Aromatase inhibitors for treatment of advanced breast cancer in postmenopausal women

Lorna Gibson; David Lawrence; Claire Dawson; Judith Bliss

doi:10.1002/14651858.CD003370.pub3

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Analysis 1.1

Comparison 1: AI versus non‐AI, Outcome 1: Overall survival (reported or calculated)

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Analysis 1.2

Comparison 1: AI versus non‐AI, Outcome 2: Progression‐free survival (reported or calculated)

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Analysis 1.3

Comparison 1: AI versus non‐AI, Outcome 3: Clinical benefit (assessable)

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Analysis 1.4

Comparison 1: AI versus non‐AI, Outcome 4: Objective response (assessable)

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Analysis 1.5

Comparison 1: AI versus non‐AI, Outcome 5: Clinical benefit (randomised)

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Analysis 1.6

Comparison 1: AI versus non‐AI, Outcome 6: Objective response (randomised)

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Analysis 2.1

Comparison 2: AI versus non‐AI: Toxicity, Outcome 1: hot flushes

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Analysis 2.2

Comparison 2: AI versus non‐AI: Toxicity, Outcome 2: nausea

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Analysis 2.3

Comparison 2: AI versus non‐AI: Toxicity, Outcome 3: vomiting

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Analysis 2.4

Comparison 2: AI versus non‐AI: Toxicity, Outcome 4: diarrhoea

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Analysis 2.5

Comparison 2: AI versus non‐AI: Toxicity, Outcome 5: rash

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Analysis 2.6

Comparison 2: AI versus non‐AI: Toxicity, Outcome 6: vaginal bleeding

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Analysis 2.7

Comparison 2: AI versus non‐AI: Toxicity, Outcome 7: thromboembolic

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Analysis 2.8

Comparison 2: AI versus non‐AI: Toxicity, Outcome 8: arthralgia

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Analysis 3.1

Comparison 3: Current AIs versus non‐AI, Outcome 1: Overall survival (reported or calculated)

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Analysis 3.2

Comparison 3: Current AIs versus non‐AI, Outcome 2: Progression‐free survival (reported or calculated)

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Analysis 3.3

Comparison 3: Current AIs versus non‐AI, Outcome 3: Clinical benefit (assessable)

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Analysis 3.4

Comparison 3: Current AIs versus non‐AI, Outcome 4: Objective response (assessable)

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Analysis 3.5

Comparison 3: Current AIs versus non‐AI, Outcome 5: Clinical benefit (randomised)

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Analysis 3.6

Comparison 3: Current AIs versus non‐AI, Outcome 6: Objective response (randomised)

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Analysis 4.1

Comparison 4: Current AIs versus non‐AI: Toxicity, Outcome 1: hot flushes

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Analysis 4.2

Comparison 4: Current AIs versus non‐AI: Toxicity, Outcome 2: nausea

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Analysis 4.3

Comparison 4: Current AIs versus non‐AI: Toxicity, Outcome 3: vomiting

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Analysis 4.4

Comparison 4: Current AIs versus non‐AI: Toxicity, Outcome 4: diarrhoea

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Analysis 4.5

Comparison 4: Current AIs versus non‐AI: Toxicity, Outcome 5: rash

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Analysis 4.6

Comparison 4: Current AIs versus non‐AI: Toxicity, Outcome 6: vaginal bleeding

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Analysis 4.7

Comparison 4: Current AIs versus non‐AI: Toxicity, Outcome 7: thromboembolic

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Analysis 4.8

Comparison 4: Current AIs versus non‐AI: Toxicity, Outcome 8: arthralgia

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Analysis 5.1

Comparison 5: AI versus different AI, Outcome 1: Overall survival (reported)

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Analysis 5.2

Comparison 5: AI versus different AI, Outcome 2: Progession‐free survival (reported or calculated)

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Analysis 5.3

Comparison 5: AI versus different AI, Outcome 3: Clinical benefit (assessable)

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Analysis 5.4

Comparison 5: AI versus different AI, Outcome 4: Objective response (assessable)

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Analysis 5.5

Comparison 5: AI versus different AI, Outcome 5: Clinical benefit (randomised)

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Analysis 5.6

Comparison 5: AI versus different AI, Outcome 6: Objective response (randomised)

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Analysis 6.1

Comparison 6: AI as first‐line therapy versus any other therapy (tamoxifen), Outcome 1: Overall survival (reported or calculated)

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Analysis 6.2

Comparison 6: AI as first‐line therapy versus any other therapy (tamoxifen), Outcome 2: Progression‐free survival (reported or calculated)

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Analysis 6.3

Comparison 6: AI as first‐line therapy versus any other therapy (tamoxifen), Outcome 3: Clinical benefit (assessable)

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Analysis 6.4

Comparison 6: AI as first‐line therapy versus any other therapy (tamoxifen), Outcome 4: Objective response (assessable)

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Analysis 6.5

Comparison 6: AI as first‐line therapy versus any other therapy (tamoxifen), Outcome 5: Clinical benefit (randomised)

