Continuing or starting with pertuzumab alongside trastuzumab and chemotherapy after surgery for women with HER2 positive cancer may not extend their life and is not cost effective, the draft guidance says.
NICE already recommends pertuzumab (also called Perjeta and made by Roche), given with trastuzumab and chemotherapy, for treating early HER2-positive breast cancer before surgery. NICE also recommends it for treating HER2-positive breast cancer that has either recurred in the breast following initial treatment or has spread from the breast to elsewhere in the body.
NICE has now published draft guidance which does not recommend pertuzumab for women with HER2 positive early breast cancer who have a high risk of the disease recurring.
The committee concluded that current research showed only a small difference in the proportion of people who remained free from invasive disease, and this effect was itself uncertain.
In addition there is a lack of evidence on by how much, if at all, adding pertuzumab might increase overall survival.
Meindert Boysen, director of the centre for technology evaluation at NICE, said: “It’s estimated that for around 1 in 4 people with early breast cancer their cancer will return despite being treated with surgery, chemotherapy and adjuvant trastuzumab. There is clearly a need for effective treatments that can prevent people developing incurable, late-stage breast cancer.
“There was a great deal of uncertainty in the available evidence of clinical effectiveness compared to existing treatments which led the committee to conclude that pertuzumab as adjuvant treatment may not result in meaningful additional benefits for patients.
”We’re therefore not currently able to recommend pertuzumab as a clinically and cost effective option for people who have a higher risk of their cancer returning. We would welcome further discussions with the company about what steps can be taken to address the concerns raised by the committee.”
Approximately 14% of people diagnosed with early breast cancer have HER2-positive disease, meaning that around 7,900 patients in the UK are diagnosed with this type of breast cancer each year.
The NICE appraisal focuses on people who have had surgery and whose cancer has already spread to their lymph nodes (node-positive disease) or people who can’t have treatment with hormonal therapy (hormone-receptor negative disease). The estimated 5000 people in these 2 subgroups have a higher risk of their cancer returning. The company argued that these patients would be more likely to benefit from adding pertuzumab to existing treatments.
Consultees, including the company, healthcare professionals and members of the public are able to comment on the draft recommendations via the NICE website until 6 July. All comments received during this consultation will be considered by the committee at its meeting in July. Final guidance is expected to be published in October.