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Clinical trials are essential in improving treatment in the world of oncology, especially for rare cancers.

Clinical Trials: Know the Basics

Can local and systemic therapies be combined to treat liver cancer?

Combining Local and Systemic Therapies in Liver Cancer

While industry and political efforts may have moved the needle for some institutions regarding the chemotherapy shortage, more needs to be done, as many patients are facing difficulty getting common cancer drugs, such as cisplatin, carboplatin and methotrexate, explained Rose DiMarco, oncology pharmacy manager at the Sidney Kimmel Cancer Center at Jefferson Health in Philadelphia.

“I want to validate the concern that (patients) may not be able to receive treatment. That concern keeps us up at night as well, and I want our patients to know that we are exploring all possible options for every shortage,” DiMarco said in an interview with CURE®.

DiMarco mentioned that the shortage has been stressful for her and her colleagues, though her institution was fortunate enough to be able to acquire chemotherapy for all Jefferson Health sites. However, she admitted that her team has to “keep an eye on (drug) usage, which requires running reports and more counting.”

The United States government is also closely monitoring the chemotherapy shortage and implementing steps to mitigate it. In a September 2023 announcement, the White House outlined that the Food and Drug Administration has taken the following steps to address the issue:

Helped cancer drug manufacturers to identify opportunities to boost production of drugs that are experiencing a shortage, as well as allowed an important of 14 lots of cisplatin from an FDA-registered facility located outside of the country. According to the statement, “these actions brought the cisplatin supply back to nearly 100% of the pre-shortage levels and are greatly alleviating the shortages of carboplatin.”

Worked with the five manufacturers of generic methotrexate to increase supplies.

Collaborate with health care professionals and drug manufacturers to ensure access to cancer treatments and other medications that are in short supply.

Despite these steps, the White House statement did mention that the shortages have not fully been resolved.

“Drug shortages are not always the same across the country, but overall, the shortage continues,” she said, mentioning that there needs to be better communication between health care providers and drug manufacturers, as, in her experience, clinicians are often hearing about supply chain issues last minute. “The manufacturers will sometimes list a restock date when supply is supposed to be available, but most times, those dates are not accurate and can lead to more stress and confusion.”

With patients and their loved ones directly affected by these supply chain issues, it is essential that they keep open lines of communication with their oncology team, DiMarco said.

“Unfortunately, there is not much patients can do because it is often out of our control as well. However, if a patient ever has an questions or concerns, they should feel comfortable asking their care team. From an oral medication standpoint, patients should always lets us know if they're having trouble getting their medications. While that may be out of our control as well, we can certainly help to see if the medication is available elsewhere or see if an alternative is a possibility,” she said.

More CURE® coverage of the chemotherapy shortage:

The Shared Responsibility to Prevent, Prepare for and Manage Drug Shortages

Patients Respond to the Ongoing Chemo Drug Shortage

Here’s How One Cancer Center Is Handling the Chemo Shortage

Chemo Drug Shortage Requires a ‘Holistic Solution’

Expert Discusses Chemo Shortage: ‘Likely to Last’ 3 to 4 Months

Expert Identifies Chemo Shortage as a 'Simple Tragedy of US Health System’

For more news on cancer updates, research and education, don’t forget to 

The chemotherapy drug shortage continues to impact patients, with common cancer drugs like cisplatin, carboplatin, and methotrexate in short supply. Despite efforts by institutions and the U.S. government to address the issue, including boosting production and importing drugs, shortages persist. Effective communication between healthcare providers and drug manufacturers is crucial, as supply chain issues often arise unexpectedly. Patients are encouraged to maintain open communication with their oncology teams to explore alternative solutions. The situation underscores the need for a comprehensive approach to managing drug shortages.

Efforts are being made to curb the ongoing chemotherapy shortage, and while things have gotten better, there is still more work to do. 

All Cancers

Patient Concerns Around Chemo Shortage Are ‘Valid,’ Pharmacist Says

Many older adults with stage 4 cancer will prioritize quality of life over survival time, highlighting the importance of conversations between patients and providers about goals of care, according to recent research presented at the 2023 ASCO Quality Care Symposium.

“Patients have so much challenging information to absorb, it is overwhelming. For older adults, it is important to ask not only about the efficacy of a treatment but also what do we know of its tolerability,” study author, Dr. Ramy Sedhom said in an interview with CURE®. “If prioritizing maintenance of independence, day-to-day functioning, and quality of life are more important than the total number of days lived, make sure all of your doctors know that.”

Sedhom, who is the medical director of Oncology and Palliative Care Penn Medicine Princeton Health and assistant professor of Clinical Medicine at the University of Pennsylvania, and his team assessed 171 patients aged 75 and older with a stage 4 solid cancer diagnosis. Eleven percent of the patients were deemed fit, while 62% were vulnerable and 27% were frail. Additionally, 12% of the population experienced cognitive impairment, while 22% had psychological health difficulties, 39% had limited social support and 29% were at risk for malnutrition. Ninety-six percent of patients were enrolled in hospice care.

