Day: June 5, 2023

Combination Therapy for Patients with Advanced Classic Hodgkin Lymphoma Boosts 1-year Survival

Photo by National Cancer Institute on Unsplash

Results from a Phase 3 trial of patients with advanced Stage (3 or 4) classic Hodgkin lymphoma who underwent initial treatment with nivolumab, a PD-1 checkpoint inhibitor, and AVD chemotherapy (N-AVD) showed that they had a significantly lower risk cancer worsening than patients treated with brentuximab vedotin, a monoclonal antibody, and AVD (BV-AVD) a year after starting treatment.

Ninety-four percent of adolescent and adult patients in the N-AVD group had progression-free survival compared with 86% in the BV-AVD arm. N-AVD was also well-tolerated as there were few serious immune-related side effects in the S1826 trial. The median follow-up was 12.1 months.

These late-breaking findings were presented by lead investigator Alex Herrera, MD, at ASCO’s 2023 Plenary Session.

“The results are remarkable. The combination of nivolumab and chemotherapy is potent and safe in patients with Stage 3 or 4 classic Hodgkin lymphoma as an initial treatment,” said Herrera. “The therapy is poised to be a standard for treatment of advanced Hodgkin lymphoma. This is indeed great news for patients with this cancer as there is another effective and safe treatment option for them.”

The S1826 trial is the largest classic Hodgkin lymphoma study ever conducted in the NCI’s National Clinical Trials Network and is also representative of a diverse patient population. About a quarter of the enrolled patients were Black or Hispanic. A partnership with the Children’s Oncology Group (COG) helped ensure the trial included young adolescents, and a quarter of enrolled patients were younger than 18 years old. Nearly two-thirds of all patients had Stage 4 cancer.

“This study speaks to the power of the National Clinical Trials Network and is an excellent example of the transformative work that the NCI funds,” said senior author Jonathan Friedberg, MS, MMSc. “Hodgkin lymphoma is not a common disease and the NCTN enabled a large network of more than 200 paediatric and adult community providers and academic medical centres to work together. Because of that, we were able to get data very quickly and directly impact patient care. This was a critical investment in cancer research and treatment.”

Patients with Stage 3 or 4 classic Hodgkin lymphoma who had not been previously treated and were age 12 or older were eligible for the trial. Of a total of 976 eligible patients, 489 were enrolled in the N-AVD arm (nivolumab plus Adriamycin, vinblastine and dacarbazine), while 487 were part of the BV-AVD group. Each group received six infusion cycles of each combination therapy.

As expected with combination chemotherapy, the most common side effects included gastrointestinal and hematologic toxicities, and fatigue. However, less than 1% of patients needed radiation after trial treatment, which is a dramatic reduction in the proportion of patients being initially treated for Hodgkin lymphoma who need radiation, especially among paediatric patients.

“The ability to maintain high rates of relapse-free survival with minimal use of radiation therapy in children with newly diagnosed advanced stage Hodgkin lymphoma will be a paradigm shift,” said Sharon Castellino, MD, MSc, chair of the COG Hodgkin lymphoma committee and director of the Leukemia and Lymphoma Program at the Aflac Cancer and Blood Disorders Center, Children’s Healthcare of Atlanta, Winship Cancer Institute at Emory University.

Brentuximab vedotin was the first antibody-drug conjugate developed for classic Hodgkin lymphoma. Several studies have demonstrated that incorporating the therapy into frontline treatment improves progression-free survival and overall survival. Despite improved outcomes, there are still serious side effects; relapses can occur.

“There is definitely a need to improve frontline therapies for Hodgkin lymphoma, particularly because a disproportionate number of patients with this disease are teens and young adults,” Herrera added.

Next steps for the trial include following patients to measure the durability of progression-free survival, overall survival and other patient outcomes.

