The Role of Active Surveillance in the Management of Men ...



Appendix Table C4.1. Descriptive characteristics of the randomized controlled trials and comparative cohort studies considered relevant to KQ4

|Author, Year |Study name |Comparison |Study duration |Sample size |Inclusion criteria |Population description: |Quality |

|[Pubmed ID] |/Database | | |(total) | |Age |Comments |

| | | | | | |PSA (ng/mL) | |

|Study design | | | | | |Tumor grade | |

| | | | | | |Stage | |

|Randomized studies –| | | | | | | |

|clinical outcomes | | | | | | | |

|Bill-Axelson213 |SPCG-4 |WW vs. RP |12.8 yr |695 |Newly diagnosed prostate cancer patients,|Age: 65 yr |A |

|2011 | | | | |younger than 75 years, with life | | |

|21542742 | | | | |expectancy >10 years, T0d-T2, WHO well- |Mean PSA: 13 | |

| | | | | |moderately differentiated tumors. | | |

|RCT | | | | | |Grade: WW, WHO 1, 47.7%; WHO 2, 52.3%; | |

| | | | | | |unknown, 0%. RP, WHO 1, 48.4%; WHO 2, | |

| | | | | | |51.3%; unknown, 0.3% | |

| | | | | | | | |

| | | | | | |Stage: WW, T1b, 14.4%; T1c, 10.9%; T2, | |

| | | | | | |74.4%; unknown, 0.3%. RP, T1b, 9.5%; | |

| | | | | | |T1c, 12.4; T2, 77.8%; unknown, 0.3% | |

|Johansson214 |Ancillary |WW vs. RP |Mean follow-up |376 (326 |Newly diagnosed prostate cancer patients,|Mean age (range): WW, 65 yr (51-74); RP,|B |

|2009 |investigation from | |4.1 yr (range: |responders) |younger than 75 years, with life |64 yr (48-74); | |

|18783877 |SPCG-4 trial | |1-8 yr) | |expectancy >10 years, T0d-T2, WHO well- | |Swedish |

| | | | | |moderately differentiated tumors, PSA10 yr. |unknown, 0%. RP, WHO 1, 46%; WHO 2, 53%,| |

| | | | | | |unknown, 1% | |

| | | | | | | | |

| | | | | | |Stage: WW, T0, 14%; T1, 24%, T2, 60%; | |

| | | | | | |unknown, 2%. RP, T0, 12%; T1, 21%; T2, | |

| | | | | | |61%; unknown, 5% | |

|Appendix Table C4.1. Descriptive characteristics of the randomized controlled trials and comparative cohort studies considered relevant to KQ4 (continued) |

|Author, Year |Study name |Comparison |Study duration |Sample size |Inclusion criteria |Population description: |Quality |

|[Pubmed ID] |/Database | | |(total) | |Age |Comments |

| | | | | | |PSA (ng/mL) | |

|Study design | | | | | |Tumor grade | |

| | | | | | |Stage | |

|Fransson225 |Ancillary |WW vs. RT |Median followup|72 (54 |Localized prostate cancer patients, no |Median age (range): WW, 78 (65-88); RT, |C |

|2009 |investigation from | |(range): WW, |responders) |previous treatment for prostate cancer, |77 (54-87) | |

|18985545 |UMEA1 trial | |114 mo | |no comorbid condition that would result | |Only 72 out of |

| | | |(95-196); RT, | |in expected survival less than that of |PSA: WW, ≤10, 37%; 11-20, 7%; 21-50, |original 166 |

|RCT | | |118 mo (77-188)| |the normal population of the same age |26%, >50, 15%; unknown, 15%. RT, ≤10, |patients in the |

| | | | | | |26%; 11-20, 26%; 21-50, 26%, >50, 4%; |trial were |

| | | | | | |unknown, 19% |included in this|

| | | | | | | |study. |

| | | | | | |Grade: WW, WHO 1, 78%; WHO 2, 22%. RT, | |

| | | | | | |WHO 1, 70%; WHO 2, 30%, unknown, 1% | |

| | | | | | | | |

| | | | | | |Stage: WW, T1a, 15%; T1b, 19%; T1c, 0%; | |

| | | | | | |T2, 78%. RT, T1a, 0%; T1b, 15%; T1c, 4%;| |

| | | | | | |T2, 81%. | |

|Randomized study – | | | | | | | |

|treatment costs | | | | | | | |

|Andersson237 |SPCG-4 |WW vs. RP |Median followup|212 |10 yr, T0d-T2 |Age: WW, 64.4 yr; RP, 64.7 yr |B |

|2011 | | |11.8 yr for the| |disease, WHO well/moderately | | |

|21265595 | | |WW and 12.2 yr | |differentiated, PSA ................
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