What is life like for someone after cancer? 

“Often it’s a series of physical adjustments,” Dr. Kevin Billingsley, surgical oncologist and chief medical officer at Yale Cancer Center and Smilow Cancer Hospital in New Haven, Connecticut, told CURE. “It takes weeks to months to recover from the physical rigors, often of a combination of chemotherapy and surgery.”

Even young, healthy people will need to rebuild themselves, Billingsley said, and this is often via a program that involves exercise under the guidance of a trainer or physical therapist, as well as some nutritional consultation.

“It can take longer than people expect,” Billingsley said. “There [are] also the emotional adjustments of getting back into the normal flow of life and dealing with the uncertainty that [accompanies] a cancer diagnosis... This is because even when treatments are highly successful, people [may] live with the uncertainty that cancer may return at some point, which can be quite stressful.”

“Remission” is something of a nonspecific term, Billingsley explained. “It is generally applied to individuals who have undergone cancer treatment, either with surgery, chemotherapy, radiation, biologic therapies or some combination of therapies, and their cancer is no longer detectable. It’s not evident on physical examination, X-rays, CT scans or other traditional detection methods,” he said. “It, unfortunately, does not mean that the cancer is completely eradicated and will not return at some point, however.”

Frank J. Penedo, who has a doctorate in clinical psychology, told 

 about what is commonly referred to as the “the survivorship care period.” Penedo is center associate director, cancer survivorship and translational behavioral sciences; director, cancer survivorship and supportive care; and director, Biopsychosocial Mechanisms and Health Outcomes Lab, at Sylvester Comprehensive Cancer Center in Miami.

We have an expanding repertoire of very active treatments that really enhance our capability to cure or manage cancer for extended periods of time. — Dr. Kevin Billingsley

“The [National Cancer Institute] defines a cancer survivor as somebody from the day of diagnosis through the balance of their life,” Penedo said. “Survivorship care is the care that a person is receiving in addition to their medical treatment post completion of their primary treatments. In that survivorship care, it’s really critical that the patient remains very involved with their care team for a variety of reasons.”

Follow-up care is really important, particularly for a young person with cancer, Billingsley said. “If there is indication of recurrent cancer or recurrent disease, we would want to get them back into some kind of treatment program, and that could be any number of treatments, but it’s critically important that people maintain a relationship with their oncologist as well as undergo a well-defined set of follow-up examinations, which are usually a combination of often blood tests as well as imaging studies,” Billingsley said.

Regarding cancer survivorship, the space is in what Billingsley described as a very exciting time in oncology. 

“We are curing more patients, more people, with the entire spectrum of treatments that we have available, including traditional cancer treatment, which is surgery, radiation and chemotherapy.

“But with the advent of immunotherapy and biologic therapies and other targeted agents, we have an expanding repertoire of very active treatments that really enhance our capability to cure or manage cancer for extended periods of time,” he said.

Increasingly, Billingsley said, cancer is being managed “like any other chronic disease, where what once was considered incurable now will be not only treatable but treatable for months to years, in many cases.”

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Articles

Life after cancer involves significant physical and emotional adjustments, often requiring months of recovery from treatments like chemotherapy and surgery. Survivorship care is crucial, involving ongoing engagement with healthcare teams to manage potential recurrences and maintain health. The term "remission" indicates undetectable cancer but doesn't guarantee eradication. Advances in oncology, including immunotherapy and biologic therapies, are transforming cancer into a manageable chronic condition, extending survival and improving quality of life. Continuous follow-up care and a multidisciplinary approach are essential for effective long-term management.

CURE spoke with experts about what life is like for patients in the survivorship care period.

With Cancer in Remission, What Is the New Normal for Patients?

It has been a special honor to serve as editor-in-chief of CURE magazine for the past 18 years. During that time, we have witnessed an accelerating pace of advances in cancer care and the underlying biology that drives it. It was also a privilege to follow the previous and co-founding editor, 

, an informed cancer survivor and wise observer who encouraged those around her to learn, act and collaborate to combine humanity and science to normalize the lives of patients with cancer. It is now my turn to hand over the editorial reins, so I take this opportunity to look back at where we have been and what we have learned, especially how the future might look in this dynamic era.

There have been successive revolutions from the earliest advances in pathology to understand that cancer came from our own cells and later to classify cancers based on the area of the body from where they arose and the accompanying clinical features. Radiation was one of the first tools that brought some relief for select patients, and the advent of chemotherapy was born out of the battlefield where nitrogen mustard, a caustic agent used in combat, was found to be effective for lymphoma and subsequent modifications created our first inventory of chemotherapy agents. Scientific advances have been made in understanding cellular physiology, receptors and aberrations in DNA as the ultimate culprit of almost all cancers.