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Analysis 6.6

Comparison 6: AI as first‐line therapy versus any other therapy (tamoxifen), Outcome 6: Objective response (randomised)

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Analysis 7.1

Comparison 7: AI as second‐line therapy versus any other therapy, Outcome 1: Overall survival (reported or calculated)

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Analysis 7.2

Comparison 7: AI as second‐line therapy versus any other therapy, Outcome 2: Progression‐free survival (reported or calculated)

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Analysis 7.3

Comparison 7: AI as second‐line therapy versus any other therapy, Outcome 3: Clinical benefit (assessable)

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Analysis 7.4

Comparison 7: AI as second‐line therapy versus any other therapy, Outcome 4: Objective response (assessable)

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Analysis 7.5

Comparison 7: AI as second‐line therapy versus any other therapy, Outcome 5: Clinical benefit (randomised)

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Analysis 7.6

Comparison 7: AI as second‐line therapy versus any other therapy, Outcome 6: Objective response (randomised)

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Table 1. Aromatase inhibitors ‐ description

Generic Name	Trade Name	Generation	Doses used
aminoglutethimide		First	125 mg, 250 mg, 500 mg, 750 mg, 1000 mg
anastrozole	Arimidex	Third, non‐steroidal	1 mg, 10 mg
atamestane		Third, steroidal	500mg
exemestane	Aromasin	Third, steroidal	25 mg
fadrozole	CGS16949A	Third, non‐steroidal	2 mg
formestane	Lentaron	Second	250 mg im
letrozole	Femara	Third, non‐steroidal	0.5 mg, 2 mg, 2.5 mg, 10 mg
vorozole		Third, non‐steroidal	2.5 mg

Table 1. Aromatase inhibitors ‐ description

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Comparison 1. AI versus non‐AI

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Overall survival (reported or calculated) Show forest plot	13		HR (IV, Fixed, 95% CI)	0.90 [0.84, 0.97]

1.1.1 aminoglutethimide (any dose)	4		HR (IV, Fixed, 95% CI)	0.94 [0.80, 1.12]
1.1.2 anastrozole 1 mg	3		HR (IV, Fixed, 95% CI)	0.90 [0.79, 1.03]
1.1.3 exemestane 25 mg	1		HR (IV, Fixed, 95% CI)	0.85 [0.72, 0.99]
1.1.4 fadrozole 2 mg	2		HR (IV, Fixed, 95% CI)	1.04 [0.77, 1.40]
1.1.5 letrozole 2.5 mg	2		HR (IV, Fixed, 95% CI)	0.88 [0.73, 1.05]
1.1.6 vorozole 2.5 mg	1		HR (IV, Fixed, 95% CI)	1.10 [0.49, 2.47]
1.2 Progression‐free survival (reported or calculated) Show forest plot	11		HR (IV, Random, 95% CI)	0.98 [0.84, 1.13]

1.2.1 aminoglutethimide (any dose)	2		HR (IV, Random, 95% CI)	1.07 [0.73, 1.55]
1.2.2 formestane 250 mg	1		HR (IV, Random, 95% CI)	0.93 [0.68, 1.28]
1.2.3 anastrozole 1 mg	2		HR (IV, Random, 95% CI)	1.05 [0.65, 1.70]
1.2.4 exemestane 25 mg	2		HR (IV, Random, 95% CI)	0.91 [0.72, 1.14]
1.2.5 letrozole 2.5 mg	3		HR (IV, Random, 95% CI)	0.87 [0.68, 1.11]
1.2.6 vorozole 2.5 mg	1		HR (IV, Random, 95% CI)	1.27 [1.04, 1.56]
1.3 Clinical benefit (assessable) Show forest plot	27	8789	Odds Ratio (M‐H, Random, 95% CI)	0.87 [0.77, 0.99]

1.3.1 aminoglutethimide (any dose)	9	1292	Odds Ratio (M‐H, Random, 95% CI)	0.79 [0.63, 1.00]
1.3.2 formestane 250 mg	2	521	Odds Ratio (M‐H, Random, 95% CI)	1.05 [0.59, 1.86]
1.3.3 anastrozole 1 mg	4	2626	Odds Ratio (M‐H, Random, 95% CI)	0.74 [0.48, 1.12]
1.3.4 exemestane 25 mg	3	1356	Odds Ratio (M‐H, Random, 95% CI)	0.86 [0.63, 1.19]
1.3.5 fadrozole 2 mg	4	982	Odds Ratio (M‐H, Random, 95% CI)	1.05 [0.80, 1.38]
1.3.6 letrozole 2.5 mg	4	1637	Odds Ratio (M‐H, Random, 95% CI)	0.77 [0.60, 1.00]
1.3.7 vorozole 2.5 mg	1	375	Odds Ratio (M‐H, Random, 95% CI)	1.35 [0.88, 2.07]
1.4 Objective response (assessable) Show forest plot	31	9595	Odds Ratio (M‐H, Random, 95% CI)	0.88 [0.77, 1.01]

