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Lange, J. M., Laviana, A. A., Penson, D. F., Lin, D. W., Bill-Axelson, A., Carlsson, S. V., . . . Etzioni, R. B. (2020). Prostate cancer mortality and metastasis under different biopsy frequencies in North American active surveillance cohorts. Cancer, 126(3), 583-592
Open this publication in new window or tab >>Prostate cancer mortality and metastasis under different biopsy frequencies in North American active surveillance cohorts
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2020 (English)In: Cancer, ISSN 0008-543X, E-ISSN 1097-0142, Vol. 126, no 3, p. 583-592Article in journal (Refereed) Published
Abstract [en]

Background Active surveillance (AS) is an accepted means of managing low-risk prostate cancer. Because of the rarity of downstream events, data from existing AS cohorts cannot yet address how differences in surveillance intensity affect metastasis and mortality. This study projected the comparative benefits of different AS schedules in men diagnosed with prostate cancer who had Gleason score (GS) <= 6 disease and risk profiles similar to those in North American AS cohorts. Methods Times of GS upgrading were simulated based on AS data from the University of Toronto, Johns Hopkins University, the University of California at San Francisco, and the Canary Pass Active Surveillance Cohort. Times to metastasis and prostate cancer death, informed by models from the Scandinavian Prostate Cancer Group 4 trial, were projected under biopsy surveillance schedules ranging from watchful waiting to annual biopsies. Outcomes included the risk of metastasis, the risk of death, remaining life-years (LYs), and quality-adjusted LYs. Results Compared with watchful waiting, AS biopsies reduced the risk of prostate cancer metastasis and prostate cancer death at 20 years by 1.4% to 3.3% and 1.0% to 2.4%, respectively; and 5-year biopsies reduced the risk of metastasis and prostate cancer death by 1.0% to 2.4% and 0.6% to 1.6%, respectively. There was little difference between annual and 5-year biopsy schedules in terms of LYs (range of differences, 0.04-0.16 LYs) and quality-adjusted LYs (range of differences, -0.02 to 0.09 quality-adjusted LYs). Conclusions Among men diagnosed with GS <= 6 prostate cancer, obtaining a biopsy every 3 or 4 years appears to be an acceptable alternative to more frequent biopsies. Reducing surveillance intensity for those who have a low risk of progression reduces the number of biopsies while preserving the benefit of more frequent schedules.

Place, publisher, year, edition, pages
WILEY, 2020
Keywords
active surveillance, biopsy, Gleason score, microsimulation, prostate cancer
National Category
Urology and Nephrology Cancer and Oncology
Identifiers
urn:nbn:se:uu:diva-408482 (URN)10.1002/cncr.32557 (DOI)000494101800001 ()31639200 (PubMedID)
Funder
Swedish Cancer Society, CAN 2014/1275
Available from: 2020-04-07 Created: 2020-04-07 Last updated: 2020-04-07Bibliographically approved
Bergengren, O., Garmo, H., Bratt, O., Holmberg, L., Johansson, E. & Bill-Axelson, A. (2019). Determinants for choosing and adhering to active surveillance for localised prostate cancer: a nationwide population-based study. BMJ Open, 9(12), Article ID e033944.
Open this publication in new window or tab >>Determinants for choosing and adhering to active surveillance for localised prostate cancer: a nationwide population-based study
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2019 (English)In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 9, no 12, article id e033944Article in journal (Refereed) Published
Abstract [en]

Objective: Knowledge about factors influencing choice of and adherence to active surveillance (AS) for prostate cancer (PC) is scarce. We aim to identify which factors most affected choosing and adhering to AS and to quantify their relative importance.

Design, setting and participants; In 2015, we sent a questionnaire to all Swedish men aged <= 70 years registered in the National Prostate Cancer Register of Sweden who were diagnosed in 2008 with low-risk PC and had undergone prostatectomy, radiotherapy or started on AS.

Outcome measurements and statistical analysis: Logistic regression was used to calculate ORs with 95% CIs for factors potentially affecting choice and adherence to AS.

Results: 1288 out of 1720 men (75%) responded, 451 (35%) chose AS and 837 (65%) underwent curative treatment. Of those starting on AS, 238 (53%) diverted to treatment within 7 years. Most men (83%) choose AS because 'My doctor recommended AS'. Factors associated with choosing AS over treatment were older age (OR 1.81, 95% CI 1.29 to 2.54), a Charlson Comorbidity Index >2 (OR 1.50, 95% CI 1.06 to 2.13), being unaccompanied when notified of the cancer diagnosis (OR 1.45, 95% CI 1.11 to 1.89). Men with a higher prostate-specific antigen (PSA) at the time of diagnosis were less likely to adhere to AS (OR 0.26, 95% CI 0.10 to 0.63). The reason for having treatment after initial AS was 'the PSA level was rising' in 55% and biopsy findings in 36%.

