[Multicenter phase II clinical trial of uroacitides injection in the treatment for advanced malignant tumors].
OBJECTIVE
To investigate the efficacy, safety and the life quality improvement of uroacitides injection in the treatment for patients with advanced malignant tumors.


METHODS
A total of 160 patients with advanced stage cancers were enrolled into this multicenter, open and non-randomized phase II clinical trial, including cancers of the lung (33 cases), liver (45 cases), breast (17 cases), esophagus (11 cases), stomach (18 cases), colon (19 cases), pancreas (3 cases) and kidney (4 cases), and glioma (10 cases). Uroacitides was administrated in a dose of 300 ml daily via the superior vena cava catheter for consecutive 4-8 weeks.


RESULTS
Of the 160 patients, 21 dropped out and one patient died during the trial. Efficacy could be evaluated in 138 patients and safety in 160. The total objective response rate (ORR, CR + PR)) and tumor control rate (CR + PR + MR + SD) of the 138 evaluable patients were 5.8% and 65.2%, respectively. Clinical benefit response (CBR) rate was 57.2%. Major adverse effects were grade I - II and reversible nausea/vomiting (21.9%) and pain (6.3%).


CONCLUSIONS
Uroacitides injection is effective in the control for various kinds of advanced cancers with mild, reversible and tolerable adverse effects, and can also improve the patient's quality of life. It is worth being studied further.
Li
Qing
Q
Department of Medical Oncology, Cancer Hospital (Institute), Chinese Academy of Medical Sciences, Beijing 100021, China.
Feng
Feng-Yi
FY
Chen
Qiang
Q
Jiao
Shun-Chang
SC
Li
Fang
F
Wang
Hua-Qing
HQ
Huang
Wen-Xia
WX
Ling
Chang-Quan
CQ
Li
Ming-Zhong
MZ
Ren
Jun
J
Zhang
Yang
Y
Qin
Feng-Zhan
FZ
Zhou
Mei-Zhen
MZ
Zhu
Run-Zhong
RZ
D001943:Breast Neoplasms / Q000097:blood / Q000188:drug therapy / Q000473:pathology; D018395:CA-19-9 Antigen / Q000097:blood; D002272:Carcinoembryonic Antigen / Q000097:blood; D002289:Carcinoma, Non-Small-Cell Lung / Q000097:blood / Q000188:drug therapy / Q000473:pathology; D002405:Catheterization, Central Venous; D015179:Colorectal Neoplasms / Q000097:blood / Q000188:drug therapy / Q000473:pathology; D006801:Humans; D008113:Liver Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D008175:Lung Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D008780:Methyltransferases / Q000008:administration & dosage / Q000009:adverse effects / Q000037:antagonists & inhibitors / Q000627:therapeutic use*; D009325:Nausea / Q000139:chemically induced; D009367:Neoplasm Staging; D010455:Peptides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010648:Phenylacetates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D012074:Remission Induction; D016879:Salvage Therapy; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced; D000509:alpha-Fetoproteins / Q000378:metabolism
D018395:CA-19-9 Antigen; D002272:Carcinoembryonic Antigen; D010455:Peptides; D010648:Phenylacetates; D000509:alpha-Fetoproteins; C480340:cell differentiation agent II; D008780:Methyltransferases