Rose McNulty

Adding radiation therapy (RT) to pembrolizumab immunotherapy increased patient responses and improved outcomes in metastatic non-small cell 

) trials included patients 18 years of age or older with metastatic NSCLC and at least 1 lesion that was untreated with radiation and could be monitored. Patients in the PEMBRO-RT trial had already received chemotherapy at some point, but the MDACC trial included both participants who were newly diagnosed and those who were previously treated. In both trials, patients were new to immunotherapy.

Each trial saw a potential benefit of RT in the combination treatment cohort, but researchers opted to conduct a pooled analysis due to the small sample size of each trial. The end points of the analysis were best abscopal response rate (ARR), best abscopal disease control rate (ACR), best 12-week ARR, best 12-week ACR, progression-free survival (PFS), and overall survival (OS).

In both trials, patients were randomly assigned to receive either pembrolizumab or combination treatment with pembrolizumab and RT. The PEMBRO-RT trial stratified patients by smoking status (<10 vs ≥10 pack-years). The MDACC trial separated them into groups based on the feasibility of the RT schedules. Neither trial was blinded due to the nature of intervention with RT.

Patients in both studies received 200 mg of pembrolizumab intravenously every 3 weeks, with or without RT. The combination therapy cohort in the PEMBRO-RT trial received the first dose of pembrolizumab less than 1 week after the last dose of RT, and the MDACC trial received the first dose of pembrolizumab concurrently with the first dose of RT. The intention-to-treat populations from both studies were included in the pooled analysis.

Of the 148 patients included in the analysis, 76 were assigned to the pembrolizumab cohort and 72 received the added RT. There were 124 patients (84%) with non-squamous histological features, and 111 (75%) had received chemotherapy prior to the study. Baseline variables, including metastatic disease volume and PD-L1 status, were the same in both treatment groups.

Lung metastases, intrathoracic lymph nodes, and lung primary disease were the most treated areas (39%, 21%, and 17%, respectively).

Median follow-up was 33 months, and the best ARR was 19.7% with pembrolizumab alone, compared to 41.7% with combination therapy (odds ratio [OR], 2.96; 95% CI, 1.42-6.20; 

= .0039). The best ACR was 43.4% in the pembrolizumab group compared with 65.3% with added RT (OR, 2.51; 1.28-4.91; 

Median PFS, another key end point, was 4.4 months in the pembrolizumab cohort and 9 months in the pembrolizumab-RT cohort (hazard ratio [HR], 0.67; 95% CI, 0.45-0.99; 

= .045). Median OS in the pembrolizumab group was 8.7 months, while the combination therapy group had a median OS of 19.2 months (HR, 0.67; 0.54-0.84; P = .0004). Authors reported no new findings in regard to the safety profile of the treatment.

Study authors concluded that combination treatment with pembrolizumab and RT was more effective than receiving pembrolizumab alone, and that the added RT significantly increased NSCLC patient outcomes. They note that the results of the analysis call for a future phase 3, randomized trial to validate the findings.

Theelan W, Chen D, Verma V, et al. Pembrolizumab with or without radiotherapy for metastatic non-small-cell lung cancer: a pooled analysis of two randomised trials. 

. Published online October 20, 2020. Accessed October 23, 2020. doi:10.1016/S2213-2600(20)30391-X

Articles

Researchers analyzed 2 randomized studies to learn how adding radiation therapy to pembrolizumab immunotherapy affects non-small cell lung cancer patient outcomes.

Pembrolizumab Plus Radiation Therapy Improves NSCLC Outcomes, Study Finds

Oncology payment and delivery reform has seen plenty of discussion, especially in the wake of a pandemic that changed virtually everything about daily life, including the way physicians practice and patients’ attitudes toward seeking care.

The future of oncology care was the key topic of interest in a 

, head of client solutions, marketing, and operations hosted the webinar, which featured a panel that included practice director 

; senior strategic advisor Roy Beveridge, MD; and 

Care delivery and payment reform are timely topics given the effect that the pandemic has had on cancer treatment. A 

 and the Community Oncology Alliance (COA), published online just ahead of discussion, showed sharp declines in screenings and treatment in 2020 compared to 2019.