1.4.1 aminoglutethimide (any dose)	11	1545	Odds Ratio (M‐H, Random, 95% CI)	0.83 [0.63, 1.09]
1.4.2 formestane 250 mg	3	1000	Odds Ratio (M‐H, Random, 95% CI)	1.23 [0.92, 1.64]
1.4.3 anastrozole 1 mg	4	2626	Odds Ratio (M‐H, Random, 95% CI)	0.95 [0.77, 1.17]
1.4.4 exemestane 25 mg	3	1356	Odds Ratio (M‐H, Random, 95% CI)	0.67 [0.33, 1.33]
1.4.5 fadrozole 2 mg	5	1056	Odds Ratio (M‐H, Random, 95% CI)	1.18 [0.85, 1.65]
1.4.6 letrozole 2.5 mg	4	1637	Odds Ratio (M‐H, Random, 95% CI)	0.65 [0.51, 0.82]
1.4.7 vorozole 2.5 mg	1	375	Odds Ratio (M‐H, Random, 95% CI)	0.70 [0.34, 1.42]
1.5 Clinical benefit (randomised) Show forest plot	27	9425	Odds Ratio (M‐H, Random, 95% CI)	0.88 [0.78, 0.99]

1.5.1 aminoglutethimide (any dose)	9	1395	Odds Ratio (M‐H, Random, 95% CI)	0.81 [0.65, 1.01]
1.5.2 formestane 250 mg	2	586	Odds Ratio (M‐H, Random, 95% CI)	1.00 [0.58, 1.70]
1.5.3 anastrozole 1 mg	4	2626	Odds Ratio (M‐H, Random, 95% CI)	0.74 [0.48, 1.12]
1.5.4 exemestane 25 mg	3	1584	Odds Ratio (M‐H, Random, 95% CI)	0.88 [0.71, 1.11]
1.5.5 fadrozole 2 mg	4	1000	Odds Ratio (M‐H, Random, 95% CI)	1.08 [0.82, 1.41]
1.5.6 letrozole 2.5 mg	4	1782	Odds Ratio (M‐H, Random, 95% CI)	0.77 [0.61, 0.96]
1.5.7 vorozole 2.5 mg	1	452	Odds Ratio (M‐H, Random, 95% CI)	1.25 [0.83, 1.88]
1.6 Objective response (randomised) Show forest plot	31	10422	Odds Ratio (M‐H, Random, 95% CI)	0.90 [0.78, 1.03]

1.6.1 aminoglutethimide (any dose)	11	1765	Odds Ratio (M‐H, Random, 95% CI)	0.89 [0.66, 1.20]
1.6.2 formestane 250 mg	3	1133	Odds Ratio (M‐H, Random, 95% CI)	1.20 [0.91, 1.60]
1.6.3 anastrozole 1 mg	4	2626	Odds Ratio (M‐H, Random, 95% CI)	0.95 [0.77, 1.17]
1.6.4 exemestane 25 mg	3	1584	Odds Ratio (M‐H, Random, 95% CI)	0.68 [0.37, 1.27]
1.6.5 fadrozole 2 mg	5	1080	Odds Ratio (M‐H, Random, 95% CI)	1.21 [0.87, 1.69]
1.6.6 letrozole 2.5 mg	4	1782	Odds Ratio (M‐H, Random, 95% CI)	0.65 [0.52, 0.82]
1.6.7 vorozole 2.5 mg	1	452	Odds Ratio (M‐H, Random, 95% CI)	0.67 [0.33, 1.37]

Comparison 1. AI versus non‐AI

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Comparison 2. AI versus non‐AI: Toxicity

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 hot flushes Show forest plot	20	8306	Odds Ratio (M‐H, Fixed, 95% CI)	1.24 [1.10, 1.41]

2.1.1 AI versus tamoxifen	7	2616	Odds Ratio (M‐H, Fixed, 95% CI)	1.07 [0.88, 1.29]
2.1.2 AI versus megestrol acetate	10	3926	Odds Ratio (M‐H, Fixed, 95% CI)	1.73 [1.40, 2.14]
2.1.3 AI versus fulvestrant	2	1546	Odds Ratio (M‐H, Fixed, 95% CI)	1.08 [0.82, 1.42]
2.1.4 AI versus medroxyprogesterone acetate	1	218	Odds Ratio (M‐H, Fixed, 95% CI)	0.20 [0.06, 0.73]
2.2 nausea Show forest plot	18		Odds Ratio (M‐H, Random, 95% CI)	Subtotals only

