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2. Research Protocol for an Observational Health Data Analysis on the Adverse Events of Systemic Treatment in Patients with Metastatic Hormone-sensitive Prostate Cancer: Big Data Analytics Using the PIONEER Platform

Author

Rajwa, Pawel, primary, Borkowetz, Angelika, additional, Abbott, Thomas, additional, Alberti, Andrea, additional, Bjartell, Anders, additional, Brash, James T., additional, Campi, Riccardo, additional, Chilelli, Andrew, additional, Conover, Mitchell, additional, Constantinovici, Niculae, additional, Davies, Eleanor, additional, De Meulder, Bertrand, additional, Eid, Sherrine, additional, Gacci, Mauro, additional, Golozar, Asieh, additional, Hafeez, Haroon, additional, Haque, Samiul, additional, Hijazy, Ayman, additional, Hulsen, Tim, additional, Josefsson, Andreas, additional, Khalid, Sara, additional, Kolde, Raivo, additional, Kotik, Daniel, additional, Kurki, Samu, additional, Lambrecht, Mark, additional, Leung, Chi-Ho, additional, Moreno, Julia, additional, Nicoletti, Rossella, additional, Nieboer, Daan, additional, Oja, Marek, additional, Palanisamy, Soundarya, additional, Prinsen, Peter, additional, Reich, Christian, additional, Raffaele Resta, Giulio, additional, Ribal, Maria J., additional, Gómez Rivas, Juan, additional, Smith, Emma, additional, Snijder, Robert, additional, Steinbeisser, Carl, additional, Vandenberghe, Frederik, additional, Cornford, Philip, additional, Evans-Axelsson, Susan, additional, N'Dow, James, additional, and Willemse, Peter-Paul M., additional

Published
2024
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4. Research protocol for an observational health data analysis on the adverse events of systemic treatment in patients with metastatic hormone-sensitive prostate cancer : big data analytics using the PIONEER platform

Author

Rajwa, Pawel, Borkowetz, Angelika, Abbott, Thomas, Alberti, Andrea, Bjartell, Anders, Brash, James T., Campi, Riccardo, Chilelli, Andrew, Conover, Mitchell, Constantinovici, Niculae, Davies, Eleanor, De Meulder, Bertrand, Eid, Sherrine, Gacci, Mauro, Golozar, Asieh, Hafeez, Haroon, Haque, Samiul, Hijazy, Ayman, Hulsen, Tim, Josefsson, Andreas, Khalid, Sara, Kolde, Raivo, Kotik, Daniel, Kurki, Samu, Lambrecht, Mark, Leung, Chi-Ho, Moreno, Julia, Nicoletti, Rossella, Nieboer, Daan, Oja, Marek, Palanisamy, Soundarya, Prinsen, Peter, Reich, Christian, Raffaele Resta, Giulio, Ribal, Maria J., Gómez Rivas, Juan, Smith, Emma, Snijder, Robert, Steinbeisser, Carl, Vandenberghe, Frederik, Cornford, Philip, Evans-Axelsson, Susan, N'Dow, James, Willemse, Peter-Paul M., Rajwa, Pawel, Borkowetz, Angelika, Abbott, Thomas, Alberti, Andrea, Bjartell, Anders, Brash, James T., Campi, Riccardo, Chilelli, Andrew, Conover, Mitchell, Constantinovici, Niculae, Davies, Eleanor, De Meulder, Bertrand, Eid, Sherrine, Gacci, Mauro, Golozar, Asieh, Hafeez, Haroon, Haque, Samiul, Hijazy, Ayman, Hulsen, Tim, Josefsson, Andreas, Khalid, Sara, Kolde, Raivo, Kotik, Daniel, Kurki, Samu, Lambrecht, Mark, Leung, Chi-Ho, Moreno, Julia, Nicoletti, Rossella, Nieboer, Daan, Oja, Marek, Palanisamy, Soundarya, Prinsen, Peter, Reich, Christian, Raffaele Resta, Giulio, Ribal, Maria J., Gómez Rivas, Juan, Smith, Emma, Snijder, Robert, Steinbeisser, Carl, Vandenberghe, Frederik, Cornford, Philip, Evans-Axelsson, Susan, N'Dow, James, and Willemse, Peter-Paul M.

