Chemotherapy alone versus chemotherapy plus radiotherapy for adults with early stage Hodgkin lymphoma

Oliver Blank; Bastian von Tresckow; Ina Monsef; Lena Specht; Andreas Engert; Nicole Skoetz

doi:10.1002/14651858.CD007110.pub3

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Figure 1

Study flow diagram.

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Figure 2

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

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Figure 3

Forest plot of comparison: 2 Overall survival ‐‐ same number of chemotherapy cycles without UK NCRI Rapid and MSKCC trial #90‐44 , outcome: 2.1 Sensitivity analysis ‐ without UK NCRI Rapid and MSKCC trial #90‐44.

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Figure 4

Forest plot of comparison: 2 Progression‐free survival, outcome: 2.1 All trials.

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Figure 5

Forest plot of comparison: 3 Complete response rate, outcome: 3.1 All trials.

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Figure 6

Forest plot of comparison: 4 Overall Response Rate, outcome: 4.1 All Trials.

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Analysis 1.1

Comparison 1 Overall survival ‐‐ same number of chemotherapy cycles, Outcome 1 All trials.

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Analysis 1.2

Comparison 1 Overall survival ‐‐ same number of chemotherapy cycles, Outcome 2 Proportion of patients early favourable.

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Analysis 1.3

Comparison 1 Overall survival ‐‐ same number of chemotherapy cycles, Outcome 3 Bulky vs non‐bulky.

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Analysis 1.4

Comparison 1 Overall survival ‐‐ same number of chemotherapy cycles, Outcome 4 Timing of radiotherapy.

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Analysis 1.5

Comparison 1 Overall survival ‐‐ same number of chemotherapy cycles, Outcome 5 Type of radiotherapy.

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Analysis 1.6

Comparison 1 Overall survival ‐‐ same number of chemotherapy cycles, Outcome 6 Type of chemotherapy.

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Analysis 1.7

Comparison 1 Overall survival ‐‐ same number of chemotherapy cycles, Outcome 7 ITT‐analysis.

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Analysis 2.1

Comparison 2 Overall survival ‐‐ same number of chemotherapy cycles without UK NCRI Rapid and MSKCC trial #90‐44, Outcome 1 Sensitivity analysis ‐ without UK NCRI RAPID and MSKCC trial #90‐44.

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Analysis 2.2

Comparison 2 Overall survival ‐‐ same number of chemotherapy cycles without UK NCRI Rapid and MSKCC trial #90‐44, Outcome 2 Proportion of patients early favourable.

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Analysis 2.3

Comparison 2 Overall survival ‐‐ same number of chemotherapy cycles without UK NCRI Rapid and MSKCC trial #90‐44, Outcome 3 Bulky vs non‐bulky.

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Analysis 2.4

Comparison 2 Overall survival ‐‐ same number of chemotherapy cycles without UK NCRI Rapid and MSKCC trial #90‐44, Outcome 4 Timing of radiotherapy.

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Analysis 2.5

Comparison 2 Overall survival ‐‐ same number of chemotherapy cycles without UK NCRI Rapid and MSKCC trial #90‐44, Outcome 5 Type of radiotherapy.

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Analysis 2.6

Comparison 2 Overall survival ‐‐ same number of chemotherapy cycles without UK NCRI Rapid and MSKCC trial #90‐44, Outcome 6 Type of chemotherapy.

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Analysis 2.7

Comparison 2 Overall survival ‐‐ same number of chemotherapy cycles without UK NCRI Rapid and MSKCC trial #90‐44, Outcome 7 ITT‐analysis.

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Analysis 3.1

Comparison 3 Progression‐free survival ‐‐ same number of chemotherapy cycles, Outcome 1 All trials.

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Analysis 3.2

Comparison 3 Progression‐free survival ‐‐ same number of chemotherapy cycles, Outcome 2 Proportion of patients early favourable.

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Analysis 3.3

Comparison 3 Progression‐free survival ‐‐ same number of chemotherapy cycles, Outcome 3 Bulky vs non‐bulky.

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Analysis 3.4

Comparison 3 Progression‐free survival ‐‐ same number of chemotherapy cycles, Outcome 4 Timing of radiotherapy.

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Analysis 3.5

Comparison 3 Progression‐free survival ‐‐ same number of chemotherapy cycles, Outcome 5 Type of radiotherapy.

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Analysis 3.6

Comparison 3 Progression‐free survival ‐‐ same number of chemotherapy cycles, Outcome 6 Type of chemotherapy.

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Analysis 3.7

Comparison 3 Progression‐free survival ‐‐ same number of chemotherapy cycles, Outcome 7 Sensitivity analysis (per protocol results of the UK NCRI RAPID, without MSKCC trial #90‐44).

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Analysis 4.1

Comparison 4 Progression‐free survival ‐‐ same number of chemotherapy cycles without UK NCRI Rapid and MSKCC trial #90‐44, Outcome 1 Sensitivity analysis ‐ without UK NCRI RAPID and MSKCC trial #90‐44.

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Analysis 4.2

Comparison 4 Progression‐free survival ‐‐ same number of chemotherapy cycles without UK NCRI Rapid and MSKCC trial #90‐44, Outcome 2 Proportion of patients early favourable.

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Analysis 4.3

Comparison 4 Progression‐free survival ‐‐ same number of chemotherapy cycles without UK NCRI Rapid and MSKCC trial #90‐44, Outcome 3 Bulky vs non‐bulky.

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Analysis 4.4

Comparison 4 Progression‐free survival ‐‐ same number of chemotherapy cycles without UK NCRI Rapid and MSKCC trial #90‐44, Outcome 4 Timing of radiotherapy.