Source: PR Newswire

Low Sexual Satisfaction in Middle Age Linked to Cognitive Decline

Photo by Ketut Subiyanto on Pexels

Low sexual satisfaction in middle age may serve as an early warning sign for future cognitive decline, according to a new study. The researchers, who tracked associations between erectile function, sexual satisfaction and cognition in hundreds of men aged 56 through 68, found that declines in sexual satisfaction and erectile function were correlated with future memory loss.

The study, published in Gerontologist, is the first to longitudinally track sexual satisfaction in tandem with sexual health and cognition, the researchers state, and its findings point to a potential novel risk factor for cognitive decline.

“What was unique about our approach is that we measured memory function and sexual function at each point in the longitudinal study, so we could look at how they changed together over time,” said Martin Sliwinski, professor of human development and family studies at Penn State and co-author on the study. “What we found connects to what scientists are beginning to understand about the link between life satisfaction and cognitive performance.”

The study explored the relationship between physical changes like the microvascular changes relevant for erectile function, and psychological changes, such as lower sexual satisfaction, to determine how the changes relate to cognition. They examined the shifts starting in middle age because it represents a transition period where declines in erectile function, cognition and sexual satisfaction begin to emerge.

Sliwinski added that while the team discovered a strong correlation between the three health factors, they can only speculate as to the cause.

“Scientists have found that if you have low satisfaction generally, you are at a higher risk for health problems like dementia, Alzheimer’s disease, cardiovascular disease and other stress-related issues that can lead to cognitive decline,” he said. “Improvements in sexual satisfaction may actually spark improvement in memory function. We tell people they should get more exercise and eat better foods. We’re showing that sexual satisfaction also has importance for our health and general quality of life.”

For the study, the researchers used survey data from 818 men who participated in the Vietnam Era Twin Study of Aging. Through neuropsychological tests, such as tests of memory and processing speed, they examined cognitive changes of participants over the 12-year span from age 56 to 68, adjusting for participants’ cognitive ability in young adulthood. Their erectile function and sexual satisfaction were measured alongside cognition, using the International Index of Erectile Function, a self-reported assessment for male sexual health. The researchers then built a statistical model to understand how the three variables changed as individuals aged.

“Research on sexual health has historically focused on quantifiable facets of sexuality like number of sexual partners or frequency of sexual activity,” said Riki Slayday, a doctoral candidate at Penn State and lead author on the study. “What we were interested in is the perception of that activity, how someone feels about their sex life, and how that influences cognitive function, because multiple people could be in the same situation physically but experience completely different levels of satisfaction.”

The study found that decreases in erectile function and sexual satisfaction were both associated with memory decline, which the researchers say points to a connection between psychological and physical health.

“When we mapped the relationship over time, we found increases or decreases in erectile function and sexual satisfaction were associated with concurrent increases or decreases in cognitive function,” Slayday said. “These associations survived adjustment for demographic and health factors, which tells us there is a clear connection between our sex lives and our cognition.”

Prior studies have found a link between microvascular changes and changes in erectile function over time. In fact, the active ingredient in Viagra (Sildenafil) was originally developed to treat cardiovascular problems, Sliwinski explained, so the connection between vascular health and erectile function is well understood. How erectile function connects to other aspects of health should be an area of focus for future research, he added.

Increasing the assessment and monitoring of erectile function as a vital sign of health may help identify those at risk of cognitive decline before their 70s, he said. The researchers note that the older adult population in the US is expected to double over the next 30 years, which means twice as many people will likely enter their 60s and experience declines in erectile function and sexual satisfaction.

“We already have a pill for treating erectile dysfunction. What we don’t have is an effective treatment for memory loss,” Sliwinski said. “Instead of the conversation being about treating ED, we should see that as a leading indicator for other health problems and also focus on improving sexual satisfaction and overall well-being, not just treating the symptom.”

Source: Penn State University

Memory Killer Cells can Improve Melanoma Survival

Melanoma Cells. Credit: National Cancer Institute

In a study published in the journal Immunity, Researchers at Karolinska Institutet and the University of Copenhagen shown that high levels of memory killer cells in cancer tissue correlate with a better survival rate in people with melanoma.

