Neo‐adjuvant and adjuvant hormone therapy for localised and locally advanced prostate cancer

Satish Kumar; Mike Shelley; Craig Harrison; Bernadette Coles; Timothy J. Wilt; Malcolm Mason

doi:10.1002/14651858.CD006019.pub2

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Analysis 1.1

Comparison 1 Neo‐adjuvant hormone therapy and Prostatectomy Versus Prostatectomy alone, Outcome 1 Overall survival.

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Analysis 1.2

Comparison 1 Neo‐adjuvant hormone therapy and Prostatectomy Versus Prostatectomy alone, Outcome 2 Disease‐free survival at 5 years (intention‐to‐treat analysis).

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Analysis 1.3

Comparison 1 Neo‐adjuvant hormone therapy and Prostatectomy Versus Prostatectomy alone, Outcome 3 pT Staging: Organ Confined (Intention‐to‐treat Analysis).

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Analysis 1.4

Comparison 1 Neo‐adjuvant hormone therapy and Prostatectomy Versus Prostatectomy alone, Outcome 4 pT Staging: Organ Confined (Case Analysis).

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Analysis 1.5

Comparison 1 Neo‐adjuvant hormone therapy and Prostatectomy Versus Prostatectomy alone, Outcome 5 pT Staging: Downstaging (Intention‐to‐treat Analysis).

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Analysis 1.6

Comparison 1 Neo‐adjuvant hormone therapy and Prostatectomy Versus Prostatectomy alone, Outcome 6 pT Staging: Downstaging (Case Analysis).

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Analysis 1.7

Comparison 1 Neo‐adjuvant hormone therapy and Prostatectomy Versus Prostatectomy alone, Outcome 7 Positive Surgical Margin Status (Intention‐to‐treat Analysis).

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Analysis 1.8

Comparison 1 Neo‐adjuvant hormone therapy and Prostatectomy Versus Prostatectomy alone, Outcome 8 Positive Surgical Margin Status (Case Analysis).

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Analysis 1.9

Comparison 1 Neo‐adjuvant hormone therapy and Prostatectomy Versus Prostatectomy alone, Outcome 9 Seminal Vesicle Invasion Rate (Intention‐to‐treat Analysis).

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Analysis 1.10

Comparison 1 Neo‐adjuvant hormone therapy and Prostatectomy Versus Prostatectomy alone, Outcome 10 Seminal Vesicle Invasion Rate (Case Analysis).

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Analysis 1.11

Comparison 1 Neo‐adjuvant hormone therapy and Prostatectomy Versus Prostatectomy alone, Outcome 11 Positive Lymph Nodes (Intention‐to‐treat Analysis).

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Analysis 1.12

Comparison 1 Neo‐adjuvant hormone therapy and Prostatectomy Versus Prostatectomy alone, Outcome 12 Positive Lymph Nodes (Case Analysis).

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Analysis 2.1

Comparison 2 Short‐term versus Long‐term Neo‐adjuvant hormone therapy and prostatectomy, Outcome 1 Positive Surgical Margin Status (Case analysis only).

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Analysis 2.2

Comparison 2 Short‐term versus Long‐term Neo‐adjuvant hormone therapy and prostatectomy, Outcome 2 pT Staging: Organ confined (Case analysis only).

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Analysis 3.1

Comparison 3 Neo‐adjuvant hormone therapy and Radiotherapy Versus Radiotherapy alone, Outcome 1 Disease‐specific survival.

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Analysis 3.2

Comparison 3 Neo‐adjuvant hormone therapy and Radiotherapy Versus Radiotherapy alone, Outcome 2 Biochemical disease‐free survival.

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Analysis 3.3

Comparison 3 Neo‐adjuvant hormone therapy and Radiotherapy Versus Radiotherapy alone, Outcome 3 Clinical disease‐free survival.

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Analysis 4.1

Comparison 4 Short‐term versus long‐term neo‐adjuvant hormone therapy Radiotherapy, Outcome 1 3 year biochemical disease‐free survival.

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Analysis 4.2

Comparison 4 Short‐term versus long‐term neo‐adjuvant hormone therapy Radiotherapy, Outcome 2 5‐year biochemical disease free survival.

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Analysis 5.1

Comparison 5 Adjuvant hormone therapy and Prostatectomy Versus Prostatectomy Alone, Outcome 1 Overall Survival: 5 Years.

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Analysis 5.2

Comparison 5 Adjuvant hormone therapy and Prostatectomy Versus Prostatectomy Alone, Outcome 2 Overall Survival: 10 Years.

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Analysis 5.3

Comparison 5 Adjuvant hormone therapy and Prostatectomy Versus Prostatectomy Alone, Outcome 3 Disease‐Free Survival: 5 Years.

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Analysis 5.4

Comparison 5 Adjuvant hormone therapy and Prostatectomy Versus Prostatectomy Alone, Outcome 4 Disease‐Free Survival: 10 Years.

