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A gastrointestinal malignancy expert discusses the role genomics play in cholangiocarcinoma, as well as how genetic profiling may identify which treatment is best for patients.
 

Genetic Profiling may Open Many Doors for Treating Cholangiocarcinoma

Use of the NeuroSAFE technique during prostate cancer surgery nearly doubled the number of patients who had no or mild erectile dysfunction approximately a year later, researchers have found.

Findings from the NeuroSAFE PROOF phase 3 trial, which was conducted at five National Health Service Hospitals in the United Kingdom, were published in 

and presented at the 2025 European Association of Urology Congress in Madrid, with researchers reporting on the use of NeuroSAFE to guide nerve sparing during robot-assisted radical prostatectomy (RARP).

In 344 patients who underwent radical prostatectomy, or the surgical removal of the prostate (173 patients in the NeuroSAFE group and 171 in the standard RARP group) at a median follow-up of 12.3 months, 39% and 23% of patients, respectively, had no or mild erectile dysfunction.

CURE spoke with NeuroSAFE PROOF researcher 

 about the study and its findings. Shaw is the lead for robotic urology for University College London Hospitals and a professor of urology at University College London.

CURE: What do you hope is the big takeaway from these findings?

 The trial that we presented in Madrid, that coincided with the Lancet Oncology paper, is definitive evidence that the new technique that we trialed, the NeuroSAFE technique, allows us to help more men get back to potency after radical prostatectomy. Radical prostatectomy, some of you will probably be aware, is an operation used to cure prostate cancer. It's really good for curing prostate cancer, but many men are left with side effects, urinary incontinence and erectile problems. And using this technique, we doubled the number of men who were able to get normal erections after the procedure compared to our standard approach.

How does the NeuroSAFE technique supplement or how is it different than the current standard of care?

It's an additional step to the operation, and it's performed during the operation whilst the patients asleep. It's designed because when we do a prostatectomy, we want to take away all the cancer and leave behind all of the important structures that surround the prostate, but they're really closely approximated. So, the prostate is a bit like an onion. It's got concentric layers running around it, and within the outer layers are the very small, microscopic nerves that send the signals for men to get erections. So where we can we peel those layers off, we leave them inside the patient, so they remain functional. And that's OK if the tumor is away from where the nerves are, but if it's close to the edge, and as it stands, we don't have a way of accurately telling us, even MRI scanning doesn't tell us exactly where the cancer finishes and the nerves are, so to a certain extent, we err on the side of caution. And sometimes we find we've taken a prostate out with the outer coverings, not done nerve sparing, whereas actually we could have done nerve sparing, and that's due to the lack of resolution on the MRI scans, it doesn't give you that sub-millimeter measure of how close you might or how far you might be from the nerves.

So this technique is designed to deal with that problem. It gives the surgeon feedback during the operation. So the approach is you do a full nerve spare, regardless of what the MRI scan looks like, and then when the prostate is removed from its attachments, it can be brought out from the inside of the patient and analyzed, and we look at the edge of it, and there's quite an involved process. It's called frozen section. We freeze the tissue, slice it super thin, and then stain it so that it can be examined by a pathologist. And if the pathologist tells you that there's cancer at the edge here, that's not good. OK, we we now need to take the nerves away, and we do that at the same sitting during the same operation. So it adds about an hour on to the patient's surgery. The patient is asleep during that time, but it allows us this control, this extra bit of information, [to determine] has nerve sparing been safe in this patient or not.

Did anything in these results surprise you and your colleagues?

I think we were optimistic that we were going to see an effect, but perhaps surprised to see that the effect was quite so marked: twice as many men a year after surgery, either with no erectile dysfunction or mild erectile dysfunction. And that's quite important, because we treat many, many men with prostate cancer. Some of them are young. The age at which we start worrying about prostate cancer is 50 in Caucasian men, 45 in patients who have relatives with prostate cancer or Afro Caribbean men.

So some of these patients are young, and it's one thing saying to a 70-year-old man who's not particularly sexually active, "You're not going to get erections again." But you tell that to someone who's 45 years old, who's maybe not in a stable relationship, that's life changing, and they've got the rest of their life to live with that. So this is really important for younger patients, sexually active patients, but particularly patients who were the conventional methods are used, MRI scanning, looking at the biopsy results, where it's felt they can't have nerve sparing, because there's a question about whether it would be safe or not,

How should these findings inform conversations that patients have with their doctors?

