Initiation of Abbott's FreeStyle Libre, a sensor-based glucose monitoring system, resulted in a dramatic decrease in diabetic ketoacidosis (DKA) rates among patients with type 1 and type 1 diabetes, according to results from a study presented today during the American Diabetes Association’s (ADA’s) 80th Scientific Sessions.

The findings from the RELIEF study, which is the largest study to date on the effect of FreeStyle Libre system on hospitalization rates for DKA, were presented by lead investigator Ronan Roussel, MD, PhD, chief of the endocrinology, diabetes, and nutrition department at Hôpital Bichat, Fédération de Diabétologie, AP-HP, Paris, France.

The FreeStyle Libre system is designed to address the pain, inconvenience, and hassles of both strip and sensor-based glucose monitoring, Dr Roussel said in the presentation. The overall study aimed to describe how prescription and use of the FreeStyle Libre device is being managed for patients with diabetes, and assess the effect on health care outcomes and associated costs in standard practice in France. For the current analysis, the investigators sought to assess the risk of hospitalization related to DKA before and after access to the FreeStyle Libre system in France in patients with type 1 and type 2 diabetes.

For the study, the investigators retrospectively analyzed DKA rates using ICD-10 codes on the French national claims database, among 33,203 individuals with type 1 diabetes and 40,955 individuals with type 2 diabetes who used the FreeStyle Libre system between August 1, 2017 and December 31, 2017. DKA rates were recorded in the year prior to the first FreeStyle Libre sensor claim and in the year after. Eligible patients enrolled in the study were classified according to their use of self-monitoring blood glucose (SBMG) test strips in the year prior to initiation of the FreeStyle Libre system.

The results showed that, overall, yearly DKA rates decreased after FreeStyle Libre initiation by 52% for patients with type 1 diabetes and 47% for patients with type 2 diabetes.

In the sub-population of patients who did not use SMBG testing in the year prior, there was a 60% reduction for patients with type 1 diabetes and 51% reduction for patients with type 2 diabetes. Marked reductions in hospitalizations were also demonstrated in patients with the most regular use of SMBG testing (59% for type 1 diabetes and 52% for type 2 diabetes), according to the study.

Additionally, reduced hospitalization rates for DKA were observed for patients treated with multiple daily injections, as well as for patients who used continuous insulin infusion.

“It is plausible that the use of the FreeStyle Libre system allowed people to detect and limit persistent hyperglycemia, and subsequently ketoacidosis,” Roussel noted in the presentation. He concluded that the analysis has significant implications for patient-centered clinical care in diabetes and also for long-term health economic outcomes in the treatment of diabetes at a national level.

1. Roussel R, Guerci B, Vicaut E, et al. Dramatic drop in ketoacidosis rate after FreeStyle Libre system initiation in type 1 and type 2 diabetes in France, especially in people with low self-monitoring of blood glucose (SBMG): A nationwide study. Presented at: The American Diabetes Association 80th Scientific Sessions; June 12-16; online.

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ADA Scientific Sessions

New findings from a study presented at the ADA’s 80th Scientific Sessions showed a dramatic drop in diabetic ketoacidosis hospitalizations in patients who used the FreeStyle Libre system

ADA 2020: FreeStyle Libre System Use Decreases Diabetic Ketoacidosis Rates

Technology-enhanced insulin education by pharmacists prior to hospital discharge led to improved outcomes for patients with diabetes, according to new research presented at the American Diabetes Association’s (ADA’s) 80th Scientific Sessions.

Proper insulin injection technique is imperative to optimizing glycemic control and ensure safe medication use. Since January 2018, unit-based pharmacists at Greenville Memorial campus have been providing insulin administration education prior to patient discharge. The study, which was presented virtually by study investigator Jessica M. Odom, PharmD, BCPS-BC-ADM, evaluated the effect of incorporating iPad insulin education videos into standardized pharmacist insulin teaching at bedside prior to inpatient discharge.

According to Odom, the 8-minute insulin administration video demonstrated how to give an insulin injection, safely dispose of sharps, and recognize and treat hypoglycemia. The video also provided other insulin educational points, such as by explaining how insulin works to lower blood glucose, as well as the difference between basal and bolus insulin.

