AVAHO

Objectives

The VA Oncology Clinical Pathway for Prostate Cancer is the first to include both tumor and germline testing to inform treatment and clinical trial eligibility for advanced disease. Anticipating increased germline testing demand, new germline testing delivery models were created to augment the existing traditional model of referring patients to genetics providers (VA or non-VA) for germline testing. The new models include: a non-traditional model where oncology clinicians perform all pre- and post-test activities and consult genetics when needed, and a hybrid model where oncology clinicians obtain informed consent and place e-consults for germline test ordering, results disclosure, and genetics follow-up, as needed. We sought to assess germline testing by delivery model.

Methods

Data sources included the National Precision Oncology Program (NPOP) dashboard and NPOP-contracted germline testing laboratories. Patient inclusion criteria: living as of 5/2/2021 with VA oncology or urology visits after 5/2/2021. We used multivariate regression to assess associations between patient characteristics and germline testing between 5/3/2021 (pathway launch) and 5/2/2022, accounting for clustering of patients within ordering clinicians.

Results

We identified 16,041 patients from 129 VA facilities with average age 75 years (SD, 8.2; range, 36- 102), 28.7% Black and 60.0% White. Only 5.6% had germline testing ordered by 60 clinicians at 67 facilities with 52.2% of orders by the hybrid model, 32.1% the non-traditional model, and 15.4% the traditional model. Patient characteristics positively associated with germline testing included care at hybrid model (OR, 6.03; 95% CI, 4.62-7.88) or non-traditional model facilities (OR, 5.66; 95% CI, 4.24-7.56) compared to the traditional model, completing tumor molecular testing (OR, 5.80; 95%CI, 4.98-6.75), and Black compared with White race (OR, 1.24; 95%CI, 1.06-1.45). Compared to patients aged < 66 years, patients aged 66-75 years and 76-85 years were less likely to have germline testing (OR, 0.74; 95%CI, 0.60-0.90; and OR, 0.67; 95%CI, 0.53-0.84, respectively).

Conclusions/Implications

Though only a small percentage of patients with advanced prostate cancer had NPOP-supported germline testing since the pathway launch, the new delivery models were instrumental to improving access to germline testing. Ongoing evaluation will help to understand observed demographic differences in germline testing. Implementation and evaluation of strategies that promote adoption of the new germline testing delivery models is needed. 0922FED AVAHO_Abstracts.indd 15 8

Objectives

The VA Oncology Clinical Pathway for Prostate Cancer is the first to include both tumor and germline testing to inform treatment and clinical trial eligibility for advanced disease. Anticipating increased germline testing demand, new germline testing delivery models were created to augment the existing traditional model of referring patients to genetics providers (VA or non-VA) for germline testing. The new models include: a non-traditional model where oncology clinicians perform all pre- and post-test activities and consult genetics when needed, and a hybrid model where oncology clinicians obtain informed consent and place e-consults for germline test ordering, results disclosure, and genetics follow-up, as needed. We sought to assess germline testing by delivery model.

Methods

Data sources included the National Precision Oncology Program (NPOP) dashboard and NPOP-contracted germline testing laboratories. Patient inclusion criteria: living as of 5/2/2021 with VA oncology or urology visits after 5/2/2021. We used multivariate regression to assess associations between patient characteristics and germline testing between 5/3/2021 (pathway launch) and 5/2/2022, accounting for clustering of patients within ordering clinicians.

Results

We identified 16,041 patients from 129 VA facilities with average age 75 years (SD, 8.2; range, 36- 102), 28.7% Black and 60.0% White. Only 5.6% had germline testing ordered by 60 clinicians at 67 facilities with 52.2% of orders by the hybrid model, 32.1% the non-traditional model, and 15.4% the traditional model. Patient characteristics positively associated with germline testing included care at hybrid model (OR, 6.03; 95% CI, 4.62-7.88) or non-traditional model facilities (OR, 5.66; 95% CI, 4.24-7.56) compared to the traditional model, completing tumor molecular testing (OR, 5.80; 95%CI, 4.98-6.75), and Black compared with White race (OR, 1.24; 95%CI, 1.06-1.45). Compared to patients aged < 66 years, patients aged 66-75 years and 76-85 years were less likely to have germline testing (OR, 0.74; 95%CI, 0.60-0.90; and OR, 0.67; 95%CI, 0.53-0.84, respectively).

Conclusions/Implications

Though only a small percentage of patients with advanced prostate cancer had NPOP-supported germline testing since the pathway launch, the new delivery models were instrumental to improving access to germline testing. Ongoing evaluation will help to understand observed demographic differences in germline testing. Implementation and evaluation of strategies that promote adoption of the new germline testing delivery models is needed. 0922FED AVAHO_Abstracts.indd 15 8

Objectives

The VA Oncology Clinical Pathway for Prostate Cancer is the first to include both tumor and germline testing to inform treatment and clinical trial eligibility for advanced disease. Anticipating increased germline testing demand, new germline testing delivery models were created to augment the existing traditional model of referring patients to genetics providers (VA or non-VA) for germline testing. The new models include: a non-traditional model where oncology clinicians perform all pre- and post-test activities and consult genetics when needed, and a hybrid model where oncology clinicians obtain informed consent and place e-consults for germline test ordering, results disclosure, and genetics follow-up, as needed. We sought to assess germline testing by delivery model.

Methods

Data sources included the National Precision Oncology Program (NPOP) dashboard and NPOP-contracted germline testing laboratories. Patient inclusion criteria: living as of 5/2/2021 with VA oncology or urology visits after 5/2/2021. We used multivariate regression to assess associations between patient characteristics and germline testing between 5/3/2021 (pathway launch) and 5/2/2022, accounting for clustering of patients within ordering clinicians.

Results

We identified 16,041 patients from 129 VA facilities with average age 75 years (SD, 8.2; range, 36- 102), 28.7% Black and 60.0% White. Only 5.6% had germline testing ordered by 60 clinicians at 67 facilities with 52.2% of orders by the hybrid model, 32.1% the non-traditional model, and 15.4% the traditional model. Patient characteristics positively associated with germline testing included care at hybrid model (OR, 6.03; 95% CI, 4.62-7.88) or non-traditional model facilities (OR, 5.66; 95% CI, 4.24-7.56) compared to the traditional model, completing tumor molecular testing (OR, 5.80; 95%CI, 4.98-6.75), and Black compared with White race (OR, 1.24; 95%CI, 1.06-1.45). Compared to patients aged < 66 years, patients aged 66-75 years and 76-85 years were less likely to have germline testing (OR, 0.74; 95%CI, 0.60-0.90; and OR, 0.67; 95%CI, 0.53-0.84, respectively).

