热疗同CapeOx化疗治疗晚期结直肠癌临床研究

Hyperthermia combined with CapeOx(capecitabine plus oxaliplatin)in the treatment of advanced colorectal cancer

背景与目的:结直肠癌是消化道最常见的恶性肿瘤,其中复发转移是晚期结直肠癌患者致死的主要原因。利用热疗联合CapeOx化疗(卡培他滨联合奥沙利铂)治疗晚期结直肠癌,探索热疗与化疗联合的协同增效作用,以便通过多学科治疗方法进一步提高晚期结直肠癌的临床疗效。方法:采取随机方法将入组晚期结直肠癌病例分成研究组和对照组,研究组接受热疗和CapeOx化疗,对照组给予单纯CapeOx化疗。化疗方案为奥沙利铂130mg/m2,第1天,卡培他滨1000/m2,每天2次,口服连续14d,3周为1个疗程。研究组在化疗的第1、5、10天接受肿瘤局部区域热疗,温度43℃,持续60min。结果:研究组24例晚期结直肠癌患者中PR14例,RR58.3%。对照组29例中PR9例,RR31.0%,两组差异有显著性(P<0.05)。研究组和对照组患者的中位PDF分别为6.5个月(95%CI:4.4～8.6个月)、5.6个月(95%CI:4.6～6.3个月),两组间差异有显著性(P<0.05)。常见不良反应为周围神经异常、胃肠道毒性、手足综合征和白细胞减少,但均较轻微。结论:热疗对CapeOx治疗晚期结直肠癌有协同增效作用,能够提高近期缓解率和延缓疾病进展时间。

Background and purpose： Colorectal cancer is the most common malignant tumor ot dlgestwe tract, recurrence and metastasis in patients with advanced colorectal cancer are the main cause for death. This study was done to explore the synergistic effectiveness between hyperthermia and CapeOx （capecitabine plus oxaliplatin） in the treatment of advanced colorectal cancer. Methods： Patients with advanced colorectal cancer were randomly assigned to study group and control group. In the study group, patients were given hyperthermia and CapeOx, which consisted of capecitabine（1 000 mg/m^2, bid, orally for 14 consecutive days）plus oxalipaltin（130 mg/m^2, day 1）, 3-weeks interval apart to each cycle. On day 1, 5, 10 during the chemotherapy, hyperthermia was given at 43 ℃ for 60 minutes in tumor area. In control group the patients only were only given CapeOx regimen. Results： By intent-to-treat analysis, the response rate was 58%, with 14 partial responses in study group （31%） with 9 partial responses in control group. The median PFS were 6.5 months （95% CI, 4.4-8,6 months） and 5.6 months （95% CI, 4.6-6.3 months）, in study and control group respectively. The difference of partial response and median PFS in two group were statistically significant （P〈0.05）. The common side effects were peripheral nerve abnormalities, gastrointestinal toxicity, hand-foot syndrome and leukocyte reduction, but these side effects were all mild. Conclusion： Hyperthermia combined with CapeOx is an effective regimen for treatment of advanced colorectal cancer with acceptable toxicity. This regimen could enhance the response rate and improve PFS when used in treatment of advanced cancer.