The study compared patients who received traditional pharmacist insulin teaching over a 6-month period versus the technology-enhanced pharmacist insulin teaching for 6 months. In the technology-enhanced teaching group, patients were able to review insulin education via an iPad at bedside and were then able to practice with demo tools, and receive coaching or corrections from a pharmacist. Patients included in the study were older than 18 years of age with either new insulin orders or, if taking insulin prior to admission, a HbA1c ≥8.5%, according to the study.

Using an 8-item survey administered pre- and post-education, the investigators assessed changes in confidence in insulin administration and storage, hypoglycemia managements, and sharps disposal on a scale of 1 to 5, with 5 indicating the highest confidence.

Average A1c at baseline was over 10%. Patients in both groups improved from their baseline scores across all 8 items in the survey. Statistically significant differences were seen across 4 survey items favoring the technology-enhanced teaching, including the right time to give insulin, how to store insulin, how to give yourself an injection, and how to prepare a dose of insulin, Odom reported. Additionally, follow-up A1c within 4 months of discharge improved to 9.4 in the traditional group and 8.7 in the iPad group, according to the findings. Diabetes-related readmissions were similar between both groups.

“Technology-enhanced education improved patient outcomes while offering a consistent and concise tool to deliver education,” Odom said in the presentation. “Patients in the study had uncontrolled diabetes, frequently were prescribed insulin in the outpatient setting, yet many had never received education on this high-risk education.”

Although inpatient education by pharmacists prior to discharge improved patient confidence in insulin administration across both groups, the use technology-enhanced insulin education may further reduce pharmacist burden without negatively affecting patient outcomes, the study concluded.

A poster presented at ADA’s 80th Scientific Sessions examines the effects of interactive pharmacist insulin teaching for patients with diabetes prior to hospital discharge.

Technology-Enhanced Insulin Education by Pharmacists Prior to Hospital Discharge Boosts Patient Confidence

A study presented at the American Diabetes Association's (ADA) 80th Scientific Sessions demonstrated promising results related to adherence, engagement, and awareness of HbA1c control in rural patients with poorly-controlled diabetes who participated in a telehealth program.

Coauthor Elizabeth A Kobe, BS, MD candidate at Duke University Medical School, presented the findings, highlighting demographic significance of the study. Kobe and her colleagues underlined that access to specialty care and intensive self-management programs are severely limited and lead to poor outcomes in patients with diabetes. Health care has recently trended toward numerous telehealth technologies, which function to expand access and opportunity for addressing health conditions, prominently diabetes management.

Investigators assessed the potential benefits and drawbacks of employing telehealth resources in routine practice through their study, which evaluated adherence to Advanced Comprehensive Diabetes Care (ACDC), a 6-month intensive telehealth intervention for patients with poor glycemic control. ACDC incorporated telemonitoring, self-management support, and clinician-guided medication management through standard Home Telehealth (HT) equipment. Investigators restructured the existing Veterans Health Administration (VHA) HT platform to cater to patients with uncontrolled type 2 diabetes, despite receiving routine care.

In a prior randomized trial, ACDC showed favorable results, suggesting the potential for improved diabetes outcomes in rural populations.

“We are pleased to see that the intervention was well-suited for delivery in clinical practice and that it remained effective in real-world settings,” Kobe said.2 “When telehealth interventions are designed to leverage existing resources, they can greatly improve diabetes care in underserved rural populations. We also believe this design-minded approach can extend to other chronic diseases.”

The multi-site study assessed 125 rurally-located patients with diabetes using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework between 2017 and 2019. Across the 5 rural VHA sites, mean HbA1c improved significantly from 9.25% at baseline to 7.89% at 6 months, additionally persisting at 12 and 18 months. The study showed acceptable implementation of the program at each site: an average of 8 to 10 of 12 scheduled ACDC calls were completed. Kobe also noted that the investigators will continue to analyze barriers and facilitators to adoption at each of the sites.

The study additionally reported demographic data related to the rural participants. Of the 125 patients, 94% were male, 89% white, and 71% were classified as rural or highly rural, “which is a positive reflection of the fact that we targeted VAs with large rural populations specifically,” Kobe said in the presentation.

