Oncology

A renewed effort to modernize and stabilize Medicare reimbursement for radiation therapy services is underway.

In mid-March, members of Congress reintroduced bipartisan federal legislation that would shift Medicare reimbursement for radiation oncology services from quantity-based payments to episode-based payments and help stabilize the declining rates of reimbursement in the field. 

The Radiation Oncology Case Rate (ROCR) Value Based Payment Program Act, sponsored by two senators and four representatives, would not only “transform” how Medicare reimburses radiation therapy services, it would also “protect access to high quality cancer care and improve outcomes for patients nationwide, while generating savings for Medicare,” according to a recent American Society for Radiation Oncology (ASTRO) press release praising the bill. 

However, the reaction among those in the field has been mixed. Whereas some radiation oncologists are aligned with the bill, others argue that the legislation was crafted without meaningful input from many who will be affected.

“There’s consensus across multiple groups within the house of radiation oncology, hospital groups, and industry, which is incredibly important,” according to Mustafa Basree, DO, a radiation oncology resident who serves on ASTRO’s government relations committee and was part of the discussion on drafting the bill. 

But, Basree acknowledged, “not everybody likes the bill.”

A core complaint is a lack of communication and input from clinicians in the field. “If we’re going to decide to design our own quality program — which is really like a dream from a clinician’s standpoint — we need a meaningful way to come together as a unified field,” said Matthew Spraker, MD, PhD, a radiation oncologist practicing in Denver. In this bill, “we’re not getting any of that.”

 

Impetus for the Bill

Amid dramatic drops in Medicare reimbursement — and with more probably on the horizon — ASTRO announced in January 2024 that the society had partnered with the American College of Radiation Oncology, the American College of Radiology, and the American Society of Clinical Oncology to lobby for payment reform. 

Cuts to Medicare reimbursement were approaching 25% at the time. These declines were related, in part, to changes in how radiation treatment was being delivered. Reimbursement has historically been based on the fraction of radiation given, but the field has increasingly embraced hypofractionated regimens and deescalated approaches, which have led to fewer billable fractions and consequently lower reimbursement. 

A recent study highlighted significant declines in reimbursement based on this shift in care. For instance, greater use of hypofractionation led to declines in reimbursement for technical services in freestanding radiation oncology offices by nearly 17% for breast cancer and 14.2% for prostate cancer between 2016 and 2022. Inflation-adjusted Medicare conversion factors fell 12.2% in hospital outpatient centers and 20.8% in freestanding offices.

These declining reimbursement rates have occurred alongside changes to radiation oncology practice patterns. A recent analysis reported a 51% increase in the number of US practices with at least 10 radiation oncologists between 2015 and 2023, and a 27% decrease in the number of solo practices during the same period. The number of practicing radiation oncologists increased by 16%, but the number of practices employing them decreased by 13%, indicating a trend toward practice consolidation. 

These changes, the analysis found, may affect patients’ access to care. In rural areas, retirement rates were higher and rates of entry of new radiation oncologists was lower compared with urban areas.

The current payment structure “has become untenable,” leading to practice consolidation that threaten patient access, especially in rural and underserved areas, a spokesperson for ASTRO told this news organization last year. 

 

What Is the ROCR Act?

The ROCR ACT was drafted by ASTRO to address these issues and reverse declines in Medicare reimbursement. 

In addition to shifting radiation oncology reimbursement from fraction-based to episode-based, the bill also aims to encourage clinicians to adoptevidence-based shorter treatment regimens, improve safety and quality by supporting new technologies, and generate savings to Medicare by eliminating outdated and costly practices that have not been shown to improve patient outcomes.

When first introduced last year, the bill did not receive a vote in Congress.

A 2025 version of the bill, introduced last month, largely aligns with the 2024 legislation but contains some “enhancements,” such as improving accreditation with increased incentive payments, outlining a revised exemption for practices with limited resources and instituting a transitional payment period for adaptive radiation therapy to allow billing to continue while a new code is created.

 

Mixed Reactions 

How has the radiation oncology community reacted to the latest ROCR Act? 

A recent survey, which included more than 500 practicing radiation oncologists, found that 61% of respondents supported implementing an episode-based payment model such as that proposed in the 2025 legislation, 17.3% neither supported nor opposed it, and 21.6% opposed the model.

“I think this supports this idea that our field would have benefited from much more open discussion in the design phases of the bill,” Spraker told this news organization.

Jason Beckta, MD, PhD, a radiation oncologist at Rutland Regional Medical Center, Vermont, agreed. 

While on board with the concept of reform and episode-based payment, given what Beckta called “the absolute absurdity of the cuts in radiation oncology,” he took issue with the lack of transparency in the rollout of the bill.

The announcement about the 2025 version of the ROCR Act came as “a complete surprise — out of nowhere — except to insiders,” Beckta said.

ASTRO held a town hall in February 2025 “featuring new information and discussion” regarding ROCR 2025, but the bill had already been finalized for submission at that point, Beckta said. 

And although Beckta and Spraker believe ASTRO had good intentions, the physicians highlighted concerns with several aspects of the bill.

“What upsets me most is the blatant regulatory capture,” Beckta said. The legislation will require all practices to be accredited by either ASTRO, the American College of Radiation Oncology, or the American College of Radiology, essentially capturing their business through a regulation or having practices “face a 2.5% penalty, which is up 1% from the prior version,” Beckta explained. 

The bill also shortens the runway to get accredited from 3 years to 2 years, Beckta noted, stressing the arduousness of the accreditation process as a hurdle for many practices.

But doing the accreditation program does not mean care will get better, Spraker said. In fact, “that is absolutely not the case.”

Another issue: Requirements for medical equipment and quality review periods seem to favor industry over patients and practices, he said, highlighting the potential role of manufacturers in determining if or when equipment updates are required.

“A field like ours has rapidly exploding technology with not-always-clear patient benefit,” said Spraker. “We’re seeing too many examples where people are leveraging that, basically to sell devices instead of to help patients,” he added. 

Furthermore, Beckta noted, the bill allows for reduced reimbursement of between 4% and 7%, depending on the circumstances — a cut to reimbursement that is being justified by saying it’s the only way the bill will get through Congress. But “it’s just a less-bad option than continued cuts to fee-for-service,” Beckta said.

