14 [1.38, 3.32]
7 Subgrouped by type of results Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	3.67 [2.57, 5.24]

7.1 preliminary results	1	1623	Risk Ratio (M‐H, Fixed, 95% CI)	2.14 [1.38, 3.32]
7.2 mature results	2	924	Risk Ratio (M‐H, Fixed, 95% CI)	7.13 [3.78, 13.45]

Comparison 10. Analysis of infection

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Comparison 11. Analysis of leucopenia

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Leucopenia Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	2.26 [2.09, 2.44]

2 Subgrouped by stage of disease Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	2.27 [2.10, 2.45]

2.1 early unfavourable stage	1	1623	Risk Ratio (M‐H, Fixed, 95% CI)	3.30 [2.90, 3.74]
2.2 advanced stage	2	924	Risk Ratio (M‐H, Fixed, 95% CI)	1.49 [1.37, 1.62]
3 Subgrouped by treatment Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	2.27 [2.10, 2.45]

3.1 only ABVD regimen	2	1820	Risk Ratio (M‐H, Fixed, 95% CI)	3.22 [2.86, 3.64]
3.2 ABVD including regimen	1	727	Risk Ratio (M‐H, Fixed, 95% CI)	1.39 [1.28, 1.50]
4 Subgrouped by number of cycles of escalated BEACOPP Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	2.27 [2.10, 2.45]

4.1 eight cycles of escalated BEACOPP	1	727	Risk Ratio (M‐H, Fixed, 95% CI)	1.39 [1.28, 1.50]
4.2 two cycles of escalated BEACOPP	1	197	Risk Ratio (M‐H, Fixed, 95% CI)	2.57 [1.71, 3.86]
4.3 two cycles of escalated BEACOPP	1	1623	Risk Ratio (M‐H, Fixed, 95% CI)	3.30 [2.90, 3.74]
5 Subgrouped by length of follow‐up Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	2.27 [2.10, 2.45]

5.1 short term follow‐up (median length up to 5 years)	2	1820	Risk Ratio (M‐H, Fixed, 95% CI)	3.22 [2.86, 3.64]
5.2 long term follow‐up (median length 10 years)	1	727	Risk Ratio (M‐H, Fixed, 95% CI)	1.39 [1.28, 1.50]
6 Subgrouped by publication form Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	2.27 [2.10, 2.45]

6.1 full text publication	2	924	Risk Ratio (M‐H, Fixed, 95% CI)	1.49 [1.37, 1.62]
6.2 abstract publication	1	1623	Risk Ratio (M‐H, Fixed, 95% CI)	3.30 [2.90, 3.74]
7 Subgrouped by type of results Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	2.27 [2.10, 2.45]

7.1 preliminary results	1	1623	Risk Ratio (M‐H, Fixed, 95% CI)	3.30 [2.90, 3.74]
7.2 mature results	2	924	Risk Ratio (M‐H, Fixed, 95% CI)	1.49 [1.37, 1.62]

Comparison 11. Analysis of leucopenia

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Comparison 12. Analysis of neutropenia

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Neutropenia Show forest plot	1	197	Risk Ratio (M‐H, Fixed, 95% CI)	1.57 [1.13, 2.19]

Comparison 12. Analysis of neutropenia

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Comparison 13. Analysis of thrombocytopenia

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Thrombocytopenia Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	18.73 [12.17, 28.82]

2 Subgrouped by stage of disease Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	18.73 [12.17, 28.82]

2.1 early unfavourable stage	1	1623	Risk Ratio (M‐H, Fixed, 95% CI)	179.86 [25.26, 1280.82]
2.2 advanced stage	2	924	Risk Ratio (M‐H, Fixed, 95% CI)	11.53 [7.30, 18.23]
3 Subgrouped by treatment Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	18.73 [12.17, 28.82]

3.1 only ABVD regimen	2	1820	Risk Ratio (M‐H, Fixed, 95% CI)	50.43 [18.84, 134.96]
3.2 ABVD including regimen	1	727	Risk Ratio (M‐H, Fixed, 95% CI)	12.17 [7.42, 19.97]
4 Subgrouped by number of cycles of escalated BEACOPP Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	18.73 [12.17, 28.82]

4.1 eight cycles of escalated BEACOPP	1	727	Risk Ratio (M‐H, Fixed, 95% CI)	12.17 [7.42, 19.97]
4.2 four cycles of escalated BEACOPP	1	197	Risk Ratio (M‐H, Fixed, 95% CI)	7.41 [2.29, 23.95]
4.3 two cycles of escalated BEACOPP	1	1623	Risk Ratio (M‐H, Fixed, 95% CI)	179.86 [25.26, 1280.82]
5 Subgrouped by length of follow‐up Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	18.73 [12.17, 28.82]

5.1 short term follow‐up (median length up to 5 years)	2	1820	Risk Ratio (M‐H, Fixed, 95% CI)	50.43 [18.84, 134.96]
5.2 long term follow‐up (median length 10 years)	1	727	Risk Ratio (M‐H, Fixed, 95% CI)	12.17 [7.42, 19.97]
6 Subgrouped by publication form Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	18.73 [12.17, 28.82]

