Ebola virus disease
Recognizing And Managing Stress From Cancer
I need to acknowledge and address the impact stress from multiple myeloma has on my mental and emotional wellbeing.
The weight of choosing the best course of a multiple myeloma treatment plan and anticipating potential relapses are significant sources of apprehension and dread. It feels like a constant balancing act, navigating different options and possible outcomes. The mere thought of relapse is enough to send shivers down my spine, causing tension and unease in myself. Using the powerful influence of our minds, I have found ways to combat negative thoughts. Silently saying mantras like "Believe in magic and miracles" and "I am healthy," I focus on positivity. Instead of labeling our prescription "chemotherapy," I refer to it as "healing elixirs." These techniques help keep my stress levels under control.
During a recent visit to my storage unit, I committed to clearing out its contents. This decision was not only financial but also in line with the Swedish tradition of "döstädning" or "death cleaning." As I sifted through the accumulated items over the years, I realized the importance of freeing my loved ones from this burden after passing on.
However, it was disheartening to see how limited my abilities were — I could not help my wife move the heavy boxes of books, retrieve essential documents from the file cabinets, or even place bags of items onto the loading dock. Helplessness and anger at my physical limitations of the fractures in my spine overwhelmed me as I watched her take on tasks that used to come quickly to me. My exasperation grew as I felt incapable of helping or rearranging items into neat piles.
As I sort through my personal vault, I sometimes observe appalling behavior toward her. My voice takes on sharp, almost barking tones whenever we speak. It dawned on me that those closest to me bore the brunt of my frustrations, and this realization allowed me to see how much stress was affecting me while clearing out my belongings.
I gazed at my "things to do" list, and a wave of sadness washed over me. My energy levels have been affected, making it difficult to check off more than one or two tasks each day. It's disconcerting not to be as productive as I used to be. The more I think about it, the more discouraged I become, yearning for my past levels of efficiency.
The weight of life's unexpected and tragic events can take a toll on our mental and physical wellbeing. When my niece's fiancé was tragically killed in a motorcycle accident, I felt the heartbreaking impact of his loss. Despite wanting to attend the memorial service, we decided to wait a couple of months before visiting my 31-year-old niece to give her space and time to grieve. When we finally did see her, she expressed immense gratitude for our support during such a difficult time. This experience made me reflect on how trauma can negatively affect us, and I wonder if the significance of losing my mother may have contributed to my diagnosis of multiple myeloma.
Every day, without fail, I gather with my group, the Bells of Hope. They offer a safe haven where we share our thoughts and struggles and find inspiration in each other's company. As the leader, I carefully choose a topic to discuss during the first part of our hour together, guiding us through deep conversations that bring understanding and insight. For the last five to 10 minutes, I close with a meditation and the words "Om mani padme hum" as a mantra of compassion and gratitude to bring us closer to inner peace. This daily commitment also serves as my faithful alarm clock from Monday to Saturday, reminding me to carve out time for self-care and mental well-being amidst the chaos of life. The lighthouse is one of the signature symbols of our heartfelt group; it symbolizes our sharing of our light, wisdom and steadfastness amid the stormy seas of life.
In addition to my regular self-care routine, I find gratification in preparing fresh, healthy meals made from organic ingredients. As in the TV show, I feel like Top Chef cleaning and chopping fresh vegetables for homemade delicious dishes. Knowing that I am nourishing my body helps me to de-stress and feel grounded.
Attending regular physical therapy sessions not only helps with my physical wellbeing but also aids in the release of tension. On Tuesday afternoons, I join a qigong class. Through this ancient Chinese practice of movement and meditation, I have found a sense of calm and balance in strengthening both my mind and body.
Every week, I make time to sing — not only for the benefit it brings to my breathing for my collapsed lungs but also for the pure enjoyment it brings me.
Finally, attending multiple myeloma support groups has been highly beneficial for me.
Sharing my concerns with our cancer community has been instrumental in helping relieve life's uncertainties.
Through these activities, I have learned the importance of staying connected with diverse communities of positive and inspirational individuals. Surrounding myself with people who uplift and encourage me has been invaluable in my quest for wellbeing and happiness. I become more mindful of how I respond to outside challenges.
So think, how do you address and manage your stress?