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Analysis 4.5

Comparison 4 Progression‐free survival ‐‐ same number of chemotherapy cycles without UK NCRI Rapid and MSKCC trial #90‐44, Outcome 5 Type of radiotherapy.

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Analysis 4.6

Comparison 4 Progression‐free survival ‐‐ same number of chemotherapy cycles without UK NCRI Rapid and MSKCC trial #90‐44, Outcome 6 Type of chemotherapy.

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Analysis 5.1

Comparison 5 Complete response rate ‐‐ same number of chemotherapy cycles, Outcome 1 All trials.

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Analysis 5.2

Comparison 5 Complete response rate ‐‐ same number of chemotherapy cycles, Outcome 2 Proportion of patients early favourable.

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Analysis 5.3

Comparison 5 Complete response rate ‐‐ same number of chemotherapy cycles, Outcome 3 Bulky vs non‐bulky.

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Analysis 5.4

Comparison 5 Complete response rate ‐‐ same number of chemotherapy cycles, Outcome 4 Timing of radiotherapy.

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Analysis 5.5

Comparison 5 Complete response rate ‐‐ same number of chemotherapy cycles, Outcome 5 Type of radiotherapy.

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Analysis 5.6

Comparison 5 Complete response rate ‐‐ same number of chemotherapy cycles, Outcome 6 Type of chemotherapy.

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Analysis 5.7

Comparison 5 Complete response rate ‐‐ same number of chemotherapy cycles, Outcome 7 ITT‐analysis.

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Analysis 6.1

Comparison 6 Complete response rate ‐‐ same number of cycles without MSKCC trial #90‐44, Outcome 1 Sensitivity analysis ‐ without MSKCC trial #90‐44.

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Analysis 6.2

Comparison 6 Complete response rate ‐‐ same number of cycles without MSKCC trial #90‐44, Outcome 2 Bulky vs non‐bulky.

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Analysis 6.3

Comparison 6 Complete response rate ‐‐ same number of cycles without MSKCC trial #90‐44, Outcome 3 Timing of radiotherapy.

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Analysis 6.4

Comparison 6 Complete response rate ‐‐ same number of cycles without MSKCC trial #90‐44, Outcome 4 Type of radiotherapy.

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Analysis 6.5

Comparison 6 Complete response rate ‐‐ same number of cycles without MSKCC trial #90‐44, Outcome 5 Type of chemotherapy.

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Analysis 6.6

Comparison 6 Complete response rate ‐‐ same number of cycles without MSKCC trial #90‐44, Outcome 6 ITT‐analysis.

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Analysis 7.1

Comparison 7 Overall response rate ‐‐ same number of chemotherapy cycles, Outcome 1 All trials.

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Analysis 7.2

Comparison 7 Overall response rate ‐‐ same number of chemotherapy cycles, Outcome 2 Proportion of patients early favourable.

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Analysis 7.3

Comparison 7 Overall response rate ‐‐ same number of chemotherapy cycles, Outcome 3 Bulky vs non‐bulky.

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Analysis 7.4

Comparison 7 Overall response rate ‐‐ same number of chemotherapy cycles, Outcome 4 Timing of radiotherapy.

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Analysis 7.5

Comparison 7 Overall response rate ‐‐ same number of chemotherapy cycles, Outcome 5 Type of radiotherapy.

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Analysis 8.1

Comparison 8 Overall response rate ‐‐ same number of chemotherapy cycles without MSKCC trial #90‐44, Outcome 1 Sensitivity analysis ‐ without MSKCC trial #90‐44.

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Analysis 9.1

Comparison 9 Adverse events‐ related mortality ‐‐ same number of chemotherapy cycles, Outcome 1 Infection‐ related mortality.

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Analysis 9.2

Comparison 9 Adverse events‐ related mortality ‐‐ same number of chemotherapy cycles, Outcome 2 Second cancer‐ related mortality.

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Analysis 9.3

Comparison 9 Adverse events‐ related mortality ‐‐ same number of chemotherapy cycles, Outcome 3 Cardiac disease‐ related mortality.

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Analysis 10.1

Comparison 10 Adverse events related mortality ‐‐ same number of chemotherapy cycles without UK NCRI Rapid and MSKCC trial #90‐44, Outcome 1 Second cancer‐ related mortality.

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Analysis 10.2

Comparison 10 Adverse events related mortality ‐‐ same number of chemotherapy cycles without UK NCRI Rapid and MSKCC trial #90‐44, Outcome 2 Cardiac disease‐ related mortality.

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Analysis 11.1

Comparison 11 Overall survival ‐ different numbers of chemotherapy cycles, Outcome 1 All trials.

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Analysis 12.1

Comparison 12 Progression‐free survival ‐‐ different numbers of chemotherapy cycles, Outcome 1 All trials.

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Analysis 12.2

Comparison 12 Progression‐free survival ‐‐ different numbers of chemotherapy cycles, Outcome 2 Proportion of patients early favourable.

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Analysis 12.3

Comparison 12 Progression‐free survival ‐‐ different numbers of chemotherapy cycles, Outcome 3 Bulky vs non‐bulky.

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Analysis 12.4

Comparison 12 Progression‐free survival ‐‐ different numbers of chemotherapy cycles, Outcome 4 Type of radiotherapy.

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Analysis 13.1

Comparison 13 Progression‐free survival ‐‐ different numbers of chemotherapy cycles without HD6, Outcome 1 Sensitivity analysis ‐ without HD6.

