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A New Path

Dr. Matthew Galsky highlights the impact of Imfinzi’s adjuvant approval for patients with muscle-invasive bladder cancer following cystectomy and chemo.

Understanding the FDA Imfinzi Combo Approval for Bladder Cancer Care

Adjuvant treatment with Imfinzi (durvalumab) plus chemotherapy, followed by single-agent, adjuvant Imfinzi following radical cystectomy, 

received U.S. Food and Drug Administration (FDA) approval

 for muscle-invasive bladder cancer in March, marking a milestone in treatment, according to Dr. Matthew Galsky.

, Galsky — who serves as a professor of medicine (hematology and medical oncology) at The Tisch Cancer Institute, part of the Mount Sinai Health System, in New York — discussed what makes this approval significant for patients and providers managing muscle-invasive bladder cancer. He goes on to share that data from the randomized, open-label, multicenter, 

 evaluated the now FDA-approved approach, which demonstrated a statistically significant improvement in event-free survival and overall survival.

Galsky is also the director of genitourinary medical oncology, co-director of the Center of Excellence for Bladder Cancer and associate director for translational tesearch at The Tisch Cancer Institute. Read 

 for patients regarding the FDA approval here.

A standard treatment for muscle-invasive bladder cancer is the surgical removal of the bladder. We know that after the bladder is removed, a subset of individuals will experience the cancer reappearing elsewhere in the body, developing metastatic recurrence, typically months to years later.

For decades, doctors attempted to combine chemotherapy with surgery to eradicate any microscopic cancer cells that might be present, aiming to reduce the risk of metastatic recurrence. When chemotherapy is administered before surgery, it's called neoadjuvant therapy. This concept of giving chemotherapy prior to surgery to treat potential microscopic spread of cancer is used in various solid tumors. When chemotherapy is given after surgery, it's known as adjuvant therapy.

For decades, the only neoadjuvant therapy [that was proven] beneficial in muscle-invasive bladder cancer was a combination of chemotherapy drugs, including cisplatin. This truly represented the standard treatment approach for many years because nothing had been shown to be superior.

Finally, after several decades, the NIAGARA trial demonstrated that integrating immunotherapy in the presurgical and postsurgical periods decreases the risk of metastatic disease development and improves longevity for patients.

Transcript has been edited for clarity and conciseness.

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

Dr. Matthew Galsky highlights the impact of Imfinzi’s adjuvant approval for patients with muscle-invasive bladder cancer following cystectomy and chemotherapy.


Tumor

Dr. Curtiland Deville Jr. discusses the importance of crafting an individualized treatment plan for patients with prostate cancer.

Crafting an Individual Treatment Plan for Patients With Prostate Cancer

, Dr. Curtiland Deville Jr. discussed the importance of crafting an individualized treatment plan for patients with prostate cancer.

Patients and providers, Deville explained, can find themselves selecting from a “menu of options,” which can include surgery and forms of radiation, such as proton therapy.

“When we see a patient, we want to develop an individualized and very customized treatment plan for them,” Deville explains.

Deville is associate professor of radiation oncology at Johns Hopkins University School of Medicine, medical director of the Johns Hopkins Proton Therapy Center and clinical director of radiation oncology at Sibley Memorial Hospital in Washington, D.C. In addition, he is co-director of the Kimmel Cancer Center Prostate Multidisciplinary Clinic at Sibley Memorial Hospital.

I think of protons as just another tool that we have. We have all the available treatment options for prostate cancer here at Sibley and at Johns Hopkins in radiation oncology. When we see a patient, we want to develop an individualized and very customized treatment plan for them. Very often, I might tell a patient that we may not conclude this conversation by stating that one specific treatment is definitively better for them; we may have a menu of options. Our job is to go through that menu and then try to rank and see what might suit this individual better.

Patients may ask me, "Well, what would you do at the end of the day?" Or when I was younger, they might say, "What would you do for your father?" And I used to like to say, "What my father would do is different than what my uncle would do in the same situation." So, it’s not necessarily about us imposing our own preferences but really trying to understand the patient in front of us and what they value and what their preferences are.

For prostate cancer, patients truly have a tremendous amount of treatment options available to them, which can include surgery or radiation. If they are deciding on a radiation pathway, we may have internal forms of radiation known as brachytherapy, which can be done with seeds or catheters; it’s called low-dose radiation or high-dose radiation.

If they are less interested in an invasive approach and prefer an external approach that is completely noninvasive, then we can consider our photon or proton therapy. There are sometimes contraindications to proton therapy that make treatment delivery harder, such as if the patient has bilateral hip implants, meaning they've had hip replacements on both sides. In that case, it’s very challenging to deliver proton therapy.

So, there may be factors as we evaluate an individual case that steer us in one direction more toward photons or more toward protons. But ultimately, if the patient is a good candidate for proton therapy, we can review the logistics, the potential side effects and all the details regarding the program and how we would develop a treatment plan for them.

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Breast MRI helps doctors detect disease in newly diagnosed and high-risk patients without replacing mammograms, according to an expert.

