Abstract
Background: Conservative management is an option for prostate cancer (PCa) patients either with the objective of delaying or even avoiding curative therapy or to wait until palliative treatment is needed. PIONEER, funded by the European Commission Innovative Medicines Initiative, aims at improving PCa care across Europe through the application of big data analytics.
Objective: to describe the clinical characteristics and long-term outcomes of PCa patients on conservative management by using an international large network of real-world data. Design, setting, and participants: From an initial cohort of more than 100,000,000 adult subjects included in 8 databases evaluated during a virtual study-a-thon hosted by PIONEER we identified newly diagnosed PCa cases (n=527,311). Among those, we selected patients who did not receive curative or palliative treatment within six months from diagnosis (n=123,146).
Outcome Measurements and Statistical Analysis: Patient and disease characteristics were reported. The number of patients who experienced main study outcomes was quantified for each stratum and the overall cohort. Kaplan-Meier analyses were used to estimate the distribution of time to event data.
Results and limitations: The most common comorbidities were hypertension (35-73%), obesity (9.2-54%) and type 2 diabetes (11-28%). The rate of PCa-related symptomatic progression ranged between 2.6-6.2%. Hospitalization (12-25%) and emergency department visits (10-14%) were common events during first year of follow-up. The probability of being free from both palliative and curative treatments decreased during follow-up. Limitations include a lake of information on patients and disease characteristics and on treatment intent.
Conclusions: Our results allow us to better understand the current landscape of patients with PCa managed with conservative treatment. PIONEER offers a unique opportunity to characterize the baseline features and outcomes of PCa patients conservatively managed using real world data.
Patient summary: Up to 25% of men with PCa managed conservatively experienced hospitalization and ED visits within the first year after diagnosis, 6% experienced PCa-related symptoms. The probability of receiving therapies for PCa decreased according to time elapsed after the diagnosis.
Take home message: Up to 25% of PCa patients managed conservatively experienced hospitalization and ED visits within 12 months after diagnosis, 6% experienced PCa-related symptomatic progression. Probabilities of receiving therapies for PCa decreased according to the time elapsed after the diagnosis.
Objective: to describe the clinical characteristics and long-term outcomes of PCa patients on conservative management by using an international large network of real-world data. Design, setting, and participants: From an initial cohort of more than 100,000,000 adult subjects included in 8 databases evaluated during a virtual study-a-thon hosted by PIONEER we identified newly diagnosed PCa cases (n=527,311). Among those, we selected patients who did not receive curative or palliative treatment within six months from diagnosis (n=123,146).
Outcome Measurements and Statistical Analysis: Patient and disease characteristics were reported. The number of patients who experienced main study outcomes was quantified for each stratum and the overall cohort. Kaplan-Meier analyses were used to estimate the distribution of time to event data.
Results and limitations: The most common comorbidities were hypertension (35-73%), obesity (9.2-54%) and type 2 diabetes (11-28%). The rate of PCa-related symptomatic progression ranged between 2.6-6.2%. Hospitalization (12-25%) and emergency department visits (10-14%) were common events during first year of follow-up. The probability of being free from both palliative and curative treatments decreased during follow-up. Limitations include a lake of information on patients and disease characteristics and on treatment intent.
Conclusions: Our results allow us to better understand the current landscape of patients with PCa managed with conservative treatment. PIONEER offers a unique opportunity to characterize the baseline features and outcomes of PCa patients conservatively managed using real world data.
Patient summary: Up to 25% of men with PCa managed conservatively experienced hospitalization and ED visits within the first year after diagnosis, 6% experienced PCa-related symptoms. The probability of receiving therapies for PCa decreased according to time elapsed after the diagnosis.
Take home message: Up to 25% of PCa patients managed conservatively experienced hospitalization and ED visits within 12 months after diagnosis, 6% experienced PCa-related symptomatic progression. Probabilities of receiving therapies for PCa decreased according to the time elapsed after the diagnosis.
| Original language | English |
|---|---|
| Pages (from-to) | 457-465 |
| Number of pages | 9 |
| Journal | European Urology |
| Volume | 85 |
| Issue number | 5 |
| Early online date | 5 Jul 2023 |
| DOIs | |
| Publication status | E-pub ahead of print - 5 Jul 2023 |
Bibliographical note
Funding statementPIONEER is funded through the IMI2 Joint Undertaking and is listed under grant agreement No. 777492. This joint undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and European Federation of Pharmaceutical Industries and Associations EFPIA. The European Health Data & Evidence Network has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement no. 806968. The Joint Undertaking is supported by the European Union’s Horizon 2020 research and innovation programme and EFPIA, a large association which represents the biopharmaceutical industry in Europe. The views communicated within are those of PIONEER. Neither the IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained herein
Data Availability Statement
In the interest of transparency and scientific reproducibility, all study materials including the computer‐executable code (which is compatible with any data set in the OMOP common data model) have been made available. Code: https://github.com/ohdsi-studies/PioneerWatchfulWaitingAnalysis apps: https://pioneer-shiny.hzdr.de/PioneerWatchfulWaiting_restricted/
The protocol is available on https://protocolexchange.researchsquare.com/article/pex-1468/v1
Keywords
- Prostate cancer
- Conservative management
- Survival
- Outcomes
- Big Data
- PIONEER
Access to Document
- Gandaglia_etal_EU_Clinical_Characterization_Of_VoR
2023 The Author(s). Published by Elsevier B.V. on behalf of European Association of Urology. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).