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Analysis 13.2

Comparison 13 Progression‐free survival ‐‐ different numbers of chemotherapy cycles without HD6, Outcome 2 Proportion of patients early favourable.

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Analysis 13.3

Comparison 13 Progression‐free survival ‐‐ different numbers of chemotherapy cycles without HD6, Outcome 3 Bulky vs non‐bulky.

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Analysis 14.1

Comparison 14 Adverse events related mortality ‐‐ different numbers of chemotherapy cycles, Outcome 1 Infection‐ related mortality.

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Analysis 14.2

Comparison 14 Adverse events related mortality ‐‐ different numbers of chemotherapy cycles, Outcome 2 Second cancer‐ related mortality.

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Analysis 14.3

Comparison 14 Adverse events related mortality ‐‐ different numbers of chemotherapy cycles, Outcome 3 Cardiac disease‐ related mortality.

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Summary of findings for the main comparison. Same number of chemotherapy cycles in both arms

Same number of chemotherapy cycles in both arms
Chemotherapy alone versus chemotherapy plus radiotherapy for adults with early stage Hodgkin lymphoma.
Outcomes	№ of participants (studies) Follow‐ up	Quality of the evidence (GRADE)	Relative effect (95% CI)	*Anticipated absolute effects^ (95% CI)**		Comment
				Risk with chemotherapy only	Risk with chemotherapy plus radiotherapy
Mortality (calculated instead of overall survival) Follow‐up : 5 years The low‐ mortality rate was taken from the EORTC‐GELA H9‐F trial, the high‐ mortality rate was taken from the Mexico B2H031trial	1388 (5 RCTs)	⊕⊕⊕⊝ MODERATE ¹	HR 0.48 (0.22 to 1.06)	Low risk to die
				30 per 1000	15 per 1000 (7 to 32)	Number of people who will die
				High risk to die
				150 per 1000	75 per 1000 (35 to 158)
Mortality sensitivity analysis (calculated instead of overall survival) ‐ without UK NCRI Rapid trial and MSKCC trial #90‐44due to high risk of other bias Follow‐up : 5 years The low‐ mortality rate was taken from the EORTC‐GELA H9‐F trial, the high‐ mortality rate was taken from the Mexico B2H031trial	816 (3 RCTs)	⊕⊕⊕⊝ MODERATE ²	HR 0.31 (0.19 to 0.52)	Low risk to die
				30 per 1000	9 per 1000 (6 to 16)	Number of people who will die
				High risk to die
				150 per 1000	49 per 1000 (30 to 81)
Relapse, progression or death (calculated instead of PFS) Follow‐up : 5 years	1351 (4 RCTs)	⊕⊕⊕⊝ MODERATE ³	HR 0.42 (0.25 to 0.72)	Low risk of progress, relapse or death
				100 per 1000	43 per 1000 (26 to 73)	Number of people who will have a progress, relapse or die
				High risk of progress, relapse or death
				300 per 1000	139 per 1000 (85 to 226)
Infection‐ related mortality	152 (1 RCT)	⊕⊕⊝⊝ LOW ⁴	RR 0.33 (0.01 to 8.06)	Study population
				13 per 1000	4 per 1000 (0 to 106)
Second cancer‐ related mortality	1199 (3 RCTs)	⊕⊕⊝⊝ LOW ⁴	RR 0.53 (0.07 to 4.29)	Study population
				9 per 1,000	5 per 1000 (1 to 39)
Cardiac disease‐ related mortality	457 (2 RCTs)	⊕⊕⊝⊝ LOW ⁴	RR 2.94 (0.31 to 27.55)	Low risk
				1 per 1,000	3 per 1000 (0 to 28)
Complete response rate	376 (3 RCTs)	⊕⊕⊝⊝ LOW ^{5, 6}	RR 1.08 (0.93 to 1.25)	Study population
				839 per 1,000	906 per 1000 (780 to 1,000)
*The risk in the intervention group (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; PFS: progre ssion‐free survival
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Substantial heterogeneity, downgraded by 1 point for inconsistency ² Sensitivity analysis, excluding two trials with potential high risk of other bias. Downgraded by 1 point for imprecision due to low number of included patients and events ³ Definition of PFS varied across trials, downgraded by 1 point for inconsistency ⁴ Very small number of events, downgraded by 2 points for imprecision ⁵Statistical heterogeneity (I ² = 67%), downgraded by 1 point for inconsistency ⁶ Low number of events, downgraded by 1 point for imprecision

Summary of findings for the main comparison. Same number of chemotherapy cycles in both arms

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Summary of findings 2. Different numbers of chemotherapy cycles in both arms

