Roche NZ welcomes Herceptin duration trial results

Roche NZ welcomes Herceptin® duration trial results.

One year Herceptin treatment confirmed as standard of care in early-stage HER2 positive breast cancer.

Roche Products (New Zealand) Limited welcomes the results of two studies, PHARE and HERA, which explore different treatment durations of Herceptin when used together with chemotherapy in early-stage HER2-positive breast cancer. [1,2] The studies were presented yesterday at the European Society of Medical Oncology (ESMO) conference in Vienna. Both studies attempt to identify whether different Herceptin treatment lengths have comparable efficacy and safety compared to the current one year standard of care.

First approved for use in 1998, Herceptin (trastuzumab) is a monoclonal antibody treatment for the 20-25% of breast cancer patients whose tumours over express the HER2-protein, which makes their disease more aggressive.

A French study, PHARE (Protocol of Herceptin Adjuvant with Reduced Exposure), looked at whether patients get the same benefit from using Herceptin for six months as they do for one year. The study involving nearly 3,400 women did not meet its primary end point of showing non-inferiority, and women receiving six months of Herceptin had a 28% higher risk of dying or their cancer returning compared to those women receiving one year of Herceptin.

Final results from the HERA (HERceptin Adjuvant) study were also presented, and confirmed that one year of Herceptin remains the standard of care. The study involved 5,100 women and showed that there was no difference in the time women lived without their disease returning if they received Herceptin for two years versus one year. After a median follow-up of eight years, the benefits of Herceptin treatment for one year remained statistically significant compared to women who did not receive Herceptin. There were no new long-term safety findings in the study.

Neither of these studies considered a nine week treatment option for Herceptin.

“Treating cancer needs to be based on an awareness of all the scientific data, and we welcome these results,” says Stuart Knight, General Manager, Roche Products New Zealand. “The HERA results, together with those from the PHARE study and other Herceptin studies involving more than 13,000 women overall, give us both the evidence and reassurance that patients with early-stage HER2-positive breast cancer should receive Herceptin for one year.”

The New Zealand Breast Cancer guidelines currently recommend one year of Herceptin combined with chemotherapy as the evidence-based standard of care, and this has been available and funded by the Government since 2008.

References:

1. Pivot X et al. PHARE Trial results comparing 6 to 12 months of trastuzumab in adjuvant early breast cancer. Presidential Symposium II, European Society of Medical Oncology, Vienna 2012. LBA5.

2. Gelber RD et al. HERA TRIAL: 2 years versus 1 year of trastuzumab after adjuvant chemotherapy in women with HER2-positive early breast cancer at 8 years of median follow up. Presidential Symposium II, European Society of Medical Oncology, Vienna 2012. LBA6.

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.

Tell your doctor if you have a history of coronary artery disease, high blood pressure, heart failure, arrhythmia (an abnormal or rapid heart-beat), angina (feeling pain, tightness, heaviness or pressure in the chest), or any other type of heart disease; lung tumours or disease; if you are taking are currently taking any other medicines for cancer, or if you have previously received treatment for cancer with medicines such as anthracyclines or cyclophosphamide; or if you are pregnant or breast-feeding, or plan to become pregnant or breast-feed.

Herceptin should not be used if you have had an allergic reaction to Herceptin, any of its ingredients, or to any medicines that are made using Chinese hamster ovary cells.

Possible unwanted effects: Common: infusion reactions such as chills, shivering, fever, nausea, vomiting, pain or discomfort (e.g. in the stomach, back, chest or neck), stiffness or shaking, weakness and soreness in muscles or joints, headache, dizziness, shortness of breath, cough, hives, skin rashes or itchy skin, weakness or fatigue, abnormal or fast heart-beat, or feeling faint. After an infusion: any of the side effects above, swelling of the feet or legs, difficulty sleeping or feeling anxious or depressed, worsening cough, runny, blocked or bleeding nose, cold- or flu-like symptoms, chest infection, pain when urinating or needing to urinate more often, diarrhoea, weight loss, hair loss, nail problems, sweating, sore throat, acne, bone pain, loss of appetite, changes in your sense of taste, constipation, indigestion, tingling, numbness, redness, drying or peeling of the hands or feet, mouth ulcers or cold sores, discharging or itchy eyes. Serious: high temperature or fever, shortness of breath or having difficulty breathing, wheezing, a sore throat with chills and fever that does not get better, sudden signs of allergy, severe coughing, chest pain spreading to the arms, neck, shoulder and/or back, abnormal or fast heart-beat, severe diarrhoea or vomiting, feeling faint, severe skin infections.

Ask your Oncologist if Herceptin is right for you. Use strictly as directed. If symptoms continue or if you experience side effects or would like more information, please talk to your Oncologist or visit www.medsafe.govt.nz for the full Herceptin Consumer Medicine Information.

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

Consumer panel dated 23 August 2011 based on CMI dated 24 September 2010.

Roche Products (New Zealand) Limited, Auckland. Phone: 0800 656 464. www.roche.co.nz.

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ENDS

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