Different anthracycline derivates for reducing cardiotoxicity in cancer patients

Elvira C van Dalen; Erna MC Michiels; Huib N Caron; Leontien CM Kremer

doi:10.1002/14651858.CD005006.pub2

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Analysis 1.1

Comparison 1 Doxorubicin versus epirubicin, Outcome 1 Clinical heart failure.

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Analysis 1.2

Comparison 1 Doxorubicin versus epirubicin, Outcome 2 Tumour response.

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Analysis 1.3

Comparison 1 Doxorubicin versus epirubicin, Outcome 3 Progression‐free survival.

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Analysis 1.4

Comparison 1 Doxorubicin versus epirubicin, Outcome 4 Overall survival.

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Analysis 1.5

Comparison 1 Doxorubicin versus epirubicin, Outcome 5 Adverse effects: leukopenia grade 3 or 4.

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Analysis 1.6

Comparison 1 Doxorubicin versus epirubicin, Outcome 6 Adverse effects: nausea / vomiting grade 3 or 4.

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Analysis 1.7

Comparison 1 Doxorubicin versus epirubicin, Outcome 7 Adverse effects: alopecia grade 3 or 4.

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Analysis 2.1

Comparison 2 Conventional doxorubicin versus liposomal‐encapsulated doxorubicin (myocet), Outcome 1 Clinical heart failure.

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Analysis 2.2

Comparison 2 Conventional doxorubicin versus liposomal‐encapsulated doxorubicin (myocet), Outcome 2 Heart failure combined.

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Analysis 2.3

Comparison 2 Conventional doxorubicin versus liposomal‐encapsulated doxorubicin (myocet), Outcome 3 Tumour response.

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Analysis 2.4

Comparison 2 Conventional doxorubicin versus liposomal‐encapsulated doxorubicin (myocet), Outcome 4 Progression‐free survival.

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Analysis 2.5

Comparison 2 Conventional doxorubicin versus liposomal‐encapsulated doxorubicin (myocet), Outcome 5 Overall survival.

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Analysis 2.6

Comparison 2 Conventional doxorubicin versus liposomal‐encapsulated doxorubicin (myocet), Outcome 6 Adverse effects: anaemia grade >=3.

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Analysis 2.7

Comparison 2 Conventional doxorubicin versus liposomal‐encapsulated doxorubicin (myocet), Outcome 7 Adverse effects: thrombocytopenia grade >=3.

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Analysis 2.8

Comparison 2 Conventional doxorubicin versus liposomal‐encapsulated doxorubicin (myocet), Outcome 8 Adverse effects: neutropenia grade 4.

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Analysis 2.9

Comparison 2 Conventional doxorubicin versus liposomal‐encapsulated doxorubicin (myocet), Outcome 9 Adverse effects: neutropenic fever (fever >=38, neutropenia grade 4, IV antibiotics and/or hospitalisation).

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Analysis 2.10

Comparison 2 Conventional doxorubicin versus liposomal‐encapsulated doxorubicin (myocet), Outcome 10 Adverse effects: nausea/vomiting grade >=3.

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Analysis 2.11

Comparison 2 Conventional doxorubicin versus liposomal‐encapsulated doxorubicin (myocet), Outcome 11 Adverse effects: stomatitis/mucositis grade >=3.

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Analysis 2.12

Comparison 2 Conventional doxorubicin versus liposomal‐encapsulated doxorubicin (myocet), Outcome 12 Adverse effects: diarrhoea grade >=3.

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Analysis 2.13

Comparison 2 Conventional doxorubicin versus liposomal‐encapsulated doxorubicin (myocet), Outcome 13 Adverse effects: asthenia/fatigue grade 3.

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Analysis 2.14

Comparison 2 Conventional doxorubicin versus liposomal‐encapsulated doxorubicin (myocet), Outcome 14 Adverse effects: cutaneous grade 3.

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Analysis 2.15

Comparison 2 Conventional doxorubicin versus liposomal‐encapsulated doxorubicin (myocet), Outcome 15 Adverse effects: infection grade >=3.

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Table 1. Criteria list for the assessment of methodological quality of included studies

Item ID	Description	Implementation
Patient selection		Note: all criteria were scored yes (+), no (‐) or unclear (?)
a	Was the allocation of participants to treatment groups randomised?	A random (unpredictable) assignment sequence must have been applied.
b	Was the treatment allocation concealed?	Allocation must have been performed by a person not responsible for determining eligibility of patients for inclusion.
Interventions
c	Was the care provider blinded to the intervention?	Adequate information about blinding must have been provided.
d	Was the patient blinded to the intervention?	Adequate information about blinding must have been provided.
Outcome assessments (for each outcome separately)
e	Was the outcome assessor blinded to the intervention?	Adequate information about blinding must have been provided.
f	Were patients lost to follow‐up described and acceptable?	For each outcome measure the number of evaluated patients must be mentioned. If the percentage of non‐evaluable patients does not exceed 20% a "yes" (+) is scored.

