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The reality of "No Evidence of Disease" isn't clear for one patient who faced melanoma.

Melanoma, NED and me

The woman who raised me and I did not always see eye to eye. In fact, as two stubborn, opinionated characters we frequently bickered, challenged and exchanged choice words with one another. 

As I reflect on 25 years strong with Mom, here are some of my favorite words that we exchanged. We gave each other many cards over the past few years, one of which she had told me she looked for a long time searching for the right message to express her feelings. It reads:

"When you have a daughter who makes you proud, makes you laugh and, very often, makes your day ... you know what joy is. When you have a daughter who is a good person with a gracious heart and generous spirit ... you know what peace is. When you have a daughter whose beauty (inside and out) is matched only by her compassion for others ... you know what love is. Because I have you for my daughter, I know what it is to be truly blessed."

When I first read those words — as I read them now — I feel so close to my mom. Recently, I found a card with the words that expressed how I feel about her. I read this aloud to her on Christmas Day.

"Dear Mom, I'm so grateful for the way I was raised. You were never afraid to be my mother — to put your foot down, to teach me right from wrong, to make sure I did my best. You always let me know I had a mama who cared about me, who believed in me, who was there for me no matter what. Growing up with that kind of love and support made such a difference in my life; it made me who I am today."

My mother was never afraid to voice her opinion or be one to mince words, to put it lightly; but she was always pure in her intentions and true in her actions, and I feel so clearly, so humbly loved. As I go forward, I remember her strength and purity, her fierce sense of pride, her generous heart and sensitivity, her sense of humor (she once packed me a peanut-butter-jelly-and-ham sandwich because I refused to pick one of the two). 

Throughout her life and especially in her fight against lung cancer, Mom set us an example in unconditional devotion, taught our family valuable life lessons and never lost her indomitable spirit.

I know Mom is with us now and always. Goodbyes are only for those who love with their eyes, because for those who love with heart and soul there is no such thing as separation. I love you Mom, Happy New Year. Rest in peace and God bless.

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

The narrative reflects on a complex yet deeply loving relationship between a daughter and her mother, characterized by mutual respect and understanding despite frequent disagreements. The daughter cherishes the heartfelt words exchanged through cards, highlighting the mother's pride, love, and unwavering support. The mother, who battled lung cancer, exemplified strength, devotion, and humor, leaving a lasting impact on her family. The daughter expresses gratitude for her upbringing and acknowledges the enduring connection with her mother, emphasizing that true love transcends physical separation.

Tumor

A Tribute to Mom

The United States Food and Drug Administration (FS) approved Welireg (belzutifan) for adult and pediatric patients 12 years and older with locally advanced, unresectable or metastatic pheochromocytoma or paraganglioma (PPGL).

This is the first FDA approval of an oral therapy for the treatment of patients with PPGL. Moreover, this regulatory approval was based off study findings from the LITESPARK-015 trial.

In the trial, a total of 72 patients were treated in cohort A1, and in this cohort of patients, the overall response rate was 26%, and responses lasted a median of 20.4 months. Among 60 patients taking blood pressure medication, 32% were able to reduce at least one of their medications by half for six months or longer.

The most common side effects, affecting up to 25% of patients, included anemia, fatigue, muscle and joint pain, low lymphocyte and white blood cell counts. Additionally, there were changes in lab values such as elevated liver enzymes, calcium, potassium and alkaline phosphatase. Other side effects reported were shortness of breath, headache, dizziness and nausea.

The LITESPARK-015 trial was an open-label, multi-cohort study. Cohort A1 included evaluable participants with measurable disease confirmed by blinded independent central review, a documented diagnosis of pheochromocytoma or paraganglioma, and locally advanced or metastatic disease not suitable for surgery or curative treatment. Patients with controlled hypertension were eligible for trial enrollment if their blood pressure medications had remained stable for at least two weeks before starting the trial. Those with carcinomatous meningitis were excluded.

The recommended Welireg dose for adults is 120 milligrams taken by mouth once daily. For children 12 and older, dosing depends on body weight: those weighing 40 kilograms or more should also receive 120 milligrams daily, while those under 40 kilograms should receive 80 milligrams daily. Treatment should continue until the cancer worsens or side effects become unmanageable.

The main efficacy measure was objective response rate, as assessed by independent review using RECIST v1.1. Additional measures included duration of response and the number of patients who reduced at least one blood pressure medication by 50% or more for at least six months.

The FDA granted this application priority review and used the Assessment Aid, a voluntary tool submitted by the drugmaker to help streamline the review process.

Other approvals for this agent include an August 2021 approval. 

 for the treatment of adult patients with von Hippel-Lindau disease who need treatment for their for renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors.

