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Renee Cowan, gynecologic oncology fellow at Memorial Sloan Kettering Cancer Center (MSK), discusses the importance of patients with ovarian cancer seeing an oncologist who specializes in the field.
 

The Importance of Seeing an Ovarian Cancer Specialist

One of this year’s MPN Heroes® talked about the importance of a supportive care team, especially as every patient with MPN presents differently.

The Power of Voice in MPN Management

Patients with myeloproliferative neoplasms (MPNs) should be actively involved in understanding their disease and communicating specific needs and concerns to healthcare providers, an expert said.

Kathryn Johnson, clinical program manager for the MPN and leukemia programs at the Icahn School of Medicine at Mount Sinai in New York, was honored at the MPN Heroes® in-person ceremony in December 2024 for her work in clinical trials in the space.

Johnson’s nominator noted that throughout the last five years, she has witnessed her dedication to providing care for patients with MPNs, while connecting them to the resources they need and advocating for them with insurance companies.

“Kathryn works with patients undergoing experimental treatments, often a daunting time filled with uncertainty,” her nominator wrote. “Yet, her presence brings an immediate sense of calm and reassurance, helping patients feel that everything will be OK.”

CURE also spoke with Johnson to learn more about how patients can lean into their care teams and trust them so that conversations about symptoms and side effects can be held in an effective manner.

Speak up. Especially with MPNs, you know, they do all manifest differently. There are things that we know that people have in common, but they're going to present differently for every person. And I think that there's a lot that people learn to grow with that they don't always realize is impacting them. So taking a good look at who they are, what their goals are, is going to be helpful to managing their care and making sure that they're vocalizing things that aren't sitting right.

And then also [I] always encourage bring a buddy, bring a sister, bring a parent, bring a spouse, bring an adult child, the people who love you, love you and support you and want to help you manage this that you're going through.

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One of this year’s MPN Heroes® talks about the importance of a supportive care team, especially since every patient with MPN presents differently.

Tumor

Conference

Dr. Eric K. Singhi discusses the significance of the FDA approval of subcutaneous Opdivo for patients with solid tumors.

A Breakdown of Trial Data that Led to the Subcutaneous Opdivo FDA Approval 

Dr. Eric K. Singhi, an assistant professor in both the Department of General Oncology and the Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine, at The University of Texas MD Anderson Cancer Center, in Houston, Texas, recently sat down for an interview with CURE®.

In the interview, he discussed the Dec. 27, 2024, Food and Drug Administration (FDA) 

approval of subcutaneous Opdivo and Qvantig

 (nivolumab and hyaluronidase-nvhy) for patients with solid tumors. He goes on to discuss the significance of the regulatory approval, as well as the trial data that led the approval.

As of Dec. 27, 2024, the FDA approved subcutaneous — or under the skin — Opdivo for patients with a wide range of solid tumors. This includes renal cell carcinoma [RCC], melanoma, non-small cell lung cancer and others. The new approval applies to almost all existing solid tumor indications for the IV [intravenous] formulation, except it is not allowed for use in combination with what we call dual immunotherapy or CTLA4 inhibition with Yervoy [ipilimumab].

This approval brings a subcutaneously administered PD1 inhibitor to the market, and it could be significant for patients because it provides a new, more convenient option for treatment. This allows patients to potentially receive treatment closer to home with less time spent at treatment facilities, and it can improve both convenience and accessibility.

, and that included 495 patients with advanced or metastatic clear cell RCC, which is a type of kidney cancer. Importantly, these patients had to have received no more than two prior lines of treatment against their cancer. The trial compared subcutaneous — under the skin — Opdivo with the IV formulation of Opdivo, which is that traditional form of immunotherapy. What they looked at was a primary focus on assessing drug pharmacokinetics. Specifically, they looked at exposure through the time average concentration and minimum concentration at steady state.

What they saw from the results perspective was that the subcutaneous, under-the-skin Opdivo was non-inferior to the IV version, so it indicated comparable levels of drug exposure. What they also saw was that the overall response rate, meaning the percentage of patients that respond to treatment, was actually higher for subcutaneous nivolumab, at 24% compared with 18% for the IV formulation. This really supports the efficacy of the subcutaneous version.

Safety profiles were also the same, or very similar between the two arms. In the subcutaneous, under-the-skin arm, the most common adverse effects were reported in at least 10% of patients, and they included fatigue, musculoskeletal pain, pruritus or intense itching, rash and cough.

Transcript was edited for clarity and conciseness.

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The FDA approved subcutaneous Opdivo (nivolumab and hyaluronidase-nvhy) for solid tumors, excluding dual immunotherapy with Yervoy. This approval, based on the CHECKMATE-67T trial, offers a more convenient treatment option, potentially improving accessibility. The trial demonstrated non-inferiority in drug exposure compared to the IV formulation, with a higher overall response rate for the subcutaneous version (24% vs. 18%). Safety profiles were similar, with common adverse effects including fatigue, musculoskeletal pain, pruritus, rash, and cough, reported in at least 10% of patients.