I think patients should be asking their doctors if they offer NeuroSAFE and discussing the relative merits of it. There are technical issues with running it. It takes a lot of coordination. It takes a team of people to prepare the slides. You've got to have a pathologist available to make the interpretation, make the call that the surgeon acts on. So I think we will see this being taken up by more centers with time. Some centers can't do it either because of geography, maybe the pathologist is not in the same building as the as the surgery. That becomes a real issue when you're talking about transferring tissue samples. But there's some new technology out there that's quite exciting. There's something called a confocal laser microscope, which gives it a similar readout. It scans the whole surface of the prostate, and that image can then be beamed to a pathologist. They might be miles away. They might be around the other side of the world. The Internet is so quick now, and the pathologist can make a call on that image.

So, I think this calls for an increase in our performing an examination of the prostate to guide nerve sparing during surgery. The practicalities of that will vary by hospital, by geography, but I think many more surgeons will be making an effort to gather this extra bit of information that clearly makes a difference to patients.

“Effect of NeuroSAFE-guided RARP versus standard RARP on erectile function and urinary continence in patients with localised prostate cancer (NeuroSAFE PROOF): a multicentre, patient-blinded, randomised, controlled phase 3 trial” by Eoin Dinneen et al., 

Transcript has been edited for clarity and conciseness.

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

The NeuroSAFE technique, used during prostate cancer surgery, significantly improves erectile function outcomes post-surgery. The NeuroSAFE PROOF phase 3 trial demonstrated that this technique nearly doubled the number of patients experiencing no or mild erectile dysfunction a year after surgery compared to standard procedures. This technique involves intraoperative analysis of prostate tissue to guide nerve sparing, enhancing surgical precision. While promising, its implementation requires coordination and resources, including pathologist availability. The findings suggest a potential shift in surgical practices to improve quality of life for prostate cancer patients.

Use of NeuroSAFE during prostatectomy nearly doubled the number of patients who had no or mild erectile dysfunction approximately a year later.

Tumor

NeuroSAFE May Increase Erectile Function After Prostate Cancer Surgery

The United States Food and Drug Administration (FDA) has approved penpulimab-kcqx with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult patients with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC), the regulatory agency has announced.

The FDA has also approved the drug as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.

The effectiveness of penpulimab-kcqx plus cisplatin or carboplatin and gemcitabine was evaluated in Study AK105-304, a multicenter trial of 291 patients with recurrent or metastatic NPC who had not been treated with prior systemic chemotherapy for recurrent or metastatic disease. Patients were treated with either penpulimab-kcqx plus cisplatin or carboplatin and gemcitabine followed by penpulimab-kcqx or placebo with cisplatin or carboplatin and gemcitabine followed by placebo.

The median progression-free survival was 9.6 months in the penpulimab-kcqx arm and 7 months in the placebo arm, with 31% and 11% of patients alive and progression-free after 12 months of follow-up, respectively. Overall survival results were immature, with 70% of pre-specified deaths for final analysis reported, but the agency reported that no detrimental trend was observed.

Additionally, the effectiveness of single-agent penpulimab-kcqx was determined in Study AK105-202. The study included 125 patients with unresectable or metastatic non-keratinizing NPC who had disease progression after platinum-based chemotherapy as well as at least one other line of therapy and received penpulimab-kcqx until disease progression or unacceptable toxicity for up to 24 months.

The objective response rate was 28%, and a median duration of response was not reached.

Immune-mediated side effects that occurred with penpulimab-kcqx included pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction and skin adverse reactions, the FDA reported.

The most common side effects, occurring in at least 20% of patients who received penpulimab-kcqx with cisplatin or carboplatin and gemcitabine were nausea, vomiting, hypothyroidism, constipation, decreased appetite, decreased weight, cough, COVID-19 infection, fatigue, rash and pyrexia.