Data from qualitative interviews found that ACDC enhanced patient engagement and improved awareness of glycemic controls; however, the program did moderately increase provider workload

Kobe discussed the reasons for the program’s success, which include its strategic intervention design that leveraged existing HT staffing and standard HT equipment and integrated naturally with the electronic health records. Additionally, the program was developed through an iterative process, focusing on 1 site and then expanding each year, as well as utilizing patient feedback.

“Despite the drastic changes that [coronavirus disease 2019] has forced health care systems to make, ACDC delivery has continued unabated,” Kobe added.

She concluded by saying that the program has made a substantial difference for rural patients with diabetes and is well-positioned for further dissemination.

1. Kobe EA, Lewinski A, Danus S, et al. Implementation of an Intensive Telehealth Intervention for Rural Patients with Uncontrolled Diabetes. Presented at: The American Diabetes Association 80th Annual Scientific Sessions; June 12-16; online.

2. Intensive Use of Telehealth Improves Glycemic Control Among Rural Patients with Type 2 Diabetes. American Diabetes Association; June 12, 2020. Accessed June 12, 2020. 

https://www.diabetes.org/newsroom/press-releases/2020/intensive-use-of-t...

Presented during ADA’s 80th Scientific Sessions, results from an analysis of a 6-month telehealth intervention showed sustained improvements in glycemic control in patients with diabetes. 

Telehealth Program Enhances Engagement, Glycemic Control in Rural Patients With Diabetes

A study published at the virtual American Diabetes Association (ADA) 80th Scientific Sessions, evaluated whether select type 2 diabetes (T2D) medications in combination with frequency of clinical touches helped predict hemoglobin A1c (HbA1c) control in patients.

Lead author Angeline Vascimini, PharmD, explained a concerning and increasingly prevalent trend: patients in rural areas are experiencing challenges in health care access and treatment. In light of recent surges in pharmacologic agents indicated for patients with T2D, along with decreasing trends in the United States of rural-practicing physicians, Vascimini asserted that pharmacists practicing in resource-limited rural areas are well-positioned to act as extenders.

Prior research has suggested that the number of clinical diabetes-related touches can largely predict outcomes in patients with T2D in rural regions. The frequency of appointments and pharmacotherapy regimen have been employed to analyze a patient’s HbA1C control.

The single center retrospective chart review, which analyzed data from the electronic medical records, included sample data from 300 patients with an IDC-10 code related to T2D. The analysis tapped data concerning demographics, HbA1c with trend, dates of diagnosis, pharmacotherapy regimen, and the number of clinical diabetes-related touches, defined as proof of diabetes-related management through office appointment or remote communication, such as telemedicine tools.

Demographic data showed that of the 300 patients included, the average age was 64 years, and 43% were female. Although the number of clinical touches did not significantly predict a patients HbA1c control, investigators did report that because patients were more frequently following HbA1c levels, outcomes had been altered. “There was a significant association for select medications when evaluated in combination with frequency of clinical touches to predict control,” the study authors wrote. “Insulin was the only agent that when evaluated solely resulted in a significantly lower HbA1c.”

The investigators’ analysis requires additional evaluation in order to focus on the combination of agents influencing HbA1c control.

1. Vascimini A, Sullivan T, Curtis SD, et al. Predictability of HbA1c Control Based on Pharmacotherapy Regimen or the Number of Diabetes-Related Touches in a Rural Population. Presented at: The American Diabetes Association 80th Scientific Sessions; June 12-16; online.

An analysis focused on patients with type 2 diabetes in rural regions, where accessibility to physicians is often limited.

ADA 2020: Pharmacists Can Improve Diabetes Outcomes in Rural Settings 

A study presented in the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program reported improved rates of progression free survival (PFS) in patients with advanced recurring endometrial cancer (EC) through treatment with cabozantinib and nivolumab.

Effective treatment for advanced recurrent endometrial cancer (EC) is limited. Vascular endothelial growth factor and inflammatory chemokines are proangiogenic factors and immune modulators involved in immune suppression, and reprogramming the tumor microenvironment by combing antiangiogenic and immunotherapy (IO) may enhance antitumor responses, according to the study’s investigators.