The genetic basis of cancer and advances in model systems that could mimic cancer in the laboratory provided targets that can be pharmacologically addressed in an explosion of new and successive therapies that were better than their predecessors. That brings us to the modern era, where many patients can expect new drugs to be developed over the course of their disease. The emerging use of artificial intelligence in every aspect of our lives is moving us at warp speed with forecasting the behavior of cancer and helping us decipher the genomic and biochemical intricacies of cancer evolution and optimal methods to arrest the cancer machinery that can make the most difficult cancers more treatable. Importantly, we expect that advances can be made in preventing cancer or detecting it long before it can take hold. We are learning more about lifestyles that can modify the timeline of aging and cancer. Even when cancer is diagnosed at later stages, treatments are being modified to have less harmful effects on the body and spirit. Combining the latest technologies with integrative approaches is making the trek through cancer smoother and less disruptive.

Over the history of CURE magazine, we have come along way, and we will continue to report on the challenges and successes in the accompanying stories that bring to life developing knowledge, along with personal stories and perspectives that can teach, illuminate and inspire.

For more news on cancer updates, research and education,

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

Reflecting on 18 years as editor-in-chief of CURE magazine, significant advancements in cancer care and biology have been observed. From early pathology to modern therapies, the understanding of cancer has evolved, with breakthroughs in genetics and model systems leading to new treatments. Artificial intelligence is accelerating cancer research, aiding in understanding and treating complex cases. Future prospects include cancer prevention, early detection, and less harmful treatments. CURE magazine remains committed to sharing stories that educate and inspire, highlighting ongoing challenges and successes in cancer care.

CURE magazine's outgoing editor-in-chief, Dr. Debu Tripathy, reflects on 18 years of advances in cancer care, the impact of AI and the evolving future of oncology treatment.

We Have Come a Long Way

For countless patients over the years, a cancer journey has involved surgery. Radical surgeries to remove the affected organ were the standard of care for many cancers, from rectal and bladder to certain types of stomach and uterine cancers. Although these surgeries offered a chance for a cure, they often came at a significant cost. Patients faced life-altering side effects, including issues with digestion, sexual function, fertility and overall quality of life.

However, a new era in cancer treatment is dawning, as we detail in this seasonal issue of CURE. Advancements in research and technology are allowing doctors to offer patients more options than ever. We explore the growing field of organ-sparing therapies, which use systemic treatments such as chemotherapy, immunotherapy and targeted therapies to shrink tumors or control the disease, potentially eliminating the need for surgery.

In this issue, you will find insight from Joanna Fawzy Doran, CEO of the nonprofit organization Triage Cancer and a CURE advisory board member, about what patients can do if they face the common issue of insurance denials during their cancer journey.

Additionally, we examine real-world data on the use of Carvykti (ciltacabtagene autoleucel) in the treatment of patients with relapsed/refractory multiple myeloma and spotlight treatment advancements for triple-negative breast cancer as part of our “Speaking Out” discussion series.

Furthermore, we speak with a pair of experts about what the “new normal” may be like for someone entering cancer survivorship.

“Often it’s kind of a series of physical adjustments,” Dr. Kevin Billingsley of Yale Cancer Center and Smilow Cancer Hospital in New Haven, Connecticut, told us. “It takes weeks to months to recover from the physical rigors, often of a combination of chemotherapy and surgery. Even young, healthy people ... need to rebuild themselves, often with a program involving exercise under the guidance of a trainer or physical therapist, as well as some nutritional consultation.

“It can take longer than people expect. There [are] also the emotional adjustments of getting back into the normal flow of life and dealing with the uncertainty that [accompanies] a cancer diagnosis. … This is because even when treatments are highly successful, people live with the uncertainty that cancer may return at some point, which can be quite stressful.”

Patients in remission enter a “survivorship care period,” as Frank J. Penedo of Sylvester Comprehensive Cancer Center in Miami told us. “The [National Cancer Institute] defines a cancer survivor as somebody from the day of diagnosis through the balance of their life,” said Penedo, who leads teams in cancer survivorship, translational behavioral sciences, and supportive care, and the psychophysical mechanisms and health out-comes lab, at Sylvester. “Survivorship care is the care that a person is receiving in addition to their medical treatment post completion of their primary treatments. In that survivorship care, it’s really critical that the patient remains very involved with their care team for a variety of reasons.”

For all the up-to-the-minute oncology updates, stay tuned to curetoday.com. There, you will find everything from breaking news on the latest Food and Drug Administration approvals to expert context on major cancer news and much more.