6.1 full text publication	2	924	Risk Ratio (M‐H, Fixed, 95% CI)	11.53 [7.30, 18.23]
6.2 abstract publication	1	1623	Risk Ratio (M‐H, Fixed, 95% CI)	179.86 [25.26, 1280.82]
7 Subgrouped by type of results Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	18.73 [12.17, 28.82]

7.1 preliminary results	1	1623	Risk Ratio (M‐H, Fixed, 95% CI)	179.86 [25.26, 1280.82]
7.2 mature results	2	924	Risk Ratio (M‐H, Fixed, 95% CI)	11.53 [7.30, 18.23]

Comparison 13. Analysis of thrombocytopenia

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Comparison 14. Analysis of alopecia

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Alopecia Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	1.97 [1.77, 2.19]

2 Subgrouped by stage of disease Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	1.97 [1.77, 2.19]

2.1 early unfavourable stage	1	1623	Risk Ratio (M‐H, Fixed, 95% CI)	2.00 [1.74, 2.31]
2.2 advanced stage	2	924	Risk Ratio (M‐H, Fixed, 95% CI)	1.93 [1.65, 2.26]
3 Subgrouped by treatment Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	1.97 [1.77, 2.19]

3.1 only ABVD regimen	2	1820	Risk Ratio (M‐H, Fixed, 95% CI)	1.85 [1.62, 2.12]
3.2 ABVD including regimen	1	727	Risk Ratio (M‐H, Fixed, 95% CI)	2.19 [1.85, 2.59]
4 Subgrouped by number of cycles of escalated BEACOPP Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	1.97 [1.77, 2.19]

4.1 eight cycles of escalated BEACOPP	1	727	Risk Ratio (M‐H, Fixed, 95% CI)	2.19 [1.85, 2.59]
4.2 four cycles of escalated BEACOPP	1	197	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.59, 1.40]
4.3 two cycles of escalated BEACOPP	1	1623	Risk Ratio (M‐H, Fixed, 95% CI)	2.00 [1.74, 2.31]
5 Subgrouped by length of follow‐up Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	1.97 [1.77, 2.19]

5.1 short term follow‐up (median length up to 5 years)	2	1820	Risk Ratio (M‐H, Fixed, 95% CI)	1.85 [1.62, 2.12]
5.2 long term follow‐up (median length 10 years)	1	727	Risk Ratio (M‐H, Fixed, 95% CI)	2.19 [1.85, 2.59]
6 Subgrouped by publication form Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	1.97 [1.77, 2.19]

6.1 full text publication	2	924	Risk Ratio (M‐H, Fixed, 95% CI)	1.93 [1.65, 2.26]
6.2 abstract publication	1	1623	Risk Ratio (M‐H, Fixed, 95% CI)	2.00 [1.74, 2.31]
7 Subgrouped by type of results Show forest plot	3	2547	Risk Ratio (M‐H, Fixed, 95% CI)	1.97 [1.77, 2.19]

7.1 preliminary results	1	1623	Risk Ratio (M‐H, Fixed, 95% CI)	2.00 [1.74, 2.31]
7.2 mature results	2	924	Risk Ratio (M‐H, Fixed, 95% CI)	1.93 [1.65, 2.26]

Comparison 14. Analysis of alopecia

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Comparison 15. Analysis of constipation

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Constipation Show forest plot	2	923	Risk Ratio (M‐H, Fixed, 95% CI)	1.19 [0.56, 2.55]

Comparison 15. Analysis of constipation

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Comparison 16. Analysis of mucositis

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mucositis Show forest plot	2	924	Risk Ratio (M‐H, Fixed, 95% CI)	6.32 [2.25, 17.75]

Comparison 16. Analysis of mucositis

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Comparison 17. Analysis of nausea/vomiting

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Nausea/vomiting Show forest plot	2	924	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.71, 1.25]

Comparison 17. Analysis of nausea/vomiting

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Comparison 18. Analysis of neurologic

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Neurologic Show forest plot	2	924	Risk Ratio (M‐H, Fixed, 95% CI)	1.14 [0.55, 2.35]

Comparison 18. Analysis of neurologic

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Comparison 19. Analysis of pain

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain Show forest plot	2	924	Risk Ratio (M‐H, Fixed, 95% CI)	4.88 [2.04, 11.66]

Comparison 19. Analysis of pain

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Comparison 20. Analysis of respiratory

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Respiratory Show forest plot	1	726	Risk Ratio (M‐H, Fixed, 95% CI)	2.12 [0.80, 5.61]

Comparison 20. Analysis of respiratory

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Comparison 21. Analysis of skin

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Skin Show forest plot	1	726	Risk Ratio (M‐H, Fixed, 95% CI)	2.60 [0.76, 8.98]

Comparison 21. Analysis of skin

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