Dr. Richard “Rick" Winneker discussed advice that he would provide to patients faced with a myeloproliferative neoplasm diagnosis.

Putting an Emphasis on Patient Collaboration in MPN Treatment

Dr. Richard “Rick" Winneker discussed advice that he would provide to patients faced with a myeloproliferative neoplasm (MPN) diagnosis, putting an emphasis in personalized care and active participation in the broader MPN community. He also goes on to emphasize the importance of consulting an MPN specialist to ensure optimal care.

, creating and managing programs, was recognized at the 

 for his dedication in uniting the patient, physician and pharmaceutical communities together in creating awareness for MPN research.

In an interview, Winneker sat down with CURE and shared his expert insights on patient care, as well as expanded on the importance of participation in groups like the MPN Research Foundation to ensure a high prioritization of research and collaboration across the field. Read more from the interview below.

The first thing I do when I meet a patient, rather than giving them advice right away, is ask them how they're doing. I want to understand what they're experiencing because I know it can be so different from one patient to the next. [However], my advice usually is: if possible, try to see an MPN specialist, if not directly, but perhaps a second opinion or a consultation of some kind. They're the ones that are really closely following this rapidly emerging field, [therefore] you want to make sure that you're experiencing the best possible outcomes that you can.

Secondly, I would say be your own best advocate. Not only that, [but] join the MPN Research Foundation. Work with us and be part of that solution that we're trying to bring forward. We want to hear from patients about what they care about most, in terms of what we should be doing next. See the right people and join us. I think that would be my message.

Among patients with breast cancer, low doses of the oral hair growth drug minoxidil — the active ingredient in over-the-counter Rogaine — taken during or after cancer treatment is associated with hair regrowth in patients and were not found to cause any serious heart-related side effects requiring additional therapies or hospitalization.

Researchers, led by a team from NYU Langone Health, published their findings in a research letter in the 

Journal of the American Academy of Dermatology.

“Based on these findings, minoxidil has been shown to be safe for patients while also being effective,” said co-senior author Dr. Kristen Lo Sicco, associate professor in the Ronald O. Perelman Department of Dermatology at NYU Grossman School of Medicine, in a news release issued by NYU Langone Health. “The effectiveness of minoxidil may therefore help patients restore their sense of self and some control in a situation where it has been visibly taken away.”

 for patients with breast cancer who receive treatment with chemotherapy, researchers explained. While 5 milligrams or less of oral minoxidil daily is a promising off-label treatment for alopecia, concerns persist regarding potential cardiovascular side effects, particularly among patients who have received treatment with anthracyclines or Herceptin (trastuzumab), they reported.

The retrospective analysis of patients with breast cancer prescribed low-dose oral minoxidil for alopecia between Nov. 16, 2012, and June 19, 2023 — including 51 patients with a median age 67 years, of whom 25 (49%) received chemotherapy and 26 (51%) underwent surgery and/or radiation alone. Investigators found that all patients had improvement or stability of alopecia after three to six months of low-dose minoxidil, with no significant difference in treatment effectiveness between patients who underwent chemotherapy and those who did not.

At six months or longer, three patients who underwent chemotherapy reported worsening alopecia, with two of those patients having corroborating physician assessments, all three having had prior taxane exposure and two also receiving doxorubicin and cyclophosphamide.

Researchers reported that 29 patients (56.9%), experienced 44 side effects, with no significant difference in side effects between groups and the majority of side effects (61.4%) being hypertrichosis. No pericardial or life-threatening side effects were reported.

CURE spoke with Lo Sicco and co-lead author Devyn Zaminski, a medical student at NYU Grossman School of Medicine, via email about the findings.

CURE: For patients with breast cancer, what do you believe is the big takeaway from these findings?

 Women are already often held to a different standard compared with men without hair. It creates an additional vulnerability for someone who has already endured so much. Our hope is that this study will help to expand the treatment options for breast cancer survivors. 

 Hair loss can be a persistent and sometimes long-lasting external reminder of a woman's breast cancer experience. We hope that breast cancer survivors feel empowered in knowing there is a safe and effective solution for treating hair loss — offering relief without adding to the stress and challenges they have already endured. 

What separates these findings from previous research on this topic?

 Low dose oral minoxidil's (LDOM) efficacy in treating chemotherapy-induced alopecia as well as other types of alopecia that breast cancer survivors suffer from has already been proven. Given oral minoxidil can cause pericardial effusions, typically at high doses that are used to treat recalcitrant hypertension, our main question was whether breast cancer survivors who were exposed to cardiotoxic chemotherapy drugs in their breast cancer treatment regimen increased the risk of severe side effects when using LDOM to treat their alopecia. This study shows the safety of LDOM in breast cancer survivors, including those who used potentially cardiotoxic drugs in their chemotherapeutic regimen.

