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Implementation of an Intervention to Improve Efficiency and Accuracy of Data Entry into the Veterans Affairs Central Cancer Registry at the Lexington VA Healthcare System
Background
The Veterans Affairs Central Cancer Registry (VACCR) is an information system, which collects and organizes data on Veterans with cancer for use in cancer surveillance activities, such as epidemiologic based efforts to reduce the overall cancer burden. Unfortunately, there was no structured standardized data acquisition method in place to ensure accurate or timely data entry of Lexington VA Healthcare System (LVAHCS) statistics. This quality improvement study evaluated the implementation of a Structured Query Language (SQL) code to identify specific documents in the Computerized Patient Records System (CPRS) electronic medical record with associated ICD-10 codes matching the reportable cancer cases in the Surveillance, Epidemiology, and End Results (SEER) program.
Methods
Outcomes Studied: Accuracy of the SQL code, rates of data entry into the VACCR pre- and postintervention. Cancer Program leadership collaborated with the VISN 9 Program Analyst to write a SQL code identifying the Veteran’s name; social security number; location by city, state, and county; and visit associated data such as visit location, ICD-10 code documented by the provider, and visit year. This code can be run manually or at a pre-determined cadence.
Results
A total of 3,099 incidences of cancer were entered into the VACCR by local Oncology Data Specialists (ODSs) for calendar years 2015 to 2022. This is approximately 238 cases yearly. After the intervention, 1692 patients were entered into the VACCR in 2023. This is an increased rate of data entry of 611%.
Conclusions
This study demonstrated the feasibility of implementing a SQL code to accurately identify Veterans with diagnoses matching the SEER list. Increasing accuracy of identification has led to increased data entry efficiency into the VACCR by local ODS staff. After proving the feasibility of this intervention, we are partnering with the VISN 9 Program Analyst to create a static, daily recurring report provided to the ODS staff. Future application of this intervention could also include expansion into other VHA sites, increasing their accuracy and timeliness of data entry. Overall, improving the timeliness and accuracy of the VACCR would subsequently improve the ability of the VHA to target interventions aimed at reducing the overall cancer burden.
Background
The Veterans Affairs Central Cancer Registry (VACCR) is an information system, which collects and organizes data on Veterans with cancer for use in cancer surveillance activities, such as epidemiologic based efforts to reduce the overall cancer burden. Unfortunately, there was no structured standardized data acquisition method in place to ensure accurate or timely data entry of Lexington VA Healthcare System (LVAHCS) statistics. This quality improvement study evaluated the implementation of a Structured Query Language (SQL) code to identify specific documents in the Computerized Patient Records System (CPRS) electronic medical record with associated ICD-10 codes matching the reportable cancer cases in the Surveillance, Epidemiology, and End Results (SEER) program.
Methods
Outcomes Studied: Accuracy of the SQL code, rates of data entry into the VACCR pre- and postintervention. Cancer Program leadership collaborated with the VISN 9 Program Analyst to write a SQL code identifying the Veteran’s name; social security number; location by city, state, and county; and visit associated data such as visit location, ICD-10 code documented by the provider, and visit year. This code can be run manually or at a pre-determined cadence.
Results
A total of 3,099 incidences of cancer were entered into the VACCR by local Oncology Data Specialists (ODSs) for calendar years 2015 to 2022. This is approximately 238 cases yearly. After the intervention, 1692 patients were entered into the VACCR in 2023. This is an increased rate of data entry of 611%.
Conclusions
This study demonstrated the feasibility of implementing a SQL code to accurately identify Veterans with diagnoses matching the SEER list. Increasing accuracy of identification has led to increased data entry efficiency into the VACCR by local ODS staff. After proving the feasibility of this intervention, we are partnering with the VISN 9 Program Analyst to create a static, daily recurring report provided to the ODS staff. Future application of this intervention could also include expansion into other VHA sites, increasing their accuracy and timeliness of data entry. Overall, improving the timeliness and accuracy of the VACCR would subsequently improve the ability of the VHA to target interventions aimed at reducing the overall cancer burden.
Background
The Veterans Affairs Central Cancer Registry (VACCR) is an information system, which collects and organizes data on Veterans with cancer for use in cancer surveillance activities, such as epidemiologic based efforts to reduce the overall cancer burden. Unfortunately, there was no structured standardized data acquisition method in place to ensure accurate or timely data entry of Lexington VA Healthcare System (LVAHCS) statistics. This quality improvement study evaluated the implementation of a Structured Query Language (SQL) code to identify specific documents in the Computerized Patient Records System (CPRS) electronic medical record with associated ICD-10 codes matching the reportable cancer cases in the Surveillance, Epidemiology, and End Results (SEER) program.
Methods
Outcomes Studied: Accuracy of the SQL code, rates of data entry into the VACCR pre- and postintervention. Cancer Program leadership collaborated with the VISN 9 Program Analyst to write a SQL code identifying the Veteran’s name; social security number; location by city, state, and county; and visit associated data such as visit location, ICD-10 code documented by the provider, and visit year. This code can be run manually or at a pre-determined cadence.
Results
A total of 3,099 incidences of cancer were entered into the VACCR by local Oncology Data Specialists (ODSs) for calendar years 2015 to 2022. This is approximately 238 cases yearly. After the intervention, 1692 patients were entered into the VACCR in 2023. This is an increased rate of data entry of 611%.
Conclusions
This study demonstrated the feasibility of implementing a SQL code to accurately identify Veterans with diagnoses matching the SEER list. Increasing accuracy of identification has led to increased data entry efficiency into the VACCR by local ODS staff. After proving the feasibility of this intervention, we are partnering with the VISN 9 Program Analyst to create a static, daily recurring report provided to the ODS staff. Future application of this intervention could also include expansion into other VHA sites, increasing their accuracy and timeliness of data entry. Overall, improving the timeliness and accuracy of the VACCR would subsequently improve the ability of the VHA to target interventions aimed at reducing the overall cancer burden.
A Phase II Study With Androgen Deprivation Therapy and Up-Front Radiotherapy in High-Intermediate and High-Risk Prostate Cancer With Stereotactic Body Radiation Therapy to Pelvic Nodes and Concomitant Prostate Boost by Simultaneous Integrated Boost
Background
The adoption of Stereotactic Body Radiation Therapy (SBRT) for prostate cancer has allowed treatment to be completed in less than 2 weeks, but has predominantly been given to the prostate only. Currently, very few prospective studies have compared delivery of SBRT versus hypofractionated radiotherapy (HFX) when giving concurrent pelvic radiation. The aim of the study is to evaluate the tolerance and efficacy of pelvic node radiotherapy and SIB to the prostate in prostate patients requiring nodal irradiation.
Methods
A total of 58 patients were irradiated with SBRT and initiated ADT therapy between 2014 and 2023. 57 patients were treated with 7.5 Gy to the prostate and 1 to 7.25 Gy. All patients were treated with 5 Gy x 5 fraction to the pelvis. This group was compared to a preselected historical cohort of 65 HFX patients with 57 of these patients treated with 67.5/50 Gy in 25 fractions, 1 with patient 67.5/45 Gy in 25 fractions, and 6 patients with 60/44-46 Gy in 20 fractions. Patients were evaluated for GU and GI toxicities according to Radiation Therapy Oncology Group Toxicity criteria at one year post radiation therapy.
Results
There were 31 grade 0 (53.4%), 1 grade 1 (1.7%), 25 grade 2 (43.1%), 1 grade 3 (1.7%) events in the SBRT group and 29 GU grade 0 (44.6%), 3 grade 1 (4.6%), and 33 grade 2 (50.8%) GU toxicities in the HFX group with no significant difference between the groups (p=0.464). There were 55 grade 0 (94.8%), 1 grade 1 (1.7%), and 2 grade 2 (3.4%) GI toxicities in the SBRT group and 59 grade 0 (90.8%), 1 grade 1 (1.5%), and 5 grade 2 (7.7%) events in the HFX group with no significant difference between the groups (p=0.381).
Conclusions
This prospective study provides data to support the use of concurrent pelvic radiation with SBRT to the prostate. Our findings suggest there is no difference in toxicity between HFX and 25 Gy pelvic radiation (5 Gy/5 fractions) concurrent with SBRT to the prostate, therefore it appears to be a safe and convenient option for veterans with prostate cancer.
Background
The adoption of Stereotactic Body Radiation Therapy (SBRT) for prostate cancer has allowed treatment to be completed in less than 2 weeks, but has predominantly been given to the prostate only. Currently, very few prospective studies have compared delivery of SBRT versus hypofractionated radiotherapy (HFX) when giving concurrent pelvic radiation. The aim of the study is to evaluate the tolerance and efficacy of pelvic node radiotherapy and SIB to the prostate in prostate patients requiring nodal irradiation.
Methods
A total of 58 patients were irradiated with SBRT and initiated ADT therapy between 2014 and 2023. 57 patients were treated with 7.5 Gy to the prostate and 1 to 7.25 Gy. All patients were treated with 5 Gy x 5 fraction to the pelvis. This group was compared to a preselected historical cohort of 65 HFX patients with 57 of these patients treated with 67.5/50 Gy in 25 fractions, 1 with patient 67.5/45 Gy in 25 fractions, and 6 patients with 60/44-46 Gy in 20 fractions. Patients were evaluated for GU and GI toxicities according to Radiation Therapy Oncology Group Toxicity criteria at one year post radiation therapy.