Certain immune T cells called tissue-resident memory cells are formed locally in the skin and other tissue, and protect against infections that they have encountered before. Some of them express proteins that enable them to kill infected cells. These “memory killer cells” can also contribute to the inflammatory skin disorders vitiligo and psoriasis. Recent research has shown that they are also involved in the body’s immune response to various cancers.

Varying responses to treatment

The memory killer cells have been shown to respond to immunotherapy, a Nobel Prize-winning cancer therapy involving the tweaking/activation of the immune system. Immunotherapy is normally administered as a complement to other cancer treatments, and there is considerable variation in how patients respond to it.

“We don’t know so much about how and why memory killer cells are formed in the skin and what it means for cancer patients,” says Professor Yenan Bryceson at Karolinska Institutet. “Finding out how these cells develop enables us to contribute to the development of more efficacious immunotherapy for diseases like melanoma.”

The study charted the development of memory killer cells in human skin, performed as a collaborative effort between KI researchers Beatrice Zitti and Elena Hoffer. The researchers isolated T cells from the skin and blood of healthy volunteers and used advanced techniques to examine gene activity and expression of different proteins. This allowed them to identify T cells in the blood with the potential to develop into memory killer cells in skin or other tissues. After knocking out specific genes, they could also demonstrate which genes are required for the maturation of memory killer cells in tissue.

More effective immunotherapy

The researchers then went on to study tumour samples from melanoma patients and found that those with a higher rate of survival also had a larger accumulation of epidermal memory killer cells.

We’ve been able to identify several factors that control the formation of memory killer cells, which play an important part in maintaining a healthy skin,” says dermatologist Liv Eidsmo, professor at the University of Copenhagen in Denmark and researcher at Karolinska Institutet, who led the study with Professor Bryceson. “There’s a fine balance between effective protection against tumours and infections in the skin and contribution to inflammatory diseases like vitiligo and psoriasis.”

The researchers now aim to harness their findings to optimise the immunotherapy-induced T-cell response to make it even better at eliminating cancer cells in tissues.

Source: Karolinska Institutet

Court Dismisses MEC’s Attempt to Quash Inquiry into her ‘Killing my Health System’ Remark

Photo by Bill Oxford on Unsplash

By Tania Broughton for GroundUp

Limpopo MEC for Health Dr Pophi Ramathuba has failed in her attempt to put a stop to a Health Professions Council of South Africa (HPCSA) inquiry into comments she made to a Zimbabwean patient when she visited Bela Bela Hospital last year.

A disciplinary inquiry had been set down for July to probe complaints against her emanating from the conversation which was widely broadcast.

While Pretoria High Court Judge Anthony Millar, in his judgment refusing to grant Ramathuba an interdict, did not detail the complaints, it is public record that she told the patient that Zimbabweans were putting a huge strain on the provincial health system.

She said: “You are killing my health system. It’s unfair.”

Ramathuba brought the application in her capacity as the MEC for health, in two parts, divided into Part A and Part B.

Part A was for an interdict pending Part B – a review application in which she would seek an order declaring the decision of the HPCSA issued against her on 9 February 2023 as unconstitutional, unlawful and invalid, and declaring that the HPCSA lacks jurisdiction over the conduct of the applicant as an MEC.

Only Part A was considered by Judge Millar this week and he ruled on Friday.

In his judgment, he said many complaints had been laid against Ramathuba with the HPCSA as a result of the conversation.

Ramathuba disputed the complaints, both in her capacity as the MEC for Health and as a medical practitioner.

“It is not in issue that the applicant has at all material times been registered as a health professional and remains so and the HPCSA is the custodian of the medical profession,” Judge Millar wrote.

The judge explained that the HPCSA has a two stage complaints procedure. The first is a preliminary inquiry, which may result in the complaint being resolved. If it is not, it is referred to a formal inquiry.