Furthermore, the most common side effects occurring in at least 20% of patients who received single-agent penpulimab-kcqx were hypothyroidism and musculoskeletal pain. Fatal side effects occured in 1% of patients, including one case each of pneumonitis, septic shock, colitis and hepatitis.

The recommended dosage of penpulimab-kcqx with cisplatin or carboplatin and gemcitabine is 200 milligrams every three weeks until disease progression or unacceptable toxicity for up to 24 months. The recommended dosage of single-agent penpulimab-kcqx is 200 milligrams every two weeks until disease progression or unacceptable toxicity for up to 24 months.

Penpulimab-kcqx, as explained by the National Cancer Institute on its website, is a monoclonal antibody that is intended to target, bind to and inhibit the protein PD-1 and its downstream signaling pathways, which may restore immune function through the activation of T cells and T cell-mediated immune responses against tumor cells. PD-1 functions as an immune checkpoint, negatively regulating T cell activation, and plays an important role in cancer’s evasion from a patient’s immune system, as the National Cancer Institute explained.

Nasopharyngeal cancer, the National Cancer Institute noted on its website, is a type of head and neck cancer that starts in the tissues of the nasopharynx. The nasopharynx, it explained, is the upper part of the pharynx, located behind the nose, and it is connected to the nostrils. In addition, openings on each side of the nasopharynx lead to the ears.

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

subscribe to CURE®’s newsletters here.

The FDA has approved penpulimab-kcqx in combination with cisplatin or carboplatin and gemcitabine for first-line treatment of recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) in adults. It is also approved as a single agent for adults with metastatic NPC after progression on platinum-based chemotherapy and another therapy. Study AK105-304 showed a median progression-free survival of 9.6 months with the combination therapy. Common side effects include nausea, hypothyroidism, and fatigue. Recommended dosages are 200 mg every three weeks or two weeks, depending on the regimen.

The FDA has approved penpulimab-kcqx with chemotherapy and as a single agent for some patients with nasopharyngeal carcinoma.

FDA Approves Penpulimab-kcqx For Nasopharyngeal Carcinoma

Professor Richard Scolyer, a top doctor and leading melanoma pathologist, was diagnosed with Glioblastoma (GBM) brain cancer in July of 2023 and told he had only a few months to live. However, Richard didn't give up. Using everything he knew about melanoma science, Richard and his team used pre-surgery combined immunotherapy and a personalized cancer vaccine, the first in the world to do so.

Patients like Richard need your support in order to access the specialists, advanced treatments, and devices they need. Give today to support the End Brain Cancer Initiative's (EBCI’s) mission and help patients and families. Learn more about Richard's story at https://www.youtube.com/watch?app=desktop&v=2D9_mlLZPdI.

Support from individuals is vital for the End Brain Cancer Initiative to continue helping patients and families facing brain cancer, brain tumors, and metastatic disease to the brain. Gifts will support free access to DIRECT support from EBCI, a wealth of resources through the EBCI Website and the EBCI Disease Education Mobile App, and patient disease education online events. People can help EBCI reach their goal of $20,000 dollars raised for GiveBIG 2025 by giving at endbraincancer.org/donate.

Gifts to EBCI for GiveBIG will also fuel the nonprofit’s advocacy efforts, giving EBCI the ability to advocate for policies that increase patient access to specialists, advanced treatments, and devices. One such policy is the Bolstering Research And Innovation Now (BRAIN) Act (H.R.2767/ S.1330), which aims to advance the quest to defeat brain tumors, once and for all, by increasing research funding, fostering collaboration, promoting critical awareness efforts, and supporting innovations in and access to care.

GiveBIG 2025 is all about that good feeling we get when we show up for others, whether it’s a family member, a neighbor, or a local nonprofit we care about. People can make good things happen at the End Brain Cancer Initiative by giving to help patients and families facing brain cancer, brain tumors, and metastatic disease to the brain.

