Page 92 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer

Observational Management Strategies with Palliative Intent

We identified 13 unique cohorts reporting followup protocols for patients who initially
received no treatment and who were subsequently treated only for symptomatic progression. We
labeled these observational management strategies as having primarily palliative intent. Of these
cohorts, seven are in the United States; two in Canada; four in the UK; one in Sweden; one
across Finland, Sweden, and Iceland; one in the Netherlands; and one in Taiwan (Table 6). Six
cohorts were formed in the pre-PSA screening era. Howard University College of Medicine was
the first institution to report enrollment of patients into an observational management program in
1967.

Table 6. Unique 13 cohorts of observational management strategies with palliative intent
Cohorts or Centers Country Beginning of enrollment
(year)
a
Howard University college of Medicine 138 US 1967
a
Orebro Medical Center 139 Sweden 1977
a
North Stockholm 140 Sweden 1978
a
Freeman Hospital 141 UK 1978
a
Western General Hospital 142 UK 1978
a
Taichung Veterans Hospital 143 Taiwan 1983
Scandinavian Prostate Cancer Group Study Number 4 Finland, Sweden, and 1989
(SPCG-4) trial 144 Iceland
Erasmus University Hospital 145 Netherlands Before 1990
Royal Marsden Hospital (before 2002) 112 UK 1993
Prostate Cancer Intervention Versus Observation Trial US 1994
(PIVOT) 146
Watchful Waiting Study 147 US 1998
Hospitals in Manchester region 148 UK Not reported (publication
year 2001)
University of Florida 149 US 2003
Hospitals in Manchester region= University Hospital of South Manchester, Withington Hospital, Christie Hospital; Hope
Hospital. Some cohorts had multiple publications providing different pieces of information on eligibility criteria and followup
protocol. In this case, only the earliest publication was used as the primary citation of the cohort. Details are described in Table 7
and 8.
a Early cohorts that did not use PSA as part of eligibility criteria or followup protocols. These cohorts are assumed to have
formed during the pre-PSA screening era.

Common Metrics: Eligibility Criteria for Observational Management
Strategies with Palliative Intent (Table 7)
The six cohorts in the pre-PSA screening era enrolled patients primarily based on clinical
staging alone. Of these, four cohorts enrolled patients with clinical stage T2 or less, 138,139,142,143
one cohort enrolled “patients without symptoms after initial outflow tract surgery or biopsy,” 141
and the other cohort enrolled both patients with clinical stage T1-2 (71 percent) and T3 (21
percent) but all patients had normal bone scan findings. 140
Of the seven cohorts in the PSA screening era, three cohorts (4 publications) enrolled
patients with clinical stage T2 or less, 137,145,146,150 one cohort enrolled patients with “low-stage,
low-grade disease,” 149 one cohort enrolled patients with any T stage N0/X, M0/X, 112 and the
other two cohorts did not report or did not use clinical stage as part of patient eligibility criteria.
The commonly used patient eligibility criteria were PSA (5 cohorts), age (4 cohorts), Gleason
score (4 cohorts), and normal bone scan findings (4 cohorts). More details of each eligibility
criterion in these seven cohorts are described in the following sections.

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