Our goal is to empower our readers with knowledge and provide patients with the information they need to make informed decisions about their cancer care. Throughout these pages, you will find personal stories and expert insights. As always, we hope you find them inspirational and informative. Thank you for reading.

Advancements in cancer treatment are shifting from radical surgeries to organ-sparing therapies, utilizing systemic treatments like chemotherapy and immunotherapy. This approach aims to reduce life-altering side effects and improve quality of life. Insights from experts highlight the challenges of insurance denials, the evolving landscape of cancer survivorship, and the importance of survivorship care. Real-world data on Carvykti for multiple myeloma and advancements in triple-negative breast cancer treatment are also discussed. The focus remains on empowering patients with knowledge for informed decision-making in their cancer care journey.

New advancements in cancer treatment are reducing the need for radical surgeries, offering organ-sparing therapies and enhancing survivorship care and support for patients.

The Dawn of a New Era in Cancer Treatment

Navigating insurance denials is the most common issue faced by Triage Cancer, a nonprofit organization dedicated to educating patients and caregivers about legal and practical aspects of a cancer journey, as its CEO told CURE.

“Certainly, the lack of understanding about people’s options and the steps that they can take contributes to not only lack of access to care but also [is] contributing to financial burden because if patients aren’t getting insurance to cover their care, they’re faced with the decision of either not getting access to that care or paying for it out of pocket,” said Joanna Fawzy Doran, who is also a member of the CURE advisory board.

Being faced with such denials, Doran said, is common for patients. “When someone is going through cancer treatment, they are very likely at some point during their continuum of care to face a denial for something, whether it’s surgery or a prescription drug or some type of treatment regimen; insurance denials are very common,” Doran said.

However, she noted that data on insurance denials are scarce because, in most cases, insurance companies are not required to share that information. “The data that we do have on insurance denials is based on laws … that require certain types of plans to provide that data, like marketplace plans,” she said, “but we do know certainly from anecdotal experience that people are experiencing denials. And that could be denials before care, so with preauthorizations for care, but it could also be after care is received, where the insurance company is denying coverage for that care.”

Patients with private insurance plans have two appeal levels available, as Doran explained. They can go through an internal appeals process conducted within the insurance company — and if the denial still stands, they have the option of an external appeal.

When a patient receives an internal denial, their insurance company is supposed to provide them with instructions on how to file an external appeal, Doran said. But, a patient can also start the process by reaching out to their state department of insurance. Depending on the state, someone may then be sent to the Department of Health and Human Services (HHS). Information on which states use a state-run process and which states’ processes are HHS-run can be found on Triage Cancer’s website.

“You get to go outside the insurance company to an independent entity, and they decide whether or not [something is] medically necessary, and that decision is binding on the insurance company,” Doran said. “So, this is what I refer to as the best-kept secret of our health care system because even though the advocacy community fought hard for this protection that was made federal law by the Affordable Care Act, no one knows about it. And when I say no one, I mean, actually, no one. I speak to providers all the time; I speak to patients; everybody is surprised that this exists.

“And a lot of times, people think that the peer-review process where the insurance company speaks to your health care provider and has a conversation is the external appeal, and it’s not — the peer review process is just an internal process for the insurance company. So even if the peer review is denied, you still get to go outside the insurance company to the external review.”

Insurance denials are a prevalent issue for cancer patients, often leading to financial burdens and limited access to care. Patients frequently encounter denials for treatments, surgeries, or medications, yet data on these denials is limited due to lack of reporting requirements. Patients with private insurance can appeal denials through internal and external processes, with the latter involving an independent review that is binding on the insurer. Despite being a federal protection under the Affordable Care Act, awareness of the external appeal process remains low among patients and providers.

The CEO of Triage Cancer discussed the “best-kept secret” of the health care system in an interview with CURE.

What Patients Need to Know About Appealing Insurance Denials 

When Sarah Rack talks about her diagnosis of rectal adenocarcinoma on Election Day 2020, she does not mince words.

It was the fear of illness and death, concern for her children — one a college sophomore at the time and the other still in high school — and the threat of surgical removal of her rectum and living the rest of her life with a colostomy, the surgical connection of the colon to an abdominal opening that lets stool be collected in a bag outside the body.

"Now, I'd be able to handle it better, but at the time, I said I'd rather be dead than have a colostomy. I was so depressed," says the 58-year-old psychiatrist who lives in Memphis, Tennessee.

But Rack was offered a possible escape from that fate: a spot in a clinical trial that would test whether treatment with medication alone could eliminate the need for surgery in people with tumors that had specific genes that suggested they would respond well to the medication.