Investigators asserted the potential of cabozantinib in inhibiting tumor cell growth by blocking necessary enzymes; immunotherapy with monoclonal antibodies, such as nivolumab, also may be effective in aiding antitumor responses by interfering with the ability of tumor cells to grow and spread; the combination of cabozantinib and nivolumab may work more effectively in EC therapies.

The study, presented by Stephanie Lheureux, MD, PhD, designed 3 arms: arm A patients received cabozantinib and nivolumab, arm B received nivolumab, and arm C  was an exploratory cohort and included post progression patients on immune therapy or patients with recurrent carcinosarcoma, who received both cabozantinib and nivolumab. The study incorporated 76 evaluable patients: 36 in arm A, 18 in arm B, and 9 in arm C, including 7 patients who crossed over from arm B to arm C. All patients had previously received at least 1 line of platinum-based chemotherapy, and had an ECOG performance status (PS) between 0 and 2.

The randomized, open-label, phase 2 trial compared the arms and evaluated data using Kaplan-Meier analysis, which estimated median PFS survival to be significant:  5.3 months in arm A and 1.9 months in arm B. In terms of the objective response rates (ORR), investigators found an ORR of 44.4% in arm A and 16.7% in arm B, also significant.

Lheureux noted the favorable findings related to clinical benefit as well, as arm A showed 69.4% clinical benefit, whereas arm B showed 22.2%.

The study began in January 2018, with plans for completion in January 2021.

The most frequent adverse events (AEs) for arm A were diarrhea, increases in aminotransferase (AST) and alanine aminotransferase (ALT), and nausea, whereas AEs for arm B included fatigue and rash.
	“Cabozantinib plus nivolumab demonstrates improved PFS compared to nivolumab in heavily pre-treated women with recurrent EC,” the authors concluded, also stating that further investigation is necessary.

1. Lheureux S, Matei D, Konstantinopoulos PA, et al. A randomized phase II study of cabozantinib and nivolumab versus nivolumab in recurrent endometrial cancer. ASCO. J Clin Oncol 38: 2020 (suppl; abstr 6010). doi: 10.1200/JCO.2020.38.15_suppl.6010.

ASCO

The study, presented at the virtual ASCO20, showed significant clinical benefit for patients with endometrial cancer who were treated with cabozantinib and nivolumab.

Cabozantinib With Nivolumab Extended PFS in Patients With Advanced Recurring Endometrial Cancer 

Professional burnout among pharmacists, already a growing concern in the United States, could be exacerbated by the coronavirus disease 2019 (COVID-19) crisis. The current pandemic strains pharmacy capacity and exposes persistent underlying problems, according to 3 experts on pharmacy burnout.

A national survey of more than 4700 pharmacist concluded that, although more than half (54.2%) of respondents reported meaningful work, 32% and 33% also said they felt “a lot” or “totally” emotionally and physically exhausted. Community pharmacists demonstrated higher rates of work exhaustion and interpersonal disengagement, as well as lower levels of professional fulfill- ment, compared with those practicing in hospitals and other work settings. A poster showing the results was pre- sented in the 2020 American Pharma- cists Association (APhA) Virtual Poster Hall Gallery.

In a video interview with Drug Topics®, study coauthor Matthew Witry, PharmD, PhD, noted the 3 predominant factors of burnout:

Along with already slumping pharmacist retention rates and closing pharmacies, the pandemic puts immense pressure on the health care profession, as pharmacists work tirelessly to support their patients and communities.

The survey findings also suggest that larger pharmacy chains should emulate independent pharmacy workplaces to improve fulfillment and lower levels of exhaustion.

“We saw lower scores for a sense of control at work in those corporate settings, which isn’t surprising, since there is more of a corporate structure with a lot of those retail environments, where a lot of those decisions are getting made at higher levels of management,” said Witry, an assistant professor in the Department of Pharmacy Practice and Science/Division of Health Services Research at The University of Iowa College of Pharmacy in Iowa City.

