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Study flow diagram.
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Figure 1

Study flow diagram.

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'Risk of bias' summary ‐ mortality at 12 months: review authors' judgements about each methodological quality item for each included study that evaluated mortality at 12 months
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Figure 2

'Risk of bias' summary ‐ mortality at 12 months: review authors' judgements about each methodological quality item for each included study that evaluated mortality at 12 months

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Funnel plot of comparison: 1 Heparin versus placebo, outcome: 1.1 Mortality at 12 months.
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Figure 3

Funnel plot of comparison: 1 Heparin versus placebo, outcome: 1.1 Mortality at 12 months.

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'Risk of bias' summary ‐ venous thromboembolism: review authors' judgements about each methodological quality item for each included study that evaluated venous thromboembolism
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Figure 4

'Risk of bias' summary ‐ venous thromboembolism: review authors' judgements about each methodological quality item for each included study that evaluated venous thromboembolism

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'Risk of bias' summary ‐ major bleeding: review authors' judgements about each methodological quality item for each included study that evaluated major bleeding
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Figure 5

'Risk of bias' summary ‐ major bleeding: review authors' judgements about each methodological quality item for each included study that evaluated major bleeding

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'Risk of bias' summary ‐ minor bleeding: review authors' judgements about each methodological quality item for each included study that evaluated minor bleeding
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Figure 6

'Risk of bias' summary ‐ minor bleeding: review authors' judgements about each methodological quality item for each included study that evaluated minor bleeding

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Comparison 1 Heparin versus placebo, Outcome 1 Mortality at 12 months.
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Analysis 1.1

Comparison 1 Heparin versus placebo, Outcome 1 Mortality at 12 months.

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Comparison 1 Heparin versus placebo, Outcome 2 Mortality at 24 months.
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Analysis 1.2

Comparison 1 Heparin versus placebo, Outcome 2 Mortality at 24 months.

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Comparison 1 Heparin versus placebo, Outcome 3 Mortality over duration of study.
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Analysis 1.3

Comparison 1 Heparin versus placebo, Outcome 3 Mortality over duration of study.

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Comparison 1 Heparin versus placebo, Outcome 4 Symptomatic VTE.
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Analysis 1.4

Comparison 1 Heparin versus placebo, Outcome 4 Symptomatic VTE.

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Comparison 1 Heparin versus placebo, Outcome 5 Symptomatic DVT.
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Analysis 1.5

Comparison 1 Heparin versus placebo, Outcome 5 Symptomatic DVT.

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Comparison 1 Heparin versus placebo, Outcome 6 Symptomatic PE.
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Analysis 1.6

Comparison 1 Heparin versus placebo, Outcome 6 Symptomatic PE.

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Comparison 1 Heparin versus placebo, Outcome 7 Major bleeding.
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Analysis 1.7

Comparison 1 Heparin versus placebo, Outcome 7 Major bleeding.

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Comparison 1 Heparin versus placebo, Outcome 8 Minor bleeding.
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Analysis 1.8

Comparison 1 Heparin versus placebo, Outcome 8 Minor bleeding.

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Comparison 1 Heparin versus placebo, Outcome 9 Thrombocytopenia.
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Analysis 1.9

Comparison 1 Heparin versus placebo, Outcome 9 Thrombocytopenia.

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Summary of findings for the main comparison. Heparin compared to placebo for ambulatory patients with cancer who have no therapeutic or prophylactic indication for anticoagulation

Heparin compared to placebo for ambulatory patients with cancer who have no therapeutic or prophylactic indication for anticoagulation

Patient or population: Ambulatory patients with cancer who have no therapeutic or prophylactic indication for anticoagulation
Settings: Outpatient
Intervention: heparin
Comparison: placebo

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Placebo

Heparin

Mortality at 12 months

Study population

RR 0.97
(0.92 to 1.01)

7013
(13 RCTs)

⊕⊕⊕⊝
MODERATE 1

Moderate‐quality evidence owing to imprecision. A survival analysis based on data from 11 studies found a hazard ratio of 0.84 (95% CI 0.74 to 0.96); however heterogeneity in that analysis was relatively high (I2 = 58%) and subgroup analyses did not conclusively identify any subgroup effect

472 per 1000

458 per 1000
(434 to 477)

Symptomatic VTE

Study population

RR 0.56
(0.42 to 0.74)

6809
(13 RCTs)

⊕⊕⊕⊕
HIGH

The data are combined for pulmonary embolism and symptomatic deep venous thrombosis

55 per 1000

31 per 1000
(23 to 41)

Major bleeding

Study population

RR 1.14
(0.7 to 1.85)

7363
(15 RCTs)

⊕⊕⊕⊝
MODERATE 2

Moderate‐quality evidence owing to imprecision

19 per 1000

21 per 1000
(13 to 35)

Minor bleeding

Study population

RR 1.32
(1.02 to 1.71)

6884
(13 RCTs)

⊕⊕⊕⊝
MODERATE 3

Moderate‐quality evidence owing to imprecision

30 per 1000

40 per 1000
(31 to 51)

*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; RCT: randomized controlled trial; RR: risk ratio; VTE: venous thromboembolism

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.

1Confidence interval includes values suggesting clinically significant benefit and values suggesting no effect.

2Confidence interval includes values suggesting clinically significant benefit and values suggesting harm.