Judge Millar said a preliminary committee had considered the complaints at a meeting at the end of January. The committee had resolved that the applicant was guilty of unprofessional conduct but that it was only a “minor transgression” and that she should be cautioned for unprofessional behaviour, unbecoming of a medical professional for “shouting at a patient’s bedside as the patient was vulnerable at the time”.

The HPCSA, in a letter to Ramathuba, said the acceptance of this penalty would not constitute a conviction and would not be reflected against her name. The matter would be regarded as finalised.

But Ramathuba refused to accept the finding. She wrote to the HPCSA in February this year, challenging it on the basis that it had no jurisdiction over her.

The HPCSA disagreed with this, and set the formal hearing dates.

“The applicant does not want the inquiry to proceed or to attend it … she says she conducted the conversation in her capacity as an MEC and not as a medical practitioner,” Judge Millar said.

“The crisp question is, is the applicant in her capacity as MEC a separate persona from the applicant as a medical practitioner. The office of the MEC is a political one whereas her status as a medical practitioner is a professional one.

“The holding of political office and remaining registered as a medical practitioner are not mutually exclusive. The one hallmark of both is that the individual concerned accepts that they are, and subject themselves to being accountable for their actions.

“It seems to me to be a wholly contrived and self-serving assertion that conduct is determined depending upon ‘which hat a person is wearing at the time’,” the judge said.

“This is simply not consistent with our constitutional values or the law. There is to my mind no distinction to be drawn between the different offices a person holds and their conduct.”

He said Ramathuba had maintained her registration with the HPCSA so she had no right to avoid its jurisdiction. If she had de-registered then the situation would be different.

“Her refusal to accept the finding of the preliminary committee means that the entire matter will serve before a different committee … she will have the opportunity to raise whatever challenge she wishes at the inquiry.

“Delaying the matter unnecessarily ending a review does not serve the interests of any of the parties.”

Judge Millar dismissed the application and ordered Ramathuba to pay the HPCSA’s costs.

Republished from GroundUp under a Creative Commons Attribution-NoDerivatives 4.0 International License.

Source: GroundUp

Hospital Association of South Africa Joins Chorus of Criticism Against NHI Bill

The Hospital Association of South Africa (HASA) has added its objections to the proposed National Health Insurance (NHI) Bill to the growing volume of objections from professional medical organisations. In common with them, HASA strongly supports universal health coverage but stands against the NHI Bill in its current form.

Their statement reads: “We believe that approving the Bill without substantive consideration of the many valid and significant recommendations and contributions made by many participants during the Parliamentary hearing is deeply regrettable and a missed opportunity by the Committee.”

Chief among their objections were the potential for corruption and mismanagement in the centralisation of medical funds as well as the many legal objections to the Fund.

Despite serious, credible concerns being raised at every turn, the NHI Bill continues to progress, with Parliamentary Portfolio Committee for Health recently giving the Bill its approval on 26 May, moving it forward to debate within the National Assembly. To support healthcare professionals, Quicknews will be running a series of articles discussing the Bill and providing resources to help them take positive action to protect healthcare services for all of their patients. The Gauteng e-toll saga has already shown that ill-conceived and damaging legislation can be brought down if there is sufficient, coordinated public opposition.

With HASA’s statement, three of the largest medical associations in South Africa have now spoken out against the controversial bill. The South African Medical Association (SAMA) and South African Private Practitioners Forum (SAPPF) have both unequivocally stated their opposition to the Bill as it is currently formulated.

In addition to other risks, South Africa faces a potential exodus of healthcare professionals. Indeed, the UK’s National Health Service has for some time been actively poaching nurses and midwives from lower-income countries like South Africa.

HASA urges National Assembly and the National Council of Provinces in their deliberations on the Bill “to insist on a multi-payer model to mitigate against the concentration of risk, an iterative rollout based on milestones rather than dates and to pay heed to the nation’s concerns that the proposed National Health Insurance Fund is susceptible to theft and corruption by proposing and approving alternate and appropriate governance structures.”

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