This approval was based on trial results showing a 49% response rate in those with kidney cancer. Among responders, 56% had responses lasting at least 12 months. The median time to response was eight months. Patients took a once-daily 120 milligram dose until disease progression or side effects became intolerable. The trial included 61 people with kidney, brain or pancreatic tumors.

the regulatory agency also approved Welireg

 for those with advanced renal cell carcinoma following treatment with a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).

The December approval was based on findings from the previous LITESPARK-005 trial, which included 746 patients with unresectable locally advanced or metastatic clear cell renal cell carcinoma that had progressed after both a PD-1 or PD-L1 checkpoint inhibitor, and a VEGF-TKI.

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don’t forget to subscribe to CURE®’s newsletters here.

The FDA has approved Welireg (belzutifan) for treating locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL) in patients aged 12 and older. This marks the first oral therapy approval for PPGL, based on the LITESPARK-015 trial, which showed a 26% overall response rate and a median response duration of 20.4 months. Common side effects include anemia, fatigue, and elevated liver enzymes. The trial's main efficacy measure was the objective response rate, with additional measures including duration of response and blood pressure medication reduction.

The FDA approved Welireg for adult and pediatric patients 12 and older with locally advanced, unresectable or metastatic pheochromocytoma or paraganglioma.

FDA Approves Welireg for Pheochromocytoma and Paraganglioma

Personalized therapeutic approaches are essential for treating patients with urologic cancers, such as bladder and kidney cancer, according to Dr. Armine Smith, a urologist at Johns Hopkins University in Washington, DC.

She went on to emphasize that these personalized treatment decisions typically involve bladder preservation or partial nephrectomy. These approaches depend on multiple individualized factors that vary with each patient, including tumor characteristics, overall health and functional outcomes. Overall, the goal is to maximize quality of life and long-term organ function, Smith says.

Smith is also the director of urologic oncology at Sibley Memorial Hospital and co-director for women's bladder cancer program at Johns Hopkins University and Greenberg Bladder Cancer Institute.

CURE: For patients newly diagnosed with bladder cancer, especially those considering bladder preservation, what are the key factors you weigh when determining if this approach is suitable, and how do you personalize the treatment plan?

: So, when considering bladder preservation, we'll look at the standard information that comes with it, like bladder tumor grade stage. There are some other additional factors that may make the patient more suitable or not for bladder preservation. [These factors include] if there are multifocal tumors, if there are any advanced stage that's present, if the tumor is unresectable, as well as [the] urological subtypes of these bladder cancers.

Those are all the important pieces of information we consider. To preserve the bladder, we need to have a functioning bladder that will give the patient good quality of life afterwards. Some other factors to consider. This is a pretty complex process. Some of the factors are just patients’ overall morbidities, you know, their health, their ability to adhere to these very stringent surveillance protocols [and] the ability to undergo these treatments.

So currently, the bladder preservation includes treatments with chemotherapy, or immunotherapy with radiation to the bladder, and resections of the bladder and the ability to continue the monitoring. All of this information comes together when we find the right personalized approach to every patient for this.

With advancements in minimally invasive and robotic surgery for kidney cancer, such as partial nephrectomy, what are the potential benefits for patients regarding recovery time and long-term kidney function?

Robotic and minimally invasive kidney surgery has been a game changer because it results in less blood loss for patients, quicker recovery, less pain during recovery, and shorter hospital stays. The robotic approach, building upon the minimally invasive approach, has allowed us to treat more complex tumors because the robotic instruments have an additional degree of motion compared to laparoscopic instruments.

As far as long-term function, partial nephrectomy preserves a significant portion of the kidney, which allows patients to have better kidney function going forward and avoid dialysis. Some studies suggest that better kidney function helps patients with their cardiovascular health, although the definitive link between surgical intervention and this benefit is still being researched.

Nevertheless, we generally aim to preserve kidney function when possible and perform minimally invasive surgery to optimize recovery and minimize pain and scarring.

What factors determine if a patient is a good candidate for partial nephrectomy?

Candidates for partial nephrectomy are usually those with tumors that are not too large, localized to the kidney, and technically resectable. Other considerations that come to mind when deciding if this is the proper treatment for the patient are their overall kidney function and select cases where preserving kidney function is crucial, such as people with a solitary kidney. In these patients, we might attempt kidney preservation even with larger tumors.

Another scenario involves younger individuals who develop kidney tumors and whom we believe might be at risk of developing more tumors in the future; these patients sometimes undergo periodic efforts to perform partial nephrectomies.

What are some of the most common misconceptions you encounter regarding urologic cancers, and what advice would you give to patients seeking reliable information and support resources?

