Weekly app monitoring can reduce fatigue and improve daily life for women with metastatic breast cancer, according to a study.

The approach involves regularly asking patients about their wellbeing through an app and responding quickly when problems are identified.

Germany’s Federal Joint Committee, known as the G-BA, has recommended that the treatment model be incorporated into standard care.

Professor Maria Karsten, senior attending physician at the Charité Breast Cancer Center and initiator of the PRO B project, said: “The new medications often no longer need to be administered at the hospital but can be taken at home.

“As a result, we see patients less frequently at the hospital, and our medical oversight has become somewhat incomplete.

“In order to close this gap and provide patients with close support in spite of the distance, we have developed the PRO B digital treatment concept.”

Around 68,000 women in Germany are living with metastatic breast cancer, meaning the disease has spread to other organs.

At this stage, the cancer is generally considered incurable. Modern treatments can, however, temporarily control the disease and extend life expectancy by several years, with some women able to continue working.

At the centre of PRO B is an app that asks women up to 52 structured questions once a week about their symptoms, daily life and emotional wellbeing.

Questions include whether they have experienced pain, felt too tired to carry out their usual activities or experienced shortness of breath.

An algorithm analyses the answers and immediately alerts the treatment team when relevant changes are detected.

The team then contacts the patient within 48 hours to decide whether any action is needed.

Karsten said: “During these phone calls, for example, we discuss whether the dosage of anti-nausea medication should be adjusted or offer practical tips for managing the various symptoms.

“But we also detect serious side effects more quickly – such as those indicated by a seemingly harmless symptom like fatigue – and can immediately schedule the patient for an appointment at the hospital.”

The study involved 909 women with metastatic breast cancer aged 19 to 81 across 52 breast cancer centres in Germany and followed them for one year.

Around half received PRO B care alongside drug-based cancer treatment.

The other half answered questions about their wellbeing once every three months and were not contacted by their treatment teams in response.

Women receiving PRO B care reported significantly less fatigue, which refers to physical, emotional or mental exhaustion that can severely restrict daily life.

They also rated their physical functioning more positively and required fewer hospital admissions.

Karsten said: “These are effects that have a noticeable impact on the patients’ daily lives; the women are more capable and better able to manage their lives.

“We even have evidence that the PRO B approach extends the remaining lifespan for some patients. We are achieving all of this not through a new medication, but simply by regularly and systematically assessing the women’s well-being and responding accordingly.”

More than 90 per cent of women in the PRO B group said after the study that they wanted the approach to become part of routine care.

Stephanie Neumann-Johnston, 51, who took part in the study, said: “I feel like the app has saved my life several times.

“There are so many situations and incidents that you can’t make sense of – you have so many questions.

“With the app, I can look up common problems and find medically reviewed information, for example, about fatigue. That way, I can help myself, also on the weekends.

“And the personal contact provides me with emotional and medical support.

“For example, I can find out whether I’m allowed to take certain medication for a fever, or get an assessment of my situation: Should I go to the emergency department with these symptoms or not? The app takes a huge weight off your shoulders.”

Based on the medical findings and a health economic analysis, the G-BA recommended in June that PRO B should be incorporated into standard care.

This would allow patients with statutory health insurance to access the model in future when they receive the relevant diagnosis.

PD Dr Christoph Kowalski, department director at the German Cancer Society and a co-author, said: “This recommendation must now be implemented as quickly as possible.

“If a new care concept offers medical and economic benefits, we should not withhold it from the most seriously ill women.”

The health insurance companies involved in the project are also planning further developments so affected women can receive routine PRO B care before its wider introduction into standard care, with access expected to begin this autumn.

The care model will continue under the name “ida”, led by Karsten and her team.

The PRO B project ran from 2020 to 2024 and received around €4.8m from the Innovation Committee of the Federal Joint Committee.

The project was led by Karsten, with consortium partners BARMER, mkk – meine krankenkasse, DAK-Gesundheit, the German Cancer Society and OnkoZert GmbH.

Breast cancer is the most common cancer among women in Germany, with around one in eight expected to develop the disease during their lifetime.

Worldwide, breast cancer is the leading cause of cancer-related deaths.

Despite advances in treatment, 30 per cent of women with early-stage breast cancer and up to 70 per cent of those with lymph node involvement in later stages develop distant metastases, which typically make the disease incurable.

For patients with metastatic breast cancer, treatment aims to prolong life while maintaining the best possible quality of life.

Since 2016, the G-BA has been responsible for supporting new forms of care that go beyond existing standards, as well as health services research aimed at improving healthcare quality in Germany.

