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Briefing Note - pegylated liposomal doxorubicin in combination with boretezomib (Caelyx plus Velcade)

SMC has not accepted pegylated liposomal doxorubicin in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.

  • Multiple myeloma is a rare cancer of a type of white blood cell called plasma cell. Patients with multiple myeloma have abnormally high levels of cancerous plasma cells, which can clump together to form tumours in the bone marrow (the organ that produces blood cells). These cells can affect the body’s ability to produce new blood cells, and produce high levels of abnormal antibodies (a type of protein) that cannot fight infection properly and directly affect the bone. Patients with multiple myeloma experience bone pain, can develop fractures, suffer from tiredness due to low iron levels in the blood and have repeated infections.
  • Multiple myeloma is mainly treated with drugs and radiation. Some people may benefit from a bone marrow transplant (a treatment to restore normal blood cell production). Liposomal doxorubicin is a drug which is given as a drip. It interacts with cells in such a way as to selectively kill cancer cells. The doxorubicin is enclosed in tiny spheres called pegylated liposomes which help to deliver the medicine from the bloodstream to the cancerous tissue rather than healthy normal tissue. The drug bortezomib can improve the activity of doxorubicine.
  • An interim analysis showed that treatment with pegylated liposomal doxorubicin and bortezomib significantly slowed down progression of disease compared with treatment with bortezomib alone by almost 3 months. Fewer patients in the combination treatment group experienced disease progression or died compared with those in the monotherapy group.
  • No new safety concerns have been identified with pegylated liposomal doxorubicin and bortezomib, although neutropenia (low number of a type of white blood cell called neutrophil) and stomatitis (inflammation of the mucous lining of the mouth) were more commonly experienced in the combination group and hand-foot syndrome (side effect of chemotherapy causing redness, swelling and pain of the palms and/or soles) only occurred in this treatment group.
  • SMC did not accept pegylated liposomal doxorubicin because there were a number of weaknesses in the economic case that the manufacturer provided, so the value for money of the treatment was not demonstrated.