Most patients (82%) prioritized quality of life over time, while 77% of patients expressed the goal of preserving their independence.

“Most of us who follow the growing literature in geriatric oncology would not be surprised to hear that most older adults prioritize function and quality of life over survival. What we found confirms previous findings,” Sedhom said. “What surprises me is the reality that leaders in our field are still slow to adopt endpoints in research studies, such as functional independence and quality of life, when it is clearly what is most important to the majority of older adults.”

End-of-Life Discussions Can ‘Lay Out a Roadmap’ of Patient Wishes and Avoid Unnecessary Cancer Care

Sedhom explained that there are two aspects of quality communication between patients and their care team in this situation. The first is understanding what is important to patients and their loved ones, while the second is weighing cost and benefits of different treatment options.

“When certain older adults with advanced comorbidity or frailty hear that a certain treatment may not improve their quality of life or how long they live, they wonder why we would recommend it,” Sedhom said. “Patients are also often surprised to hear that chemotherapy in certain incurable cancers improve survival by only a few months (when studied in younger, healthier patients). The take-home point is that goals, values and prioritize are unique in individual persons. It is our responsibility to elicit these values and align care with what is most important.”

Moving forward, Sedhom hopes that more emphasis is put on patient goals and desires, rather than finding the most aggressive treatment that may inhibit quality of life.

“I'd love to see quality measures around asking what is most important — to both patients and caregivers. These should not only be measured but perhaps incentivized by payers,” he said. “From a science perspective, we need to start including measures of treatment tolerability and quality of life measures in treatment trials. We have been asking to include older adults in clinical trials - this is important - and at the same time, even in younger patients, we are still not answering questions around how do our everyday treatments impact quality of life.”

Recent research underscores the importance of prioritizing quality of life over survival time for older adults with stage 4 cancer. Conversations between patients and providers about care goals are crucial. A study involving 171 patients aged 75 and older revealed that most prioritize quality of life and independence. Despite this, research often overlooks these endpoints. Effective communication should focus on understanding patient values and weighing treatment costs and benefits. Emphasizing patient goals and including quality of life measures in trials is essential for aligning care with patient priorities.

Older adults with late stage cancer often prioritize quality of life and independence over survival time, which may change their treatment plan, an expert said.

Older Adults Should Discuss Cancer Care Goals With Providers

A population-based study of nearly 7,000 long-term cancer survivors found that diabetes among long-term cancer survivors “was associated with cancer site, older age, lower education, higher socioeconomic deprivation, higher body mass index, physical inactivity, other comorbidities, and poorer prognosis,” with cancer survivors who also have diabetes facing a risk of death that is 29% higher than that faced by survivors who do not have diabetes, according to a study published in the journal 

The study, conducted by a team of German researchers, drew on information from 6,952 long-term cancer survivors who had received diagnoses of breast, colorectal or prostate cancer between 1994 and 2004, were recruited for participation between 2008 and 2011 and were then followed until 2019, with 962 (13.8%) of long-term cancer survivors reporting that they had diabetes at the start of the study and 1,828 cancer-free individuals serving as controls in the study.

While the study found that diabetes was as prevalent in cancer-free participants as it was among long-term cancer survivors who had survived at least five years after receiving their diagnosis, researchers were sure to put those findings in context.

“We want to stress that our finding of no increased prevalence of (diabetes) in (long-term cancer survivors) should not be interpreted as an indication of a lower risk of (diabetes) in this population,” researchers wrote. “Rather, it highlights the potentially poor prognosis in cancer patients with diabetes and survivors, and the need for an improved care to reduce the risk of (diabetes) and its consequences in cancer patients and survivors.”

, researchers noted previous work which showed that as much as a third of cancer survivors live with concurrent diabetes and explained that diabetes can impact cancer survival due to vascular complications, promoting cancer progression and metastasis and inducing therapy resistance.

The researchers stated that their findings display the need for improved communication and coordination of care between specialists and general practitioners to support continuity of care for patients.

“Individuals with type 2 (diabetes) experience an increased risk of all‐cause mortality compared with those without (diabetes), which is attributed to a wide range of cardiovascular or non-cardiovascular diseases (e.g., ischemic heart disease, stroke, chronic renal disease, chronic obstructive pulmonary disease, pneumonia, liver cirrhosis, viral hepatitis, incident cancer),” researchers noted. “The increase of mortality in cancer survivors with concurrent (diabetes) is also likely to be related to the increase of potentially fatal events from diabetic complications.