Surgical removal of the affected organ was once a foregone conclusion in many cancers, including certain cancers of the rectum, colon, stomach, bladder and uterus. These life-altering surgeries may have consequences for digestion, excretion, fertility, sexual function and countless other aspects of daily life. But now, an increasing number of people with some of these cancers have a choice: surgical removal of the organ or systemic therapy and added surveillance.

“Depending on the organs involved and what the surgical pathway would have looked like, surgical resection can greatly reduce your quality of life,” says Dr. Kaysia Ludford, an assistant professor in the Department of General Oncology at The University of Texas MD Anderson Cancer Center in Houston. “An organ-sparing approach is paradigm-shifting.” 

Although the removal of an organ often offers the greatest chance of a cure in cancers such as rectal and bladder, these surgeries come at a cost. For some people, rectal resection can mean living with a permanent colostomy along with other potential collateral effects. “Even with a minimally invasive approach, we can affect sexual function, bladder function and fertility,” says Dr. Fergal Fleming, a colorectal surgeon at the University of Rochester Medical Center in New York.

The same is true of bladder removal, a procedure called radical cystectomy, for bladder cancer. The procedure not only takes the bladder but also part of the small intestine, which is used to create a “neobladder,” a pouch to hold urine. Nearby organs and tissue are also removed, which can affect fertility and sexual function.

"It’s fraught with complications," says Dr. Roger Li, a genitourinary oncologist at Moffitt Cancer Center in Tampa, Florida, "because it’s one of the most complex surgeries we do in urology, and it’s oftentimes done in a patient population who is not at their healthiest."

Saving Organs in Cancers With Specific Genes

Rack got into a clinical trial at MD Anderson that tested whether treatment with the immune checkpoint inhibitor Keytruda (pembrolizumab) before surgery might eliminate the need for surgery in people whose tumors had cells with mutations in genes that correct DNA errors, a condition known as mismatch repair deficiency.

Twenty-seven of the 35 trial participants, including Rack, had colon or rectal adenocarcinoma. The remaining eight had adenocarcinoma of the stomach, pancreas, duodenum (an upper part of the small intestine), ampulla (a small opening that enters the duodenum) or uterus. One patient had a type of brain tumor called a meningioma.

They received Keytruda every three weeks for six months. At the six-month mark, they could have surgery or continue the medication for a year, followed by observation.

Eighteen participants chose the nonsurgical option of Keytruda, 10 of whom completed the full year. After three years of follow-up, 14 of the 18 patients were alive with an intact organ. Two patients were lost to follow-up. One patient died of unrelated causes. Another died from disease progression. Although the majority of those in the study and the majority who benefitted from treatment had colorectal cancer, one patient who took the nonsurgical option had gastric cancer and is still in remission now, nearly four years later.

“The patient still has the organ intact and didn’t require the stomach to be resected,” says Ludford, who co-led the study. “As you can imagine, certain organs have serious implications for quality of life if they have to be resected, [such as] the stomach, for instance, so we want to explore the possibility of sparing those organs, and that’s what led to this study.”

The results were published in 2023 in the 

. In a similar study, 14 people with locally advanced rectal cancer with mismatch repair deficiency had a complete clinical response to the immunotherapy drug Jemperli (dostarlimab), which works in the same way as Keytruda, eliminating the need for surgery.

Rectal tumors do not have to carry the mismatch repair deficiency mutation to be eligible for a nonsurgical approach. The treatment plan for many rectal cancers used to be what is called “sandwich therapy,” Fleming says. “You got a little bit of radiation and a very small dose of chemo, which we call a sensitizing dose; then you’d have surgery and then three to six months of chemo afterwards.” But now researchers are testing the effects of front-loading the treatment plan with all the systemic therapies and radiation and then reassessing to see whether the patient still needs surgery.

Not too long ago, Fleming says, “Chemoradiation [for rectal cancer] without surgery would have been considered heresy.” Now, he adds: “Sometimes very well-read, motivated patients say they don’t want surgery, and also, we started seeing very good responses to systemic therapy. It wasn’t actually the primary end point of some of these studies, but they started realizing patients had a complete response.”

The approach is showing promise in many other cancers as well. Published research has explored the effects of organ-sparing approaches in cancers of the throat, vagina, sinus cavity and bladder.

Organ-sparing treatment for bladder cancer has allowed 65-year-old Darrell Murray of Orlando, Florida, to keep his bladder intact since his cancer diagnosis in 2016 and, for the most part, carry on with life as usual.