Its Innovation Fund is financed through contributions from statutory health insurance plans and the Health Fund.

A woman with advanced ovarian cancer has become the first patient globally to receive an experimental off-the-shelf cell therapy.

Tracy Tomlinson, 58, was given the experimental drug ZI-MA4-1 at the Christie NHS Foundation Trust in Manchester.

The treatment forms part of a clinical trial evaluating its use against several cancer types, including ovarian, lung, head and neck cancers and sarcomas.

The Christie is leading the trial, with a second site at the Royal Marsden in London. It involves patients with advanced cancers who may have few other treatment options.

Tomlinson, from Chadderton in Greater Manchester, has undergone surgery and multiple rounds of chemotherapy since she was diagnosed in 2020.

She said: “They’ve got rid of the cancer twice but then it came back about two and a half years ago, and we’ve never seemed to get rid of it since then.

“The chemotherapy has shrunk it but when treatment stops, it has come back.

“It is a lot to live with and there’s been ups and downs – there’s been elation, there’s been disappointment, and bits in between.

“But I try very, very hard to remain very positive. Every day that I wake up is a positive. You’ve got to have hope.”

ZI-MA4-1 combines two approaches to cancer treatment.

It uses natural killer cells, known as NK cells, which are specialist immune cells that identify and destroy abnormal cells.

T-cell receptors on the donor cells are also engineered to recognise and target tumours producing a protein called Mage-A4.

Mage-A4 is found in several types of cancer and is considered by experts to be a potential target for attacking abnormal cells.

Unlike personalised treatments, ZI-MA4-1 is designed as an off-the-shelf therapy using immune cells from donors.

The treatment is manufactured in advance rather than being made separately for each patient, with hundreds of doses potentially produced from one manufacturing batch.

Experts believe this approach could make advanced cell therapies available to more patients, more quickly and at a lower cost.

Tomlinson was diagnosed with ovarian cancer that had spread shortly before Christmas 2020 and began treatment immediately.

By summer 2021, scans showed no evidence of disease, but the cancer returned around a year later.

Despite further treatment and 48 chemotherapy infusions, the cancer continued to return.

The former Civil Service manager was diagnosed with stage 3C ovarian cancer, meaning cancer growths had spread into the peritoneum, the tissue lining the abdominal cavity.

She currently has a tumour between her liver and kidney, as well as smaller tumours elsewhere.

She said: “They’ve got rid of the cancer twice but then it came back about two and a half years ago, and we’ve never seemed to get rid of it since then.

“The chemotherapy has shrunk it but when treatment stops, it has come back.

“It is a lot to live with and there’s been ups and downs – there’s been elation, there’s been disappointment, and bits in between.

“But I try very, very hard to remain very positive. Every day that I wake up is a positive. You’ve got to have hope.”

Tomlinson said she had been target-driven during her working life and had set herself high standards.

“But you can’t control cancer,” she said. “What I can control is how I look at it, how I deal with it, and trying to eat healthily and taking the positives in everything.

“And I’ve learned to appreciate the smallest of things that we take for granted – and the people around you and what they mean to you.

“Also, the beauty of outside and the trees and the colour of the trees and the birds singing.

“We just go from A to B, don’t we? Busy, busy, busy. But we never slow down and take in the wonder of what’s around us.

“I often think, ‘I’m still here’, and that’s helped me think, ‘Why can’t I still be here in 10 years?’, ‘Why can’t I still be here in 15 years?’

“And I believe taking all the treatments offered to me is helping me kick that can a bit further down the road.

“I don’t want to go anywhere. I’ve still got a lot of things I want to do and things I want to achieve.”

Tomlinson said her husband Paul, whom she married in 2022, is her “rock”. She is also close to her son Harry, 28.

Last year, she was referred to the Christie’s early-phase clinical trials team for extensive screening and learned she was eligible for the Zima-101 clinical trial.

She said: “I decided almost straight away that I was going to go for it.

“Then afterwards you think, ‘Am I doing the right thing?’, because it is a little bit scary being the first person in the world to have the treatment.”

She has received three infusions of the therapy, with the option of a fourth depending on her scan results.

She said: “If it benefits me, absolutely fantastic. But if it benefits other people in the future, that’s important too.

“I don’t want to have gone through everything I’ve gone through for nothing. I want to feel like I have made a difference.”

Professor Fiona Thistlethwaite, consultant medical oncologist at the Christie, said: “While this is an early-stage study primarily focused on safety, it represents an exciting step forward in efforts to develop new treatment options for people like Tracy with advanced solid tumours.

