Clinical Observation Of Nimotuzumab Combined With Chemotherapy As Second-or Later-line Treatment For Advanced Non-small Cell Lung Cancer

Objective: Nimotuzumab is a kind of humanized monoclonal antibody. It can be competitive inhibition of endogenous ligands to the epidermal growth factor receptor(EGFR), blocking EGFR downstream signaling pathways mediated and cytological effect, and inhibiting tumor cell proliferation, promote apoptosis of tumor cells. The aim of this study was to observe the efficacy and safety of Nimotuzumab combined with chemotherapy as second- or later-line treatment for advanced non-small cell lung cancer and related factors which may affect the curative effect.Methods: Clinical data of 29 patients with advanced non-small cell lung cancer from March 2009 to June 2014 in internal tumor department of tumor hospital of Liaoning province were collected as research subjects. All patients were confirmed by pathology or histology, and received nimotuzumab combined with chemotherapy as second- or later-line treatment. All patients had never used nimotuzumab before the treatment. Chemotherapy was selected according to the actual situation of patient. The dose of nimotuzumab was 400 mg once a week. All selected chemotherapy regimens are repeated per 3 weeks as a cycle. Curative effects were evaluated after every 2 cycles. The treatment didn’t stop until disease progression or un-tolerable adverse reaction. The efficacy of therapy was evaluated according to RECIST 1.1, and toxicity and side effects by NCI-CTC 4.0. The data were analyzed separately according to gender, age, pathological type, ECOG score, degree of differentiation subgroup, etc. The problem of statistic may use SPSS20.0 statistics software. The analysis of efficacy of therapy may use the Fisher exacted testing, and apply Kaplan-Meier to evaluate survival time, the log-rank test to test survival curves, with P < 0.05 for the difference was statistically significant.Results: Efficacy and side effect were evaluated in all 29 patients. 12 patients received second-line treatment, and the else 17 patients received later-line treatment. According to RECIST1.1, the results were as follows. None with complete remission, 5 cases were partial remission(17.2%), 12 cases were stable disease(41.4%), 12 cases were progression disease(41.4%). The objective response rate(ORR) was 17.2% and the disease control rate(DCR) was 58.6%, The median progression-free survival time(mPFS) was 3.6 months and the median overall survival(mOS) was 10.5 months. Of the 12 patients who received second-line regimen, 3 cases were partial remission, 5 cases were stable disease, and 4 cases were progression disease, ORR 33.3%,DCR 66.7%,mPFS was 3.6 months,mOS was 11.9 months;and of the patients in later-line regimen was used in 17 cases, 2 cases were partial remission, 7 cases were stable disease, and 8 cases were progression disease, ORR 11.8 %,DCR 52.9%,mPFS was 3.3 months,mOS was 9.9 months. But by the statistical tests, there was no statistically significant difference of the curative effect between the two groups above. In addition, in 9 patients complicated with brain metastasis, 8 cases received whole brain radiotherapy before combine treatment. In these cases,2 cases were partial remission, 4 cases were stable disease, 2 cases were progression disease, the effective rate was 25.0%, the local control ratio was 75.0%. The effect of the changes of brain lesions were consistent with the overall effect. Safety data analysis shows that the main side effects comprise bone marrow suppression, gastrointestinal reactions and liver function damage, mostly class I to II. These side effects improved after symptomatic treatment. There had not occurred serious adverse events such as heart failure, shock, etc. And clinical treatment related deaths did not occurred in the treatment.Conclusions: The combination of nimotuzumab and chemotherapy as the second-or later-line treatment of NSCLC has good curative effect, especially to those who have suffer brain metastasis. In the safe dose range, increase the dosage may increase the rate of ORR, and did not increase the risk of related adverse reactions. In the treatment of patients with brain metastases from non-small cell lung cancer, Nimotuzumab combined with chemotherapy may be superior to chemotherapy alone after whole brain radiotherapy. Nimotuzumab was well tolerated in the increase of it to chemotherapy.