Results
There were 31 grade 0 (53.4%), 1 grade 1 (1.7%), 25 grade 2 (43.1%), 1 grade 3 (1.7%) events in the SBRT group and 29 GU grade 0 (44.6%), 3 grade 1 (4.6%), and 33 grade 2 (50.8%) GU toxicities in the HFX group with no significant difference between the groups (p=0.464). There were 55 grade 0 (94.8%), 1 grade 1 (1.7%), and 2 grade 2 (3.4%) GI toxicities in the SBRT group and 59 grade 0 (90.8%), 1 grade 1 (1.5%), and 5 grade 2 (7.7%) events in the HFX group with no significant difference between the groups (p=0.381).
Conclusions
This prospective study provides data to support the use of concurrent pelvic radiation with SBRT to the prostate. Our findings suggest there is no difference in toxicity between HFX and 25 Gy pelvic radiation (5 Gy/5 fractions) concurrent with SBRT to the prostate, therefore it appears to be a safe and convenient option for veterans with prostate cancer.
Background
The adoption of Stereotactic Body Radiation Therapy (SBRT) for prostate cancer has allowed treatment to be completed in less than 2 weeks, but has predominantly been given to the prostate only. Currently, very few prospective studies have compared delivery of SBRT versus hypofractionated radiotherapy (HFX) when giving concurrent pelvic radiation. The aim of the study is to evaluate the tolerance and efficacy of pelvic node radiotherapy and SIB to the prostate in prostate patients requiring nodal irradiation.
Methods
A total of 58 patients were irradiated with SBRT and initiated ADT therapy between 2014 and 2023. 57 patients were treated with 7.5 Gy to the prostate and 1 to 7.25 Gy. All patients were treated with 5 Gy x 5 fraction to the pelvis. This group was compared to a preselected historical cohort of 65 HFX patients with 57 of these patients treated with 67.5/50 Gy in 25 fractions, 1 with patient 67.5/45 Gy in 25 fractions, and 6 patients with 60/44-46 Gy in 20 fractions. Patients were evaluated for GU and GI toxicities according to Radiation Therapy Oncology Group Toxicity criteria at one year post radiation therapy.
Results
There were 31 grade 0 (53.4%), 1 grade 1 (1.7%), 25 grade 2 (43.1%), 1 grade 3 (1.7%) events in the SBRT group and 29 GU grade 0 (44.6%), 3 grade 1 (4.6%), and 33 grade 2 (50.8%) GU toxicities in the HFX group with no significant difference between the groups (p=0.464). There were 55 grade 0 (94.8%), 1 grade 1 (1.7%), and 2 grade 2 (3.4%) GI toxicities in the SBRT group and 59 grade 0 (90.8%), 1 grade 1 (1.5%), and 5 grade 2 (7.7%) events in the HFX group with no significant difference between the groups (p=0.381).
Conclusions
This prospective study provides data to support the use of concurrent pelvic radiation with SBRT to the prostate. Our findings suggest there is no difference in toxicity between HFX and 25 Gy pelvic radiation (5 Gy/5 fractions) concurrent with SBRT to the prostate, therefore it appears to be a safe and convenient option for veterans with prostate cancer.
Identifying Barriers in Germline Genetic Testing Referrals for Breast Cancer: A Single-Center Experience
Background
Purpose: to review the number of genetic testing referrals for breast cancer at the Stratton VA Medical Center and identify barriers that hinder testing, aiming to improve risk reduction strategies and therapeutic options for patients. National guidelines recommend genetic testing for breast cancer susceptibility genes in specific patient populations, such as those under 50, those with a high-risk family history, high-risk pathology, male breast cancer, or Ashkenazi Jewish ancestry. Despite efforts to adhere to these guidelines, several barriers persist that limit testing rates among eligible patients.
Methods
The medical oncology team selected breast cancer as the focus for reviewing adherence to germline genetic testing referrals in the Stratton VA Medical Center. With assistance from cancer registrars, a list of genetics referrals for breast cancer from January to December 2023 was compiled. Descriptive analysis was conducted to assess referral rates, evaluation visit completion rates, genetic testing outcomes, and reasons for non-completion of genetic testing.
Results
During the study period, 32 patients were referred for germline genetic testing for breast cancer. Of these, 26 (81%) completed the evaluation visit, and 11 (34%) underwent genetic testing. Of these, 7 patients had noteworthy results, and 2 patients (6%) were found to carry pathogenic variants: BRCA2 and CDH1. Reasons for non-completion included perceived irrelevance without biological children, need for additional time to consider testing, fear of exacerbating self-harm thoughts, and fear of losing service connection. Additionally, 2 patients did not meet the guidelines for testing per genetic counselor.
Conclusions
This project marks the initial step in identifying barriers to germline genetic testing for breast cancer based on an extensive review of patients diagnosed and treated at a single VA site. Despite the removal of the service connection clause from the consent form, some veterans still declined testing due to fear of losing their service connection. The findings emphasize the importance of educating providers on counseling techniques and education of veterans to enhance risk reduction strategies and patient care. Further research is essential to quantify the real-world outcomes and longterm impacts of improving genetic counseling rates on patient management and outcomes.
Background
Purpose: to review the number of genetic testing referrals for breast cancer at the Stratton VA Medical Center and identify barriers that hinder testing, aiming to improve risk reduction strategies and therapeutic options for patients. National guidelines recommend genetic testing for breast cancer susceptibility genes in specific patient populations, such as those under 50, those with a high-risk family history, high-risk pathology, male breast cancer, or Ashkenazi Jewish ancestry. Despite efforts to adhere to these guidelines, several barriers persist that limit testing rates among eligible patients.
Methods
The medical oncology team selected breast cancer as the focus for reviewing adherence to germline genetic testing referrals in the Stratton VA Medical Center. With assistance from cancer registrars, a list of genetics referrals for breast cancer from January to December 2023 was compiled. Descriptive analysis was conducted to assess referral rates, evaluation visit completion rates, genetic testing outcomes, and reasons for non-completion of genetic testing.
Results
During the study period, 32 patients were referred for germline genetic testing for breast cancer. Of these, 26 (81%) completed the evaluation visit, and 11 (34%) underwent genetic testing. Of these, 7 patients had noteworthy results, and 2 patients (6%) were found to carry pathogenic variants: BRCA2 and CDH1. Reasons for non-completion included perceived irrelevance without biological children, need for additional time to consider testing, fear of exacerbating self-harm thoughts, and fear of losing service connection. Additionally, 2 patients did not meet the guidelines for testing per genetic counselor.
Conclusions
This project marks the initial step in identifying barriers to germline genetic testing for breast cancer based on an extensive review of patients diagnosed and treated at a single VA site. Despite the removal of the service connection clause from the consent form, some veterans still declined testing due to fear of losing their service connection. The findings emphasize the importance of educating providers on counseling techniques and education of veterans to enhance risk reduction strategies and patient care. Further research is essential to quantify the real-world outcomes and longterm impacts of improving genetic counseling rates on patient management and outcomes.
Background
Purpose: to review the number of genetic testing referrals for breast cancer at the Stratton VA Medical Center and identify barriers that hinder testing, aiming to improve risk reduction strategies and therapeutic options for patients. National guidelines recommend genetic testing for breast cancer susceptibility genes in specific patient populations, such as those under 50, those with a high-risk family history, high-risk pathology, male breast cancer, or Ashkenazi Jewish ancestry. Despite efforts to adhere to these guidelines, several barriers persist that limit testing rates among eligible patients.
Methods
The medical oncology team selected breast cancer as the focus for reviewing adherence to germline genetic testing referrals in the Stratton VA Medical Center. With assistance from cancer registrars, a list of genetics referrals for breast cancer from January to December 2023 was compiled. Descriptive analysis was conducted to assess referral rates, evaluation visit completion rates, genetic testing outcomes, and reasons for non-completion of genetic testing.
Results
During the study period, 32 patients were referred for germline genetic testing for breast cancer. Of these, 26 (81%) completed the evaluation visit, and 11 (34%) underwent genetic testing. Of these, 7 patients had noteworthy results, and 2 patients (6%) were found to carry pathogenic variants: BRCA2 and CDH1. Reasons for non-completion included perceived irrelevance without biological children, need for additional time to consider testing, fear of exacerbating self-harm thoughts, and fear of losing service connection. Additionally, 2 patients did not meet the guidelines for testing per genetic counselor.
Conclusions
This project marks the initial step in identifying barriers to germline genetic testing for breast cancer based on an extensive review of patients diagnosed and treated at a single VA site. Despite the removal of the service connection clause from the consent form, some veterans still declined testing due to fear of losing their service connection. The findings emphasize the importance of educating providers on counseling techniques and education of veterans to enhance risk reduction strategies and patient care. Further research is essential to quantify the real-world outcomes and longterm impacts of improving genetic counseling rates on patient management and outcomes.
Do We Need More Screen Time? Patterns of Telehealth Utilization for Patients With Prostate Cancer in the Veterans Health Administration (VHA)
Background
Prostate cancer is the most common cancer in the VHA. Telehealth use has increased and has the potential to improve access for patients. We examined patterns of care for VHA patients with prostate cancer, including whether visits were in person, by telephone or by video.
Methods
Using the VHA Corporate Data Warehouse, we extracted data on all incident cases of prostate cancer from 1/1/2016-1/31/2023 with sufficient information (Gleason score, prostate-specific antigen [PSA], and tumor stage) to categorize into National Comprehensive Cancer Network (NCCN) risk strata. We excluded patients who died within 1 year of diagnosis and those with no evidence of PSA testing, prostate biopsy or treatment within 2 years. We categorized all outpatient visits related to a person’s Urology- and Medical Oncology based care – including the visit modality – based on administrative visit stop codes. We defined ‘during COVID’ as visits after 3/11/2020. We calculated the percent of visits performed by modality in each year after diagnosis.