“It’s the screening, it’s the treatment, it’s the follow-up aftercare,” Beveridge said. “All facets of oncology care have been significantly impacted. And as you begin to look at the data, you realize this is going to impact us as a society for many years to come.”

The data showed that patient outcomes could be negatively affected by the trends, and Grady noted the implications that those data have when it comes to practicing oncology.

“From the business of oncology, this is also substantial,” Grady explained. “From a lack of predictability in fee-for-service (FFS) revenue this is significant, and from perhaps a lack of predictability if you are bearing risk in an alternative payment model with CMS or with a commercial health plan in that contractual arrangement, this also has ramifications.”

Beveridge also noted that the type of care for patients will shift as a lack of screenings leads to detection at later stages of disease, which will have a significant impact in the coming years.

Despite the negative effects stemming from the pandemic, the panelists agreed that a silver lining in the ordeal has been the significant growth in telehealth offerings and coverage.

“There were already environmental factors that were facilitating the adoption of telehealth, but with the pandemic and the flexibilities that the federal government and the states moved to put in place, we saw explosive growth,” Sullivan said. That is particularly true in the community oncology setting as opposed to hospital settings, she noted.

Even so, Sullivan stressed the importance of both monitoring the success of telehealth and seeing what still needs more facilitation or reimbursement incentives. That will help determine which of the flexibilities during the public health emergency should remain in the long term.

“When you talk to physicians and patients, they are much more accepting of telehealth than they were, say, back in January of this year,” Beveridge added. “I think that’s a very positive thing in terms of what this crisis has resulted in. People are much more comfortable with using technology when it’s available and accepting something that is good standard of care.”

While the government also moved to give patients the ability to use home health for physician-administered drugs, the complexity and safety issues involved with those products have slowed the shift to home health, according to Sullivan. Going forward, she expects different approaches will be taken depending on the therapeutic area and drug type when it comes to home health.

Beveridge agreed, noting that it is not as simple as providing drugs in the home. The drugs that oncology nurses administer are complicated and dangerous, requiring a certain skillset and a very controlled environment. 

On the payment reform end, one obstacle when it comes to value-based models has been a disrupted baseline for setting risk-based payment or benchmark prices to enter into either downside risk or value-based contracts, Grady explained. But he thinks that value-based models are here to stay in oncology, depending on the practice setting.

“In [the Oncology Care Model], we’ve started to see that it is the small or mid-sized community oncologists that are outperforming or demonstrating characteristics of performance more so than health systems,” Grady said. That has to do with factors like patient flow and attribution, interventions, 24/7 care, and now telehealth. That and managing diagnosis to treatment are some key characteristics he cites for successful practices in value-based models.

Of note is also the upcoming implementation of the Radiation Oncology Model (RO) at the beginning of 2021. Sullivan sees it as a signal that the Center for Medicare and Medicaid Innovation wants to find ways to move more toward bundled, prospective payment models.

For his part, Grady hopes that physicians who see FFS revenue dropping do not jump to capitation just for a predictable salary.

“Just because you have a ceiling price doesn’t necessarily mean that ceiling-based medicine results in the appropriate care or the right sort of care that even a payer would like to see,” Grady said. He foresees CMMI implementing a combination of strategies when Oncology Care First (OCF) eventually launches. “They’ve given a FFS-based model in medical oncology, the OCM, toward a benchmark or set price. Now they’re looking at a fully prospective payment model in RO, and we’re likely to see a blend of the two in OCF.”

With innovations and advances in therapy, practitioners have made great strides in patient care. Beveridge considers precision, specialized medicine to be a key aspect of improvements in care. The understanding of genetics and biologics surrounding conditions has also improved.

“Now we have to understand our patients really clearly and understand the associated data to optimally treat these people based on really specific characterization of their tumors and the patient’s performance status,” Beveridge said.

Butler raised the issue of chimeric antigen receptor (CAR) T-cell therapies, products that have introduced complexities to the market when it comes to how to pay for treatment. Any durable, potentially curative therapies challenge the system, she explained, because the system is better set up to pay for treatments for chronic conditions and treatments that are not curative.

“We’ve got a long way to go to speed up the regulatory system and payment infrastructure to account for some of these innovations,” Grady said. Developing unique and innovative payment systems to match the innovations in treatment is necessary to make them available to the patients who can benefit from them, the panelists agree.

