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Briefing note: trabectedin (Yondelis)

trabectedin (Yondelis®)

SMC did not accept trabectedin in combination with pegylated liposomal doxorubicin (PLD) for the treatment of patients with relapsed platinum-sensitive ovarian cancer.

  • In the UK, ovarian cancer is the fourth most common cancer in women. It is more common in women of menopausal age but may affect young women.   
  • Ovarian cancer is usually treated with a combination of surgery and chemotherapy. Ovarian cancer that responds to chemotherapy with a platinum-containing drug is called platinum sensitive. Trabectedin is a new anticancer drug that works by damaging the genetic material of the cancer cells and stopping them from multiplying. It is given every three weeks as a 3 hour infusion after PLD. In addition, patients should receive corticosteroids to prevent vomiting and to protect the liver. Additional anti sickness medicines may be given as needed.
  • The manufacturer asked SMC to consider trabectedin in patients with partially platinum-sensitive disease (ie platinum-free interval of 6–12 months) as an alternative to PLD monotherapy.
  • A study showed that trabectedin in combination with PLD prolonged progression-free survival in patients with partially platinum-sensitive ovarian cancer by 1.7 months compared with PLD monotherapy. An analysis showed that treatment with trabectedin and PLD significantly improved overall survival in the target population by almost 6 months compared with PLD monotherapy.
  • Side effects of the digestive system were common in both treatment groups, with nausea and vomiting more commonly reported by the trabectedin/PLD group. Other side effects experienced by patients treated with trabectedin and PLD include blood abnormalities (that is, levels of red and white blood cells below the normal levels) and increases in blood alkaline phosphatases (which suggests increased activity of bone cells or bone disorders) and liver enzymes. There was a high number of cases of heart failure reported in the combination treatment group.
  • SMC did not accept trabectedin for use in NHSScotland because of weaknesses in the economic model submitted by the manufacturer together with the high cost of the treatment meant it was not considered to be value for money.