2.2.1 AI versus tamoxifen	6	2548	Odds Ratio (M‐H, Random, 95% CI)	1.29 [0.78, 2.13]
2.2.2 AI versus megestrol acetate	9	3755	Odds Ratio (M‐H, Random, 95% CI)	1.77 [1.33, 2.35]
2.2.3 AI versus medroxyprogesterone acetate	1	53	Odds Ratio (M‐H, Random, 95% CI)	8.19 [0.40, 166.83]
2.2.4 AI versus fulvestrant	2	1539	Odds Ratio (M‐H, Random, 95% CI)	1.01 [0.77, 1.32]
2.3 vomiting Show forest plot	8		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.3.1 AI versus tamoxifen	2	1239	Odds Ratio (M‐H, Fixed, 95% CI)	1.23 [0.79, 1.90]
2.3.2 AI versus megestrol acetate	5	2319	Odds Ratio (M‐H, Fixed, 95% CI)	2.03 [1.42, 2.90]
2.3.3 AI versus fulvestrant	1	846	Odds Ratio (M‐H, Fixed, 95% CI)	0.90 [0.60, 1.35]
2.4 diarrhoea Show forest plot	10		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.4.1 AI versus tamoxifen	3	2149	Odds Ratio (M‐H, Fixed, 95% CI)	1.64 [1.06, 2.55]
2.4.2 AI versus megestrol acetate	5	1961	Odds Ratio (M‐H, Fixed, 95% CI)	1.48 [1.02, 2.13]
2.4.3 AI versus fulvestrant	2	1090	Odds Ratio (M‐H, Fixed, 95% CI)	1.23 [0.79, 1.90]
2.5 rash Show forest plot	15		Odds Ratio (M‐H, Random, 95% CI)	Subtotals only

2.5.1 AI versus tamoxifen	4	711	Odds Ratio (M‐H, Random, 95% CI)	33.61 [4.71, 239.97]
2.5.2 AI versus megestrol acetate	8	3219	Odds Ratio (M‐H, Random, 95% CI)	2.06 [0.92, 4.62]
2.5.3 AI versus medroxyprogesterone acetate	2	271	Odds Ratio (M‐H, Random, 95% CI)	36.80 [3.35, 404.73]
2.5.4 AI versus fulvestrant	1	397	Odds Ratio (M‐H, Random, 95% CI)	1.39 [0.77, 2.50]
2.6 vaginal bleeding Show forest plot	6		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.6.1 AI versus tamoxifen	1	1017	Odds Ratio (M‐H, Fixed, 95% CI)	0.45 [0.16, 1.32]
2.6.2 AI versus megestrol acetate	3	1462	Odds Ratio (M‐H, Fixed, 95% CI)	0.22 [0.10, 0.45]
2.6.3 AI versus medroxyprogesterone acetate	2	271	Odds Ratio (M‐H, Fixed, 95% CI)	0.13 [0.02, 0.71]
2.7 thromboembolic Show forest plot	6		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.7.1 AI versus tamoxifen	2	1228	Odds Ratio (M‐H, Fixed, 95% CI)	0.48 [0.27, 0.85]
2.7.2 AI versus megestrol acetate	3	863	Odds Ratio (M‐H, Fixed, 95% CI)	0.54 [0.26, 1.10]
2.7.3 AI versus fulvestrant	1	846	Odds Ratio (M‐H, Fixed, 95% CI)	1.14 [0.56, 2.31]
2.8 arthralgia Show forest plot	6		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.8.1 AI versus tamoxifen	2	1031	Odds Ratio (M‐H, Fixed, 95% CI)	1.14 [0.81, 1.60]
2.8.2 AI versus megestrol acetate	4	1439	Odds Ratio (M‐H, Fixed, 95% CI)	1.40 [0.98, 2.00]

Comparison 2. AI versus non‐AI: Toxicity

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Comparison 3. Current AIs versus non‐AI

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 Overall survival (reported or calculated) Show forest plot	6		HR (IV, Fixed, 95% CI)	0.88 [0.80, 0.96]

3.1.1 anastrozole 1 mg	3		HR (IV, Fixed, 95% CI)	0.90 [0.79, 1.03]
3.1.2 exemestane 25 mg	1		HR (IV, Fixed, 95% CI)	0.85 [0.72, 0.99]
3.1.3 letrozole 2.5 mg	2		HR (IV, Fixed, 95% CI)	0.88 [0.73, 1.05]
3.2 Progression‐free survival (reported or calculated) Show forest plot	7		HR (IV, Random, 95% CI)	0.93 [0.78, 1.12]

3.2.1 anastrozole 1 mg	2		HR (IV, Random, 95% CI)	1.05 [0.65, 1.70]
3.2.2 exemestane 25 mg	2		HR (IV, Random, 95% CI)	0.91 [0.72, 1.14]
3.2.3 letrozole 2.5 mg	3		HR (IV, Random, 95% CI)	0.87 [0.68, 1.11]
3.3 Clinical benefit (assessable) Show forest plot	11	5619	Odds Ratio (M‐H, Random, 95% CI)	0.80 [0.66, 0.97]

3.3.1 anastrozole 1 mg	4	2626	Odds Ratio (M‐H, Random, 95% CI)	0.74 [0.48, 1.12]
3.3.2 exemestane 25 mg	3	1356	Odds Ratio (M‐H, Random, 95% CI)	0.86 [0.63, 1.19]
3.3.3 letrozole 2.5 mg	4	1637	Odds Ratio (M‐H, Random, 95% CI)	0.77 [0.60, 1.00]
3.4 Objective response (assessable) Show forest plot	11	5619	Odds Ratio (M‐H, Random, 95% CI)	0.79 [0.65, 0.97]