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Quadruplet Shows 'Excellent Activity' In Myeloma Patients Who Defer HSCT
Adding the CD38 monoclonal antibody isatuximab (Sarclisa) to a backbone of carfilzomib (Kyprolis), lenalidomide (Revlimid), and dexamethasone (KRd) induced deep and durable responses in a multiple myeloma study of untreated transplant-eligible patients, although the phase II trial missed its primary endpoint of complete response.
The quadruplet regimen was active with and without hematopoietic stem cell transplant (HSCT) and regardless of standard-risk or high-risk disease status, reported Elizabeth O'Donnell, MD, of the Dana-Farber Cancer Institute in Boston, and colleagues.
Of 50 patients in the intent-to-treat population, 32% achieved a complete response after four cycles of therapy. The overall response rate (ORR) was 90%, and 78% achieved at least a very good partial response (VGPR).
After completion of consolidation -- upfront HSCT plus two more cycles of therapy or deferred HSCT plus four more cycles -- 58% of patients achieved a complete response, the ORR was maintained at 90%, and 86% achieved a VGPR or better.
While the study did not meet the prespecified threshold for the primary endpoint of complete response rate, the combination "did show excellent activity comparable with that of other four-drug regimens," O'Donnell and coauthors wrote in Lancet Haematology.
For example, they pointed out that the complete response rate of 32% was similar to that in the MASTER trial, in which patients who received the anti-CD38 antibody daratumumab (Darzalex) with KRd after four cycles had a 36% complete response rate.
O'Donnell and colleagues also emphasized that of the 45 patients who were evaluable for response after four cycles of treatment, just five proceeded to undergo high-dose melphalan (Alkeran) and autologous HSCT, with the remaining 40 choosing to receive a total of eight cycles of isatuximab plus KRd while keeping HSCT as an option for later on.
The ORR among those 40 patients was 100%, with 65% achieving a complete response (stringent complete response and complete response) and 98% a VGPR or better.
"We show that deep and durable responses can be achieved without high-dose melphalan and also provide a regimen for high-risk patients with extended duration of isatuximab and carfilzomib," the authors said.
In a commentary accompanying the study, Natalie Callander, MD, of the Wisconsin Institutes for Medical Research in Madison, suggested that use of triplet combinations for newly diagnosed multiple myeloma have "nearly been supplanted by four-component regimens, typically including an immunomodulatory drug, a proteasome inhibitor, a steroid, and the newest addition, an anti-CD38 antibody."
She observed that results from the GRIFFIN and PERSEUS trials that used the combination of lenalidomide, bortezomib (Velcade), dexamethasone, and daratumumab, as well as the MASTER trial, "have led to the expectation that regimens for newly diagnosed multiple myeloma need to offer an ORR in excess of 90%."
However, she also noted that these trials incorporated melphalan with HSCT, which is "an intervention that has come into question" after failing to improve overall survival in the DETERMINATION trial.
Furthermore, Callander noted that there are concerns that mutagenesis of hematopoietic DNA caused by high-dose melphalan could be associated with the development of secondary malignancies in multiple myeloma patients who undergo HSCT.
Thus, she suggested that the current study "should give encouragement to those who continue to search for highly effective regimens that could offer prolonged myeloma disease control without the routine incorporation of HSCT."
The so-called SKylaRk study was a single-arm, phase II trial conducted at three cancer centers. Patients had a median age of 59 years (range 40-70), 54% were male, and 46% had high-risk cytogenetics.
The evaluable patients (45 of 50 who initiated therapy) completed four cycles of isatuximab plus KRd and underwent stem cell collection. The upfront HSCT group then underwent high-dose melphalan and autologous HSCT, followed by two additional cycles of treatment, while the transplant-deferred group received four additional cycles of isatuximab plus KRd. Patients who achieved a partial response or better continued on to maintenance therapy (determined based on cytogenic risk).
In addition to the response rates described above, results for minimal residual disease (MRD) were available after completion of four cycles of therapy for 28 patients achieving a VGPR or better. Of those, 43% were MRD negative at a threshold of one in 10-5 nucleated cells and 18% (five patients) at a threshold of 10-6.
After completion of eight cycles, 66% of the 41 patients with MRD results were negative using a threshold of 10-5 and 17% at 10-6.
The 24-month progression-free survival rate reached 91.3% (95% CI 83.4-99.8) and overall survival was 95.8% (95% CI 90.2-100).
