Data show Roche’s new subcutaneous form of Herceptin is preferred by patients and could save resources in Europe’s hospitals

Roche (SIX: RO, ROG; OTCQX: RHHBY) today presented data from the PrefHer study at the European Cancer Congress (ECC) in Amsterdam showing that its new, EU-approved subcutaneous formulation of Herceptin (trastuzumab) is preferred by patients and healthcare teams alike, reduces the time patients spend receiving treatment, can free up healthcare providers’ time and helps improve health centre efficiency. PrefHer is one of the first ever studies to examine patient preference for a cancer therapy.

 “Living with breast cancer is very challenging and being able to lead as normal a life as possible during treatment is incredibly important.” said Hal Barron, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Patients prefer the subcutaneous formulation of Herceptin to the intravenous form because they spend less time in hospital and it also saves valuable time for healthcare providers.”

More than 80,000 patients receive Herceptin each year in Europe, and patients may be treated with the medicine for several years. In the PrefHer study, use of the subcutaneous formulation cut the time patients with early breast cancer spent in chemotherapy suites by more than half (58%), potentially providing capacity and resource savings for hospitals and healthcare teams.

Additionally, almost all patients (92%) preferred the less invasive subcutaneous formulation. Overwhelmingly, this was because patients spent less time at the treatment centre and felt they experienced less pain or irritation than with the intravenous form.

The data are featured in a poster presentation1 today at ECC in Amsterdam by Erwin de Cock from the United BioSource Corporation in Barcelona, Spain (Abstract P128, Monday 30 September, Hall 4). The PrefHer patient preference data2 were presented on Saturday by Prof. Lesley Fallowfield, from Brighton & Sussex Medical School, University of Sussex, in Falmer, UK (Abstract P719, Saturday 28 September, Hall 4).

About the PrefHer study

PrefHer is an international phase II, randomised, multicentre, cross-over study designed to determine patient preference regarding the route of administration of Herceptin. Over 400 patients with HER2-positive early breast cancer were enrolled in the study, which is currently ongoing at over 70 sites in 12 countries. Patients undergoing adjuvant treatment with Herceptin were randomised to receive four cycles of Herceptin administered subcutaneously followed by four cycles of Herceptin administered intravenously, or the reverse sequence, in two study arms:

Cohort 1 patients received four cycles of subcutaneous Herceptin via a single-use injection device (SID) and four cycles of IV Herceptin.

Cohort 2 patients received four cycles of subcutaneous Herceptin via a hand-held syringe and four cycles of IV Herceptin.

 A time-and-motion substudy is being conducted alongside the trial to collect data on the time healthcare professionals at the treatment centres spend on activities related to each patient treatment session. The process time per patient is calculated as the sum of the mean task times when Herceptin was administered via IV versus Herceptin via the subcutaneous route.

At ECC, time-and-motion data from both the SID (Cohort 1) and hand-held syringe (Cohort 2) is presented for France, Switzerland, Denmark and Italy, click here for table.

About Roche’s HER2-targeted medicines

Roche has been leading research into the HER2 pathway for over 30 years and is committed to improving the health, quality of life and survival for patients with both early and metastatic stage HER2-positive disease.

Roche has developed a number of innovative medicines which have helped transform the treatment of HER2-positive breast cancer. HER2-positive breast cancer is a particularly aggressive form of the disease which affects approximately 20 percent of patients. Over the past 15 years the outlook for patients with HER2 disease has improved to the extent that patients with the disease experience better outcomes than those of patients with HER2-negative disease.

Eligibility for treatment with Roche HER2-medicines is determined by a diagnostic test, saving time from the outset by identifying those patients who will likely benefit from them.

About breast cancer

Breast cancer is the most common cancer among women worldwide3. Each year, about 1.4 million new cases of breast cancer are diagnosed worldwide, and over 450,000 women will die of the disease annually3. In HER2-positive breast cancer, increased quantities of the human epidermal growth factor receptor 2 (HER2) are present on the surface of the tumour cells. This is known as “HER2 positivity” and affects approximately 15-20 percent of women with breast cancer4. HER2-positive cancer is a particularly aggressive form of breast cancer5.

 References

1. De Cock, E. Manual injection of subcutaneous trastuzumab vs intravenous infusion for HER2-positive early breast cancer: A time-and-motion study. European Cancer Congress, abstract #P128.
2. Fallowfield, L. Reasons for patients’ preferences for subcutaneous or intravenous trastuzumab in the PrefHer study. European Cancer Congress, abstract #P719.
3. Ferlay J, Shin HR, Bray F, Forman D, Mathers C and Parkin DM GLOBOCAN 2008, Cancer Incidence and Mortality Worldwide: IARC Cancer Base No. 10 [Internet]. Lyon, France: International Agency for Research on Cancer; 2010. Available from: http://globocan.iarc.fr.
4. Wolff A.C et al. American Society of Clinical Oncology/ College of American Pathologists Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer. Arch Pathol Lab Med—Vol 131, January 2007.
5. Slamon D et al. Adjuvant Trastuzumab in HER2-Positive Breast Cancer. N Engl J Med 2011; 365:1273-83.