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Analysis 6.1

Comparison 6 Adjuvant hormone therapy and Radiotherapy Versus Radiotherapy alone, Outcome 1 Overall Survival: 5 Years.

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Analysis 6.2

Comparison 6 Adjuvant hormone therapy and Radiotherapy Versus Radiotherapy alone, Outcome 2 Overall Survival: 10 Years.

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Analysis 6.3

Comparison 6 Adjuvant hormone therapy and Radiotherapy Versus Radiotherapy alone, Outcome 3 Disease‐Specific Survival: 5 Years.

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Analysis 6.4

Comparison 6 Adjuvant hormone therapy and Radiotherapy Versus Radiotherapy alone, Outcome 4 Disease‐Free Survival: 10 Years.

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Table 1. Definition of outcomes used in this review

Outcomes	Definition
Time‐to‐progression	A measure of the time after a disease is treated until the disease starts to get worse
Progression‐Free Survival	The probability that a patient will remain alive, without the disease getting worse
Disease progression	Cancer that continues to grow or spread
Overall Survival	Percentage of subjects in a study who have survived for a defined period of time. A.K.A. Survival rate.
Recurrence (Disease Recurrence/ Relapse)	Cancer that has returned after a period of time during which the cancer could not be detected. The cancer may come back to the same place as the original (primary) tumour or to another place in the body.
Disease‐Free Survival	Length of time after treatment during which no cancer is found
Disease‐Specific Survival	The percentage of subjects in a study who have survived a particular disease for a defined period of time. In calculating the percentage, only deaths from the disease being studied are counted
Surgical Margins	Surgical removal of a tumor with an additional margin of normal tissue, and the outer edge is coated with ink.
Positive (+) Surgical Margins	Cancer cells that are in contact with the inked outer surface (margin) are described as positive.
Negative (‐) Surgical Margins	Cancer cells not found at the edge of the inked tissue (Margin) are described as negative
Pathological (pT) Staging	The staging of cancer cells determined by tissue sample removed during surgery or a biopsy.
Seminal Vesicle Rate	The proportion of patients that have tumour infiltrating the seminal vesicles.
Positive Lymph Nodes	Tumour has spread to the lymph nodes ‐ generally the pelvic lymph nodes in prostate cancer.

Table 1. Definition of outcomes used in this review

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Comparison 1. Neo‐adjuvant hormone therapy and Prostatectomy Versus Prostatectomy alone

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Overall survival Show forest plot	3	827	Odds Ratio (M‐H, Fixed, 95% CI)	1.11 [0.67, 1.85]

2 Disease‐free survival at 5 years (intention‐to‐treat analysis) Show forest plot	4	1129	Odds Ratio (M‐H, Fixed, 95% CI)	1.20 [0.95, 1.52]

3 pT Staging: Organ Confined (Intention‐to‐treat Analysis) Show forest plot	4	922	Odds Ratio (M‐H, Fixed, 95% CI)	2.30 [1.72, 3.08]

4 pT Staging: Organ Confined (Case Analysis) Show forest plot	4	811	Odds Ratio (M‐H, Fixed, 95% CI)	2.61 [1.93, 3.53]

5 pT Staging: Downstaging (Intention‐to‐treat Analysis) Show forest plot	2	648	Odds Ratio (M‐H, Fixed, 95% CI)	2.42 [1.50, 3.90]

6 pT Staging: Downstaging (Case Analysis) Show forest plot	2	563	Odds Ratio (M‐H, Fixed, 95% CI)	2.60 [1.61, 4.21]

7 Positive Surgical Margin Status (Intention‐to‐treat Analysis) Show forest plot	8	1802	Odds Ratio (M‐H, Fixed, 95% CI)	0.34 [0.27, 0.42]

8 Positive Surgical Margin Status (Case Analysis) Show forest plot	8	1600	Odds Ratio (M‐H, Fixed, 95% CI)	0.32 [0.26, 0.40]

9 Seminal Vesicle Invasion Rate (Intention‐to‐treat Analysis) Show forest plot	2	516	Odds Ratio (M‐H, Fixed, 95% CI)	1.10 [0.70, 1.73]

10 Seminal Vesicle Invasion Rate (Case Analysis) Show forest plot	2	467	Odds Ratio (M‐H, Fixed, 95% CI)	1.09 [0.69, 1.71]

11 Positive Lymph Nodes (Intention‐to‐treat Analysis) Show forest plot	5	1247	Odds Ratio (M‐H, Fixed, 95% CI)	0.63 [0.43, 0.93]

12 Positive Lymph Nodes (Case Analysis) Show forest plot	5	1070	Odds Ratio (M‐H, Fixed, 95% CI)	0.67 [0.45, 1.00]

Comparison 1. Neo‐adjuvant hormone therapy and Prostatectomy Versus Prostatectomy alone

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Comparison 2. Short‐term versus Long‐term Neo‐adjuvant hormone therapy and prostatectomy