Different numbers of chemotherapy cycles in both arms
Chemotherapy alone versus chemotherapy plus radiotherapy for adults with early stage Hodgkin lymphoma
Outcomes	№ of participants (studies) Follow‐ up	Quality of the evidence (GRADE)	Relative effect (95% CI)	*Anticipated absolute effects^ (95% CI)**		Comment
				Risk with chemotherapy only	Risk with chemotherapy plus radiotherapy
Mortality (calculated instead of overall survival) Follow‐up : 5 years The low‐ mortality rate was taken from the EORTC‐GELA H9‐F trial, the high‐ mortality rate was taken from the Mexico B2H031trial	276 (1 RCT)	⊕⊕⊝⊝ LOW ¹	HR 2.12 (1.03 to 4.37)	Low risk to die
				30 per 1000	63 per 1000 (31 to 125)	Number of people who will die
				High risk to die
				150 per 1000	291 per 1000 (154 to 508)
Relapse, progression or death (calculated instead of PFS) Follow‐up : 5 years	1176 (3 RCTs)	⊕⊕⊝⊝ LOW ²	HR 0.42 (0.14 to 1.24)	Low risk of progress, death
				100 per 1000	43 per 1000 (15 to 122)	Number of people who will have a progress, relapse or die
				High risk of progress, death
				300 per 1000	139 per 1000 (49 to 357)
Relapse, progression or death (calculated instead of PFS) sensitivity analysis ‐ without HD6trial due to high risk of other bias Follow‐up : 5 years	900 2 (RCTs)	⊕⊕⊕⊝ MODERATE ³	HR 0.24 (0.07 to 0.88)	Low risk of progress, death
				100 per 1000	25 per 1000 (7 to 88)	Number of people who will have a progress, relapse or die
				High risk of progress, death
				300 per 1000	82 per 1000 (25 to 269)
Infection‐ related mortality	276 (1 RCT)	⊕⊕⊝⊝ LOW ¹	RR 6.90 (0.36 to 132.34)	Low risk
				1 per 1000	7 per 1000 (0 to 132)	H10F; H10U; HD6
Second cancer‐ related mortality	276 (1 RCT)	⊕⊕⊝⊝ LOW ¹	RR 2.22 (0.70 to 7.03)	Study population
				29 per 1000	65 per 1000 (20 to 205)
Cardiac disease‐ related mortality	276 (1 RCT)	⊕⊕⊝⊝ LOW ¹	RR 0.99 (0.14 to 6.90)	Study population
				15 per 1000	14 per 1000 (2 to 101)
Complete response rate				not reported
*The risk in the intervention group (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 ; PFS: progression‐free surviv al
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Very low number of events, downgraded by 2 points for imprecision ² Serious heterogeneity (I² = 84%), downgraded by 2 points for inconsistency

Summary of findings 2. Different numbers of chemotherapy cycles in both arms

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Table 1. Overview of study characteristics

	CALGB 7751	H10F	H10U	HD6	EORTC‐GELA H9‐F	Mexico B2H031	MSKCC trial #90‐44	UK NCRI Rapid
Number of patients evaluated	18: chemotherapy 19: chemotherapy plus radiotherapy	193: chemotherapy 188: chemotherapy plus radiotherapy	268: chemotherapy 251: chemotherapy plus radiotherapy	137: chemotherapy 139: chemotherapy plus radiotherapy	130: chemotherapy 448: chemotherapy plus radiotherapy	99: chemotherapy 102: chemotherapy plus radiotherapy	76: chemotherapy 76: chemotherapy plus radiotherapy	211: chemotherapy 209: chemotherapy plus radiotherapy
Chemotherapy and radiotherapy	6 cycles of CVPP +/‐ involved‐field radiotherapy (dosage unknown)	4 cycles of ABVD vs 3 cycles of ABVD + 30 Gy (+6 Gy) involved node radiotherapy	6 cycles of ABVD vs 4 cycles of ABVD + 30 Gy (+6 Gy) involved node radiotherapy	4 cycles of ABVD or 2 cycles of ABVD + 35 Gy subtotal nodal radiotherapy	6 cycles of EBVP +/‐ IF radiotherapy	6 cycles of ABVD +/‐ EF‐radiotherapy	6 cycles of ABVD +/‐ EF or IF radiotherapy	3 cycles of ABVD +/‐ 30 Gy IF‐radiotherapy
Median duration of follow‐up	1.8 years	1.1 years	1.1 years	11.3 years	4.3 years	11.4 years	5.6 years	60 months

Table 1. Overview of study characteristics

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Table 2. Definitions of progression outcomes

Trial	Definition of progression outcome.
EORTC‐GELA H9‐F	Definition of disease‐free survival not reported (Note all patients are in CR at the time of randomisation).
H10F/H10U	From the date of random assignment to date of progression—as relapse after previous complete remission or progression after reaching partial remission (>= 50% decrease and resolution of B symptoms and no new lesions) or progressive disease (50% increase from nadir of any previous partial remission lesions or appearance of new lesions) on computed tomography scan measurements during protocol treatment or death resulting from any cause, whichever occurred first.
HD6	Measured as event‐free survival from the date of randomisation until the date of disease progression or death from any cause.
Mexico B2H031	Contradictory definitions. In the methods section: “Disease free survival was calculated for CR patients from the beginning of treatment until clinically or radiologically and biopsy proven relapse.” In the results section the percentage disease free were calculated based on the full population.
MSKCC trial #90‐44	Time from enrolment until any progression of disease.
UK NCRI Rapid	Time from the date of randomisation to first progression, relapse, or death, whichever occurred first.

Table 2. Definitions of progression outcomes

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Comparison 1. Overall survival ‐‐ same number of chemotherapy cycles

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 All trials Show forest plot	5	1388	Hazard Ratio (Random, 95% CI)	0.48 [0.22, 1.06]

2 Proportion of patients early favourable Show forest plot	4	968	Hazard Ratio (Random, 95% CI)	0.31 [0.19, 0.50]

2.1 All patients early favourable	1	578	Hazard Ratio (Random, 95% CI)	0.27 [0.04, 1.74]
2.2 Mixed patient population (˜ 30 to 50% patients early unfavourable)	1	152	Hazard Ratio (Random, 95% CI)	0.31 [0.08, 1.15]
2.3 All patients early unfavourable	2	238	Hazard Ratio (Random, 95% CI)	0.31 [0.18, 0.54]
3 Bulky vs non‐bulky Show forest plot	4	1351	Hazard Ratio (Random, 95% CI)	0.47 [0.18, 1.19]