ASTRO leadership has expressed strong support for the bill. In the recent ASTRO press release, Howard M. Sandler, MD, chair of the ASTRO Board of Directors, called the ROCR Act “the only viable policy solution designed to provide payment stability for the field of radiation oncology in 2026 and beyond.” 

The ROCR Act, which is broadly supported by more than 80 organizations, “represents a balanced, evidence-based policy solution to safeguard access to high value cancer treatment for Americans,” Sandler said. 

“I believe in this bill,” Basree added.

Basree touted the replacement of a fee-for-service model with a “value-based payment system, ensuring predictable, fair reimbursement for the field” as a major win for stabilizing Medicare reimbursement. The bill also includes measures to improve patient access, such as providing discounted transportation for patients — a significant need, particularly in rural areas, he explained.

Although not everyone is happy with the bill, ASTRO did aim “to build coalition of support,” Basree said. “It’s an uphill battle, for sure, but we should press forward and hope for the best,” he added.

Even with their concerns, both Spraker and Beckta are optimistic that improvements to the bill can still be made, and urge colleagues to study the bill, speak out, and engage to help promote the best possible policy.

Basree reported receiving reimbursement for meeting travel and lodging as both a Fellow and member of the Association of Residents in Radiation Oncology. Spraker and Beckta reported having no relevant disclosures.

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

A renewed effort to modernize and stabilize Medicare reimbursement for radiation therapy services is underway.

In mid-March, members of Congress reintroduced bipartisan federal legislation that would shift Medicare reimbursement for radiation oncology services from quantity-based payments to episode-based payments and help stabilize the declining rates of reimbursement in the field. 

The Radiation Oncology Case Rate (ROCR) Value Based Payment Program Act, sponsored by two senators and four representatives, would not only “transform” how Medicare reimburses radiation therapy services, it would also “protect access to high quality cancer care and improve outcomes for patients nationwide, while generating savings for Medicare,” according to a recent American Society for Radiation Oncology (ASTRO) press release praising the bill. 

However, the reaction among those in the field has been mixed. Whereas some radiation oncologists are aligned with the bill, others argue that the legislation was crafted without meaningful input from many who will be affected.

“There’s consensus across multiple groups within the house of radiation oncology, hospital groups, and industry, which is incredibly important,” according to Mustafa Basree, DO, a radiation oncology resident who serves on ASTRO’s government relations committee and was part of the discussion on drafting the bill. 

But, Basree acknowledged, “not everybody likes the bill.”

A core complaint is a lack of communication and input from clinicians in the field. “If we’re going to decide to design our own quality program — which is really like a dream from a clinician’s standpoint — we need a meaningful way to come together as a unified field,” said Matthew Spraker, MD, PhD, a radiation oncologist practicing in Denver. In this bill, “we’re not getting any of that.”

 

Impetus for the Bill

Amid dramatic drops in Medicare reimbursement — and with more probably on the horizon — ASTRO announced in January 2024 that the society had partnered with the American College of Radiation Oncology, the American College of Radiology, and the American Society of Clinical Oncology to lobby for payment reform. 

Cuts to Medicare reimbursement were approaching 25% at the time. These declines were related, in part, to changes in how radiation treatment was being delivered. Reimbursement has historically been based on the fraction of radiation given, but the field has increasingly embraced hypofractionated regimens and deescalated approaches, which have led to fewer billable fractions and consequently lower reimbursement. 

A recent study highlighted significant declines in reimbursement based on this shift in care. For instance, greater use of hypofractionation led to declines in reimbursement for technical services in freestanding radiation oncology offices by nearly 17% for breast cancer and 14.2% for prostate cancer between 2016 and 2022. Inflation-adjusted Medicare conversion factors fell 12.2% in hospital outpatient centers and 20.8% in freestanding offices.

These declining reimbursement rates have occurred alongside changes to radiation oncology practice patterns. A recent analysis reported a 51% increase in the number of US practices with at least 10 radiation oncologists between 2015 and 2023, and a 27% decrease in the number of solo practices during the same period. The number of practicing radiation oncologists increased by 16%, but the number of practices employing them decreased by 13%, indicating a trend toward practice consolidation. 

These changes, the analysis found, may affect patients’ access to care. In rural areas, retirement rates were higher and rates of entry of new radiation oncologists was lower compared with urban areas.

The current payment structure “has become untenable,” leading to practice consolidation that threaten patient access, especially in rural and underserved areas, a spokesperson for ASTRO told this news organization last year. 

 

What Is the ROCR Act?

The ROCR ACT was drafted by ASTRO to address these issues and reverse declines in Medicare reimbursement. 

In addition to shifting radiation oncology reimbursement from fraction-based to episode-based, the bill also aims to encourage clinicians to adoptevidence-based shorter treatment regimens, improve safety and quality by supporting new technologies, and generate savings to Medicare by eliminating outdated and costly practices that have not been shown to improve patient outcomes.

When first introduced last year, the bill did not receive a vote in Congress.

A 2025 version of the bill, introduced last month, largely aligns with the 2024 legislation but contains some “enhancements,” such as improving accreditation with increased incentive payments, outlining a revised exemption for practices with limited resources and instituting a transitional payment period for adaptive radiation therapy to allow billing to continue while a new code is created.

 

Mixed Reactions 

How has the radiation oncology community reacted to the latest ROCR Act? 

A recent survey, which included more than 500 practicing radiation oncologists, found that 61% of respondents supported implementing an episode-based payment model such as that proposed in the 2025 legislation, 17.3% neither supported nor opposed it, and 21.6% opposed the model.

“I think this supports this idea that our field would have benefited from much more open discussion in the design phases of the bill,” Spraker told this news organization.

Jason Beckta, MD, PhD, a radiation oncologist at Rutland Regional Medical Center, Vermont, agreed. 

While on board with the concept of reform and episode-based payment, given what Beckta called “the absolute absurdity of the cuts in radiation oncology,” he took issue with the lack of transparency in the rollout of the bill.

The announcement about the 2025 version of the ROCR Act came as “a complete surprise — out of nowhere — except to insiders,” Beckta said.

ASTRO held a town hall in February 2025 “featuring new information and discussion” regarding ROCR 2025, but the bill had already been finalized for submission at that point, Beckta said. 

