今又生联合化疗治疗晚期恶性肿瘤的近期疗效观察

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目的观察今又生(重组人p53腺病毒注射液)联合化学治疗(简称化疗)晚期恶性肿瘤的有效性和安全性。方法选择2009年1月至2010年3月经过病理组织学和/或细胞学证实为晚期恶性肿瘤患者21例,其中男性13例,女性8例;年龄22~73岁,中位年龄53岁。鼻咽癌6例,非小细胞肺癌6例,肝癌3例,胃癌2例,结肠癌2例,直肠癌1例,乳腺癌1例。接受今又生联合化疗的治疗方案。按照实体瘤的疗效评价标准(RECIST)评估患者的近期疗效。用卡氏评分(KPS)评估患者的生活质量,按照WHO抗癌药物毒副作用分级标准评价毒性反应。结果 21例患者中,完全缓解(CR)1例,部分缓解(PR)11例,稳定(SD)6例,疾病进展(PD)3例;客观有效率(RR)为57.1%(12/21),疾病控制率(DCR)为85.7%(18/21)。生活质量改善者有13例(61.9%),生活质量稳定者6例(28.6%),生活质量下降者2例(9.5%)。G3/4毒性主要与化疗有关,包括白细胞减少、恶心、呕吐等。今又生引起的不良反应主要是发热,其中有23.8%(5/21)患者出现Ⅰ度发热反应,38.1%(8/21)患者出现Ⅱ度发热反应。结论今又生联合化疗能够使晚期恶性肿瘤患者获得较好的近期临床疗效,改善患者的生活质量,且毒性低,安性好,但远期疗效仍需观察。 Objective To observe the effectiveness and safety of this new product (Recombinant human p53 adenovirus injection) combined with chemotherapy (referred to as chemotherapy) for advanced malignancies. Methods Twenty-one patients with advanced malignant tumors confirmed by histopathology and / or cytology from January 2009 to March 2010 were selected, including 13 males and 8 females. The median age was 22 to 73 years and the median age was 53 years. 6 cases of nasopharyngeal carcinoma, 6 cases of non-small cell lung cancer, 3 cases of liver cancer, 2 cases of gastric cancer, 2 cases of colon cancer, 1 case of rectal cancer and 1 case of breast cancer. Accept the treatment of this combination of chemotherapy and rehabilitation programs. The patient’s immediate effect was assessed according to the RECIST criteria for solid tumors. The patient’s quality of life was assessed by Kappa’s score (KPS), and the toxicity was evaluated according to WHO classification criteria for toxic side effects of anticancer drugs. Results Among the 21 patients, there were 1 complete remission (CR), 11 partial remission (PR), 6 stable (SD) and 3 progressive disease (PD). The objective response rate was 57.1% (12/21) ), The disease control rate (DCR) was 85.7% (18/21). There were 13 patients (61.9%) with improved quality of life, 6 patients (28.6%) with stable quality of life, and 2 patients (9.5%) with decreased quality of life. G3 / 4 toxicity mainly associated with chemotherapy, including leukopenia, nausea, vomiting and so on. Adverse reactions caused by this newborn were mainly fever, of which 23.8% (5/21) had grade I fever and 38.1% (8/21) had grade II fever. Conclusions The combination of chemotherapy and neoadjuvant chemotherapy can make the patients with advanced malignant tumors get better clinical efficacy in the near future and improve the quality of life of patients with low toxicity and good safety. However, the long-term efficacy still needs to be observed.
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