Results
Among the 60,381 men with prostate cancer, 61% were White, 33% Black; 5% Hispanic; 32% rural. For NCCN category, 30% had high risk prostate cancer, which increased with age, 50% had intermediate risk and 20% had low risk. Prior to COVID, for visits to Urology within the first year after diagnosis, 79% were in person, 20% were by telephone and 0.1% were by video. Visits to Oncology within the first year after diagnosis were similar—82% in person, 16% by phone and 0.3% by video.
Discussion
During the COVID period, video visits increased significantly but remained a small proportion, accounting for only 2% of visits for both Urology and Oncology. Video visits increased during the COVID-19 pandemic but remained rare. Across many diseases and conditions, the quality of care for video visits has been at least as good as for in-person care.
Conclusions
There is a missed opportunity to provide care by video within VHA for patients with prostate cancer, particularly given that about 1/3 of patients are from rural areas. Future analyses will examine barriers to video telehealth and the impact of video visits on quality and equity of prostate cancer care.
Background
Prostate cancer is the most common cancer in the VHA. Telehealth use has increased and has the potential to improve access for patients. We examined patterns of care for VHA patients with prostate cancer, including whether visits were in person, by telephone or by video.
Methods
Using the VHA Corporate Data Warehouse, we extracted data on all incident cases of prostate cancer from 1/1/2016-1/31/2023 with sufficient information (Gleason score, prostate-specific antigen [PSA], and tumor stage) to categorize into National Comprehensive Cancer Network (NCCN) risk strata. We excluded patients who died within 1 year of diagnosis and those with no evidence of PSA testing, prostate biopsy or treatment within 2 years. We categorized all outpatient visits related to a person’s Urology- and Medical Oncology based care – including the visit modality – based on administrative visit stop codes. We defined ‘during COVID’ as visits after 3/11/2020. We calculated the percent of visits performed by modality in each year after diagnosis.
Results
Among the 60,381 men with prostate cancer, 61% were White, 33% Black; 5% Hispanic; 32% rural. For NCCN category, 30% had high risk prostate cancer, which increased with age, 50% had intermediate risk and 20% had low risk. Prior to COVID, for visits to Urology within the first year after diagnosis, 79% were in person, 20% were by telephone and 0.1% were by video. Visits to Oncology within the first year after diagnosis were similar—82% in person, 16% by phone and 0.3% by video.
Discussion
During the COVID period, video visits increased significantly but remained a small proportion, accounting for only 2% of visits for both Urology and Oncology. Video visits increased during the COVID-19 pandemic but remained rare. Across many diseases and conditions, the quality of care for video visits has been at least as good as for in-person care.
Conclusions
There is a missed opportunity to provide care by video within VHA for patients with prostate cancer, particularly given that about 1/3 of patients are from rural areas. Future analyses will examine barriers to video telehealth and the impact of video visits on quality and equity of prostate cancer care.
Background
Prostate cancer is the most common cancer in the VHA. Telehealth use has increased and has the potential to improve access for patients. We examined patterns of care for VHA patients with prostate cancer, including whether visits were in person, by telephone or by video.
Methods
Using the VHA Corporate Data Warehouse, we extracted data on all incident cases of prostate cancer from 1/1/2016-1/31/2023 with sufficient information (Gleason score, prostate-specific antigen [PSA], and tumor stage) to categorize into National Comprehensive Cancer Network (NCCN) risk strata. We excluded patients who died within 1 year of diagnosis and those with no evidence of PSA testing, prostate biopsy or treatment within 2 years. We categorized all outpatient visits related to a person’s Urology- and Medical Oncology based care – including the visit modality – based on administrative visit stop codes. We defined ‘during COVID’ as visits after 3/11/2020. We calculated the percent of visits performed by modality in each year after diagnosis.
Results
Among the 60,381 men with prostate cancer, 61% were White, 33% Black; 5% Hispanic; 32% rural. For NCCN category, 30% had high risk prostate cancer, which increased with age, 50% had intermediate risk and 20% had low risk. Prior to COVID, for visits to Urology within the first year after diagnosis, 79% were in person, 20% were by telephone and 0.1% were by video. Visits to Oncology within the first year after diagnosis were similar—82% in person, 16% by phone and 0.3% by video.
Discussion
During the COVID period, video visits increased significantly but remained a small proportion, accounting for only 2% of visits for both Urology and Oncology. Video visits increased during the COVID-19 pandemic but remained rare. Across many diseases and conditions, the quality of care for video visits has been at least as good as for in-person care.
Conclusions
There is a missed opportunity to provide care by video within VHA for patients with prostate cancer, particularly given that about 1/3 of patients are from rural areas. Future analyses will examine barriers to video telehealth and the impact of video visits on quality and equity of prostate cancer care.
Asynchronous Bilateral Breast Cancer in a Male Patient
Background
Bilateral male breast cancer remains a rare occurrence with limited representation in published literature. Here we present a case of an 82-yearold male with asynchronous bilateral breast cancer.
Case Presentation
Our patient is an 82-year-old male past smoker initially diagnosed with left T1aN0M0 invasive lobular carcinoma in 2010 that was ER, PR positive and HER2 negative. He underwent a left mastectomy with sentinel node biopsy and was given tamoxifen therapy for 10 years. In 2020, the patient was also diagnosed with lung squamous cell carcinoma and was treated with stereotactic body radiotherapy. In September 2023, he started noticing discharge from his right nipple. A PET CT scan revealed hyper-metabolic activity in the bilateral upper lung lobes and slightly increased activity in the right breast. A biopsy of the left upper lobe showed atypical cells. He also underwent a right breast mastectomy and sentinel lymph node biopsy which showed grade 1-2 ductal carcinoma in situ and negative sentinel lymph nodes. The tumor board recommended no further treatment after his mastectomy and genetic testing which is currently pending.
Discussion
Male breast cancer comprises just 1% of breast cancer cases, with asynchronous bilateral occurrences being exceedingly rare. A review of PubMed literature yielded only 2 documented case reports. Male breast cancer usually diagnosed around ages 60 to 70 years. The predominant histopathological diagnosis is invasive ductal adenocarcinoma that more frequently expresses ER/PR over HER2. It often manifests as a painless lump, frequently diagnosed at an advanced stage, possibly due to factors such as lower screening rates in males and less breast parenchyma. Local treatment options include surgery and radiotherapy. Neoadjuvant tamoxifen therapy is appropriate for ER and PR expressing cancers and chemotherapy can be used for non-hormone expressing or metastatic tumors. Given its rarity, management and diagnostic strategies for male breast cancer are often adapted from research on female breast cancer
Conclusions
Our case is of a relatively uncommon incident of asynchronous bilateral male breast cancer, emphasizing the need for expanded research efforts in male breast cancer. An enhanced understanding could lead to improved diagnosis and management strategies, potentially enhancing survival outcomes.
Background
Bilateral male breast cancer remains a rare occurrence with limited representation in published literature. Here we present a case of an 82-yearold male with asynchronous bilateral breast cancer.
Case Presentation
Our patient is an 82-year-old male past smoker initially diagnosed with left T1aN0M0 invasive lobular carcinoma in 2010 that was ER, PR positive and HER2 negative. He underwent a left mastectomy with sentinel node biopsy and was given tamoxifen therapy for 10 years. In 2020, the patient was also diagnosed with lung squamous cell carcinoma and was treated with stereotactic body radiotherapy. In September 2023, he started noticing discharge from his right nipple. A PET CT scan revealed hyper-metabolic activity in the bilateral upper lung lobes and slightly increased activity in the right breast. A biopsy of the left upper lobe showed atypical cells. He also underwent a right breast mastectomy and sentinel lymph node biopsy which showed grade 1-2 ductal carcinoma in situ and negative sentinel lymph nodes. The tumor board recommended no further treatment after his mastectomy and genetic testing which is currently pending.
Discussion
Male breast cancer comprises just 1% of breast cancer cases, with asynchronous bilateral occurrences being exceedingly rare. A review of PubMed literature yielded only 2 documented case reports. Male breast cancer usually diagnosed around ages 60 to 70 years. The predominant histopathological diagnosis is invasive ductal adenocarcinoma that more frequently expresses ER/PR over HER2. It often manifests as a painless lump, frequently diagnosed at an advanced stage, possibly due to factors such as lower screening rates in males and less breast parenchyma. Local treatment options include surgery and radiotherapy. Neoadjuvant tamoxifen therapy is appropriate for ER and PR expressing cancers and chemotherapy can be used for non-hormone expressing or metastatic tumors. Given its rarity, management and diagnostic strategies for male breast cancer are often adapted from research on female breast cancer
Conclusions
Our case is of a relatively uncommon incident of asynchronous bilateral male breast cancer, emphasizing the need for expanded research efforts in male breast cancer. An enhanced understanding could lead to improved diagnosis and management strategies, potentially enhancing survival outcomes.
Background
Bilateral male breast cancer remains a rare occurrence with limited representation in published literature. Here we present a case of an 82-yearold male with asynchronous bilateral breast cancer.
Case Presentation
Our patient is an 82-year-old male past smoker initially diagnosed with left T1aN0M0 invasive lobular carcinoma in 2010 that was ER, PR positive and HER2 negative. He underwent a left mastectomy with sentinel node biopsy and was given tamoxifen therapy for 10 years. In 2020, the patient was also diagnosed with lung squamous cell carcinoma and was treated with stereotactic body radiotherapy. In September 2023, he started noticing discharge from his right nipple. A PET CT scan revealed hyper-metabolic activity in the bilateral upper lung lobes and slightly increased activity in the right breast. A biopsy of the left upper lobe showed atypical cells. He also underwent a right breast mastectomy and sentinel lymph node biopsy which showed grade 1-2 ductal carcinoma in situ and negative sentinel lymph nodes. The tumor board recommended no further treatment after his mastectomy and genetic testing which is currently pending.