Table 1. Criteria list for the assessment of methodological quality of included studies

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Table 2. Quality assessment of included studies

Study	a	b	c	d	e	f	Intervention
Batist 2001	+	?	?	?	Clinical heart failure, subclinical heart failure, tumour response, PFS: +; adverse effects: ?	Clinical heart failure, subclinical heart failure, tumour response, PFS, OS, adverse effects: +	Doxorubicin versus liposomal‐encapsulated doxorubicin (myocet).
Brambilla 1986	+	?	?	?	Clinical heart failure, subclinical heart failure, tumour response, PFS: ?	Clinical heart failure: ?; subclinical heart failure, PFS: ‐; tumour response, OS: +	Doxorubicin versus epirubicin.
Chan 2004	+	?	?	?	Clinical heart failure, subclinical heart failure, tumour response, PFS, adverse effects: ?	Clinical heart failure, subclinical heart failure, tumour response, PFS, OS, adverse effects: +	Epirubicin versus liposomal‐encapsulated doxorubicin (myocet).
FESG 1998	+	?	?	?	Clinical heart failure, tumour response, PFS, adverse effects: ?	Clinical heart failure, tumour response, PFS, OS: +; adverse effects: ‐	Doxorubicin versus epirubicin.
Gasparini 1991	+	?	?	?	Clinical heart failure, tumour response, PFS, adverse effects: ?	Clinical heart failure, tumour response, PFS, OS, adverse effects: +	Doxorubicin versus epirubicin.
Harris 2002	+	?	?	?	Clinical heart failure, adverse effects: ?; subclinical heart failure, tumour response, PFS: +	Clinical heart failure, subclinical heart failure, tumour response, PFS, OS, adverse effects: +	Doxorubicin versus liposomal‐encapsulated doxorubicin (myocet).
IMBSWE 1988	+	?	?	?	Clinical heart failure, tumour response, adverse effects: ?	Clinical heart failure, tumour response, PFS, OS, adverse effects (with the exeption of alopecia: ‐): +	Doxorubicin versus epirubicin.
Mouridsen 1984	+	?	?	?	Clinical heart failure, tumour response, PFS: ?	Clinical heart failure, tumour response, PFS, OS: ‐	Doxorubicin versus epirubicin.

Table 2. Quality assessment of included studies

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Table 3. Descriptive results of survival in epirubicin vs doxorubicin

Study	Progr‐free survival	Overall survival
Brambilla 1986	Not evaluated in review.	Median: in epirubicin group > 16 months (7‐25+), in doxorubicin group > 18 months (6‐28+) (no significant difference)
FESG 1988	Median: in epirubicin group 220 days (30‐1230), in doxorubicin group 270 days (30‐1380) (no significant difference)	Median: in epirubicin group 450 days (20‐1582), in doxorubicin group 530 days (36‐1681) (no significant difference)
Gasparini 1991	In epirubicin group range 2 to 11 months, in doxorubicin group 3 to 14 months (P=0.91)	Median: in epirubicin group 12 months, in doxorubicin group 11 months (no significant difference)
IMBSWE 1988	Median: in epirubicin group 273 days, in doxorubicin group 314 days (P=0.59)	Median: in epirubicin group 591 days, in doxorubicin group 613 days (P=0.75)
Mouridsen 1987	No significant differences between both treatment groups (P=0.41)	No significant differences between both treatment groups (P=0.90)

Table 3. Descriptive results of survival in epirubicin vs doxorubicin

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Table 4. Adverse effects: epirubicin versus liposomal‐encapsulated doxorubicin (myocet)

Adverse effect	n/N myocet pts	n/N epirubicin pts	RR (95% CI)	P‐value
Anaemia grade >=3	19/80	11/80	1.73 (0.88 ‐ 3.39)	0.11
Thrombocytopenia grade >=3	3/80	2/80	1.50 (0.26 ‐ 8.74)	0.65
Neutropenia grade 4	66/80	52/80	1.17 (1.05 ‐ 1.53)	0.01
Prolonged neutropenia grade 4 (>=7 days)	20/80	24/80	0.83 (0.50 ‐ 1.38)	0.48
Febrile neutropenia (fever >=38 C, neutropenia grade 4, IV antibiotics and/or hospitalisation)	4/80	1/80	4.00 (0.46 to 35.01)	0.21
Infection grade >=3	5/80	1/80	5.00 (0.60 ‐ 41.85)	0.14
Nausea / vomiting grade >=3	16/80	15/80	1.07 (0.57 ‐ 2.01)	0.84
Stomatitis / mucositis grade 3	5/80	0/80	11.00 (0.62 ‐ 195.69)	0.10
Diarrhoea grade 3	1/80	1/80	1.00 (0.06 ‐ 15.71)	1.00
Asthenia / fatigue grade 3	0/80	1/80	0.33 (0.01 ‐ 8.06)	0.50
Cutaneous grade 3	0/80	1/80	0.33 (0.01 ‐ 8.06)	0.50
Injection site toxicity grade 3	0/80	1/80	0.33 (0.01 ‐ 8.06)	0.50