Abstract

Combination therapies in metastatic hormone-sensitive prostate cancer (mHSPC), which include the addition of an androgen receptor signaling inhibitor and/or docetaxel to androgen deprivation therapy, have been a game changer in the management of this disease stage. However, these therapies come with their fair share of toxicities and side effects. The goal of this observational study is to report drug-related adverse events (AEs), which are correlated with systemic combination therapies for mHSPC. Determining the optimal treatment option requires large cohorts to estimate the tolerability and AEs of these combination therapies in “real-life” patients with mHSPC, as provided in this study. We use a network of databases that includes population-based registries, electronic health records, and insurance claims, containing the overall target population and subgroups of patients defined by unique certain characteristics, demographics, and comorbidities, to compute the incidence of common AEs associated with systemic therapies in the setting of mHSPC. These data sources are standardised using the Observational Medical Outcomes Partnership Common Data Model. We perform the descriptive statistics as well as calculate the AE incidence rate separately for each treatment group, stratified by age groups and index year. The time until the first event is estimated using the Kaplan-Meier method within each age group. In the case of episodic events, the anticipated mean cumulative counts of events are calculated. Our study will allow clinicians to tailor optimal therapies for mHSPC patients, and they will serve as a basis for comparative method studies.

Published
2024
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5. Research Protocol for an Observational Health Data Analysis on the Adverse Events of Systemic Treatment in Patients with Metastatic Hormone-sensitive Prostate Cancer: Big Data Analytics Using the PIONEER Platform

Author

MS Urologische Oncologie, Cancer, Rajwa, Pawel, Borkowetz, Angelika, Abbott, Thomas, Alberti, Andrea, Bjartell, Anders, Brash, James T, Campi, Riccardo, Chilelli, Andrew, Conover, Mitchell, Constantinovici, Niculae, Davies, Eleanor, De Meulder, Bertrand, Eid, Sherrine, Gacci, Mauro, Golozar, Asieh, Hafeez, Haroon, Haque, Samiul, Hijazy, Ayman, Hulsen, Tim, Josefsson, Andreas, Khalid, Sara, Kolde, Raivo, Kotik, Daniel, Kurki, Samu, Lambrecht, Mark, Leung, Chi-Ho, Moreno, Julia, Nicoletti, Rossella, Nieboer, Daan, Oja, Marek, Palanisamy, Soundarya, Prinsen, Peter, Reich, Christian, Raffaele Resta, Giulio, Ribal, Maria J, Gómez Rivas, Juan, Smith, Emma, Snijder, Robert, Steinbeisser, Carl, Vandenberghe, Frederik, Cornford, Philip, Evans-Axelsson, Susan, N'Dow, James, Willemse, Peter-Paul M, MS Urologische Oncologie, Cancer, Rajwa, Pawel, Borkowetz, Angelika, Abbott, Thomas, Alberti, Andrea, Bjartell, Anders, Brash, James T, Campi, Riccardo, Chilelli, Andrew, Conover, Mitchell, Constantinovici, Niculae, Davies, Eleanor, De Meulder, Bertrand, Eid, Sherrine, Gacci, Mauro, Golozar, Asieh, Hafeez, Haroon, Haque, Samiul, Hijazy, Ayman, Hulsen, Tim, Josefsson, Andreas, Khalid, Sara, Kolde, Raivo, Kotik, Daniel, Kurki, Samu, Lambrecht, Mark, Leung, Chi-Ho, Moreno, Julia, Nicoletti, Rossella, Nieboer, Daan, Oja, Marek, Palanisamy, Soundarya, Prinsen, Peter, Reich, Christian, Raffaele Resta, Giulio, Ribal, Maria J, Gómez Rivas, Juan, Smith, Emma, Snijder, Robert, Steinbeisser, Carl, Vandenberghe, Frederik, Cornford, Philip, Evans-Axelsson, Susan, N'Dow, James, and Willemse, Peter-Paul M

Published
2024

6. Research Protocol for an Observational Health Data Analysis on the Adverse Events of Systemic Treatment in Patients with Metastatic Hormone-sensitive Prostate Cancer:Big Data Analytics Using the PIONEER Platform