And although Beckta and Spraker believe ASTRO had good intentions, the physicians highlighted concerns with several aspects of the bill.

“What upsets me most is the blatant regulatory capture,” Beckta said. The legislation will require all practices to be accredited by either ASTRO, the American College of Radiation Oncology, or the American College of Radiology, essentially capturing their business through a regulation or having practices “face a 2.5% penalty, which is up 1% from the prior version,” Beckta explained. 

The bill also shortens the runway to get accredited from 3 years to 2 years, Beckta noted, stressing the arduousness of the accreditation process as a hurdle for many practices.

But doing the accreditation program does not mean care will get better, Spraker said. In fact, “that is absolutely not the case.”

Another issue: Requirements for medical equipment and quality review periods seem to favor industry over patients and practices, he said, highlighting the potential role of manufacturers in determining if or when equipment updates are required.

“A field like ours has rapidly exploding technology with not-always-clear patient benefit,” said Spraker. “We’re seeing too many examples where people are leveraging that, basically to sell devices instead of to help patients,” he added. 

Furthermore, Beckta noted, the bill allows for reduced reimbursement of between 4% and 7%, depending on the circumstances — a cut to reimbursement that is being justified by saying it’s the only way the bill will get through Congress. But “it’s just a less-bad option than continued cuts to fee-for-service,” Beckta said.

ASTRO leadership has expressed strong support for the bill. In the recent ASTRO press release, Howard M. Sandler, MD, chair of the ASTRO Board of Directors, called the ROCR Act “the only viable policy solution designed to provide payment stability for the field of radiation oncology in 2026 and beyond.” 

The ROCR Act, which is broadly supported by more than 80 organizations, “represents a balanced, evidence-based policy solution to safeguard access to high value cancer treatment for Americans,” Sandler said. 

“I believe in this bill,” Basree added.

Basree touted the replacement of a fee-for-service model with a “value-based payment system, ensuring predictable, fair reimbursement for the field” as a major win for stabilizing Medicare reimbursement. The bill also includes measures to improve patient access, such as providing discounted transportation for patients — a significant need, particularly in rural areas, he explained.

Although not everyone is happy with the bill, ASTRO did aim “to build coalition of support,” Basree said. “It’s an uphill battle, for sure, but we should press forward and hope for the best,” he added.

Even with their concerns, both Spraker and Beckta are optimistic that improvements to the bill can still be made, and urge colleagues to study the bill, speak out, and engage to help promote the best possible policy.

Basree reported receiving reimbursement for meeting travel and lodging as both a Fellow and member of the Association of Residents in Radiation Oncology. Spraker and Beckta reported having no relevant disclosures.

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

A renewed effort to modernize and stabilize Medicare reimbursement for radiation therapy services is underway.

In mid-March, members of Congress reintroduced bipartisan federal legislation that would shift Medicare reimbursement for radiation oncology services from quantity-based payments to episode-based payments and help stabilize the declining rates of reimbursement in the field. 

The Radiation Oncology Case Rate (ROCR) Value Based Payment Program Act, sponsored by two senators and four representatives, would not only “transform” how Medicare reimburses radiation therapy services, it would also “protect access to high quality cancer care and improve outcomes for patients nationwide, while generating savings for Medicare,” according to a recent American Society for Radiation Oncology (ASTRO) press release praising the bill. 

However, the reaction among those in the field has been mixed. Whereas some radiation oncologists are aligned with the bill, others argue that the legislation was crafted without meaningful input from many who will be affected.

“There’s consensus across multiple groups within the house of radiation oncology, hospital groups, and industry, which is incredibly important,” according to Mustafa Basree, DO, a radiation oncology resident who serves on ASTRO’s government relations committee and was part of the discussion on drafting the bill. 

But, Basree acknowledged, “not everybody likes the bill.”

A core complaint is a lack of communication and input from clinicians in the field. “If we’re going to decide to design our own quality program — which is really like a dream from a clinician’s standpoint — we need a meaningful way to come together as a unified field,” said Matthew Spraker, MD, PhD, a radiation oncologist practicing in Denver. In this bill, “we’re not getting any of that.”

 

Impetus for the Bill

Amid dramatic drops in Medicare reimbursement — and with more probably on the horizon — ASTRO announced in January 2024 that the society had partnered with the American College of Radiation Oncology, the American College of Radiology, and the American Society of Clinical Oncology to lobby for payment reform. 

Cuts to Medicare reimbursement were approaching 25% at the time. These declines were related, in part, to changes in how radiation treatment was being delivered. Reimbursement has historically been based on the fraction of radiation given, but the field has increasingly embraced hypofractionated regimens and deescalated approaches, which have led to fewer billable fractions and consequently lower reimbursement. 

A recent study highlighted significant declines in reimbursement based on this shift in care. For instance, greater use of hypofractionation led to declines in reimbursement for technical services in freestanding radiation oncology offices by nearly 17% for breast cancer and 14.2% for prostate cancer between 2016 and 2022. Inflation-adjusted Medicare conversion factors fell 12.2% in hospital outpatient centers and 20.8% in freestanding offices.

These declining reimbursement rates have occurred alongside changes to radiation oncology practice patterns. A recent analysis reported a 51% increase in the number of US practices with at least 10 radiation oncologists between 2015 and 2023, and a 27% decrease in the number of solo practices during the same period. The number of practicing radiation oncologists increased by 16%, but the number of practices employing them decreased by 13%, indicating a trend toward practice consolidation. 

These changes, the analysis found, may affect patients’ access to care. In rural areas, retirement rates were higher and rates of entry of new radiation oncologists was lower compared with urban areas.

The current payment structure “has become untenable,” leading to practice consolidation that threaten patient access, especially in rural and underserved areas, a spokesperson for ASTRO told this news organization last year. 

 

What Is the ROCR Act?

The ROCR ACT was drafted by ASTRO to address these issues and reverse declines in Medicare reimbursement. 

In addition to shifting radiation oncology reimbursement from fraction-based to episode-based, the bill also aims to encourage clinicians to adoptevidence-based shorter treatment regimens, improve safety and quality by supporting new technologies, and generate savings to Medicare by eliminating outdated and costly practices that have not been shown to improve patient outcomes.

When first introduced last year, the bill did not receive a vote in Congress.