Conclusions/Implications

Though only a small percentage of patients with advanced prostate cancer had NPOP-supported germline testing since the pathway launch, the new delivery models were instrumental to improving access to germline testing. Ongoing evaluation will help to understand observed demographic differences in germline testing. Implementation and evaluation of strategies that promote adoption of the new germline testing delivery models is needed. 0922FED AVAHO_Abstracts.indd 15 8

Background

There are no studies in oncologic literature that report biomarker alterations in Vietnam War veterans with lung cancers. Our study elucidates genetic mutations in veterans with lung cancer exposed to Agent Orange (AO) and compares them to non-Agent Orange exposed (NAO) veterans.

Methods

We collected data of veterans with lung cancers from VA Central California Health Care System who had NGS testing via Foundation One CDx from January 2007 to January 2022. We collected data of AO versus NAO veterans including age, race, gender, smoking and exposure history, histologic subtypes, treatment modalities, PDL-1, and molecular mutations. Median PFS and OS were calculated between AO and NAO in all veterans and adenocarcinoma group after first-line therapy in months by Kaplan-Meier R log-rank test.

Results

There were total of 58 lung cancer veterans, 27 AO and 31 NAO. 33 (56.9%) veterans had adenocarcinoma (20 AO vs 13 NAO). Veterans were White (81%), male (93%) and all had tobacco exposure. The median age at diagnosis was 72 years in both groups. 65.5% had stage III-IV disease. Veterans with AO adenocarcinoma had more early stage I-II disease (50%) as compared to NAO (16%). The AO group had more PDL1 expression (TPS > 1%). 15/31 (48.4%) NAO received immunotherapy vs 7/27 (25.9%) AO. 104 molecular mutations were identified. Veterans with AO had more ROS1, MET, and NRAS while NAO had more EGFR, KRAS, and NF1 mutations. In adenocarcinoma group, AO had more MET and less KRAS while NAO has more KRAS, TP53, and EGFR. The median PFS and OS for all veterans with AO vs NAO were 8 mo vs 6 mo and 12 mo vs 10 mo, respectively (non-significant [NS]). In adenocarcinoma group the median PFS and OS for AO vs NAO veterans were 8 mo vs 4 mo and 11.75 mo vs 6 mo, respectively (NS).

Conclusions

Our study is the first to report molecular biomarkers in AO and NAO veterans with lung cancers. We found different markers between the groups. The median PFS and OS of AO and adenocarcinoma AO veterans were longer due to early stage diagnoses while NAO vetera

Background

There are no studies in oncologic literature that report biomarker alterations in Vietnam War veterans with lung cancers. Our study elucidates genetic mutations in veterans with lung cancer exposed to Agent Orange (AO) and compares them to non-Agent Orange exposed (NAO) veterans.

Methods

We collected data of veterans with lung cancers from VA Central California Health Care System who had NGS testing via Foundation One CDx from January 2007 to January 2022. We collected data of AO versus NAO veterans including age, race, gender, smoking and exposure history, histologic subtypes, treatment modalities, PDL-1, and molecular mutations. Median PFS and OS were calculated between AO and NAO in all veterans and adenocarcinoma group after first-line therapy in months by Kaplan-Meier R log-rank test.

Results

There were total of 58 lung cancer veterans, 27 AO and 31 NAO. 33 (56.9%) veterans had adenocarcinoma (20 AO vs 13 NAO). Veterans were White (81%), male (93%) and all had tobacco exposure. The median age at diagnosis was 72 years in both groups. 65.5% had stage III-IV disease. Veterans with AO adenocarcinoma had more early stage I-II disease (50%) as compared to NAO (16%). The AO group had more PDL1 expression (TPS > 1%). 15/31 (48.4%) NAO received immunotherapy vs 7/27 (25.9%) AO. 104 molecular mutations were identified. Veterans with AO had more ROS1, MET, and NRAS while NAO had more EGFR, KRAS, and NF1 mutations. In adenocarcinoma group, AO had more MET and less KRAS while NAO has more KRAS, TP53, and EGFR. The median PFS and OS for all veterans with AO vs NAO were 8 mo vs 6 mo and 12 mo vs 10 mo, respectively (non-significant [NS]). In adenocarcinoma group the median PFS and OS for AO vs NAO veterans were 8 mo vs 4 mo and 11.75 mo vs 6 mo, respectively (NS).

Conclusions

Our study is the first to report molecular biomarkers in AO and NAO veterans with lung cancers. We found different markers between the groups. The median PFS and OS of AO and adenocarcinoma AO veterans were longer due to early stage diagnoses while NAO vetera

Background

There are no studies in oncologic literature that report biomarker alterations in Vietnam War veterans with lung cancers. Our study elucidates genetic mutations in veterans with lung cancer exposed to Agent Orange (AO) and compares them to non-Agent Orange exposed (NAO) veterans.

Methods

We collected data of veterans with lung cancers from VA Central California Health Care System who had NGS testing via Foundation One CDx from January 2007 to January 2022. We collected data of AO versus NAO veterans including age, race, gender, smoking and exposure history, histologic subtypes, treatment modalities, PDL-1, and molecular mutations. Median PFS and OS were calculated between AO and NAO in all veterans and adenocarcinoma group after first-line therapy in months by Kaplan-Meier R log-rank test.

Results

There were total of 58 lung cancer veterans, 27 AO and 31 NAO. 33 (56.9%) veterans had adenocarcinoma (20 AO vs 13 NAO). Veterans were White (81%), male (93%) and all had tobacco exposure. The median age at diagnosis was 72 years in both groups. 65.5% had stage III-IV disease. Veterans with AO adenocarcinoma had more early stage I-II disease (50%) as compared to NAO (16%). The AO group had more PDL1 expression (TPS > 1%). 15/31 (48.4%) NAO received immunotherapy vs 7/27 (25.9%) AO. 104 molecular mutations were identified. Veterans with AO had more ROS1, MET, and NRAS while NAO had more EGFR, KRAS, and NF1 mutations. In adenocarcinoma group, AO had more MET and less KRAS while NAO has more KRAS, TP53, and EGFR. The median PFS and OS for all veterans with AO vs NAO were 8 mo vs 6 mo and 12 mo vs 10 mo, respectively (non-significant [NS]). In adenocarcinoma group the median PFS and OS for AO vs NAO veterans were 8 mo vs 4 mo and 11.75 mo vs 6 mo, respectively (NS).

Conclusions

Our study is the first to report molecular biomarkers in AO and NAO veterans with lung cancers. We found different markers between the groups. The median PFS and OS of AO and adenocarcinoma AO veterans were longer due to early stage diagnoses while NAO vetera

Introduction

Metastatic colorectal cancer (mCRC) is one of the most common and lethal cancers. Nextgeneration sequencing (NGS) has been recommended as a tool to help guide treatment by identifying actionable genetic mutations. However, data regarding realworld usage of NGS in a Veterans Affairs (VA) health care system is lacking. We conducted a retrospective observational study of the patterns of NGS usage in patients with mCRC at the South Texas Veterans Affairs Healthcare System (STVAHCS).

