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More fuel for the radiation vs. surgery in prostate cancer debate comes from a study suggesting that patients with high-risk localized prostate cancer treated with external beam radiotherapy (EBRT) plus brachytherapy – with or without androgen deprivation (AD) – have survival rates equivalent to those of patients treated with radical prostatectomy (RP).
However, patients treated with EBRT and androgen deprivation without brachytherapy had significantly worse survival compared with patients treated with surgery, according to Ronald D. Ennis, MD, of Rutgers Cancer Institute of New Jersey, New Brunswick, and his colleagues.
“The data reported herein suggest that RT plus brachytherapy with or without AD and RP are associated with similar survival. This finding reinforces the need for patients to seek opinions from both a urologic oncologic surgeon with expertise in RP and a radiation oncologist with expertise in brachytherapy. The natural human tendency for physicians to prefer their modality necessitates this dual consultation approach, preferably in a single joint consultation visit,” the researchers wrote. The report was published in the Journal of Clinical Oncology.
The investigators attempted to control for variables that could influence the results by drawing on data on a large number of patients – 42,765 – who were treated at a large number of facilities across the United States. In addition, they incorporated data on clinical stage and Gleason score for all patients, prostate-specific antigen measurements, comorbidities, and socioeconomic factors that are either known or thought to influence treatment decisions.
They used inverse probability of treatment weight to adjust for imbalances of covariables among the treatment groups, and then created weighted time-dependent Cox proportional hazard models to estimate the effects of each type of treatment on survival.
Their sample included 24,688 patients who underwent RP, 15,435 who received EBRT with AD, and 2,642 who underwent EBRT and brachytherapy with or without AD.
They found no statistical difference in survival between RP and EBRT plus brachytherapy with/without AD in inverse probability of treatment weighted analysis. The hazard ratio for EBRT/brachytherapy was 1.17, but this was not statistically significant (95% confidence interval, 0.88-1.55).
In contrast. EBRT plus AD was associated with significantly worse survival, with a hazard ration of 1.53 (95% CI, 1.22-1.92).
The authors noted that “this finding reinforces the importance of complications, particularly in the urinary, sexual, and bowel domains, in combination with patient priorities and preferences, in determining an individual patient’s optimal choice. Significant data have been published in recent years regarding patient-reported outcomes that should be shared with all new patients to help guide them to their personal optimal treatment.”
They added that for some patients, quality of life may be a more important factor than survival when choosing a treatment modality.
SOURCE: Ennis et al. J Clin Oncol. 2018 Feb 28. doi: 10.1200/JCO.2017.75.9134
Clinicians interpreting this and other retrospective studies using large cancer registry data need to consider:
1) Whether treatment groups are comparable. For most retrospective studies, treatment groups are not comparable. Surgery versus RT is especially difficult to compare. In many studies in various cancers that have compared surgery alone versus surgery plus adjuvant therapy, the latter patients are inherently healthier. The ability or inability of investigators to address these confounding issues is central to assessing the quality of the evidence in a study.
(2) Limitations related to the data elements that are contained in the registry and data accuracy.
(3) Whether the results are believable clinically. If survival is the endpoint in a study, when do the survival curves separate – and is that consistent with the known clinical course of a particular disease? The main advantage of randomized trials is the ability to create comparable patient groups and minimize confounding, which is also the biggest limitation of retrospective studies. In clinical scenarios where multiple randomized trials have consistently confirmed a result (e.g., adding androgen deprivation therapy to RT improves survival for high-risk patients), repeated retrospective analyses asking these same questions that may show either the same or an opposite result are less useful.
Perhaps the biggest challenge in conducting studies using cancer registry data and interpreting their results as researchers and clinicians relates to the personal biases most of us harbor; these biases tempt us to analyze registry data in an attempt to refute clinical trials and to selectively believe studies that provide results supporting our own biases. For each clinician interpreting retrospective results along with or in absence of clinical trial data, recognizing our own biases by following the framework outlined previously to assess the quality and believability of each study can potentially remove the greatest confounder of all.
Ronald C. Chen, MD, MPH, is associate professor of radiation oncology at the University of North Carolina at Chapel Hill. He serves in a consulting or advisory role for Medivation/Astellas, Accuray, and Bayer, and has received research funding from Accuray. His remarks are adapted from an editorial (J Clin Oncol. 2018 Feb 28. doi: 0.1200/JCO.2017.77.5833).
Clinicians interpreting this and other retrospective studies using large cancer registry data need to consider:
1) Whether treatment groups are comparable. For most retrospective studies, treatment groups are not comparable. Surgery versus RT is especially difficult to compare. In many studies in various cancers that have compared surgery alone versus surgery plus adjuvant therapy, the latter patients are inherently healthier. The ability or inability of investigators to address these confounding issues is central to assessing the quality of the evidence in a study.