A 2025 version of the bill, introduced last month, largely aligns with the 2024 legislation but contains some “enhancements,” such as improving accreditation with increased incentive payments, outlining a revised exemption for practices with limited resources and instituting a transitional payment period for adaptive radiation therapy to allow billing to continue while a new code is created.

 

Mixed Reactions 

How has the radiation oncology community reacted to the latest ROCR Act? 

A recent survey, which included more than 500 practicing radiation oncologists, found that 61% of respondents supported implementing an episode-based payment model such as that proposed in the 2025 legislation, 17.3% neither supported nor opposed it, and 21.6% opposed the model.

“I think this supports this idea that our field would have benefited from much more open discussion in the design phases of the bill,” Spraker told this news organization.

Jason Beckta, MD, PhD, a radiation oncologist at Rutland Regional Medical Center, Vermont, agreed. 

While on board with the concept of reform and episode-based payment, given what Beckta called “the absolute absurdity of the cuts in radiation oncology,” he took issue with the lack of transparency in the rollout of the bill.

The announcement about the 2025 version of the ROCR Act came as “a complete surprise — out of nowhere — except to insiders,” Beckta said.

ASTRO held a town hall in February 2025 “featuring new information and discussion” regarding ROCR 2025, but the bill had already been finalized for submission at that point, Beckta said. 

And although Beckta and Spraker believe ASTRO had good intentions, the physicians highlighted concerns with several aspects of the bill.

“What upsets me most is the blatant regulatory capture,” Beckta said. The legislation will require all practices to be accredited by either ASTRO, the American College of Radiation Oncology, or the American College of Radiology, essentially capturing their business through a regulation or having practices “face a 2.5% penalty, which is up 1% from the prior version,” Beckta explained. 

The bill also shortens the runway to get accredited from 3 years to 2 years, Beckta noted, stressing the arduousness of the accreditation process as a hurdle for many practices.

But doing the accreditation program does not mean care will get better, Spraker said. In fact, “that is absolutely not the case.”

Another issue: Requirements for medical equipment and quality review periods seem to favor industry over patients and practices, he said, highlighting the potential role of manufacturers in determining if or when equipment updates are required.

“A field like ours has rapidly exploding technology with not-always-clear patient benefit,” said Spraker. “We’re seeing too many examples where people are leveraging that, basically to sell devices instead of to help patients,” he added. 

Furthermore, Beckta noted, the bill allows for reduced reimbursement of between 4% and 7%, depending on the circumstances — a cut to reimbursement that is being justified by saying it’s the only way the bill will get through Congress. But “it’s just a less-bad option than continued cuts to fee-for-service,” Beckta said.

ASTRO leadership has expressed strong support for the bill. In the recent ASTRO press release, Howard M. Sandler, MD, chair of the ASTRO Board of Directors, called the ROCR Act “the only viable policy solution designed to provide payment stability for the field of radiation oncology in 2026 and beyond.” 

The ROCR Act, which is broadly supported by more than 80 organizations, “represents a balanced, evidence-based policy solution to safeguard access to high value cancer treatment for Americans,” Sandler said. 

“I believe in this bill,” Basree added.

Basree touted the replacement of a fee-for-service model with a “value-based payment system, ensuring predictable, fair reimbursement for the field” as a major win for stabilizing Medicare reimbursement. The bill also includes measures to improve patient access, such as providing discounted transportation for patients — a significant need, particularly in rural areas, he explained.

Although not everyone is happy with the bill, ASTRO did aim “to build coalition of support,” Basree said. “It’s an uphill battle, for sure, but we should press forward and hope for the best,” he added.

Even with their concerns, both Spraker and Beckta are optimistic that improvements to the bill can still be made, and urge colleagues to study the bill, speak out, and engage to help promote the best possible policy.

Basree reported receiving reimbursement for meeting travel and lodging as both a Fellow and member of the Association of Residents in Radiation Oncology. Spraker and Beckta reported having no relevant disclosures.

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

For years, the default definitive treatment for patients with early-stage I non–small cell lung cancer (NSCLC) has been surgical resection, typically minimally invasive lobectomy with systematic lymph node dissection.

Guidelines from the National Comprehensive Cancer Network (NCCN), the American Society of Clinical Oncology, and the European Society for Medical Oncology all list surgery (in particular, lobectomy) as the primary local therapy for fit, operable patients with stage I NSCLC.

More recently, however, stereotactic body radiotherapy (SBRT), also called stereotactic ablative radiotherapy, has emerged as a definitive treatment option for stage I NSCLC, especially for older, less fit patients who are unsuitable or deemed high-risk for surgery.

“We see patients in our practice who cannot undergo surgery or who may not have adequate lung function to be able to tolerate surgery, and for these patients who are medically inoperable or surgically unresectable, radiation therapy may be a reasonable option,” Charu Aggarwal, MD, MPH, professor and lung cancer specialist, University of Pennsylvania, Philadelphia, told this news organization.

Given some encouraging data suggesting that SBRT could provide similar survival outcomes and be an alternative to surgery for operable disease, SBRT is also increasingly being considered in these early-stage patients. However, other evidence indicates that SBRT may be associated with higher rates of regional and distant recurrences and worse long-term survival, particularly in operable patients.

What may ultimately matter most is carefully selecting operable patients who undergo SBRT.

Aggarwal has encountered certain patients who are fit for surgery but would rather have radiation therapy. “This is an individual decision, and these patients are usually discussed at tumor board and in multidisciplinary discussions to really make sure that they’re making the right decision for themselves,” she explained.

 

The Pros and Cons of SBRT

SBRT is a nonsurgical approach in which precision high-dose radiation is delivered in just a few fractions — typically, 3, 5, or 8, depending on institutional protocols and tumor characteristics.

SBRT is performed on an outpatient basis, usually over 1-2 weeks, with most patients able to resume usual activities with minimal to no delay. Surgery, on the other hand, requires a hospital stay and takes most people about 2-6 weeks to return to regular activities. SBRT also avoids anesthesia and surgical incisions, both of which come with risks.

The data on SBRT in early-stage NSCLC are mixed. While some studies indicate that SBRT comes with promising survival outcomes, other research has reported worse survival and recurrence rates.