3.1 Bulky disease	1	201	Hazard Ratio (Random, 95% CI)	0.29 [0.17, 0.51]
3.2 Non‐bulky disease	3	1150	Hazard Ratio (Random, 95% CI)	0.60 [0.16, 2.27]
4 Timing of radiotherapy Show forest plot	5	1388	Hazard Ratio (Random, 95% CI)	0.48 [0.22, 1.06]

4.1 Radiotherapy after chemotherapy	3	1150	Hazard Ratio (Random, 95% CI)	0.60 [0.16, 2.27]
4.2 Sandwich technique (CT‐RT‐CT)	1	201	Hazard Ratio (Random, 95% CI)	0.29 [0.17, 0.51]
4.3 Chemotherapy after radiotherapy	1	37	Hazard Ratio (Random, 95% CI)	0.63 [0.11, 3.65]
5 Type of radiotherapy Show forest plot	5	1388	Hazard Ratio (Random, 95% CI)	0.48 [0.22, 1.06]

5.1 Involved field	3	1035	Hazard Ratio (Random, 95% CI)	0.83 [0.26, 2.67]
5.2 Extended field	1	201	Hazard Ratio (Random, 95% CI)	0.29 [0.17, 0.51]
5.3 Mixed radiotherapy	1	152	Hazard Ratio (Random, 95% CI)	0.31 [0.08, 1.15]
6 Type of chemotherapy Show forest plot	5	1388	Hazard Ratio (Random, 95% CI)	0.48 [0.22, 1.06]

6.1 ABVD	3	773	Hazard Ratio (Random, 95% CI)	0.53 [0.17, 1.68]
6.2 CVPP	1	37	Hazard Ratio (Random, 95% CI)	0.63 [0.11, 3.65]
6.3 EBVP	1	578	Hazard Ratio (Random, 95% CI)	0.27 [0.04, 1.73]
7 ITT‐analysis Show forest plot	5	1388	Hazard Ratio (Random, 95% CI)	0.48 [0.22, 1.06]

7.1 ITT‐analysis	4	1351	Hazard Ratio (Random, 95% CI)	0.47 [0.18, 1.19]
7.2 No ITT‐analysis	1	37	Hazard Ratio (Random, 95% CI)	0.63 [0.11, 3.65]

Comparison 1. Overall survival ‐‐ same number of chemotherapy cycles

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Comparison 2. Overall survival ‐‐ same number of chemotherapy cycles without UK NCRI Rapid and MSKCC trial #90‐44

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Sensitivity analysis ‐ without UK NCRI RAPID and MSKCC trial #90‐44 Show forest plot	3	816	Hazard Ratio (Random, 95% CI)	0.31 [0.19, 0.52]

2 Proportion of patients early favourable Show forest plot	3	816	Hazard Ratio (Random, 95% CI)	0.31 [0.19, 0.52]

2.1 All patients early favourable	1	578	Hazard Ratio (Random, 95% CI)	0.27 [0.04, 1.74]
2.2 All patients early unfavourable	2	238	Hazard Ratio (Random, 95% CI)	0.31 [0.18, 0.54]
3 Bulky vs non‐bulky Show forest plot	2	779	Hazard Ratio (Random, 95% CI)	0.29 [0.17, 0.50]

3.1 Bulky disease	1	201	Hazard Ratio (Random, 95% CI)	0.29 [0.17, 0.51]
3.2 Non‐bulky disease	1	578	Hazard Ratio (Random, 95% CI)	0.27 [0.04, 1.74]
4 Timing of radiotherapy Show forest plot	3	816	Hazard Ratio (Random, 95% CI)	0.31 [0.19, 0.52]

4.1 Radiotherapy after chemotherapy	1	578	Hazard Ratio (Random, 95% CI)	0.27 [0.04, 1.74]
4.2 Sandwich technique (CT‐RT‐CT)	1	201	Hazard Ratio (Random, 95% CI)	0.29 [0.17, 0.51]
4.3 Chemotherapy after radiotherapy	1	37	Hazard Ratio (Random, 95% CI)	0.63 [0.11, 3.65]
5 Type of radiotherapy Show forest plot	3	816	Hazard Ratio (Random, 95% CI)	0.31 [0.19, 0.52]

5.1 Involved field	2	615	Hazard Ratio (Random, 95% CI)	0.42 [0.12, 1.51]
5.2 Extended field	1	201	Hazard Ratio (Random, 95% CI)	0.29 [0.17, 0.51]
6 Type of chemotherapy Show forest plot	3	816	Hazard Ratio (Random, 95% CI)	0.31 [0.19, 0.52]

6.1 ABVD	1	201	Hazard Ratio (Random, 95% CI)	0.29 [0.17, 0.51]
6.2 CVPP	1	37	Hazard Ratio (Random, 95% CI)	0.63 [0.11, 3.65]
6.3 EBVP	1	578	Hazard Ratio (Random, 95% CI)	0.27 [0.04, 1.73]
7 ITT‐analysis Show forest plot	3	816	Hazard Ratio (Random, 95% CI)	0.31 [0.19, 0.52]

7.1 ITT‐analysis	2	779	Hazard Ratio (Random, 95% CI)	0.29 [0.17, 0.50]
7.2 No ITT‐analysis	1	37	Hazard Ratio (Random, 95% CI)	0.63 [0.11, 3.65]

Comparison 2. Overall survival ‐‐ same number of chemotherapy cycles without UK NCRI Rapid and MSKCC trial #90‐44

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Comparison 3. Progression‐free survival ‐‐ same number of chemotherapy cycles

