Retevmo (selpercatinib) demonstrated response improvements in previously treated patients with 

 fusion-positive non-small cell lung cancer (NSCLC), according to findings presented at the virtual 2021 ASCO Annual Meeting.

“However, results should be interpreted with caution, as a limitation of this analysis was that immediate prior response assessment was based on physician-reported best response in patients’ medical history and may not follow RECIST criteria,” the researchers said.

This study consisted of 218 evaluable patients (median age 61 years) who previously received platinum-based chemotherapy. The majority had an ECOG (or the measurement to describe a patient’s level of functioning in terms of ability to care for themselves, daily activity and physical ability; with zero being fully active and four being disabled) of 0/1, with an average of two (range: 1-15) prior systematic therapies, across 89 sites in 16 countries.

The primary endpoint of the study was objective response rate (or the rate of a measurable response to the treatment), with secondary endpoints of progression-free survival (time during and after treatment when the patient lives without disease progression), duration of response (or the length of time that a tumor continues to respond to treatment without the cancer growing or spreading) and safety.

The study compared each patient’s best overall response to their prior therapy to the response elicited from Retevmo.

The objective response rate with Retevmo was 57% which was “markedly higher,” the researchers wrote, than responses for prior treatment at 16%.

A total of 108 patients (50%) did not respond to prior therapy but did respond to Retevmo. There were 16 patients (7%) who responded to both Retevmo and prior therapy, 18 patients (8%) who responded to prior therapy but not Retevmo and 76 patients (35%) who did not respond to either.

Objective response rate was improved regardless of prior therapy, chemotherapy plus immune checkpoint inhibitor (57% versus 14%), single-agent immune checkpoint inhibitor (48% versus 3%) or chemotherapy (58% versus 15%).

Fewer patients had progressive disease with Retevmo best overall response (2%), compared with immediate prior therapy (28%). Median duration of response was also longer compared with prior therapy, with an average of 11.8 months versus 3.4 months.

“A global, randomized, phase 3 trial (LIBRETTO-431; NCT04194944) evaluating (Retevmo) compared with standard frontline therapy (Altima/ carboplatin with or without Keytruda) is ongoing,” the researchers concluded.

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Previously treated patients with non-small cell lung cancer tended to have better responses with Retevmo than they did with prior treatments. 

Retevmo Shows Improvement for Previously Treated Patients With Non-Small Cell Lung Cancer 

Pralsetinib (Gavreto) elicited promising responses and tolerability in patients with 

 fusion-positive non-small cell lung cancer (NSCLC), including those who were not eligible for platinum-based therapy.

“These data are real important because it supports the importance of early biomarker testing for all patients with metastatic NSCLC prior to treatment initiation to inform optimal healthcare decisions,” said Giuseppe Curigliano, MD, PhD, associate professor of medical oncology at the University of Milano in Italy and head of the division of early drug development at the European Institute of Oncology in Italy, at the 2021 virtual ASCO Annual Meeting about updated data from the ARROW trial.

The phase 1/2 study was conducted at 84 sites in 13 countries. In particular, the safety population for this study included 233 patients with 

 fusion-positive NSCLC and 238 patients with other RET-altered solid tumors. In particular, 216 patients (median age, 60 years; 48% men) with 

fusion-positive NSCLC had measurable disease.

Originally patients who were treatment-naïve were not eligible, which was a requirement that was later removed by a protocol amendment. There were 25 patients who were enrolled after this eligibility revision (median age, 54 years; 44% men).

The study had a primary endpoint of objective response rate (ORR). Follow-up was conducted for a median of 17.1 months.

For the 216 patients who received pralsetinib and were 

 fusion-positive, the ORR was 69% (95%, CI, 62-75), DCR was 92% (95%, CI; 87-95), CBR was 77% (95%, CI; 71-82) and median DoR was 22.3 months (95%, CI; 15.1-not reached).

In the post-eligibility population with 25 patients, the ORR was 88% (95% CI, 69-98), CBR was 88% (95% CI, 69-98), DCR was 96% (95% CI, 80-100). In addition, median DoR and median PFS was not reached.

