Table 2 Included studies assessing parenteral oestrogen alone

From: Parenteral oestrogen in the treatment of prostate cancer: a systematic review

Study

N

Comparator

Follow-up

All-cause mortality

Prostate cancer mortality

Cardiovascular adverse events

Study quality

PEP at 240 mg monthly a

 Hedlund et al (2002, 2007)

917

Comparator: triptorelin 3.75 mg month−1 i.m.+flutamide 250 mg t.i.d., p.o. (n=298)

or optionally orchidectomy (n=159)

Median:

PEP: 27.1 months

Comparator: 27.4 months (brief report at 12 years)

PEP: 277/455 (60.9%)

Comparator: 279/455 (61.3%)

PEP: 239/455 (52.5%)

Comparator: 252/455 (55.4%)

PEP: 80/455 (17.6%), 23 fatal (5.1%)

Comparator: 59/455 (13.0%), 23 fatal (5.1%)

High quality, blind outcome assessment, central randomisation

 Mikkola et al (1998, 2005, 2007)

444

Orchidectomy

2 years; subgroup analyses at 3 and 10 years

2 years:

PEP: 27/227 (11.9%)

2 years:

PEP: 8/227 (3.5%)

2 years:

PEP: 24/227 (10.6%), 14 fatal (7.5%)

Adequate study design but inadequate reporting of withdrawals

    

Orchidectomy: 23/217 (10.6%)

Orchidectomy: 7/217 (3.2%)

Orchidectomy: 10/217 (4.6%), 5 fatal (2.3%)

 
    

10 years:

M0: PEP: 97/125 (77.6%)

Orchidectomy: 88/119 (73.9%)

M1: PEP: 94/102 (92.2%)

Orchidectomy: 91/98 (92.9%)

10 years: M0: PEP: 44/125 (35.2%) Orchidectomy: 47/119 (39.5%);

M1: PEP: 76/102 (74.5%) Orchidectomy: 61/98 (62.2%)

Mortality at 10 years: M0: PEP: 28/125 (22.4%) Orchidectomy: 13/119 (10.9%);

M1: PEP: 11/102 (10.8%) Orchidectomy: 12/98 (12.2%)

 

 Henriksson et al (1999)

33

Orchidectomy

2 years

PEP: 0/17 (0%) Orchidectomy: 1/16 (6.2%)

Not reported

PEP: 1/17 (5.9%) Orchidectomy: 4/16 (25.0%)

Pilot study, method of randomisation not described

PEP at 160 mg monthly a

 Lukkarinen and Kontturi (1994)

236

LHRH: goserelin s.c. depot injection 3.6 mg per 28 days

Mean:

PEP: 23 months

LHRH: 26 months

PEP: 13/107 (12.1%)

LHRH: 14/129 (10.8%)

PEP: 3/107 (2.8%)

LHRH: 3/129 (2.3%)

PEP: 23/107 (21.5%), 7 fatal (6.5%)

LHRH: 13/129 (10.1%), 8 fatal (6.2%)

Inadequate reporting of withdrawals

 Haapiainen et al (1990)

200

Orchidectomy

>2 years

PEP: 12/125 (9.6%)

Orchidectomy: 6/75 (8.0%)

PEP: 6/125 (4.8%)

Orchidectomy: 5/75 (6.7%)

CVS mortality:

PEP: 2/125 (1.6%)

Orchidectomy: 1/75 (1.3%)

Inadequate reporting of withdrawals

      

Non-fatal events NR

 

 Aro et al (1988, 1989, 1993)

147

LHRH: buserelin 6.6 mg per 8 weeks; implant s.c.

3 years

NR

NR

PEP: 5/70 (7.1%), 4 fatal (5.7%)

LHRH: 6/77 (7.8%), 4 fatal (5.2%)

Adequate study design

 Bishop et al (1989)

117

Orchidectomy

NR

NR

NR

PEP: 8/61 (13.1%), 3 fatal (4.9%)

Insufficient information to assess

      

Orchidectomy: 4/56 (7.1%), all fatal

 

Oestradiol undecylate at 100 mg monthly

 Jacobi et al (1980)

42

Cyproterone acetate 300 mg week−1 i.m.

NR

NR

NR

PEP: 16/21 (76.2%), 2 fatal (9.5%)

Insufficient information to assess

      

Cyproterone: 0/21 (0%)

 

5 mg β-diethyl-oestradiol applied as cream b.i.d.

 Steg et al (1983)

56

Oral DES 1 mg t.i.d., p.o.

NR

NR

NR

Cream: 0/29 (0%)

DES: 5/27 (18.5%), 2 fatal (7.4%)

Insufficient information to assess

  1. CVS=cardiovascular system; LHRH=luteinising hormone-releasing hormone; N=number of patients; NR=not reported; PEP=polyoestradiol phosphate; PEP+=PEP combined with oral oestrogen.
  2. Studies are ordered by sample size within dosage categories.
  3. Since increased cardiovascular risk occurs primarily during the first 2 years of oestrogen therapy, where trials report CVS events for more than one follow-up period, those closest to 2 years are given.
  4. aIn some trials, participants may have had higher initial treatment doses or may have received other additional treatment. The dose given here is the routine dose given for the duration of the trial. Further details can be found in the full evidence tables (see Appendix 7 of CRD report).
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