Table 4. Adverse effects: epirubicin versus liposomal‐encapsulated doxorubicin (myocet)

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Comparison 1. Doxorubicin versus epirubicin

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Clinical heart failure Show forest plot	5	1036	Risk Ratio (M‐H, Random, 95% CI)	0.36 [0.12, 1.11]

2 Tumour response Show forest plot	5	1036	Risk Ratio (M‐H, Random, 95% CI)	0.94 [0.82, 1.08]

3 Progression‐free survival Show forest plot	2		Hazard ratio (Random, 95% CI)	1.05 [0.76, 1.44]

4 Overall survival Show forest plot	2		Hazard ratio (Random, 95% CI)	0.95 [0.65, 1.39]

5 Adverse effects: leukopenia grade 3 or 4 Show forest plot	2	546	Risk Ratio (M‐H, Random, 95% CI)	0.50 [0.31, 0.80]

6 Adverse effects: nausea / vomiting grade 3 or 4 Show forest plot	2	546	Risk Ratio (M‐H, Random, 95% CI)	0.77 [0.61, 0.97]

7 Adverse effects: alopecia grade 3 or 4 Show forest plot	3	796	Risk Ratio (M‐H, Random, 95% CI)	0.85 [0.52, 1.38]

Comparison 1. Doxorubicin versus epirubicin

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Comparison 2. Conventional doxorubicin versus liposomal‐encapsulated doxorubicin (myocet)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Clinical heart failure Show forest plot	2	521	Risk Ratio (M‐H, Random, 95% CI)	0.20 [0.05, 0.75]

2 Heart failure combined Show forest plot	2	521	Risk Ratio (M‐H, Random, 95% CI)	0.38 [0.24, 0.59]

3 Tumour response Show forest plot	2	521	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.80, 1.26]

4 Progression‐free survival Show forest plot	2		hazard ratio (Random, 95% CI)	1.01 [0.83, 1.24]

5 Overall survival Show forest plot	2		hazard ratio (Random, 95% CI)	1.12 [0.83, 1.53]

6 Adverse effects: anaemia grade >=3 Show forest plot	2	521	Risk Ratio (M‐H, Random, 95% CI)	0.83 [0.61, 1.13]

7 Adverse effects: thrombocytopenia grade >=3 Show forest plot	2	521	Risk Ratio (M‐H, Random, 95% CI)	1.09 [0.60, 1.97]

8 Adverse effects: neutropenia grade 4 Show forest plot	2	521	Risk Ratio (M‐H, Random, 95% CI)	0.82 [0.72, 0.94]

9 Adverse effects: neutropenic fever (fever >=38, neutropenia grade 4, IV antibiotics and/or hospitalisation) Show forest plot	2	521	Risk Ratio (M‐H, Random, 95% CI)	0.88 [0.53, 1.45]

10 Adverse effects: nausea/vomiting grade >=3 Show forest plot	2	521	Risk Ratio (M‐H, Random, 95% CI)	0.65 [0.44, 0.98]

11 Adverse effects: stomatitis/mucositis grade >=3 Show forest plot	2	521	Risk Ratio (M‐H, Random, 95% CI)	0.58 [0.32, 1.05]

12 Adverse effects: diarrhoea grade >=3 Show forest plot	2	521	Risk Ratio (M‐H, Random, 95% CI)	0.33 [0.12, 0.87]

13 Adverse effects: asthenia/fatigue grade 3 Show forest plot	2	521	Risk Ratio (M‐H, Random, 95% CI)	0.85 [0.52, 1.41]

14 Adverse effects: cutaneous grade 3 Show forest plot	2	521	Risk Ratio (M‐H, Random, 95% CI)	0.68 [0.08, 5.45]

15 Adverse effects: infection grade >=3 Show forest plot	2	521	Risk Ratio (M‐H, Random, 95% CI)	0.78 [0.21, 2.89]

Comparison 2. Conventional doxorubicin versus liposomal‐encapsulated doxorubicin (myocet)

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