Author

Rajwa, Pawel, Borkowetz, Angelika, Abbott, Thomas, Alberti, Andrea, Bjartell, Anders, Brash, James T., Campi, Riccardo, Chilelli, Andrew, Conover, Mitchell, Constantinovici, Niculae, Davies, Eleanor, De Meulder, Bertrand, Eid, Sherrine, Gacci, Mauro, Golozar, Asieh, Hafeez, Haroon, Haque, Samiul, Hijazy, Ayman, Hulsen, Tim, Josefsson, Andreas, Khalid, Sara, Kolde, Raivo, Kotik, Daniel, Kurki, Samu, Lambrecht, Mark, Leung, Chi Ho, Moreno, Julia, Nicoletti, Rossella, Nieboer, Daan, Oja, Marek, Palanisamy, Soundarya, Prinsen, Peter, Reich, Christian, Raffaele Resta, Giulio, Ribal, Maria J., Gómez Rivas, Juan, Smith, Emma, Snijder, Robert, Steinbeisser, Carl, Vandenberghe, Frederik, Cornford, Philip, Evans-Axelsson, Susan, N'Dow, James, Willemse, Peter Paul M., Rajwa, Pawel, Borkowetz, Angelika, Abbott, Thomas, Alberti, Andrea, Bjartell, Anders, Brash, James T., Campi, Riccardo, Chilelli, Andrew, Conover, Mitchell, Constantinovici, Niculae, Davies, Eleanor, De Meulder, Bertrand, Eid, Sherrine, Gacci, Mauro, Golozar, Asieh, Hafeez, Haroon, Haque, Samiul, Hijazy, Ayman, Hulsen, Tim, Josefsson, Andreas, Khalid, Sara, Kolde, Raivo, Kotik, Daniel, Kurki, Samu, Lambrecht, Mark, Leung, Chi Ho, Moreno, Julia, Nicoletti, Rossella, Nieboer, Daan, Oja, Marek, Palanisamy, Soundarya, Prinsen, Peter, Reich, Christian, Raffaele Resta, Giulio, Ribal, Maria J., Gómez Rivas, Juan, Smith, Emma, Snijder, Robert, Steinbeisser, Carl, Vandenberghe, Frederik, Cornford, Philip, Evans-Axelsson, Susan, N'Dow, James, and Willemse, Peter Paul M.

Abstract

Combination therapies in metastatic hormone-sensitive prostate cancer (mHSPC), which include the addition of an androgen receptor signaling inhibitor and/or docetaxel to androgen deprivation therapy, have been a game changer in the management of this disease stage. However, these therapies come with their fair share of toxicities and side effects. The goal of this observational study is to report drug-related adverse events (AEs), which are correlated with systemic combination therapies for mHSPC. Determining the optimal treatment option requires large cohorts to estimate the tolerability and AEs of these combination therapies in “real-life” patients with mHSPC, as provided in this study. We use a network of databases that includes population-based registries, electronic health records, and insurance claims, containing the overall target population and subgroups of patients defined by unique certain characteristics, demographics, and comorbidities, to compute the incidence of common AEs associated with systemic therapies in the setting of mHSPC. These data sources are standardised using the Observational Medical Outcomes Partnership Common Data Model. We perform the descriptive statistics as well as calculate the AE incidence rate separately for each treatment group, stratified by age groups and index year. The time until the first event is estimated using the Kaplan-Meier method within each age group. In the case of episodic events, the anticipated mean cumulative counts of events are calculated. Our study will allow clinicians to tailor optimal therapies for mHSPC patients, and they will serve as a basis for comparative method studies.

Published
2024

8. Cost-effectiveness of enzalutamide versus apalutamide versus androgen deprivation therapy alone for the treatment of metastatic castration-sensitive prostate cancer in Canada

Author

Saad, Fred, Chilelli, Andrew, Hui, Benny, Muratov, Sergey, Ganguli, Arijit, North, Scott, and Shayegan, Bobby

Subjects
Male, Canada, Health Policy, Cost-Benefit Analysis, Androgen Antagonists, Bayes Theorem, Prostatic Neoplasms, Castration-Resistant, Thiohydantoins, Benzamides, Nitriles, Phenylthiohydantoin, Androgens, Humans, Castration, health care economics and organizations
Abstract

There are no direct comparisons of the relative cost-effectiveness of second-generation anti-androgens (enzalutamide and apalutamide) used in managing metastatic castration-sensitive prostate cancer (mCSPC) in Canada. This study compared the cost-effectiveness of enzalutamide versus apalutamide versus androgen deprivation therapy (ADT) alone (standard of care) in patients with mCSPC from the Canadian public payer perspective using a Markov model with a 15-year time horizon. Efficacy data for enzalutamide and ADT alone were informed by the ARCHES and ENZAMET clinical trials, while a Bayesian network meta-analysis enabled comparison with apalutamide and ADT alone. Over the 15-year period, enzalutamide achieved the highest number of life-years (LY, 7.6) and quality-adjusted life-years (QALY, 5.62) compared with apalutamide (LY, 6.1; QALY, 4.59) and ADTs (LY, 4.9; QALY, 3.61). Enzalutamide incurred the most costs ($349,345) compared with apalutamide ($294,349) and ADT ($162,550). Sequential analysis showed that enzalutamide lies on the cost-effectiveness frontier with ADT alone (incremental cost-effectiveness ratio: $92,868/QALY), with apalutamide extendedly dominated through enzalutamide and ADT alone. Limitations include the heterogeneity of the studies included in the network meta-analysis and the validations for the treatment sequencing assumptions in the modeling. Enzalutamide was the most effective treatment option for mCSPC in the Canadian market, with the greatest LYs and QALYs, and incurred the most costs.

Published
2022
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