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厄洛替尼联合卡培他滨作为转移性胰腺癌一线治疗的 II 期临床试验(XELTA 研究)。

Phase II trial of erlotinib plus capecitabine as first-line treatment for metastatic pancreatic cancer (XELTA study).

机构信息

Servicio de Oncología Médica, Complejo Hospitalario Universitario de Santiago de Compostela, Travesía de Choupana s/n. 15706 Santiago de Compostela, Spain.

出版信息

Anticancer Res. 2013 Feb;33(2):717-23.

PMID:23393373
Abstract

AIM

To evaluate the efficacy and safety of erlotinib plus capecitabine for metastatic pancreatic cancer.

PATIENTS AND METHODS

This was a multicenter, uncontrolled, phase II trial. Patients with untreated metastatic pancreatic cancer received oral capecitabine at 1,000 mg/m(2) twice daily on days 1-14, of a 21-day treatment cycle; and oral erlotinib at 150 mg daily.

RESULTS

Thirty-two patients were enrolled. The overall response rate (ORR) was 6%, with a median time to treatment failure of 2.1 months. The median follow-up was 7.6 months. The median progression-free survival was 2.1 months and median overall survival was 4.3 months. The one-year survival rate was 22%. Major grade 1 and 2 non-hematological toxicities were skin rash (34%), asthenia (31%) and diarrhea (31%). Grade 3 hematological toxicity was <13%. No grade 4 toxicities were detected. None of the patients died due to treatment toxicity.

CONCLUSION

The combination of capecitabine with erlotinib is an active regimen with a favorable safety profile for patients with metastatic pancreatic cancer.

摘要

目的

评估厄洛替尼联合卡培他滨治疗转移性胰腺癌的疗效和安全性。

患者和方法

这是一项多中心、非对照、Ⅱ期临床试验。未经治疗的转移性胰腺癌患者接受卡培他滨口服,剂量为 1000mg/m2,每日 2 次,第 1-14 天;同时口服厄洛替尼,剂量为 150mg/d。

结果

共纳入 32 例患者。总体缓解率(ORR)为 6%,中位无进展生存期为 2.1 个月。中位随访时间为 7.6 个月。中位无进展生存期为 2.1 个月,中位总生存期为 4.3 个月。1 年生存率为 22%。主要的 1 级和 2 级非血液学毒性为皮疹(34%)、乏力(31%)和腹泻(31%)。3 级血液学毒性<13%。未发生 4 级毒性。无患者因治疗毒性而死亡。

结论

卡培他滨联合厄洛替尼治疗转移性胰腺癌具有较好的疗效和安全性。

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