Methods

We identified patients with a diagnosis of mCRC evaluated and treated at STVAHCS between January 1, 2018 and June 1, 2022. We assessed the prevalence of utilizing NGS on solid tumor samples performed by Foundation One and identified the presence of different molecular aberrations detected by NGS.

Results

65 patients were identified. Median age was 68 years. 63 (96.9%) were males and 2 (3.1%) were females. 29 (44.6%) were Hispanic, 25 (38.5%) were White, 10 (15.4%) were African American and 1 (1.5%) was Pacific Islander. NGS was performed in 34 (52.3%) patients. The most common reasons for not performing NGS were unknown/not documented (54.8%), early mortality (29%), lack of adequate tissue (12.9%) and patient refusal of treatment (3.2%). The most common molecular aberrations identified in patients who had NGS were TP53 (73.5%), APC (64.7%), KRAS (47.1%), ATM (20.6%), SMAD4 (14.7%) and BRAF (14.7%). All patients who had NGS were found to have at least one identifiable mutation.

Conclusions

 Approximately 50% of patients with mCRC did not have NGS performed on their tissue sample. This rate is similar to other real-world studies in non-VA settings. Documented reasons for lack of NGS testing included inadequate tissue and early patient mortality. Other potential reasons could be lack of efficient VA clinical testing protocols, use of simple molecular testing rather than comprehensive NGS testing and limited knowledge of availability of NGS among providers. Measures that can be taken to increase utilization of NGS include incorporating NGS testing early in the disease course, incorporating testing into VA clinical pathways, improving physician education, increasing the size of solid tissue samples and ordering liquid biopsies where solid tissue is deficient.

Introduction

Metastatic colorectal cancer (mCRC) is one of the most common and lethal cancers. Nextgeneration sequencing (NGS) has been recommended as a tool to help guide treatment by identifying actionable genetic mutations. However, data regarding realworld usage of NGS in a Veterans Affairs (VA) health care system is lacking. We conducted a retrospective observational study of the patterns of NGS usage in patients with mCRC at the South Texas Veterans Affairs Healthcare System (STVAHCS).

Methods

We identified patients with a diagnosis of mCRC evaluated and treated at STVAHCS between January 1, 2018 and June 1, 2022. We assessed the prevalence of utilizing NGS on solid tumor samples performed by Foundation One and identified the presence of different molecular aberrations detected by NGS.

Results

65 patients were identified. Median age was 68 years. 63 (96.9%) were males and 2 (3.1%) were females. 29 (44.6%) were Hispanic, 25 (38.5%) were White, 10 (15.4%) were African American and 1 (1.5%) was Pacific Islander. NGS was performed in 34 (52.3%) patients. The most common reasons for not performing NGS were unknown/not documented (54.8%), early mortality (29%), lack of adequate tissue (12.9%) and patient refusal of treatment (3.2%). The most common molecular aberrations identified in patients who had NGS were TP53 (73.5%), APC (64.7%), KRAS (47.1%), ATM (20.6%), SMAD4 (14.7%) and BRAF (14.7%). All patients who had NGS were found to have at least one identifiable mutation.

Conclusions

 Approximately 50% of patients with mCRC did not have NGS performed on their tissue sample. This rate is similar to other real-world studies in non-VA settings. Documented reasons for lack of NGS testing included inadequate tissue and early patient mortality. Other potential reasons could be lack of efficient VA clinical testing protocols, use of simple molecular testing rather than comprehensive NGS testing and limited knowledge of availability of NGS among providers. Measures that can be taken to increase utilization of NGS include incorporating NGS testing early in the disease course, incorporating testing into VA clinical pathways, improving physician education, increasing the size of solid tissue samples and ordering liquid biopsies where solid tissue is deficient.

Introduction

Metastatic colorectal cancer (mCRC) is one of the most common and lethal cancers. Nextgeneration sequencing (NGS) has been recommended as a tool to help guide treatment by identifying actionable genetic mutations. However, data regarding realworld usage of NGS in a Veterans Affairs (VA) health care system is lacking. We conducted a retrospective observational study of the patterns of NGS usage in patients with mCRC at the South Texas Veterans Affairs Healthcare System (STVAHCS).

Methods

We identified patients with a diagnosis of mCRC evaluated and treated at STVAHCS between January 1, 2018 and June 1, 2022. We assessed the prevalence of utilizing NGS on solid tumor samples performed by Foundation One and identified the presence of different molecular aberrations detected by NGS.

Results

65 patients were identified. Median age was 68 years. 63 (96.9%) were males and 2 (3.1%) were females. 29 (44.6%) were Hispanic, 25 (38.5%) were White, 10 (15.4%) were African American and 1 (1.5%) was Pacific Islander. NGS was performed in 34 (52.3%) patients. The most common reasons for not performing NGS were unknown/not documented (54.8%), early mortality (29%), lack of adequate tissue (12.9%) and patient refusal of treatment (3.2%). The most common molecular aberrations identified in patients who had NGS were TP53 (73.5%), APC (64.7%), KRAS (47.1%), ATM (20.6%), SMAD4 (14.7%) and BRAF (14.7%). All patients who had NGS were found to have at least one identifiable mutation.

Conclusions

 Approximately 50% of patients with mCRC did not have NGS performed on their tissue sample. This rate is similar to other real-world studies in non-VA settings. Documented reasons for lack of NGS testing included inadequate tissue and early patient mortality. Other potential reasons could be lack of efficient VA clinical testing protocols, use of simple molecular testing rather than comprehensive NGS testing and limited knowledge of availability of NGS among providers. Measures that can be taken to increase utilization of NGS include incorporating NGS testing early in the disease course, incorporating testing into VA clinical pathways, improving physician education, increasing the size of solid tissue samples and ordering liquid biopsies where solid tissue is deficient.

Nearly 123,000 cancer deaths – or almost 30% of all cancer deaths – in the United States in 2019 were linked to cigarette smoking, a new analysis suggests.

That corresponds to more than 2 million person-years of lost life and nearly $21 billion in annual lost earnings.

“During the past few decades, smoking has substantially declined in the U.S., followed by great declines in mortality from lung cancer and some other smoking-related cancers,” said lead author Farhad Islami, MD, senior scientific director of cancer disparity research at the American Cancer Society.

AtnoYdur/Thinkstock

Despite this “remarkable progress, our results indicate that smoking is still associated with about 30% of all cancer deaths and substantial lost earnings in the U.S., and that more work should be done to further reduce smoking in the country,” he said.