(2) Limitations related to the data elements that are contained in the registry and data accuracy.
(3) Whether the results are believable clinically. If survival is the endpoint in a study, when do the survival curves separate – and is that consistent with the known clinical course of a particular disease? The main advantage of randomized trials is the ability to create comparable patient groups and minimize confounding, which is also the biggest limitation of retrospective studies. In clinical scenarios where multiple randomized trials have consistently confirmed a result (e.g., adding androgen deprivation therapy to RT improves survival for high-risk patients), repeated retrospective analyses asking these same questions that may show either the same or an opposite result are less useful.
Perhaps the biggest challenge in conducting studies using cancer registry data and interpreting their results as researchers and clinicians relates to the personal biases most of us harbor; these biases tempt us to analyze registry data in an attempt to refute clinical trials and to selectively believe studies that provide results supporting our own biases. For each clinician interpreting retrospective results along with or in absence of clinical trial data, recognizing our own biases by following the framework outlined previously to assess the quality and believability of each study can potentially remove the greatest confounder of all.
Ronald C. Chen, MD, MPH, is associate professor of radiation oncology at the University of North Carolina at Chapel Hill. He serves in a consulting or advisory role for Medivation/Astellas, Accuray, and Bayer, and has received research funding from Accuray. His remarks are adapted from an editorial (J Clin Oncol. 2018 Feb 28. doi: 0.1200/JCO.2017.77.5833).
Clinicians interpreting this and other retrospective studies using large cancer registry data need to consider:
1) Whether treatment groups are comparable. For most retrospective studies, treatment groups are not comparable. Surgery versus RT is especially difficult to compare. In many studies in various cancers that have compared surgery alone versus surgery plus adjuvant therapy, the latter patients are inherently healthier. The ability or inability of investigators to address these confounding issues is central to assessing the quality of the evidence in a study.
(2) Limitations related to the data elements that are contained in the registry and data accuracy.
(3) Whether the results are believable clinically. If survival is the endpoint in a study, when do the survival curves separate – and is that consistent with the known clinical course of a particular disease? The main advantage of randomized trials is the ability to create comparable patient groups and minimize confounding, which is also the biggest limitation of retrospective studies. In clinical scenarios where multiple randomized trials have consistently confirmed a result (e.g., adding androgen deprivation therapy to RT improves survival for high-risk patients), repeated retrospective analyses asking these same questions that may show either the same or an opposite result are less useful.
Perhaps the biggest challenge in conducting studies using cancer registry data and interpreting their results as researchers and clinicians relates to the personal biases most of us harbor; these biases tempt us to analyze registry data in an attempt to refute clinical trials and to selectively believe studies that provide results supporting our own biases. For each clinician interpreting retrospective results along with or in absence of clinical trial data, recognizing our own biases by following the framework outlined previously to assess the quality and believability of each study can potentially remove the greatest confounder of all.
Ronald C. Chen, MD, MPH, is associate professor of radiation oncology at the University of North Carolina at Chapel Hill. He serves in a consulting or advisory role for Medivation/Astellas, Accuray, and Bayer, and has received research funding from Accuray. His remarks are adapted from an editorial (J Clin Oncol. 2018 Feb 28. doi: 0.1200/JCO.2017.77.5833).
More fuel for the radiation vs. surgery in prostate cancer debate comes from a study suggesting that patients with high-risk localized prostate cancer treated with external beam radiotherapy (EBRT) plus brachytherapy – with or without androgen deprivation (AD) – have survival rates equivalent to those of patients treated with radical prostatectomy (RP).
However, patients treated with EBRT and androgen deprivation without brachytherapy had significantly worse survival compared with patients treated with surgery, according to Ronald D. Ennis, MD, of Rutgers Cancer Institute of New Jersey, New Brunswick, and his colleagues.
“The data reported herein suggest that RT plus brachytherapy with or without AD and RP are associated with similar survival. This finding reinforces the need for patients to seek opinions from both a urologic oncologic surgeon with expertise in RP and a radiation oncologist with expertise in brachytherapy. The natural human tendency for physicians to prefer their modality necessitates this dual consultation approach, preferably in a single joint consultation visit,” the researchers wrote. The report was published in the Journal of Clinical Oncology.
The investigators attempted to control for variables that could influence the results by drawing on data on a large number of patients – 42,765 – who were treated at a large number of facilities across the United States. In addition, they incorporated data on clinical stage and Gleason score for all patients, prostate-specific antigen measurements, comorbidities, and socioeconomic factors that are either known or thought to influence treatment decisions.