“The most important observation is that in the expansion cohort of real-world and first-line treatment of (non-small cell lung cancer) patients with 

fusion-positive tumor, the overall response rate was 88%, providing support for RET inhibitor as a first-line standard of care because the response rate was better in this population (with) respect to the previous eligibility criteria population,” Curigliano said.

The median duration of response in patients with prior platinum-based chemotherapy was 22.3 months (95% CI, 15.1-not reached). Curigliano added that it was too early to analyze data regarding the duration of response in treatment-naïve patients.

Overall, 26 patients (6%) out of 471 patients in the entire study discontinued treatment due to treatment-related adverse events. In all tumor types, 15% of patients had treatment-related neutropenia leading to treatment interruption whereas 14% had neutropenia from the treatment which resulted in a dose reduction. Less than 1% of patients discontinued treatment from treatment-related neutropenia.

“It means that pralsetinib was very well tolerated,” Curigliano said.

Curigliano, G, Gainor JF, Griesinger F, et al. Safety and efficacy of pralsetinib in patients with advanced RET fusion-positive non-small cell lung cancer: Update from the ARROW trial. Presented at: 2021 ASCO Annual Meeting; June 4-8, 2021; Virtual. Abstract 9089.

Pralsetinib elicited promising responses and tolerability in patients with RET fusion-positive non-small cell lung cancer (NSCLC), including those who were not eligible for platinum-based therapy.  

 Pralsetinib Is Tolerable, Durable in RET Fusion+ NSCLC

Virtual visits from cancer care coordinators with veteran colon cancer survivors decreased anxiety and improved patients’ satisfaction during the COVID-19 pandemic, according to a virtual poster presentation at the Oncology Nursing Society Congress.

Due to social distancing requirements during the COVID-19 pandemic, many veterans who are cancer survivors experienced changes in treatment protocols and schedules. This resulted in higher levels of stress and anxiety about changes in their outcome and survival, on top of stress about their cancer diagnosis, noted Janice Schwartz, MSN, OCN, RN, an oncology certified nurse at the New Mexico VA Healthcare System, said during the presentation.

“As a cancer care coordinator, my role morphed abruptly in March 2020. I was faced with calling veterans living with a cancer diagnosis to advise them of cancelled procedures, visits and surgeries due to the COVID-19 pandemic. I found veterans living with a cancer diagnosis were experiencing new stressors. Already experiencing anxiety related to the diagnosis of cancer that we are all familiar with, they now face limitations of [COVID-19] further impacting their lives.”

Providers found a new way to connect with this population to improve communication through virtual visits to potentially decrease stress about COVID-19 and improve patients’ satisfaction regarding their survivorship care.

“I have found maintaining visual contact with a veteran allows them to feel connected, to know that we are still here for them and has improved patient’s satisfaction,” Schwartz said.

Prior to the virtual appointments, veterans were emailed instructions on how to use the platform and scheduling on a personal laptop, tablet, computer or smartphone. Upon completion of the appointment, they were emailed a survey, of which 100% were returned.

During the virtual appointments, veterans were given reassurance regarding cancer treatment and recommendations, in addition to COVID-19 safety measures and processes to decrease possible exposure.

A total of 95% of the veterans reported an overall decrease in anxiety after the virtual appointment. The appointments decreased COVID-19 related stress in 90% of veterans and led to improved patient satisfaction in 96% of veterans.

The virtual appointments resulted in the following:

overall convenience (less time off work, avoidance of travel and expenses, not having to search for parking and ability to stay safely at home),

decreased anxiety (decreased post-traumatic stress disorder symptoms, less worry and less nervousness),

decreased stressors (ability to stay safety at home, understanding safety measures implemented in the hospital and review of recommended)

and improved satisfaction (personalized visit vs. phone call, ability to see their chart and reports through shared screen options and requested to have virtual post COVID-19).

Limitations of the virtual appointments included requiring an electronic device with a camera, connection to internet, Apple misfunctions, remembering usernames and passwords.

“I’ve learned by saying that perhaps if we look to the end of the rainbow and search for the silver lining of [COVID-19], we would see the many advances in care such as virtual platforms that will continue to improve care and decrease barriers for our veterans long after [the COVID-19 pandemic],” Schwartz concluded.