The study was published online in the International Journal of Cancer.

Dr. Islami and colleagues had found that lost earnings from cancer deaths in 2015 came to nearly $95 billion. Other research showed that a substantial portion of lost earnings from cancer deaths could be traced to cigarette smoking, but estimates were more than a decade old.

To provide more recent estimates and help guide tobacco control policies, Dr. Islami and colleagues estimated person-years of life lost (PYLL) and lost earnings from cigarette smoking-related cancer deaths in 2019.

Of the 418,563 cancer deaths in adults ages 25-79 years, an estimated 122,951 could be linked to cigarette smoking. That corresponds to 29.4% of all cancer deaths and roughly 2.2 million PYLL. Translated to lost earnings, the authors estimated $20.9 billion total, with average lost earnings of $170,000 per cancer death linked to smoking.

By cancer type, lung cancer accounted for about 62%, or $12.9 billion, of the total lost earnings linked to smoking, followed by esophageal cancer (7%, or $1.5 billion), colorectal cancer (6%, or $1.2 billion), and liver cancer (5%, or $1.1 billion).

Smoking-related death rates were highest in the 13 “tobacco nation” states with weaker tobacco control policies and a higher rate of cigarette smoking. These states are Alabama, Arkansas, Indiana, Kentucky, Louisiana, Michigan, Mississippi, Missouri, Ohio, Oklahoma, South Carolina, Tennessee, and West Virginia.

The lost earnings rate in all 13 tobacco nation states combined was about 44% higher, compared with other states and the District of Columbia combined, and the annual PYLL rate was 47% higher in tobacco nation states.

The researchers estimated that if PYLL and lost earnings rates in all states matched those in Utah, which has the lowest rates, more than half of the total PYLL and lost earnings nationally would have been avoided. In other words, that would mean 1.27 million PYLL and $10.5 billion saved in 2019.

Ending the ‘scourge of tobacco’

To kick the smoking habit, health providers should “screen patients for tobacco use, document tobacco use status, advise people who smoke to quit, and assist in attempts to quit,” Dr. Islami said.

Getting more people to screen for lung cancer in the United States is also important, given that only 6.6% of eligible people in 2019 received screening.

In a statement, Lisa Lacasse, president of the American Cancer Society Cancer Action Network, said this report “further demonstrates just how critical reducing tobacco use is to ending suffering and death from cancer.”

To end the “scourge of tobacco,” local, state, and federal lawmakers need to pass proven tobacco control policies, she said.

These include regular and significant tobacco tax increases, thorough statewide smoke-free laws, and enough funding for state programs to prevent and stop smoking. It also means ensuring all Medicaid enrollees have access to all services that can help smokers quit as well as access to all FDA-approved medications that help users stop smoking.

“We have the tools to get this done, we just need lawmakers to act,” Ms. Lacasse said.

A version of this article first appeared on WebMD.com.

Nearly 123,000 cancer deaths – or almost 30% of all cancer deaths – in the United States in 2019 were linked to cigarette smoking, a new analysis suggests.

That corresponds to more than 2 million person-years of lost life and nearly $21 billion in annual lost earnings.

“During the past few decades, smoking has substantially declined in the U.S., followed by great declines in mortality from lung cancer and some other smoking-related cancers,” said lead author Farhad Islami, MD, senior scientific director of cancer disparity research at the American Cancer Society.

AtnoYdur/Thinkstock

Despite this “remarkable progress, our results indicate that smoking is still associated with about 30% of all cancer deaths and substantial lost earnings in the U.S., and that more work should be done to further reduce smoking in the country,” he said.

The study was published online in the International Journal of Cancer.

Dr. Islami and colleagues had found that lost earnings from cancer deaths in 2015 came to nearly $95 billion. Other research showed that a substantial portion of lost earnings from cancer deaths could be traced to cigarette smoking, but estimates were more than a decade old.

To provide more recent estimates and help guide tobacco control policies, Dr. Islami and colleagues estimated person-years of life lost (PYLL) and lost earnings from cigarette smoking-related cancer deaths in 2019.

Of the 418,563 cancer deaths in adults ages 25-79 years, an estimated 122,951 could be linked to cigarette smoking. That corresponds to 29.4% of all cancer deaths and roughly 2.2 million PYLL. Translated to lost earnings, the authors estimated $20.9 billion total, with average lost earnings of $170,000 per cancer death linked to smoking.

By cancer type, lung cancer accounted for about 62%, or $12.9 billion, of the total lost earnings linked to smoking, followed by esophageal cancer (7%, or $1.5 billion), colorectal cancer (6%, or $1.2 billion), and liver cancer (5%, or $1.1 billion).

Smoking-related death rates were highest in the 13 “tobacco nation” states with weaker tobacco control policies and a higher rate of cigarette smoking. These states are Alabama, Arkansas, Indiana, Kentucky, Louisiana, Michigan, Mississippi, Missouri, Ohio, Oklahoma, South Carolina, Tennessee, and West Virginia.

The lost earnings rate in all 13 tobacco nation states combined was about 44% higher, compared with other states and the District of Columbia combined, and the annual PYLL rate was 47% higher in tobacco nation states.

The researchers estimated that if PYLL and lost earnings rates in all states matched those in Utah, which has the lowest rates, more than half of the total PYLL and lost earnings nationally would have been avoided. In other words, that would mean 1.27 million PYLL and $10.5 billion saved in 2019.

Ending the ‘scourge of tobacco’

To kick the smoking habit, health providers should “screen patients for tobacco use, document tobacco use status, advise people who smoke to quit, and assist in attempts to quit,” Dr. Islami said.

Getting more people to screen for lung cancer in the United States is also important, given that only 6.6% of eligible people in 2019 received screening.

In a statement, Lisa Lacasse, president of the American Cancer Society Cancer Action Network, said this report “further demonstrates just how critical reducing tobacco use is to ending suffering and death from cancer.”

To end the “scourge of tobacco,” local, state, and federal lawmakers need to pass proven tobacco control policies, she said.

These include regular and significant tobacco tax increases, thorough statewide smoke-free laws, and enough funding for state programs to prevent and stop smoking. It also means ensuring all Medicaid enrollees have access to all services that can help smokers quit as well as access to all FDA-approved medications that help users stop smoking.

“We have the tools to get this done, we just need lawmakers to act,” Ms. Lacasse said.

A version of this article first appeared on WebMD.com.

Nearly 123,000 cancer deaths – or almost 30% of all cancer deaths – in the United States in 2019 were linked to cigarette smoking, a new analysis suggests.

That corresponds to more than 2 million person-years of lost life and nearly $21 billion in annual lost earnings.

“During the past few decades, smoking has substantially declined in the U.S., followed by great declines in mortality from lung cancer and some other smoking-related cancers,” said lead author Farhad Islami, MD, senior scientific director of cancer disparity research at the American Cancer Society.