Regarding safety, the most common grade 3/4 side-effects included neutropenia (26%), elevated alanine aminotransferase (12%), fatigue (6%), thrombocytopenia (6%), acute kidney injury (4%), anemia (4%), and febrile neutropenia (4%).
Grade 1/2 infusion-related reactions occurred in 20% of patients. There were two deaths assessed as unrelated to treatment.
Along with the single-arm, non-randomized trial design, another limitation of the study was that, while response after four cycles has been used in some studies of newly diagnosed multiple myeloma, other trials have used responses after high-dose melphalan and transplantation, the authors pointed out.
"A later timepoint could have allowed for additional treatment to deepen responses further and increase the likelihood of achieving the primary endpoint (with or without high-dose melphalan)," they suggested.
Mike Bassett is a staff writer focusing on oncology and hematology. He is based in Massachusetts.
Disclosures
This was an investigator-initiated study supported by Amgen and Sanofi.
O'Donnell reported consulting, honoraria, travel fees, and participation in the advisory board for Sanofi. Coauthors reported multiple relationships with industry.
Callander received payment or honoraria for presentations for Research to Practice.
Primary Source
The Lancet Haematology
Source Reference: O'Donnell E, et al "Isatuximab, carfilzomib, lenalidomide, and dexamethasone in patients with newly diagnosed, transplantation-eligible multiple myeloma (SKylaRk): a single-arm, phase 2 trial" Lancet Haematol 2024; DOI: 10.1016/S2352-3026(24)00070-X.
Secondary Source
The Lancet Haematology
Source Reference: Callander N "Another quadruplet therapy for multiple myeloma: the beginning of the end for autologous haematopoietic stem-cell transplantation?" Lancet Haematol 2024; DOI: 10.1016/S2352-3026(24)00097-8.
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NICE Recommends Nexpovio For Multiple Myeloma Patients, Addressing Treatment Gaps
The guidance recommends the use of small molecule Nexpovio (selinexor) in combination with bortezomib and dexamethasone for eligible patients who have undergone 1 or 2 prior treatments.
This recommendation is poised to fill crucial gaps in the treatment pathway, potentially making over a thousand patients eligible for a therapy that could delay cancer progression and extend survival.
Dr. Neil Rabin, consultant hematologist at University College London Hospitals, hailed the decision as a significant advancement in addressing the unmet needs of myeloma patients.
He said: "Being able to use different treatments that work in a variety of ways is critically important to help evade and overcome the cancer's defense mechanisms. Today's news has enabled just that and means we now have a new way to treat this complex and challenging blood cancer."
Multiple myelomaMultiple myeloma, often referred to as 'myeloma,' remains incurable for the majority of patients, necessitating multiple lines of treatment.
"Despite advances in treatment, most patients relapse and will require multiple lines of treatment. Therefore, it is critical to have as many different treatment options as possible that target the cancer cells in different ways to maximize the possibility of patients responding to treatment, and helping keep the cancer at bay," says Nelluri Geetha, pharma analyst at GlobalData.
Shelagh McKinlay, director of research and advocacy at Myeloma UK, lauded the decision as a victory for the myeloma community, highlighting Nexpovio's novel mechanism of action, which differs from existing treatments.
"This treatment's novel mechanism of action means it can help fight myeloma in a completely different way to other currently available treatments. Until we have a cure, it is absolutely vital that all patients are given as many options to tackle their cancer as possible – no matter where they are on their treatment journey," she says.
Nexpovio functions by restoring the body's anti-cancer defense mechanisms, particularly by blocking the action of exportin 1 (XPO1), a protein found in high amounts in myeloma cells.
Rick Coope, general manager at Menarini Stemline UK, is pleased with the collaboration between the industry, NICE, and the myeloma community.
Improving outcomes for myeloma patientsHe said: "We are incredibly proud that in Menarini Stemline's first engagement with NICE, we have successfully reached an agreement for two appraisals – and three lines of therapy - in such a short period."
The company says the recommendation of Nexpovio by NICE represents a significant milestone in addressing treatment gaps and improving outcomes for multiple myeloma patients in the UK.
Coope added: "Today's announcement is a significant development for the myeloma community and shows what is possible with true collaboration between industry, NICE, and the myeloma patient and physician community."
NICE's recommendation not only highlights its potential to address significant unmet needs in myeloma treatment but also underscores the importance of ongoing collaboration between stakeholders in advancing patient care and access to innovative therapies.
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