Murray had non-muscle invasive bladder cancer, an early-stage cancer restricted to the lining of the bladder. He got the standard therapy — 21 rounds of bacillus Calmette-Guerin (BCG), a combination therapy that includes a cancer vaccine and immunotherapy. Afterward, he was cancer-free until a recurrence in 2020.

The thinking in bladder cancer has typically been that if it recurs after BCG, there is a higher risk for it to spread into the muscle wall of the bladder, becoming what is called muscle invasive and eventually metastasizing. “There has traditionally been this aggressive approach that once you develop recurrence, it’s an indication for us to perform radical cystectomy to remove the bladder and reconstruct the urinary tract,” Li says.

Since 2020, Murray has had four recurrences. “Every physician, every time,” Murray says, “would bring up cystectomy as an option. I realize that’s the gold standard, but I had to ask myself what life would look like with a cystectomy.”

“They would take the bladder, prostate, lymph nodes and about 18 inches of your intestine to create a vessel for urine,” Murray says. “But the intestines are designed to absorb nutrients, not store urine. You’d absorb waste products from your kidney in the neobladder. There’s mucus buildup and sometimes blockages, so you have to catheterize yourself.”

Increasingly, people like Murray with recurrences of non-muscle invasive bladder cancer are being offered alternatives to surgery. At every turn, Murray has chosen to keep his bladder and receive the next available medication. He reasons that even after radical cystectomy, there is no guarantee a recurrence will not happen.

After Murray’s first recurrence, he had six rounds of Keytruda; after another recurrence, he had eight rounds of chemotherapy; on the third recurrence, he had BCG plus interferon, which helps the body’s immune system fight diseases.

Finally, at the fourth recurrence, Murray was almost ready to give in and have his bladder removed when he was offered a spot in the BOND-003 trial led by Li at Moffitt Cancer Center. In this trial, people with non-muscle invasive cancer that did not respond to BCG received 21 treatments with the oncolytic, or tumor-destroying, virus cretostimogene grenadenorepvec (CG0070), designed to replicate inside cancer cells and kill them. It also releases a protein that helps the immune system kill cancer cells.

Murray was among the more than 75% of trial participants who had a complete response to the treatment. The Food and Drug Administration has granted the experimental drug both fast-track and breakthrough therapy designations to speed its path to approval. Research is underway to test the same approach in muscle invasive bladder cancer.

Murray is once again cancer-free. He has been for over two years.

Although he has no regrets about keeping his bladder intact, the treatments he has endured over the past eight years have been no picnic, he says. Bladder cancer medications are intravesical, which means they go directly into the bladder, and the patient must hold them in, resisting an intense urge to urinate, for a half-hour or more. “I kind of liken it to battery acid, Coca-Cola and a package of Mentos,” Murray says of the sensation. “It was really tough sometimes.” The more treatments he underwent, the harder it was.

Is Organ-Sparing Treatment Right for You?

Each time Murray faced a recurrence, he carefully weighed the surgical versus nonsurgical approach. “I wouldn’t say it was a no-brainer,” he says.

People who have the option of organ-sparing cancer treatment should consider several issues. First, they should understand their individual risk of recurrence and whether a recurrence might be more aggressive.

They should compare the options. When comparing the removal of a vital organ and treatment with medication, organ removal typically requires a longer recovery and significant adjustment to a new life without the organ. Still, those facing this choice should ensure that they can tolerate the intense medication therapy they would receive instead of organ removal. That includes possible side effects from medication and downtime after treatment days.

Patients should also understand what kind of follow-up will be needed in the coming months and years. A nonsurgical approach usually requires more follow-up, imaging and testing than would be required of someone who had the organ removed. This is to ensure the cancer has not come back and to catch it early if it has.

The treatment and intense follow-up often require travel to a large cancer center. “Individuals need to have access to the medical facility where they can continue this very close monitoring,” Ludford said. Transportation, additional time, added costs, time away from work and child care or eldercare may all figure into this increased monitoring.

Finally, organ-sparing treatment might be best suited to people who are less prone to anxiety. All those follow-up tests can be a source of great anxiety.

“This is something we chat with our patients about,” Fleming says. “How do you cope with uncertainty? Some people can just shut the door on uncertainty while others just can’t stop looking at the issue.” Most patients in Fleming’s practice who choose to watch and wait, even if they have a recurrence, are happy with their decision, he says.

Rack, the psychiatrist in Memphis who had rectal cancer, traveled to MD Anderson in Houston for Keytruda infusions every three weeks for 18 months. After finishing treatment, she went back to Houston for scans and labs every three months for about a year. Now, she goes every six months.