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 All trials Show forest plot	4	1351	Hazard Ratio (Random, 95% CI)	0.42 [0.25, 0.72]

2 Proportion of patients early favourable Show forest plot	4	1351	Hazard Ratio (Random, 95% CI)	0.42 [0.25, 0.72]

2.1 All patients early favourable	1	578	Hazard Ratio (Random, 95% CI)	0.27 [0.17, 0.43]
2.2 Mixed patient population (˜ 30 to 50% patients early unfavourable)	2	572	Hazard Ratio (Random, 95% CI)	0.71 [0.43, 1.17]
2.3 All patients early unfavourable	1	201	Hazard Ratio (Random, 95% CI)	0.29 [0.17, 0.48]
3 Bulky vs non‐bulky Show forest plot	4	1351	Hazard Ratio (Random, 95% CI)	0.42 [0.25, 0.72]

3.1 Bulky disease	1	201	Hazard Ratio (Random, 95% CI)	0.29 [0.17, 0.48]
3.2 Non‐bulky disease	3	1150	Hazard Ratio (Random, 95% CI)	0.50 [0.24, 1.03]
4 Timing of radiotherapy Show forest plot	4	1351	Hazard Ratio (Random, 95% CI)	0.42 [0.25, 0.72]

4.1 Radiotherapy after chemotherapy	3	1150	Hazard Ratio (Random, 95% CI)	0.50 [0.24, 1.03]
4.2 Sandwich technique (CT‐RT‐CT)	1	201	Hazard Ratio (Random, 95% CI)	0.29 [0.17, 0.48]
5 Type of radiotherapy Show forest plot	4	1351	Hazard Ratio (Random, 95% CI)	0.42 [0.25, 0.72]

5.1 Involved field	2	998	Hazard Ratio (Random, 95% CI)	0.40 [0.17, 0.94]
5.2 Extended field	1	201	Hazard Ratio (Random, 95% CI)	0.29 [0.17, 0.48]
5.3 Mixed radiotherapy	1	152	Hazard Ratio (Random, 95% CI)	0.85 [0.37, 1.94]
6 Type of chemotherapy Show forest plot	4	1351	Hazard Ratio (Random, 95% CI)	0.42 [0.25, 0.72]

6.1 ABVD	3	773	Hazard Ratio (Random, 95% CI)	0.51 [0.26, 0.99]
6.2 EBVP	1	578	Hazard Ratio (Random, 95% CI)	0.27 [0.17, 0.43]
7 Sensitivity analysis (per protocol results of the UK NCRI RAPID, without MSKCC trial #90‐44) Show forest plot	3	1199	Hazard Ratio (Random, 95% CI)	0.30 [0.22, 0.41]

Comparison 3. Progression‐free survival ‐‐ same number of chemotherapy cycles

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Comparison 4. Progression‐free survival ‐‐ same number of chemotherapy cycles without UK NCRI Rapid and MSKCC trial #90‐44

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Sensitivity analysis ‐ without UK NCRI RAPID and MSKCC trial #90‐44 Show forest plot	2	779	Hazard Ratio (Random, 95% CI)	0.28 [0.20, 0.39]

2 Proportion of patients early favourable Show forest plot	2	779	Hazard Ratio (Random, 95% CI)	0.28 [0.20, 0.39]

2.1 All patients early favourable	1	578	Hazard Ratio (Random, 95% CI)	0.27 [0.17, 0.43]
2.2 All patients early unfavourable	1	201	Hazard Ratio (Random, 95% CI)	0.29 [0.17, 0.48]
3 Bulky vs non‐bulky Show forest plot	2	779	Hazard Ratio (Random, 95% CI)	0.28 [0.20, 0.39]

3.1 Bulky disease	1	201	Hazard Ratio (Random, 95% CI)	0.29 [0.17, 0.48]
3.2 Non‐bulky disease	1	578	Hazard Ratio (Random, 95% CI)	0.27 [0.17, 0.43]
4 Timing of radiotherapy Show forest plot	2	779	Hazard Ratio (Random, 95% CI)	0.28 [0.20, 0.39]

4.1 Radiotherapy after chemotherapy	1	578	Hazard Ratio (Random, 95% CI)	0.27 [0.17, 0.43]
4.2 Sandwich technique (CT‐RT‐CT)	1	201	Hazard Ratio (Random, 95% CI)	0.29 [0.17, 0.48]
5 Type of radiotherapy Show forest plot	2	779	Hazard Ratio (Random, 95% CI)	0.28 [0.20, 0.39]

5.1 Involved field	1	578	Hazard Ratio (Random, 95% CI)	0.27 [0.17, 0.43]
5.2 Extended field	1	201	Hazard Ratio (Random, 95% CI)	0.29 [0.17, 0.48]
6 Type of chemotherapy Show forest plot	2	779	Hazard Ratio (Random, 95% CI)	0.28 [0.20, 0.39]

6.1 ABVD	1	201	Hazard Ratio (Random, 95% CI)	0.29 [0.17, 0.48]
6.2 EBVP	1	578	Hazard Ratio (Random, 95% CI)	0.27 [0.17, 0.43]

Comparison 4. Progression‐free survival ‐‐ same number of chemotherapy cycles without UK NCRI Rapid and MSKCC trial #90‐44

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Comparison 5. Complete response rate ‐‐ same number of chemotherapy cycles

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 All trials Show forest plot	3	376	Risk Ratio (M‐H, Random, 95% CI)	1.08 [0.93, 1.25]