AtnoYdur/Thinkstock

Despite this “remarkable progress, our results indicate that smoking is still associated with about 30% of all cancer deaths and substantial lost earnings in the U.S., and that more work should be done to further reduce smoking in the country,” he said.

The study was published online in the International Journal of Cancer.

Dr. Islami and colleagues had found that lost earnings from cancer deaths in 2015 came to nearly $95 billion. Other research showed that a substantial portion of lost earnings from cancer deaths could be traced to cigarette smoking, but estimates were more than a decade old.

To provide more recent estimates and help guide tobacco control policies, Dr. Islami and colleagues estimated person-years of life lost (PYLL) and lost earnings from cigarette smoking-related cancer deaths in 2019.

Of the 418,563 cancer deaths in adults ages 25-79 years, an estimated 122,951 could be linked to cigarette smoking. That corresponds to 29.4% of all cancer deaths and roughly 2.2 million PYLL. Translated to lost earnings, the authors estimated $20.9 billion total, with average lost earnings of $170,000 per cancer death linked to smoking.

By cancer type, lung cancer accounted for about 62%, or $12.9 billion, of the total lost earnings linked to smoking, followed by esophageal cancer (7%, or $1.5 billion), colorectal cancer (6%, or $1.2 billion), and liver cancer (5%, or $1.1 billion).

Smoking-related death rates were highest in the 13 “tobacco nation” states with weaker tobacco control policies and a higher rate of cigarette smoking. These states are Alabama, Arkansas, Indiana, Kentucky, Louisiana, Michigan, Mississippi, Missouri, Ohio, Oklahoma, South Carolina, Tennessee, and West Virginia.

The lost earnings rate in all 13 tobacco nation states combined was about 44% higher, compared with other states and the District of Columbia combined, and the annual PYLL rate was 47% higher in tobacco nation states.

The researchers estimated that if PYLL and lost earnings rates in all states matched those in Utah, which has the lowest rates, more than half of the total PYLL and lost earnings nationally would have been avoided. In other words, that would mean 1.27 million PYLL and $10.5 billion saved in 2019.

Ending the ‘scourge of tobacco’

To kick the smoking habit, health providers should “screen patients for tobacco use, document tobacco use status, advise people who smoke to quit, and assist in attempts to quit,” Dr. Islami said.

Getting more people to screen for lung cancer in the United States is also important, given that only 6.6% of eligible people in 2019 received screening.

In a statement, Lisa Lacasse, president of the American Cancer Society Cancer Action Network, said this report “further demonstrates just how critical reducing tobacco use is to ending suffering and death from cancer.”

To end the “scourge of tobacco,” local, state, and federal lawmakers need to pass proven tobacco control policies, she said.

These include regular and significant tobacco tax increases, thorough statewide smoke-free laws, and enough funding for state programs to prevent and stop smoking. It also means ensuring all Medicaid enrollees have access to all services that can help smokers quit as well as access to all FDA-approved medications that help users stop smoking.

“We have the tools to get this done, we just need lawmakers to act,” Ms. Lacasse said.

A version of this article first appeared on WebMD.com.

Recently, a home test for oral and throat cancer was launched in the United States, and it is being marketed directly to the general public, aimed at former or current tobacco users and anyone 50 years or older.

Individuals can order the test – CancerDetect Test for Oral & Throat Cancer – directly from its maker, Viome Life Sciences, for $399.

It is not covered by medical insurance, and is not approved by the Food and Drug Administration. The test is being marketed under the agency’s “laboratory developed test” rubric.

People who qualify and buy the test are mailed a saliva collection tube, which they fill and mail back. The company then analyzes the RNA for changes in human cells and the oropharyngeal microbiome that are associated with cancer. During a 15-minute telemedicine conference – included in the $399 cost – those who test positive are told to follow up with a secondary care center for a definitive diagnosis.

For people who test positive but have no visible lesion to biopsy, doctors will likely opt for surveillance, computer scientist Guruduth Banavar, PhD, Viome’s chief technology officer, told this news organization.

Dr. Banavar said people have been buying the test every day since it was launched in early August, but he declined to give specific sales figures.

CancerDetect’s tagline is “test at home for peace of mind.” The test “brings unprecedented accuracy to early cancer detection and prevention,” the company said in a press release announcing the launch.

The test showed an overall specificity of 94% and sensitivity of 84.2%-90% for cancer in Viome’s  latest study, which is posted on medRxiv.org as a preprint. Banavar said it has been submitted to a top-tier medical journal.

Viome plans to market CancerDetect “in every possible way” to consumers, including social media, Dr. Banavar said. CancerDetect is not sold on Amazon at the moment, but the company sells another at-home test for gut microbiome plus cellular health on the website. 

As for outreach to the medical community, “we will start doing that with dentists first” and then eventually oncologists and other doctors, but “our primary target is to get out to the consumers themselves,” Dr. Banavar said.

Viome’s main goal is to help consumers be proactive regarding their health, he said.
 

An expert opinion

The marketing push means that sooner or later, oncologists will likely have to deal with a patient who tests positive on CancerDetect, so this news organization turned to numerous experts for their thoughts. None had heard about the test, but one responded with comments.

“I am happy to see industry working on strategies for the early detection of oral and throat cancers,” and CancerDetect has “potential,” said surgical oncologist Saral Mehra, MD, MBA, chief of head and neck surgery at Yale University, New Haven, Conn.

However, after reviewing the study posted on medRxiv, Dr. Mehra advised caution. He said he was concerned about false negative results leading to missed cancers and false positives leading to unnecessary anxiety and testing.

According to the medRxiv preprint, the test was developed and validated using saliva samples from 1,175 people 50 years or older as well as adults with a history of tobacco use. 

In the 230-sample validation cohort, CancerDetect correctly classified 18 out of 20 people with oral squamous cell carcinoma (OSCC) and 64/76 with oropharyngeal squamous cell carcinoma (OPSCC), yielding sensitivities of 90% and 84.2%, respectively. 

The test also correctly identified 126/134 people as cancer free, for a specificity of 94%.

Results were similar between early and late-stage disease, but mixed in subgroups. Among people younger than age 50, for instance, 4/4 (100%) with OSCC and 2/3 (66.7%) with OPSCC were correctly classified as positive. Among older people, 15/17 (88.2%) with OSCC and 62/73 (84.9%) with OPSCC were correctly classified

Commenting on the results, Dr. Mehra noted that “the power of the study, especially for subgroup analysis, was low,” and investigators “used both advanced-stage and early-stage cancer patients in the model, while the target population for this test is early stage. 

“The research needs to be tightened significantly on specific target populations, the models adjusted to really limit false negatives, and a plan [put in place] to act upon positive results,” he said.