This may be the major cause that a roughly 30% increased risk of death was observed to be associated with (diabetes) in our study.”

These findings are the latest data reported throughout 2023 regarding poor outcomes experienced by patients with both diabetes and a history of cancer.

Diabetes was among the modifiable chronic health conditions cited alongside living in a socioeconomically disadvantaged area as contributing to an increased risk of death at least five years after diagnosis for childhood cancer survivors 

 showed that older patients with type 2 diabetes saw a 1.5-fold increased risk of mortality from colorectal, pancreatic, endometrial and liver cancers.

 showed that immunotherapy treatment with Keytruda (pembrolizumab) is not as effective among patients with both metastatic non-small cell lung cancer and preexisting diabetes), while 

other research published in the same journal

 linked diabetes to poor survival outcomes among patients with colorectal cancer who undergo surgery.

 showed survival outcomes for patients with multiple myeloma to be worse of those patients also had diabetes.

Speaking with CURE® earlier this year, Dr. Brandon Blue, a clinical instructor in the Department of Malignant Hematology at Moffitt Cancer Center in Florida, stressed that for patients with cancer who are co-managing other conditions, clear communication with their care team is crucial.

“Be vocal to your doctor and let them know that you have diabetes and (make sure) that your doctor is aware of it, first of all,” Blue advised. “Because sometimes, as cancer doctors, I must admit, we get so entangled about the cancer and treating the cancer, sometimes we forget some of the other diagnoses that these patients have.”

Blue also said that “as a patient, you have to be kind of your best advocate to make sure that you actually are checking your blood sugar. … We give people so much information about chemotherapy and all the side effects of those things that sometimes people forget about their blood pressure medicines or their diabetes medicines, just because the chemo and the cancer is really the scary thing and the big thing on the front of people's minds. And so, I don't want people to forget about some of these other issues, because clearly it states in this study, that diabetes does matter.”

A study of nearly 7,000 long-term cancer survivors revealed that diabetes is linked to a 29% higher mortality risk compared to non-diabetic survivors. Factors such as cancer site, age, socioeconomic status, and comorbidities influence diabetes prevalence among survivors. The study emphasizes the need for improved care coordination between specialists and general practitioners to manage diabetes in cancer patients. Diabetes can exacerbate cancer progression and therapy resistance, highlighting the importance of addressing this comorbidity. Effective communication and patient advocacy are crucial for managing diabetes alongside cancer treatment.

Long-term cancer survivors experience diabetes at similar rates as individuals who are cancer-free, but cancer survivors with diabetes face a potentially higher risk of death, researchers have found.

Diabetes Increases Mortality Risk for Long-Term Cancer Survivors

Survivor care plans are beneficial to survivors of cancer in terms of receiving cancer-related follow-up care, a recent study found.

For both adult survivors of cancer and survivors of childhood cancer, survivor care plans (SCP) have been shown to be beneficial, as more survivors are inclined to attend cancer-related follow-up care visits and have better overall quality of life, according to a findings from a recent study published in the journal, 

and “From Cancer Patient to Cancer Survivor: Lost in Transition,” a book from National Academies Press, SCPs provide survivors with information such as their cancer history and their risk of developing late effects in the future. These plans also offer a schedule of recommended check-ups and treatment for late effects such as bone-modifying agents for potential risk of osteoporosis (decrease in the amount and thickness of bone tissue) or steroid replacement therapy for insufficiencies in the adrenal glands (located atop the kidneys that produce hormones to regulate essential functions such as blood pressure).

In the respective study, there was a total of 1,123 participants, all who were survivors of cancer and were in remission. There were 499 participants in the study who were adult survivors and 402 participants who were survivors of childhood cancer. The authors of the study also included participants who were currently child survivors but recruited their parents to complete the necessary surveys for children younger than age 16.

Adult survivors of cancer had an average age of 62.4 years in the study, whereas the average age for survivors of childhood cancer was 21.3 years. The study authors found that the most common cancer types among the survivors in the study included breast cancer in adults and acute lymphoblastic leukemia in childhood survivors of cancer.

From the total participants in the study, “only 10.7% of survivors of adult cancer and 22.0% of survivors of childhood cancer reported having received an SCP,” the study authors wrote.

Regarding survivors who attended cancer-related follow-up care visits, the authors noted that 75.8% of the adult survivors in the study visited their oncologist and 66.8% visited their general practitioner. Furthermore, the authors determined that more than half of the survivors of childhood cancer attended a specialized long-term follow-up clinic and half visited their general practitioner for cancer-related follow-up care.

For survivors with SCPs, the study authors found that some survivors reported that they did not receive reminders to attend cancer-related follow-up care visits, which included 12.3% for adult survivors and 39.5% for childhood survivors.

The authors of the study also identified the propensity of attending cancer-related follow-up care visits.

