Summary Purpose: The purpose of this study was to evaluate the short- and long-term efficacy and toxicity of the human ized anti-epidermal growth factor receptor (EGFR) monoclonal antibody h-R3 when combined with radiotherapy for the treatment of locally advanced nasopharyngeal carcinoma (NPC).. Methods: 35 patients with stage III-IVb NPC with moderate- or strong-intensity EGFR expression were randomly divided into either a radiotherapy alone group or a group receiving radiotherapy combined with h-R3. Results: The complete remission (CR) rates of the combination group at three time points were significantly high er (p<0.05) than those of the radiotherapy alone group. Overall survival, 3-year local control rate, and no distant metastasis rate did not differ between the two groups. No severe toxicity was noticed. Conclusion: h-R3 is an agent with good safety profile which could help enhance the radiation antitumor effect in locally advanced NPC, but it did not seem to exhibit significant long-term efficacy.

Phase II clinical trial of h-R3 combined with radiotherapy in locally advanced nasopharyngeal carcinoma.

Background and objective Nimotuzumab is a humanized IgG1 type monoclonal antibody targeting epidermal growth factor receptor, and can enhance chemosensitivity and radiosensitivity of certain cancers. The aim of this study is to investigate the effects of nimotuzumab on the chemosensitivities of PC9 human lung adenocarcinoma cells to common chemtherapeutic drugs including ciaplatin, gemcitabine, paclitaxel, pemetrexed and vinorelbine, and to elucidate possible mechanisms. Methods PC9 human lung adenocarcinoma cell line was used in the study. Cell proliferation was determined by WST-1 assay and cell apoptosis was detected by TUNEL assay. Cell cycle distribution was analyzed by DNA analysis with FACS. Tublin and microfilaments were observed by immunofluorescence staining. Results Nimotuzumab significantly enhanced the chemosensitivity of PC9 cells to paclitaxel. Cell proliferation was inhibited significantly (P<0.05) and cell apoptosis rate was higher in nimotuzumab combined with low dose paclitaxel (0.05 μg/mL) group (P=0.013). G2/M arrest was increased significantly by nimotuzumab combined with paclitaxel group (P<0.05). Nimotuzumab caused aggregation of tublin and microfilaments into well organized microtubules. Conclusion Nimotuzumab enhanced the chemosensitivity of PC9 cell to paclitaxel by enhancing G2/M arrest and aggregation of tublin and microfilaments. Therefore, Nimotuzumab combined with taxane drugs could be a potential effective regimen in non-small cell lung cancer.
	
	DOI: 10.3779/j.issn.1009-3419.2015.02.09

Nimotuzumab significantly enhances chemosensitivity of PC9 human lung adenocarcinoma cells to paclitaxel in vitro

目的:研究尼妥珠单抗靶向治疗联合常规化疗方案治疗晚期非小细胞肺癌的临床疗效.方法:70例非小细胞肺癌患者随机分为靶向组和常规组,各35例,评估两组患者治疗2、4个周期后的疗效,采集肿瘤组织并检测PI3K/AKT通路、MAPK/ERK通路、JAK2/STAT3通路的激活情况.结果:(1)近期疗效:化疗后2、4个周期时,靶向组患者的CR、PR、SD例数显著多于常规组(P＜0.05);PD例数显著少于常规组(P＜0.05);(2)信号通路分子的表达量:靶向组患者肿瘤组织中PI3K、AKT、MAPK、ERK1、ERK2、JAK2、STAT3的表达量均显著低于常规组(P＜0.05);(3)信号通路下游分子的表达量:靶向组患者肿瘤组织中FasL、Bim的表达量显著高于常规组(P＜0.05),Bcl 2、Survivin、VEGF、HIF-1α、EPO的表达量显著低于常规组(P＜0.05).结论:尼妥珠单抗靶向治疗联合常规化疗方案能够取得更为确切的近期疗效,抑制PI3K/AKT通路、MAPK/ERK通路、JAK2/STAT3通路的激活情况,是治疗晚期非小细胞肺癌更为理想的方案.

Effects of Nimotuzumab Targeted Therapy Combined with Conventional Chemotherapy on Advanced Non-Small Cell Lung Cancer

Overexpression of epidermal growth factor receptor (EGFR) is common in non-small-cell lung cancer (NSCLC) and has been recently shown to contribute to cancer chemoresistance. It has been reported that the EGFR antibodies such as cetuximab in combination with chemotherapy could lead to an absolute benefit of overall survival (OS) compared with chemotherapy alone. In this study, we investigated the effects of nimotuzumab (h-R3), a humanized anti-EGFR antibody, in combination with docetaxel (DTX), on DTX-resistant human lung adenocarcinoma cell line SPC-A1 (SPC-A1/DTX) both in vitro and in vivo. Immunohistochemistry and FCM assays demonstrated that SPC-A1/DTX cells had a relatively higher rate of EGFR overexpression than SPC-A1 cells. Accordingly, SPC-A1/DTX cells were approximately 13.7 times resistant to DTX than SPC-A1 cells. The combined therapy of h-R3 and DTX showed strong synergistic suppressive effect on cell proliferation of SPC-A1/DTX cells in vitro. The synergistic antitumor effect was also observed in SPC-A1/DTX xenograft-bearing nude mice. Further study showed that h-R3 could lead to a significant cell arrest at G1 phase of cell cycle in both SPC-A1DTX and SPC-A1 cells. A dramatic increase of apoptosis rate was detected in h-R3-treated SPC-A1/DTX but not SPC-A1 cells. Moreover, when combined with DTX, h-R3 brought higher apoptosis rate in SPC-A1/DTX cells rather than in SPC-A1 cells. In conclusion, our results suggested that h-R3 could significantly enhance chemosensitivity of human lung adenocarcinoma cells to DTX, at least partially by induction of G1 phase arrest and cell apoptosis.

Nimotuzumab increases chemosensitivity of human lung adenocarcinoma cell lines to docetaxel.

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Nimotuzumab increases chemosensitivity of human lung adenocarcinoma cell lines to docetaxel.