Findings from a separate survey conducted by the National Pharmacy Technician Association showed that most chain and mass retail pharmacy technicians do not feel safe at work during the current pandemic, with just 26.1% reporting feeling safe compared with 63.8% of independent pharmacy technicians.

Caroline Gaither, PhD, FAPhA, coauthor of the study presented at APhA, senior associate dean of the Professional Education Divisions, and a professor in the Department of Pharmaceutical Care and Health Systems at the University of Minnesota College of Pharmacy, agreed that chain pharmacies may be experiencing more acute levels of burnout amid the pandemic.

“The corporate-owned chain environment in particular is really suffering related to their satisfaction. The workload has increased very much, and we’ve been looking at that, as well,” she told Drug Topics®. “They’re telling us that the workloads have gotten higher and the staffing has decreased, and that has increased their feeling of job stress and also influenced their satisfaction levels.”

The survey results linked burnout in all domains with the likelihood of leaving one’s position, suggesting that reducing burnout could help promote pharmacist retention, according to the authors.

As the pandemic intensifies burnout factors, pharmacy closures in both rural and metropolitan areas in recent years, as well as discussions of pharmacy benefit managers cutting reimbursements, compound the issue.

“If anything, this pandemic has made us think about the importance of access. Having pharmacies where we need them is important,” Witry said.

Jon Schommer, MS, PhD, RPh, also a study coauthor and a professor in the Department of Pharmaceutical Care and Health Systems at the University of Minnesota College of Pharmacy, encouraged scrutinizing workplace conditions during the pandemic.

“In addition to burnout, which is something that you would like to avoid, we also do research in the area of what’s called well-being,” he told Drug Topics® in a video interview. “And that’s being able to have constructive conditions at work and beyond, even in your personal life, that enable workers to thrive and achieve their full potential.

“Part of that also is something called resilience: the ability of a person or a group of people or even a system to adapt and rebound and even grow from adverse conditions, stress, or trauma,” he continued. “When you think of this COVID-19 situation, we’re all also keeping an eye on work conditions that will support resilience. Can you actually grow and take advantage of very stress- ful and difficult situations?”

Gaither discussed the National Academies of Science, Engineering, and Medicine’s explanation of clinician burnout, which includes 2-pronged influences. On 1 side are the frontline workers and health care providers working for a particular health care organization that has varying policies and procedures, whereas the other side determines work system factors, including job demand, workload, and the number of work hours.

“If there’s a good balance there, then the health providers are able to really thrive and do the work, but when the job demands become too high, that’s where you can get into some of the more negative consequences,” Gaither said.

“Now, the other piece of that is, they say that these work system factors are also influenced by the individual-so, how much resilience that person has, their ability to cope with adversity, and also how much their work interferes with their personal life,” Gaither continued. “I really like the model, because they’ve started to talk about the system factors that are beyond what the individual provider is able to contribute and that the burnout is not necessarily related to some kind of individual failure, but it’s really related to kind of the way the work environment is structured.”

A contributing factor to burnout, according to Schommer: Community pharmacy practice is increasingly pressuring pharmacists to conveniently and quickly distribute medications.

“We’re finding that in community pharmacy practice, the distribution of pharmaceuticals is so vital, and you have to have that pressure on you all day long to be as efficient as possible. At the same time, community pharmacies are being recognized by the public by government agencies, such as CDC [the Centers for Disease Control and Pre- vention]...as health care access points, that you can get vaccinations, immunizations, screenings, and point of care testing,” he said. “There are a lot of patient care and public health services that are being provided.”

The experts put forth the idea of moral injury, in which health providers pursue their responsibilities but face constraints within their organization that affect their well-being and ability practice at their best.

Pharmacists remain eager to take on more responsibilities, according to Witry. “Pharmacists are probably feeling really appreciated. They’re making a difference-getting that care to people, being that access point, answering important questions, being a source of care,” he said. “When people aren’t going to their primary care physician appointments, they can still call their pharmacist or they can still talk to the pharmacist across the plexiglass.”

However, issues within the health care systems must be addressed so that pharmacists can do their job and avoid burnout.

