A 6-month treatment with Herceptin is as good as 12 months to prevent the return of breast cancer

A new study conducted jointly by the University of Warwick's Clinical Trials Unit has shown that shortening the duration of a therapy for bad cancer patients will not increase the duration of therapy for patients with bad cancer. did not increase the risk of recurrence of their cancer.

The majority of cancer clinical trials evaluate either new treatments or additional treatments compared to current standard treatment. However, equally important issues for patients and care teams are the reduction of treatment duration and the resulting toxicities, as well as the possibility of achieving this result without damaging the results. Results of clinical trials published in The lancet Today (June 6) show that women treated with Herceptin for early-stage HER2 positive bad cancer for 6 months were as successful in terms of risk of bad cancer recurrence as those receiving conventional treatment current 12 months. Six months have also significantly reduced treatment-related side effects, including heart problems.

The PERSEPHONE study, a NIHR-funded study and translational research funded by Cancer Research UK, recruited more than 4,000 women with early-stage HER2-positive bad cancer. He compared a six-month course of Herceptin to the current twelve-month standard to determine whether the shorter treatment was similar or no worse than the longer treatment. This is the largest trial of its kind on the impact of Herceptin duration reduction.

The trial, led by a team from Cambridge University and the University of Warwick's Clinical Trials Unit, involved 4088 women and is larger than any previous study in this area. It showed that 89.4% of patients taking six months of treatment were without bad cancer after four years, compared to 89.8% of patients taking treatment for twelve months. These results show that women who took Herceptin for six months are no worse off than patients receiving standard 12-month treatment for bad cancer recurrence. In addition, only 3% of women in the six-month group had to stop taking the drug because of heart problems, compared to 8% of the 12-month group. This trial is consistent with standard NHS practice, in which chemotherapy and Herceptin are given before or after surgery.

Herceptin has constituted a major breakthrough in prolonging and saving the lives of women with HER2 receptor-bearing bad cancer on the surface of their cancer cells. About 15 in every 100 women with early-stage bad cancer have HER2-positive disease. Herceptin is a targeted therapy that works by attaching itself to HER2 receptors, thus preventing cancer cells from multiplying and dividing. On the basis of clinical trials, a 12-month treatment was adopted as the norm with the need for 18 injections every three weeks. However, another clinical study, the FinHer trial, suggested that shorter duration could be as effective, which would significantly reduce side effects and costs for patients and health care systems. NIHR funded this study to compare the standard 12-month treatment with a shorter 6-month treatment.

Professor Janet Dunn, who led the trial at Warwick's Clinical Trials Unit, said, "The NHRI is an excellent funder for these types of trials because it ultimately refines patient treatment. with the maximum benefits badured The data collected on the experiences reported by patients confirm the time spent by patients during treatment and the impact of any treatment on their quality of life in the long term. "

Lead author of the study, Professor Helena Earl, professor of clinical anticancer medicine at the University of Cambridge and at Cancer Research UK at Cambridge Center, said: "We would like to thank the 4088 patients who participated in our study as well as the tireless efforts and dedication of the Warwick and Cambridge teams: the trial would not have been possible without the help of the NHS clinical research network from 152 teams in UK centers. United has recruited patients, and the PERSEPHONE trial team has benefited immensely from an invaluable partnership with patient advocates in the study.

"The trial included patients receiving or expected to receive Herceptin as standard in the NHS for HER2-positive bad cancer.The result indicates that there are a large number of patients for whom a reduced treatment duration of six months with Herceptin This data can now be added to all existing data on Herceptin, an adjuvant to be extensively reviewed by the bad cancer community, with a view to considering changes in practice. The study also suggests that some groups may not be able to change their treatment without consulting their doctor Women who are currently taking this drug should be researched to further define women who can reduce the duration of their treatment. to do so, translational research badyzing blood and tissue samples read during the test to look for biomarkers to identify the Ps subgroup where shorter or longer durations could be adapted. "

The trial also collected qualitative research data on patient-reported experiences with Herceptin. The most commonly reported adverse reactions in one-third of women are pain and fatigue, with significant effects on daily functioning and quality of life. Cost savings for 6 months Herceptin compared to 12 months were presented at the ESMO conference in October 2018 and were estimated at £ 9,699 per patient. A detailed cost-effectiveness badysis including a life-time model, subgroup badyzes and societal cost badysis is underway. Because HER2 + bad cancer is a significant global burden, adjuvant treatment for 6 months would save hundreds of millions of dollars a year worldwide. Worldwide, this will have a significant impact on middle and low-income countries, as it will make it easier for Herceptin (an essential medicine designated by the World Health Organization) to treat many more women with HIV. 39, HER2-positive early bad cancer.

Professor Charles Swanton, Chief Clinician at Cancer Research UK, said: "The work of Cancer Research UK has paved the way for the development of Herceptin, which has saved the lives of thousands of women with bad cancer. , despite years of research, has been able to determine the optimal duration of Herceptin treatment, either to delay cancer recurrence or to cure patients with HER2-positive bad cancer following surgery .

"These eagerly awaited results give the bad cancer research community an opportunity to re-evaluate the time available for this targeted therapy to allow patients to live longer and with a better quality of life.

"The next important steps are to determine which patients can stop Herceptin at 6 months and for whom prolonged treatment is needed."

Maggie Wilcox, president of Independent Cancer Patient Voice (ICPV), patient of the PERSEPHONE trial, said: "I am delighted to have participated in this historic trial which is an important step in reducing the duration of treatment Most clinical trials add new treatments to standard practice while reducing the duration of Herceptin use.The collection of experiences reported by patients throughout the trial will illuminate dramatically future practices and benefit patients. "ICPV is collaborating with the Persephone team to help disseminate these exciting results."

The results of the PERSEPHONE trial, published in The lancet Today were presented at the ASCO Annual Meeting of June 2018 in Chicago. The full report, which will include an badysis to determine the impact of treatment duration on quality of life with the experiences reported by patients, as well as a detailed cost-effectiveness badysis, will be published. in the NIHR library of journals.