Conclusions: A doctors recommendation strongly affects which treatment is chosen for men with low-risk PC. Rising PSA values were the main factor for initiating treatment for men on AS. These findings need be considered by healthcare providers who wish to increase the uptake of and adherence to AS.

Place, publisher, year, edition, pages
BMJ PUBLISHING GROUP, 2019
National Category
Urology and Nephrology Cancer and Oncology
Identifiers
urn:nbn:se:uu:diva-407279 (URN)10.1136/bmjopen-2019-033944 (DOI)000512773400283 ()31874896 (PubMedID)
Funder
Swedish Cancer Society
Available from: 2020-03-23 Created: 2020-03-23 Last updated: 2020-03-23Bibliographically approved
Cazzaniga, W., Garmo, H., Robinson, D., Holmberg, L., Bill-Axelson, A. & Stattin, P. (2019). Mortality after radical prostatectomy in a matched contemporary cohort in Sweden compared to the Scandinavian Prostate Cancer Group 4 (SPCG-4) study. BJU International, 123(3), 421-428
Open this publication in new window or tab >>Mortality after radical prostatectomy in a matched contemporary cohort in Sweden compared to the Scandinavian Prostate Cancer Group 4 (SPCG-4) study
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2019 (English)In: BJU International, ISSN 1464-4096, E-ISSN 1464-410X, Vol. 123, no 3, p. 421-428Article in journal (Refereed) Published
Abstract [en]

OBJECTIVE: To investigate if results in terms of absolute risk in mature randomised trials are relevant for contemporary decision-making. To do so, we compared the outcome for men in the radical prostatectomy (RP) arm of the Scandinavian Prostate Cancer Group Study number 4 (SPCG-4) randomised trial with matched men treated in a contemporary era before and after compensation for the grade migration and grade inflation that have occurred since the 1980s.

PATIENTS AND METHODS: A propensity score-matched analysis of prostate cancer mortality and all-cause mortality in the SPCG-4 and matched men in the National Prostate Cancer Register (NPCR) of Sweden treated in 1998-2006 was conducted. Cumulative incidence of prostate cancer mortality and all-cause mortality was calculated. Cox proportional hazards regression analyses were used to estimate hazard ratios (HR) and 95% confidence intervals (CIs) for a matching on original Gleason Grade Groups (GGG) and second, matching with GGG increased one unit for men in the NPCR.

RESULTS: Matched men in the NPCR treated in 2005-2006 had half the risk of prostate cancer mortality compared to men in the SPCG-4 (HR 0.46, 95% CI 0.19-1.14). In analysis of men matched on an upgraded GGG in the NPCR, this difference was mitigated (HR 0.73, 95% CI 0.36-1.47).

CONCLUSIONS: Outcomes after RP for men in the SPCG-4 cannot be directly applied to men in the current era, mainly due to grade inflation and grade migration. However, by compensating for changes in grading, similar outcomes after RP were seen in the SPCG-4 and NPCR. In order to compare historical trials with current treatments, data on temporal changes in detection, diagnostics, and treatment have to be accounted for.

Keywords
Gleason Grade Groups, mortality, National Prostate Cancer Register of Sweden, Scandinavian Prostate Cancer Group Study Number 4, #PCSM, #ProstateCancer
National Category
Medical and Health Sciences Urology and Nephrology
Identifiers
urn:nbn:se:uu:diva-381179 (URN)10.1111/bju.14563 (DOI)000460173100013 ()30253031 (PubMedID)
Funder
Swedish Research Council, 2017-00847
Available from: 2019-04-05 Created: 2019-04-05 Last updated: 2019-04-12Bibliographically approved
Ahlberg, M. S., Adami, H.-O., Beckmann, K., Bertilsson, H., Bratt, O., Cahill, D., . . . Bill-Axelson, A. (2019). PCASTt/SPCG-17-a randomised trial of active surveillance in prostate cancer: rationale and design. BMJ Open, 9(8)
Open this publication in new window or tab >>PCASTt/SPCG-17-a randomised trial of active surveillance in prostate cancer: rationale and design
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2019 (English)In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 9, no 8Article in journal (Refereed) Published
Abstract [en]