“Do the pharmacists feel that their employers kind of have their backs? Do they feel supported? Are employers really stepping up to take care of their health providers? I think [that] is something that also probably needs to change,” Gaither said. “And then this idea of the profit motive in health care- there’s a lot of things that we could do better with if we had more resources and more reimbursements...to really provide patient care.”

APhA

“Are employers really stepping up to take care of their health providers? I think [that] is something that also probably needs to change.”

Experts Examine the Many Factors of Pharmacist Burnout

A study published in the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program demonstrated that switching from subcutaneous (SubQ) to generic intravenous (IV) bortezomib can significantly mitigate the overall cost of bortezomib for patients.

Latest Global Analysis Examines Mortality Rates of Patients With COVID-19, Thoracic Cancers

It is estimated that the United States spent $370 billion in 2019 on pharmaceuticals, and by 2020 the cost of cancer will reach $158 billion, the study investigators wrote. Global sales in 2019 from SubQ bortezomib will exceed $1 billion.

 Investigators stressed the need for cost containment strategies to combat high prices for drug therapies.

According to the study, switching patients to generic IV bortezomib could potentially decrease overall costs related to bortezomib by $300-400 million globally.

Generic bortezomib was first approved by the FDA in January 2018 but can only be administered intravenously, according to the study.

Previous studies have evaluated the occurrence of peripheral neuropathy and supported the study’s hypothesis that patients who have not developed bortezomib-induced peripheral neuropathy (BIPN) after or during 4 cycles of subQ bortezomib could be switched to IV bortezomib without significantly increasing neuropathy.

Patients were assessed at a Boston Medical Center Health System hematology outpatient clinic. The study, performed between November 2018 and November 2019, incorporated 15 participants who had completed 4 cycles of SubQ bortezomib, had either grade 1 or no BIPN, and received approval from the hematology/oncology providers and nursing departments. Following provider approval, pharmacists updated the patient’s treatment plan orders to IV bortezomib generic formulation.

 Patients were able to be moved to generic IV bortezomib regardless of indication or dose if the other criteria were met.

The results found no new cases of neuropathy in their growing data set, effectively demonstrating the potential to replace subQ with generic IV bortezomib.

“Global adoption of this protocol has the potential to substantially reduce drug costs related to multiple myeloma,” the investigators wrote.

1. Shah B. Jhaveri R, Sanchorawala V, et al. Successful transition from bortezomib subcutaneous to generic intravenous bortezomib: Cost savings initiative with global economic impact. ASCO. J Clin Oncol 38; 2020 (suppl; abstr e19375). doi: 10.1200/JCO.2020.38.15_suppl.e19375.
	2. Jhaveri R, Sanchorawala V, Sloan JM, et al. Successful Transition from Bortezomib Subcutaneous (SubQ) to Generic Intravenous (IV) Borezomib: Cost Savings Initiative with Global Economic Impact. Blood. 2019; 134 (Supplement_1) 4758. doi: https://doi.org/10.1182/blood-2019-128992.

The study’s authors examined the opportunity to decrease the overall cost of bortezomib by $300-400 million by switching patients to the generic version.

ASCO20: Switching to Generic Bortezomib Can Yield Significant Cost Savings 

Medical cannabis and cannabinoid use for symptom management in oncology care has been increasingly significantly in the United States; however, evidence for the efficacy and safety of this use is ambiguous. A systematic review presented in the 2020 American Society of Clinical Oncology Virtual Scientific Program evaluated recent evidence for cannabis and cannabinoid as adjuvant therapy in palliative and supportive oncology care.

Led by investigator Sebastian Jugl, BScPharm, RPh, the research team used the most recent available evidence published from 2016 through 2019, which was inclusive of randomized controlled trials (RCTs) and observational studies evaluating multiple cancer-related outcomes through August 2016. The review excluded studies conducted outside of the United States, studies that did not evaluate cannabis or cannabinoid in oncology care, review not conducted in accordance with systemic best practices, and preclinical studies. A total of 24 studies were included in the qualitative synthesis.

Overall, utilization studies reported a range of 18.3-40.0% of patients with cancer as prevalent users of cannabis and/or cannabinoid, according to the poster.

Regarding the effect of cannabis and cannabinoid use on cancer-related adverse effects, the investigators looked at cancer-related pain, nausea and vomiting, and cancer-related anorexia/cachexia.