I think what comes to mind when you ask this question is bladder cancer. One misconception is that some people don't realize smoking causes bladder cancer; they think it only causes lung cancer. The other misconception I hear is that bladder cancer is a disease of male smokers. However, it can happen in men and women, young and old. Smoking is one of the known risk factors, but chemical exposures and sometimes a genetic predisposition can also lead to it.

Another misconception is that there's a one-size-fits-all approach to these cancers. Again, talking about bladder cancer, some cases are easily treatable and don't pose a risk to life, while others require ongoing treatments and surveillance and carry the risk of progressing to metastatic disease.

When I talk to patients, I usually provide them with reliable sources of information they can turn to, such as the Bladder Cancer Advocacy Network, the American Urological Association, and many larger institutions, including ours, have web pages that provide more information about these kinds of disease states.

Transcript has been edited for clarity and conciseness.

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

Personalized therapeutic approaches are crucial for treating urologic cancers, focusing on bladder preservation and partial nephrectomy based on individual patient factors. These factors include tumor characteristics, overall health, and functional outcomes, aiming to enhance quality of life and organ function. Minimally invasive and robotic surgeries for kidney cancer offer benefits like reduced recovery time and improved long-term kidney function. Misconceptions about urologic cancers, such as the belief that smoking only causes lung cancer, highlight the need for reliable information and support resources for patients.

Dr. Armine Smith discusses the importance of personalized therapeutic approaches for the treatment of urologic cancers, such as bladder or kidney cancer.


The Importance of Personalized Treatment Approaches for Urologic Cancers

Mary Anderson, B.S.N., RN, OCN, embodies the spirit of an Extraordinary Healer, having dedicated more than 35 years to oncology nursing through different roles in pediatric oncology, infusion nursing and oral oncology, and now spearheading a national community for nurses through the National Community Oncology Dispensing Association (NCODA).

In all of these roles, she has embodied care for her patients and a desire to advocate for the role of oncology nurses. As senior manager of nurse initiatives at NCODA, Mary elevates the role of oncology nurses within medically integrated care teams across the country, empowering them with knowledge, confidence and tools to provide exceptional patient-centered care.

When Mary was an oral chemotherapy nurse navigator at Norton Cancer Institute in Louisville, Kentucky, she assisted the clinic with formalizing an oral anticancer treatment navigation program.

Mary’s influence on this topic extends to her co-authorship of the Oncology Association of Nurse Navigation practice guidelines for oral oncolytic management, ensuring best practices are widely accessible. Mary’s dedication to advancing and advocating for oncology nursing is evident in her work as a conference presenter and peer reviewer for a nursing journal, providing critical insights that elevate the profession. Her leadership includes serving as president of the Greater Louisville Oncology Nursing Society and earning recognition as Nurse of the Year in 2019 from the Norton Cancer Institute.

Mary Anderson’s lifelong commitment to innovation, education and advocacy improves the lives of patients and empowers her peers. She truly exemplifies what it means to be an Extraordinary Healer.

Mary Anderson’s lifelong commitment to innovation, education and advocacy improves the lives of patients and empowers her peers.

Mary Anderson, a seasoned oncology nurse with over 35 years of experience, has significantly contributed to the field through various roles, including pediatric oncology and oral oncology. As the senior manager of nurse initiatives at NCODA, she enhances the role of oncology nurses in integrated care teams. Her work includes co-authoring practice guidelines for oral oncolytic management and leading initiatives at the Norton Cancer Institute. Recognized as Nurse of the Year in 2019, her dedication to innovation and advocacy continues to empower patients and peers alike.

Mary Anderson, B.S.N., RN, OCN, embodies the spirit of an Extraordinary Healer.

Conference

A Lifelong Advocate and Innovator 

The phase 2 GIANT trial will evaluate Opdivo with or without relatlimab in IDH-wildtype newly diagnosed glioblastoma.

Clinical Trial to Evaluate Opdivo, Opdualag in Glioblastoma

Following the results of a hypothesis-generating study of immunotherapy in glioblastoma, a type of brain cancer, a phase 2 clinical trial is set to evaluate Opdivo (nivolumab) with or without relatlimab, a combination known as Opdualag, among patients with isocitrate dehydrogenase (IDH)-wildtype newly diagnosed glioblastoma.

The GIANT trial, set to be held in the United States at Duke University in Durham, North Carolina, was designed by professor Georgina Long, following up on her research into glioblastoma that was published in 

Long is the medical director of Melanoma Institute Australia (MIA) and chair of melanoma medical oncology and translational research at MIA and Royal North Shore Hospital, The University of Sydney. 

 article looked at the case of one patient with IDH-wild-type, MGMT promoter unmethylated glioblastoma who received treatment with a single dose of triplet immunotherapy followed by surgery who, after 17 months, showed no definitive sign of recurrence.