3Confidence interval includes values suggesting clinically significant harm and values suggesting no effect.

Figuras y tablas -
Summary of findings for the main comparison. Heparin compared to placebo for ambulatory patients with cancer who have no therapeutic or prophylactic indication for anticoagulation
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Table 1. Glossary

Term

Definition

Adjuvant therapy

Assisting in the amelioration or cure of disease

Anticoagulation

The process of hindering the clotting of blood especially by treatment with an anticoagulant

Antithrombotic

Used against or tending to prevent thrombosis (clotting)

Bacteremia

The presence of bacteria in the blood

Central venous line

Synthetic tube that is inserted into a central (large) vein of a patient to provide temporary intravenous access for the administration of fluid, medication or nutrients

Coagulation

Clotting

Deep vein thrombosis (DVT)

A condition marked by the formation of a thrombus within a deep vein (as of the leg or pelvis) that may be asymptomatic or be accompanied by symptoms (such as swelling and pain) and that is potentially life‐threatening if dislodgment of the thrombus results in pulmonary embolism

Fibrin

A white insoluble fibrous protein formed from fibrinogen by the action of thrombin, especially in the clotting of blood

Fondaparinux

An anticoagulant medication

Hemostatic system

The system that shortens the clotting time of blood and stops bleeding

Heparin

An enzyme occurring especially in the liver and lungs that prolongs the clotting time of blood by preventing the formation of fibrin. Two forms of heparin that are used as anticoagulant medications are: unfractionated heparin (UFH) and low molecular weight heparins (LMWH)

Impedance plethysmography

A technique that measures the change in blood volume (venous blood volume as well as the pulsation of the arteries) for a specific body segment

Kappa statistics

A measure of degree of non‐random agreement between observers and/or measurements of a specific categorical variable

Metastasis

The spread of cancer cells from the initial or primary site of disease to another part of the body

Oncogene

A gene having the potential to cause a normal cell to become cancerous

Osteoporosis

A condition that especially affects older women and is characterized by a decrease in bone mass with decreased density and enlargement of bone spaces producing porosity and brittleness

Parenteral nutrition

The practice of feeding a patient intravenously, circumventing the gut

Pulmonary embolism (PE)

Embolism of a pulmonary artery or one of its branches that is produced by foreign matter and most often a blood clot originating in a vein of the leg or pelvis and that is marked by labored breathing, chest pain, fainting, rapid heart rate, cyanosis, shock and sometimes death

Stroma

The supporting framework of an organ typically consisting of connective tissue

Thrombin

A proteolytic enzyme formed from prothrombin that facilitates the clotting of blood by catalyzing conversion of fibrinogen to fibrin

Thrombocytopenia

Persistent decrease in the number of blood platelets that is often associated with hemorrhagic conditions

Thrombosis

The formation or presence of a blood clot within a blood vessel

Vitamin K antagonists

Anticoagulant medications that are used for anticoagulation. Warfarin is a vitamin K antagonist

Warfarin

An anticoagulant medication that is a vitamin K antagonist, which is used for anticoagulation

Ximelagatran

An anticoagulant medication
Figuras y tablas -
Table 1. Glossary
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Table 2. LMWH: definitions of prophylactic and therapeutic dosages

LMWH

Generic name

Prophylactic dose

Therapeutic dose

Lovenox

Enoxaparin

40 mg once daily

1 mg/kg twice daily

Fragmin

Dalteparin

2500 to 5000 units once daily

200 U/kg once daily or
100 U/kg twice daily

Innohep, Logiparin

Tinzaparin,

4500 units once daily

90 U/kg twice daily

Fraxiparine

Nadroparin

35 to 75 anti‐Xa international units/kg once daily

175 anti‐Xa int. units/kg once daily

Certoparin

Sandoparin

3000 anti‐Xa international units once daily

—
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Table 2. LMWH: definitions of prophylactic and therapeutic dosages
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Comparison 1. Heparin versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality at 12 months Show forest plot

13

7013

Risk Ratio (M‐H, Random, 95% CI)

0.97 [0.92, 1.01]

2 Mortality at 24 months Show forest plot

7

1621

Risk Ratio (M‐H, Random, 95% CI)

0.95 [0.90, 1.00]

3 Mortality over duration of study Show forest plot

11

5254

Hazard Ratio (Random, 95% CI)

0.84 [0.74, 0.96]

4 Symptomatic VTE Show forest plot

13

6809

Risk Ratio (M‐H, Random, 95% CI)

0.56 [0.43, 0.74]

5 Symptomatic DVT Show forest plot

9

6209

Risk Ratio (M‐H, Random, 95% CI)

0.49 [0.28, 0.86]

6 Symptomatic PE Show forest plot

9

6245

Risk Ratio (M‐H, Random, 95% CI)

0.59 [0.37, 0.96]

7 Major bleeding Show forest plot

15

7305

Risk Ratio (M‐H, Random, 95% CI)

1.13 [0.63, 2.01]

8 Minor bleeding Show forest plot

13

6884

Risk Ratio (M‐H, Random, 95% CI)

1.32 [1.02, 1.71]

9 Thrombocytopenia Show forest plot

9

4890

Risk Ratio (M‐H, Random, 95% CI)

0.54 [0.26, 1.12]
Figuras y tablas -
Comparison 1. Heparin versus placebo
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