As far as policies and priorities with implications in oncology, the panel highlighted that another Trump administration would put focus on international reference pricing, a redesign of Medicare Part D benefit and reform rebates, and a ruling on the Affordable Care Act from the Supreme Court. A Biden administration, on the other hand, would focus on expanding eligibility for Medicare, direct Medicare negotiation, and a drug price review board.

The perfect storm of a pandemic and the resulting economic downturn has put Healthcare at the forefront of political campaigning ahead of the election, Sullivan noted, and much of the future of care is likely dependent on the outcome.

Experts in cancer care and payment discussed the future of oncology care in a panel discussion hosted by Avalere Health on October 21, 2020.

Experts Discuss Oncology Care and Payment Reform in Avalere Webinar

Screening and treatments for breast, colon, prostate, and lung cancers saw harsh declines in 2020 due to the coronavirus disease 2019 (COVID-19) pandemic, and oncology care delivery has yet to fully rebound, 

 published online ahead of publication in the November issue of 

Study authors warn that the fallout could be increased cancer morbidity and mortality for years to come.

 (COA), analyzed billing trends for common cancer procedures from March to July 2020. Data were collected from a large medical claims clearinghouse database that represented 5%-7% of the Medicare Fee for Service (FFS) population. They showed that cancer screenings, office visits, biopsies, therapies, and surgeries were all heavily impacted by the pandemic, with variations by cancer type and the type of provider.

Screenings for breast, colon, prostate, and lung cancer dropped dramatically (by 85%, 75%, 74%, and 56%, respectively) at the peak of the pandemic in April 2020 compared with 2019. Delays in screening can negatively impact patients in a big way.

“If that happens, whatever the cause may be, there'll be higher mortality from cancer, and patients will be diagnosed later in the course of disease,” 

, MD, study co-author, president and managing physician of Florida Cancer Specialists and Research Institute, and member of the COA Board of Directors told 

) in an interview. “Instead of getting surgery and being cured, maybe there'll be no chance of surgery, and there'll be just palliative care, chemotherapy, immunotherapy, or whatever the treatment options are.”

He added that patients who are diagnosed at a later stage with more complex disease or comorbidities have the potential to increase the cost of care to the health system and to payers, so being proactive and getting patient screenings back to their pre-COVID-19 levels is imperative on that front as well as for patient outcomes.

In addition to the drop in screenings early in the pandemic, there were 2 significant dips in billing for the top 23 physician-administered oncology products (determined by 2018 Medicare Part B spending). In April of 2020, billing for those products was down 26% compared to 2019. After a rebound in June, which saw a relatively better 17% decline compared to last year, July saw an even worse decline (-31%).

There were also 2 distinct drops in billing for the administration of chemotherapy compared to last year. At professional practices, chemotherapy administration dropped by 19% in March of 2020 versus 2019, 28% in April, 30% in May, 19% in June, and 31% in July. Institutional practices saw declines of 10%, 21%, 21%, 16%, and 31%, respectively. Reductions were also seen in both April and July for breast (-71% and -31%), colon (-79% and -33%), and lung biopsies (-58% and -47%).

The authors, led by Debra Patt, MD, PhD, MBA, of Texas Oncology, suspect that the second waves of billing declines in the latter months of the pandemic speak to the typical time between screening, diagnosis, and treatment. “Due to the extended timeline of a patient’s cancer treatment journey, there is an expected lag of up to three months between when a patient is screened for cancer and is subsequently scheduled for a biopsy and then eventually receives treatment,“ the authors wrote.

Patient evaluation and management (E&M) visits saw the most significant dip in April, when hospital outpatient E&M visits were down 74% from 2019. The drop was more significant in new patient E&M visits than for established patients.

Overall, providers in institutional settings saw larger dips in cancer care delivery than those in community settings by an average of 10 percentage points from April to July, likely due to the resource and supply chain barriers posed by the pandemic. Patient reluctance to seek care at the hospital may also have played a part, the authors note. Telehealth, which was implemented largely by community oncology practices, helped quell that issue but could not bridge the gap.

“I admire the hospital systems, as they had to handle the acute crisis of a lot of incoming patients with COVID-19. They had to put all their resources into the acute care of such patients,” Gordan explained. “There's 95% telehealth in community oncology versus a much lower number, in the single digits, in hospital oncology practices. This is because the hospitals are dealing with many more complex problems. But essentially, the way we [adapt] in community oncology tends to be faster.”