Given these findings, what sorts of conversations addressing hair loss should patients with breast cancer have with their care team?

 This is a great question that we have asked ourselves too! Our next question to explore in research is, can we safely use LDOM throughout one's chemotherapy regimen and help prevent chemotherapy induced alopecia (CIA)? Currently, most providers wait until the chemotherapy course has been completed. While not a focus of this study, we also want patients and providers to recognize the significant role that scalp cooling can play in helping to prevent CIA as well.

Why is addressing hair loss important for the overall well-being and quality of life of patients with breast cancer?

 Studies have shown that alopecia is associated with poorer quality of life as well as psychosocial conditions, including anxiety and depression. Those suffering from cancer still want to feel like themselves and alopecia often robs people of feeling normal. Board certified dermatologists are uniquely equipped with the skill set to treat this patient population and in doing so, helping to restore their identities.

 Studies indicate that some women opt for less effective breast cancer treatments out of fear for hair loss side effects. This alone speaks to the profound impact hair loss can have on an individual's emotional and physical well-being. We hope our findings can help better address the needs of breast cancer survivors and improve their quality of life after treatment.

Is there anything else you would like the CURE readership to know about this topic?

 Yes, and thank you for asking! Cranial prostheses or wigs are another very important part of someone's alopecia treatment plan. Unfortunately, insurances often deny coverage for cranial prostheses for many types of alopecia. Fortunately, we can help to advocate as individuals! The @alopeciajusticelague (AJL) is working alongside NAAF (National Alopecia Areata Foundation) to empower constituents to advocate for coverage of wigs as a piece of durable medical equipment under Medicare, just as a breast prosthesis would be for someone going through breast reconstructive surgery. Please visit the AJL page and take less than one minute to sign up for our digitized advocacy form, in collaboration with NAAF!

Low-dose oral minoxidil is effective for hair regrowth in breast cancer patients experiencing alopecia due to chemotherapy, without causing serious cardiovascular side effects. A study involving 51 patients showed improvement or stability in alopecia after three to six months of treatment. While some patients experienced side effects, none were life-threatening. The findings suggest that minoxidil can be a safe option for managing hair loss, potentially improving the quality of life for breast cancer survivors. Advocacy for insurance coverage of cranial prostheses is also emphasized.

Low-dose oral minoxidil, the hair growth drug that is the active ingredient in Rogaine, may be safe and effective for patients with breast cancer.

Minoxidil May Safely Aid in Hair Growth for Patients With Breast Cancer

Adding the PARP inhibitor veliparib to treatment with temozolomide did not significantly extend overall survival (OS) in patients with newly diagnosed, MGMT-hypermethylated glioblastoma, according to findings from a randomized, phase 2/3 clinical trial published in 

Although the investigational combination was well tolerated and had an acceptable elevation in grade 3 or 4 hematologic toxicities, the median overall survival (OS) in patients treated in the phase 3 analysis was 24.8 months for the placebo arm compared with 28.1 months in the veliparib arm. Therefore, this difference in survival did not meet the investigation’s prespecified efficacy end point. Notably, study authors added that there was separation of the survival curves that favored the investigational arm over 24 and 48 months of follow-up.

Additionally, there was no significant difference in progression-free survival (PFS) between the treatment groups and no identified statistically significant differences regarding OS across stratification variables of age, ECOG performance status, extent of resection, and tumor-treating field (TTF) use.

“This randomized clinical trial did not demonstrate a significant OS benefit for patients with MGMT-hypermethylated glioblastoma treated with adjuvant temozolomide combined with veliparib. While PFS was superimposable, there was a trend for higher survival with veliparib plus temozolomide treatment at intermediate points,” study authors wrote in the 

 article. “The results for each of these studies could be explained if a more effective experimental treatment produced a deeper nadir in tumor cell burden.”

Standard treatments for glioblastoma, which is the most common primary malignant brain tumor, includes surgery and radiotherapy with concurrent temozolomide followed by adjuvant temozolomide and TTFs. Even in patients with MGMT-hypermethylated glioblastoma, therapy resistance leads to tumor progression and death. However, there is a strong rationale to evaluate PARP1 inhibitors as chemosensitizing agents due to prior improvement in survival following treatment of patients with breast, ovarian or prostates cancers.

“Veliparib is in a category of drugs called a PARP inhibitor, which works by not allowing cancer cells to repair damaged DNA. When these damages build up in a cell, it can lead to cell death which is the goal of these types of drugs,” Dr. Priya U. Kumthekar explained in a news release from Northwestern University.

