Safety and radiation-enhancing effect of sodium glycididazole in locoregionally advanced laryngeal cancers previously treated with platinum-containing chemotherapy regimens: A preliminary report.
OBJECTIVE
To determine the safety and radiation-enhancing effect of sodium glycididazole in laryngeal squamous cell carcinoma (stage T3-4,N0-3,M0) with conventional radiotherapy.


METHODS
Patients with locoregional advanced laryngeal cancer (stage T3-4,N0-3,M0) were included: group 1(control, n=30)were not administered of sodium glycididazole; group 2 (test, n=30) received sodium glycididazole at a dose of 700 mg/m(2) intravenous infusion 30 minutes before radiotherapy three times a week. Surrogate end-points of efficacy were tumor and nodal size. Safety parameters were vomiting, nausea, mucositis, laryngeal edema, esophagus and skin reaction, dysphagia, dyspnea, neurological deficit. Patients were evaluated weekly during treatment for 7 weeks and thereafter monthly for 3 months.


RESULTS
In the test, the overall response rate was 88.89% (95%CI, 71.00-97.00%) at 7 weeks and 92.59% (95%CI, 76.00 to 99.00%) at 1 month of follow-up. In the control, the overall response rate was 62.5% (95%CI, 41.00 to 81.00%) at 7 weeks and 58.33% (95%CI, 37.00 to 78.00%) at 1 month of follow-up. The short-term locoregional response rate was better in the test group at 7 weeks (p=0.027) and at 1 month (p=0.005) of follow-up. The test group had significantly more nausea and vomiting in weeks 1 (p=0.047), 2 (p=0.007), and 3 (p=0.01) of treatment.


CONCLUSIONS
The study indicates sodium glycididazole is an effective radiation-enhancing agent that improves short-term locoregional control and is well tolerated in patients with locoregionally advanced laryngeal cancer.
Zeng
Y C
YC
Department of Medical Oncology, Shengjing Hospital, China Medical University, Shenyang, PR China.
Wu
R
R
Xu
Z G
ZG
Zhang
X Y
XY
Fan
G L
GL
Wu
L N
LN
Wang
Y M
YM
Hao
S H
SH
Zheng
W
W
Chen
X D
XD
Chi
F
F
Zhang
Z Y
ZY
Li
X
X
Jin
X Y
XY
Chen
W
W
Wang
S L
SL
Xiao
F D
FD
Wang
E Y
EY
Dong
X Q
XQ
Zhang
L B
LB
Jia
M X
MX
Xia
H H X
HH
Zhang
H B
HB
Li
Y
Y
D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000532:radiotherapy*; D005260:Female; D006801:Humans; D007822:Laryngeal Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D008297:Male; D008795:Metronidazole / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D011838:Radiation-Sensitizing Agents / Q000627:therapeutic use*; D014839:Vomiting / Q000139:chemically induced
D011838:Radiation-Sensitizing Agents; C466518:sodium bimetrondazole glycinate; D008795:Metronidazole