Discussion
Male breast cancer comprises just 1% of breast cancer cases, with asynchronous bilateral occurrences being exceedingly rare. A review of PubMed literature yielded only 2 documented case reports. Male breast cancer usually diagnosed around ages 60 to 70 years. The predominant histopathological diagnosis is invasive ductal adenocarcinoma that more frequently expresses ER/PR over HER2. It often manifests as a painless lump, frequently diagnosed at an advanced stage, possibly due to factors such as lower screening rates in males and less breast parenchyma. Local treatment options include surgery and radiotherapy. Neoadjuvant tamoxifen therapy is appropriate for ER and PR expressing cancers and chemotherapy can be used for non-hormone expressing or metastatic tumors. Given its rarity, management and diagnostic strategies for male breast cancer are often adapted from research on female breast cancer
Conclusions
Our case is of a relatively uncommon incident of asynchronous bilateral male breast cancer, emphasizing the need for expanded research efforts in male breast cancer. An enhanced understanding could lead to improved diagnosis and management strategies, potentially enhancing survival outcomes.
Metastatic Prostate Cancer Presenting as Pleural and Pericardial Metastases: A Case Report and Literature Review
Background
Metastatic prostate cancer typically manifests with metastases to the lungs, bones, and adrenal glands. Here, we report a unique case where the initial presentation involved pleural nodules, subsequently leading to the discovery of pleural and pericardial metastases.
Case Presentation
Our patient, a 73-year-old male with a history of active tobacco use disorder, COPD, and right shoulder melanoma (2004), initially presented to his primary care physician for a routine visit. Following a Low Dose Chest CT scan (LDCT), numerous new pleural nodules were identified. Physical examination revealed small nevi and skin tags, but no malignant characteristics. Initial concerns centered on the potential recurrence of malignant melanoma with pleural metastases or an inflammatory condition. Subsequent PET scan results raised significant suspicion of malignancy. PSA was 2.41. Pleuroscopy biopsies revealed invasive nonsmall cell carcinoma, positive for NKX31 and MOC31, but negative for S100, PSA, and synaptophysin. This pattern strongly suggests metastatic prostate cancer despite the absence of PSA staining. (Stage IV B: cTxcN1cM1c). A subsequent PSMA PET highlighted extensive metastatic involvement in the pericardium, posterior and mediastinal pleura, mediastinum, and ribs. Treatment commenced with Degarelix followed by the standard regimen of Docetaxel, Abiraterone, and prednisone. Genetic counseling and palliative care services were additionally recommended.
Discussion
Prostate cancer typically spreads to bones, lungs, liver, and adrenal glands. Rarely, it appears in sites like pericardium and pleura. Pleural metastases are usually found postmortem; clinical diagnosis is rare. Pericardial metastases are exceptionally uncommon, with few documented cases. The precise mechanism of metastatic dissemination remains uncertain, with theories suggesting spread through the vertebral-venous plexus or via the vena cava to distant organs. Treatment approaches vary based on symptomatic effusions, ranging from pericardiocentesis, thoracocentesis to chemotherapy, radiotherapy, and hormone therapy. Studies have shown systemic docetaxel to be effective in managing pleural and pericardial symptoms. Despite their rarity, healthcare providers should consider these possibilities when encountering pleural thickening or pericardial abnormalities on imaging studies.
Conclusions
Pleural and pericardial metastases represent uncommon occurrences in prostate cancer. Continued research efforts can facilitate early detection of metastatic disease, enabling more effective and precisely targeted management strategies when symptoms manifest.
Background
Metastatic prostate cancer typically manifests with metastases to the lungs, bones, and adrenal glands. Here, we report a unique case where the initial presentation involved pleural nodules, subsequently leading to the discovery of pleural and pericardial metastases.
Case Presentation
Our patient, a 73-year-old male with a history of active tobacco use disorder, COPD, and right shoulder melanoma (2004), initially presented to his primary care physician for a routine visit. Following a Low Dose Chest CT scan (LDCT), numerous new pleural nodules were identified. Physical examination revealed small nevi and skin tags, but no malignant characteristics. Initial concerns centered on the potential recurrence of malignant melanoma with pleural metastases or an inflammatory condition. Subsequent PET scan results raised significant suspicion of malignancy. PSA was 2.41. Pleuroscopy biopsies revealed invasive nonsmall cell carcinoma, positive for NKX31 and MOC31, but negative for S100, PSA, and synaptophysin. This pattern strongly suggests metastatic prostate cancer despite the absence of PSA staining. (Stage IV B: cTxcN1cM1c). A subsequent PSMA PET highlighted extensive metastatic involvement in the pericardium, posterior and mediastinal pleura, mediastinum, and ribs. Treatment commenced with Degarelix followed by the standard regimen of Docetaxel, Abiraterone, and prednisone. Genetic counseling and palliative care services were additionally recommended.
Discussion
Prostate cancer typically spreads to bones, lungs, liver, and adrenal glands. Rarely, it appears in sites like pericardium and pleura. Pleural metastases are usually found postmortem; clinical diagnosis is rare. Pericardial metastases are exceptionally uncommon, with few documented cases. The precise mechanism of metastatic dissemination remains uncertain, with theories suggesting spread through the vertebral-venous plexus or via the vena cava to distant organs. Treatment approaches vary based on symptomatic effusions, ranging from pericardiocentesis, thoracocentesis to chemotherapy, radiotherapy, and hormone therapy. Studies have shown systemic docetaxel to be effective in managing pleural and pericardial symptoms. Despite their rarity, healthcare providers should consider these possibilities when encountering pleural thickening or pericardial abnormalities on imaging studies.
Conclusions
Pleural and pericardial metastases represent uncommon occurrences in prostate cancer. Continued research efforts can facilitate early detection of metastatic disease, enabling more effective and precisely targeted management strategies when symptoms manifest.
Background
Metastatic prostate cancer typically manifests with metastases to the lungs, bones, and adrenal glands. Here, we report a unique case where the initial presentation involved pleural nodules, subsequently leading to the discovery of pleural and pericardial metastases.
Case Presentation
Our patient, a 73-year-old male with a history of active tobacco use disorder, COPD, and right shoulder melanoma (2004), initially presented to his primary care physician for a routine visit. Following a Low Dose Chest CT scan (LDCT), numerous new pleural nodules were identified. Physical examination revealed small nevi and skin tags, but no malignant characteristics. Initial concerns centered on the potential recurrence of malignant melanoma with pleural metastases or an inflammatory condition. Subsequent PET scan results raised significant suspicion of malignancy. PSA was 2.41. Pleuroscopy biopsies revealed invasive nonsmall cell carcinoma, positive for NKX31 and MOC31, but negative for S100, PSA, and synaptophysin. This pattern strongly suggests metastatic prostate cancer despite the absence of PSA staining. (Stage IV B: cTxcN1cM1c). A subsequent PSMA PET highlighted extensive metastatic involvement in the pericardium, posterior and mediastinal pleura, mediastinum, and ribs. Treatment commenced with Degarelix followed by the standard regimen of Docetaxel, Abiraterone, and prednisone. Genetic counseling and palliative care services were additionally recommended.
Discussion
Prostate cancer typically spreads to bones, lungs, liver, and adrenal glands. Rarely, it appears in sites like pericardium and pleura. Pleural metastases are usually found postmortem; clinical diagnosis is rare. Pericardial metastases are exceptionally uncommon, with few documented cases. The precise mechanism of metastatic dissemination remains uncertain, with theories suggesting spread through the vertebral-venous plexus or via the vena cava to distant organs. Treatment approaches vary based on symptomatic effusions, ranging from pericardiocentesis, thoracocentesis to chemotherapy, radiotherapy, and hormone therapy. Studies have shown systemic docetaxel to be effective in managing pleural and pericardial symptoms. Despite their rarity, healthcare providers should consider these possibilities when encountering pleural thickening or pericardial abnormalities on imaging studies.
Conclusions
Pleural and pericardial metastases represent uncommon occurrences in prostate cancer. Continued research efforts can facilitate early detection of metastatic disease, enabling more effective and precisely targeted management strategies when symptoms manifest.
Timing of Blood Pressure Dosing Doesn’t Matter (Again): BedMed and BedMed-Frail
This transcript has been edited for clarity.
Tricia Ward: I’m joined today by Dr. Scott R. Garrison, MD, PhD. He is a professor in the Department of Family Medicine at the University of Alberta in Edmonton, Alberta, Canada, and director of the Pragmatic Trials Collaborative.
You presented two studies at ESC. One is the BedMed study, comparing day vs nighttime dosing of blood pressure therapy. Can you tell us the top-line findings?
BedMed and BedMed-Frail
Dr. Garrison: We were looking to validate an earlier study that suggested a large benefit of taking blood pressure medication at bedtime, as far as reducing major adverse cardiovascular events (MACEs). That was the MAPEC study. They suggested a 60% reduction. The BedMed trial was in hypertensive primary care patients in five Canadian provinces. We randomized well over 3000 patients to bedtime or morning medications. We looked at MACEs — so all-cause death or hospitalizations for acute coronary syndrome, stroke, or heart failure, and a bunch of safety outcomes.
Essentially, . It was safe to take it at bedtime. But it did not convey any extra cardiovascular benefit.
Ms. Ward: And then you did a second study, called BedMed-Frail. Do you want to tell us the reason you did that?