One potential reason for higher recurrence rates with SBRT is the lack of pathologic nodal staging, which only happens after surgery, as well as lower rates of nodal evaluation with endobronchial ultrasound or mediastinoscopy before surgery or SBRT. Without nodal assessments, clinicians may miss a more aggressive histology or more advanced nodal stage, which would go undertreated if patients received SBRT.

 

Latest Data in Large Cohort

A recent study published in Lung Cancer indicated that, when carefully selected, operable patients with early NSCLC have comparable survival with lobectomy or SBRT.

In the study, Dutch researchers took an in-depth look at survival and recurrence patterns in a retrospective cohort study of 2183 patients with clinical stage I NSCLC treated with minimally invasive lobectomy or SBRT. The study includes one of the largest cohorts to date, with robust data collection on baseline characteristics, comorbidities, tumor size, performance status, and follow-up.

Patients receiving SBRT were typically older (median age, 74 vs 67 years), had higher comorbidity burdens (Charlson index ≥ 5 in 57% of SBRT patients vs 23% of surgical patients), worse performance status, and lower lung function. To adjust for these differences, the researchers used propensity score weighting so the SBRT group’s baseline characteristics were comparable with those in the surgery group.

The surgery cohort had more invasive nodal evaluation: 21% underwent endobronchial ultrasound or mediastinoscopy vs only 12% in the SBRT group. The vast majority in both groups had PET-CT staging, reflecting modern imaging-based workups.

While 5-year local recurrence rates between the two groups were similar (13.1% for SBRT vs 12.1% for surgery), the 5-year regional recurrence rate was significantly higher after SBRT than lobectomy (18.1% vs 14.2%; hazard ratio [HR], 0.74), as was the distant metastasis rate (26.2% vs 20.2%; HR, 0.72).

Mortality at 30 days was higher after surgery than SBRT (1.0% vs 0.2%). And in the unadjusted analysis, 5-year overall survival was significantly better with lobectomy than SBRT (70.2% vs 40.3%).

However, when the analysis only included patients with similar baseline characteristics, overall survival was no longer significantly different in the two groups (HR, 0.89; 95% CI, 0.65-1.20). Lung cancer–specific mortality was also not significantly different between the two treatments (HR, 1.08), but the study was underpowered to detect significant differences in this outcome on the basis of a relatively low number of deaths from NSCLC.

Still, even after comparing similar patients, recurrence-free survival was notably better with surgery (HR, 0.70), due to fewer regional recurrences and distant metastases. Overall, 13% of the surgical cohort had nodal upstaging at pathology, meaning that even in clinically “node-negative” stage I disease, a subset of patients had unsuspected nodal involvement.

Patients receiving SBRT did not have pathologic nodal staging, raising the possibility of occult micrometastases. The authors noted that the proportion of SBRT patients with occult lymph node metastases is likely at least equal to that in the surgery group, but these metastases would go undetected without pathologic assessment.

Missing potential occult micrometastases in the SBRT group likely contributed to higher regional recurrence rates over time. By improving nodal staging, more patients with occult lymph node metastases who would be undertreated with SBRT may be identified before treatment, the authors said.

 

What Do Experts Say?

So, is SBRT an option for patients with stage I NSCLC?

Opinions vary.

“If you got one shot for a cure, then you want to do the surgery because that’s what results in a cure,” said Raja Flores, MD, chairman of Thoracic Surgery, Mount Sinai Health System, New York City.

Flores noted that the survival rate with surgery is high in this population. “There’s really nothing out there that can compare,” he said.

In his view, surgery “remains the gold standard.” However, “radiation could be considered in nonsurgical candidates,” he said.

The most recent NCCN guidelines align with Flores’ take. The guidelines say that SBRT is indicated for stage IA-IIA (N0) NSCLC in patients who are deemed “medically inoperable, high surgical risk as determined by thoracic surgeon, and those who decline surgery after thoracic surgical consultation.”

Clifford G. Robinson, MD, agreed. “In the United States, we largely treat patients with SBRT who are medically inoperable or high-risk operable and a much smaller proportion who decline surgery,” said Robinson, professor of radiation oncology and chief of SBRT at Washington University in St. Louis, St. Louis. “Many patients who are deemed operable are not offered SBRT.”

Still, for Robinson, determining which patients are best suited for surgery or SBRT remains unclear.

“Retrospective comparisons are fraught with problems because of confounding,” Robinson told this news organization. “That is, the healthier patients get surgery, and the less healthy ones get SBRT. No manner of fancy statistical manipulation can remove that fact.”

In fact, a recent meta-analysis found that the most significant variable predicting whether surgery or SBRT was superior in retrospective studies was whether the author was a surgeon or radiation oncologist.

Robinson noted that multiple randomized trials have attempted to randomize patients with medically operable early-stage NSCLC to surgery or SBRT and failed to accrue, largely due to patients’ “understandable unwillingness to be randomized between operative vs nonoperative interventions when most already prefer one or the other approach.”

Flores highlighted another point of caution about interpreting trial results: Not all early-stage NSCLC behaves similarly. “Some are slow-growing ‘turtles,’ and others are aggressive ‘rabbits’ — and the turtles are usually the ones that have been included in these radiotherapy trials, and that’s the danger,” he said.

While medical operability is the primary factor for deciding the treatment modality for early-stage NSCLC, there are other more subtle factors that can play into the decision.

These include prior surgery or radiotherapy to the chest, prior cancers, and social issues, such as the patient being a primary caregiver for another person and job insecurity, that might make recovery from surgery more challenging. And in rare instances, a patient may be medically fit to undergo surgery, but the cancer is technically challenging to resect due to anatomic issues or prior surgery to the chest, Robinson added.

 

A Winner?

Results from two ongoing, highly anticipated randomized trials expected in the next several years will hopefully provide additional insights and clarify ongoing uncertainties about the optimal treatment strategies for operable patients with stage I NSCLC.

STABLE-MATES is comparing outcomes after sublobar resection and SBRT in high-risk operable stage I NSCLC, and VALOR is evaluating outcomes after anatomic pulmonary resections and SBRT in patients with stage I NSCLC who have a long life expectancy and are fit enough to tolerate surgery.

But Robinson said his group believes that trying to decide on a winner is a “fool’s errand” and is instead running a pragmatic study across multiple academic and community centers around the United States and Canada where patients choose therapy based on their personal preferences and guidance from their physicians. The researchers will carefully track baseline comorbidity and frailty and assess serial quality-of-life changes over time.