3.4.1 anastrozole 1 mg	4	2626	Odds Ratio (M‐H, Random, 95% CI)	0.95 [0.77, 1.17]
3.4.2 exemestane 25 mg	3	1356	Odds Ratio (M‐H, Random, 95% CI)	0.67 [0.33, 1.33]
3.4.3 letrozole 2.5 mg	4	1637	Odds Ratio (M‐H, Random, 95% CI)	0.65 [0.51, 0.82]
3.5 Clinical benefit (randomised) Show forest plot	11	5992	Odds Ratio (M‐H, Random, 95% CI)	0.81 [0.67, 0.97]

3.5.1 anastrozole 1 mg	4	2626	Odds Ratio (M‐H, Random, 95% CI)	0.74 [0.48, 1.12]
3.5.2 exemestane 25 mg	3	1584	Odds Ratio (M‐H, Random, 95% CI)	0.88 [0.71, 1.11]
3.5.3 letrozole 2.5 mg	4	1782	Odds Ratio (M‐H, Random, 95% CI)	0.77 [0.61, 0.96]
3.6 Objective response (randomised) Show forest plot	11	5992	Odds Ratio (M‐H, Random, 95% CI)	0.80 [0.66, 0.96]

3.6.1 anastrozole 1 mg	4	2626	Odds Ratio (M‐H, Random, 95% CI)	0.95 [0.77, 1.17]
3.6.2 exemestane 25 mg	3	1584	Odds Ratio (M‐H, Random, 95% CI)	0.68 [0.37, 1.27]
3.6.3 letrozole 2.5 mg	4	1782	Odds Ratio (M‐H, Random, 95% CI)	0.65 [0.52, 0.82]

Comparison 3. Current AIs versus non‐AI

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Comparison 4. Current AIs versus non‐AI: Toxicity

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
4.1 hot flushes Show forest plot	9		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

4.1.1 AI versus tamoxifen	3	2048	Odds Ratio (M‐H, Fixed, 95% CI)	1.13 [0.91, 1.39]
4.1.2 AI versus megestrol acetate	4	2036	Odds Ratio (M‐H, Fixed, 95% CI)	1.69 [1.24, 2.30]
4.1.3 AI versus fulvestrant	2	1539	Odds Ratio (M‐H, Fixed, 95% CI)	1.07 [0.81, 1.41]
4.2 nausea Show forest plot	9		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

4.2.1 AI versus tamoxifen	3	2048	Odds Ratio (M‐H, Fixed, 95% CI)	0.89 [0.72, 1.11]
4.2.2 AI versus megestrol acetate	4	2036	Odds Ratio (M‐H, Fixed, 95% CI)	1.45 [1.09, 1.95]
4.2.3 AI versus fulvestrant	2	1539	Odds Ratio (M‐H, Fixed, 95% CI)	1.01 [0.77, 1.32]
4.3 vomiting Show forest plot	5		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

4.3.1 AI versus tamoxifen	1	1017	Odds Ratio (M‐H, Fixed, 95% CI)	1.07 [0.67, 1.72]
4.3.2 AI versus megestrol acetate	3	1636	Odds Ratio (M‐H, Fixed, 95% CI)	1.77 [1.11, 2.83]
4.3.3 AI versus fulvestrant	1	846	Odds Ratio (M‐H, Fixed, 95% CI)	0.90 [0.60, 1.35]
4.4 diarrhoea Show forest plot	7		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

4.4.1 AI versus tamoxifen	2	1927	Odds Ratio (M‐H, Fixed, 95% CI)	1.49 [0.95, 2.35]
4.4.2 AI versus megestrol acetate	3	1278	Odds Ratio (M‐H, Fixed, 95% CI)	2.40 [1.34, 4.29]
4.4.3 AI versus fulvestrant	2	1090	Odds Ratio (M‐H, Fixed, 95% CI)	1.23 [0.79, 1.90]
4.5 rash Show forest plot	4		Odds Ratio (M‐H, Random, 95% CI)	Subtotals only

4.5.1 AI versus megestrol acetate	3	1636	Odds Ratio (M‐H, Random, 95% CI)	1.63 [0.47, 5.70]
4.5.2 AI versus fulvestrant	1	397	Odds Ratio (M‐H, Random, 95% CI)	1.39 [0.77, 2.50]
4.6 vaginal bleeding Show forest plot	3		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

4.6.1 AI versus tamoxifen	1	1017	Odds Ratio (M‐H, Fixed, 95% CI)	0.45 [0.16, 1.32]
4.6.2 AI versus megestrol acetate	2	915	Odds Ratio (M‐H, Fixed, 95% CI)	0.29 [0.13, 0.65]
4.7 thromboembolic Show forest plot	3		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