Also, the ability of CancerDetect to pick up premalignant lesions – “the greatest value in a screening test” – is not clear, he added.

Viome’s Dr. Banavar said that CancerDetect is in its first iteration, and the test uses machine learning, so its diagnostic performance will improve with the ongoing addition of real-world data.

The company is organizing a pivotal trial to gain formal FDA approval, with results expected in a year and a half or so, he said.

Viome is pushing ahead with its RNA diagnosis technology for the entire range of alimentary canal cancers and disorders, including inflammatory bowel disease. The company has partnered with pharmaceutical companies, including GSK, for vaccines, Dr. Banavar said.  

Dr. Mehra reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Recently, a home test for oral and throat cancer was launched in the United States, and it is being marketed directly to the general public, aimed at former or current tobacco users and anyone 50 years or older.

Individuals can order the test – CancerDetect Test for Oral & Throat Cancer – directly from its maker, Viome Life Sciences, for $399.

It is not covered by medical insurance, and is not approved by the Food and Drug Administration. The test is being marketed under the agency’s “laboratory developed test” rubric.

People who qualify and buy the test are mailed a saliva collection tube, which they fill and mail back. The company then analyzes the RNA for changes in human cells and the oropharyngeal microbiome that are associated with cancer. During a 15-minute telemedicine conference – included in the $399 cost – those who test positive are told to follow up with a secondary care center for a definitive diagnosis.

For people who test positive but have no visible lesion to biopsy, doctors will likely opt for surveillance, computer scientist Guruduth Banavar, PhD, Viome’s chief technology officer, told this news organization.

Dr. Banavar said people have been buying the test every day since it was launched in early August, but he declined to give specific sales figures.

CancerDetect’s tagline is “test at home for peace of mind.” The test “brings unprecedented accuracy to early cancer detection and prevention,” the company said in a press release announcing the launch.

The test showed an overall specificity of 94% and sensitivity of 84.2%-90% for cancer in Viome’s  latest study, which is posted on medRxiv.org as a preprint. Banavar said it has been submitted to a top-tier medical journal.

Viome plans to market CancerDetect “in every possible way” to consumers, including social media, Dr. Banavar said. CancerDetect is not sold on Amazon at the moment, but the company sells another at-home test for gut microbiome plus cellular health on the website. 

As for outreach to the medical community, “we will start doing that with dentists first” and then eventually oncologists and other doctors, but “our primary target is to get out to the consumers themselves,” Dr. Banavar said.

Viome’s main goal is to help consumers be proactive regarding their health, he said.
 

An expert opinion

The marketing push means that sooner or later, oncologists will likely have to deal with a patient who tests positive on CancerDetect, so this news organization turned to numerous experts for their thoughts. None had heard about the test, but one responded with comments.

“I am happy to see industry working on strategies for the early detection of oral and throat cancers,” and CancerDetect has “potential,” said surgical oncologist Saral Mehra, MD, MBA, chief of head and neck surgery at Yale University, New Haven, Conn.

However, after reviewing the study posted on medRxiv, Dr. Mehra advised caution. He said he was concerned about false negative results leading to missed cancers and false positives leading to unnecessary anxiety and testing.

According to the medRxiv preprint, the test was developed and validated using saliva samples from 1,175 people 50 years or older as well as adults with a history of tobacco use. 

In the 230-sample validation cohort, CancerDetect correctly classified 18 out of 20 people with oral squamous cell carcinoma (OSCC) and 64/76 with oropharyngeal squamous cell carcinoma (OPSCC), yielding sensitivities of 90% and 84.2%, respectively. 

The test also correctly identified 126/134 people as cancer free, for a specificity of 94%.

Results were similar between early and late-stage disease, but mixed in subgroups. Among people younger than age 50, for instance, 4/4 (100%) with OSCC and 2/3 (66.7%) with OPSCC were correctly classified as positive. Among older people, 15/17 (88.2%) with OSCC and 62/73 (84.9%) with OPSCC were correctly classified

Commenting on the results, Dr. Mehra noted that “the power of the study, especially for subgroup analysis, was low,” and investigators “used both advanced-stage and early-stage cancer patients in the model, while the target population for this test is early stage. 

“The research needs to be tightened significantly on specific target populations, the models adjusted to really limit false negatives, and a plan [put in place] to act upon positive results,” he said.

Also, the ability of CancerDetect to pick up premalignant lesions – “the greatest value in a screening test” – is not clear, he added.

Viome’s Dr. Banavar said that CancerDetect is in its first iteration, and the test uses machine learning, so its diagnostic performance will improve with the ongoing addition of real-world data.

The company is organizing a pivotal trial to gain formal FDA approval, with results expected in a year and a half or so, he said.

Viome is pushing ahead with its RNA diagnosis technology for the entire range of alimentary canal cancers and disorders, including inflammatory bowel disease. The company has partnered with pharmaceutical companies, including GSK, for vaccines, Dr. Banavar said.  

Dr. Mehra reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Recently, a home test for oral and throat cancer was launched in the United States, and it is being marketed directly to the general public, aimed at former or current tobacco users and anyone 50 years or older.

Individuals can order the test – CancerDetect Test for Oral & Throat Cancer – directly from its maker, Viome Life Sciences, for $399.

It is not covered by medical insurance, and is not approved by the Food and Drug Administration. The test is being marketed under the agency’s “laboratory developed test” rubric.

People who qualify and buy the test are mailed a saliva collection tube, which they fill and mail back. The company then analyzes the RNA for changes in human cells and the oropharyngeal microbiome that are associated with cancer. During a 15-minute telemedicine conference – included in the $399 cost – those who test positive are told to follow up with a secondary care center for a definitive diagnosis.

For people who test positive but have no visible lesion to biopsy, doctors will likely opt for surveillance, computer scientist Guruduth Banavar, PhD, Viome’s chief technology officer, told this news organization.

Dr. Banavar said people have been buying the test every day since it was launched in early August, but he declined to give specific sales figures.

CancerDetect’s tagline is “test at home for peace of mind.” The test “brings unprecedented accuracy to early cancer detection and prevention,” the company said in a press release announcing the launch.

The test showed an overall specificity of 94% and sensitivity of 84.2%-90% for cancer in Viome’s  latest study, which is posted on medRxiv.org as a preprint. Banavar said it has been submitted to a top-tier medical journal.

Viome plans to market CancerDetect “in every possible way” to consumers, including social media, Dr. Banavar said. CancerDetect is not sold on Amazon at the moment, but the company sells another at-home test for gut microbiome plus cellular health on the website. 

As for outreach to the medical community, “we will start doing that with dentists first” and then eventually oncologists and other doctors, but “our primary target is to get out to the consumers themselves,” Dr. Banavar said.

