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吉西他滨和顺铂治疗复发性或转移性食管鳞状细胞癌患者的长期结果:一项 II 期试验。

Long-term outcomes of gemcitabine and cisplatin in patients with recurrent or metastatic esophageal squamous cell carcinoma: a phase II trial.

机构信息

Department of Medical Oncology, Cancer Institute & Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100021, China.

出版信息

Chin Med J (Engl). 2011 Dec;124(23):4012-7.

PMID:22340334
Abstract

BACKGROUND

Esophageal cancer is the sixth most common cause of cancer-related death worldwide. Prior studies had demonstrated potential synergistic antitumor activity of gemcitabine in combination with cisplatin. Therefore, we studied the efficacy and tolerability of such combination for esophageal cancer.

METHODS

Between October 2003 and October 2006, thirty-eight patients with metastatic or recurrent advanced squamous cell carcinoma of the esophagus were enrolled. The median number of treatment cycles per patient was 4 (range 1 - 7). Gemcitabine was given at 1000 mg/m(2) over 30 minutes on days 1, 8 and cisplatin 40 mg/m2 was given on days 1, 2 in an every 21-day cycle.

RESULTS

The median follow-up for all 38 patients was 76 months (range 11 - 88 months). The overall response rate was 42.1% (95%CI, 25.5% - 56.5%). Median progression-free survival and median survival for all patients were 4.1 months (95%CI, 3.0 - 5.7 months) and 10 months (95%CI, 7 - 12 months), respectively. Patients with a response had significantly longer median survival compared with the patients without a response (11 months vs. 7.5 months, P = 0.0069). Overall survival at 1 year was 36.8%, at 2 years was 10.5%, and at 5 years was 5.3%. The most common grade 3 - 4 toxicity for all patients was leucopenia (44.7%).

CONCLUSIONS

This cisplatin-gemcitabine regimen was manageable and had significant efficacy in patients with esophageal squamous cell carcinoma. Patients with a response had improved survival time. Furthermore, a small number of the patients with metastatic esophageal cancer were still alive in 5 years with this regimen.

摘要

背景

食管癌是全球第六大常见癌症相关死因。先前的研究表明,吉西他滨联合顺铂具有潜在的协同抗肿瘤活性。因此,我们研究了该联合方案治疗食管癌的疗效和耐受性。

方法

2003 年 10 月至 2006 年 10 月,共纳入 38 例转移性或复发性晚期食管鳞状细胞癌患者。中位治疗周期数为 4 个(范围 1-7 个)。吉西他滨 1000mg/m2,静脉滴注 30 分钟,第 1、8 天;顺铂 40mg/m2,静脉滴注,第 1、2 天,每 21 天为一个周期。

结果

所有 38 例患者的中位随访时间为 76 个月(范围 11-88 个月)。总体缓解率为 42.1%(95%CI,25.5%-56.5%)。所有患者的中位无进展生存期和中位总生存期分别为 4.1 个月(95%CI,3.0-5.7 个月)和 10 个月(95%CI,7-12 个月)。有缓解的患者中位总生存期明显长于无缓解的患者(11 个月 vs. 7.5 个月,P=0.0069)。1 年总生存率为 36.8%,2 年总生存率为 10.5%,5 年总生存率为 5.3%。所有患者最常见的 3-4 级毒性为白细胞减少(44.7%)。

结论

该顺铂-吉西他滨方案治疗食管鳞状细胞癌疗效显著,不良反应可耐受。有缓解的患者生存时间更长。此外,采用该方案治疗转移性食管癌的少数患者在 5 年内仍存活。

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