Of the 15 studies analyzed for cancer-related pain, data from 2 recent RCTs did not show a significant effect. However, in 1 RCT, a per protocol analyses demonstrated numerically favorable primary outcomes. Another study’s post hoc analyses indicated a statistically favorable treatment effect for Sativex, an oromucosal THC/CBD spray, in US patients older than 65 years. Two observational studies reported positive results.

One recent study supported improvement in outcomes for patients treated with cannabinoid for cancer-related nausea and vomiting; however, findings were inconclusive. Additionally, most evidence was largely inconclusive for cancer-related anorexia/cachexia.

The investigators noted that all evaluated systematic reviews were either of critically low quality or moderate quality, suggesting that “heterogeneity of findings reported for cancer-related outcomes has remained challenging to translate into clinical recommendations.”

However, no recent studies reported worse outcomes as compared with placebo or active comparator.

1. Jugl S, Keshwani S, Joseph V, et al. Abstract 12091: A systematic review of evidence for cannabis and cannabinoids as adjuvant therapy in palliative and supportive oncology care. Presented at: 2020 ASCO Virtual Scientific Program; May 29-31; online. Doi: 10.1200/JCO.2020.38.15_suppl.12091

A systematic review of medical cannabis and cannabinoid use in oncology care demonstrated varied results. 

Systematic Review Evaluates Cannabis, Cannabinoids in Palliative and Supportive Oncology Care

Targeted therapy osimertinib (Tagrisso) demonstrated significant improvements in disease-free survival in patients with localized non-small cell lung cancer (NSCLC) who were treated following surgery, according to new data presented in the 2020 American Society of Clinical Oncology Virtual Scientific Program. 

The findings, which come from an unplanned interim analysis of the phase 3 ADAURA trial, were presented by lead author Roy S. Herbst, MD, PhD, in a press briefing in advance of the annual meeting. 

 tyrosine kinase inhibitor (TKI), is approved for the first-line treatment of patients with metastatic NSCLC with tumors that have 

 mutations. The results from this study show efficacy in the adjuvant setting for patients with earlier stage disease and the same mutations. 

NSCLC represents 85% of all lung cancer cases, with an estimated 30% of patients presenting with resectable disease at diagnosis, according to Dr Herbst, who is the Chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital, and the Associate Cancer Center Director for Translational Research at Yale Cancer Center. Adjuvant chemotherapy is currently the standard of care for patients with resected stage II-IIIA NSCLC and select patients with stage IB disease; however, recurrence rates are high. 

The trial included 682 patients with primary non-squamous stage IB-IIIA NSCLC and confirmed 

 mutation who were randomized to receive adjuvant osimertinib or placebo. Patients in the study had complete resection of primary NSCLC and were fully recovered from surgery. Patients in the osimertinib group took 80-mg tablets once daily, for up to 3 years, and postoperative chemotherapy was allowed. 

Overall, patients with stage II-IIIA had an 83% reduction in the risk of disease recurrence or death, according to the data. At 2 years, disease-free survival was 90% in the osimertinib group compared with 44% in the placebo group for patients with stage II-IIIA NSCLC with an EGFR mutation. In the overall population (stage IB-IIIA), osimertinib reduced the risk of disease recurrence or death by 79% compared with placebo. At 2 years, disease-free survival was 89% for those treated with osimertinib compared with 53% in placebo-treated patients. 

According to Herbst, adjuvant osimertinib is the first targeted agent in a global randomized trial to show statistically significant and clinically meaningful improvement in disease-free survival in this patient population.

The secondary end point, overall survival, was immature at the time of analysis. 

The safety profile of osimertinib in this study was consistent with its known safety profile and the drug was generally tolerable. 

According to Dr Herbst, the trial was a “home run.” 

“It’s an important advance to see a targeted therapy significantly delay disease recurrence following surgery in patients with non-small cell lung cancer. We can now treat patients earlier,” he said. 