Dr. Garrison: BedMed-Frail took place in a nursing home population. We believed that it was possible that frail, older adults might have very different risks and benefits, and that they would probably be underrepresented, as they normally are in the main trial.
We thought that because bedtime blood pressure medications would be theoretically preferentially lowering night pressure, which is already the lowest pressure of the day, that if you were at risk for hypotensive or ischemic adverse events, that might make it worse. We looked at falls and fractures; worsening cognition in case they had vascular dementia; and whether they developed decubitus ulcers (pressure sores) because you need a certain amount of pressure to get past any obstruction — in this case, it’s the weight of your body if you’re lying in bed all the time.
We also looked at problem behaviors. People who have dementia have what’s called “sundowning,” where agitation and confusion are worse as the evening is going on. We looked at that on the off chance that it had anything to do with blood pressures being lower. And the BedMed-Frail results mirror those of BedMed exactly. So there was no cardiovascular benefit, and in this population, that was largely driven by mortality; one third of these people died every year.
Ms. Ward: The median age was about 88?
Dr. Garrison: Yes, the median age was 88. There was no cardiovascular mortality advantage to bedtime dosing, but neither was there any signal of safety concerns.
Other Complementary and Conflicting Studies
Ms. Ward: These two studies mirror the TIME study from the United Kingdom.
Dr. Garrison: Yes. We found exactly what TIME found. Our point estimate was pretty much the same. The hazard ratio in the main trial was 0.96. Theirs, I believe, was 0.95. Our findings agree completely with those of TIME and differ substantially from the previous trials that suggested a large benefit.
Ms. Ward: Those previous trials were MAPEC and the Hygia Chronotherapy Trial.
Dr. Garrison: MAPEC was the first one. While we were doing our trial, and while the TIME investigators were doing their trial, both of us trying to validate MAPEC, the same group published another study called Hygia, which also reported a large reduction: a 45% reduction in MACE with bedtime dosing.
Ms. Ward: You didn’t present it, but there was also a meta-analysis presented here by somebody independent.
Dr. Garrison: Yes, Ricky Turgeon. I know Ricky. We gave him patient-level data for his meta-analysis, but I was not otherwise involved.
Ms. Ward: And the conclusion is the same.
Dr. Garrison: It’s the same. He only found the same five trials: MAPEC, Hygia, TIME, BedMed, and BedMed-Frail. Combining them all together, the CIs still span 1.0, so it didn’t end up being significant. But he also analyzed TIME and the BedMed trials separately — again suggesting that those trials showed no benefit.
Ms. Ward: There was a TIME substudy of night owls vs early risers or morning people, and there was a hint (or whatever you should say for a subanalysis of a neutral trial) that timing might make a difference there.
Dr. Garrison: They recently published, I guess it is a substudy, where they looked at people’s chronotype according to whether you consider yourself an early bird or a night owl. Their assessment was more detailed. They reported that if people were tending toward being early birds and they took their blood pressure medicine in the morning, or if they were night owls and they took it in the evening, that they tended to have statistically significantly better outcomes than the opposite timing. In that analysis, they were only looking at nonfatal myocardial infarction and nonfatal stroke.
We did ask something that was related. We asked people: “Do we consider yourself more of an early bird or a night owl?” So we do have those data. For what I presented at ESC, we just looked at the primary outcome; we did subgroups according to early bird, night owl, and neither, and that was not statistically significant. It didn’t rule it out. There were some trends in the direction that the TIME group were suggesting. We do intend to do a closer look at that.
But, you know, they call these “late-breaking trials,” and it really was in our case. We didn’t get the last of our data from the last province until the end of June, so we still are finishing up the analysis of the chronotype portion — so more to come in another month or so.
Do What You Like, or Stick to Morning Dosing?
Ms. Ward: For the purposes of people’s take-home message, does this mostly apply to once-daily–dosed antihypertensives?
Dr. Garrison: It was essentially once-daily medicines that were changed. The docs did have the opportunity to consolidate twice-daily meds into once-daily or switch to a different medication. That’s probably the area where adherence was the biggest issue, because it’s largely beta-blockers that were given twice daily at baseline, and they were less likely to want to change.
At 6 months, 83% of once-daily medications were taken per allocation in the bedtime group and 95% per allocation in the morning group, which was actually pretty good. For angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and calcium-channel blockers, the adherence was excellent. Again, it was beta-blockers taken twice a day where it fell down, and then also diuretics. But if you combine all diuretic medications (ie, pure diuretics and combo agents), still, 75% of them were successful at taking them at bedtime. Only 15% of people switching a diuretic to bedtime dosing actually had problems with nocturia. Most physicians think that they can’t get their patients to take those meds at bedtime, but you can. There’s probably no reason to take it at bedtime, but most people do tolerate it.
Ms. Ward: Is your advice to take it whenever you feel like? I know when TIME came out, Professor George Stergiou, who’s the incoming president of the International Society of Hypertension, said, well, maybe we should stick with the morning, because that’s what most of the trials did.
Dr. Garrison: I think that›s a perfectly valid point of view, and maybe for a lot of people, that could be the default. There are some people, though, who will have a particular reason why one time is better. For instance, most people have no problems with calcium-channel blockers, but some get ankle swelling and you’re more likely to have that happen if you take them in the morning. Or lots of people want to take all their pills at the same time; blood pressure pills are easy ones to switch the timing of if you’re trying to accomplish that, and if that will help adherence. Basically, whatever time of day you can remember to take it the best is probably the right time.
Ms. Ward: Given where we are today, with your trials and TIME, do you think this is now settled science that it doesn’t make a difference?
Dr. Garrison: I’m probably the wrong person to ask, because I clearly have a bias. I think the methods in the TIME trial are really transparent and solid. I hope that when our papers come out, people will feel the same. You just have to look at the different trials. You need people like Dr. Stergiou to wade through the trials to help you with that.
Ms. Ward: Thank you very much for joining me today and discussing this trial.
Scott R. Garrison, MD, PhD, is Professor, Department of Family Medicine, University of Alberta in Edmonton, Alberta, Canada, and Staff Physician, Department of Family Medicine, Kaye Edmonton Clinic, and he has disclosed receiving research grants from Alberta Innovates (the Alberta Provincial Government) and the Canadian Institutes of Health Research (the Canadian Federal Government).
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Tricia Ward: I’m joined today by Dr. Scott R. Garrison, MD, PhD. He is a professor in the Department of Family Medicine at the University of Alberta in Edmonton, Alberta, Canada, and director of the Pragmatic Trials Collaborative.
You presented two studies at ESC. One is the BedMed study, comparing day vs nighttime dosing of blood pressure therapy. Can you tell us the top-line findings?
BedMed and BedMed-Frail
Dr. Garrison: We were looking to validate an earlier study that suggested a large benefit of taking blood pressure medication at bedtime, as far as reducing major adverse cardiovascular events (MACEs). That was the MAPEC study. They suggested a 60% reduction. The BedMed trial was in hypertensive primary care patients in five Canadian provinces. We randomized well over 3000 patients to bedtime or morning medications. We looked at MACEs — so all-cause death or hospitalizations for acute coronary syndrome, stroke, or heart failure, and a bunch of safety outcomes.
Essentially, . It was safe to take it at bedtime. But it did not convey any extra cardiovascular benefit.
Ms. Ward: And then you did a second study, called BedMed-Frail. Do you want to tell us the reason you did that?
Dr. Garrison: BedMed-Frail took place in a nursing home population. We believed that it was possible that frail, older adults might have very different risks and benefits, and that they would probably be underrepresented, as they normally are in the main trial.
We thought that because bedtime blood pressure medications would be theoretically preferentially lowering night pressure, which is already the lowest pressure of the day, that if you were at risk for hypotensive or ischemic adverse events, that might make it worse. We looked at falls and fractures; worsening cognition in case they had vascular dementia; and whether they developed decubitus ulcers (pressure sores) because you need a certain amount of pressure to get past any obstruction — in this case, it’s the weight of your body if you’re lying in bed all the time.
We also looked at problem behaviors. People who have dementia have what’s called “sundowning,” where agitation and confusion are worse as the evening is going on. We looked at that on the off chance that it had anything to do with blood pressures being lower. And the BedMed-Frail results mirror those of BedMed exactly. So there was no cardiovascular benefit, and in this population, that was largely driven by mortality; one third of these people died every year.
Ms. Ward: The median age was about 88?
Dr. Garrison: Yes, the median age was 88. There was no cardiovascular mortality advantage to bedtime dosing, but neither was there any signal of safety concerns.
Other Complementary and Conflicting Studies
Ms. Ward: These two studies mirror the TIME study from the United Kingdom.
Dr. Garrison: Yes. We found exactly what TIME found. Our point estimate was pretty much the same. The hazard ratio in the main trial was 0.96. Theirs, I believe, was 0.95. Our findings agree completely with those of TIME and differ substantially from the previous trials that suggested a large benefit.
Ms. Ward: Those previous trials were MAPEC and the Hygia Chronotherapy Trial.
Dr. Garrison: MAPEC was the first one. While we were doing our trial, and while the TIME investigators were doing their trial, both of us trying to validate MAPEC, the same group published another study called Hygia, which also reported a large reduction: a 45% reduction in MACE with bedtime dosing.
Ms. Ward: You didn’t present it, but there was also a meta-analysis presented here by somebody independent.
Dr. Garrison: Yes, Ricky Turgeon. I know Ricky. We gave him patient-level data for his meta-analysis, but I was not otherwise involved.
Ms. Ward: And the conclusion is the same.