Kumthekar, who is one of the study authors, currently serves as an associate professor of medicine in the Division of Hematology and Oncology and is a member of the Robert H. Lurie Comprehensive Cancer Center at Northwestern University Feinberg School of Medicine, in Evanston, Illinois.

“When glioblastoma is MGMT promoter-methylated, this means that it is more susceptible or more sensitive to the effects of alkylating chemotherapy, or in this case temozolomide. While patients who have tumors that are MGMT promoter-methylated fare better than those whose tumors do not possess this, the current treatment regimen remains a noncurative option,” she added in the same news release.

Based on this rationale, investigators aimed to answer this question: Does the PARP inhibitor veliparib enhance the efficacy of temozolomide in patients with newly diagnosed, MGMT promoter hypermethylated glioblastoma?

Taking a Deeper Dive Into the Phase 2/3 Trial

Patients aged 18 and older were eligible for enrollment onto the phase 2/3 study so long as they had MGMT-hypermethylated glioblastoma without 1p/19q co-deletion, completion of concurrent temozolomide treatment and radiotherapy with recovery from treatment, platelet nadir levels of 75,000/mm

 or greater, an ECOG performance status of 2 or less, and adequate organ function and seizure control.

Eligible participants were enrolled and randomly assigned between treatment arms between Dec. 15, 2014, and Dec. 15, 2018, onto the study. Patients were stratified by age, ECOG status, extent of resection and planned use of TTF.

PFS served as the primary end point of the phase 2 portion of the study while OS served as the primary end point for phase 3.

Notably, study authors noted that, “The treatment groups were well balanced regarding baseline variables.”

In the phase 2 portion of the study, 322 patients were randomized to treatment, while 125 patients were added in the phase 3 accrual, making a total of 447 patients in the final analysis of the phase 3 trial. The median age range for these patients was 60 years old and a majority of patients were male.

"The results reported in this randomized clinical trial highlight the importance of developing more precise predictive biomarkers to identify the subset of patients with the greatest temozolomide-sensitizing potential. ... The present study potentially provides a road-map for a highly efficient clinical evaluation strategy for PARP1-selective or other novel chemosensitizing strategies in newly diagnosed glioblastoma,” study authors concluded.

The addition of the PARP inhibitor veliparib to temozolomide treatment did not significantly improve overall survival (OS) in patients with newly diagnosed, MGMT-hypermethylated glioblastoma, as shown in a phase 2/3 trial. Although the combination was well tolerated, the OS difference between the veliparib and placebo arms was not statistically significant. Progression-free survival (PFS) was similar across treatment groups. The study underscores the need for precise predictive biomarkers to identify patients who may benefit from temozolomide-sensitizing strategies, offering a framework for future clinical evaluations.

Veliparib plus temozolomide did not significantly extend overall survival in patients with newly diagnosed, MGMT-hypermethylated glioblastoma.

Veliparib and Temozolomide Combo Does Not Significantly Extend Survival for Patients With Glioma

Emily Armstrong is one of the best nurses I have had the privilege to have worked with. Her level of wisdom and care for her patients is unmatched.

I was a newer oncology nurse, and she was always my go-to resource when we worked together. She was knowledgeable on the different reasons why we administer drugs over a certain amount of time and how different regimens differ. Her knowledge of chemotherapy extended beyond the basics of nursing knowledge, and she knew many pharmaceutical and non-pharmaceutical interventions when treating oncologic symptoms. She was always willing to share her knowledge with me.

Now that we work at different clinics and I am more experienced, she frequently brings up in conversation differences of practices, and questions what is most beneficial or what is evidence-based. If it is an outdated practice, she pushes for change and questions the practice with her management. This increases the quality and improves patient experience wherever she is working. She is an excellent clinician and an asset to our profession.

Emily fights very hard for her patients. She will adamantly advocate for a patient when she sees the need. I have seen this on too many different occasions to provide a specific example. Her expertise allows her to confidently do this despite her sometimes-timid personality. Emily is especially helpful, always willing to grab her patients a blanket, position them or give them encouragement. Emily constantly works for the best possible outcome for her patients and increases the level of the nursing professionalism wherever she practices.

Emily Armstrong, Rose Sawyer, and Ruth Cummings exemplify exceptional oncology nursing through their dedication, expertise, and patient advocacy. Emily's extensive knowledge and commitment to evidence-based practices enhance patient care and professional standards. Rose's experience as an infusion nurse allows her to provide comprehensive patient education and emotional support, fostering trust and strong patient relationships. Ruth's compassion and commitment to individualized care, along with her proactive approach to patient comfort, highlight her dedication to the VA mission and her role as an extraordinary healer in oncology nursing.

Emily Armstrong, Rose Sawyer and Ruth Cummings, oncology nurses, are recognized for their dedication, expertise and patient advocacy at Denver Health.

Renee Cowan

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