放化疗联合与单独化疗对晚期食管癌生存期影响的比较

Prospective non-randomized study of chemotherapy combined with radiotherapy versus chemotherapy alone in patients with metastatic or relapsed esophageal squamous cell carcinoma

目的探讨放化疗联合与单独化疗对晚期食管癌生存期和疾病进展时间的影响,观察紫杉醇联合顺铂治疗晚期食管癌的近期疗效和不良反应。方法47例晚期和术后转移复发的食管鳞癌患者,应用紫杉醇175 mg/m2静脉点滴,d1;DDP 75 mg/m2静脉点滴,d1;21 d为1个周期。每2个周期评价疗效,将获得CR、PR和SD的患者非随机的分成可测量病灶的放射治疗组(A组)和继续化疗或观察组(B组)。结果入组的47例患者均可评价疗效,其中CR 1例,PR 19例,SD 24例, PD 3例,总有效率(CR+PR)为42.6%(95%CI为0.28～0.58)。A组21例行放疗,中位疾病进展时间(TTP)为10个月,中位生存期为13个月;B组23例行化疗或未再治疗,其中位TTP为5个月,中位生存期11个月,两组差异均有统计学意义(P<0.015,P<0.024)。化疗最常见的不良反应为脱发和骨髓抑制,无Ⅲ度以上不良反应和化疗相关死亡。放疗的不良反应主要为轻度骨髓抑制和乏力,但无中途停止和放疗相关死亡。结论紫杉醇联合DDP化疗后再放疗较单独化疗可延长晚期食管癌患者的生存时间,耐受性好,值得临床深入探讨。

Objective To investigate the time to progression （TTP）and overall survival in patients with previously untreated metastatic or relapsed esophageal squamous cell carcinoma treated with chemotherapy（ paclitaxel plus cisplatin）combined with radiotherapy versus chemotherapy alone, and also to evaluate the efficacy and toxicity of the regimen. Methods In this prospective and non-randomized study, 47 patients with definite measurable lesion and having no previous chemotherapy were enrolled. All patients were treated with paclitaxel 175 mg/m^2 by 2-hour iv infusion on dl and cisplatin 75 mg/m^2 by iv infusion on dl, which were repeated every 21 days. After 2-6 cycles of chemotherapy, those who gained CR, PR or SD werenon - randomly assinged into radiotherapy group （ group A ） or non - radiotherapy group （ group B ） . Results Totally, 47 patients were enrolled into this study, and all of them were valuable for response. One patient achieved complete response （CR）, 19 partial response （PR）, 24 stable disease （SD）, and 3 were found to have disease progression （PD）. The overall response rate of chemotherapy was 42.6% （95% CI, 0.28-0. 58）. Twenty-one of these 47 patients were sequentially treated with radiotherapy. The median survival and TIP was 13 months and 10 months in the group A , versus 11 months and 5 months in the group B （P 〈0.024, P 〈0.015）, respectively. The most common toxicities were neutropenia and alopecia. There were no grade 4 clinical toxicity and treatment-related death in this series. Systemic adverse effects frequently occurred during radiotherapy were esophagitis and fatigue, which were tolerable. Conclusion The combined therapy using chemotherapy（ paclitaxel ＋ cisplatin）followed by radiotherapy is effective, tolerable, and statistically superior to chemotherapy alone in patients with metastatic or relapsed esophageal squamous cell carcinoma.