A clinical trial on docetaxel and carboplatin therapy with or without nimotuzumab for the treatment of advanced nonsmall cell lung cancer.
BACKGROUND
To evaluate the role of nimotuzumab in combination with chemotherapy in patients with advanced nonsmall cell lung cancer (NSCLC) through progress-free survival, changes in tumor marker expression and adverse drug reactions.


METHODS
A total of 59 NSCLC patients were randomized into two groups. The treatment group (n = 30) received nimotuzumab (200 mg) with docetaxel (60 mg/m2) and carboplatin (area under curve = 5), whereas the control group (n = 29) received chemotherapy at the same dosage. All patients received two cycles of treatment lasting for 42 days. The serum tumor biomarker levels were measured on the day before treatment and at 60 days after treatment.


RESULTS
The efficacy of treatment for the treatment and control groups were 36.7% and 27.6%, respectively; this difference was not statistically significant. However, progression-free survival (PFS) was significantly prolonged by 1 month in the treatment group. Peripheral blood CYFRA21-1 decreased significantly during treatment with a more extensive decrease in the treatment group, although the difference between the groups was not statistically significant. The neuron-specific enolase levels significantly decreased across all 59 patients. The carcinoembryonic antigen levels decreased significantly in the treatment group, but remained stable in the control group throughout the treatment period. Nimotuzumab was well tolerated by patients with only three cases of Grades I and II skin rash and no other toxic symptoms.


CONCLUSIONS
Nimotuzumab with docetaxel and carboplatin can enhance the short-term clinical efficacy by extending the duration of PFS and was generally well tolerated by patients.
National Clinical Research Center of Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.
Daliang
D
Qi
Yan
Y
Cui
Qingsheng
Q
Wang
Chongbiao
C
Huang
Jie
J
Xu
Yanzhuo
Y
Yang
Liang
L
Xin
Ye
Y
Tian
Xin Angelique
XA
Qi
D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D014408:Biomarkers, Tumor; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality / Q000473:pathology*; D016022:Case-Control Studies; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality / Q000473:pathology*; D008297:Male; D009367:Neoplasm Staging; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
D061067:Antibodies, Monoclonal, Humanized; D014408:Biomarkers, Tumor; D043823:Taxoids; D000077143:Docetaxel; C501466:nimotuzumab; D016190:Carboplatin