4.7.1 AI versus tamoxifen	1	1017	Odds Ratio (M‐H, Fixed, 95% CI)	0.53 [0.30, 0.96]
4.7.2 AI versus megestrol acetate	1	515	Odds Ratio (M‐H, Fixed, 95% CI)	0.71 [0.30, 1.73]
4.7.3 AI versus fulvestrant	1	846	Odds Ratio (M‐H, Fixed, 95% CI)	1.14 [0.56, 2.31]
4.8 arthralgia Show forest plot	3		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

4.8.1 AI versus tamoxifen	2	1031	Odds Ratio (M‐H, Fixed, 95% CI)	1.14 [0.81, 1.60]
4.8.2 AI versus megestrol acetate	1	363	Odds Ratio (M‐H, Fixed, 95% CI)	1.77 [0.89, 3.51]

Comparison 4. Current AIs versus non‐AI: Toxicity

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Comparison 5. AI versus different AI

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
5.1 Overall survival (reported) Show forest plot	2		HR (IV, Fixed, 95% CI)	Subtotals only

5.1.1 letrozole	2		HR (IV, Fixed, 95% CI)	0.91 [0.82, 1.02]
5.2 Progession‐free survival (reported or calculated) Show forest plot	2		HR (IV, Fixed, 95% CI)	Subtotals only

5.2.1 letrozole	2		HR (IV, Fixed, 95% CI)	0.97 [0.90, 1.04]
5.3 Clinical benefit (assessable) Show forest plot	5		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

5.3.1 letrozole	4	1687	Odds Ratio (M‐H, Fixed, 95% CI)	0.77 [0.62, 0.95]
5.3.2 anastrozole	2	663	Odds Ratio (M‐H, Fixed, 95% CI)	1.29 [0.92, 1.79]
5.4 Objective response (assessable) Show forest plot	5		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

5.4.1 letrozole	4	1687	Odds Ratio (M‐H, Fixed, 95% CI)	0.62 [0.50, 0.78]
5.4.2 anastrozole	2	663	Odds Ratio (M‐H, Fixed, 95% CI)	1.59 [1.07, 2.37]
5.5 Clinical benefit (randomised) Show forest plot	5		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

5.5.1 letrozole	4	2098	Odds Ratio (M‐H, Fixed, 95% CI)	0.82 [0.68, 0.98]
5.5.2 anastrozole	2	773	Odds Ratio (M‐H, Fixed, 95% CI)	1.25 [0.90, 1.72]
5.6 Objective response (randomised) Show forest plot	5		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

5.6.1 letrozole	4	2098	Odds Ratio (M‐H, Fixed, 95% CI)	0.66 [0.54, 0.82]
5.6.2 anastrozole	2	782	Odds Ratio (M‐H, Fixed, 95% CI)	1.50 [1.01, 2.23]

Comparison 5. AI versus different AI

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Comparison 6. AI as first‐line therapy versus any other therapy (tamoxifen)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
6.1 Overall survival (reported or calculated) Show forest plot	3		HR (IV, Fixed, 95% CI)	0.99 [0.86, 1.14]

6.1.1 aminoglutethimide as first‐line therapy	1		HR (IV, Fixed, 95% CI)	1.12 [0.82, 1.53]
6.1.2 anastrozole as first‐line therapy	1		HR (IV, Fixed, 95% CI)	0.97 [0.81, 1.16]
6.1.3 fadrozole as first‐line therapy	1		HR (IV, Fixed, 95% CI)	0.91 [0.63, 1.32]
6.2 Progression‐free survival (reported or calculated) Show forest plot	4		HR (IV, Fixed, 95% CI)	0.78 [0.71, 0.86]

6.2.1 aminoglutethimide	1		HR (IV, Fixed, 95% CI)	0.84 [0.65, 1.08]
6.2.2 formestane as first‐line therapy	1		HR (IV, Fixed, 95% CI)	0.93 [0.68, 1.28]
6.2.3 anastrozole as first‐line therapy	1		HR (IV, Fixed, 95% CI)	0.82 [0.71, 0.95]
6.2.4 letrozole as first‐line therapy	1		HR (IV, Fixed, 95% CI)	0.70 [0.60, 0.82]
6.3 Clinical benefit (assessable) Show forest plot	9	3252	Odds Ratio (M‐H, Random, 95% CI)	0.69 [0.51, 0.92]

6.3.1 aminoglutethimide (any dose)	3	479	Odds Ratio (M‐H, Random, 95% CI)	0.63 [0.42, 0.93]
6.3.2 formestane 250 mg	1	348	Odds Ratio (M‐H, Random, 95% CI)	1.36 [0.87, 2.13]
6.3.3 anastrozole 1 mg	2	1259	Odds Ratio (M‐H, Random, 95% CI)	0.48 [0.16, 1.44]
6.3.4 exemestane 25 mg	1	113	Odds Ratio (M‐H, Random, 95% CI)	0.47 [0.22, 0.99]
6.3.5 fadrozole 2 mg	1	209	Odds Ratio (M‐H, Random, 95% CI)	1.09 [0.58, 2.06]
6.3.6 letrozole 2.5 mg	1	844	Odds Ratio (M‐H, Random, 95% CI)	0.63 [0.48, 0.82]
6.4 Objective response (assessable) Show forest plot	11	3503	Odds Ratio (M‐H, Random, 95% CI)	0.77 [0.59, 1.00]