Today, cancer-free, she says she actually enjoyed the trips to the cancer center in Texas. “The treatment down there was great, and then I’d come back to work and put it out of mind,” she says.

As for whether Rack regrets holding onto the organ where her cancer scare began, there is no question she made the right choice, she says. “This is one of the happiest times in all my life.”

Organ-sparing treatments are emerging as viable alternatives to traditional surgical interventions for certain cancers, offering patients the possibility of maintaining organ function and quality of life. Clinical trials, such as those involving immune checkpoint inhibitors like Keytruda, have shown promising results in patients with specific genetic mutations, allowing some to avoid surgery altogether. This approach requires careful consideration of individual risk factors, potential side effects, and the need for ongoing surveillance. Patients must weigh the benefits of preserving organs against the demands of intensive treatment and follow-up.

Feature

Avoiding surgery for rectal cancer, Sarah Rack of Memphis traveled to Houston for treatment every three weeks for 18 months. 

Organ-Sparing Treatments Bring New Life After Cancer

Among patients with advanced castration-sensitive prostate cancer, health-related quality of life was not statistically different between those receiving Erleada (apalutamide) alone or in combination with Zytiga (abiraterone acetate) and prednisone compared with those receiving androgen-deprivation therapy (ADT) plus Zytiga and prednisone, according to findings in 

Health-related quality of life was evaluated using the Functional Assessment of Cancer Therapy–Prostate (FACT-P) questionnaire and its subscales. The questionnaire was completed at baseline and every four weeks until week 25. FACT-P scores range from 0 to 156, with higher scores indicating better quality of life, according to study authors.

There were no significant differences in baseline mean FACT-P total scores or subscales across the three treatment groups: ADT plus Zytiga and prednisone, 118.5; Erleada, 116.1; and Zytiga and prednisone plus Erleada, 114.9.

Health-related quality of life was maintained during the treatment period, with no statistically significant differences at 25 weeks in mean FACT-P total scores or subscales: ADT plus Zytiga and prednisone, 122.3; Erleada monotherapy, 119.5; and Zytiga and prednisone plus Erleada, 119.9.

The Erleada monotherapy and Zytiga and prednisone plus Erleada groups did not experience meaningful improvements in health-related quality of life compared with the ADT plus Zytiga and prednisone group, except in time to deterioration of the emotional well-being score. This outcome was more favorable in those who received Erleada alone, with a 63% reduction in risk compared with the ADT plus Zytiga and prednisone group, which had a 44% reduction in risk.

A prostate-specific antigen level of 0.2 nanograms per milliliter or lower at week 25 was observed in 31 of 41 patients (75.6%) in the ADT plus Zytiga and prednisone group, 24 of 40 patients (60%) in the Erleada monotherapy group and 31 of 39 patients (79.5%) in the Erleada plus Zytiga and prednisone group. The two-year overall survival rates were 92.5% for the ADT plus Zytiga and prednisone group, 87.9% for the Erleada monotherapy group and 92.7% for the Erleada plus Zytiga and prednisone arm.

Treatment-related side effects of any grade were reported in 30 of 42 patients (71.4%) in the ADT plus Zytiga and prednisone group, 34 of 42 patients (81%) in the Erleada monotherapy group and 36 of 44 patients (81.8%) in the Erleada plus Zytiga and prednisone group.

Grade 3 (severe) and 4 (life-threatening) treatment-related side effects occurred in eight of 42 patients (19%) in the ADT plus Zytiga and prednisone group, seven of 42 patients (16.7%) in the Erleada monotherapy group and 10 of 44 patients (22.7%) in the Erleada plus Zytiga and prednisone group. Lower rates of hot flashes and hypertension were reported in patients who received Erleada monotherapy.

Gynecomastia affected 23 of 42 patients (54.8%), and breast pain was reported by six of 42 patients (14.3%) in the Erleada monotherapy group, both higher than rates observed in the other two groups. No new safety signals were detected in
the study.

“Androgen Receptor Pathway Inhibitor Therapy for Advanced Prostate Cancer: Secondary Analysis of a Randomized Clinical Trial” by Dr. Diogo Assed Bastos et al., 

In patients with advanced castration-sensitive prostate cancer, health-related quality of life (HRQOL) was similar across treatment groups receiving Erleada (apalutamide) alone, APA plus Zytiga (abiraterone acetate) and Deltasone (prednisone), or ADT plus AAP. The study, published in JAMA Network Open, found no significant differences in HRQOL scores at 25 weeks. However, the APA-alone group showed a more favorable time to deterioration in emotional well-being. PSA levels and overall survival rates were comparable, with varying side effect profiles across treatment groups.

