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A phase I study of nimotuzumab plus docetaxel in chemotherapy-refractory/resistant patients with advanced non-small-cell lung cancer

  
@article{CJCR9301,
	author = {Jun Zhao and Minglei Zhuo and Zhijie Wang and Jianchun Duan and Yuyan Wang and Shuhang Wang and Tongtong An and Meina Wu and Jie Wang},
	title = {A phase I study of nimotuzumab plus docetaxel in chemotherapy-refractory/resistant patients with advanced non-small-cell lung cancer},
	journal = {Chinese Journal of Cancer Research},
	volume = {28},
	number = {1},
	year = {2016},
	keywords = {},
	abstract = {Background:  To determine the safety and therapeutic efficacy of nimotuzumab (h-R3) combined with docetaxel in advanced non-small-cell lung cancer (NSCLC) patients who have failed to respond to prior first-line chemotherapy.
Methods:  In this single-center, open-label, dose-escalating phase I trial, patients with epidermal growth factor receptor (EGFR)-expressing stage IV NSCLC were treated with nimotuzumab plus docetaxel according to a dose escalation schedule. The safety and efficacy of the combination treatment were observed and analyzed.
Results:  There were 12 patients with EGFR-expressing stage IV NSCLC enrolled. The dose of nimotuzumab was escalated from 200 to 600  mg/week. The  longest administration of  study drug  was 40 weeks at the 600 mg/week dose level. Grade III–IV toxicities included neutropenia and fatigue, and other toxicities included rash. Dose-limiting toxicity occurred with Grade 3 fatigue at the 200 mg dose level of nimotuzumab and Grade 4 neutropenia with pneumonia at the 600 mg dose level of nimotuzumab. No objective responses were observed, and stable disease was observed in eight patients (66.7%). The median progression-free survival (PFS) was 4.4 months in all patients, 1.3 months in patients with the EGFR mutation, and 4.4 months in those with wild type EGFR (EGFR WT). The median survival time (MST) was
21.1 months in all patients, 21.1 months in patients with EGFR mutation, and 26.4 months in patients with EGFR WT.
Conclusions:  Nimotuzumab and  docetaxel combination therapy was  found to  be  well tolerated   and
efficacious. Further study of nimotuzumab is warranted in advanced NSCLC patients.},
	issn = {1993-0631},	url = {http://cjcr.amegroups.com/article/view/9301}
}