“The goal is to create a calculator that a given patient might use in the future to determine what patients like them would have received, complete with expected outcomes and side effects,” Robinson said.

Robinson cautioned, however, that it “seems unlikely, given the existing literature, that one of the treatments will be truly ‘superior’ to the other one and lead to the ‘losing’ treatment fading away since both are excellent options with pros and cons.”

Aggarwal, Robinson, and Flores had no relevant disclosures.

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

For years, the default definitive treatment for patients with early-stage I non–small cell lung cancer (NSCLC) has been surgical resection, typically minimally invasive lobectomy with systematic lymph node dissection.

Guidelines from the National Comprehensive Cancer Network (NCCN), the American Society of Clinical Oncology, and the European Society for Medical Oncology all list surgery (in particular, lobectomy) as the primary local therapy for fit, operable patients with stage I NSCLC.

More recently, however, stereotactic body radiotherapy (SBRT), also called stereotactic ablative radiotherapy, has emerged as a definitive treatment option for stage I NSCLC, especially for older, less fit patients who are unsuitable or deemed high-risk for surgery.

“We see patients in our practice who cannot undergo surgery or who may not have adequate lung function to be able to tolerate surgery, and for these patients who are medically inoperable or surgically unresectable, radiation therapy may be a reasonable option,” Charu Aggarwal, MD, MPH, professor and lung cancer specialist, University of Pennsylvania, Philadelphia, told this news organization.

Given some encouraging data suggesting that SBRT could provide similar survival outcomes and be an alternative to surgery for operable disease, SBRT is also increasingly being considered in these early-stage patients. However, other evidence indicates that SBRT may be associated with higher rates of regional and distant recurrences and worse long-term survival, particularly in operable patients.

What may ultimately matter most is carefully selecting operable patients who undergo SBRT.

Aggarwal has encountered certain patients who are fit for surgery but would rather have radiation therapy. “This is an individual decision, and these patients are usually discussed at tumor board and in multidisciplinary discussions to really make sure that they’re making the right decision for themselves,” she explained.

 

The Pros and Cons of SBRT

SBRT is a nonsurgical approach in which precision high-dose radiation is delivered in just a few fractions — typically, 3, 5, or 8, depending on institutional protocols and tumor characteristics.

SBRT is performed on an outpatient basis, usually over 1-2 weeks, with most patients able to resume usual activities with minimal to no delay. Surgery, on the other hand, requires a hospital stay and takes most people about 2-6 weeks to return to regular activities. SBRT also avoids anesthesia and surgical incisions, both of which come with risks.

The data on SBRT in early-stage NSCLC are mixed. While some studies indicate that SBRT comes with promising survival outcomes, other research has reported worse survival and recurrence rates.

One potential reason for higher recurrence rates with SBRT is the lack of pathologic nodal staging, which only happens after surgery, as well as lower rates of nodal evaluation with endobronchial ultrasound or mediastinoscopy before surgery or SBRT. Without nodal assessments, clinicians may miss a more aggressive histology or more advanced nodal stage, which would go undertreated if patients received SBRT.

 

Latest Data in Large Cohort

A recent study published in Lung Cancer indicated that, when carefully selected, operable patients with early NSCLC have comparable survival with lobectomy or SBRT.

In the study, Dutch researchers took an in-depth look at survival and recurrence patterns in a retrospective cohort study of 2183 patients with clinical stage I NSCLC treated with minimally invasive lobectomy or SBRT. The study includes one of the largest cohorts to date, with robust data collection on baseline characteristics, comorbidities, tumor size, performance status, and follow-up.

Patients receiving SBRT were typically older (median age, 74 vs 67 years), had higher comorbidity burdens (Charlson index ≥ 5 in 57% of SBRT patients vs 23% of surgical patients), worse performance status, and lower lung function. To adjust for these differences, the researchers used propensity score weighting so the SBRT group’s baseline characteristics were comparable with those in the surgery group.

The surgery cohort had more invasive nodal evaluation: 21% underwent endobronchial ultrasound or mediastinoscopy vs only 12% in the SBRT group. The vast majority in both groups had PET-CT staging, reflecting modern imaging-based workups.

While 5-year local recurrence rates between the two groups were similar (13.1% for SBRT vs 12.1% for surgery), the 5-year regional recurrence rate was significantly higher after SBRT than lobectomy (18.1% vs 14.2%; hazard ratio [HR], 0.74), as was the distant metastasis rate (26.2% vs 20.2%; HR, 0.72).

Mortality at 30 days was higher after surgery than SBRT (1.0% vs 0.2%). And in the unadjusted analysis, 5-year overall survival was significantly better with lobectomy than SBRT (70.2% vs 40.3%).

However, when the analysis only included patients with similar baseline characteristics, overall survival was no longer significantly different in the two groups (HR, 0.89; 95% CI, 0.65-1.20). Lung cancer–specific mortality was also not significantly different between the two treatments (HR, 1.08), but the study was underpowered to detect significant differences in this outcome on the basis of a relatively low number of deaths from NSCLC.

Still, even after comparing similar patients, recurrence-free survival was notably better with surgery (HR, 0.70), due to fewer regional recurrences and distant metastases. Overall, 13% of the surgical cohort had nodal upstaging at pathology, meaning that even in clinically “node-negative” stage I disease, a subset of patients had unsuspected nodal involvement.

Patients receiving SBRT did not have pathologic nodal staging, raising the possibility of occult micrometastases. The authors noted that the proportion of SBRT patients with occult lymph node metastases is likely at least equal to that in the surgery group, but these metastases would go undetected without pathologic assessment.

Missing potential occult micrometastases in the SBRT group likely contributed to higher regional recurrence rates over time. By improving nodal staging, more patients with occult lymph node metastases who would be undertreated with SBRT may be identified before treatment, the authors said.

 

What Do Experts Say?

So, is SBRT an option for patients with stage I NSCLC?

Opinions vary.

“If you got one shot for a cure, then you want to do the surgery because that’s what results in a cure,” said Raja Flores, MD, chairman of Thoracic Surgery, Mount Sinai Health System, New York City.

Flores noted that the survival rate with surgery is high in this population. “There’s really nothing out there that can compare,” he said.

