尼妥珠单抗联合同步放化疗治疗局部晚期食管癌的近期疗效分析

Mass Screening for the Short-term Effects of Nimotuzumab Combined with Synchronal Radio-chemotherapy in the Treatment of Locally Advanced Esophageal Carcinoma

目的:评价尼妥珠单抗联合同步放化疗治疗局部晚期食管癌患者的近期疗效。方法:将65例局部晚期食管癌患者分为3组,单纯放疗组14例;同步放化疗组29例;尼妥珠单抗联合同步放化疗组(联合治疗组)22例。观察近期疗效、治疗不良反应。结果:65例患者中完全缓解7例,部分缓解46例,稳定病情8例,病情进展4例,总有效率81.5%。其中单纯放疗组总有效率57.1%;同步放化疗组总有效率86.2%;联合治疗组总有效率90.9%,仅有2例患者出现Ⅰ度皮疹,1例患者出现Ⅰ度恶心,有2例患者出现轻度血压下降,均未影响治疗。结论:联合治疗组、同步放化疗组的近期有效率高于单纯放疗组,但联合治疗组是否优于同步放化疗还无定论;尼妥珠单抗的近期不良反应小,患者耐受性好。

Objective： To evaluate the short-term, adverse effects of nimotuzumab combined with synchronal radio-chemotherapy in the treatment of locally advanced esophageal carcinoma. Methods： Sixty-five patients, treated in our hospital from January 2010 to January 2011, with inoperable, locally advanced esophageal cancer, were divided into three groups. In the radiotherapy group, 14 patients were treated with radiotherapy alone. Intensity-modulated radiotherapy （IMRT） was conducted, with fractional doses of 1.8 Gy/F to 2.2 Gy/F, five times a week with an overall treatment time of six to nine weeks, and a total dose of 50 Gy to 66 Gy. In the synchronal radio-chemotherapy group, 29 patients were treated with radiotherapy and chemotherapy, using the same radiotherapy regimen as in the radiotherapy group. In addition, the patients were also treated with the TP scheme for two to four cycles, and radiotherapy and chemotherapy were conducted simultaneously. In the group with nimotuzumab combined with synchronal radio-chemotherapy, 22 patients were treated with the same radiotherapy and chemotherapy regimen as in the synchronal radio-chemotherapy group. In addition, the patients were administered 200 mg of nimotuzumab per week, for a total of six to nine times. Short-term adverse effects were monitored. Results： Among the 65 patients, complete remission （CR） was seen in 7, partial remission （PR） in 46, stable disease （SD） in 8, and progressive development （PD） in 4; the total response rate was 81.5%. In Group A （radiotherapy group）, PR was found in 8 cases, SD in 4, and PD in 2; the total response rate was 57.1%. In Group B （synchronal radio-chemotherapy）, CR was found in 3 cases, PR in 22, SD in 2, and PD in 2; the total response rate was 86.2%. In Group C （nimotuzumab combined with synchronal radio-chemotherapy）, CR was found in 4 cases, PR in 16, and NC in 2; the total response rate was 90.9%, and only 2 patients （9.1%） developed a skin rash （grade I ）, 1 patient （4.5%） experienced nausea （grade I ）, 2 patients （9.1%） exhibited a mild lowering of blood pressure, but recovered without treatment. Treatment was not affected in any of these cases. Conclusion： The short-term response rates of patients with locally advanced esophageal carcinoma in Groups B and C are higher than those in Group A. However, whether treatment with nimotuzumab combined with synchronal radio-chemotherapy is more effective than treatment with synchronal radiochemotherapy is uncertain. Nimotuzumab, which has mild side effects, is tolerated well. As the sample size in this study is small, validation using a larger sample size is needed.