Dr. Garrison: It’s the same. He only found the same five trials: MAPEC, Hygia, TIME, BedMed, and BedMed-Frail. Combining them all together, the CIs still span 1.0, so it didn’t end up being significant. But he also analyzed TIME and the BedMed trials separately — again suggesting that those trials showed no benefit.
Ms. Ward: There was a TIME substudy of night owls vs early risers or morning people, and there was a hint (or whatever you should say for a subanalysis of a neutral trial) that timing might make a difference there.
Dr. Garrison: They recently published, I guess it is a substudy, where they looked at people’s chronotype according to whether you consider yourself an early bird or a night owl. Their assessment was more detailed. They reported that if people were tending toward being early birds and they took their blood pressure medicine in the morning, or if they were night owls and they took it in the evening, that they tended to have statistically significantly better outcomes than the opposite timing. In that analysis, they were only looking at nonfatal myocardial infarction and nonfatal stroke.
We did ask something that was related. We asked people: “Do we consider yourself more of an early bird or a night owl?” So we do have those data. For what I presented at ESC, we just looked at the primary outcome; we did subgroups according to early bird, night owl, and neither, and that was not statistically significant. It didn’t rule it out. There were some trends in the direction that the TIME group were suggesting. We do intend to do a closer look at that.
But, you know, they call these “late-breaking trials,” and it really was in our case. We didn’t get the last of our data from the last province until the end of June, so we still are finishing up the analysis of the chronotype portion — so more to come in another month or so.
Do What You Like, or Stick to Morning Dosing?
Ms. Ward: For the purposes of people’s take-home message, does this mostly apply to once-daily–dosed antihypertensives?
Dr. Garrison: It was essentially once-daily medicines that were changed. The docs did have the opportunity to consolidate twice-daily meds into once-daily or switch to a different medication. That’s probably the area where adherence was the biggest issue, because it’s largely beta-blockers that were given twice daily at baseline, and they were less likely to want to change.
At 6 months, 83% of once-daily medications were taken per allocation in the bedtime group and 95% per allocation in the morning group, which was actually pretty good. For angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and calcium-channel blockers, the adherence was excellent. Again, it was beta-blockers taken twice a day where it fell down, and then also diuretics. But if you combine all diuretic medications (ie, pure diuretics and combo agents), still, 75% of them were successful at taking them at bedtime. Only 15% of people switching a diuretic to bedtime dosing actually had problems with nocturia. Most physicians think that they can’t get their patients to take those meds at bedtime, but you can. There’s probably no reason to take it at bedtime, but most people do tolerate it.
Ms. Ward: Is your advice to take it whenever you feel like? I know when TIME came out, Professor George Stergiou, who’s the incoming president of the International Society of Hypertension, said, well, maybe we should stick with the morning, because that’s what most of the trials did.
Dr. Garrison: I think that›s a perfectly valid point of view, and maybe for a lot of people, that could be the default. There are some people, though, who will have a particular reason why one time is better. For instance, most people have no problems with calcium-channel blockers, but some get ankle swelling and you’re more likely to have that happen if you take them in the morning. Or lots of people want to take all their pills at the same time; blood pressure pills are easy ones to switch the timing of if you’re trying to accomplish that, and if that will help adherence. Basically, whatever time of day you can remember to take it the best is probably the right time.
Ms. Ward: Given where we are today, with your trials and TIME, do you think this is now settled science that it doesn’t make a difference?
Dr. Garrison: I’m probably the wrong person to ask, because I clearly have a bias. I think the methods in the TIME trial are really transparent and solid. I hope that when our papers come out, people will feel the same. You just have to look at the different trials. You need people like Dr. Stergiou to wade through the trials to help you with that.
Ms. Ward: Thank you very much for joining me today and discussing this trial.
Scott R. Garrison, MD, PhD, is Professor, Department of Family Medicine, University of Alberta in Edmonton, Alberta, Canada, and Staff Physician, Department of Family Medicine, Kaye Edmonton Clinic, and he has disclosed receiving research grants from Alberta Innovates (the Alberta Provincial Government) and the Canadian Institutes of Health Research (the Canadian Federal Government).
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Tricia Ward: I’m joined today by Dr. Scott R. Garrison, MD, PhD. He is a professor in the Department of Family Medicine at the University of Alberta in Edmonton, Alberta, Canada, and director of the Pragmatic Trials Collaborative.
You presented two studies at ESC. One is the BedMed study, comparing day vs nighttime dosing of blood pressure therapy. Can you tell us the top-line findings?
BedMed and BedMed-Frail
Dr. Garrison: We were looking to validate an earlier study that suggested a large benefit of taking blood pressure medication at bedtime, as far as reducing major adverse cardiovascular events (MACEs). That was the MAPEC study. They suggested a 60% reduction. The BedMed trial was in hypertensive primary care patients in five Canadian provinces. We randomized well over 3000 patients to bedtime or morning medications. We looked at MACEs — so all-cause death or hospitalizations for acute coronary syndrome, stroke, or heart failure, and a bunch of safety outcomes.
Essentially, . It was safe to take it at bedtime. But it did not convey any extra cardiovascular benefit.
Ms. Ward: And then you did a second study, called BedMed-Frail. Do you want to tell us the reason you did that?
Dr. Garrison: BedMed-Frail took place in a nursing home population. We believed that it was possible that frail, older adults might have very different risks and benefits, and that they would probably be underrepresented, as they normally are in the main trial.
We thought that because bedtime blood pressure medications would be theoretically preferentially lowering night pressure, which is already the lowest pressure of the day, that if you were at risk for hypotensive or ischemic adverse events, that might make it worse. We looked at falls and fractures; worsening cognition in case they had vascular dementia; and whether they developed decubitus ulcers (pressure sores) because you need a certain amount of pressure to get past any obstruction — in this case, it’s the weight of your body if you’re lying in bed all the time.
We also looked at problem behaviors. People who have dementia have what’s called “sundowning,” where agitation and confusion are worse as the evening is going on. We looked at that on the off chance that it had anything to do with blood pressures being lower. And the BedMed-Frail results mirror those of BedMed exactly. So there was no cardiovascular benefit, and in this population, that was largely driven by mortality; one third of these people died every year.
Ms. Ward: The median age was about 88?
Dr. Garrison: Yes, the median age was 88. There was no cardiovascular mortality advantage to bedtime dosing, but neither was there any signal of safety concerns.
Other Complementary and Conflicting Studies
Ms. Ward: These two studies mirror the TIME study from the United Kingdom.
Dr. Garrison: Yes. We found exactly what TIME found. Our point estimate was pretty much the same. The hazard ratio in the main trial was 0.96. Theirs, I believe, was 0.95. Our findings agree completely with those of TIME and differ substantially from the previous trials that suggested a large benefit.
Ms. Ward: Those previous trials were MAPEC and the Hygia Chronotherapy Trial.
Dr. Garrison: MAPEC was the first one. While we were doing our trial, and while the TIME investigators were doing their trial, both of us trying to validate MAPEC, the same group published another study called Hygia, which also reported a large reduction: a 45% reduction in MACE with bedtime dosing.
Ms. Ward: You didn’t present it, but there was also a meta-analysis presented here by somebody independent.
Dr. Garrison: Yes, Ricky Turgeon. I know Ricky. We gave him patient-level data for his meta-analysis, but I was not otherwise involved.
Ms. Ward: And the conclusion is the same.
Dr. Garrison: It’s the same. He only found the same five trials: MAPEC, Hygia, TIME, BedMed, and BedMed-Frail. Combining them all together, the CIs still span 1.0, so it didn’t end up being significant. But he also analyzed TIME and the BedMed trials separately — again suggesting that those trials showed no benefit.
Ms. Ward: There was a TIME substudy of night owls vs early risers or morning people, and there was a hint (or whatever you should say for a subanalysis of a neutral trial) that timing might make a difference there.
Dr. Garrison: They recently published, I guess it is a substudy, where they looked at people’s chronotype according to whether you consider yourself an early bird or a night owl. Their assessment was more detailed. They reported that if people were tending toward being early birds and they took their blood pressure medicine in the morning, or if they were night owls and they took it in the evening, that they tended to have statistically significantly better outcomes than the opposite timing. In that analysis, they were only looking at nonfatal myocardial infarction and nonfatal stroke.
We did ask something that was related. We asked people: “Do we consider yourself more of an early bird or a night owl?” So we do have those data. For what I presented at ESC, we just looked at the primary outcome; we did subgroups according to early bird, night owl, and neither, and that was not statistically significant. It didn’t rule it out. There were some trends in the direction that the TIME group were suggesting. We do intend to do a closer look at that.
But, you know, they call these “late-breaking trials,” and it really was in our case. We didn’t get the last of our data from the last province until the end of June, so we still are finishing up the analysis of the chronotype portion — so more to come in another month or so.
Do What You Like, or Stick to Morning Dosing?
Ms. Ward: For the purposes of people’s take-home message, does this mostly apply to once-daily–dosed antihypertensives?
Dr. Garrison: It was essentially once-daily medicines that were changed. The docs did have the opportunity to consolidate twice-daily meds into once-daily or switch to a different medication. That’s probably the area where adherence was the biggest issue, because it’s largely beta-blockers that were given twice daily at baseline, and they were less likely to want to change.
At 6 months, 83% of once-daily medications were taken per allocation in the bedtime group and 95% per allocation in the morning group, which was actually pretty good. For angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and calcium-channel blockers, the adherence was excellent. Again, it was beta-blockers taken twice a day where it fell down, and then also diuretics. But if you combine all diuretic medications (ie, pure diuretics and combo agents), still, 75% of them were successful at taking them at bedtime. Only 15% of people switching a diuretic to bedtime dosing actually had problems with nocturia. Most physicians think that they can’t get their patients to take those meds at bedtime, but you can. There’s probably no reason to take it at bedtime, but most people do tolerate it.