6.4.1 aminoglutethimide (any dose)	4	656	Odds Ratio (M‐H, Random, 95% CI)	0.75 [0.45, 1.25]
6.4.2 formestane 250 mg	1	348	Odds Ratio (M‐H, Random, 95% CI)	1.20 [0.77, 1.87]
6.4.3 anastrozole 1 mg	2	1259	Odds Ratio (M‐H, Random, 95% CI)	0.85 [0.65, 1.11]
6.4.4 exemestane 25 mg	1	113	Odds Ratio (M‐H, Random, 95% CI)	0.26 [0.11, 0.62]
6.4.5 fadrozole 2 mg	2	283	Odds Ratio (M‐H, Random, 95% CI)	1.20 [0.69, 2.09]
6.4.6 letrozole 2.5 mg	1	844	Odds Ratio (M‐H, Random, 95% CI)	0.58 [0.42, 0.78]
6.5 Clinical benefit (randomised) Show forest plot	9	3451	Odds Ratio (M‐H, Random, 95% CI)	0.74 [0.56, 0.98]

6.5.1 aminoglutethimide (any dose)	3	533	Odds Ratio (M‐H, Random, 95% CI)	0.74 [0.51, 1.08]
6.5.2 formestane 250 mg	1	409	Odds Ratio (M‐H, Random, 95% CI)	1.25 [0.85, 1.86]
6.5.3 anastrozole 1 mg	2	1259	Odds Ratio (M‐H, Random, 95% CI)	0.48 [0.16, 1.44]
6.5.4 exemestane 25 mg	1	122	Odds Ratio (M‐H, Random, 95% CI)	0.55 [0.27, 1.13]
6.5.5 fadrozole 2 mg	1	221	Odds Ratio (M‐H, Random, 95% CI)	1.23 [0.69, 2.21]
6.5.6 letrozole 2.5 mg	1	907	Odds Ratio (M‐H, Random, 95% CI)	0.65 [0.50, 0.84]
6.6 Objective response (randomised) Show forest plot	11	3746	Odds Ratio (M‐H, Random, 95% CI)	0.81 [0.62, 1.05]

6.6.1 aminoglutethimide (any dose)	4	748	Odds Ratio (M‐H, Random, 95% CI)	0.83 [0.48, 1.45]
6.6.2 formestane 250 mg	1	409	Odds Ratio (M‐H, Random, 95% CI)	1.18 [0.77, 1.80]
6.6.3 anastrozole 1 mg	2	1259	Odds Ratio (M‐H, Random, 95% CI)	0.85 [0.65, 1.11]
6.6.4 exemestane 25 mg	1	122	Odds Ratio (M‐H, Random, 95% CI)	0.30 [0.13, 0.69]
6.6.5 fadrozole 2 mg	2	301	Odds Ratio (M‐H, Random, 95% CI)	1.28 [0.76, 2.15]
6.6.6 letrozole 2.5 mg	1	907	Odds Ratio (M‐H, Random, 95% CI)	0.59 [0.43, 0.79]

Comparison 6. AI as first‐line therapy versus any other therapy (tamoxifen)

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Comparison 7. AI as second‐line therapy versus any other therapy

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
7.1 Overall survival (reported or calculated) Show forest plot	2		HR (IV, Fixed, 95% CI)	0.80 [0.66, 0.96]

7.1.1 anastrozole as second‐line therapy	1		HR (IV, Fixed, 95% CI)	0.78 [0.61, 1.00]
7.1.2 letrozole as second‐line therapy	1		HR (IV, Fixed, 95% CI)	0.82 [0.63, 1.07]
7.2 Progression‐free survival (reported or calculated) Show forest plot	8		HR (IV, Random, 95% CI)	1.08 [0.94, 1.23]

7.2.1 aminoglutethimide (any dose)	1		HR (IV, Random, 95% CI)	1.25 [0.91, 1.72]
7.2.2 formestane 250 mg biweekly	2		HR (IV, Random, 95% CI)	1.03 [0.90, 1.19]
7.2.3 anastrozole 1 mg	1		HR (IV, Random, 95% CI)	1.34 [1.16, 1.55]
7.2.4 exemestane 25 mg	2		HR (IV, Random, 95% CI)	0.91 [0.72, 1.14]
7.2.5 letrozole 2.5 mg	1		HR (IV, Random, 95% CI)	0.98 [0.77, 1.25]
7.2.6 vorozole 2.5 mg	1		HR (IV, Random, 95% CI)	1.27 [1.04, 1.56]
7.3 Clinical benefit (assessable) Show forest plot	16	5410	Odds Ratio (M‐H, Fixed, 95% CI)	0.99 [0.88, 1.11]