Viome’s main goal is to help consumers be proactive regarding their health, he said.
 

An expert opinion

The marketing push means that sooner or later, oncologists will likely have to deal with a patient who tests positive on CancerDetect, so this news organization turned to numerous experts for their thoughts. None had heard about the test, but one responded with comments.

“I am happy to see industry working on strategies for the early detection of oral and throat cancers,” and CancerDetect has “potential,” said surgical oncologist Saral Mehra, MD, MBA, chief of head and neck surgery at Yale University, New Haven, Conn.

However, after reviewing the study posted on medRxiv, Dr. Mehra advised caution. He said he was concerned about false negative results leading to missed cancers and false positives leading to unnecessary anxiety and testing.

According to the medRxiv preprint, the test was developed and validated using saliva samples from 1,175 people 50 years or older as well as adults with a history of tobacco use. 

In the 230-sample validation cohort, CancerDetect correctly classified 18 out of 20 people with oral squamous cell carcinoma (OSCC) and 64/76 with oropharyngeal squamous cell carcinoma (OPSCC), yielding sensitivities of 90% and 84.2%, respectively. 

The test also correctly identified 126/134 people as cancer free, for a specificity of 94%.

Results were similar between early and late-stage disease, but mixed in subgroups. Among people younger than age 50, for instance, 4/4 (100%) with OSCC and 2/3 (66.7%) with OPSCC were correctly classified as positive. Among older people, 15/17 (88.2%) with OSCC and 62/73 (84.9%) with OPSCC were correctly classified

Commenting on the results, Dr. Mehra noted that “the power of the study, especially for subgroup analysis, was low,” and investigators “used both advanced-stage and early-stage cancer patients in the model, while the target population for this test is early stage. 

“The research needs to be tightened significantly on specific target populations, the models adjusted to really limit false negatives, and a plan [put in place] to act upon positive results,” he said.

Also, the ability of CancerDetect to pick up premalignant lesions – “the greatest value in a screening test” – is not clear, he added.

Viome’s Dr. Banavar said that CancerDetect is in its first iteration, and the test uses machine learning, so its diagnostic performance will improve with the ongoing addition of real-world data.

The company is organizing a pivotal trial to gain formal FDA approval, with results expected in a year and a half or so, he said.

Viome is pushing ahead with its RNA diagnosis technology for the entire range of alimentary canal cancers and disorders, including inflammatory bowel disease. The company has partnered with pharmaceutical companies, including GSK, for vaccines, Dr. Banavar said.  

Dr. Mehra reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A new study suggests that oncologists can safely pull back on standard locoregional radiotherapy (RT) in select patients with cT1-2N1 breast cancer who are treated with primary chemotherapy prior to surgery. The key is to divide patients by risk level and treat them according to the study’s guidelines, the researchers reported.

“We think this study is a good step towards de-escalation, which should lead to equal survival chances but better quality of life,” lead study author Sabine de Wild, MD, a PhD student at Maastricht (the Netherlands) University Medical Center, said in an interview.

The study, published in The Lancet Oncology, was intended to provide insight into which breast cancer patients need adjuvant locoregional radiotherapy following postchemotherapy surgery, coauthor Liesbeth Boersma, MD, PhD, a radiation oncologist at Maastricht University Medical Center, said in an interview. “It is not yet known which of these patients would benefit from adjuvant locoregional radiotherapy and to what extent the response of the tumor to the chemotherapy should be taken into account.”

For the study, believed to be the first prospective analysis tackling this topic, researchers tracked 838 patients in The Netherlands who were treated for cT1-2N1 breast cancer with primary chemotherapy and surgery of the breast and axilla from 2011-2015. Tumors were less than 5 cm and metastases were one to three axillary nodes.

The subjects were divided into groups based on risk of locoregional recurrence, and each group underwent different therapies.

• Low-risk group: no metastases were present in the nodes (n = 291). “We omitted regional radiotherapy, and we omitted RT of the chest wall in case of a mastectomy. After breast conserving surgery, regular RT of the breast was recommended,” Dr. de Wild said.
• Intermediate-risk group, one to three metastases were still present (n = 370). “We omitted regional radiotherapy, but irradiated the chest wall or breast,” she said.
• High-risk group, three metastases were present (n = 177). “We did not de-escalate, and all patients were treated with locoregional RT,” she said.

According to the study, “the 5-year locoregional recurrence rate in all patients was 2.2% (95% confidence interval, 1.4-3.4). The 5-year locoregional recurrence rate was 2.1% (95% CI, 0.9-4.3) in the low-risk group, 2.2% (95% CI, 1.0-4.1) in the intermediate-risk group, and 2.3% (95% CI, 0.8-5.5) in the high-risk group.”

In 26% of cases, patients received more radiotherapy than the study guidelines suggested. “Remarkably,” the researchers wrote, “this did not seem to affect locoregional recurrence rate, recurrence­-free interval, and overall survival in a statistically significant or clinically relevant way.”

As for limitations, the authors noted that, “in each risk group, the actual sample size treated according to the study guideline was smaller than required based on the power calculation. Nevertheless, when performing the analyses in the subset of patients treated according to the study guideline, the upper limit of 95% CI of 5­-year locoregional recurrence rate did not exceed 7.8%.”

The study authors wrote that, “in the future, the results of this study might lead to more frequent omission of locoregional radiotherapy, which could result in lower morbidity and a better quality of life for patients with breast cancer who are receiving primary chemotherapy.”

However, Dr. de Wild said randomized trials are necessary “to investigate how treatment can be individualized further, i.e., by taking into account specific tumor characteristics.” Also, most patients in the study underwent axillary lymph node dissection, “while patients in daily practice may instead undergo targeted axillary dissection. Future studies are needed to determine if less radiotherapy is also safe in patients in whom axillary lymph node dissection is omitted.”

The study was funded by the Dutch Cancer Society. One coauthor reported a pending patent plus grants from AstraZeneca, Eurocept Plaza, Roche, Genentech, Gilead Sciences, Tesaro, Novartis, Dutch Cancer Society, ZonMw, and A Sister’s Hope; as well as consulting fees and other financial support from a variety of pharmaceutical companies. The other authors had no disclosures.

A new study suggests that oncologists can safely pull back on standard locoregional radiotherapy (RT) in select patients with cT1-2N1 breast cancer who are treated with primary chemotherapy prior to surgery. The key is to divide patients by risk level and treat them according to the study’s guidelines, the researchers reported.

“We think this study is a good step towards de-escalation, which should lead to equal survival chances but better quality of life,” lead study author Sabine de Wild, MD, a PhD student at Maastricht (the Netherlands) University Medical Center, said in an interview.

