Die Amerikaanse voedsel- en dwelmadministrasie (hierna verwys as FDA) het Portrazza (necitumumab) in kombinasie met gemcitabien en cisplatien goedgekeur in die behandeling van gevorderde (metastatiese) plaveiselagtige nie-kleinselle longkanker op 24 November 2015, en word die eerste Goedgekeur vir eerste-lyn behandeling van pasiënte met gevorderde plaveiselagtige nie-kleinselle longkanker.
Lung cancer is currently the malignant tumor with the highest morbidity and mortality, with more than 1 million deaths due to lung cancer worldwide each year. According to clinical and histopathological characteristics, lung cancer can be roughly divided into two types: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), of which non-small cell lung cancer accounts for about 85% of all lung cancers. Nie-kleinselle longkanker can be further divided into squamous and non-squamous non-small cell lung cancer, which includes lung adenocarcinoma. Squamous non-small cell Long kanker accounts for about 30% of all lung cancers. The prognosis of patients is poor, and the 5-year survival rate is less than 5%. The research and treatment of squamous NSCLC lags far behind lung adenokarsinoom. One of the important reasons is that there are too few driving gene markers known to help make clinical treatment decisions. The targeted treatment of lung squamous cell carcinoma faces difficulties and challenges . Because of the greater risk of pulmonary hemorrhage, bevacizumab is not recommended for lung squamous cell carcinoma. Due to economic utility considerations, cetuximab is also limited. As of now, its first-line treatment still has huge medical needs.
At present, the first-line treatment plan for the treatment of squamous non-small cell lung cancer at home and abroad is platinum-containing two-drug chemotherapy (studies have confirmed that cisplatin combined with gemcitabine is more effective), and the second-line treatment abroad is docetaxel or docetaxel combined with a new target Xiang, immunotherapy drugs nivolumab and ramucirumab. Among them, nivolumab is the immunotherapie drug OPDIVO (PD-1 inhibitor), and ramucirumab is an anti-vascular endothelial growth factor (VEGF) inhibitor. These targeted drugs are not listed in the country. This time, Portrazza was approved for use in combination with gemcitabine and cisplatin, becoming the first targeted drug approved for first-line treatment of patients with advanced squamous non-small cell lung cancer.
Necitumumab (trade name: Portrazza) is a human recombinant IgG1 monoclonal antibody of EGFR. EGFR (epidermal growth factor receptor) is a multifunctional glycoprotein widely distributed on the cell membrane of various tissues of the human body. It is a tyrosine kinase Type receptor is one of the four members of the HER / ErbB family, and its mutation or overexpression is associated with malignant phenotypes such as malignant proliferation, inhibition of apoptosis, local infiltration, vascularization, and tumor metastasis of tumor cells.
Necitumumab se veiligheid en doeltreffendheid studie is gesien in 'n eerste-lyn multi-sentrum, gerandomiseerde, oop fase III kliniese proef SQUIRE, wat 1,093 XNUMX pasiënte met gevorderde plaveiselagtige nie-kleinselle longkanker ingesluit. Die pasiënte is ewekansig in twee groepe verdeel en het Gemcitabine + cisplatin + Necitumumab (GP-regime gekombineer met Necitumumab) en gemcitabine + cisplatin-terapie alleen ontvang (GP-regime alleen).
Die resultate dui daarop dat GP gekombineer met necitumumab-behandelingsgroep algehele oorlewing aansienlik verbeter het (HR 0.84; 95% CI: 0.74-0.96; p = 0.01) in vergelyking met GP chemoterapie alleen groep, en die mediaan oorlewingstyd van pasiënte is 11.5 maande (95) % CI: 10.4-12.6), en die oorlewingstyd van die gemcitabine + cisplatin twee-middel groep was 9.9 maande (95% CI: 8.9-11.1), en die risiko van dood is verminder met 16% in die drie-geneesmiddel kombinasie groep, en die mediaan van die twee groepe het nie gevorder nie. Die oorlewingsperiodes was 5.7 vs 5.5 maande. Necitumumab is egter nie effektief vir die behandeling van pasiënte met nie-plaveiselagtige nie-kleinselle longkanker.
Die mees algemene newe-effekte van Necitumumab sluit uitslag en hipomagnesemie in, wat weer spierswakheid, epilepsie, onreëlmatige hartklop, ens veroorsaak. Skielike hartstilstand en skielike dood kan ook voorkom, dus moet die voorskrywende dokter spesiale aandag gee.
Dr. Richard Pazdur, hoof van die departement van hematologie en onkologieprodukte by die FDA se sentrum vir geneesmiddelevaluering en -navorsing, het gesê: “Die tipes longkanker verskil baie, so die keuse van behandeling hang af van die tipe pasiënt. Portrazza wat vandag goedgekeur is, is long-plaveiselkarsinoom 'n Nuwe opsie vir pasiënte om oorlewing te verleng. “
Necitumumab (handelsnaam: Portrazza) word bemark deur Eli Lilly and Company van die Verenigde State. Die nivolumab (handelsnaam: OPDIVO, goedgekeur vir die behandeling van plaveiselagtige nie-kleinselle longkanker op 22 Junie 2015) wat in die artikel genoem word, behoort aan Bristol-Myers Squibb, ramucirumab (Handelsnaam: Cyramza, goedgekeur vir die behandeling van plaveisel) nie-kleinselle longkanker op 21 April 2014) Dit is ook 'n produk van Eli Lilly van die Verenigde State. Hierdie drie middels is nie in die land gelys nie.