A study found no significant HRQOL differences between Erleada-based therapies and ADT plus AAP for advanced castration-sensitive prostate cancer.

Erleada Combo Shows Comparable Quality of Life Outcomes in Prostate Cancer

Among patients with stage 3 unresectable non-small cell lung cancer (NSCLC), the first participant has been dosed in the phase 2 CONVERGE study, according to a news release from biotechnology company Nanobiotix. The randomized, controlled clinical trial is evaluating the potential first-in-class radioenhancer JNJ-1900 (NBTXR3) in patients being treated with standard-of-care chemoradiation followed by consolidation Imfinzi (durvalumab).

“We believe the true value of [NBTXR3] is driven by its potential to address the unmet needs of the millions of patients each year who receive radiotherapy as part of their treatment,” said Laurent Levy, Chief Executive Officer and Chairman of the Executive Board at Nanobiotix. “With a clear path to potential registration in head and neck cancer established through NANORAY-312, the first patient dosed in the CONVERGE study in [non-small cell lung cancer] NSCLC brings us another step closer to delivering for the large number of patients [NBTXR3] is designed to serve.”

Who is Eligible For CONVERGE Study Enrollment?

According to the clinical trial page
at clinicaltrials.gov, CONVERGE is evaluating the addition of NBTXR3 to concurrent platinum-based doublet chemotherapy with radiation therapy, followed by consolidation immunotherapy, and whether this enhances the objective response rate in patients with locally advanced, unresectable stage 3 NSCLC.

To be considered eligible for enrollment, patients must be candidates for chemotherapy with radiation therapy; have a pathologically confirmed NSCLC diagnosis within three months prior to enrollment; present with unresectable stage 3IIIA or 3IIIB NSCLC; have at least one target lesion suitable for intratumoral or /intranodal injection and external beam radiation therapy; and have an ECOG performance status of 0 or 1.

Participants are considered ineligible for enrollment in the study if they have a history of primary immunodeficiency; organ transplantation requiring immunosuppression; significant cardiac events within three months before enrollment; concurrent or recent malignancies other than NSCLC; and known hypersensitivity to study drugs or components.

Patients with active bleeding diathesis or patients requiring anticoagulation or antiplatelet therapy that cannot be safely modified for procedures are also excluded.

The novel, potentially first-in-class oncology product NBTXR3 comprises functionalized hafnium oxide crystal nanoparticles administered via one-time intratumoral injection and activated by radiotherapy. The proof-of-concept for NBTXR3 was demonstrated in soft tissue sarcomas, leading to the agent receiving a European CE mark in 2019.

The agent’s mechanism of action is designed to induce substantial tumor cell death within the injected tumor when activated by radiotherapy, thereby triggering an adaptive immune response and establishing long-term anticancer memory. Consequently, the company anticipates that NBTXR3 could be applied to any solid tumor treatable with radiotherapy and be adaptable to any therapeutic combination, especially with immune checkpoint inhibitors.

The radiotherapy-activated NBTXR3 is under evaluation for multiple solid tumor indications as a stand-alone treatment and in combination with anti-PD-1 immune checkpoint inhibitors. These initiatives include the global, randomized NANORAY-312 trial, which is focused on locally advanced head and neck squamous cell carcinomas. In February 2020, the Food and Drug Administration granted fast track designation to NBTXR3 activated by radiotherapy, with or without Erbitux (cetuximab), for patients with locally advanced head and neck squamous cell carcinoma who are ineligible for platinum-based chemotherapy.

In 2019, the company entered a comprehensive clinical research partnership with The University of Texas MD Anderson Cancer Center to sponsor multiple phase 1 and 2 trials evaluating NBTXR3 across various tumor types and therapeutic combinations. Nanobiotix announced a license agreement with Janssen Pharmaceuticals, a Johnson & Johnson company, for the global co-development and commercialization of NBTXR3 in 2023.

The phase 2 CONVERGE study has commenced dosing its first participant to evaluate the radioenhancer JNJ-1900 (NBTXR3) in stage III unresectable non-small cell lung cancer (NSCLC) patients. This trial investigates the efficacy of NBTXR3 combined with standard chemoradiation and consolidation durvalumab. NBTXR3, a hafnium oxide nanoparticle, is activated by radiotherapy to induce tumor cell death and an adaptive immune response. The study aims to enhance objective response rates in NSCLC, with eligibility criteria including specific NSCLC stages and performance status, while excluding certain medical conditions.

The first participant has been dosed on the phase 2 CONVERGE study evaluating NBTXR3 in stage III, unresectable non–small cell lung cancer.