1. Herbst RS, Tsuboi M, John T, et al. Osimertinib as adjuvant therapy in patients (pts) with stage IB-IIIA EGFR mutation positive (EGFRm) NSCLC after complete tumor resection: ADAURA. Presented at: 2020 ASCO Virtual Scientific Program, May 29-31; online. Doi: 10.1200/JCO.2020.38.18_suppl.LBA5

2. Post-Surgery Osimertinib Delays Disease Recurrence in Patients With Localized Non-Small Cell Lung Cancer (NSCLC). News Release. ASCO; May 28, 2020. Accessed May 29, 2020. 

https://www.asco.org/about-asco/press-center/news-releases/post-surgery-osimertinib-delays-disease-recurrence-patients

Targeted therapy osimertinib (Tagrisso) demonstrated significant improvements in disease-free survival in patients with localized non-small cell lung cancer (NSCLC) who were treated following surgery.

Adjuvant Osimertinib Therapy Delays Disease Recurrence in Localized NSCLC

A study presented at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program found that pembrolizumab (Keytruda) delivered significant improvement in progression-free survival (PFS) compared with chemotherapy for first-line treatment for microsatellite-instability high/mismatch repair deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC).

Presented by lead author Thierry AndrÃ©, MD, Sorbonne UniversitÃ© and HÃ´pital Saint Antoine in Paris, France, the study results demonstrated that pembrolizumab improved PFS by 16.5 months, compared with chemotherapy without targeted therapy treatment, which demonstrated 8.2 months of PFS.

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In MSI-H/dMMR, DNA repair is impaired and effectively facilitates mutations. Previous research has estimated that 5% of individuals with metastatic colorectal cancer have high microsatellite instability, therefore exhibiting high levels of mutations. Prior studies have also found MSI-H/dMMR tumors to be associated with decreased survival and patients to be less responsive to chemotherapy.

Pembrolizumab blocks PD-1 receptor activity in order to allow an individual’s immune system to attack cancer cells. The drug has been approved by the FDA for adult and pediatric patients with previously treated MSI-H metastatic tumors, regardless of tumor type or site, according to the study’s authors.

The phase 3 KEYNOTE-177 study included 307 treatment-naÃ¯ve participants with confirmed MSI-H/dMMR stage IV CRC, ECOG performance status (PS) of 0 or 1, and measurable disease. Patients were randomly assigned to receive chemotherapy or 200 mg every 3 weeks for up to 35 cycles or until unacceptable toxicity, disease progression, or patient/physician withdrawal.

PFS was 55.3% in patients receiving pembrolizumab at 12 months follow up, compared with 37.3% PFS with chemotherapy; at 24 months, 48.3% in the pembrolizumab group showed PFS, compared with 18.6% of the chemotherapy group, according to the results.

Eleven percent of patients receiving pembrolizumab experienced complete response and no detectable cancer; 32.7% experienced reduced tumor size (partial response); 30.9% showed stable disease. On the other hand, 3.9% of those receiving chemotherapy showed complete response; 29.2% had a partial response; 42.2% maintained stable disease.

The pembrolizumab group additionally experienced less frequent severe adverse events (AEs) related to treatment compared to the chemotherapy group, with 22% of pembrolizumab patients having severe AEs compared with 66% of those receiving chemotherapy.

“These long-awaited trial results will change clinical practice,” said AndrÃ© during the ASCO20 virtual press briefing. “Pembrolizumab works in non-randomized studies in this group of patients with advanced disease. This randomized study demonstrates a huge benefit in first line with pembrolizumab and should be the new standard of care.”2

1. Andre T, Shiu K, Kin TW, et al. Pembrolizumab versus chemotherapy for microsatellite instability-high/mismatch repair deficient metastatic colorectal cancer: The phase 3 KEYNOTE-177 study. Presented at 2020 American Society of Clinical Oncology Virtual Scientific Program; May 29-31; online.
	2. Pembrolizumab Doubles Time to Disease Progression in Patients With Advanced Colorectal Cancer With Specific DNA Mutations. News Release. ASCO; May 28, 2020. Accessed May 29. 2020. https://www.asco.org/about-asco/press-center/news-releases/pembrolizumab-doubles-time-disease-progression-patients.

The study marks the first time that the drug has demonstrated benefit for front-line therapy in patients with this type of colorectal cancer.

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