2 Proportion of patients early favourable Show forest plot	3	376	Risk Ratio (M‐H, Random, 95% CI)	1.08 [0.93, 1.25]

2.1 Mixed patient population (˜ 30 to 50% patients early unfavourable)	1	138	Risk Ratio (M‐H, Random, 95% CI)	1.0 [0.92, 1.09]
2.2 All patients early unfavourable	2	238	Risk Ratio (M‐H, Random, 95% CI)	1.22 [0.84, 1.78]
3 Bulky vs non‐bulky Show forest plot	3	376	Risk Ratio (M‐H, Random, 95% CI)	1.08 [0.93, 1.25]

3.1 Bulky disease	1	201	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.93, 1.20]
3.2 Non‐bulky disease	2	175	Risk Ratio (M‐H, Random, 95% CI)	1.21 [0.73, 2.01]
4 Timing of radiotherapy Show forest plot	3	376	Risk Ratio (M‐H, Random, 95% CI)	1.08 [0.93, 1.25]

4.1 Radiotherapy after chemotherapy	1	138	Risk Ratio (M‐H, Random, 95% CI)	1.0 [0.92, 1.09]
4.2 Sandwich technique (CT‐RT‐CT)	1	201	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.93, 1.20]
4.3 Chemotherapy after radiotherapy	1	37	Risk Ratio (M‐H, Random, 95% CI)	1.55 [1.06, 2.27]
5 Type of radiotherapy Show forest plot	3	376	Risk Ratio (M‐H, Random, 95% CI)	1.08 [0.93, 1.25]

5.1 Involved field	1	37	Risk Ratio (M‐H, Random, 95% CI)	1.55 [1.06, 2.27]
5.2 Extended field	1	201	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.93, 1.20]
5.3 Mixed	1	138	Risk Ratio (M‐H, Random, 95% CI)	1.0 [0.92, 1.09]
6 Type of chemotherapy Show forest plot	3	376	Risk Ratio (M‐H, Random, 95% CI)	1.08 [0.93, 1.25]

6.1 CVPP	1	37	Risk Ratio (M‐H, Random, 95% CI)	1.55 [1.06, 2.27]
6.2 ABVD	2	339	Risk Ratio (M‐H, Random, 95% CI)	1.02 [0.95, 1.09]
7 ITT‐analysis Show forest plot	3	376	Risk Ratio (M‐H, Random, 95% CI)	1.08 [0.93, 1.25]

7.1 ITT‐analysis	2	339	Risk Ratio (M‐H, Random, 95% CI)	1.02 [0.95, 1.09]
7.2 No ITT‐analysis	1	37	Risk Ratio (M‐H, Random, 95% CI)	1.55 [1.06, 2.27]

Comparison 5. Complete response rate ‐‐ same number of chemotherapy cycles

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Comparison 6. Complete response rate ‐‐ same number of cycles without MSKCC trial #90‐44

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Sensitivity analysis ‐ without MSKCC trial #90‐44 Show forest plot	2	238	Risk Ratio (M‐H, Random, 95% CI)	1.22 [0.84, 1.78]

2 Bulky vs non‐bulky Show forest plot	2	238	Risk Ratio (M‐H, Random, 95% CI)	1.22 [0.84, 1.78]

2.1 Bulky disease	1	201	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.93, 1.20]
2.2 Non‐bulky disease	1	37	Risk Ratio (M‐H, Random, 95% CI)	1.55 [1.06, 2.27]
3 Timing of radiotherapy Show forest plot	2	238	Risk Ratio (M‐H, Random, 95% CI)	1.22 [0.84, 1.78]

3.1 Sandwich technique (CT‐RT‐CT)	1	201	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.93, 1.20]
3.2 Chemotherapy after radiotherapy	1	37	Risk Ratio (M‐H, Random, 95% CI)	1.55 [1.06, 2.27]
4 Type of radiotherapy Show forest plot	2	238	Risk Ratio (M‐H, Random, 95% CI)	1.22 [0.84, 1.78]

4.1 Involved field	1	37	Risk Ratio (M‐H, Random, 95% CI)	1.55 [1.06, 2.27]
4.2 Extended field	1	201	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.93, 1.20]
5 Type of chemotherapy Show forest plot	2	238	Risk Ratio (M‐H, Random, 95% CI)	1.22 [0.84, 1.78]

5.1 CVPP	1	37	Risk Ratio (M‐H, Random, 95% CI)	1.55 [1.06, 2.27]
5.2 ABVD	1	201	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.93, 1.20]
6 ITT‐analysis Show forest plot	2	238	Risk Ratio (M‐H, Random, 95% CI)	1.22 [0.84, 1.78]

6.1 ITT‐analysis	1	201	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.93, 1.20]
6.2 No ITT‐analysis	1	37	Risk Ratio (M‐H, Random, 95% CI)	1.55 [1.06, 2.27]

Comparison 6. Complete response rate ‐‐ same number of cycles without MSKCC trial #90‐44

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Comparison 7. Overall response rate ‐‐ same number of chemotherapy cycles

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 All trials Show forest plot	2	339	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.94, 1.07]

2 Proportion of patients early favourable Show forest plot	2	339	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.94, 1.07]

2.1 All patients early favourable	1	138	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.91, 1.06]
2.2 Mixed patient population (˜ 30 to 50% patients early unfavourable)	1	201	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.92, 1.18]
3 Bulky vs non‐bulky Show forest plot	2	339	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.94, 1.07]

3.1 Bulky disease	1	201	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.92, 1.18]
3.2 Non‐bulky disease	1	138	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.91, 1.06]
4 Timing of radiotherapy Show forest plot	2	339	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.94, 1.07]