The study, published in The Lancet Oncology, was intended to provide insight into which breast cancer patients need adjuvant locoregional radiotherapy following postchemotherapy surgery, coauthor Liesbeth Boersma, MD, PhD, a radiation oncologist at Maastricht University Medical Center, said in an interview. “It is not yet known which of these patients would benefit from adjuvant locoregional radiotherapy and to what extent the response of the tumor to the chemotherapy should be taken into account.”

For the study, believed to be the first prospective analysis tackling this topic, researchers tracked 838 patients in The Netherlands who were treated for cT1-2N1 breast cancer with primary chemotherapy and surgery of the breast and axilla from 2011-2015. Tumors were less than 5 cm and metastases were one to three axillary nodes.

The subjects were divided into groups based on risk of locoregional recurrence, and each group underwent different therapies.

• Low-risk group: no metastases were present in the nodes (n = 291). “We omitted regional radiotherapy, and we omitted RT of the chest wall in case of a mastectomy. After breast conserving surgery, regular RT of the breast was recommended,” Dr. de Wild said.
• Intermediate-risk group, one to three metastases were still present (n = 370). “We omitted regional radiotherapy, but irradiated the chest wall or breast,” she said.
• High-risk group, three metastases were present (n = 177). “We did not de-escalate, and all patients were treated with locoregional RT,” she said.

According to the study, “the 5-year locoregional recurrence rate in all patients was 2.2% (95% confidence interval, 1.4-3.4). The 5-year locoregional recurrence rate was 2.1% (95% CI, 0.9-4.3) in the low-risk group, 2.2% (95% CI, 1.0-4.1) in the intermediate-risk group, and 2.3% (95% CI, 0.8-5.5) in the high-risk group.”

In 26% of cases, patients received more radiotherapy than the study guidelines suggested. “Remarkably,” the researchers wrote, “this did not seem to affect locoregional recurrence rate, recurrence­-free interval, and overall survival in a statistically significant or clinically relevant way.”

As for limitations, the authors noted that, “in each risk group, the actual sample size treated according to the study guideline was smaller than required based on the power calculation. Nevertheless, when performing the analyses in the subset of patients treated according to the study guideline, the upper limit of 95% CI of 5­-year locoregional recurrence rate did not exceed 7.8%.”

The study authors wrote that, “in the future, the results of this study might lead to more frequent omission of locoregional radiotherapy, which could result in lower morbidity and a better quality of life for patients with breast cancer who are receiving primary chemotherapy.”

However, Dr. de Wild said randomized trials are necessary “to investigate how treatment can be individualized further, i.e., by taking into account specific tumor characteristics.” Also, most patients in the study underwent axillary lymph node dissection, “while patients in daily practice may instead undergo targeted axillary dissection. Future studies are needed to determine if less radiotherapy is also safe in patients in whom axillary lymph node dissection is omitted.”

The study was funded by the Dutch Cancer Society. One coauthor reported a pending patent plus grants from AstraZeneca, Eurocept Plaza, Roche, Genentech, Gilead Sciences, Tesaro, Novartis, Dutch Cancer Society, ZonMw, and A Sister’s Hope; as well as consulting fees and other financial support from a variety of pharmaceutical companies. The other authors had no disclosures.

A new study suggests that oncologists can safely pull back on standard locoregional radiotherapy (RT) in select patients with cT1-2N1 breast cancer who are treated with primary chemotherapy prior to surgery. The key is to divide patients by risk level and treat them according to the study’s guidelines, the researchers reported.

“We think this study is a good step towards de-escalation, which should lead to equal survival chances but better quality of life,” lead study author Sabine de Wild, MD, a PhD student at Maastricht (the Netherlands) University Medical Center, said in an interview.

The study, published in The Lancet Oncology, was intended to provide insight into which breast cancer patients need adjuvant locoregional radiotherapy following postchemotherapy surgery, coauthor Liesbeth Boersma, MD, PhD, a radiation oncologist at Maastricht University Medical Center, said in an interview. “It is not yet known which of these patients would benefit from adjuvant locoregional radiotherapy and to what extent the response of the tumor to the chemotherapy should be taken into account.”

For the study, believed to be the first prospective analysis tackling this topic, researchers tracked 838 patients in The Netherlands who were treated for cT1-2N1 breast cancer with primary chemotherapy and surgery of the breast and axilla from 2011-2015. Tumors were less than 5 cm and metastases were one to three axillary nodes.

The subjects were divided into groups based on risk of locoregional recurrence, and each group underwent different therapies.

• Low-risk group: no metastases were present in the nodes (n = 291). “We omitted regional radiotherapy, and we omitted RT of the chest wall in case of a mastectomy. After breast conserving surgery, regular RT of the breast was recommended,” Dr. de Wild said.
• Intermediate-risk group, one to three metastases were still present (n = 370). “We omitted regional radiotherapy, but irradiated the chest wall or breast,” she said.
• High-risk group, three metastases were present (n = 177). “We did not de-escalate, and all patients were treated with locoregional RT,” she said.

According to the study, “the 5-year locoregional recurrence rate in all patients was 2.2% (95% confidence interval, 1.4-3.4). The 5-year locoregional recurrence rate was 2.1% (95% CI, 0.9-4.3) in the low-risk group, 2.2% (95% CI, 1.0-4.1) in the intermediate-risk group, and 2.3% (95% CI, 0.8-5.5) in the high-risk group.”

In 26% of cases, patients received more radiotherapy than the study guidelines suggested. “Remarkably,” the researchers wrote, “this did not seem to affect locoregional recurrence rate, recurrence­-free interval, and overall survival in a statistically significant or clinically relevant way.”

As for limitations, the authors noted that, “in each risk group, the actual sample size treated according to the study guideline was smaller than required based on the power calculation. Nevertheless, when performing the analyses in the subset of patients treated according to the study guideline, the upper limit of 95% CI of 5­-year locoregional recurrence rate did not exceed 7.8%.”

The study authors wrote that, “in the future, the results of this study might lead to more frequent omission of locoregional radiotherapy, which could result in lower morbidity and a better quality of life for patients with breast cancer who are receiving primary chemotherapy.”

However, Dr. de Wild said randomized trials are necessary “to investigate how treatment can be individualized further, i.e., by taking into account specific tumor characteristics.” Also, most patients in the study underwent axillary lymph node dissection, “while patients in daily practice may instead undergo targeted axillary dissection. Future studies are needed to determine if less radiotherapy is also safe in patients in whom axillary lymph node dissection is omitted.”

The study was funded by the Dutch Cancer Society. One coauthor reported a pending patent plus grants from AstraZeneca, Eurocept Plaza, Roche, Genentech, Gilead Sciences, Tesaro, Novartis, Dutch Cancer Society, ZonMw, and A Sister’s Hope; as well as consulting fees and other financial support from a variety of pharmaceutical companies. The other authors had no disclosures.