In his view, surgery “remains the gold standard.” However, “radiation could be considered in nonsurgical candidates,” he said.

The most recent NCCN guidelines align with Flores’ take. The guidelines say that SBRT is indicated for stage IA-IIA (N0) NSCLC in patients who are deemed “medically inoperable, high surgical risk as determined by thoracic surgeon, and those who decline surgery after thoracic surgical consultation.”

Clifford G. Robinson, MD, agreed. “In the United States, we largely treat patients with SBRT who are medically inoperable or high-risk operable and a much smaller proportion who decline surgery,” said Robinson, professor of radiation oncology and chief of SBRT at Washington University in St. Louis, St. Louis. “Many patients who are deemed operable are not offered SBRT.”

Still, for Robinson, determining which patients are best suited for surgery or SBRT remains unclear.

“Retrospective comparisons are fraught with problems because of confounding,” Robinson told this news organization. “That is, the healthier patients get surgery, and the less healthy ones get SBRT. No manner of fancy statistical manipulation can remove that fact.”

In fact, a recent meta-analysis found that the most significant variable predicting whether surgery or SBRT was superior in retrospective studies was whether the author was a surgeon or radiation oncologist.

Robinson noted that multiple randomized trials have attempted to randomize patients with medically operable early-stage NSCLC to surgery or SBRT and failed to accrue, largely due to patients’ “understandable unwillingness to be randomized between operative vs nonoperative interventions when most already prefer one or the other approach.”

Flores highlighted another point of caution about interpreting trial results: Not all early-stage NSCLC behaves similarly. “Some are slow-growing ‘turtles,’ and others are aggressive ‘rabbits’ — and the turtles are usually the ones that have been included in these radiotherapy trials, and that’s the danger,” he said.

While medical operability is the primary factor for deciding the treatment modality for early-stage NSCLC, there are other more subtle factors that can play into the decision.

These include prior surgery or radiotherapy to the chest, prior cancers, and social issues, such as the patient being a primary caregiver for another person and job insecurity, that might make recovery from surgery more challenging. And in rare instances, a patient may be medically fit to undergo surgery, but the cancer is technically challenging to resect due to anatomic issues or prior surgery to the chest, Robinson added.

 

A Winner?

Results from two ongoing, highly anticipated randomized trials expected in the next several years will hopefully provide additional insights and clarify ongoing uncertainties about the optimal treatment strategies for operable patients with stage I NSCLC.

STABLE-MATES is comparing outcomes after sublobar resection and SBRT in high-risk operable stage I NSCLC, and VALOR is evaluating outcomes after anatomic pulmonary resections and SBRT in patients with stage I NSCLC who have a long life expectancy and are fit enough to tolerate surgery.

But Robinson said his group believes that trying to decide on a winner is a “fool’s errand” and is instead running a pragmatic study across multiple academic and community centers around the United States and Canada where patients choose therapy based on their personal preferences and guidance from their physicians. The researchers will carefully track baseline comorbidity and frailty and assess serial quality-of-life changes over time.

“The goal is to create a calculator that a given patient might use in the future to determine what patients like them would have received, complete with expected outcomes and side effects,” Robinson said.

Robinson cautioned, however, that it “seems unlikely, given the existing literature, that one of the treatments will be truly ‘superior’ to the other one and lead to the ‘losing’ treatment fading away since both are excellent options with pros and cons.”

Aggarwal, Robinson, and Flores had no relevant disclosures.

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

For years, the default definitive treatment for patients with early-stage I non–small cell lung cancer (NSCLC) has been surgical resection, typically minimally invasive lobectomy with systematic lymph node dissection.

Guidelines from the National Comprehensive Cancer Network (NCCN), the American Society of Clinical Oncology, and the European Society for Medical Oncology all list surgery (in particular, lobectomy) as the primary local therapy for fit, operable patients with stage I NSCLC.

More recently, however, stereotactic body radiotherapy (SBRT), also called stereotactic ablative radiotherapy, has emerged as a definitive treatment option for stage I NSCLC, especially for older, less fit patients who are unsuitable or deemed high-risk for surgery.

“We see patients in our practice who cannot undergo surgery or who may not have adequate lung function to be able to tolerate surgery, and for these patients who are medically inoperable or surgically unresectable, radiation therapy may be a reasonable option,” Charu Aggarwal, MD, MPH, professor and lung cancer specialist, University of Pennsylvania, Philadelphia, told this news organization.

Given some encouraging data suggesting that SBRT could provide similar survival outcomes and be an alternative to surgery for operable disease, SBRT is also increasingly being considered in these early-stage patients. However, other evidence indicates that SBRT may be associated with higher rates of regional and distant recurrences and worse long-term survival, particularly in operable patients.

What may ultimately matter most is carefully selecting operable patients who undergo SBRT.

Aggarwal has encountered certain patients who are fit for surgery but would rather have radiation therapy. “This is an individual decision, and these patients are usually discussed at tumor board and in multidisciplinary discussions to really make sure that they’re making the right decision for themselves,” she explained.

 

The Pros and Cons of SBRT

SBRT is a nonsurgical approach in which precision high-dose radiation is delivered in just a few fractions — typically, 3, 5, or 8, depending on institutional protocols and tumor characteristics.

SBRT is performed on an outpatient basis, usually over 1-2 weeks, with most patients able to resume usual activities with minimal to no delay. Surgery, on the other hand, requires a hospital stay and takes most people about 2-6 weeks to return to regular activities. SBRT also avoids anesthesia and surgical incisions, both of which come with risks.

The data on SBRT in early-stage NSCLC are mixed. While some studies indicate that SBRT comes with promising survival outcomes, other research has reported worse survival and recurrence rates.

One potential reason for higher recurrence rates with SBRT is the lack of pathologic nodal staging, which only happens after surgery, as well as lower rates of nodal evaluation with endobronchial ultrasound or mediastinoscopy before surgery or SBRT. Without nodal assessments, clinicians may miss a more aggressive histology or more advanced nodal stage, which would go undertreated if patients received SBRT.

 

Latest Data in Large Cohort

A recent study published in Lung Cancer indicated that, when carefully selected, operable patients with early NSCLC have comparable survival with lobectomy or SBRT.