Schwartz J, Valdez-Boyle L. Colorectal Cancer Survivorship: Enhancing Communication During COVID-19 Through Cancer Care Coordinator Virtual Visits in the Veterans Healthcare System. Presented at: Oncology Nursing Society 46th Annual Congress. April 20, 22, 27 & 29, 2021. Virtual.

Due to the COVID-19 pandemic, many patients’ and survivors’ care has changed, but one nurse and her team sought to make this population more comfortable and safe during these times with virtual visits.

COVID-19 Pandemic Shows ‘Silver Lining’ of Virtual Visits for Veterans Who Have Survived Cancer

Survivors of cancer who recently finished treatment and are at least 60 years of age struggled with coping during the COVID-19 pandemic, which may highlight the need for the development of a remote-access resource for coping during this pandemic.

“We all know that in 2020, COVID-19 affected numerous people around the globe, and the World Health Organization acknowledged that those who are the most vulnerable to the negative effects of COVID-19 are those who are older than 60 years of age,” said Jacqueline Galica, RN, PhD, CON(C), nurse scientist at Queen’s University in Kingston, Ontario, Canada, during the presentation at the virtual Oncology Nursing Society Congress. “And given that nearly 9 out of 10 cancer diagnoses occur among people who are older than 60 years of age means that this group is an important group to study during the pandemic.”

After the first year of treatment, survivors have many needs and require resources for support, including psychological and informational support. This is especially true for those over the age of 60 because of other comorbidities they might have. Due to the COVID-19 pandemic, these resources were limited to these patients. Researchers sough to see how this population who completed treatment in the last year were coping during the pandemic.

Researchers interviewed 30 participants (56.7% women, mean age, 72 years). According to the presentation, questions asked of these participants included:

How does the COVID-19 pandemic affect their access to formerly used and/or desired resources/supports?

What coping recourses are they using during the pandemic?

How do these resources help (or not) to meet their cancer-related care needs?

What are their reflections on the pandemic? What are their suggestions for suitable resources and delivery methods when traditionally offered resources are limited or unavailable?

Results showed that survivors were initiating coping mechanisms on their own including acceptance (29 participants, 96.7%), self-distraction (28 participants, 93.3%) and taking action (28 participants, 93.3%). Participants also reported using instrumental (26 participants, 87%) and emotional support strategies (25 participants, 83.3%).

During the analysis, the researchers found interconnected themes in the population such as drawing on lived experiences, redeploying coping strategies and complications of cancer survivorships in a pandemic.

Drawing on lived experiences meant survivors were using coping strategies that they had already known about through pasts illnesses or through someone they knew who had a past illness, as well as other life experiences such as work, specifically those who had a background of knowledge in health.

The second theme seen was redeploying coping strategies, meaning they were not new. Participants continued on their way of life during the pandemic or “even magnified their formally used strategies during the pandemic,” said Galica. Participants also reported taking up new and old activities to keep them distracted from their concerns.

The last was complications of cancer survivorships in a pandemic. “Sometimes cancer survivors observed a dissonance between the coping strategies that were available to them versus those that were familiar. And this made it challenging for them to cope with their cancer-related concerns,” said Galica. This was seen specifically in participants who still experienced side effects that affected their ability to engage in former activities that they enjoyed; some either modified expectations or stopped altogether.

Participants had 4 general recommendations for future care. The first being enhanced baseline information, meaning given more knowledge in the beginning from their oncology team to prepare for self-management if there were to be an interruption in care. Secondly, participants reported that changes in visitor care was a concern. Thirdly, older patients acknowledged the need for technology integration and felt it could be used more and less in certain settings. Lastly, participants valued the use of masks and other personal protection equipment and felt it increased awareness to help protect people who are vulnerable to a common cold or the flu even after this pandemic.

Implications of this study include that clinicians can use a strength-based approach in survivors as they draw from their past experiences. Also, the need to enhance resources to support coping, specifically using remote methods when patients cannot attend and in person session during a pandemic or not.

Limitations of the study include not collecting data on functional status, timing of recruitment (the summer allowed participants to get out and enjoy outdoor activities) and response bias.

