Concurrent chemoradiotherapy with nimotuzumab and capecitabine for patients with unresectable, postoperative residual, or recurrent gastric cancer:a prospective study
Department of Radiation Oncology (Lu NN,Jin J,Ren H,Tang Y,Wang X,Li N,Feng YR,Wang SHL,网WH,Song YW,Liu YP,Fang H,Zhang JJ,Li SH,Li YX),Department of Diagnostic Radiology (Jiang LM),National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences,Peking Union Medical College,Beijing 100021,China
Abstract： Objective To investigate the adverse effects and short-term therapeutic effect of concurrent chemoradiotherapy with nimotuzumab and capecitabine for patients with unresectable, postoperative residual, or recurrent gastric cancer. Methods A prospective phase Ⅱ study was performed in patients with pathologically confirmed gastric cancer. Inclusion criteria were as follows:unresectable, postoperative residual, or recurrent gastric cancer in which lesions could be measured;lesions which could receive radiotherapy;expected survival time>3 months. All patients received intensity-modulated radiotherapy (54 Gy in 30 fractions for planned gross tumor volume, 45 Gy in 25 fractions for the prophylactic area in lymph nodes) and concurrent capecitabine (1 600 mg/m2 per day for 35 days) and nimotuzumab (200 mg once a week). Common Terminology Criteria for Adverse Events, version 3.0 and Response Evaluation Criteria in Solid Tumors were used to evaluate acute adverse effects and short-term therapeutic effect. ResultsA total of 30 patients were enrolled from 2010 to 2013. The median age was 57 years (range 35-66 years). There were 23 patients with postoperative residual or recurrent gastric cancer and 7 with unresectable gastric cancer. Twenty-eight patients received chemotherapy before being enrolled in this study and achieved stable disease or progression. During concurrent chemoradiotherapy, 5 patients (17%) experienced grade 3 acute adverse events, mainly thrombocytopenia (10%). At one month after treatment, the in-field objective response rate and stable disease rate were 43%(complete response 4%, partial response 39%) and 50%, respectively, and the systemic objective response rate and stable disease rate were 32% and 43%, respectively. Conclusions In patients with unresectable, postoperative residual, or recurrent gastric cancer, concurrent chemoradiotherapy with nimotuzumab and capecitabine has good safety, tolerability, short-term therapeutic effect, and in-field control. Clinical Trial Registry ClinicalTrials.gov, registration number:NCT01180166.
. Concurrent chemoradiotherapy with nimotuzumab and capecitabine for patients with unresectable, postoperative residual, or recurrent gastric cancer:a prospective study[J]. Chinese Journal of Radiation Oncology, 2016, 25(5): 457-461.
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