Ms. Ward: Is your advice to take it whenever you feel like? I know when TIME came out, Professor George Stergiou, who’s the incoming president of the International Society of Hypertension, said, well, maybe we should stick with the morning, because that’s what most of the trials did.
Dr. Garrison: I think that›s a perfectly valid point of view, and maybe for a lot of people, that could be the default. There are some people, though, who will have a particular reason why one time is better. For instance, most people have no problems with calcium-channel blockers, but some get ankle swelling and you’re more likely to have that happen if you take them in the morning. Or lots of people want to take all their pills at the same time; blood pressure pills are easy ones to switch the timing of if you’re trying to accomplish that, and if that will help adherence. Basically, whatever time of day you can remember to take it the best is probably the right time.
Ms. Ward: Given where we are today, with your trials and TIME, do you think this is now settled science that it doesn’t make a difference?
Dr. Garrison: I’m probably the wrong person to ask, because I clearly have a bias. I think the methods in the TIME trial are really transparent and solid. I hope that when our papers come out, people will feel the same. You just have to look at the different trials. You need people like Dr. Stergiou to wade through the trials to help you with that.
Ms. Ward: Thank you very much for joining me today and discussing this trial.
Scott R. Garrison, MD, PhD, is Professor, Department of Family Medicine, University of Alberta in Edmonton, Alberta, Canada, and Staff Physician, Department of Family Medicine, Kaye Edmonton Clinic, and he has disclosed receiving research grants from Alberta Innovates (the Alberta Provincial Government) and the Canadian Institutes of Health Research (the Canadian Federal Government).
A version of this article first appeared on Medscape.com.
FROM ESC 2024
Beyond Borders: Tonsillar Squamous Cell Carcinoma with Intriguing Liver Metastasis
Background
Oropharyngeal squamous cell carcinoma (OPSCC) arises in the middle pharynx, including the tonsils, base of the tongue, and surrounding tissues. While OPSCC commonly metastasizes to regional lymph nodes, distant metastases to sites like the liver are rare, occurring in about 1-4% of cases with advanced disease.
Case Presentation
A 66-year-old male presented to the emergency department with recurrent right-sided facial swelling and a two-week history of sore throat. CT imaging revealed a large right tonsillar mass extending to the base of the tongue. Further evaluation with PET scan showed hypermetabolic activity in the right tonsil, multiple hypermetabolic lymph nodes in the right neck (stations 1B, 2, 3, 4, 5), right supraclavicular fossa, and small retropharyngeal nodes. Additionally, PET scan detected a hypermetabolic lesion in the liver and focal activity at T10 suggestive of bone metastasis. Fine needle aspiration (FNA) confirmed squamous cell carcinoma. Biopsy of the liver lesion revealed metastatic squamous cell carcinoma with basaloid differentiation, positive for p40 and p63 stains. Clinical staging was T2b cN2 cM1. The patient’s case was discussed in tumor boards, leading to a treatment plan of palliative radiotherapy with radiosensitizer (weekly carboplatin/paclitaxel) due to recent myocardial infarction, precluding cisplatin or 5FU use. Post-radiotherapy, Pembrolizumab was planned based on 60% PD-L1 expression. The patient opted to forego additional systemic chemotherapy and currently receives Keytruda every three weeks.
Discussion
Liver metastases from head and neck SCC are rare, highlighting the complexity of treatment decisions in such cases. Effective management requires a multidisciplinary approach to optimize therapeutic outcomes while considering patient-specific factors and comorbidities.
Conclusions
This case underscores the challenges and poor prognosis associated with tonsillar SCC with liver metastases. It underscores the need for personalized treatment strategies tailored to the unique characteristics of each patient’s disease.
Background
Oropharyngeal squamous cell carcinoma (OPSCC) arises in the middle pharynx, including the tonsils, base of the tongue, and surrounding tissues. While OPSCC commonly metastasizes to regional lymph nodes, distant metastases to sites like the liver are rare, occurring in about 1-4% of cases with advanced disease.
Case Presentation
A 66-year-old male presented to the emergency department with recurrent right-sided facial swelling and a two-week history of sore throat. CT imaging revealed a large right tonsillar mass extending to the base of the tongue. Further evaluation with PET scan showed hypermetabolic activity in the right tonsil, multiple hypermetabolic lymph nodes in the right neck (stations 1B, 2, 3, 4, 5), right supraclavicular fossa, and small retropharyngeal nodes. Additionally, PET scan detected a hypermetabolic lesion in the liver and focal activity at T10 suggestive of bone metastasis. Fine needle aspiration (FNA) confirmed squamous cell carcinoma. Biopsy of the liver lesion revealed metastatic squamous cell carcinoma with basaloid differentiation, positive for p40 and p63 stains. Clinical staging was T2b cN2 cM1. The patient’s case was discussed in tumor boards, leading to a treatment plan of palliative radiotherapy with radiosensitizer (weekly carboplatin/paclitaxel) due to recent myocardial infarction, precluding cisplatin or 5FU use. Post-radiotherapy, Pembrolizumab was planned based on 60% PD-L1 expression. The patient opted to forego additional systemic chemotherapy and currently receives Keytruda every three weeks.
Discussion
Liver metastases from head and neck SCC are rare, highlighting the complexity of treatment decisions in such cases. Effective management requires a multidisciplinary approach to optimize therapeutic outcomes while considering patient-specific factors and comorbidities.
Conclusions
This case underscores the challenges and poor prognosis associated with tonsillar SCC with liver metastases. It underscores the need for personalized treatment strategies tailored to the unique characteristics of each patient’s disease.
Background
Oropharyngeal squamous cell carcinoma (OPSCC) arises in the middle pharynx, including the tonsils, base of the tongue, and surrounding tissues. While OPSCC commonly metastasizes to regional lymph nodes, distant metastases to sites like the liver are rare, occurring in about 1-4% of cases with advanced disease.
Case Presentation
A 66-year-old male presented to the emergency department with recurrent right-sided facial swelling and a two-week history of sore throat. CT imaging revealed a large right tonsillar mass extending to the base of the tongue. Further evaluation with PET scan showed hypermetabolic activity in the right tonsil, multiple hypermetabolic lymph nodes in the right neck (stations 1B, 2, 3, 4, 5), right supraclavicular fossa, and small retropharyngeal nodes. Additionally, PET scan detected a hypermetabolic lesion in the liver and focal activity at T10 suggestive of bone metastasis. Fine needle aspiration (FNA) confirmed squamous cell carcinoma. Biopsy of the liver lesion revealed metastatic squamous cell carcinoma with basaloid differentiation, positive for p40 and p63 stains. Clinical staging was T2b cN2 cM1. The patient’s case was discussed in tumor boards, leading to a treatment plan of palliative radiotherapy with radiosensitizer (weekly carboplatin/paclitaxel) due to recent myocardial infarction, precluding cisplatin or 5FU use. Post-radiotherapy, Pembrolizumab was planned based on 60% PD-L1 expression. The patient opted to forego additional systemic chemotherapy and currently receives Keytruda every three weeks.
Discussion
Liver metastases from head and neck SCC are rare, highlighting the complexity of treatment decisions in such cases. Effective management requires a multidisciplinary approach to optimize therapeutic outcomes while considering patient-specific factors and comorbidities.
Conclusions
This case underscores the challenges and poor prognosis associated with tonsillar SCC with liver metastases. It underscores the need for personalized treatment strategies tailored to the unique characteristics of each patient’s disease.
ENT Multidisciplinary Workgroup
Background
The care of veterans with head and neck cancers requires a team approach among multiple disciplines throughout the entire trajectory of their cancer treatment course. Veterans with head and neck cancer have complicated treatments including surgery, radiation, chemotherapy and reconstructive surgery which can affect swallow function, speech, taste and physical appearance. Many patients who get treated for head and neck cancer will have lasting side effects of treatment. Veterans with cancer are more likely than the general population to have mental health comorbidities such as anxiety, depression and PTSD. Many head and neck cancer patients have used tobacco and/or alcohol as coping mechanisms for these issues. A new diagnosis of cancer may exacerbate their mental illness. Tobacco cessation may exacerbate anxiety for patients who have used tobacco as a coping mechanism. Ongoing alcohol use can complicate treatment. All of these issues can create delays in care.
Methods
In August 2019, a task force (“the ENT Multidisciplinary Workgroup”) was formed at VA Connecticut Healthcare System (“VACHS”) including representatives from ENT, Speech Pathology, Nutrition, Palliative Care and Oncology with the specific goal of improved coordination of care for head and neck cancer patients. Regular weekly meetings began in September 2019 to identify and track patients and to make referrals for appropriate diagnostic testing, treatment and supportive care.
Discussion
Weekly meeting among the core members of the ENT workgroup led to identification of patient needs earlier in the illness course than was observed prior to this workgroup initiative. Each week several opportunities are identified to improve patient care. This is a dynamic, ongoing process that has improved communication among key members of the interdisciplinary team that cares for these very complex patients and has led to the development of quality improvement initiatives that are reproducible at other VA sites.
Background
The care of veterans with head and neck cancers requires a team approach among multiple disciplines throughout the entire trajectory of their cancer treatment course. Veterans with head and neck cancer have complicated treatments including surgery, radiation, chemotherapy and reconstructive surgery which can affect swallow function, speech, taste and physical appearance. Many patients who get treated for head and neck cancer will have lasting side effects of treatment. Veterans with cancer are more likely than the general population to have mental health comorbidities such as anxiety, depression and PTSD. Many head and neck cancer patients have used tobacco and/or alcohol as coping mechanisms for these issues. A new diagnosis of cancer may exacerbate their mental illness. Tobacco cessation may exacerbate anxiety for patients who have used tobacco as a coping mechanism. Ongoing alcohol use can complicate treatment. All of these issues can create delays in care.