“It really showed that, despite what the oncology field thinks about glioblastoma, the immune system is not able to be activated against it; you can actually do that in certain circumstances,” Long said. “So when I came up with the idea and the hypothesis, because I developed drugs in melanoma — yes, we are curing over 50% of patients with immune stimulants or immunotherapy, [but] we still have 45% of patients who die from melanoma, and they die quickly — from my experience in the translational lab and in the clinic, because I'm a medical oncologist and translational researcher, my thinking about those sort of patients and the resistance to immunotherapy is what I applied to the glioblastoma.”

In light of the findings, the GIANT trial has an estimated start date of June 1, 2025, and will enroll approximately 92 patients, according to its listing on clinicaltrials.gov.

Long discussed her findings and the upcoming GIANT trial in an interview with 

The principles are: First of all, choose the right immunotherapies. You need to use CTLA-4. That's very important as part of your regimen in these terrible, terrible tumors. No. 2, use it early. Immunotherapy is best if you're going to test it. Test it early. No. 3, that publication was hypothesis-generating. We don't want to give false hope. We now need to show clinical benefit in a trial, and we are opening that. In fact, I designed that within six weeks and got the drugs within 10 weeks of that diagnosis of that patient. Then No. 4, the science showed activation of T cells infiltrating the glioblastoma after treatment, and [the] drug bound to the T cells. They're the four principles from that piece of work that I led, and now the trial should open in 2025 across America and Australia. It's an Australian trial driven by the Australians, but the Americans came on board, and now it's co-led by Duke University and the [Walter and Eliza Hall Institute of Medical Research] and [Peter MacCallum Cancer Centre] in Australia, but that came from the work I did and I put together.

For more news on cancer updates, research and education,

An artificial intelligence (AI) tool accurately predicted the risk of relapse in patients with pediatric cancer compared with other traditional approaches, according to a recent article from the 

Furthermore, the AI tool may be broadly adaptable to track and predict risk for patients with other cancers and chronic diseases undergoing surveillance imaging, according to study findings published in

The temporal learning model predicted recurrence of low- or high-grade glioma within one year post treatment with 75% to 89% accuracy, significantly outperforming single-image predictions, which have hovered at approximately 50%. Accuracy improved when more posttreatment images were used.

The AI tool is trained to analyze multiple brain scans over time, according to the news article. These results may lead to improved care for children with brain tumor gliomas, which, as noted in the article, are typically treatable but vary in risk of recurrence.

“Many pediatric gliomas are curable with surgery alone, but when relapses occur, they can be devastating,” corresponding author Dr. Benjamin Kann said in the article. “It is very difficult to predict who may be at risk of recurrence, so patients undergo frequent follow-up with magnetic resonance imaging for many years, a process that can be stressful and burdensome for children and families. We need better tools to identify early which patients are at the highest risk of recurrence.”

Kann is from the Artificial Intelligence in Medicine (AIM) Program at Mass General Brigham and the Department of Radiation Oncology at Brigham and Women’s Hospital in Boston. He is also an assistant professor of radiation oncology at Harvard Medical School.

The study included nearly 4,000 scans from 715 pediatric patients. A technique was then employed, called temporal learning, which has not been used previously for medical imaging AI research, and trained the AI tool to synthesize multiple brain scans taken over the span of several months after surgery. Researchers first trained the model to sequence postsurgery MRIs chronologically, helping it learn to detect subtle changes. They then refined the model to link those changes with later cancer recurrence when appropriate.

“Many pediatric gliomas are curable with surgery alone, but when relapses occur, they can be devastating,” Kann said in the article.

The researchers cautioned that further validation in additional settings is needed before clinical use. They want to launch clinical trials to determine whether AI-informed risk predictions can improve care by reducing imaging for low-risk patients or offering early targeted therapies to those at high risk.

“We have shown that AI is capable of effectively analyzing and making predictions from multiple images, not just single scans,” first author Divyanshu Tak, of the AIM Program at Mass General Brigham and the Department of Radiation Oncology at Brigham and Women’s Hospital, said in the article. “This technique may be applied in many settings where patients get serial, longitudinal imaging, and we’re excited to see what this project will inspire.”

An AI tool has demonstrated superior accuracy in predicting relapse risk in pediatric cancer patients, particularly those with gliomas, compared to traditional methods. The tool, utilizing a temporal learning model, analyzes multiple brain scans over time, achieving 75% to 89% accuracy in predicting glioma recurrence within a year post-treatment. This approach significantly outperforms single-image predictions. The study, involving nearly 4,000 scans from 715 patients, highlights the potential for AI to enhance personalized monitoring and care, though further validation and clinical trials are necessary before widespread clinical application.

An AI model using serial brain scans predicted glioma recurrence in children with up to 89% accuracy, outperforming single-image methods.

Gina King

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