Galica, J. Haase, K. Liu, Z. How older cancer survivors are coping amid the COVID-19 pandemic: A mixed-methods study. Presented at: Oncology Nursing Society 46th Annual Congress. April 20, 22, 27 & 29 2021. Virtual.

Survivors of cancer go through coping during the first year after treatment and require specific resources. But these were limited due to the pandemic resulting in survivors self-coping with known mechanisms. 

Older Cancer Survivors Struggle to Cope During the COVID-19 Pandemic

Financial toxicity (FT) has been linked to increased mortality rates, but can be improved with financial intervention for patients, according to a pilot study presented by Thomas G. Knight, MD, from the Levine Cancer Institute at the 2020 ASH Meeting and Exposition.

Knight and other researchers hypothesized that, “Comprehensive intervention on the financial aspects of care for these patients would lead to decreased mortality.”

, Dr. Knight commented on how this study affects knowledge we already have, “showing that with comprehensive intervention, you can really make an impact on the problem in a meaningful way.”

The pilot study consisted of 105 patients with high-risk hematologic malignancies or bone marrow failure syndrome because, as mentioned in the peresentation, they “are thought to be extremely vulnerable to financial toxicity,” because of the high treatment costs and health care utilization.

Patients were surveyed to agree or disagree with the following two statements, which came from the COST measure, at their visits during a six-month period: “I know I have enough money in savings, retirement or assets to cover my treatment” and “I am satisfied with my current financial situation.” The survey also included the PROMIS Global-10 measure which ranks symptoms, functioning and health related quality of life on a scale of 1 to 10. FT was defined as scoring five or less, with a maximum of 10.  

There was a total of 59 patients who qualified as experiencing FT and were entered into a three-step intervention. The first was with a nurse looking for gaps in care and trying to find grants and coverage for the patient. The second was a medication review with a pharmacist to hopefully reduce cost of medication or discuss with the doctor for an alternative therapy or medications. The final intervention was with a community pro-bono financial planner; here they talked about budgeting, financial planning, asset management and other general financial advice based on the patient’s income, and treatment expenses.

Patients who were in the FT group reported they could not afford prescription (16.8%), Over-the-counter medications (15.9%), and doctors visits (6.5%). A total of 48.6% of patients reported that in order to pay for their health expenses, they reduced spending on food and clothing; 51.4% used savings; and 11.2% would only partially fill their prescriptions.

After intervention 34.7% of patients were made eligible for grants from foundations. The pharmacy team was able to obtain free or reduced medication costs for those qualified, through manufacturer’s assistance and other programs. Some patients were also able to receive gas cards, food pantry items and transportation assistance.

During the study, those in the intervention group had a 27% mortality rate, while the group receiving standard care was at 43%.

In regard to overall survival (OS), after six months it was 81.4% for the intervention group, compared to 73.9% in the standard of care group. At the 12-month mark 73% were alive in the intervention group, and 46.4% of people were alive in the standard care group.

“High risk hematologic malignancy patients are at high risk for increased complications due to financial concerns,” Knight said. “Intervening on financial toxicity in a comprehensive way including navigators, pharmacists, and financial counselors is effective and leads to decreased mortality.”

Not only did the intervention improve survival rates for patients but it also improved on a better quality of life. When measured by PROMIS, physical and mental health scores increased significantly from the baseline of the study.

“It’s so easy sometimes to go in and identify that this is an issue, but the harder work is trying to see if we can make an impact, I’m an individualist at heart so that has been my focus, trying to devise systems to fix it” says Knight. He says it is important to continue focus on this because we can really impact patients lives with this research.

Colleen Moretti

Articles

Retevmo Shows Improvement for Previously Treated Patients With Non-Small Cell Lung Cancer

Pralsetinib Is Tolerable, Durable in RET Fusion+ NSCLC

COVID-19 Pandemic Shows ‘Silver Lining’ of Virtual Visits for Veterans Who Have Survived Cancer

Older Cancer Survivors Struggle to Cope During the COVID-19 Pandemic

Improving Outcomes for Patients Experiencing Financial Toxicity