“Survivors of adult cancer who received an SCP were significantly more likely to report having visited their general practitioner for cancer-related follow-up care than nonrecipients,” the authors wrote. “Survivors of childhood cancer who received an SCP, as compared to nonrecipients, were more likely to attend cancer-related follow-up care appointments at least annually and attend a long-term follow-up clinic.” It was also noted in the study that survivors of childhood cancer who received SCPs were less likely to claim that they do not receive reminders to attend follow-up visits.

Quality of life was another aspect that the authors analyzed within the study. They found that “SCP (recipients) predicted a greater global quality of life for survivors of adult cancer, health-related quality of life for survivors of childhood cancer as proxy-reported by parents, and satisfaction with cancer-related follow-up care for survivors of childhood cancer and parents.”

Survivor care plans (SCPs) have been shown to significantly benefit cancer survivors by enhancing their participation in follow-up care and improving their quality of life. A study involving 1,123 cancer survivors revealed that SCPs provide crucial information on cancer history and future risks, along with a schedule for recommended check-ups. Despite their benefits, only a small percentage of survivors reported receiving SCPs. Those with SCPs were more likely to attend follow-up care and reported higher satisfaction and quality of life, highlighting the importance of SCPs in survivorship care.

Cancer survivors who received care plans were more likely to regularly attend cancer-related follow-up care visits, researchers found.

Survivor Care Plans Lead to Higher Follow-Up Care Retention Rates

The first patient has been dosed in a phase 1/2 clinical trial evaluating a novel drug, SNS-101, for the treatment of patients with advanced solid cancers. Additionally, according to a press release from Sensei Bio, the manufacturer of the drug, patients can also currently enroll in an arm of the trial that is investigating SNS-101 plus Libtayo (cemiplimab).

There are three parts of the clinical trial:

Part A is a phase 1 dose escalation trial (meaning that researchers will increase the dose until they determine the best dosing of the agent) of SNS-101 administered alone.

Part B is a phase 1 dose escalation trial evaluating SNS-101 in combination with Libtayo.

Phase C is a phase 2 expansion cohort (meaning that more patients will be able to enroll) of SNS-101 alone or in combination with Libtayo.

For parts A and B, the main goals of the trial are to determine the incidence, nature and severity of side effects, as well as the maximum tolerated dose of SNS-101, while the main goal of part C is objective response rate (percentage of patients whose disease shrinks or disappears from treatment) after approximately one year.

Other endpoints of the study include how SNS-101 works in and interacts with the body; number of patients with anti-SNS-101 antibodies in the body after the last administration of the drug; objective response rate; duration of response disease control rate at one year; progression-free survival (percentage of patients whose did not die or experience disease progression) at one year; and side effects.

SNS-101 is an immunotherapy agent that targets the VISTA protein, which plays a role in regulating the immune system. Similarly, Libtayo is also an immunotherapy drug. This agent targets and inhibits the PD-1 protein, which helps cancer cells to essentially hide from the immune system. Once the PD-1/PD-L1 pathway is inhibited, the patient’s immune system can better find and fight the cancer.

“We are pleased with the rapid enrollment of our clinical trial and are excited to evaluate SNS-101 as a combination therapy earlier than anticipated,” John Celebi, president and chief executive officer of Sensei Biotherapeutics, said in a press release. “Sensei is now treating patients at a dose significantly higher than any VISTA antibody for which clinical data have been reported, while dosing less frequently at a rate of once every three weeks. We believe these important differentiators underscore the vast potential of SNS-101 to treat patients with solid tumors.”

To be eligible for participating in the trial, patients must have a locally advanced, unresectable or metastatic solid tumor; be refractory or intolerant standard of care; have measurable disease; be able to perform all or most of their daily activities independently; have a life expectancy of three or more months; provide treatment biopsy samples; have adequate organ function; and be willing to prevent pregnancy.

The pharmaceutical company announced that it expects to have initial pharmacokinetic (how the drug interacts with the body) and safety data within the first few months of 2024, with preliminary anti-tumor data sometime within 2024 as well.

For more news on cancer updates, research and education, don’t forget to 

A phase 1/2 clinical trial is underway to evaluate SNS-101, a novel immunotherapy targeting the VISTA protein, for advanced solid cancers. The trial includes three parts: dose escalation of SNS-101 alone, dose escalation with Libtayo, and a phase 2 expansion cohort. The primary goals are to assess side effects, maximum tolerated dose, and objective response rate. SNS-101, combined with Libtayo, aims to enhance immune response against cancer. Initial pharmacokinetic and safety data are expected in early 2024, with preliminary anti-tumor data later that year.

A phase 1/2 trial is examining the novel agent, SNS-101, with or without Libtayo for the treatment of patients with advanced solid cancers.  

Ghassan K. Abou-Alfa, M.D.

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