December 8, 2017

SOLD trial confirms 12 months of Herceptin* (trastuzumab) is standard of care

The SOLD1 (The Synergism Or Long Duration) study was sponsored by the Finnish Breast Cancer Group and PHARMAC in New Zealand.

Results showed, at 5 years, patients with breast cancer were more likely to have their cancer return or die if their Herceptin was stopped at 9 weeks compared to a full 12 months.*

The authors concluded on stage at SABCS that "Chemotherapy plus 1-year of anti-HER2 therapy should remain the standard".

The study looked at whether patients get the same benefit from using Herceptin for 9 weeks as they do for 12 months, when used with chemotherapy in early HER2-positive breast cancer. The results of the study were presented today at the San Antonio Breast Cancer Symposium (SABCS).

Herceptin® (trastuzumab) is a treatment for the 20-25% of breast cancer patients whose tumours have too much HER2-protein, which makes their disease more aggressive.

The current global standard of care for early HER2-positive breast cancer is 12 months of Herceptin. This practice is supported by the results of four large trials in more than 10,000 women which showed that 12 months of Herceptin significantly reduced the recurrence of breast cancer, compared to women who received chemotherapy alone.

The SOLD study involving 2,100 women with early HER2-positive breast cancer did not meet its primary end point of showing non-inferiority. Women receiving 9 weeks of Herceptin were at an increased risk of disease recurrence than patients who received Herceptin for 12 months.

Other studies evaluating shorter durations of Herceptin, such as PHARE (6 vs. 12 months) and Short-HER (9 weeks vs. 12 months) have also failed to show non-inferiority to 12 months of Herceptin.

In NZ, Herceptin is registered by Medsafe as a 12-month treatment for patients with early HER2-positive breast cancer and this has been available and funded by the government since 2008.

Roche NZ continues to support the research and development of innovative breast cancer treatments to improve outcomes for women.

Breast cancer is the most common cancer in women and leads to more than 600 deaths every year in NZ.

* (n=140 for 9 weeks vs. n=105 for 1 year).

Reference

1. A randomized phase III study of adjuvant trastuzumab for a duration of 9 weeks versus 1 year, combined with adjuvant taxane-anthracycline chemotherapy, for early HER2-positive breast cancer (the SOLD study). Joensuu H et al. Abstract GS3-04. San Antonio Breast Symposium 5 – 9 Dec 2017.

For further information about Roche breast cancer treatments please view:

http://cancerinfo.co.nz/cancer-type/breast-cancer

About Roche

F. Hoffmann-La Roche & Co. was founded in 1896 in Basel, Switzerland and is the parent company of Roche Products (NZ) Ltd (Roche) which started operating in NZ in 1973. The current Roche team of more than 30 dedicated employees has the primary goal of facilitating New Zealanders' access to innovative medicines. Roche is a leading developer of cancer medicines.

Media contact: Brenda Saunders, Trio Communications. Ph:021 777 171.

Herceptin Breast Cancer Consumer Panel
Herceptin® (trastuzumab), 150mg and 440mg vials, is a Prescription Medicine used to treat patients with early breast cancer and metastatic (spreading) breast cancer who have tumours with a large amount of the HER2 protein. Do not use Herceptin if: you have early breast cancer and have had an LVEF test (measures how well your heart can pump blood) of less than 45% or you have symptoms of heart failure; you have had an allergic reaction to trastuzumab or any of the ingredients, benzyl alcohol, or to any medicines that are made using Chinese hamster ovary cells. Tell your doctor if: you have a history of coronary artery disease, high blood pressure, heart failure, arrhythmia (an abnormal or rapid heartbeat), angina (feeling pain, tightness, heaviness or pressure in the chest), or any other type of heart disease; you are currently taking any other medicines, including medicines for cancer, or if you have previously received chemotherapy treatment with medicines known as anthracyclines; you have breathing or lung problems; you are pregnant or breast-feeding, or plan to become pregnant or breastfeed. Tell your doctor immediately or go to your nearest Accident and Emergency Centre if you notice any of the following: swelling of your lips, face, tongue or throat with difficulty breathing; severe shortness of breath, difficulty breathing or wheezing; severe chest pain spreading out to the arms, neck, shoulder and/or back; rash, itching or hives on the skin; fever or chills; abnormal or irregular heartbeat; severe swelling of the hands, feet or legs; severe coughing. Possible common side effects may also include: getting tired more easily after light physical activity; shortness of breath, especially when lying down or if it disturbs your sleep; runny or blocked nose or nosebleeds; difficulty sleeping, anxiety or depression; weakness or soreness in muscles and/or joints; increased cough; feeling dizzy, tired, looking pale; flu and/or cold symptoms; frequent infections with fever, severe chills, sore throat or mouth ulcers; hot flushes; diarrhoea; changes in weight; redness, dryness or peeling of the hands or feet; unusual hair loss or thinning; nail problems; eye problems such as producing more tears, swollen runny eyes or conjunctivitis (eye infection). Herceptin has risks and benefits. Ask your Oncologist if Herceptin is right for you. Use strictly as directed. If symptoms continue or you have side effects, see your healthcare professional. For further information on Herceptin, please talk to your healthcare professional or visit www.medsafe.govt.nz for Herceptin Consumer Medicine Information.

Herceptin is a funded medicine for patients with HER2-positive breast cancer who meet predefined criteria. A prescription charge and normal Doctor's fees may apply.

Consumer panel dated 01 September 2015 based on CMI dated 12 May 2015. Roche Products (New Zealand) Limited, Auckland. Phone: 0800 656 464. www.roche.co.nz. All trademarks mentioned herein are protected by law.