Introduction Overtreatment of localised prostate cancer is substantial despite increased use of active surveillance. No randomised trials help define how to monitor patients or when to initiate treatment with curative intent. Methods and analysis A randomised, multicentre, intervention trial designed to evaluate the safety of an MRI-based active surveillance protocol, with standardised triggers for repeated biopsies and radical treatment. The aim is to reduce overtreatment of prostate cancer. 2000 men will be randomly allocated to either surveillance according to current practice or to standardised triggers at centres in Sweden, Norway, Finland and the UK. Men diagnosed in the past 12 months with prostate cancer, <= T2a, prostate-specific antigen (PSA) <15ng/mL, PSA density <less than or equal to>0.2ng/mL/cc, any International Society of Urological Pathology (ISUP) grade 1 are eligible. Men with ISUP grade 2 in <30% of cores on systematic biopsy and <10mm cancer in one core on systematic or targeted biopsy are also eligible. Men diagnosed on systematic biopsy should have an MRI and targeted biopsies against Prostate Imaging and Reporting Data System V.2 3-5 lesions before inclusion. Identical follow-up in the two study arms: biannual PSA testing, yearly clinical examination and MRI every second year. In the experimental arm, standardised triggers based on MRI and PSA density elicit repeated biopsies. MRI and histopathological progression trigger radical treatment. Primary outcome measure is progression-free survival. Secondary outcome measures are cumulative incidence of metastatic disease, treatments with curative intent, pT3-4 at radical prostatectomy, switch to watchful waiting, prostate cancer mortality and quality of life. Inclusion started in October 2016 and in October 2018; 275 patients have been enrolled. Ethics and dissemination Ethical approval was obtained in each participating country. Results for the primary and secondary outcome measures will be submitted for publication in peer-reviewed journals. Trial registration number NCT02914873.

Place, publisher, year, edition, pages
BMJ PUBLISHING GROUP, 2019
Keywords
active surveillance, MRI, prostate cancer, randomised trial
National Category
Urology and Nephrology
Identifiers
urn:nbn:se:uu:diva-401175 (URN)10.1136/bmjopen-2018-027860 (DOI)000502537200134 ()31444180 (PubMedID)
Funder
Swedish Cancer Society, 2016/466Swedish Cancer Society, 2014/1275Swedish Research Council, 2016-00177Swedish Research Council, 2016-01293
Available from: 2020-01-07 Created: 2020-01-07 Last updated: 2020-01-07Bibliographically approved
Bill-Axelson, A., Holmberg, L. & Garmo, H. (2019). Radical Surgery or Watchful Waiting in Prostate Cancer Reply [Letter to the editor]. New England Journal of Medicine, 380(11), 1084-1084
Open this publication in new window or tab >>Radical Surgery or Watchful Waiting in Prostate Cancer Reply
2019 (English)In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 380, no 11, p. 1084-1084Article in journal, Letter (Other academic) Published
National Category
Cancer and Oncology General Practice
Identifiers
urn:nbn:se:uu:diva-380667 (URN)10.1056/NEJMc1900410 (DOI)000461210000019 ()30865809 (PubMedID)
Available from: 2019-04-01 Created: 2019-04-01 Last updated: 2019-04-01Bibliographically approved
Trinquart, L., Bill-Axelson, A. & Rider, J. R. (2019). Restricted Mean Survival Times to Improve Communication of Evidence from Cancer Randomized Trials and Observational Studies. European Urology, 76(2), 137-139
Open this publication in new window or tab >>Restricted Mean Survival Times to Improve Communication of Evidence from Cancer Randomized Trials and Observational Studies
2019 (English)In: European Urology, ISSN 0302-2838, E-ISSN 1873-7560, Vol. 76, no 2, p. 137-139Article in journal, Editorial material (Other academic) Published
Place, publisher, year, edition, pages
Elsevier, 2019
National Category
Urology and Nephrology
Identifiers
urn:nbn:se:uu:diva-390418 (URN)10.1016/j.eururo.2019.04.002 (DOI)000474574000011 ()31031048 (PubMedID)
Available from: 2019-08-12 Created: 2019-08-12 Last updated: 2019-08-12Bibliographically approved
Steineck, G., Akre, O. & Bill-Axelson, A. (2019). Solid Science for the Upside but Lack of Solid Science for the Downside-Towards Cutting-edge Prostate-cancer Screening. European Urology, 76(1), 52-53
Open this publication in new window or tab >>Solid Science for the Upside but Lack of Solid Science for the Downside-Towards Cutting-edge Prostate-cancer Screening
2019 (English)In: European Urology, ISSN 0302-2838, E-ISSN 1873-7560, Vol. 76, no 1, p. 52-53Article in journal, Editorial material (Other academic) Published
Place, publisher, year, edition, pages
Elsevier, 2019
National Category
Urology and Nephrology
Identifiers
urn:nbn:se:uu:diva-389915 (URN)10.1016/j.eururo.2019.03.043 (DOI)000470968100022 ()30975451 (PubMedID)
Available from: 2019-08-02 Created: 2019-08-02 Last updated: 2019-08-02Bibliographically approved
Kinsella, N., Stattin, P., Cahill, D., Brown, C., Bill-Axelson, A., Bratt, O., . . . Van Hemelrijck, M. (2018). Factors Influencing Men's Choice of and Adherence to Active Surveillance for Low-risk Prostate Cancer: A Mixed-method Systematic Review. European Urology, 74(3), 261-280
Open this publication in new window or tab >>Factors Influencing Men's Choice of and Adherence to Active Surveillance for Low-risk Prostate Cancer: A Mixed-method Systematic Review
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2018 (English)In: European Urology, ISSN 0302-2838, E-ISSN 1873-7560, Vol. 74, no 3, p. 261-280Article, review/survey (Refereed) Published
Abstract [en]