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Positive Surgical Margin Status (Case analysis only) Show forest plot	3	805	Odds Ratio (M‐H, Fixed, 95% CI)	0.56 [0.39, 0.80]

1.1 6 months versus 3 months hormone therapy	2	305	Odds Ratio (M‐H, Fixed, 95% CI)	0.69 [0.41, 1.17]
1.2 8 months versus 3 months hormone therapy	1	500	Odds Ratio (M‐H, Fixed, 95% CI)	0.48 [0.29, 0.77]
2 pT Staging: Organ confined (Case analysis only) Show forest plot	3	805	Odds Ratio (M‐H, Fixed, 95% CI)	1.41 [1.05, 1.89]

2.1 6 months versus 3 months hormone therapy	2	305	Odds Ratio (M‐H, Fixed, 95% CI)	1.37 [0.86, 2.18]
2.2 8 months versus 3 months hormone therapy	1	500	Odds Ratio (M‐H, Fixed, 95% CI)	1.44 [0.99, 2.09]

Comparison 2. Short‐term versus Long‐term Neo‐adjuvant hormone therapy and prostatectomy

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Comparison 3. Neo‐adjuvant hormone therapy and Radiotherapy Versus Radiotherapy alone

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Disease‐specific survival Show forest plot	2	991	Odds Ratio (M‐H, Fixed, 95% CI)	0.99 [0.75, 1.32]

2 Biochemical disease‐free survival Show forest plot	3	1097	Odds Ratio (M‐H, Fixed, 95% CI)	1.93 [1.45, 2.56]

3 Clinical disease‐free survival Show forest plot	2	991	Odds Ratio (M‐H, Fixed, 95% CI)	1.86 [1.43, 2.40]

Comparison 3. Neo‐adjuvant hormone therapy and Radiotherapy Versus Radiotherapy alone

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Comparison 4. Short‐term versus long‐term neo‐adjuvant hormone therapy Radiotherapy

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 3 year biochemical disease‐free survival Show forest plot	2	893	Odds Ratio (M‐H, Fixed, 95% CI)	1.06 [0.81, 1.39]

1.1 8 verses 3 months of neoadjuvant therapy and radiotherapy	1	361	Odds Ratio (M‐H, Fixed, 95% CI)	1.03 [0.68, 1.56]
1.2 6 versus 3 months of neo‐adjuvant therapy and radiotherapy	1	532	Odds Ratio (M‐H, Fixed, 95% CI)	1.08 [0.76, 1.54]
2 5‐year biochemical disease free survival Show forest plot	2	893	Odds Ratio (M‐H, Fixed, 95% CI)	0.91 [0.67, 1.24]

2.1 8 months verses 3 months of neo‐adjuvant hormonal therapy and Radiotherapy	1	361	Odds Ratio (M‐H, Fixed, 95% CI)	1.00 [0.54, 1.85]
2.2 6 months versus 3 months of neo‐adjuvant therapy and Radiotherapy	1	532	Odds Ratio (M‐H, Fixed, 95% CI)	0.88 [0.62, 1.26]

Comparison 4. Short‐term versus long‐term neo‐adjuvant hormone therapy Radiotherapy

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Comparison 5. Adjuvant hormone therapy and Prostatectomy Versus Prostatectomy Alone

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Overall Survival: 5 Years Show forest plot	2	407	Odds Ratio (M‐H, Fixed, 95% CI)	1.50 [0.79, 2.84]

2 Overall Survival: 10 Years Show forest plot	2	407	Odds Ratio (M‐H, Fixed, 95% CI)	0.53 [0.33, 0.84]

3 Disease‐Free Survival: 5 Years Show forest plot	2	407	Odds Ratio (M‐H, Fixed, 95% CI)	3.73 [2.30, 6.03]

4 Disease‐Free Survival: 10 Years Show forest plot	2	407	Odds Ratio (M‐H, Fixed, 95% CI)	2.06 [1.34, 3.15]

Comparison 5. Adjuvant hormone therapy and Prostatectomy Versus Prostatectomy Alone

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Comparison 6. Adjuvant hormone therapy and Radiotherapy Versus Radiotherapy alone

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Overall Survival: 5 Years Show forest plot	4	2844	Odds Ratio (M‐H, Fixed, 95% CI)	1.29 [1.07, 1.56]

2 Overall Survival: 10 Years Show forest plot	2	1059	Odds Ratio (M‐H, Fixed, 95% CI)	1.44 [1.13, 1.84]

3 Disease‐Specific Survival: 5 Years Show forest plot	2	1392	Odds Ratio (M‐H, Fixed, 95% CI)	2.10 [1.53, 2.88]

4 Disease‐Free Survival: 10 Years Show forest plot	2	1059	Odds Ratio (M‐H, Fixed, 95% CI)	1.96 [1.49, 2.56]

Comparison 6. Adjuvant hormone therapy and Radiotherapy Versus Radiotherapy alone

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