Breaking Down the CONVERGE Study of NBTXR3 in Stage 3 Unresectable NSCLC

In a real-world setting, standard-of-care Carvykti (ciltacabta-gene autoleucel) has been shown to elicit responses from nearly all participating patients with relapsed/ refractory multiple myeloma (R/R MM).

Carvykti is a type of chimeric antigen receptor-T (CAR-T ) cell therapy, which, as explained by the National Cancer Institute, involves a patient’s T cells — part
of the immune system — being extracted, changed in a laboratory to attack cancer cells, grown in the laboratory and infused back into the patient.

Overall and complete response rates were 89% and 70%, respectively, in
all patients who received Carvykti, 94% and 74% in 191 patients who received conforming Carvykti and 95% and 76% in 152 patients treated with conforming Carvykti with fludarabine/ cyclophosphamide lymphodepletion.

A comforming treatment is administered according to the specifications of
the FDA’s approval, and lymphodepletion is a short course of chemotherapy administered before CAR-T cell therapy.

 for adults with R/R MM who had received at least four prior lines of treatment. In 2024, the agency approved Carvykti for patients who received at least one prior line of therapy.

, that led to the FDA’s 2022 approval of Carvykti, the overall response rate was 98%, with 83% stringent complete response, according to findings published in 2023.

Patients with R/R MM who underwent leukapheresis, or the collection of healthy white blood cells from a patient, for Carvykti manufacturing at 16 American academic medical centers were included in the study, published in Blood, with 255 patients undergoing leukapheresis and 236 receiving Carvykti.

Of the real-world patients, 54% would not have met the eligibility criteria for CARTITUDE-1.

Senior author Dr. Doris K. Hansen of Moffitt Cancer Center’s Department
of Blood and Marrow Transplant and Cellular Immunotherapy, explained in an interview with 

 why such real-world findings are significant.

“Clinical trials are invaluable because they serve as the gold standard for introducing new therapies and advancing science,” Hansen explained.

“However, clinical trials often have strict eligibility criteria. Patients must meet very specific criteria to participate — they need to have good organ function, stable blood counts and no significant comorbidities."

In contrast, Hansen said, the patients seen in day-to-day clinical practice often have a variety of health challenges, with many patients having comorbid conditions like cardiac issues or renal impairment, and with about 20% of those diagnosed with myeloma experiencing kidney problems. “Additionally,” Hansen said, “some patients may have plasma cell leukemia, amyloidosis or myeloma-related bone damage, which can lead to fractures, pain and even reduced mobility or wheelchair use. These factors often make patients ineligible for clinical trials. ... It is, therefore, very important to report on the experiences of these patients. By studying their outcomes, we can understand how treatments perform in real-world scenarios, as opposed to the controlled, ideal conditions of clinical trials.”

The eligibility criteria for CARTITUDE-1 included adequate organ function, limited comorbidities and having no prior exposure to B-cell maturation antigentargeted therapy.

Cytokine release syndrome was experienced by 75% of patients, with grade 3 (severe) or higher in 5%. Immune effector cell-associated neurotoxicity syndrome was seen in 14%, with grade 3 or higher in 4%. Delayed neurotoxicity was reported in 10% of patients.

Researchers reported a 10% nonrelapse mortality rate, mostly from infections, and noted that second primary malignancies, excluding nonmelanoma skin cancers, were seen in 5.5% of patients and myeloid malignancies/acute leukemia in 1.7%.

 such as Carvykti, as explained by the National Cancer Institute, involves a patient’s T cells, part of the immune system, being extracted, changed in a laboratory to attack cancer cells, grown in the laboratory and infused back into the patient. Carvykti is currently approved by the FDA to be administered in the second line of treatment.

Safety and Efficacy of Standard of Care Ciltacabtagene Autoleucel for Relapsed/Refractory Multiple Myeloma” by Dr. Surbhi Sidana, et al., 

Carvykti (ciltacabtagene autoleucel) demonstrates significant efficacy in real-world settings for relapsed or refractory multiple myeloma, with 89% of patients responding and 70% achieving complete response. Despite many patients not meeting clinical trial criteria, outcomes were comparable to the CARTITUDE-1 trial. At 13 months, median progression-free survival and overall survival were not reached, with 12-month estimates at 68% and 82%, respectively. Side effects included cytokine release syndrome and neurotoxicity. Carvykti, a CAR-T cell therapy, is FDA-approved for patients with multiple prior treatments.

The CAR-T cell therapy Carvykti has been shown to be effective among patients outside the confines of a clinical trial.

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