Methods
In August 2019, a task force (“the ENT Multidisciplinary Workgroup”) was formed at VA Connecticut Healthcare System (“VACHS”) including representatives from ENT, Speech Pathology, Nutrition, Palliative Care and Oncology with the specific goal of improved coordination of care for head and neck cancer patients. Regular weekly meetings began in September 2019 to identify and track patients and to make referrals for appropriate diagnostic testing, treatment and supportive care.
Discussion
Weekly meeting among the core members of the ENT workgroup led to identification of patient needs earlier in the illness course than was observed prior to this workgroup initiative. Each week several opportunities are identified to improve patient care. This is a dynamic, ongoing process that has improved communication among key members of the interdisciplinary team that cares for these very complex patients and has led to the development of quality improvement initiatives that are reproducible at other VA sites.
Background
The care of veterans with head and neck cancers requires a team approach among multiple disciplines throughout the entire trajectory of their cancer treatment course. Veterans with head and neck cancer have complicated treatments including surgery, radiation, chemotherapy and reconstructive surgery which can affect swallow function, speech, taste and physical appearance. Many patients who get treated for head and neck cancer will have lasting side effects of treatment. Veterans with cancer are more likely than the general population to have mental health comorbidities such as anxiety, depression and PTSD. Many head and neck cancer patients have used tobacco and/or alcohol as coping mechanisms for these issues. A new diagnosis of cancer may exacerbate their mental illness. Tobacco cessation may exacerbate anxiety for patients who have used tobacco as a coping mechanism. Ongoing alcohol use can complicate treatment. All of these issues can create delays in care.
Methods
In August 2019, a task force (“the ENT Multidisciplinary Workgroup”) was formed at VA Connecticut Healthcare System (“VACHS”) including representatives from ENT, Speech Pathology, Nutrition, Palliative Care and Oncology with the specific goal of improved coordination of care for head and neck cancer patients. Regular weekly meetings began in September 2019 to identify and track patients and to make referrals for appropriate diagnostic testing, treatment and supportive care.
Discussion
Weekly meeting among the core members of the ENT workgroup led to identification of patient needs earlier in the illness course than was observed prior to this workgroup initiative. Each week several opportunities are identified to improve patient care. This is a dynamic, ongoing process that has improved communication among key members of the interdisciplinary team that cares for these very complex patients and has led to the development of quality improvement initiatives that are reproducible at other VA sites.
Multimodal Treatment Approaches for Basaloid Squamous Cell Carcinoma of the Larynx
Background
Basaloid squamous cell carcinoma (BSCC) is an aggressive laryngeal cancer with high recurrence and metastasis rates. Its rarity complicates diagnosis and optimal treatment selection, underscoring the significance of comprehensive data collection through national cancer registries. Historically, surgical intervention has been the primary approach to management.The RTOG 91-11 randomized trial catalyzed a paradigm shift, prioritizing laryngealpreserving treatments. The study provided evidence for radiotherapy in early-stage disease (stages 1-2) and combined chemoradiotherapy in advanced disease (stages 3-4). Consequently, organ preservation protocols gained traction, maintaining laryngeal anatomy while achieving comparable oncologic outcomes to total laryngectomy. This shift emphasizes exploring multimodal, laryngeal-sparing regimens to optimize quality of life without compromising disease control. However, further research utilizing large databases is needed to elucidate survival outcomes associated with these approaches.
Methods
We used the National Cancer Database to identify patients diagnosed with BSCC of the larynx (ICD-O-3 histology code 8083) between 2004-2019 (Nf1487). General patient characteristics were assessed using descriptive statistics. Survival was evaluated using Kaplan-Meier curves and log-rank tests. Significance was set at p< 0.05.
Results
For early-stage patients, the estimated survival was 93.179 months. Surgery demonstrated the most favorable outcome with a median survival of 100.957 months, significantly higher than non-surgical patients (85.895 months, p=0.028). Survival did not differ between patients who received only chemotherapy (p=0.281), radiation (p=0.326), or chemoradiation (p=0.919) and those received other treatment modalities. In late-stage patients, the estimated survival was 61.993 months. Surgery yielded the most favorable outcome with a median survival of 70.484 months, significantly higher than non-surgical patients (54.153 months, p< 0.001). Patients who received only chemotherapy (p< 0.001), radiation (p< 0.001) and chemoradiation (p=0.24) had a worse survival outcome compared to those who received other treatment modalities.
Conclusions
The study results indicate that surgical resection could potentially improve survival outcomes for patients diagnosed with advanced-stage laryngeal BSCC. Conversely, for those with earlystage BSCC, larynx-preserving treatment modalities such as radiation, chemotherapy or concurrent chemoradiation appear to achieve comparable survival rates to primary surgical management. These results highlight the importance of careful consideration of treatment modalities based on disease staging at initial presentation.
Background
Basaloid squamous cell carcinoma (BSCC) is an aggressive laryngeal cancer with high recurrence and metastasis rates. Its rarity complicates diagnosis and optimal treatment selection, underscoring the significance of comprehensive data collection through national cancer registries. Historically, surgical intervention has been the primary approach to management.The RTOG 91-11 randomized trial catalyzed a paradigm shift, prioritizing laryngealpreserving treatments. The study provided evidence for radiotherapy in early-stage disease (stages 1-2) and combined chemoradiotherapy in advanced disease (stages 3-4). Consequently, organ preservation protocols gained traction, maintaining laryngeal anatomy while achieving comparable oncologic outcomes to total laryngectomy. This shift emphasizes exploring multimodal, laryngeal-sparing regimens to optimize quality of life without compromising disease control. However, further research utilizing large databases is needed to elucidate survival outcomes associated with these approaches.
Methods
We used the National Cancer Database to identify patients diagnosed with BSCC of the larynx (ICD-O-3 histology code 8083) between 2004-2019 (Nf1487). General patient characteristics were assessed using descriptive statistics. Survival was evaluated using Kaplan-Meier curves and log-rank tests. Significance was set at p< 0.05.
Results
For early-stage patients, the estimated survival was 93.179 months. Surgery demonstrated the most favorable outcome with a median survival of 100.957 months, significantly higher than non-surgical patients (85.895 months, p=0.028). Survival did not differ between patients who received only chemotherapy (p=0.281), radiation (p=0.326), or chemoradiation (p=0.919) and those received other treatment modalities. In late-stage patients, the estimated survival was 61.993 months. Surgery yielded the most favorable outcome with a median survival of 70.484 months, significantly higher than non-surgical patients (54.153 months, p< 0.001). Patients who received only chemotherapy (p< 0.001), radiation (p< 0.001) and chemoradiation (p=0.24) had a worse survival outcome compared to those who received other treatment modalities.
Conclusions
The study results indicate that surgical resection could potentially improve survival outcomes for patients diagnosed with advanced-stage laryngeal BSCC. Conversely, for those with earlystage BSCC, larynx-preserving treatment modalities such as radiation, chemotherapy or concurrent chemoradiation appear to achieve comparable survival rates to primary surgical management. These results highlight the importance of careful consideration of treatment modalities based on disease staging at initial presentation.
Background
Basaloid squamous cell carcinoma (BSCC) is an aggressive laryngeal cancer with high recurrence and metastasis rates. Its rarity complicates diagnosis and optimal treatment selection, underscoring the significance of comprehensive data collection through national cancer registries. Historically, surgical intervention has been the primary approach to management.The RTOG 91-11 randomized trial catalyzed a paradigm shift, prioritizing laryngealpreserving treatments. The study provided evidence for radiotherapy in early-stage disease (stages 1-2) and combined chemoradiotherapy in advanced disease (stages 3-4). Consequently, organ preservation protocols gained traction, maintaining laryngeal anatomy while achieving comparable oncologic outcomes to total laryngectomy. This shift emphasizes exploring multimodal, laryngeal-sparing regimens to optimize quality of life without compromising disease control. However, further research utilizing large databases is needed to elucidate survival outcomes associated with these approaches.
Methods
We used the National Cancer Database to identify patients diagnosed with BSCC of the larynx (ICD-O-3 histology code 8083) between 2004-2019 (Nf1487). General patient characteristics were assessed using descriptive statistics. Survival was evaluated using Kaplan-Meier curves and log-rank tests. Significance was set at p< 0.05.
Results
For early-stage patients, the estimated survival was 93.179 months. Surgery demonstrated the most favorable outcome with a median survival of 100.957 months, significantly higher than non-surgical patients (85.895 months, p=0.028). Survival did not differ between patients who received only chemotherapy (p=0.281), radiation (p=0.326), or chemoradiation (p=0.919) and those received other treatment modalities. In late-stage patients, the estimated survival was 61.993 months. Surgery yielded the most favorable outcome with a median survival of 70.484 months, significantly higher than non-surgical patients (54.153 months, p< 0.001). Patients who received only chemotherapy (p< 0.001), radiation (p< 0.001) and chemoradiation (p=0.24) had a worse survival outcome compared to those who received other treatment modalities.
Conclusions
The study results indicate that surgical resection could potentially improve survival outcomes for patients diagnosed with advanced-stage laryngeal BSCC. Conversely, for those with earlystage BSCC, larynx-preserving treatment modalities such as radiation, chemotherapy or concurrent chemoradiation appear to achieve comparable survival rates to primary surgical management. These results highlight the importance of careful consideration of treatment modalities based on disease staging at initial presentation.