In the study, Dutch researchers took an in-depth look at survival and recurrence patterns in a retrospective cohort study of 2183 patients with clinical stage I NSCLC treated with minimally invasive lobectomy or SBRT. The study includes one of the largest cohorts to date, with robust data collection on baseline characteristics, comorbidities, tumor size, performance status, and follow-up.

Patients receiving SBRT were typically older (median age, 74 vs 67 years), had higher comorbidity burdens (Charlson index ≥ 5 in 57% of SBRT patients vs 23% of surgical patients), worse performance status, and lower lung function. To adjust for these differences, the researchers used propensity score weighting so the SBRT group’s baseline characteristics were comparable with those in the surgery group.

The surgery cohort had more invasive nodal evaluation: 21% underwent endobronchial ultrasound or mediastinoscopy vs only 12% in the SBRT group. The vast majority in both groups had PET-CT staging, reflecting modern imaging-based workups.

While 5-year local recurrence rates between the two groups were similar (13.1% for SBRT vs 12.1% for surgery), the 5-year regional recurrence rate was significantly higher after SBRT than lobectomy (18.1% vs 14.2%; hazard ratio [HR], 0.74), as was the distant metastasis rate (26.2% vs 20.2%; HR, 0.72).

Mortality at 30 days was higher after surgery than SBRT (1.0% vs 0.2%). And in the unadjusted analysis, 5-year overall survival was significantly better with lobectomy than SBRT (70.2% vs 40.3%).

However, when the analysis only included patients with similar baseline characteristics, overall survival was no longer significantly different in the two groups (HR, 0.89; 95% CI, 0.65-1.20). Lung cancer–specific mortality was also not significantly different between the two treatments (HR, 1.08), but the study was underpowered to detect significant differences in this outcome on the basis of a relatively low number of deaths from NSCLC.

Still, even after comparing similar patients, recurrence-free survival was notably better with surgery (HR, 0.70), due to fewer regional recurrences and distant metastases. Overall, 13% of the surgical cohort had nodal upstaging at pathology, meaning that even in clinically “node-negative” stage I disease, a subset of patients had unsuspected nodal involvement.

Patients receiving SBRT did not have pathologic nodal staging, raising the possibility of occult micrometastases. The authors noted that the proportion of SBRT patients with occult lymph node metastases is likely at least equal to that in the surgery group, but these metastases would go undetected without pathologic assessment.

Missing potential occult micrometastases in the SBRT group likely contributed to higher regional recurrence rates over time. By improving nodal staging, more patients with occult lymph node metastases who would be undertreated with SBRT may be identified before treatment, the authors said.

 

What Do Experts Say?

So, is SBRT an option for patients with stage I NSCLC?

Opinions vary.

“If you got one shot for a cure, then you want to do the surgery because that’s what results in a cure,” said Raja Flores, MD, chairman of Thoracic Surgery, Mount Sinai Health System, New York City.

Flores noted that the survival rate with surgery is high in this population. “There’s really nothing out there that can compare,” he said.

In his view, surgery “remains the gold standard.” However, “radiation could be considered in nonsurgical candidates,” he said.

The most recent NCCN guidelines align with Flores’ take. The guidelines say that SBRT is indicated for stage IA-IIA (N0) NSCLC in patients who are deemed “medically inoperable, high surgical risk as determined by thoracic surgeon, and those who decline surgery after thoracic surgical consultation.”

Clifford G. Robinson, MD, agreed. “In the United States, we largely treat patients with SBRT who are medically inoperable or high-risk operable and a much smaller proportion who decline surgery,” said Robinson, professor of radiation oncology and chief of SBRT at Washington University in St. Louis, St. Louis. “Many patients who are deemed operable are not offered SBRT.”

Still, for Robinson, determining which patients are best suited for surgery or SBRT remains unclear.

“Retrospective comparisons are fraught with problems because of confounding,” Robinson told this news organization. “That is, the healthier patients get surgery, and the less healthy ones get SBRT. No manner of fancy statistical manipulation can remove that fact.”

In fact, a recent meta-analysis found that the most significant variable predicting whether surgery or SBRT was superior in retrospective studies was whether the author was a surgeon or radiation oncologist.

Robinson noted that multiple randomized trials have attempted to randomize patients with medically operable early-stage NSCLC to surgery or SBRT and failed to accrue, largely due to patients’ “understandable unwillingness to be randomized between operative vs nonoperative interventions when most already prefer one or the other approach.”

Flores highlighted another point of caution about interpreting trial results: Not all early-stage NSCLC behaves similarly. “Some are slow-growing ‘turtles,’ and others are aggressive ‘rabbits’ — and the turtles are usually the ones that have been included in these radiotherapy trials, and that’s the danger,” he said.

While medical operability is the primary factor for deciding the treatment modality for early-stage NSCLC, there are other more subtle factors that can play into the decision.

These include prior surgery or radiotherapy to the chest, prior cancers, and social issues, such as the patient being a primary caregiver for another person and job insecurity, that might make recovery from surgery more challenging. And in rare instances, a patient may be medically fit to undergo surgery, but the cancer is technically challenging to resect due to anatomic issues or prior surgery to the chest, Robinson added.

 

A Winner?

Results from two ongoing, highly anticipated randomized trials expected in the next several years will hopefully provide additional insights and clarify ongoing uncertainties about the optimal treatment strategies for operable patients with stage I NSCLC.

STABLE-MATES is comparing outcomes after sublobar resection and SBRT in high-risk operable stage I NSCLC, and VALOR is evaluating outcomes after anatomic pulmonary resections and SBRT in patients with stage I NSCLC who have a long life expectancy and are fit enough to tolerate surgery.

But Robinson said his group believes that trying to decide on a winner is a “fool’s errand” and is instead running a pragmatic study across multiple academic and community centers around the United States and Canada where patients choose therapy based on their personal preferences and guidance from their physicians. The researchers will carefully track baseline comorbidity and frailty and assess serial quality-of-life changes over time.

“The goal is to create a calculator that a given patient might use in the future to determine what patients like them would have received, complete with expected outcomes and side effects,” Robinson said.

Robinson cautioned, however, that it “seems unlikely, given the existing literature, that one of the treatments will be truly ‘superior’ to the other one and lead to the ‘losing’ treatment fading away since both are excellent options with pros and cons.”

Aggarwal, Robinson, and Flores had no relevant disclosures.

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