Context: Despite support for active surveillance (AS) as a first treatment choice for men with low-risk prostate cancer (PC), this strategy is largely underutilised.

Objective: To systematically review barriers and facilitators to selecting and adhering to AS for low-risk PC.

Evidence acquisition: We searched PsychINFO, PubMed, Medline 2000-now, Embase, CINAHL, and Cochrane Central databases between 2002 and 2017 using the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) statement. The Purpose, Respondents, Explanation, Findings and Significance (PREFS) and Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) quality criteria were applied. Forty-seven studies were identified.

Evidence synthesis: Key themes emerged as factors influencing both choice and adherence to AS: (1) patient and tumour factors (age, comorbidities, knowledge, education, socioeconomic status, family history, grade, tumour volume, and fear of progression/side effects); (2) family and social support; (3) provider (speciality, communication, and attitudes); (4) healthcare organisation (geography and type of practice); and (5) health policy (guidelines, year, and awareness).

Conclusions: Many factors influence men's choice and adherence to AS on multiple levels. It is important to learn from the experience of other chronic health conditions as well as from institutions/countries that are making significant headway in appropriately recruiting men to AS protocols, through standardised patient information, clinician education, and nationally agreed guidelines, to ultimately decrease heterogeneity in AS practice.

Patient summary: We reviewed the scientific literature for factors affecting men's choice and adherence to active surveillance (AS) for low-risk prostate cancer. Our findings suggest that the use of AS could be increased by addressing a variety of factors such as information, psychosocial support, clinician education, and standardised guidelines. 

Place, publisher, year, edition, pages
ELSEVIER SCIENCE BV, 2018
Keywords
Active surveillance, Treatment choice, Adherence, Prostate cancer, Facilitators, Barriers, Treatment selection, Chronic disease adherence
National Category
Urology and Nephrology
Identifiers
urn:nbn:se:uu:diva-365166 (URN)10.1016/j.eururo.2018.02.026 (DOI)000441547900015 ()29598981 (PubMedID)
Funder
Swedish Cancer Society, 2012/475
Available from: 2018-11-09 Created: 2018-11-09 Last updated: 2018-11-09Bibliographically approved
Johansson, E., Steineck, G., Holmberg, L., Johansson, J.-E., Nyberg, T. & Bill-Axelson, A. (2018). Quality of life after radical prostatectomy or watchful waiting with or without androgen deprivation therapy: The SPCG-4 Randomized Trial. European Urology Oncology, 1(2), 134-142
Open this publication in new window or tab >>Quality of life after radical prostatectomy or watchful waiting with or without androgen deprivation therapy: The SPCG-4 Randomized Trial
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2018 (English)In: European Urology Oncology, Vol. 1, no 2, p. 134-142Article in journal (Refereed) Published
Abstract [en]

Background: Men with prostate cancer experience adjuvant androgen deprivation therapy (ADT) differently.

Objective: To evaluate the effect of ADT on quality of life (QoL), patients' experience of clinical check-ups, and differences in cancer information as explanatory factors.

Design, setting, and participants: A study-specific questionnaire was sent to all men randomized in the SPCG-4 trial to radical prostatectomy (RP) or watchful waiting (WW) still alive (400/695) and a control group of 281 men.

Intervention: ADT.

Outcome measurements and statistical analysis: Self-assessed QoL, worry at clinical check-ups, and amount of information received. Estimated relative risks with associated 95% confidence intervals (CI) for risk comparisons between groups using a log-binomial regression.

