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Patients in Scotland with an advanced and incurable form of gastric cancer (stomach and gastro-oesophageal) could benefit from the life-extending treatment Herceptin, which has been given the green light by the Scottish Medicines Consortium (SMC) for routine use on the NHS. Herceptin has been recommended for use in combination with chemotherapy (capecitabine or 5-fluorouracil and cisplatin) for previously untreated patients with HER2-positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction. It was approved under the SMC’s new Patient and Clinician Engagement (PACE) process – with access now in line with England and Wales.
Kate Cunningham, Campaign Director at the charity OCHRE, said: “The approval of Herceptin by the SMC today is extremely positive news for Scottish patients with this rare and incurable type of gastric cancer. The prognosis has been typically poor and patients are often given only a year to live from diagnosis. We’ve seen only marginal medical progress in this area for two decades and as such, there has been high unmet need for new treatment options. When medicines show they can prolong survival, it is vital that patients can immediately benefit from them.”
Data from the landmark study of the drug (ToGA) showed that the Herceptin combination prolongs the lives of certain patients by nearly half a year (5.6 months) in the pre-planned analysis – representing a 45.2% increase in median life-expectancy, compared with the current standard of care, chemotherapy alone (median overall survival: 18.0 months versus 12.4 months (IHC3+ subgroup HR 0.57; 95% CI 0.41-0.79).
Professor Russell Petty, Professor of Medical Oncology at the University of Dundee and Consultant Medial Oncologist at NHS Tayside and a lead researcher in gastric cancer said: “This approval has been much anticipated for patients and clinicians in Scotland. The Herceptin combination has been shown to extend survival and control cancer for significantly longer than the current standard of care – showing a magnitude of benefit never seen before, it is a genuine breakthrough in the treatment of gastric cancer. It is also encouraging to see that the PACE process has allowed Scottish patients to access this treatment, in line with the rest of the UK. This approval marks a much needed significant step forward in the treatment of this form of cancer in Scotland.”
Herceptin is a humanised, targeted antibody – designed to hunt out HER2 (a protein receptor found on the surface of cells, which turns cancerous when over-produced) and block the ‘survive and multiply’ signals it sends directly into the cell. The mode of action of Herceptin activates the body’s immune system and suppresses HER2 to target and destroy the tumour.
Herceptin has been shown to have a manageable tolerability profile when used in combination with chemotherapy. The most common side effects identified in the ToGA study were consistent with the established safety profiles of Herceptin and chemotherapy. Rates of overall grade 3 or 4 side effects and cardiac adverse events did not differ between groups.