4.1 Radiotherapy after chemotherapy	1	138	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.91, 1.06]
4.2 Sandwich technique (CT‐RT‐CT)	1	201	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.92, 1.18]
5 Type of radiotherapy Show forest plot	2	339	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.94, 1.07]

5.1 Extended field	1	201	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.92, 1.18]
5.2 Mixed	1	138	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.91, 1.06]

Comparison 7. Overall response rate ‐‐ same number of chemotherapy cycles

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Comparison 8. Overall response rate ‐‐ same number of chemotherapy cycles without MSKCC trial #90‐44

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Sensitivity analysis ‐ without MSKCC trial #90‐44 Show forest plot	1	201	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.92, 1.18]

Comparison 8. Overall response rate ‐‐ same number of chemotherapy cycles without MSKCC trial #90‐44

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Comparison 9. Adverse events‐ related mortality ‐‐ same number of chemotherapy cycles

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Infection‐ related mortality Show forest plot	1	152	Risk Ratio (M‐H, Random, 95% CI)	0.33 [0.01, 8.06]

2 Second cancer‐ related mortality Show forest plot	3	1199	Risk Ratio (M‐H, Random, 95% CI)	0.53 [0.07, 4.29]

3 Cardiac disease‐ related mortality Show forest plot	2	457	Risk Ratio (M‐H, Random, 95% CI)	2.94 [0.31, 27.55]

Comparison 9. Adverse events‐ related mortality ‐‐ same number of chemotherapy cycles

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Comparison 10. Adverse events related mortality ‐‐ same number of chemotherapy cycles without UK NCRI Rapid and MSKCC trial #90‐44

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Second cancer‐ related mortality Show forest plot	2	779	Risk Ratio (M‐H, Random, 95% CI)	0.71 [0.02, 33.60]

2 Cardiac disease‐ related mortality Show forest plot	1	37	Risk Ratio (M‐H, Random, 95% CI)	2.85 [0.12, 65.74]

Comparison 10. Adverse events related mortality ‐‐ same number of chemotherapy cycles without UK NCRI Rapid and MSKCC trial #90‐44

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Comparison 11. Overall survival ‐ different numbers of chemotherapy cycles

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 All trials Show forest plot	1	276	Hazard Ratio (Random, 95% CI)	2.12 [1.03, 4.37]

Comparison 11. Overall survival ‐ different numbers of chemotherapy cycles

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Comparison 12. Progression‐free survival ‐‐ different numbers of chemotherapy cycles

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 All trials Show forest plot	3	1176	Hazard Ratio (Random, 95% CI)	0.42 [0.14, 1.24]

2 Proportion of patients early favourable Show forest plot	3	1176	Hazard Ratio (Random, 95% CI)	0.42 [0.14, 1.24]

2.1 All patients early favourable	1	381	Hazard Ratio (Random, 95% CI)	0.11 [0.03, 0.40]
2.2 All patients early unfavourable	2	795	Hazard Ratio (Random, 95% CI)	0.67 [0.26, 1.76]
3 Bulky vs non‐bulky Show forest plot	3	1176	Hazard Ratio (Random, 95% CI)	0.42 [0.14, 1.24]

3.1 Bulky disease	1	519	Hazard Ratio (Random, 95% CI)	0.41 [0.22, 0.75]
3.2 Non‐bulky disease	2	657	Hazard Ratio (Random, 95% CI)	0.37 [0.04, 3.61]
4 Type of radiotherapy Show forest plot	3	1176	Hazard Ratio (Random, 95% CI)	0.42 [0.14, 1.24]

4.1 Subtotal nodal radiation	1	276	Hazard Ratio (Random, 95% CI)	1.09 [0.62, 1.93]
4.2 Involved node	2	900	Hazard Ratio (Random, 95% CI)	0.24 [0.07, 0.88]

Comparison 12. Progression‐free survival ‐‐ different numbers of chemotherapy cycles

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Comparison 13. Progression‐free survival ‐‐ different numbers of chemotherapy cycles without HD6

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Sensitivity analysis ‐ without HD6 Show forest plot	2	900	Hazard Ratio (Random, 95% CI)	0.24 [0.07, 0.88]

2 Proportion of patients early favourable Show forest plot	2	900	Hazard Ratio (Random, 95% CI)	0.24 [0.07, 0.88]

2.1 All patients early favourable	1	381	Hazard Ratio (Random, 95% CI)	0.11 [0.03, 0.40]
2.2 All patients early unfavourable	1	519	Hazard Ratio (Random, 95% CI)	0.41 [0.22, 0.75]
3 Bulky vs non‐bulky Show forest plot	2	900	Hazard Ratio (Random, 95% CI)	0.24 [0.07, 0.88]

3.1 Bulky disease	1	519	Hazard Ratio (Random, 95% CI)	0.41 [0.22, 0.75]
3.2 Non‐bulky disease	1	381	Hazard Ratio (Random, 95% CI)	0.11 [0.03, 0.40]

Comparison 13. Progression‐free survival ‐‐ different numbers of chemotherapy cycles without HD6

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Comparison 14. Adverse events related mortality ‐‐ different numbers of chemotherapy cycles

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Infection‐ related mortality Show forest plot	1	276	Risk Ratio (M‐H, Random, 95% CI)	6.9 [0.36, 132.34]

2 Second cancer‐ related mortality Show forest plot	1	276	Risk Ratio (M‐H, Random, 95% CI)	2.22 [0.70, 7.03]

3 Cardiac disease‐ related mortality Show forest plot	1	276	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.14, 6.90]

Comparison 14. Adverse events related mortality ‐‐ different numbers of chemotherapy cycles

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