7.3.1 aminoglutethimide (any dose)	4	686	Odds Ratio (M‐H, Fixed, 95% CI)	0.90 [0.66, 1.23]
7.3.2 formestane 250 mg biweekly	1	173	Odds Ratio (M‐H, Fixed, 95% CI)	0.75 [0.41, 1.39]
7.3.3 anastrozole 1mg	2	1367	Odds Ratio (M‐H, Fixed, 95% CI)	1.04 [0.84, 1.29]
7.3.4 exemestane 25 mg	2	1243	Odds Ratio (M‐H, Fixed, 95% CI)	0.95 [0.75, 1.20]
7.3.5 fadrozole 2 mg	3	773	Odds Ratio (M‐H, Fixed, 95% CI)	1.04 [0.77, 1.41]
7.3.6 letrozole 2.5 mg	3	793	Odds Ratio (M‐H, Fixed, 95% CI)	0.91 [0.68, 1.23]
7.3.7 vorozole 2.5mg	1	375	Odds Ratio (M‐H, Fixed, 95% CI)	1.35 [0.88, 2.07]
7.4 Objective response (assessable) Show forest plot	18	5937	Odds Ratio (M‐H, Fixed, 95% CI)	0.98 [0.86, 1.13]

7.4.1 aminoglutethimide (any dose)	5	734	Odds Ratio (M‐H, Fixed, 95% CI)	0.94 [0.68, 1.30]
7.4.2 formestane 250 mg biweekly	2	652	Odds Ratio (M‐H, Fixed, 95% CI)	1.24 [0.84, 1.83]
7.4.3 anastrozole 1 mg	2	1367	Odds Ratio (M‐H, Fixed, 95% CI)	1.12 [0.84, 1.50]
7.4.4 exemestane 25 mg	2	1243	Odds Ratio (M‐H, Fixed, 95% CI)	0.89 [0.63, 1.26]
7.4.5 fadrozole 2 mg	3	773	Odds Ratio (M‐H, Fixed, 95% CI)	1.17 [0.76, 1.80]
7.4.6 letrozole 2.5 mg	3	793	Odds Ratio (M‐H, Fixed, 95% CI)	0.76 [0.53, 1.08]
7.4.7 vorozole 2.5 mg	1	375	Odds Ratio (M‐H, Fixed, 95% CI)	0.70 [0.34, 1.42]
7.5 Clinical benefit (randomised) Show forest plot	16	6432	Odds Ratio (M‐H, Fixed, 95% CI)	1.00 [0.90, 1.11]

7.5.1 aminoglutethimide (any dose)	4	1320	Odds Ratio (M‐H, Fixed, 95% CI)	1.06 [0.85, 1.31]
7.5.2 formestane 250 mg biweekly	1	177	Odds Ratio (M‐H, Fixed, 95% CI)	0.72 [0.40, 1.31]
7.5.3 anastrozole 1 mg	2	1367	Odds Ratio (M‐H, Fixed, 95% CI)	1.04 [0.84, 1.29]
7.5.4 exemestane 25 mg	2	1462	Odds Ratio (M‐H, Fixed, 95% CI)	0.93 [0.74, 1.16]
7.5.5 fadrozole 2 mg	3	779	Odds Ratio (M‐H, Fixed, 95% CI)	1.04 [0.77, 1.41]
7.5.6 letrozole 2.5 mg	3	875	Odds Ratio (M‐H, Fixed, 95% CI)	0.91 [0.68, 1.21]
7.5.7 vorozole 2.5mg	1	452	Odds Ratio (M‐H, Fixed, 95% CI)	1.25 [0.83, 1.88]
7.6 Objective response (randomised) Show forest plot	18	7113	Odds Ratio (M‐H, Fixed, 95% CI)	1.04 [0.92, 1.18]

7.6.1 aminoglutethimide (any dose)	5	1475	Odds Ratio (M‐H, Fixed, 95% CI)	1.15 [0.91, 1.45]
7.6.2 formestane 250 mg biweekly	2	724	Odds Ratio (M‐H, Fixed, 95% CI)	1.22 [0.84, 1.79]
7.6.3 anastrozole 1 mg	2	1367	Odds Ratio (M‐H, Fixed, 95% CI)	1.12 [0.84, 1.50]
7.6.4 exemestane 25 mg	2	1462	Odds Ratio (M‐H, Fixed, 95% CI)	0.87 [0.62, 1.24]
7.6.5 fadrozole 2 mg	3	779	Odds Ratio (M‐H, Fixed, 95% CI)	1.17 [0.76, 1.80]
7.6.6 letrozole 2.5 mg	3	854	Odds Ratio (M‐H, Fixed, 95% CI)	0.80 [0.56, 1.13]
7.6.7 vorozole 2.5 mg	1	452	Odds Ratio (M‐H, Fixed, 95% CI)	0.67 [0.33, 1.37]

Comparison 7. AI as second‐line therapy versus any other therapy

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