The End Brain Cancer Initiative is a 501(c)3 non-profit patient organization focused on disease education, awareness, outreach and increasing patient access. The End Brain Cancer Initiative, formerly known as the Chris Elliott Fund, is dedicated to ensuring that all patients diagnosed with brain cancer, a brain tumor, or metastatic disease to the brain have equal access to advanced diagnostics, treatments, specialists, and clinical trial participation. We believe that IMMEDIATE ACCESS to these options provides this patient community with the best HOPE for survival and sustained quality of life. We partner with industry, patients, researchers, advocacy groups, medical teams, hospital networks and others to educate patients and their caregivers so they can have empowered conversations with medical teams. Learn more about and support the End Brain Cancer Initiative’s work and mission at EndBrainCancer.org.

Professor Richard Scolyer, a renowned melanoma pathologist, was diagnosed with Glioblastoma in 2023. Despite a grim prognosis, he utilized his expertise to undergo innovative treatments, including pre-surgery combined immunotherapy and a personalized cancer vaccine. The End Brain Cancer Initiative (EBCI) supports patients like Richard by providing access to specialists, treatments, and resources. Donations to EBCI aid in advocacy efforts, such as the BRAIN Act, and help achieve fundraising goals like GiveBIG 2025. EBCI is committed to ensuring equal access to advanced care for brain cancer patients.

People can help EBCI reach their goal of $20,000 dollars raised for GiveBIG 2025 by giving at endbraincancer.org/donate.

NOINDEX

NOFOLLOW

Support Patient Access and Education with the End Brain Cancer Initiative for GiveBIG 2025

The End Brain Cancer Initiative (EBCI) is currently seeking Primary Central Nervous System Lymphoma (PCNSL) patients and care partners to participate in an online roundtable discussion on April 11, 2025, from 11AM to 12:30PM Pacific Time.

The PCNSL Online Roundtable will help further resources and education provided to this patient population by doing a deep dive into the results of their recent PCNSL patient and care partner survey. The roundtable, sponsored by Ono Pharmaceutical, will be moderated by Dellann Elliott Mydland, President and CEO of the End Brain Cancer Initiative.

Patients and care partners interested in participating in this discussion should fill out the interest form at endbraincancer.org/pcnsl before March 31, 2025. Qualifying participants will be compensated $75 for their time.

Ono Pharmaceutical Co., Ltd., headquartered in Osaka, is an R&D-oriented pharmaceutical company committed to creating innovative medicines in specific areas. Ono focuses its research on oncology, immunology, neurology, and specialty area with high medical needs as priority areas for discovery and development of innovative medicines. For further information, please visit the company’s website at https://www.ono-pharma.com/en.

To support/donate to the End Brain Cancer Initiative’s increased access and health delivery for patients, mission, services and programs, please visit EndBrainCancer.org

The End Brain Cancer Initiative (EBCI) is a 501(c)3 non-profit patient advocacy organization focused on disease education, awareness, outreach, increasing patient access and improving Standard of Care. The End Brain Cancer Initiative, formerly known as the Chris Elliott Fund (CEF), is dedicated to ensuring that all patients diagnosed with brain cancer, a brain tumor, or metastatic disease to the brain have equal access to advanced diagnostics, treatments, specialists, and clinical trial participation. We believe that IMMEDIATE ACCESS to these options provides this patient community with the best HOPE for survival and sustained quality of life. We partner with industry, patients, researchers, advocacy groups, medical teams, hospital networks and others to educate patients and their caregivers so they can have empowered conversations with their medical teams. Learn more about the End Brain Cancer Initiative at EndBrainCancer.org.

The End Brain Cancer Initiative (EBCI) is organizing an online roundtable for Primary Central Nervous System Lymphoma (PCNSL) patients and care partners on April 11, 2025. This event aims to enhance resources and education for this patient group by analyzing recent survey results. Sponsored by Ono Pharmaceutical, the roundtable will be moderated by EBCI's President, Dellann Elliott Mydland. Participants will receive $75 for their involvement. EBCI is a non-profit focused on improving access to advanced diagnostics and treatments for brain cancer patients.

Primary Central Nervous System Lymphoma Patient and Care Partner Roundtable Hosted by the End Brain Cancer Initiative

Registration is now open for the 2025 Know All Your Treatment Options (KAYTO25) online patient disease education event/webinar

Registration is now open for the 2025 Know All Your Treatment Options (KAYTO25) online patient disease education event/webinar, hosted by the End Brain Cancer Initiative (EBCI), on Friday, May 16th, 2025, from 11 AM to 2 PM Pacific Time.

