Phase II trial of fortnightly irinotecan (CPT-11) in the treatment of colorectal cancer patients resistant to previous fluoropyrimidine-based chemotherapy

被引：10

作者：

García-Girón C. ^{[1
]}

Palomo A.G. ^{[2
]}

López C.A. ^{[3
]}

Carbonero A.L. ^{[4
]}

Ureña M.M. ^{[5
]}

Cebrián E.A. ^{[6
]}

Galíndez R.B. ^{[7
]}

Yustos M.A. ^{[8
]}

Gallego J.A. ^{[9
]}

机构：

[1] Servicio de Oncología Médica, Hospital General Yagüe, 09005 Burgos, Avenida del Cid

[2] Servicio de Oncología Médica, Hospital Virgen Blanca, León

[3] Servicio de Oncología Médica, Hospital General de Albacete, Albacete

[4] Servicio de Oncología Médica, Fundación Jiménez Díaz, Madrid

[5] Servicio de Oncología Médica, Hospital de Móstoles, Madrid

[6] Servicio de Oncología Médica, Hospital Virgen de la Luz, Cuenca

[7] Servicio de Oncología Médica, Hospital de Cruces, Baracaldo, Vizcaya

[8] Servicio de Oncología Médica, Hospital Príncipe de Asturias, Alcalá de Henares, Madrid

[9] Servicio de Oncología Médica, Hospital Provincial de Zamora, Zamora

来源：

Clinical and Translational Oncology | 2005年 / 7卷 / 6期

关键词：

5-FU; Colorectal cancer; CPT-11; Fluoropyrimidine; Irinotecan;

D O I：

10.1007/BF02710170

中图分类号：

学科分类号：

摘要：

Introduction. This phase II study investigated the anti-tumour activity and toxicity of CPT-11 (250 mg/m2 i.v. infusion over 60 minutes) administered every 2 weeks as second-line chemotherapy in patients with advanced colorectal cancer (CRC). Material and methods. Patients (n=63) with histology diagnosis of advanced CRC and proven resistance to previous fluoropyrimidine therapy were enrolled. Results. A total of 510 CPT-11 cycles were administered, with a mean of 8 cycles per patient (range: 1-32). The median relative dose intensity was 93%. Partial response (PR) was obtained in 11 patients (17.5%; 95%CI: 8.1%-26.7%) and 29 patients (46.0%) showed stable disease (clinical benefit of 63.5%). The median duration of response was 6.8 months (95%CI: 6.1-7.5 months), median survival was 8.8 months (95%CI: 6.3-11.5 months) and median time to disease progression was 4.5 months (95%CI: 3.9-5.0 months). Overall, this schedule of CPT-11 chemotherapy was well tolerated by the patient. Neutropenia was the most frequent grade 3/4 haematological toxicity (20.6% of patients and 4.1% of cycles). Neutropenia with concurrent fever or infection occurred in 7 patients (11.1%). Late onset diarrhoea was the most frequent grade 3/4 non-ha-ematological toxicity (19.0% of patients and 2.3% of cycles). Other, lower-incidence, toxicities were anaemia, fever, infection, mucositis, nausea and vomiting. There were no toxic deaths. Conclusions. We found that CPT-11, administered as 250 mg/m2 i.v. infusion over 60 minutes every 2 weeks, was active and well tolerated schedule in the second-line chemotherapy of advanced CRC patients. This bi-weekly scheme could be used as an alternative to the weekly or the every-three-we-ek schedule as well as in combined therapies with other chemotherapeutic agents for the treatment of advanced, metastatic, CRC.

引用

页码：244 / 249

页数：5

共 26 条

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