Results and limitations: The SPCG-4 men had median follow-up of 12.2 yr and median age of 77.0 yr; 26% in the RP group and 40% in the WW group received ADT treatment. High QoL for men without ADT was 36% for the RP group, 44% for the WW group, and 45% for the control group. High QoL for men with ADT was 30% for the RP group and 20% for the WW group. Among men with ADT, those in the WW group received significantly less information about the disease than men in the RP group. Receiving no or little information about prostate cancer was reported by 17% of patients in the RP group and 39% in the WW group among men receiving ADT (relative risk 0.44, 95% CI 022-0.89). At clinical check-ups, men treated with ADT had significantly higher levels of worry, regardless of study group, than men without ADT. Limitations include the lack of longitudinal data and a low number of men receiving ADT in the RP group.

Conclusions: Men on WW without ADT reported high QoL comparable to that for men without prostate cancer. ADT treatment in the WW group was associated with the lowest scores for all psychological parameters, and these men reported that they were least informed about prostate cancer and its consequences.

Patient summary: Good communication and information from caregivers are associated with less negative psychological effects at prostate cancer progression.

Keywords
Prostate cancer, Quality of life, Androgen deprivation therapy, Castration, Radical prostatectomy, Watchful waiting, Randomized trial, Information
National Category
Urology and Nephrology Cancer and Oncology
Identifiers
urn:nbn:se:uu:diva-158093 (URN)10.1016/j.euo.2018.03.003 (DOI)000474513200007 ()
Funder
Swedish Cancer Society
Note

Manuscript title: Quality of life after radical prostatectomy or watchful waiting with or without androgen deprivation therapy: The Scandinavian Prostate Cancer Group-4 Randomized Trial

Available from: 2011-08-30 Created: 2011-08-30 Last updated: 2019-12-11Bibliographically approved
Bill-Axelson, A., Holmberg, L., Garmo, H., Taari, K., Busch, C., Nordling, S., . . . Johansson, J.-E. (2018). Radical Prostatectomy or Watchful Waiting in Prostate Cancer: 29-Year Follow-up. New England Journal of Medicine, 379(24), 2319-2329
Open this publication in new window or tab >>Radical Prostatectomy or Watchful Waiting in Prostate Cancer: 29-Year Follow-up
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2018 (English)In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 379, no 24, p. 2319-2329Article in journal (Refereed) Published
Abstract [en]

BACKGROUND Radical prostatectomy reduces mortality among men with clinically detected localized prostate cancer, but evidence from randomized trials with long-term followup is sparse.

METHODS We randomly assigned 695 men with localized prostate cancer to watchful waiting or radical prostatectomy from October 1989 through February 1999 and collected follow-up data through 2017. Cumulative incidence and relative risks with 95% confidence intervals for death from any cause, death from prostate cancer, and metastasis were estimated in intention-to-treat and per-protocol analyses, and numbers of years of life gained were estimated. We evaluated the prognostic value of histopathological measures with a Cox proportional-hazards model.

RESULTS By December 31, 2017, a total of 261 of the 347 men in the radical-prostatectomy group and 292 of the 348 men in the watchful-waiting group had died; 71 deaths in the radical-prostatectomy group and 110 in the watchful-waiting group were due to prostate cancer (relative risk, 0.55; 95% confidence interval [CI], 0.41 to 0.74; P<0.001; absolute difference in risk, 11.7 percentage points; 95% CI, 5.2 to 18.2). The number needed to treat to avert one death from any cause was 8.4. At 23 years, a mean of 2.9 extra years of life were gained with radical prostatectomy. Among the men who underwent radical prostatectomy, extracapsular extension was associated with a risk of death from prostate cancer that was 5 times as high as that among men without extracapsular extension, and a Gleason score higher than 7 was associated with a risk that was 10 times as high as that with a score of 6 or lower (scores range from 2 to 10, with higher scores indicating more aggressive cancer).

CONCLUSIONS Men with clinically detected, localized prostate cancer and a long life expectancy benefited from radical prostatectomy, with a mean of 2.9 years of life gained. A high Gleason score and the presence of extracapsular extension in the radical prostatectomy specimens were highly predictive of death from prostate cancer.

National Category
Urology and Nephrology General Practice
Identifiers
urn:nbn:se:uu:diva-372932 (URN)10.1056/NEJMoa1807801 (DOI)000452872600007 ()30575473 (PubMedID)
Funder
Swedish Cancer Society, 07 05 12 CAN 2014/1275The Karolinska Institutet's Research Foundation
Available from: 2019-01-10 Created: 2019-01-10 Last updated: 2019-01-10Bibliographically approved
Organisations
Identifiers
ORCID iD: ORCID iD iconorcid.org/0000-0002-4559-1217

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