They used inverse probability of treatment weight to adjust for imbalances of covariables among the treatment groups, and then created weighted time-dependent Cox proportional hazard models to estimate the effects of each type of treatment on survival.
Their sample included 24,688 patients who underwent RP, 15,435 who received EBRT with AD, and 2,642 who underwent EBRT and brachytherapy with or without AD.
They found no statistical difference in survival between RP and EBRT plus brachytherapy with/without AD in inverse probability of treatment weighted analysis. The hazard ratio for EBRT/brachytherapy was 1.17, but this was not statistically significant (95% confidence interval, 0.88-1.55).
In contrast. EBRT plus AD was associated with significantly worse survival, with a hazard ration of 1.53 (95% CI, 1.22-1.92).
The authors noted that “this finding reinforces the importance of complications, particularly in the urinary, sexual, and bowel domains, in combination with patient priorities and preferences, in determining an individual patient’s optimal choice. Significant data have been published in recent years regarding patient-reported outcomes that should be shared with all new patients to help guide them to their personal optimal treatment.”
They added that for some patients, quality of life may be a more important factor than survival when choosing a treatment modality.
SOURCE: Ennis et al. J Clin Oncol. 2018 Feb 28. doi: 10.1200/JCO.2017.75.9134
More fuel for the radiation vs. surgery in prostate cancer debate comes from a study suggesting that patients with high-risk localized prostate cancer treated with external beam radiotherapy (EBRT) plus brachytherapy – with or without androgen deprivation (AD) – have survival rates equivalent to those of patients treated with radical prostatectomy (RP).
However, patients treated with EBRT and androgen deprivation without brachytherapy had significantly worse survival compared with patients treated with surgery, according to Ronald D. Ennis, MD, of Rutgers Cancer Institute of New Jersey, New Brunswick, and his colleagues.
“The data reported herein suggest that RT plus brachytherapy with or without AD and RP are associated with similar survival. This finding reinforces the need for patients to seek opinions from both a urologic oncologic surgeon with expertise in RP and a radiation oncologist with expertise in brachytherapy. The natural human tendency for physicians to prefer their modality necessitates this dual consultation approach, preferably in a single joint consultation visit,” the researchers wrote. The report was published in the Journal of Clinical Oncology.
The investigators attempted to control for variables that could influence the results by drawing on data on a large number of patients – 42,765 – who were treated at a large number of facilities across the United States. In addition, they incorporated data on clinical stage and Gleason score for all patients, prostate-specific antigen measurements, comorbidities, and socioeconomic factors that are either known or thought to influence treatment decisions.
They used inverse probability of treatment weight to adjust for imbalances of covariables among the treatment groups, and then created weighted time-dependent Cox proportional hazard models to estimate the effects of each type of treatment on survival.
Their sample included 24,688 patients who underwent RP, 15,435 who received EBRT with AD, and 2,642 who underwent EBRT and brachytherapy with or without AD.
They found no statistical difference in survival between RP and EBRT plus brachytherapy with/without AD in inverse probability of treatment weighted analysis. The hazard ratio for EBRT/brachytherapy was 1.17, but this was not statistically significant (95% confidence interval, 0.88-1.55).
In contrast. EBRT plus AD was associated with significantly worse survival, with a hazard ration of 1.53 (95% CI, 1.22-1.92).
The authors noted that “this finding reinforces the importance of complications, particularly in the urinary, sexual, and bowel domains, in combination with patient priorities and preferences, in determining an individual patient’s optimal choice. Significant data have been published in recent years regarding patient-reported outcomes that should be shared with all new patients to help guide them to their personal optimal treatment.”
They added that for some patients, quality of life may be a more important factor than survival when choosing a treatment modality.
SOURCE: Ennis et al. J Clin Oncol. 2018 Feb 28. doi: 10.1200/JCO.2017.75.9134
FROM JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: This analysis of cancer registry data suggests that surgery and external beam radiotherapy plus brachytherapy have similar survival outcomes in patients with localized high-risk cancers.
Major finding: The hazard ratio for EBRT/brachytherapy vs. radical prostatectomy was 1.17 and was not statistically significant.
Data source: Retrospective review of data on 42,765 patients with localized high-risk prostate cancer.
Disclosures: No funding source was reported. Coauthor Madhu Mazumdar, PhD, reported National Cancer Institute funding. All other authors had no disclosures.
Source: Ennis et al. J Clin Oncol. 2018 Feb 28. doi: 10.1200/JCO.2017.75.9134.