“We hope the knowledge gained will help shape future cancer treatments and ultimately improve outcomes for patients.”

Dr Jon Lim, consultant medical oncologist in advanced immunotherapy and cell therapy at the Christie, told PA: “What’s very exciting about this is that these are essentially not kind of antibody-based, but living cells.

“These are live immune cells that are infused in hundreds of millions back to the patient, and the idea of this is that it is a little bit more targeted.

“The reason this is very interesting is because this is the first of its kind globally in this approach, where it’s taking donor immune cells, manipulating or engineering them, and putting them into the recipient.

“Tracy is essentially getting somebody else’s immune cells that have been engineered to ‘see’ her cancer.

“We’re very excited. This is a novel approach in the cell therapy space. We are also really showcasing what we can do in the UK.”

Namir Hassan, chief executive of Norwegian company Zelluna, which makes ZI-MA4-1, described Tomlinson’s first dose as a “landmark moment”.

He said: “It represents the moment when years of research moved beyond the laboratory and into the clinic, offering a new potential treatment option for patients facing advanced cancers with limited alternatives.”

Only around 15 per cent of women survive ovarian cancer for five years or more after diagnosis.

Dr Diana Hernandez, director of immune and advanced therapies at Anthony Nolan, said: “NK cells have huge potential as off-the-shelf therapies, and this trial takes us one step closer to a wider application of engineered NK cells in the targeted treatment of cancers.”

Johnson & Johnson has offered an estimated US$5.5bn settlement covering about 76,000 claims that its talc products caused ovarian cancer.

The proposed agreement could end a contentious legal dispute over the company’s baby powder and other talc-based products that has lasted around a decade.

Johnson & Johnson said the settlement covers claims consolidated in a federal court in New Jersey and related cases in state court.

The claims represent nearly all the remaining talc cases against the US multinational, according to the company.

Johnson & Johnson has previously settled most claims alleging that its talc contained asbestos and caused mesothelioma.

Mesothelioma is a rare cancer affecting the lining of organs, most commonly the lungs, and is usually linked to asbestos exposure.

Law firms representing claimants confirmed the proposed deal, describing it as a good resolution after around 10 years of litigation.

The agreement must be accepted by 95 per cent of ovarian cancer claimants in state or federal court before it becomes final.

Erik Haas, vice-president of litigation at Johnson & Johnson, said the claims were “meritless” and that the company was willing to settle to bring the litigation to a close.

“While we are confident the company would have ultimately prevailed with further litigation, as it has in the vast majority of cases tried to date, this resolution allows the company to put this matter behind it and remain focused on its mission to develop medicines and devices that save lives,” Haas said.

The company expects to pay US$3bn in 2027, with further payments due in 2028.

The deal could be worth more, depending on how many people take part in the settlement.

Chris Seeger, a lawyer representing around 2,500 clients with talc claims who helped negotiate the agreement, said Johnson & Johnson could ultimately pay US$7bn or more.

The settlement assigns specific values to qualifying ovarian cancer claims but does not cap the company’s total payout.

“We got a fair settlement, and our clients are going to be happy with it,” Seeger said.

Johnson & Johnson reached the agreement after a series of court victories, including wins in individual trials and successful efforts to disqualify claimants’ lawyers from the litigation.

The company also secured court rulings against experts used by claimants to support their cases.

A federal judge last week questioned whether individual claimants could prove that talc had specifically caused their ovarian cancer.

Johnson & Johnson has consistently denied that its talc products caused cancer, maintaining that the products were safe and did not contain asbestos.

The company stopped selling talc-based baby powder in the US in 2020 and switched to a cornstarch-based product.

Litigation resumed in March 2025 after being paused for more than three years while Johnson & Johnson pursued a bankruptcy strategy known as the “Texas two step”.

The company filed three bankruptcies through a shell-company subsidiary in an attempt to settle the cases. Each bankruptcy was dismissed.

Before the bankruptcy attempts, Johnson & Johnson had a mixed record in talc trials.

These included a multibillion-dollar verdict for 22 women who said baby powder caused their ovarian cancer, alongside trials won by Johnson & Johnson and other verdicts later reduced on appeal.

Unlike the proposed bankruptcy settlements, the latest agreement applies only to existing claims and does not cover future lawsuits.

Seeger said excluding future claims made more money available for current claimants than the bankruptcy proposal and would allow all claims to be paid within 18 months rather than over more than a decade.