This free annual online event is designed specifically for members of the brain tumor, brain cancer, and metastasized brain tumor community to hear directly from top specialists, including researchers, in the field about advanced and FDA approved treatment options, clinical trials, devices, diagnostics, etc. that they may not have heard about and to “DIRECTLY CONNECT” this patient population to many of these specialists. The event is free to attend due to corporate sponsorships, but pre-registration is required: endbraincancer.org/know-all-your-treatment-options-2025/.

KAYTO attendees will hear from multiple presenters, including a representative from Telix Pharmaceuticals, one of the presenting sponsors of this event. Telix is at the forefront of developing advanced imaging agents to improve the diagnosis and management of brain cancers, particularly gliomas. Telix’s brain cancer program comprises an investigational therapy and an investigational PET imaging agent – both small molecule-based. The company aims to provide clearer and more specific imaging results, aiding in the accurate differentiation between tumor progression and treatment-related changes.

Visit endbraincancer.org/know-all-your-treatment-options-2025/ to learn more about sponsorship opportunities to support this patient disease education online event.

Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Visit http://www.telixpharma.com/ for further information.

The 2025 Know All Your Treatment Options (KAYTO25) online event, hosted by the End Brain Cancer Initiative, will take place on May 16th, 2025. This free event aims to educate the brain tumor community about advanced treatment options and connect them with specialists. Sponsored by companies like Telix Pharmaceuticals, the event will feature presentations on innovative imaging agents for brain cancer management. The End Brain Cancer Initiative, a non-profit organization, focuses on improving patient access to diagnostics, treatments, and clinical trials, enhancing survival and quality of life.

Registration Open for the 2025 Know All Your Treatment Options Webinar Hosted by the End Brain Cancer Initiative

Each May, for over a decade, the End Brain Cancer Initiative (EBCI) has presented the National HOPE Award to a brain cancer patient who deeply inspires us with their courage and story. EBCI established this patient disease education initiative and award to highlight exceptional people who have done exceptional things during their brain cancer journey, all while inspiring others.

The deadline for submitting HOPE Award nominations is April 16th, 2025. To submit a nomination, people can visit https://endbraincancer.org/hope-award-nomination/. 

Patrick “Paddy” O'Donnell is the 2024 National HOPE Award recipient. Paddy was a 20-year-old collegiate ice hockey goaltender at the University of Utah when he had a seizure. He woke up in the Neuro ICU connected to tubes and monitors wondering what happened. A biopsy revealed he had Glioblastoma (GBM) and three tumors. Paddy was nominated by his mother, Anne O'Donnell. "Paddy had to create his own HOPE and sought answers and second opinions about his treatment," she said. "End Brain Cancer Initiative was vital in our search, at the most critical time, availing us of options and direct contact with experts in the field whom Dellann knew personally."

The 2025 HOPE Award recipient will be announced during the End Brain Cancer Initiative's Know All Your Treatment Options (KAYTO25) online patient disease education event/webinar on May 16th, 2025. This free annual online event is designed specifically for members of the brain tumor, brain cancer, and metastasized brain tumor community to hear directly from top specialists, including researchers, in the field about advanced and FDA approved treatment options, clinical trials, devices, diagnostics, etc. that they may not have heard about and to “DIRECTLY CONNECT” this patient population to many of these specialists. The event is free to attend due to corporate sponsorships, but pre-registration is required: endbraincancer.org/know-all- your-treatment-options-2025/.

To support/donate to the End Brain Cancer Initiative’s increased access and health delivery for patients, mission, services and programs, please visit EndBrainCancer.org. 

The End Brain Cancer Initiative (EBCI) annually presents the National HOPE Award to a brain cancer patient who inspires with their courage and story. The 2024 recipient is Patrick “Paddy” O'Donnell, a collegiate ice hockey goaltender diagnosed with Glioblastoma. The 2025 recipient will be announced at the KAYTO25 event, which connects patients with specialists and provides information on advanced treatments. EBCI, a non-profit organization, focuses on disease education, awareness, and increasing patient access to advanced diagnostics and treatments, aiming to improve survival and quality of life.

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