Breast MRI Offers Sensitive Imaging for High-Risk and Diagnosed Patients

Breast MRI is a powerful tool because of its sensitivity, helping doctors detect cancers that might not appear on a mammogram, according to Dr. Pouneh Razavi. She explained that breast MRI uses contrast to highlight areas where cancer may be growing faster than normal tissue, making it an important resource for certain patients.

Razavi, director of breast imaging for Johns Hopkins National Capital Region, shared that MRI is typically reserved for two groups: patients with a new diagnosis of breast cancer and those with a higher-than-average lifetime risk. For high-risk patients, MRI is offered once a year alongside yearly mammograms, typically spaced six months apart.

Razavi emphasized that MRI complements — but never replaces — mammography. By using both imaging tools and improving collaboration among care teams, she said, patients can receive a more accurate diagnosis and tailored treatment plans.

CURE: Can you explain when a breast MRI is typically recommended for patients with breast cancer?

 Breast MRI is indeed a powerful tool. It's powerful because it is very sensitive. With a breast MRI, what we do is we give contrast that is taken up via IV, either through the hand or through the arm for the patient, and then the contrast is picked up by all the breast tissue. What we do is we look at serial images, consecutive images following the administration of contrast to see if there's any lesion that might be taking up contrast at a different rate than the normal breast tissue.

The reason this is so helpful is because cancers generally recruit more blood vessels to themselves. So, they will pick up contrast at a faster rate than the regular breast tissue, the normal breast tissue. So, that's what we're looking at when we look at a breast MRI. So, it is very sensitive, and for that reason, it's a very powerful tool. We generally reserve it for two sets of populations.

No. 1 is patients with a new diagnosis of breast cancer, and No. 2 is patients who we know are at a higher lifetime risk of getting breast cancer than the average population. For those higher than lifetime-risk patients, we will offer a mammogram once a year. Mammogram is key. We never drop the mammogram. And we offer an MRI — usually at the six-month interval from the mammogram — once a year.

I ran into a fellow cancer survivor at the bagel store. It was a joy to see Colleen. She’d made it through three bouts of cancer, and I’d made it through two. She asked me how I was feeling, and I told her, “I’m doing well.”

She replied, “One day at a time.” This is a phrase that I could hear over and over.

I have to admit that I don’t always adhere to this philosophy, but I should. One day at a time. After all, isn’t that enough?

We agreed that we would start walking in the neighborhood. This would be good for both of us. Our shared cancer experience is not understood by everyone. She’s someone who I can truly open up with.

I know this woman from kindergarten. We had the same teacher, and after kindergarten, she transferred to the Catholic school in town. But we’d always maintained a friendship.

That night, I got a call from my best friend, Carol, who’d just lost her mentor to cancer. She was broken up, as he had passed unexpectedly. I was at a loss for words in an attempt to comfort her. Then the words of my neighbor, Colleen, washed over me.

My best friend repeated my words. “One day at a time.” The words seemed to make an impression on her. She told me more bad news. Her younger sister had stage 1 lung cancer and had to be operated on.

Cancer was all around me. I couldn’t get away from it. All I could say was “One day at a time.”

“Very. It’s past my bedtime. I haven’t eaten.”

“Have some food and go to bed,” I said.

“I’m sure that will help. And I will take it one day at a time.”

Colleen’s words were powerful. They had comforted me and now Carol. I hope they comfort you.

Cancer makes it difficult to see into the future. We might not be able to take it month by month or year by year, but we can do it day by day. Who knows? Maybe you’re going hour by hour.

And as for walking around the neighborhood with Colleen, I think I’ll make a habit of that.

Walking is something that I don’t like to do by myself. I find it kind of boring, but when I have someone to chat with as I walk, I can go for miles.

That was a lucky encounter when I saw Colleen in the bagel store. She was a gift from the universe, giving me a message that I needed right then. And I was glad I could pass the message onto Carol and now to you, the reader.

Messages from the universe come to me in various ways. Sometimes I hear them on the radio and sometimes I get an intuitive sense of something, but the message is usually conveyed by another person speaking to me. Colleen hadn’t known that her “day-by-day” communication would go as far as it did, but I was spreading it like wildfire. It was a good message, and people needed to hear it.

These are bad times. Cancer only makes them worse.

A chance encounter with a fellow cancer survivor, Colleen, reinforces the powerful mantra "one day at a time" for the author, who has faced cancer twice. This simple yet profound philosophy offers comfort and resilience in the face of cancer's uncertainties. The author shares this message with a friend grieving a mentor's loss and facing a family member's diagnosis. Walking with Colleen becomes a therapeutic routine, highlighting the importance of companionship and shared experiences. The narrative underscores the significance of living in the present and finding solace in small, supportive gestures.

A chance meeting with my childhood friend reminded me — and others — that living with cancer means taking things one day at a time.

A Fellow Cancer Survivor Gives Me a Useful Message 

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., 

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.

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 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.

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