The study authors aim to raise awareness of the potential fallout from delays in screenings and cancer treatment and encourage people to stay on track with preventive and continuing care. Now that practices have created protocol to keep patients safe as they seek care, Gordan hopes that those who need cancer care will be able to receive it without worry.

“I hope we, as providers, continue to educate and show that it is important to maintain preventive care,” Gordan said. “And so we hope to get behind processes and procedures related to public service announcements, to hopefully get the word out there that we cannot stop taking care of ourselves.”

Patt D, Gordan L, Diaz M, et al. The Impact of COVID-19 on Cancer Care: How the pandemic is delaying cancer diagnosis and treatment for American seniors. 

 Published online October 21, 2020. Accessed October 22, 2020. doi:10.1200/CCI.20.00134

Cancer screenings and treatments saw a sharp decline during the early months of the pandemic. The authors of a new study on the delays in care warn that the fallout may be grim. 

Cancer Care Delays in COVID-19 Could Lead to Higher Morbidity, Mortality

The coronavirus disease 2019 (COVID-19) pandemic has caused widespread delays and cancellations in the health care world, including in cancer care. And for breast cancer patients facing delays in surgery, this could result in close to 3000 additional deaths over a 10-year period, according to an 

The database, a tool used to provide data and insight to drug developers and investors, estimates that there will be 335,779 new breast cancer cases in the United States in 2020, 319,700 of which will be non-metastatic.

Those patients have good potential for positive outcomes when treated quickly and appropriately, but delays in care can make a significant difference. The press release highlights a 

 that estimates a 60-day delay in breast cancer surgery to cause a 4% increase in the number of deaths after 5 years and 7% more deaths at 10 years.

With those percentages and the estimated number of new cases over the entire year in mind, Kantar Health expects that 79,925 new non-metastatic breast cancer cases were diagnosed in the first 3 months of the pandemic when 

elective surgery was temporarily suspended

 in hospitals bogged down by COVID-19 patients. That would lead to 1598 deaths 5 years after diagnosis and 2797 deaths at 10 years.

 Younger women faced more postponements, most often related to ovarian suppression hormone therapies. But overall, the study found that 44% of breast cancer survivors reported delays in treatment due to COVID-19. The study authors noted that “interruptions in care due to disasters often result in increased rates of disease progression, pain, and excess mortality.”

The Kantar Health analysis also expects the cost of cancer treatment to rise because of the number of patients whose disease will become metastatic at some point. They estimate that breast cancer car will cost an additional $215.2 million at 5 years post-COVID-19 and $376.7 million 10 years after.

“The effects of the pandemic will be felt deeply in many disease areas, but none more so than in oncology,” Jeremy Brody, chief strategy officer at Kantar Health, said in the release. “It is important that patients continue to maintain their regular appointments and screenings to detect and treat breast cancer. The COVID-19 global pandemic needs to be a catalyst for the health care system to seek new ways to reach patients and ensure early detection screenings continue.”

1. COVID-19 Related Breast Cancer Surgery Delays Could Result in Nearly 3,000 Additional Deaths Over a 10 Year Period. News Release. Businesswire; October 19, 2020. Accessed October 19, 2020. 

https://www.businesswire.com/news/home/20201019005633/en/COVID-19-Related-Breast-Cancer-Surgery-Delays-Could-Result-in-Nearly-3000-Additional-Deaths-Over-a-10-Year-Period

2. Papautsky EL, Hamlish T. Patient‑reported treatment delays in breast cancer care during the COVID‑19 pandemic. 

Published online August 9, 2020. doi:10.1007/s10549-020-05828-7

A new analysis predicts close to 3000 additional deaths over a 10-year period in patients who faced delays in breast cancer treatment during the pandemic.  

Author | Rose McNulty

Articles

Pembrolizumab Plus Radiation Therapy Improves NSCLC Outcomes, Study Finds

Experts Discuss Oncology Care and Payment Reform in Avalere Webinar

Cancer Care Delays in COVID-19 Could Lead to Higher Morbidity, Mortality

COVID-19 Delays in Breast Cancer Surgery Could Mean More Deaths Over Next Decade