吉西他滨固定剂量率给药治疗31例晚期恶性肿瘤的临床观察

Clinical observation of gemcitabine administered in the manner of fixed dose rate in advanced malignant tumor patients of 31 cases

目的探讨含吉西他滨"固定剂量率"输注的联合方案治疗恶性肿瘤的疗效及安全性。方法31例经病理或细胞学确诊的晚期恶性肿瘤患者,接受吉西他滨联合铂类方案化疗(其中吉西他滨采用10mg/m2·min速度静脉输注即"固定剂量率"法输注,每21d重复,每例患者至少完成2周期化疗,并评价疗效,每一化疗周期结束后均进行毒性反应评价。结果全组病例总有效率41.9%;临床获益率(CR+PR+SD)74.2%。毒性反应主要为血液学毒性,尤其Ⅲ/IV度血小板减少28.9%(24/83)周期,Ⅲ/IV度白细胞减少占22.9%(19/83)周期。且复治病例Ⅲ/Ⅳ度白细胞、血小板减少发生率明显高于初治病例,统计学有显著性差异(P(0.05)。而非血液学毒性反应发生率较低,程度较轻。结论以吉西他滨"固定剂量率"输注为基础的联合方案治疗晚期恶性肿瘤,方法是可行的,具有较高的近期有效率及临床受益率,非血液学毒性反应较轻,患者耐受性较好,但其血液学毒性较为显著,需引起足够重视,值得进一步研究其临床应用价值。

Objective This study was to investigate the efficacy and toxicities of gemcitabine at a fixed dose rate of 10mg/m^2 per minute infusion combined with platin-based regimens in advanced malignant tumor patients. Methods Total 31 pathologically or cytologically diagnosed patients with malignant tumors were enrolled. The patients were given gemcitabine at a fixed dose rate of 10mg/m^2 per minute infusion on days 1,8,combined with platin-based regimens（cisplatin at a dose of 75mg/m^2 or carboplatin at dose of AUC=5 on days 8） every 21 days. Each patient received at least two cycles chemotherapy with GP regiment. The response was evaluated after two cycles and toxicities were documented after each cycle. Results Of the 31 patients, overall response rate（CR＋PR） was 41.9% and clinical benefit rate （CR＋PR＋SD） was 74.2%. The major side effect was hematological toxicity. The rate of grade Ⅲ/Ⅳ thrombocytopenia and leucocytopenia was 28.9% （24/83）and 22.9% （19/83） in all patients respectively. The rate of grade Ⅲ/Ⅳ thrombocytopenia and leucocytopenia in the refractory patients was higher than that in the newly-diagnosed patients. There was significant statistic difference between them（P 〈 0.05）. But non- hematological toxicity was slight. Conclusion Gemcitabine at a fixed dose rate combined with platin-based regimens is feasible and efficacy scheme in the treatment of advanced malignant tumor patients. Non-hematological toxicity is well-tolerated. But hematological toxicity is distinguished. It makes us be prudent to utilize this regimen. It is worthy to investigate the value of gemcitabine at a fixed dose rate in the future clinical trial.